Category: 3. Business

Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November

Tonmya is the first new FDA-approved medicine for fibromyalgia in more than 15 years

Cash and cash equivalents of $190.1 million reported as of September 30, 2025; current cash runway expected to fund operations into the first quarter of 2027

CHATHAM, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company today announced financial results for the third quarter ended September 30, 2025, and provided an overview of recent operational highlights.

“Following U.S. Food and Drug Administration (FDA) approval of Tonmya™, we are focused on execution of the U.S. launch later this month to bring the first new treatment option for fibromyalgia to patients and clinicians in more than 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We have built the commercial infrastructure, market access capabilities, and brand awareness to position Tonmya for a strong launch and sustainable market presence.”

Dr. Lederman continued, “Turning to our pipeline, we were excited to in-license TNX-4800, a Phase 2-ready, long-acting human monoclonal antibody for the seasonal prevention of Lyme disease, and to announce a collaboration with Massachusetts General Hospital to conduct an investigator-initiated Phase 2 study of TNX-1500 for the prevention of kidney transplant rejection. Our priorities are clear: launch Tonmya successfully, advance our pipeline strategically, and drive sustainable growth that benefits patients and shareholders.”

Commercial Updates

Tonmya (cyclobenzaprine HCl sublingual tablets) 2.8 mg: a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults

• In August, the FDA approved Tonmya, the first new fibromyalgia therapy in more than 15 years.
• In September, the Company established the wholesale acquisition cost (WAC) for Tonmya.
• In October, Tonix announced the commercial launch of Tonmya will commence before the end of November.
• 90 Tonmya sales representatives have been in the field for over a month, in preparation for the November launch.
• Tonix has contracted with its existing wholesalers and specialty pharmacies for the distribution of Tommya.
• Tonix has also contracted with companies to assist with prescription fulfillment and patient access.
• The Company strengthened its commercial organization with the appointment of Ganesh Kamath as Head of Market Access to lead pricing, payer strategy, and reimbursement for the Tonmya launch.

Tosymra^® (sumatriptan nasal spray) 10 mg: approved treatment of acute migraine in adults

• Effective January 1, 2026, Tosymra has preferred exclusive placement on a payer formulary representing approximately 16 million covered lives.

Pipeline Updates

TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg: in development for major depressive disorder (MDD)

• In August, Tonix held a positive Type B Pre-Investigational New Drug (IND) meeting with the FDA regarding TNX-102 SL for MDD.
• In October, the Company filed the IND, and, upon receiving IND clearance, Tonix intends to initiate a Phase 2 study mid-year 2026.

TNX-1500 (dimeric Fc modified anti-CD40L, humanized monoclonal antibody [mAb]): third generation anti-CD40L under investigation for prophylaxis of kidney transplant rejection, with the potential to also be a treatment for autoimmune disorders.

• In October, Tonix presented an update at the Japan Society for Transplantation annual congress, highlighting Phase 1 safety and biomarker results and outlining next steps toward Phase 2 evaluation in allo-transplantation.
• In November, Tonix announced a collaboration with Massachusetts General Hospital to advance a Phase 2 open-label, investigator-initiated, clinical trial of TNX-1500 in kidney transplant recipients in 1H 2026.

TNX-4800 (anti-OspA mAb): long-acting human mAb in development for the prevention of Lyme disease

• In September, Tonix announced in-licensing worldwide rights to TNX-4800, from UMass Chan Medical School. TNX-4800 is a fully human mAb that targets and kills Borrelia burgdorferi inside infected deer ticks when they have bitten treated animals and ingested their blood.
• Adaptive Phase 2/3 study will test whether TNX-4800 protects humans by killing B. burgdorferi inside infected deer ticks when they have bitten treated humans and ingested their blood.
• There are currently no FDA-approved vaccines or prophylactics to protect against Lyme Disease.
• Tonix plans to initiate the adaptive Phase 2/3 study during tick season in 2027.

TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome

• In September, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled trial in 2H 2026 in children and adolescents.
• TNX-2900 has Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval.

Financials

As of September 30, 2025, Tonix had $190.1 million in cash and cash equivalents, compared with $98.8 million as of December 31, 2024. Net cash used in operations was approximately $60.2 million for the nine months ended September 30, 2025, compared to $46.3 million for the same period in 2024.

Based on its current operating plan, the Company believes its cash on hand as of September 30, 2025, together with $34.7 million in net proceeds received from equity offerings during the fourth quarter 2025, will fund planned operating and capital expenditures into the first quarter of 2027.

Third Quarter 2025 Financial Results

Net product revenue for the three months ended September 30, 2025 was approximately $3.3 million, compared to $2.8 million for the same period in 2024; revenue reflected combined net sales of Zembrace^® SymTouch^® (sumatriptan injection) and Tosymra^® (sumatriptan nasal spray). Cost of sales for the three months ended September 30, 2025 was approximately $1.4 million, compared to $1.6 million for the same period in 2024.

Research and development expenses for the three months ended September 30, 2025 were $9.3 million, compared to $9.1 million for the same period in 2024. The increase was predominately due to increased manufacturing expenses of $2.3 million, offset by a reduction in clinical expenses of $2.1 million, as a result of pipeline prioritization period over period.

Selling, general and administrative expenses for the three months ended September 30, 2025 were $25.7 million, compared to $7.7 million in 2024. The increase is predominately due to spending on sales and marketing relating to Tonmya.

Net loss available to common stockholders was $32.0 million, or $3.59 per share (basic and diluted), for the third quarter 2025, compared to a net loss of $14.2 million, or $22.68 per share, for the same period in 2024. The basic and diluted weighted-average common shares outstanding for the third quarter 2025 were 8,922,792, compared to 626,669 for the same period in 2024.

Tonix Pharmaceuticals Holding Corp.*
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for Tonmya^TM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults: Zembrace^® SymTouch^® and Tosymra^®. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

* Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars In Thousands Except Per Share Amounts)
	Three Months Ended September 30,						Nine Months Ended September 30,
		2025			2024			2025			2024
REVENUE:
Product revenues, net	$	3,290		$	2,822		$	7,717		$	7,512
COSTS AND EXPENSES:
Cost of sales		1,367			1,555			5,582			6,582
Research and development		9,289			9,114			27,545			31,675
General and administrative		25,701			7,707			52,007			24,519
Asset impairment charges		–			–			–			58,957
Total operating expenses		36,357			18,376			85,134			121,733
Operating Loss		(33,067	)		(15,554	)		(77,417	)		(114,221	)
Grant income		982						2,941			1,668
(Loss) gain on change in fair value of warrant liabilities		–			1,668			–			6,150
Loss on Extinguishment		–			–			(2,092	)		–
Interest income, net		1,231			18			2,802			21
Interest expense		–			(301	)		(89	)		(954	)
Other expense, net		(1,156	)		(44	)		(3,256	)		(592	)
Net loss available to common stockholders	$	(32,010	)	$	(14,213	)	$	(77,111	)	$	(107,928	)
Net loss per common share, basic and diluted	$	(3.59	)	$	(22.68	)	$	(10.42	)	$	(466.17	)
Weighted average common shares outstanding, basic and diluted		8,922,792			626,669			7,403,400			231,523

TONIX PHARMACEUTICALS HOLDING CORP. CONDENSED CONSOLIDATED BALANCE SHEETS (In Thousands) (Unaudited)
	September 30, 2025				December 31, 20241
Assets
Cash and cash equivalents	$	190,055			$	98,776
Accounts receivable, net		3,481				3,683
Inventory		5,729				8,408
Prepaid expenses and other		8,806				8,135
Total current assets		208,071				119,002
Other non-current assets		44,369				43,888
Total assets	$	252,440			$	162,890
Liabilities and stockholders’ equity
Total liabilities	$	21,297			$	23,332
Stockholders’ equity		231,143				139,558
Total liabilities and stockholders’ equity	$	252,440			$	162,890

¹The condensed consolidated balance sheet for the year ended December 31, 2024 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals 
investor.relations@tonixpharma.com 
(862) 799-8599 

Brian Korb 
astr partners 
(917) 653-5122 
brian.korb@astrpartners.com 

Media Contacts
Mary Ann Ondish
Tonix Pharmaceuticals
maryann.ondish@tonixpharma.com

Ray Jordan 
Putnam Insights 
ray@putnaminsights.com 

INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information.
To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Indication and Usage
Zembrace^® SymTouch^® (sumatriptan succinate) injection (Zembrace) and Tosymra^® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:

• discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded

Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:

• history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
• uncontrolled high blood pressure
• hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
• severe liver problems
• taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
• are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
• an allergy to sumatriptan or any of the components of Zembrace or Tosymra

Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:

• changes in color or sensation in your fingers and toes
• sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
• cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
• increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
• medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
• serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
• hives (itchy bumps); swelling of your tongue, mouth, or throat
• seizures even in people who have never had seizures before

The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Source: Tonix Pharmaceuticals Holding Corp.

Released November 10, 2025

• YUPELRI^® net sales reached an all-time high of $71.4 million, recognized by Viatris, up 15% year-over-year ¹ , and achieved record brand profitability
• Open-label portion of the pivotal Phase 3 CYPRESS study of ampreloxetine now complete; topline readout on track for Q1 2026
• Company to host an ampreloxetine focused virtual Key Opinion Leader (KOL) event for investors on December 8, 2025
• TRELEGY year-to-date sales on track to achieve $50 million milestone in 2025 ²
• Strong balance sheet with $333 million in cash and no debt

DUBLIN, Nov. 10, 2025 /PRNewswire/ — Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) today reported financial and operational results for the third quarter of 2025.

“Theravance delivered strong results in the third quarter, highlighted by record YUPELRI net sales and the achievement of non-GAAP breakeven, underscoring our commitment to financial and operational discipline,” said Rick E Winningham, Chief Executive Officer of Theravance Biopharma. “In parallel, we continue to advance ampreloxetine toward topline results from the pivotal Phase 3 CYPRESS study in the first quarter of 2026. Backed by a strong balance sheet, durable YUPELRI cash flow, and multiple high-value milestones ahead, we approach this important catalyst from a position of strength—ready to deliver results that could transform the standard of care for multiple system atrophy patients and drive lasting value for patients and shareholders.” 

Operational Highlights:

YUPELRI ^® (revefenacin) inhalation solution, the first and only once-daily, nebulized LAMA (long-acting muscarinic antagonist) bronchodilator approved in the U.S. for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD):

• Achieved all-time high U.S. net sales of $71.4 million in Q3 2025, increasing 15% year-over-year (YoY) (Q3 2025 vs Q3 2024)¹ driven by customer demand growth of 6% YoY (Q3 2025 vs Q3 2024)³ and improved net pricing due to favorable channel mix.
• Approximately $54 million required in Q4 2025 to trigger $25 million milestone for the achievement of $250 million of net sales in 2025.⁴
• Increased doses pulled through the hospital channel by 29% YoY (Q3 2025 vs Q3 2024), reflecting another quarter of strong momentum.⁵
• Presented two oral presentations at the 2025 CHEST Annual Meeting that further support YUPELRI as an effective maintenance treatment for patients with COPD.

Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA):

• Completed enrollment in the pivotal Phase 3 CYPRESS trial in August 2025; the open-label portion of the study has now completed, with topline results expected in Q1 2026.
• The Company continues to prepare for an expedited NDA submission and, if data are supportive, is planning to request priority FDA review.
• Theravance to host a virtual KOL event for investors on December 8, 2025, at 10:30 AM ET, featuring Dr. Horacio Kaufmann, M.D.; F. B. Axelrod Professor of Neurology and Professor of Medicine at NYU Grossman School of Medicine. The event will discuss the significant unmet need in patients with nOH due to MSA, ampreloxetine’s potential as a precision medicine approach in these patients, and if data are supportive, the significant commercial opportunity.
• A manuscript titled “Establishing Minimally Clinically Important Differences for the Orthostatic Hypotension Questionnaire (OHQ)” by Kaufmann H, et al. has been published in Clinical Autonomic Research.
• Presented one platform presentation and three poster presentations at the International Symposium on The Autonomic Nervous System. The presentations highlighted the results from the previous REDWOOD trial, where we observed a durable symptomatic nOH benefit with improvement in activities of daily living in the pre-specified subgroup analysis in patients with MSA treated with ampreloxetine.⁶ Additional data was presented on the rigorous methodologies we developed based on previous trials experience to support enrollment and patient retention in the ongoing Phase 3 CYPRESS study.

TRELEGY 

GSK reported third quarter 2025 global net sales of approximately $1.0 billion (up 24% vs. the third quarter of 2024) and year-to-date net sales of approximately $2.9 billion (up 13% vs. 2024 year-to-date):

• On track to exceed full year (FY) 2025 global net sales of ~$3.4 billion required to trigger $50 million milestone from Royalty Pharma.
  • Approximately $471 million of global net sales required in Q4 2025 to trigger the $50 million milestone.
• FY 2026 global net sales of ~$3.5 billion required to trigger an additional $100M milestone from Royalty Pharma.

Disease State Awareness

• Launched a new disease education campaign (www.nOHuncovered.com) for healthcare professionals (HCPs) to raise awareness and deepen scientific understanding of the pathophysiology underlying neurogenic orthostatic hypotension (nOH) associated with Multiple System Atrophy (MSA) in October 2025.

Third Quarter Financial Results

• Revenue: Total revenue for the third quarter of 2025 was $20.0 million, consisting entirely of Viatris collaboration revenue. Viatris collaboration revenue increased by $3.1 million, or 19%, in the third quarter compared to the same period in 2024. The Viatris collaboration revenue represents amounts receivable from Viatris and comprises the Company’s 35% share of net sales of YUPELRI, as well as its proportionate amount of the total shared commercial costs incurred by the two companies. The non-shared YUPELRI costs incurred by Theravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, Theravance Biopharma’s implied 35% share of net sales of YUPELRI for the third quarter of 2025 was $25.0 million which represented a 15% increase compared to the same period in 2024.
• Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2025 were $8.1 million, compared to $9.3 million in the same period in 2024. Third quarter R&D expenses included total non-cash share-based compensation of $1.1 million.
• Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the third quarter of 2025 were $18.3 million, compared to $16.9 million in the same period in 2024. Third quarter SG&A expenses included total non-cash share-based compensation of $3.5 million.
• Share-Based Compensation: Share-based compensation expenses for the third quarter of 2025 were $4.6 million, compared to $5.0 million in the same period in 2024. Share-based compensation expenses consisted of $1.1 million for R&D and $3.5 million for SG&A in the third quarter of 2025, compared to $1.1 million and $3.9 million, respectively, in the same period in 2024.
• Income Taxes: Income tax benefit for the third quarter of 2025 was $6.5 million, compared to a $2.6 million income tax expense in the same period in 2024. The benefit reflects a favorable true-up related to taxes from the $225.0 million TRELEGY royalty sale in Q2 2025.
• Net Income: Net income was $3.6 million in the third quarter of 2025 compared to a net loss of $12.7 million in the same period in 2024. The net income benefited from the income tax benefit as noted above. Excluding the $6.5 million income tax benefit, third quarter net loss would have been $2.9 million.
• Non-GAAP Net Income from Operations⁷: Non-GAAP net income from operations was $2.3 million in the third quarter of 2025 compared to a non-GAAP net loss from operations of $2.9 million in the same period in 2024. See the section titled “Non-GAAP Financial Measures” for more information.
• Cash Position: Cash, cash equivalents and marketable securities totaled $332.7 million as of September 30, 2025.

2025 Financial Guidance 

• Operating Expenses ( excluding share-based compensation) : The Company continues to expect full year 2025 R&D expenses of $32 million to $38 million and SG&A expenses of $50 million to $60 million, in each case excluding share-based compensation.
• Share-Based Compensation: The Company continues to expect full-year share-based compensation expenses of $18 million to $20 million.
• Non-GAAP Net Income from Operations⁷: Achieved breakeven non-GAAP net income in Q3 2025; non-GAAP margin expected to remain at similar breakeven levels in Q4 2025, excluding one-time items, reflecting sustained operating discipline.

Strategic Review Committee

• Theravance Biopharma announced on November 12, 2024, that the Board of Directors had formed a Strategic Review Committee (the “Committee”), composed entirely of independent directors to assess all strategic alternatives available to the Company.
• The Company remains focused on disciplined capital allocation and returning excess cash to shareholders. The Committee will continue to evaluate a range of alternatives to further enhance shareholder value, though there can be no assurance that additional transactions will occur.

Conference Call and Live Webcast Today at 5:00 pm EST

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm EST / 2:00 pm PST / 10:00 pm GMT. To participate in the live call by telephone, please pre-register here. Those interested in the live audio webcast of the conference call may access it by clicking here or visiting the Events and Presentations page under the Investors Section on Theravance Biopharma’s website.

A replay of the webcast will be available on Theravance Biopharma’s website for 30 days through December 10, 2025.

About Ampreloxetine 

Ampreloxetine, an investigational, once-daily, selective norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The unique benefits of ampreloxetine treatment reported in MSA patients from Study 0170 included an increase in norepinephrine levels, a favorable impact on blood pressure, clinically meaningful and durable symptom improvement, and no signal for worsening of supine hypertension. In the U.S., the Company has been granted an Orphan Drug Designation for ampreloxetine for the treatment of symptomatic nOH in patients with MSA and, if results from the ongoing Phase 3 CYPRESS study are supportive, plans to file an NDA for full approval in this indication.

About CYPRESS (Study 0197), a Phase 3 Study

Study 0197 (NCT05696717) has completed enrollment. This is a registrational Phase 3, multi-center, randomized withdrawal study to evaluate the efficacy and durability of ampreloxetine in participants with MSA and symptomatic nOH after 20 weeks of treatment; the primary endpoint of the study is change in the Orthostatic Hypotension Symptom Assessment (OHSA) composite score. The Study includes four periods: screening, open label (12-week period, participants will receive a single daily 10 mg dose of ampreloxetine), randomized withdrawal (eight-week period, double-blind, placebo-controlled, participants will receive a single daily 10 mg dose of placebo or ampreloxetine), and a long-term treatment extension. Secondary outcome measures include change from baseline in Orthostatic Hypotension Daily Activity Scale (OHDAS) item 1 (activities that require standing for a short time) and item 3 (activities that require walking for a short time).

About Multiple System Atrophy (MSA) and Symptomatic Neurogenic Orthostatic Hypotension (nOH) 

MSA is a progressive brain disorder that affects movement and balance and disrupts the function of the autonomic nervous system. The autonomic nervous system controls body functions that are mostly involuntary. One of the most frequent autonomic symptoms associated with MSA is a sudden drop in blood pressure upon standing (nOH).⁸ There are approximately 50,000 MSA patients in the US⁹ and 70-90% of MSA patients experience nOH symptoms.¹⁰ Despite available therapies, many MSA patients remain symptomatic with nOH.¹¹

Neurogenic orthostatic hypotension (nOH) is a rare disorder defined as a fall in systolic blood pressure of ⩾20 mm Hg or diastolic blood pressure of ⩾10 mm Hg, within 3 minutes of standing. Severely affected patients are unable to stand for more than a few seconds because of their decrease in blood pressure, leading to cerebral hypoperfusion and syncope. A debilitating condition, nOH results in a range of symptoms including dizziness, lightheadedness, fainting, fatigue, blurry vision, weakness, trouble concentrating, and head and neck pain.

About Theravance Biopharma 

Theravance Biopharma, Inc.’s focus is to deliver Medicines that Make a Difference^® in people’s lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI^® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational once-daily norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in MSA patients. The Company is committed to creating/driving shareholder value.

For more information, please visit www.theravance.com.

THERAVANCE BIOPHARMA^®, THERAVANCE^® and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries).

YUPELRI^® is a registered trademark of Viatris Specialty LLC. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.

Forward-Looking Statements

This press release will contain certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma, Inc. (the “Company”) intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s expectations regarding its future profitability, expenses and uses of cash, the Company’s goals, designs, strategies, plans and objectives, future growth of YUPELRI sales, future milestone or royalty payments, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, the safety, efficacy or differentiation of our investigational therapy, commercial potential and market opportunity of our investigational therapy, the status of patent infringement litigation initiated by the Company and its partner against certain generic companies in federal district courts, and expectations around the use of OHSA scores as endpoints for clinical trials. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: factors that could increase the Company’s cash requirements or expenses beyond its expectations and any factors that could adversely affect its profitability, whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company’s product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company’s shares, and general economic and market conditions. Other risks affecting the Company are in the Company’s Form 10-Q filed with the SEC on August 13, 2025, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma’s filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma’s results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

Non-GAAP Financial Measures

Theravance Biopharma provides a non-GAAP profitability target and a non-GAAP metric in this press release. Theravance Biopharma believes that the non-GAAP profitability target and non-GAAP net income (loss) provide meaningful information to assist investors in assessing prospects for future performance and actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results and the Company’s cash position. Because non-GAAP financial targets and metrics, such as non-GAAP profitability and non-GAAP net income (loss), are not standardized, it may not be possible to compare these measures with other companies’ non-GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma’s non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company’s actual GAAP results and other targets.

Please see the appendix attached to this press release for a reconciliation of non-GAAP net income (loss) to its corresponding measure, net income (loss). A reconciliation of non-GAAP net income (loss) to its corresponding GAAP measure is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding, and the potential variability of, expenses and other factors in the future.

Contact:
[email protected]
650-808-4045

SOURCE Theravance Biopharma, Inc.

The Dublin, Ohio-based chain said during a conference call with investors Friday that it planned to begin closing restaurants in the fourth quarter of this year. The company said it expected a “mid-single-digit percentage” of its U.S. stores to be affected, but it didn’t give any more details.

Wendy’s ended the third quarter with 6,011 U.S. restaurants. If 5% of those locations were impacted, it would mean 300 store closures.

The new round of closures comes on top of the closure of 240 U.S. Wendy’s locations in 2024. At the time, Wendy’s said that many of the 55-year-old chain’s restaurants are simply out of date.

Ken Cook, Wendy’s interim CEO, said Friday the company believes closing locations that are underperforming – whether it’s from a financial or customer service perspective – will help improve traffic and profitability at its remaining U.S. restaurants.

Cook became Wendy’s CEO in July after the company’s previous CEO, Kirk Tanner, left to become the president and CEO of Hershey Co.

“When we look at the system today, we have some restaurants that do not elevate the brand and are a drag from a franchisee financial performance perspective. The goal is to address and fix those restaurants,” Cook said during a conference call with investors.

Cook said in some cases, Wendy’s will make improvements to struggling stores, including adding technology or equipment. In other cases, it will transfer ownership to a different operator or close the restaurant altogether.

U.S. fast food chains have been struggling to attract lower-income U.S. consumers in the past few years as inflation has raised prices. In the July-September period, Wendy’s said its U.S. same-store sales, or sales at locations open at least a year, fell 5% compared to the same period last year.

Cook said $5 and $8 meal deals — which have been matched by McDonald’s — have helped bring some traffic back to its U.S. stores. But Wendy’s isn’t doing a good job of bringing in new customers, Cook said, so the company plans to shift its marketing to emphasize its value and the freshness of its ingredients.

Wendy’s shares dropped 7% Friday. On Monday, they were down 6% in afternoon trading.

In his annual shareholder letter—the last one he will pen as CEO before Berkshire vice chair Greg Abel takes over on Jan. 1—Buffett suggested chief executives are driven by greed and selfishness to drive up their own pay after seeing competitors ratchet up their own remunerations.

“What often bothers very wealthy CEOs—they are human, after all—is that other CEOs are getting even richer,” he said. “Envy and greed walk hand in hand. And what consultant ever recommended a serious cut in CEO compensation or board payments?”

Buffett’s remarks come on the heels of Tesla investors approving CEO Elon Musk’s record-breaking $1 trillion pay package on Thursday. The compensation package, contingent on the EV company reaching an $8.5 trillion market capitalization, would make the already-world’s-richest-man into the first trillionaire. Musk’s net worth is currently about $449 billion.

The next day, EV competitor Rivian announced a $4.6 billion compensation package for CEO RJ Scaringe over the next decade, modeled after Musk’s plan. The package, which would double Scaringe’s base salary of $2 billion, is also dependent on the automaker reaching certain operating income and cash flow targets over the next seven years.

Tesla and Rivian did not immediately respond to Fortune’s requests for comment.

Buffett, reflecting on 60 years of leading his multi-industry conglomerate, said in his letter that companies’ disclosures of CEO pay was in part an effort to make executives at least a little self-conscious about the amount of money they were earning. However, what was intended as a gesture to humble instead became a contest of superiority.

“During my lifetime, reformers sought to embarrass CEOs by requiring the disclosure of the compensation of the boss compared to what was being paid to the average employee,” Buffett said. “Proxy statements promptly ballooned to 100-plus pages compared to 20 or less earlier. But the good intentions didn’t work; instead they backfired.” 

“Based on the majority of my observations—the CEO of company ‘A’ looked at his competitor at company ‘B’ and subtly conveyed to his board that he should be worth more. Of course, he also boosted the pay of directors and was careful who he placed on the compensation committee,” he added. “The new rules produced envy, not moderation.”

Indeed, compensation packages have swelled extravagantly, climbing 34.7% among the U.S.’s 100 largest low-wage employers from 2019 to 2024, according to an August report from the Institute for Policy Studies. The CEO-to-worker pay ratio similarly ballooned, growing from 560:1 in 2019 to 632:1 last year. Inordinate pay packages have helped make the country’s wealthiest billionaires $698 billion richer this year, per an Oxfam report published this month. Buffett, in contrast, has an annual salary of $100,000 (though his net worth sits at around $150 billion thanks to his investments, making him the 11th richest person on earth).

Other financial giants have spoken out against exorbitant pay packages, Musk’s in particular. Norges Investment Management, the entity behind Norway’s $2 trillion sovereign wealth fund and a 1.14% stakeholder in Tesla, voted against Musk’s compensation plan.

“While we appreciate the significant value created under Mr. Musk’s visionary role,” the group said in a statement last week, “we are concerned about the total size of the award, dilution, and lack of mitigation of key person risk—consistent with our views on executive compensation.”

Following the March 2025 decision by the FDA to expand the indication of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to include adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) who have received an androgen receptor pathway inhibitor (ARPI) for whom a delay of taxane-based chemotherapy is appropriate, key factors such as the nature of disease progression and patient preferences and treatment goals must be carefully weighed to properly identify ideal candidates for this approach, according to Daniel J. George, MD.¹

Radioligand Therapy vs Chemotherapy in mCRPC

• In March 2025, the FDA expanded the indication of lutetium Lu 177 vipivotide tetraxetan to include adult patients with PSMA-positive mCRPC who have received an ARPI and for whom a delay of taxane-based chemotherapy is appropriate.

• Factors to consider when selecting between lutetium Lu 177 vipivotide tetraxetan and chemotherapy in this setting include the nature of disease progression, patient- and disease-related factors, and patient preference.

• Ongoing studies could help define a role for radioligand therapy in earlier prostate cancer settings.

The regulatory decision was based on data from the phase 3 PSMAfore trial (NCT04689828), which showed that patients who received the radioligand therapy achieved a significant radiographic progression-free survival compared with those who transitioned to another ARPI (HR, 0.41; 95% CI, 0.29-0.56; P < .0001). The expanded indication followed the initial March 2022 FDA approval of the agent for the treatment of adult patients with PSMA-positive mCRPC who previously received an ARPI and taxane-based chemotherapy.²

In an interview with OncLive®, George, the Eleanor Easley Distinguished Professor in the School of Medicine, Medicine, Medical Oncology, a professor of Medicine, Medicine, Medical Oncology; and a professor in urology at Duke Health in Durham, North Carolina, discussed which patients he considers for treatment with lutetium Lu 177 vipivotide tetraxetan, the future of radioligand therapy in prostate cancer, and other novel treatment approaches being investigated for patients who experience disease progression on an ARPI-based regimen.

OncLive: What is your approach for treating patients with mCRPC who experience disease progression following an ARPI-based regimen?

George: When patients have metastatic hormone-sensitive prostate cancer [(mHSPC) and are receiving] an ARPI, the prognosis can be quite good in some cases, particularly in those with good prostate-specific antigen [PSA] responses. As the disease progresses into castration-resistant metastatic disease on an ARPI, the clock is ticking.

These are patients who need to be aware, even if they feel well and asymptomatic, that their life expectancy is in that 2-to-3-year range, and it’s not indefinite. The changes are going to come quicker; the need to take on potentially more adverse effects with cytotoxic therapy is going to be greater, and [we need] to recognize that the expectations of therapy are going to be more modest in this setting. With all that said, it’s a spectrum. We have patients who have slow PSA rising and minimal metastatic disease burden on ARPI, for whom we’re going to be comfortable doing a clinical trial of an investigational, unproven agent. We’re going to be comfortable using sipuleucel-T [Provenge] and other types of less immediately cytotoxic therapies.

[Many] patients will have more rapidly progressive disease, higher volume disease, and risk of complications and symptoms. For those patients, using cytotoxic therapy, whether that’s taxane-based therapy or a radioligand therapy, [such as] lutetium Lu 177 vipivotide tetraxetan, is the first major treatment decision.

What are some of the factors you consider when deciding to give chemotherapy or deferring it in favor of radioligand therapy to a patient with mCRPC who is eligible for both treatments?

When I’m addressing a patient at that critical juncture of post-ARPI with disease progression, I’m looking at a couple of things. How is that disease progression? Is it clinical? Is it radiographic? Is it PSA only? Is it a combination of all 3? I’m looking at their tumor volume as well, and at whether the patient is a chemotherapy candidate.

In the real world, a lot of ou r patients are just not good chemotherapy candidates. [Even] if they are, it’s going to come at a physical cost. They [are often] frail and [have] other [comorbidities] that are going to clinically worsen from that chemotherapy. These are the factors that I [use to determine] whether they’re good up-front chemotherapy candidates. If they are willing, starting chemotherapy is a good choice because we know that lutetium Lu 177 vipivotide tetraxetan has an [overall] survival [OS] benefit post-chemotherapy.

We also know that [lutetium Lu 177 vipivotide tetraxetan] has a significant benefit prechemotherapy, and for many of our patients who are not chemotherapy candidates. I use chemotherapy fitness as my first judge, and then it’s patient preference. At the end of the day, they get a voice and this a shared decision. A lot of patients want to put chemotherapy off until they really need to do it, and I’m perfectly comfortable with that. Starting with lutetium Lu 177 vipivotide tetraxetan in the majority of patients is absolutely a reasonable course.

What is your approach to PSMA testing when you are considering using lutetium Lu 177 vipivotide tetraxetan?

[To me, when a patient] has emerging castrate resistance in their disease, that’s the best time to get a PSMA-PET scan. First, it’s our best staging. It’s our most sensitive test for assessing the full extent of the disease, and it gives me peace of mind that there isn’t visceral disease hiding in there. If it is lymph node–only disease, I can feel confident there isn’t [disease] in the bone. Importantly, if there’s oligometastatic disease, if these patients have 1 or 2 areas that are growing but really the rest of the disease is still ARPI responsive, I’ll consider some of these are patients for tumor-directed radiotherapies.

It’s also a theranostic for lutetium Lu 177 vipivotide tetraxetan and I use it as such. It’s important also to be able to gauge at this point in time how ubiquitous and intense that PSMA uptake is. I’m also talking with my nuclear medicine physicians about the scan and their interpretation.

Where do you see the story of radioligand therapy going next within the prostate cancer treatment paradigm?

Lutetium Lu 177 vipivotide tetraxetan has shown us is that there is a role for this therapy throughout the disease continuum, from hormone-sensitive disease all the way through chemotherapy-refractory castration-resistant disease. Not unlike how ARPIs were developed, the goalposts have changed as we move into these other disease spaces.

I’m less worried about being able to see the OS end points as we move earlier and earlier [into new disease settings], because there are so many other things that affect the outcomes in these patients. I’m more interested in the ability to get to minimal residual disease [MRD]. If we think about what our goals are for patients with early mHSPC, historically we’ve [designed] the registrational trials to look at rPFS and OS, but if you talk about our patients, those aren’t necessarily their goals. They want to get to MRD and to get off therapy.

In the future, if radioligand therapies are part of the mix of treatments, whether they be up-front combinations or induction followed by consolidation or maintenance therapy, they may allow us to get patients off treatment—maybe not all patients, but some patients in the metastatic, hormone-sensitive setting. That’s going to be an important aspect of this.

Our goal as patient advocates is ultimately to come up with a combination or sequence of therapies that get us to MRD in the greatest number of patients and ultimately get patients off treatment. If that’s a cure, that’s wonderful, but even a break from therapy for these patients is welcome in order to restore some of their functionality and overall health.

Are there any novel agents being developed for patients with mCRPC that are of particular interest to you?

It’s probably one of the most exciting times in prostate cancer drug development right now. We have more mechanisms to target now than ever before, and what started out as just basically the AR pathway has now expanded to PSMA-targeted approaches—not just radioligands, but potentially antibody-drug conjugates and bispecific antibodies.

Beyond PSMA, we’re seeing evidence for [targeting] KLK2 and STEAP2 [alterations]. We’re getting more targets in prostate cancer, and we’re getting mechanisms to start targeting. Other targets that are drivers of more aggressive forms of prostate cancer, and more androgen-independent forms of prostate cancer are coming into clinic. This is an incredibly important aspect, because before we were limited to what we could target in prostate cancer. We’d get these next-generation sequences and our big list of mutations, and things would be non-actionable.

You’re going to see now more and more actionable targets in that profiling is going to become more and more critical in how we’re treat these patients. That’s going to make the testing and diagnostics all the more important. And I hope you know that today, we can already justify doing that on a systematic level for everybody with advanced prostate cancer, knowing that these therapies are coming.

References

1. FDA expands Pluvicto’s metastatic castration-resistant prostate cancer indication. FDA. March 28, 2025. Accessed November 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-expands-pluvictos-metastatic-castration-resistant-prostate-cancer-indication
2. FDA approves Pluvicto for metastatic castration-resistant prostate cancer. FDA. March 23, 2022. Accessed November 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pluvicto-metastatic-castration-resistant-prostate-cancer?utm_medium=email&utm_source=govdelivery

The S&P 500 climbed 1.3% to claw back three-quarters of its drop from last week, which was its first weekly loss in four. The Dow Jones Industrial Average was up 245 points, or 0.5%, as of 1:15 p.m. Eastern time, and the Nasdaq composite was 2.1% higher.

Nvidia was by far the strongest force lifting the market and rallied 4.8%. It’s a bounceback after Nvidia and other winners in the frenzy around artificial-intelligence technology were at the center of last week’s drop. Critics say their stock prices shot too high and too fast in the mania around AI, drawing comparisons to the 2000 dot-com bubble that ultimately burst.

Taiwan Semiconductor Manufacturing Co., which makes chips for Nvidia and other companies, saw its stock that trades in United States rise 3.1% after reporting that its revenue climbed nearly 17% in October from a year earlier. While such growth is strong compared with other companies, it’s a slowdown from TSMC’s earlier performance.

Another AI darling, Palantir Technologies, jumped 8.9% for the biggest gain in the S&P 500. That helped it recover some of its loss since it delivered a profit report last week that topped analysts’ expectations.

Losses for health insurers helped keep the market’s gains in check, though. They fell as uncertainty remains about whether Washington will extend expiring health care tax credits, a sticking point on Capitol Hill that’s created the longest-ever shutdown for the U.S. government.

That’s even as the Senate took the first steps on Sunday to end the shutdown.

President Donald Trump suggested in a social media post over the weekend that cash being sent to “money sucking” insurance companies should instead go directly to people so they can buy their own health insurance.

Humana fell 3.3%, Elevance Health sank 3.8% and Centene dropped 7.6%.

The effects of the government’s shutdown have become more apparent following the cancellations of thousands of flights over the weekend. Towers are facing shortages as some air traffic controllers — unpaid for weeks — have stopped showing up for work.

Besides the pain at airports, the U.S. government’s shutdown has also delayed important reports on the economy. A resumption could upset financial markets if the released logjam shows data that dashes traders’ expectations for coming cuts to interest rates.

The wide expectation is for the Federal Reserve to continue cutting its main interest rate in hopes of shoring up what has been a slowing job market. Wall Street loves lower interest rates because they can give the economy a boost while also pushing prices for investments upward.

But the Fed has said it may have to halt its cuts if inflation worsens because lower interest rates can give inflation more fuel.

Without updates from the U.S. government on jobs and the economy, traders have instead been trawling profit reports from companies for clues about how things are going.

Tyson Foods climbed 1.6% after the seller of chicken and other proteins reported a stronger profit for the latest quarter than analysts expected. It benefited from increases in prices for its pork and beef of 11% to 17%.

Roughly four out of every five companies in the S&P 500 that have reported their results for the summer have also topped analysts’ profit expectations so far, according to FactSet. Companies usually beat analysts’ estimates each quarter, but the pressure was high this time around because they needed to justify the big moves upward for their stock prices since April.

Delivering bigger profits is one of the easier ways companies can quiet criticism that their stock prices have become too expensive.

Companies have also been giving generally strong forecasts for upcoming results, according to Bank of America strategist Savita Subramanian. That has analysts’ expectations for earnings in 2026 nearly all the way back to where they were before Trump shocked financial markets with his “Liberation Day” announcement of worldwide tariffs in April.

In stock markets abroad, indexes rallied across much of Europe and Asia.

South Korea’s Kospi jumped 3% for one of the bigger gains. Chip company SK Hynix, which is cooperating with Nvidia on artificial intelligence, leaped 4.5%. Its bigger rival, Samsung Electronics, climbed 2.8%.

In the bond market, the yield on the 10-year Treasury edged down to 4.10% from 4.11% late Friday.