Category: 3. Business

• In two replicate Phase 3 studies, upadacitinib (RINVOQ^®) achieved the co-primary endpoints of 50% reduction in Total Vitiligo Area Scoring Index (T-VASI 50) from baseline and 75% reduction in Facial Vitiligo Area Scoring Index (F-VASI 75) from baseline at week 48¹
• Both studies met key ranked secondary endpoints¹

NORTH CHICAGO, Ill., Oct. 29, 2025 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced positive topline results from two replicate Phase 3 studies evaluating the safety and efficacy of upadacitinib (RINVOQ^®;15 mg, once daily  in adult and adolescent patients living with non-segmental vitiligo (NSV).¹ NSV, the most common form of vitiligo (occurring in over 90% of patients), is characterized by symmetrical and bilateral white patches on both sides of the body.^2-4

“Vitiligo is more than a skin condition – it’s a chronic autoimmune disease that can deeply affect a person’s confidence, identity and daily life,” said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. “There are no approved systemic medical therapies for achieving re-pigmentation in vitiligo. These Phase 3 results represent a significant milestone in AbbVie’s commitment to supporting patients and expanding our immunology portfolio to deliver innovative solutions.” 

The Total Vitiligo Area Scoring Index (T-VASI) is a tool that measures the extent of de-pigmentation over the entire body while F-VASI measures de-pigmentation of the face, an area among the most visible and psychosocially impactful for people living with NSV. Across both studies approximately 70% of subjects had T-VASI > 10 at baseline. In both studies, upadacitinib achieved the co-primary endpoints of T-VASI 50 (≥50% reduction from baseline in T-VASI score) and F-VASI 75 (≥75% reduction from baseline in F-VASI score) at week 48 versus placebo. Across both studies, statistically significant differences were observed with upadacitinib versus placebo in key ranked secondary endpoints, including F-VASI 50 at week 48.¹

Key efficacy results are summarized below:

“For many people living with vitiligo, the journey is marked by uncertainty, frustration and a lack of medicines that can treat the disease systemically,” said Thierry Passeron, M.D., Ph.D., professor and chair, Department of Dermatology, Université Côte d’Azur. “These positive results indicate that targeting the underlying inflammation may offer a systemic treatment option which could help patients achieve visible results.”

The safety profile of upadacitinib in both studies was generally consistent with that observed in approved indications. No new safety signals were observed. Across both studies, the most frequent treatment-emergent adverse events (TEAEs) in the 48 weeks upadacitinib treatment groups were upper respiratory tract infection, acne and nasopharyngitis. In study 1, treatment-emergent serious adverse events (TESAEs) occurred in 3.9% and 4% of patients in the upadacitinib 15 mg and placebo groups, respectively.  In study 2, TESAEs occurred in 2% and 1% of patients in the upadacitinib 15 mg and placebo groups, respectively. There were no adjudicated cases of any major cardiovascular event (MACE) or venous thromboembolism (VTE) in the studies. Three malignancy events were reported: one was reported in both placebo groups (1% each) of studies 1 and 2, and one was reported in the upadacitinib 15 mg group (0.5%) in study 1 (genital neoplasm). There were no deaths reported in the upadacitinib treated groups across both studies. There was one death reported in the placebo group in study 2.¹

Use of upadacitinib in NSV is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About Vitiligo  
Vitiligo is a chronic autoimmune disease characterized by the loss of pigment-producing cells (melanocytes), resulting in white patches of skin that can appear anywhere on the body and at any time. It is the most common depigmenting disorder worldwide, affecting approximately 0.5% to 2.3% of the global population. Non-segmental vitiligo (NSV) is the predominant form of the disease, accounting for roughly 84% of cases. NSV typically presents as symmetrical, bilateral patches on both sides of the body. While location varies, many patients report patches on critical areas such as the face, feet, hands and groin. The daily challenges of living with vitiligo can lead to mental health conditions, with a high prevalence of depression and anxiety. 

About Viti-Up Clinical Trials 
Upadacitinib M19-044 was conducted under a single protocol encompassing two replicate Phase 3 studies (Study 1 and Study 2) with independent randomization, investigative sites, data collection, analysis and reporting for each study. The trials were designed to evaluate the efficacy, safety and tolerability of upadacitinib in adult and adolescent patients (ages 12 and older) living with non-segmental vitiligo (NSV) who were eligible for systemic therapy. In Period A of both studies, participants were randomized in a 2:1 ratio to receive either upadacitinib 15 mg once daily or placebo for 48 weeks. Participants who completed Period A were eligible to enter Period B, a 112-week open-label extension in which all patients received upadacitinib 15 mg once daily. In total, Study 1 and Study 2 Periods A and B span 160 weeks. The two trials randomized 614 participants with NSV across 90 sites worldwide. More information on these trials can be found at www.clinicaltrials.gov (NCT06118411). 

The co-primary endpoints were based on the achievement of Total Vitiligo Area Scoring Index (T-VASI) 50, defined as at least 50% reduction in T-VASI from baseline, at week 48, and the achievement of Facial Vitiligo Area Scoring Index (F-VASI) 75, defined as at least 75% reduction in F-VASI from baseline, at week 48 with the treatment of upadacitinib 15 mg compared with placebo in adults and adolescents with NSV. 

The secondary endpoints include the achievement of F-VASI 50, defined as at least a 50% reduction in F-VASI from baseline, at week 48, and the achievement of F-VASI 75, defined as at least a 75% reduction in facial vitiligo area from baseline, at week 24. These endpoints were designed to assess the degree and timing of re-pigmentation on the face, an area among the most visible and psychosocially impactful for people living with NSV. Study 1 also included an analysis using 3D digital imaging to assess facial repigmentation, measured in a subset of the study population.

About RINVOQ^® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. In human leukocyte cellular assays, RINVOQ inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.

RINVOQ (upadacitinib) U.S. Uses and Important Safety Information⁵

RINVOQ is a prescription medicine used to treat:

• Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
• Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated.
• Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
• Adults with giant cell arteritis (GCA).
• Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.
• Adults with moderate to severe Crohn’s disease (CD) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers.

It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn’s disease.

• Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis.

RINVOQ/RINVOQ LQ is a prescription medicine used to treat:

• Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
• Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.

It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis. 

IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib)

What is the most important information I should know about RINVOQ*?

RINVOQ may cause serious side effects, including:

• Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
• Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
• Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP’s advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
• Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
• Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
• Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
• Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting.
• Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.

Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:

• Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of an infection, such as:

• Have TB or have been in close contact with someone with TB.
• Are a current or past smoker.
• Have had a heart attack, other heart problems, or stroke.
• Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
• Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
• Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you’ve been to these types of areas, ask your HCP.
• Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
• Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
• There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110.
• Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

• Medicines for fungal or bacterial infections
• Rifampicin or phenytoin
• Medicines that affect your immune system

If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I avoid while taking RINVOQ?
Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.

What should I do or tell my HCP AFTER starting RINVOQ?

• Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
• Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
  • Discomfort in the center of your chest that lasts for more than a few minutes or that 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
  • Weaknesses in one part or on one side of your body
  • Slurred speech
• Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including:

• Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.

What are other possible side effects of RINVOQ?
Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis).
A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.
Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP.
These are not all the possible side effects of RINVOQ.

How should I take RINVOQ/RINVOQ LQ?
RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP.
*Unless otherwise stated, “RINVOQ” in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ. 

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. 
Please click here for the Full Prescribing Information and Medication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie 
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube. 

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

References:

1. AbbVie. Data on file ABVRRTI82042
2. Ezzedine K, et al. Lancet. 2015;386(9988):74–84
3. Mazzei Weiss ME. Cutis. 2020;105(4):189–90
4. Ezzedine K, Lim HW, Suzuki T, et al. Revised classification/nomenclature of vitiligo and related issues: the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2012;25(3):E1-13
5. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025

Contacts:

 

 

SOURCE AbbVie

Developed in collaboration with Janes, the IBM Defense Model delivers actionable, defense-specific insights in secured environments

Oct 29, 2025

WASHINGTON, Oct. 29, 2025 /PRNewswire/ — IBM (NYSE: IBM) today announced the general availability of the IBM Defense Model, a purpose-built AI model designed to deliver reliable intelligence for defense and national security. Developed together with Janes, a leading provider of open-source defense intelligence, the IBM Defense Model combines IBM’s enterprise-grade AI technology with Janes domain-specific data to empower agencies to make decisions with speed, precision and confidence in secured, mission-critical environments.

Unlike general-purpose large language models, the IBM Defense Model is optimized for defense-specific tasks and deployable in air-gapped, classified, and edge settings. The model aligns with IBM’s focus on smaller fit-for-purpose, open-source AI models and datasets – developed and fine-tuned for specific domains and use cases – that can deliver exceptional value and drive innovation. Built on IBM’s Granite foundation models and delivered via IBM watsonx.ai, the solution supports planning, reporting, and strategy. 

“Defense organizations need AI they can trust – solutions that deliver accurate insights without compromising security or ethics,” said Vanessa Hunt, General Manager, Technology, U.S. Federal Market for IBM. “The IBM Defense Model provides a fit-for-purpose capability that accelerates mission planning and enhances operational readiness, while reinforcing IBM’s commitment to responsible AI.”

Key features and benefits:

• Defense specific training: trained on military doctrine, including Janes data, to understand domain-specific terminology and operational context. Unlike other models, IBM’s approach focuses on teaching the model how to interpret real-time data from trusted sources – like an intelligence analyst – rather than memorizing static datasets. This helps to reduce hallucinations and maintain mission relevance.
• Powered by IBM’s trusted technology: built on IBM’s Granite models, the world’s first open models to achieve ISO 42001 certification for AI governance.
• Secured deployment: supports air-gapped and classified environments for maximum security.
• Continuous intelligence updates: integrated with Janes dynamic defense intelligence data for operational relevance.
• Mission relevant use cases: defense planning, analyst reporting, document enrichment, wargaming, and simulation.

“Our collaboration with IBM brings together Janes trusted defense intelligence and IBM’s advanced AI capabilities,” said Blake Bartlett, CEO for Janes. “This model helps to ensure defense organizations can access timely, relevant insights in secured environments, helping them make informed decisions with confidence.”

The IBM Defense Model is now available. For more information, visit https://www.ibm.com/products/watsonx-ai/defense-model.

About IBM

IBM is a leading provider of global hybrid cloud and AI, and consulting expertise. We help clients in more than 175 countries capitalize on insights from their data, streamline business processes, reduce costs and gain the competitive edge in their industries. Thousands of governments and corporate entities in critical infrastructure areas such as financial services, telecommunications and healthcare rely on IBM’s hybrid cloud platform and Red Hat OpenShift to affect their digital transformations quickly, efficiently and securely. IBM’s breakthrough innovations in AI, quantum computing, industry-specific cloud solutions and consulting deliver open and flexible options to our clients. All of this is backed by IBM’s long-standing commitment to trust, transparency, responsibility, inclusivity and service. Visit www.ibm.com

Media contact

Banks Willis

banks.willis@ibm.com 

SOURCE IBM

Ticker changing from “FI” to “FISV”

MILWAUKEE–(BUSINESS WIRE)–
Fiserv, Inc. (NYSE: FI), a leading global provider of payments and financial services technology, today announced its intention to transfer the listing of its Class A Common Stock (the “common stock”) to Nasdaq from the New York Stock Exchange. The Company expects its common stock to begin trading on the Nasdaq Global Select Market on November 11, 2025 under its original Nasdaq ticker symbol “FISV.”

In addition to its common stock listing, Fiserv will also transfer the listing of seven bonds to Nasdaq.

Bond symbol	Issuer Name	New Bond symbol
FI/28C	Fiserv Funding Unlimited Company 2.875% Senior Notes due 2028	FISV28C
FI/32	Fiserv Funding Unlimited Company 3.500% Senior Notes due 2032	FISV32
FI/36	Fiserv Funding Unlimited Company 4.000% Senior Notes due 2036	FISV36
FI27	Fiserv, Inc. 1.125% Senior Notes due 2027	FISV27
FI30	Fiserv, Inc. 1.625% Senior Notes due 2030	FISV30
FI31	Fiserv, Inc. 3.000% Senior Notes due 2031	FISV31
FI31A	Fiserv, Inc. 4.500% Senior Notes due 2031	FISV31A

About Fiserv Fiserv, Inc. (NYSE: FI), a Fortune 500 company, moves more than money. As a global leader in payments and financial technology, the company helps clients achieve best-in-class results through a commitment to innovation and excellence in areas including account processing and digital banking solutions; card issuer processing and network services; payments; e-commerce; merchant acquiring and processing; and Clover^®, the world’s smartest point-of-sale system and business management platform. Fiserv is a member of the S&P 500^® Index, one of TIME Magazine’s Most Influential Companies™, and one of Fortune^® World’s Most Admired Companies™. Visit fiserv.com and follow on social media for more information and the latest company news.

FI-G

View source version on businesswire.com: https://www.businesswire.com/news/home/20251029726852/en/

For more information contact:

Media Relations:

Melissa Moritz

VP, Corporate Communications

Fiserv, Inc.

+1-516-410-1188

Melissa.Moritz@fiserv.com

Investor Relations:

Julie Chariell

SVP, Investor Relations

Fiserv, Inc.

+1-332-282-2685

Julie.Chariell@fiserv.com

Source: Fiserv, Inc.

Released October 29, 2025

• Ampreloxetine clinical development program to be featured in four presentations at the upcoming International Symposium on The Autonomic Nervous System
• Topline results from the ongoing Phase 3 CYPRESS study of ampreloxetine anticipated in Q1 2026

DUBLIN, Oct. 29, 2025 /PRNewswire/ — Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced that it will be participating at the 36^th International Symposium on the Autonomic Nervous System, organized by the American Autonomic Society (AAS), taking place November 5-8, 2025, in Clearwater Beach, FL. The Company will have one platform presentation and three poster presentations on its clinical development program for ampreloxetine, a potential first-in-class norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) symptoms due to multiple system atrophy (MSA).

“We are excited to have a strong presence at the upcoming International Symposium on the Autonomic Nervous System. Our platform presentation will highlight 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 ampreloxetine¹,” commented Lucy Norcliffe-Kaufmann, Ph.D., Theravance Biopharma’s Executive Director of Clinical Science. “Additionally, we are pleased to share the rigorous methodologies we developed based on our previous trial experience to support enrollment and patient retention. By applying these insights, we were well positioned to successfully address the executional challenges associated with clinical studies in rare and severe neurodegenerative diseases.”

Presentations information and key findings:

Platform presentation: Precision therapy with ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy
Presenter: Lucy Norcliffe-Kaufmann, Ph.D.; Theravance Biopharma’s Executive Director of Clinical Science and Associate Professor, New York University Langone Health Dysautonomia Center
Session date and time: Saturday, November 8, 2025, at 8:30 am ET

The following three posters will be presented at Poster Session II, taking place on Thursday, November 6, 2025, at 7:00-8:30 pm ET:

Poster title: The impact of ampreloxetine on supine hypertension: an ambulatory blood pressure monitoring study
Presenter: Lucy Norcliffe-Kaufmann, Ph.D.; Theravance Biopharma’s Executive Director of Clinical Science and Associate Professor, New York University Langone Health Dysautonomia Center
Poster number: 9

Poster title: Retention strategies in rare disease clinical trials: a case study of symptomatic treatment for multiple system atrophy
Presenter: Molly Szpyhulsky, MBA, BSN, RN; Theravance Biopharma U.S.
Poster number: 15

Poster title: Enrollment strategies in a phase III trial for MSA-related nOH: insights from global investigators
Presenter: Molly Szpyhulsky, MBA, BSN, RN; Theravance Biopharma U.S.
Poster number: 10

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 US, 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 the Phase 3 CYPRESS (Study 0197) Study
The CYPRESS Study (NCT05696717) 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 the Phase 3 SEQUOIA (Study 0169) and REDWOOD (Study 0170) Studies  
Study 0169 (NCT03750552) was a Phase 3, 4-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ampreloxetine compared to placebo in patients with symptomatic nOH (n=195). Patients from Study 0169 were eligible to enter into Study 0170 (NCT03829657), a Phase 3, multi-center, 22-week study comprising a 16-week open-label period and a 6-week double-blind, placebo-controlled, randomized withdrawal period to evaluate the sustained benefit in efficacy and safety of ampreloxetine in patients with symptomatic nOH. The primary endpoint for Study 0170 of treatment failure at week 6 was defined as a worsening of both Orthostatic Hypotension Symptom Assessment Scale (OHSA) question #1 and Patient Global Impression of Severity (PGI-S) scores by 1.0 point. After Study 0169 did not meet its primary endpoint, the Company took actions to close out the ongoing clinical program including Study 0170. The study was more than 80% enrolled (n=128/154 planned) despite stopping early. The primary endpoint was not statistically significant for the overall population of patients, which included patients with Parkinson’s disease, pure autonomic failure and MSA (odds ratio=0.6; p-value=0.196). The pre-specified subgroup analysis by disease type suggests the benefit seen in patients receiving ampreloxetine was largely driven by MSA patients (n=40). An odds ratio of 0.28 (95% CI: 0.05, 1.22) was observed in MSA patients indicating a 72% reduction in the odds of treatment failure with ampreloxetine compared to placebo. The benefit to MSA patients was observed in multiple endpoints including OHSA composite, Orthostatic Hypotension Daily Activities Scale (OHDAS) composite, Orthostatic Hypotension Questionnaire (OHQ) composite and OHSA #1.¹ 

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).² There are approximately 50,000 MSA patients in the US³ and 70-90% of MSA patients experience nOH symptoms.⁴ Despite available therapies, many MSA patients remain symptomatic with nOH.⁵

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 disorder, 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 royalty payments, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation 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; contingent payments due to the Company from the sale of the Company’s TRELEGY ELLIPTA royalty interests to Royalty Pharma, 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.

Contact:
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¹ Freeman R, et al. Precision therapy with ampreloxetine for neurogenic orthostatic hypotension in multiple system atrophy. MedRxiv. https://www.medrxiv.org/content/10.1101/2025.08.12.25332833v1.
²https://medlineplus.gov/genetics/condition/multiple-system-atrophy/
³ UCSD Neurological Institute (25K-75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Stroke (15K-50K).
⁴ Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999).
⁵ Data on file. MSA Natural History Statistics, NYU September 2019.

SOURCE Theravance Biopharma, Inc.