Category: 3. Business

Samsung Electronics is expected to report a 39% drop in second-quarter operating profit on Tuesday, as delays in supplying high-bandwidth memory chips to Nvidia (NVDA, Financials) drag down the company’s artificial intelligence business.

The South Korean tech giant is forecast to post operating profit of 6.3 trillion won ($4.62 billion) for the AprilJune quarter. That would mark Samsung’s lowest quarterly profit in six periods and a sharp decline from 10.4 trillion won a year earlier.

The setback comes as competitors SK Hynix and Micron Technology (MU, Financials) benefit from a surge in demand for HBM chips used in AI data centers. Unlike its rivals, Samsung’s gains have been limited due to U.S. restrictions on chip sales to China and delays in getting Nvidia certification for its HBM3E 12-high chips.

HBM revenue likely remained flat in the second quarter, as China sales restrictions persist and Samsung has yet to begin supplying its HBM3E 12-high chips to Nvidia, said Ryu Young-ho, senior analyst at NH Investment & Securities.

Samsung had said in March that meaningful progress could come by June, but it has declined to confirm whether the chips have passed Nvidia’s qualification process. However, U.S.-based Advanced Micro Devices (AMD, Financials) said last month that Samsung has started supplying the chip to it.

While chip earnings are under pressure, Samsung’s smartphone sales are expected to remain firm, with some buyers stockpiling ahead of potential U.S. tariffs. President Donald Trump has proposed a 25% duty on smartphones not made in the United States, with a July 9 deadline for reciprocal trade tariffs across multiple countries.

Adding to the uncertainty, the U.S. is also considering revoking authorizations that currently allow Samsung and other chipmakers to receive U.S. technology for their factories in China.

Samsung shares have risen about 19% this year but remain the weakest performer among major memory chipmakers, trailing the broader KOSPI index’s 27.3% gain. As of 0447 GMT on Monday, Samsung shares were down 1.9% compared with a 0.3% rise in the KOSPI.

Samsung will announce official second-quarter results on Tuesday.

This article first appeared on GuruFocus.

Investigational triplet regimens containing venetoclax (Venclexta) demonstrated clinical efficacy among patients with IDH-mutated acute myeloid leukemia (AML) who are ineligible to receive intensive chemotherapy, according to findings from a pair of phase 1b/2 trials (NCT03471260; NCT04774393) published in Journal of Clinical Oncology.¹

Among all evaluable patients (n = 60), the composite complete remission (CRc) rate was 92%, and the objective response rate (ORR) was 95%. Additionally, data showed a median time to first response and best response of 27 days and 61 days, respectively.

Among those with IDH1-mutated disease (n = 37), the CRc rate was 86%, and the minimal residual disease (MRD) negativity rate was 81%; these respective rates were 100% and 95% among patients with IDH2 mutations (n = 23). The CRc rate was 71% in patients with treated-secondary AML (tsAML; n = 17) compared with 98% among those with non-tsAML (n = 43).

Data showed a median overall survival (OS) that was not reached (NR; 95% CI, 31.3-NR) in patients with IDH1 mutations vs 35.2 months (95% CI, 14.2-NR) among those with IDH2 mutations; the 2-year OS rates were 73% and 65%, respectively. Additionally, the median event-free survival (EFS) in each group was NR (95% CI, 36.8-NR) vs 26.5 months (95% CI, 11.0-NR), with respective 2-year EFS rates of 72% vs 60%. The 2-year cumulative incidence of relapse (CIR) was 24% (95% CI, 0%-43%) in the IDH1-mutated subgroup and 24% (95% CI, 0%-46%) in the IDH2-mutated subgroup.

In the non-tsAML and tsAML populations, respectively, the median OS was NR (95% CI, NR-NR) vs 10.9 months (95% CI, 7.8-NR), and the 2-year OS rates were 84% and 34%. Additionally, the median EFS was NR (95% CI, 36.8-NR) and 7.7 months (95% CI, 4.8-NR) in each group, with respective 2-year EFS rates of 79% and 34%. At 2 years, the CIR rate was 20% (95% CI, 0%-36%) vs 38% (95% CI, 0%-65%).

“In summary, these data demonstrate excellent outcomes of IDH-triplet therapy in the treatment of newly diagnosed, [intensive chemotherapy]–ineligible IDH-mutant AML. Enrollment on these trials is ongoing…with expansion to additional clinical sites to augment enrollment and confirm generalizability among academic settings,” lead study author Courtney D. DiNardo, MD, MSCE, from the Department of Leukemia at The University of Texas MD Anderson Cancer Center, wrote with coauthors.¹ “Prospective studies comparing IDH-triplet versus IDH-doublet regimens are warranted.”

In one of the investigator-initiated phase 1b/2 trials, patients were assigned to receive venetoclax orally each day on days 1 to 14; oral ivosidenib (Tibsovo) daily on days 15 to 28 of the first cycle, followed by days 1 to 28 of each subsequent cycle; and azacitidine (Vidaza) intravenously or subcutaneously on days 1 to 7 of 28-day cycles.² Treatment persisted until disease progression or unacceptable toxicity. This trial only included patients with IDH1-mutated AML.

In the other trial, patients received oral decitabine/cedazuridine on days 1 to 5, oral venetoclax on days 1 to 14, and oral ivosidenib or oral enasidenib (Idhifa) on days 1 to 28 of 28-day cycles for 12 cycles or until disease progression or unacceptable toxicity.³ Patients with IDH1 mutations received ivosidenib as part of their regimen, while those with IDH2 mutations received enasidenib.

The dual primary end points of both trials were the safety and efficacy of the combination regimens. Investigators evaluated efficacy based on CRc within the first 5 cycles of study treatment. Other end points included OS, EFS, CIR, and DOR.

The median patient age was 71 years (range, 62-87), and most patients were White (92%). Of note, most patients had de novo AML (58%), adverse-risk disease per European Leukemia Network (ELN) 2022 criteria (78%), favorable-risk disease per ELN 2024 guidelines (72%), and IDH1 mutations (63%).

The median number of treatment cycles was 5 (range, 1-52), and the most common reasons for treatment discontinuation included stem cell transplant (49%), relapse (23%), patient choice (10%), lack of response (8%), and death (5%). Among patients in remission, 16% and 12% required red cell transfusions and platelet transfusions, respectively.

Any-grade nonhematologic adverse effects (AEs) occurred in 77% of patients, the most common of which included infections (42%), hyperbilirubinemia (27%), diarrhea (20%), and transaminitis (15%). Grade 3 or higher AEs affected 43% of patients and included hyperbilirubinemia (5%), differentiation syndrome (3%), diarrhea (2%), and transaminitis (2%).

References

1. DiNardo CD, Marvin-Peek J, Loghavi S, et al. Outcomes of frontline triplet regimens with a hypomethylating agent, venetoclax, and isocitrate dehydrogenase inhibitor for intensive chemotherapy–ineligible patients with isocitrate dehydrogenase–mutated AML. J Clin Oncol. Published online June 13, 2025. doi:10.1200/JCO-25-00640
2. Ivosidenib and venetoclax with or without azacitidine in treating patients with IDH1 mutated hematologic malignancies. ClinicalTrials.gov. Updated April 23, 2025. Accessed July 7, 2025. https://tinyurl.com/59ndw64d
3. Decitabine/​cedazuridine and venetoclax in combination with ivosidenib or enasidenib for the treatment of relapsed or refractory acute myeloid leukemia. ClinicalTrials.gov. Updated June 3, 2025. Accessed July 7, 2025. https://tinyurl.com/42rkyns4

Europe’s car industry could return to producing 16.8 million cars a year – equal to its post-2008 crisis peak – if the EU maintains its 2035 clean cars target and strengthens industrial and demand policies, a new study finds. That would result in automotive value chain jobs being kept at today’s numbers, according to the report published today by green group T&E.

The report modelled the impact of maintaining the EU’s 2035 zero-emission goal and implementing new industrial policies to boost domestic EV production such as electrification targets for corporate fleets and support for made-in-EU cars and batteries. In that scenario, the automotive value chain’s contribution (Gross Value Added) to the European economy would increase by 11% by 2035 compared to today.

Batteries and charging

Job displacement in vehicle manufacturing could be offset by the creation of more than 100,000 new jobs in battery-making by 2030 and 120,000 in charging by 2035, the study finds. The EU could produce up to 900 GWh of batteries a year (currently 187 GWh) by 2030 if it stands by its zero-emission target and implements supportive industrial strategies. The economic output of the charging sector could increase almost fivefold to €79 billion by 2035.

But weakening the zero-emission goal – as EU lawmakers are under pressure to do – and failing to put in place comprehensive industrial policies could see the European automotive value chain’s contribution to the economy decline by €90 billion by 2035, the report finds. There could be a loss of up to 1 million jobs compared to today. Up to two-thirds of planned battery investments in the EU could also be lost while the charging industry would be deprived of €120 billion in prospective revenue over the next 10 years.

Julia Poliscanova, Senior Director for Vehicles & Emobility Supply Chains at T&E, said: “It’s a make or break moment for Europe’s automotive industry as the global competition to lead the production of electric cars, batteries and chargers is immense. Europe’s success hinges on the road that EU politicians take today. Keeping the 2035 zero-emissions goal alongside adopting strong industrial and demand policies is the EU’s best chance to return to greater car production, maintain job levels and increase the economic value of its auto industry.”

T&E said the EU needed to prioritise electric car industrial leadership across its climate and industrial policies if it’s to maintain the automotive sector’s economic contribution and job levels and to maximise new investment and jobs in the battery and charging sectors. That includes:

1. Maintaining the 2030-2035 car CO₂ targets in the upcoming regulatory review, flanked by EU-wide measures to support demand.

2. Introducing production aid for EV batteries in both EU and national funding streams, alongside incentives to source EU-made components and materials.

3. Implementing the EU Alternative Fuels Infrastructure Regulation and electricity market reforms and grids action plans to speed up charger roll-out and grid connections and permitting.

4. Mainstreaming social conditionality for quality jobs, and strengthening technology and skills transfer provisions in foreign direct investment.

Three industry associations reviewed the report and support its high-level message on the economic and employment potential of Europe’s electric vehicle transition – which requires both stable targets and stronger industrial and demand policies – without endorsing all aspects of the report:

Chris Heron, Secretary General of E-Mobility Europe, said: “There are hundreds and thousands of new jobs still for Europe to seize in its electric vehicle transition, but only through political courage and decisiveness. The global race for electric car leadership is already underway, and we can’t let other regions get out of reach. Europe needs to keep the conviction of its 2035 target to guide investment into electric vehicles, batteries, materials, and charging. But it also needs a tangible step up in its industrial and demand policies, to prove to companies it really means business.”

Ilka von Dalwigk, Director General of RECHARGE, said: “This study echoes what industry leaders have long cautioned: Europe risks losing one of the most strategic sectors of the green transition. The EU’s questioning of the 2035 target and its lack of effective support schemes for battery production endangers one of the most important cleantech industries. This study confirms that if we move on these quickly, we can secure hundreds of gigawatt-hours of locally-made, clean batteries.”

Lucie Mattera, Secretary General of ChargeUp Europe, said: “The energy transition is a catalyst for Europe’s competitiveness – driving innovation, investment, and new opportunities. The charging infrastructure sector plays a key role in this transformation and is on track to create long-term value and a range of quality jobs across the continent. To fully realise this potential, stable and predictable regulatory conditions such as the 2035 target are essential.”

About T&E

T&E is Europe’s leading advocate for clean transport and energy. The non-profit organisation wants to change the way transport is powered, accelerating the transition through zero-emission mobility and energy systems that are affordable and have minimal impacts on our health, climate and environment.

About E-Mobility Europe

E-Mobility Europe is the voice for Europe’s collective electric vehicle ecosystem (formerly AVERE), with a membership including national EV associations, vehicle manufacturer, supply chain, fleet owners, and technology providers. E-Mobility Europe advocates for Europe’s successful transition to electric vehicles, in a way that benefits both the region’s people and its industries.

About RECHARGE

RECHARGE is the European industry association for advanced rechargeable and lithium batteries. Founded in 1998, it is our mission to promote advanced rechargeable batteries as a key technology that will contribute to a more empowered, sustainable and circular economy by enabling decarbonised electricity and mobility, and cutting-edge consumer products. RECHARGE’s unique membership covers all aspects of the advanced rechargeable battery value chain: From suppliers of primary and secondary raw materials, to battery and original equipment manufacturers (OEMs), to logistic partners and battery recyclers.

About ChargeUp Europe

ChargeUp Europe is the industry association for the electric vehicle (EV) charging infrastructure sector. Our association works to accelerate the switch to zero emission mobility and ensure that EV drivers can enjoy a seamless charging experience with access to high quality, readily available charging infrastructure across Europe. As of today, our member companies are active in all 27 EU Member States, the UK and EFTA.

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RelativityOne users in five more countries will be empowered with enhanced document review and privilege identification capabilities

CHICAGO, July 7, 2025 /PRNewswire/ — Relativity, a global legal technology company, today announced that two of its generative AI solutions, Relativity aiR for Review and Relativity aiR for Privilege, will now be made available to all RelativityOne instances located in Hong Kong, India, Japan, Singapore and South Korea. Expanding on its previous availability, legal, investigation, and compliance teams in Asia will be equipped with the generative-AI powered document review solution and privilege review solution to help navigate the full spectrum of legal data challenges while reaping the benefits of better infrastructure and privacy.

“Asia’s diverse legal landscape presents unique and evolving challenges, and legal teams across the region need technology that can keep pace,” said Chris Brown, Chief Product Officer at Relativity. “Whether it be for litigation, regulatory responses, or internal investigations, Relativity aiR products provide the necessary features to manage large volumes of data more effectively. As adoption grows across the globe, and real-world use cases continue to demonstrate impact, Relativity’s customers and partners can feel confident in the power and practicality of AI in their workflows.”

Enhancing the capabilities of legal teams across Asia with intelligent tools

Customers and partners in five additional countries will now be able to leverage aiR for Review and aiR for Privilege to deliver exceptional efficiency and accuracy in document and privilege review. This regional expansion underscores Relativity’s commitment to providing innovative solutions that align with the evolving needs of legal professionals in Asia and across the globe.

“Customers in Asia are facing a perfect storm — small teams, complex and diverse data sources, multilingual review, and constant pressure from clients to cut costs,” said Stuart Hall, Principal at Control Risks. “The launch of Relativity aiR in Asia couldn’t be more timely, offering Control Risks’ customers a real opportunity to simplify and streamline cross-border investigations and disputes with smarter tools and workflows.”

The introduction of Relativity aiR products in Asia is bolstered by the region’s growing demand for secure, scalable legal technology. Built within RelativityOne, these AI tools allow firms to harness the power of automation without compromising security or performance. By operating in a cloud-native environment, legal and compliance teams can eliminate the burden of managing physical infrastructure, standardize workflows across jurisdictions and redirect resources toward strategic analysis.

In response to the growing volume of investigative matters, organizations will be able to utilize aiR for Review to support a wide range of use cases beyond litigation — including internal investigations into fraud, bribery, corruption and whistleblower complaints. Legal and compliance teams can also rely on the tool for Know Your Customer (KYC) reviews, cross-border data transfer assessments and anti-money laundering efforts. Its versatility extends even further, supporting M&A due diligence, risk assessments, trade secret theft inquiries, white-collar investigations and HR-related matters.

For organizations concerned with data protection, Relativity’s cloud-native products, including aiR, offer peace of mind with enterprise-grade security and privacy controls. Backed by the company’s in-house security team, Relativity embeds protection into every stage of its product lifecycle. This security-first approach ensures that as firms adopt cutting-edge AI tools, their information is properly safeguarded.

Looking ahead, Relativity remains focused on empowering users through innovation, delivering rich insights and addressing their most pressing needs. In the coming months, new capabilities will be introduced within aiR for Review and aiR for Privilege. One upcoming enhancement is aiR for Review’s prompt kickstarter capability, which will greatly reduce manual work related to prompt criteria development. Soon, users will be able to upload case background documents — such as review protocols or disclosure requests—and an expert prompt that drives aiR for Review will automatically be produced, allowing users to accelerate analyses. This feature produces a comprehensive matter overview, including key people, organizations, term descriptions and relevance criteria. From there, teams can refine prompts as needed, accelerating the review process and enabling practitioners to take immediate action.

Additionally, aiR for Privilege users will soon be able to find privileged content faster by automating context building that the AI uses to make decisions. Furthermore, a brand-new entity classifier will more accurately identify and classify the entities within each case. This enhancement will help better identify and define the roles of individuals and organizations in a matter, improving precision and efficiency in privilege review.

Unlocking new possibilities for innovation

To achieve their goals with greater precision and reduced overhead, more than 200 customers have embraced aiR for Review, while over 140 have chosen aiR for Privilege to support their workflows. The scalability and transparent natural language reasoning of this industry-leading technology help customers secure faster results while uncovering deeper insights from data.

KordaMentha, an independent and trusted advisory and investment firm working across industries throughout Australia and Asia Pacific, has transformed its legal discovery approach since adopting aiR for Review. The solution has surfaced insights that conventional methods would have overlooked entirely. A recent case study highlights how aiR for Review enabled a defensible and comprehensive review under a tight disclosure deadline, in total saving 25+ days and reducing costs by 85%. With subject matter experts leading the process, KordaMentha was able to uncover several unanticipated findings that drove organizational change.

“Whether as a renowned center for international arbitration, a market with extensive regulatory and investigative demands, or a source of exponential data growth, Asia is a dynamic region uniquely suited to Relativity’s aiR suite,” said Roman Barbera, Partner at KordaMentha. “Building on RelativityOne’s proven ability to navigate diverse languages and data types, aiR delivers exceptional scalability and insight. We’re excited to deploy this trusted and secure AI solution in a region where KordaMentha is already deeply embedded, and where the need for fast, intelligent and defensible data analysis continues to grow.”

In addition to the current aiR product availability, Relativity aiR for Case Strategy, a cutting-edge solution that makes it faster and simpler for litigation attorneys to extract facts, craft case narratives and prepare for depositions and trial, is currently in limited general availability and is expected to become generally available to all regions with access to aiR products later this year.

For more information about the expansion of aiR availability in Asia, please register for the webinar “Transforming Legal Work in Asia: Introducing Relativity aiR for Review and aiR for Privilege,” taking place on July 22. The webinar will offer a first-hand look at aiR for Review and aiR for Privilege through live demonstrations and real stories from early adopters who’ve already transformed their practices. Request a demo from the Relativity team here.

About Relativity
Relativity makes software to help users organize data, discover the truth and act on it. Its SaaS product, RelativityOne, manages large volumes of data and quickly identifies key issues during litigation and internal investigations. Relativity has more than 300,000 users in approximately 40 countries serving thousands of organizations globally primarily in legal, financial services and government sectors, including the U.S. Department of Justice and 198 of the Am Law 200. Please contact Relativity at [email protected] or visit www.relativity.com for more information.

Media Contact: [email protected]

Logo – https://mma.prnewswire.com/media/445801/new_Relativity_logo_Logo_v2.jpg 

The maternity fashion retailer Seraphine, whose clothes were worn by the Princess of Wales during her three pregnancies, has ceased trading and entered administration.

Consultancy firm Interpath confirmed to the BBC on Monday that it had been appointed as administrators by the company and that the “majority” of its 95 staff had been made redundant.

It said the brand had experienced “trading challenges” in recent times with sales being hit by “fragile consumer confidence”.

The fashion retailer was founded in 2002, but perhaps hit its peak when Catherine wore its maternity clothes on several occasions, leading to items quickly selling out.

Prior to the confirmation that administrators had been appointed, which was first reported by the Financial Times, Seraphine’s website was offering discounts on items as big as 60%. Its site now appears to be inaccessible to shoppers.

The main job of administration is to save the company, and administrators will try to rescue it by selling it, or parts of it. If that is not possible it will be closed down and all its saleable assets sold.

Will Wright, UK chief executive of Interpath, said economic challenges such as “rising costs and brittle consumer confidence” had proved “too challenging to overcome” for Seraphine.

Interpath said options are now being explored for the business and its assets, including the Seraphine brand.

The retailer’s flagship store was in Kensington High Street, London, but other well-known shops, such as John Lewis and Next, also stocked its goods.

The rise in popularity of Seraphine, driven in part by Royalty wearing its clothes, led to the company listing on the London Stock Exchange in 2021, before being taking back into private ownership in 2023.

Interpath said in April this year, the company “relaunched its brand identity, with a renewed focus on form, function and fit”.

“However, with pressure on cashflow continuing to mount, the directors of the business sought to undertake an accelerated review of their investment options, including exploring options for sale and refinance,” a statement said.

“Sadly, with no solvent options available, the directors then took the difficult decision to file for the appointment of administrators.”

Staff made redundant as a result of the company’s downfall are to be supported making claims to the redundancy payments service, Interpath added.

The first half of 2025 marked a dynamic period in pulmonology, with major FDA milestones, promising trial readouts, and continued momentum in precision medicine for respiratory conditions. Most notably, the FDA granted landmark approval to mepolizumab as the first biologic for eosinophilic COPD, signaling a shift toward more targeted treatment for a challenging COPD phenotype. Other regulatory progress included FDA acceptance of a gene therapy BLA for recurrent respiratory papillomatosis, an ultrarare disease with no approved treatments, and encouraging steps toward new therapies for pulmonary arterial hypertension and progressive pulmonary fibrosis.

Meanwhile, clinical pipelines produced a mix of breakthroughs and setbacks. Positive results for TPIP and brensocatib suggested new hope for patients with PAH and bronchiectasis—2 historically underserved populations. Nerandomilast also showed statistically significant benefit in progressive pulmonary fibrosis, potentially expanding options for this debilitating disease. However, tezepelumab failed to meet its endpoint in a COPD trial, underscoring the complexity of inflammation-driven phenotypes.

Check out this H1 2025 pulmonology month in review for a recap of HCPLive’s coverage of the top pulmonology news and research from the past few months:

Regulatory Actions in H1 2025

FDA Approves Mepolizumab for Eosinophilic COPD

On May 22, the FDA has approved mepolizumab (Nucala) as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype. In the phase 3 MATINEE trial, mepolizumab demonstrated a statistically significant and clinically meaningful 21% reduction in the annualized rate of moderate or severe exacerbations (0.80 events per year) compared to placebo (1.01 events per year; rate ratio, 0.79; 95% CI, 0.66 to 0.94; P = .01), successfully meeting the primary endpoint.

Related content: Expanding Precision Medicine in COPD With Mepolizumab, with Frank Sciurba, MD

FDA Accepts BLA for PRGN-2012 for Recurrent Respiratory Papillomatosis

On February 25, the FDA accepted Precigen, Inc.’s BLA for PRGN-2012 (zopapogene imadenovec), an investigational gene therapy targeted for adults with recurrent respiratory papillomatosis (RRP), a rare disease that requires repeated surgeries with no current therapeutic alternative. A Prescription Drug User Fee Act (PDUFA) action date of August 27, 2025, was set, with no plans to hold an advisory committee meeting.

H1 Data Readouts

Merck Halts Phase 3 HYPERION Trial of Sotatercept for Final Analysis

On January 30, Merck halted the Phase 3 HYPERION trial evaluating sotatercept-csrk (WINREVAIR) versus placebo in adults with recently diagnosed PAH and plans to proceed with the final analysis. Merck indicated the decision to stop HYPERION before its scheduled end date was based on positive data from the interim analysis of ZENITH and an overall review of data from the sotatercept clinical trial program.

Tezepelumab Fails Study Endpoint of Reducing Moderate-to-Severe COPD Exacerbations

Tezepelumab was not seen to reduce the annualized rate of moderate or severe COPD exacerbations, thus failing the primary endpoint of COURSE, a phase 2a trial (NCT04039113). Singh and colleagues found that the annualized rate of moderate or severe COPD exacerbations represented a nonsignificant change and thus did not meet the trial’s primary endpoint.

Nerandomilast Meets Primary Endpoint in Improving FVC in Progressive Pulmonary Fibrosis

Nerandomilast met the primary endpoint in the Phase 3 FIBRONEER-ILD trial, significantly improving forced vital capacity (FVC) among individuals with progressive pulmonary fibrosis (PPF), compared with placebo. Based on these findings, Boehringer Ingelheim announced plans to submit an NDA for nerandomilast to the FDA.

Brensocatib Improved Outcomes, Slowed Decline in People With Bronchiectasis
In April, Brensocatib showed efficacy in reducing pulmonary exacerbations and slowing disease progression in patients with non-cystic fibrosis bronchiectasis. The positive results from the Phase 3 trial suggest brensocatib could become a novel therapeutic option for this underserved population.​

Related content: Investigating Brensocatib, Potential First Treatment for Bronchiectasis, with James Chalmers, MBChB, PhD

TPIP Boasts Significant Outcome Improvements for PAH in Phase 2b

In June, Insmed announced positive phase 2b results for treprostinil palmitil inhalation powder (TPIP), meeting its primary endpoint of significantly reducing pulmonary vascular resistance in patients with pulmonary arterial hypertension (PAH). Based on findings from a randomized, placebo-controlled trial, TPIP treatment led to notable improvements in exercise capacity and biomarkers of heart strain, supporting its potential as an effective once-daily prostanoid therapy. Safety analysis showed TPIP was generally well tolerated despite higher rates of common prostanoid-related adverse events like cough and headache. Insmed plans to initiate phase 3 trials for TPIP in PAH and pulmonary hypertension associated with interstitial lung disease starting later this year and into early 2026.

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