Successfully transitioned into a fully integrated commercial-stage company following the first two independent launches of TRYNGOLZA and DAWNZERA. Performance attribution for TRYNGOLZA was driven by a compelling clinical profile and strong execution, exceeding expectations with $108 million in full-year revenue. Achieved breakthrough Phase III results for olezarsen in severe hypertriglyceridemia, demonstrating an unprecedented 85% reduction in acute pancreatitis events. Strategic positioning in neur ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), announced today the U.S. Food and Drug Administration (FDA) approval of NUMELVI™ (atinvicitinib tablets) – the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs six months of age and older. The product is expected to b. ...

Fourth Quarter and Full Year 2025 Earnings Call February 25, 2026 Call Agenda Catherine Owen Adams Chief Executive Officer Welcome Commercial Update Tom Garner Executive Vice President, Chief Commercial Officer Elizabeth H.Z. Thompson, Ph.D. Executive Vice President, Head of Research and Development R&D Update Financial Update Mark Schneyer Executive Vice President, Chief Financial Officer Al Kildani Senior Vice President, IR and Corporate Communications CEO Opening Remarks Closing Remarks Catherine Owen Ad ...

Core Insights - United Therapeutics Corporation reported fourth-quarter results that exceeded earnings expectations but fell short on revenue, leading to a more than 9% increase in shares intra-day [1] Financial Performance - Adjusted earnings per share for the fourth quarter were $7.70, surpassing the consensus estimate of $7.10 by $0.60 [1] - Revenue for the fourth quarter totaled $790.2 million, below expectations of $815.24 million, but represented a 7% increase from $735.9 million in the prior-year quarter [2] - Full-year 2025 revenue reached a record $3.18 billion, up 11% from 2024 [2] Product Revenue Breakdown - Total Tyvaso revenue grew 12% to $464.3 million in the fourth quarter, driven by Tyvaso DPI, which increased 24% to $338.6 million [3] - Growth in Tyvaso revenue was attributed to higher quantities sold due to continued patient expansion and increased commercial utilization linked to Medicare Part D redesign under the Inflation Reduction Act [3] - Orenitram revenue rose 12% to $121.2 million [3] Net Income and Future Outlook - Net income for the quarter reached $364.3 million, or $7.70 per diluted share, compared to $301.3 million, or $6.19 per diluted share, in the fourth quarter of 2024 [4] - For full-year 2025, net income totaled $1.33 billion, up from $1.20 billion in 2024 [4] - Management indicated that the ADVANCE OUTCOMES and TETON-1 clinical programs are expected to deliver pivotal data that could expand treatment options [4]

Corbus Pharmaceuticals (NasdaqCM:CRBP) FY Conference February 25, 2026 03:20 PM ET Speaker0Afternoon, everyone, welcome back to Oppenheimer's 36th Annual Healthcare Conference. I'm Jeff Jones, one of the biotech analysts on the team here, I'm delighted to welcome Yuval Cohen, CEO of Corbus Pharmaceuticals. Well, I can talk. Good afternoon, Yuval. How are you?Speaker1Hello, Jeff. How are you?Speaker0Good. Thank you for joining us today. It's, you know, a great way to kick off an exciting 2026 for you guys.Sp ...

SAN DIEGO, Feb. 25, 2026 (GLOBE NEWSWIRE) -- Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of Corcept Therapeutics Incorporated (NASDAQ: CORT) common stock between October 31, 2024 and December 30, 2025, both dates inclusive (the “Class Period”), have until April 21, 2026 to seek appointment as lead plaintiff of the Corcept class action lawsuit. Captioned Allegheny County Employees’ Retirement System v. Corcept Therapeutics Incorporated, No. 26-cv-01525 (N.D. Cal.), the Corcept cla ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Ultragenyx To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Ultragenyx between August 3, 2023 and December 26, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Feb. 25, 2026 (GLOBE NEWSWIRE) -- ...

Core Viewpoint - Gilead Sciences' experimental single-tablet HIV treatment demonstrates low discontinuation rates and high patient satisfaction, indicating its potential as a viable option for patients after viral suppression [1] Group 1: Treatment Efficacy - The experimental treatment showed discontinuation rates due to adverse events of 1.6% and 0.5% in the two treatment arms, which are considered low [1] - After 48 weeks, 0.8% of patients on the combination pill had detectable virus levels, compared to 1.1% of those on multi-tablet regimens, suggesting better viral suppression [1] Group 2: Patient Satisfaction - Participants reported higher treatment satisfaction after switching to the experimental single-tablet regimen, as noted in a paper published in The Lancet [1] Group 3: Regulatory Plans - Gilead plans to submit data from the trials to regulatory authorities, although the combination treatment has not yet received approval [1]

Summary of Nasus Pharmaceuticals Conference Call Company Overview - **Company**: Nasus Pharmaceuticals - **Industry**: Clinical-stage pharmaceutical company focused on intranasal products for acute medical conditions - **Key Product**: NS002, an intranasal powder epinephrine product for anaphylaxis, designed as a needle-free alternative to EpiPen [1][3] Core Points and Arguments - **Product Development**: - NS002 is being developed to provide rapid and reliable drug delivery using proprietary powder-based intranasal technology [1][3] - The product aims to address the limitations of EpiPen, including needle phobia and bulkiness [7][9] - Nasus has a robust pipeline with additional products in development, including ondansetron for chemotherapy-induced nausea and two undisclosed products in metabolic and cardiovascular spaces [4][24] - **Market Opportunity**: - The anaphylaxis market is valued at approximately $2.5 billion annually, expected to grow to $4-5 billion due to rising allergy incidences [9][10] - There are about 20 million patients in the U.S. with severe Type I allergies, yet only one-third have a prescription for EpiPen, indicating a significant market opportunity for needle-free alternatives [10][11] - **Clinical Performance**: - NS002 has demonstrated superior absorption and pharmacokinetic properties compared to EpiPen, including the shortest Tmax (time to maximal concentration) and T100 (time to reach 100 picograms of epinephrine) [12][13] - In clinical studies, 91% of subjects achieved the 100 picogram threshold at 5 minutes, compared to 67% for EpiPen [14][19] - The product has shown consistent performance even under nasal allergic challenge conditions, maintaining effective absorption levels [16][20] - **Safety and Tolerability**: - The product was well tolerated with no serious adverse events reported, and most adverse events were mild and self-resolving [21][22] - Local side effects were primarily related to the nasal administration, while systemic side effects were comparable to EpiPen [22] Additional Important Content - **Intellectual Property**: Nasus holds a broad patent portfolio covering its powder technology and individual products, with patents extending to 2038 [22] - **Financial Position**: The company is fully funded through the NDA submission planned for mid-2027, supported by recent PIPE financing [32] - **Market Dynamics**: There is a growing trend towards needle-free epinephrine products, with historical precedents in other therapeutic categories showing rapid market shifts towards such alternatives [29][30] Conclusion - Nasus Pharmaceuticals is positioned to capitalize on the growing demand for needle-free epinephrine products, with a strong clinical pipeline and favorable pharmacokinetic data supporting its lead product, NS002. The company is well-funded and has a clear strategy to navigate the competitive landscape, aiming to establish itself as a leader in the anaphylaxis treatment market [24][25]

US FDA approves Eton Pharma's hormonal disorder drug | ReutersSkip to main content[Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv]Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kell/File Photo [Purchase Licensing Rights, opens new tab]- Companies[Eton Pharmaceuticals Inc]Follow[U.S. Food and Drug Administration]FollowFeb 25 (Reuters) - The U.S. Food and Drug Administration ...