Pfizer accused Novo Nordisk of trying to stifle competition in the weight-loss market by attempting to acquire obesity startup Metsera, the second lawsuit in four days as Pfizer tries to retain its grip on a deal that Novo upended last week https://t.co/34n1OHzA9r ...

Financial Data and Key Metrics Changes - Total ORLADEYO revenue was $159.1 million, representing a 37% year-over-year growth, with $141.6 million (89%) coming from the US [19][20] - Non-GAAP operating profit for Q3 2025 was $51.7 million, an increase of 107% year-over-year [20] - Non-GAAP net income for the quarter was $35.6 million, resulting in non-GAAP EPS of $0.17 per share [20] - The company finished the quarter with $269 million in cash, with a pro forma cash balance of approximately $294 million and zero term debt [21] Business Line Data and Key Metrics Changes - ORLADEYO continues to show strong growth, with new prescriptions exceeding the total from the same quarter last year [9][10] - The company raised its ORLADEYO revenue guidance to between $590 million and $600 million for the year [7] - The paid patient rate for ORLADEYO was 82%, consistent with typical second-half patterns [9] Market Data and Key Metrics Changes - The company added 64 new prescribers in the US, exceeding the average of the past eight quarters [9] - The market simulation predicts $1 billion in peak revenue for BioCryst in 2029, despite the sale of the European business [10] Company Strategy and Development Direction - The company plans to spin out or partner the DME program to focus on rare diseases [5] - The acquisition of Astria Therapeutics is expected to strengthen the company's presence in HAE and solidify a double-digit growth trajectory for its portfolio [18] - The company aims to leverage its expertise in HAE with the addition of Nevenobart, anticipating double-digit revenue growth well into the 2030s [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in maintaining patient retention rates despite new competition, citing strong control and satisfaction among patients [27][28] - The company expects to remain profitable on a non-GAAP basis and cash flow positive during the development period of Nevenobart [23] Other Important Information - The company successfully closed the sale of its European business, which allowed for the repayment of Pharmakon debt and improved financial positioning [18] - The company is exploring various capital allocation opportunities to generate value for stockholders [21] Q&A Session Summary Question: What contributed to the 37% year-over-year revenue growth? - The growth was driven by steady volume growth and an improvement in paid rates, particularly in the Medicare segment [26][27] Question: What factors are driving new prescriber numbers? - Physicians are becoming more comfortable with ORLADEYO's long-term evidence and real-world effectiveness [33][34] Question: How does the company view the impact of new entrants in the market? - While some patients may switch to injectables, the company does not expect a significant change in new patient prescribing patterns or overall retention rates [42] Question: What is the strategy for pediatric ORLADEYO approval? - The company is already targeting physicians who treat pediatric patients and is prepared for a launch shortly after approval [43] Question: What is the status of the Netherton syndrome program? - Enrollment is slightly delayed, but the company is optimistic about the ongoing studies and the potential for higher dosing [51][52]

Lawsuit says the proposed merger of the weight-loss drugmakers could kill off a smaller competitor. ...

– Data to be featured in two oral presentations on December 8, 2025 – – Broad development program assesses ziftomenib across diverse AML segments and treatment paradigms to inform appropriate use – SAN DIEGO and TOKYO, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA, “Kura”) and Kyowa Kirin Co., Ltd. (TSE: 4151, “Kyowa Kirin”) today announced that results from the KOMET-007 combination trial of ziftomenib, a once-daily, oral investigational menin inhibitor, will be featured in two oral p ...

Unprecedented Phase 1 CML efficacy data with 64% MMR achievement by 24 weeks in a refractory patient population Encouraging safety and tolerability profile at all doses evaluated Company to host investor update call on December 8th at 4:30pm ET FOSTER CITY, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a clinical stage oncology company, today announced that data from the ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR: ...

Accessibility StatementSkip Navigation Oral presentation highlights the first time it's been demonstrated that the DOR is expressed on tumor-associated MDSCs, and that DOR inhibition reprograms multiple mechanisms of MDSC- induced immunosuppression representing a new target in overcoming acquired resistance to cancer immunotherapy The first demonstration that DOR is expressed on Tumor-Associated Macrophages (TAMs), with DOR inhibition modulating their immunosuppressive capabilities Presentation from The Mof ...

Abstract available on ASH websiteSAN DIEGO and TORONTO, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (TSX: APS), a clinical-stage precision oncology company developing a tuspetinib (TUS) based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced that an abstract from its TUSCANY study of tuspetinib with standard of care venetoclax and azacitidine in patients with newly diagnosed AML has been selected for p ...

Tabelecleucel BLA currently under U.S. Food and Drug Administration (FDA) Priority Review as potentially the first approved therapy in the U.S. for EBV+ PTLD with a Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026 First allogeneic T-Cell therapy BLA offers hope to EBV+ PTLD patients who have limited treatment options and lifespan measured in only a few weeks to months following failure of initial treatment Accessibility StatementSkip Navigation EBV+ PTLD is an ultra-rare, acute, ...

Findings further demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders Data from innovative pipeline signals progress toward improved outcomes in haemophilia A, lymphoma, and multiple myeloma Basel, 3 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading haematology portfolio at the 67th American Society of Hematology (ASH) Annua ...

Core Insights - AIM ImmunoTech Inc. has been granted a European patent for its proprietary dsRNA compositions aimed at treating Long COVID, specifically covering Ampligen (rintatolimod) [1] - The company is focused on advancing its pancreatic cancer clinical program while the new patent enhances its intellectual property portfolio and validates Ampligen's potential as a broad-spectrum immunotherapy [2] Company Overview - AIM ImmunoTech Inc. is an immuno-pharma company dedicated to developing therapeutics for various cancers, immune disorders, and viral diseases, including COVID-19 [4] - The lead product, Ampligen, is a first-in-class investigational drug that acts as a dsRNA and TLR3 agonist, demonstrating broad-spectrum activity in clinical trials [4] Clinical Research and Development - Ampligen has shown a broad-spectrum, early-onset antiviral effect by stimulating a strong innate immune response, with data indicating significant decreases in viral replication in SARS-CoV-1 studies [3] - A Phase 2 study (AMP-518) has reported positive topline results, suggesting that Ampligen is generally well tolerated and may reduce fatigue in patients with Long COVID [3]