GAITHERSBURG, Md., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it will report its third quarter 2025 financial results on Thursday, November 6, 2025. Altimmune management will host a conference call at 8:30 a.m. ET on November 6 to discuss financial results and provide a business update. The conference call will be webcast live on Altim ...

Core Insights - Apellis Pharmaceuticals reported strong third quarter 2025 results, highlighting significant progress in its commercial and development portfolio, including a new regulatory approval for EMPAVELI, a first-in-class C3 therapy for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) [2][5][12] Financial Performance - Total revenue for Q3 2025 was $458.6 million, a substantial increase from $196.8 million in Q3 2024, driven by product sales and a $275 million upfront payment from Sobi [8][12] - U.S. net product revenue for SYFOVRE was $150.9 million, while EMPAVELI generated $26.8 million in net product revenue [5][8] - Cash and cash equivalents stood at $479 million as of September 30, 2025, indicating a strong financial position to support future growth [14] Product Developments - EMPAVELI received FDA approval on July 28, 2025, as the first treatment for C3G and primary IC-MPGN, showing a 68% reduction in proteinuria in clinical trials [6][12] - The launch of EMPAVELI has seen 152 new patient start forms in the first two months, indicating strong early adoption [5][6] - SYFOVRE continues to lead the geographic atrophy market with a market share exceeding 60% and a 4% increase in total injection demand quarter-over-quarter [12][16] Research and Development - R&D expenses decreased to $68.2 million in Q3 2025 from $88.6 million in Q3 2024, reflecting cost management efforts [10] - The company plans to initiate pivotal studies for focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) by the end of 2025 [6][12] Strategic Collaborations - Apellis and Sobi have a collaboration agreement for the global co-development of pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights [18][12] - The recent royalty purchase agreement with Sobi allows Apellis to receive up to $300 million in exchange for 90% of future ex-U.S. royalties for Aspaveli [12][8]

BETHESDA, Md., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced a poster presentation at the Society for Neuroscience annual meeting, Neuroscience 2025, being held November 15th–19th in San Diego, CA. Details are as follows: Session Type: PosterSession Number: PSTR438Session Title: Developing Parkinson' ...

Over 790,000 total VOQUEZNA® prescriptions filled to dateFilled VOQUEZNA prescriptions increased 28% from Q2 2025Net revenues of $49.5 million, up 25% quarter over quarter, and cash operating expenses down 43% quarter over quarterFull-year 2025 revenue guidance updated to $170–$175 million; company expects to achieve operating profitability in 2026Management to host conference call today, October 30, 2025, at 8:00 a.m. ET FLORHAM PARK, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) --  Phathom Pharmaceuticals, Inc. ( ...

Previously reported data showed that in a diet-induced obesity mouse model, IBIO-610 drives fat-selective, GLP-1-synergistic weight loss and prevents weight regain following GLP-1 treatment discontinuation New non-human primate data projects a human half-life of up to 100 days, potentially enabling treatment with only twice-yearly dosing Extended half-life data and differentiated mechanism of action reinforce IBIO-610’s potential as a leading next-generation therapy for obesity and cardiometabolic disease S ...

LONDON & GAITHERSBURG, Md., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announces that it will release its third quarter 2025 financial results and operational highlights before open of U.S. markets on Wednesday, November 12, 2025. Management will host a conference call and webcast at 8:30am EST / 1:30pm GMT to discuss the company’s fi ...

Core Insights - Agios Pharmaceuticals reported financial results for Q3 2025, highlighting a focus on key milestones for its drug PYRUKYND in treating thalassemia and sickle cell disease [1][2]. Financial Performance - PYRUKYND generated $12.9 million in net revenues for Q3 2025, a 44% increase from $9.0 million in Q3 2024 and a 3% increase from $12.5 million in Q2 2025 [5][6]. - The company reported a net loss of $103.4 million for Q3 2025, compared to a net income of $947.9 million in Q3 2024, which was primarily due to a milestone payment and sale of royalty rights recorded in the previous year [7][17]. Product Development and Regulatory Updates - The PDUFA goal date for PYRUKYND's supplemental New Drug Application (sNDA) for thalassemia has been extended to December 7, 2025, due to a request for a Risk Evaluation and Mitigation Strategy (REMS) [6][11]. - The European Medicines Agency's CHMP has adopted a positive opinion for PYRUKYND in thalassemia, with a final decision expected by early 2026 [5][6]. - The RISE UP Phase 3 trial for sickle cell disease is expected to provide topline results by year-end 2025, potentially leading to a U.S. commercial launch in 2026 [5][11]. Research and Development - The Phase 2b trial for tebapivat in lower-risk myelodysplastic syndromes (MDS) has completed enrollment, with topline results anticipated in early 2026 [5][11]. - Research and Development expenses for Q3 2025 were $86.8 million, an increase of $14.3 million compared to Q3 2024, driven by higher clinical trial costs [11][17]. Cash Position - As of September 30, 2025, Agios had $1.3 billion in cash, cash equivalents, and marketable securities, down from $1.5 billion at the end of 2024 [5][11].

AGOURA HILLS, Calif., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. (OTCQB: OTLC), a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat cancer patients by leveraging its novel PDAOAI platform and deep knowledge in nanomedicines and the tumor microenvironment, announced today that Sapu Nano will be featuring its investigational intravenous Deciparticle™ everolimus (Sapu003) have been accepted for presentation at the 2025 San Antonio Bre ...

‒ Q3 2025 Net Revenue of $785 million; GAAP Net Income of $2 million; Diluted Income per Share of $0.01 ‒‒ Adjusted EBITDA of $160 million; Adjusted Diluted EPS of $0.17 ‒‒ Updated 2025 Full Year Guidance ‒ BRIDGEWATER, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the third quarter ended September 30, 2025. “Amneal delivered another strong quarter and updated our 2025 outlook, underscoring the strength of our ...

Core Viewpoint - Oculis Holding AG has announced the pricing of an offering of 5,432,098 ordinary shares at $20.25 per share, aiming to raise a total of $110 million before expenses, to support the development of its neuroprotective clinical candidate, Privosegtor, and for general corporate purposes [1][2]. Group 1: Offering Details - The financing consists of an underwritten offering of 4,691,358 ordinary shares and a registered direct offering of 740,740 ordinary shares, with the total expected to close around November 3, 2025 [3]. - Of the shares being offered, 2,635,801 are new shares issued from the Company's existing capital band, while 3,500,000 are treasury shares [3]. - The issuance of new shares will increase the total number of registered shares authorized by the Company to 57,169,475 [3]. Group 2: Use of Proceeds - The net proceeds from the financing will be utilized to advance the development of Privosegtor for treating acute optic neuritis (AON) and non-arteritic anterior ischemic optic neuropathy (NAION), along with working capital and general corporate purposes [2]. Group 3: Management and Advisors - J.P. Morgan, Leerink Partners, and Pareto Securities are acting as joint bookrunning managers for the underwritten offering, while Van Lanschot Kempen is the manager and Arctica Finance serves as a financial advisor [4]. Group 4: Company Overview - Oculis is a global biopharmaceutical company focused on innovations in neuro-ophthalmic conditions, with a late-stage clinical pipeline that includes three core product candidates: Privosegtor, OCS-01, and Licaminlimab [6]. - The company is headquartered in Switzerland and operates in the U.S. and Iceland, led by an experienced management team supported by international healthcare investors [6].