WALTHAM, Mass., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced its fourth quarter and full year 2024 financial results and business highlights.
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Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results
TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy. The European Commission is expected to announce a final decision in the coming months.
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Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma
DURHAM, N.C., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, today announced that it will report financial results for the fourth quarter of fiscal year 2024 before the market opens on Tuesday, March 11, 2025. The Company’s management will host a conference call at 8:30 a.m. Eastern Time that same day to discuss the results and provide a business update.
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Bioventus to Report Fourth Quarter of Fiscal Year 2024 Financial Results on March 11, 2025
Basel, February 28, 2025 – Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Fabhalta® (iptacopan) – a first-in-class oral Factor B inhibitor of the alternative complement pathway – for the treatment of adults with C3 glomerulopathy (C3G)1.
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Novartis oral Fabhalta® (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy (C3G)
EC approval decision anticipated in second quarter of 2025 EC approval decision anticipated in second quarter of 2025
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Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa
DALLAS, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced that it will report financial results for the fourth quarter and full year ended December 31, 2024 on Wednesday, March 27, 2025 after the close of the stock market. The Company will host a corresponding conference call at 5:00 pm Eastern Time to discuss the results.
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Spectral AI Schedules 2024 Fourth Quarter and Full Year Financial Results and Conference Call
BOSTON, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided an update on the interim analysis for Study 1 of the Essential3 program of ulixacaltamide in essential tremor (ET), an update on other therapies in development and a financial update.
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Praxis Precision Medicines Provides Update on Essential3 and Corporate Update
REDWOOD CITY, Calif., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced a late-breaking oral presentation of briquilimab data from the Phase 1b/2a BEACON in CSU study at the 2025 AAD Annual Meeting, being held March 7 - 11, 2025, in Orlando, FL. The presentation will consist of data from patients included in the Company’s January 8th, 2025, disclosure of preliminary data from the BEACON study.
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Jasper Therapeutics Announces Late-Breaking Briquilimab Presentation at the American Academy of Dermatology (AAD) Annual Meeting
If approved, daratumumab will be the only anti-CD38 available for all patient types across newly diagnosed multiple myeloma, cementing daratumumab as a foundational therapy in the frontline setting.
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Johnson & Johnson’s DARZALEX® (daratumumab) subcutaneous-based regimen receives positive CHMP opinion for patients with newly diagnosed...
ISELIN, N.J., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, an investigational ophthalmic product which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).