SNY - Earnings announcements

Adds fast-growing and only approved medicine for advanced and indolent systemic mastocytosis to the Sanofi portfolioPARIS and CAMBRIDGE, Mass., June 2, 2025 /PRNewswire/ -- Sanofi and Blueprint Medicines Corporation (Blueprint), a US-based, publicly traded biopharmaceutical company specializing in systemic mastocytosis (SM), a rare immunological disease, and other KIT-driven diseases, have entered into an agreement under which Sanofi will acquire Blueprint. The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the US and the EU

― Entered into a collaboration and ex-U.S. license agreement with Sanofi for the development and commercialization of losmapimod ― ― On track to report topline data for Phase 3 REACH trial of losmapimod in facioscapulohumeral muscular dystrophy (FSHD) in the fourth quarter of 2024 ― ― Industry veteran, Patrick Horn M.D., Ph.D., appointed as chief medical officer ― ― Conference call and webcast scheduled for 8:00 a.m. ET today ― CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, toda

― Sanofi receives exclusive rights to commercialize losmapimod in all territories outside the U.S.; Fulcrum retains full U.S. commercialization rights ― ― Fulcrum will receive an upfront payment of $80.0 million, and is eligible to receive $975.0 million in potential milestones, plus royalties on ex-U.S. product sales; parties will share future global development costs 50:50 ― ― Conference call and webcast scheduled for 8:00 a.m. ET today to discuss the collaboration and other recent corporate developments, in conjunction with the first quarter 2024 financial results ― CAMBRIDGE, Mass., May 13, 2024 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.® (Fulcrum) (NASDAQ:FULC), a c

Announces co-exclusive licensing agreement with Sanofi to co-commercialize COVID-19 vaccine, develop novel COVID-19-Influenza combination vaccines and develop multiple new vaccines utilizing Novavax's Matrix-MTM adjuvantThis agreement represents a potential multi-billion dollar revenue opportunity for Novavax including:$500 million upfront payment Approximately $70 million equity investment in NovavaxUp to $700 million in COVID-19 and combination product near-term milestones, plus ongoing tiered royalties on product salesUp to $200 million in milestones plus royalties for each new vaccine developed utilizing Novavax's Matrix-MTM adjuvantAnnounces addition of standalone influenza vaccine to P

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine in th

U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediatelyFirst authorization for a COVID-19 vaccine represents a breakthrough scientific achievement to help combat this devastating pandemic The companies previously signed an agreement to supply a total of 40 million doses to the U.K. with delivery in 2020 and 2021 U.S. FDA and EU EMA decisions on authorization are expected in December NEW YORK and MAINZ, GERMANY, December 2, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in th

EMA confirms successful application for Conditional Marketing Authorization for BNT162b2, which Pfizer and BioNTech submitted yesterday In addition to submission to EMA, FDA and U.K. MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world Data from the Phase 3 clinical study demonstrated a vaccine efficacy rate for BNT162b2 of 95% against COVID-19, with no safety concerns observed to date NEW YORK and MAINZ, GERMANY, December 1, 2020 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have submitted on Monday, November 30, 2020,