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Press releases published on September 8, 2025
Tevogen Values TVGN-489 at $9–$11 Billion rNPV, Its First Clinical Product From the Proprietary ExacTcell™ Allogeneic T Cell Platform
GlobeNewswire
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September 8, 2025
WARREN, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today shared the risk-adjusted net present value (rNPV) estimate of $9 billion to $11 billion for TVGN-489, an allogeneic precision T cell …
New 4-Year Data for Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) Presented at ICIEM
GlobeNewswire
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September 8, 2025
PRINCETON, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), today announced the presentation of new 4-year muscle function, muscle strength and biomarker endpoints from the PROPEL open-label extension (OLE) study of …
MediciNova Provides Shareholder Update on Key Developments
GlobeNewswire
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September 8, 2025
LA JOLLA, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the “Company”), provides a …
Queen Latifah Named Spokeswoman as WeightWatchers Launches First Comprehensive Menopause Programme
GlobeNewswire
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September 8, 2025
NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- WW International, Inc. (NASDAQ: WW) (“WeightWatchers” or the “Company”), the global leader in science-backed weight management, today announced the launch of WeightWatchers for Menopause, a groundbreaking …
Lexicon Pharmaceuticals Announces Submission of Additional Data to U.S. FDA Supporting the Benefit-Risk Profile of Zynquista® in Type 1 Diabetes
GlobeNewswire
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September 8, 2025
Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December 2024 complete response letter Company seeks alignment on reasonable path forward for Zynquista NDA resubmission FDA feedback …
Moleculin Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia
GlobeNewswire
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September 8, 2025
Spain site opens with two R/R AML subjects enrolled; One treated On track to recruit 45 subjects in 4Q25 for initial data unblinding HOUSTON, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late- …
Pelthos Therapeutics to Participate in Upcoming September Investor Conferences
GlobeNewswire
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September 8, 2025
DURHAM, N.C., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company (“Pelthos” or the “Company”) committed to commercializing innovative therapeutic products for high unmet patient needs, today …
HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Complete the Acquisition of Dura Medical; Initial Acquisition in Network of Interventional Psychiatry Clinics
GlobeNewswire
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September 8, 2025
Dura Medical, together with pending acquisitions of Neurospa TMS and Cohen …
UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
GlobeNewswire
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September 8, 2025
PRINCETON, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement …
BioAtla Announces Regulatory Update on Clinical Development Plan for Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma (OPSCC) Following Productive Type B (End of Phase 2) Meeting with FDA
GlobeNewswire
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September 8, 2025
FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approval Company continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the …
Keros Therapeutics Presents Additional Clinical Data from its KER-065 Program at the American Society of Bone and Mineral Research 2025 Annual Meeting
GlobeNewswire
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September 8, 2025
LEXINGTON, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders …
Spectral Medical Sponsors Unite for Sepsis Symposium, Chicago September 8 – 9, 2025
GlobeNewswire
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September 8, 2025
Company to present at session titled “Personalizing Sepsis Treatment” TORONTO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and …
Vaxart Announces Adjournment of Special Meeting of Stockholders
GlobeNewswire
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September 8, 2025
Meeting adjourned to September 19, 2025 at 8:30 a.m. Pacific Time Adjournment provides stockholders with more time given changes in Board composition, additional governance change considerations and future potential disclosures Vaxart encourages all …
BullFrog AI’s bfPREP™ and bfLEAP® Platforms Deliver Real-World Impact in Eleison Pharmaceuticals Collaboration
GlobeNewswire
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September 8, 2025
Joint oncology conference submission planned and follow-on contract discussion underway Validates BullFrog AI’s enterprise-grade platform strategy, combining automation and human-in-the-loop oversight for scalable, trustworthy analytics GAITHERSBURG, Md., …
ElevateBio Appoints Larry Lockwood, Ph.D., as Chief Commercial Officer
GlobeNewswire
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September 8, 2025
WALTHAM, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- ElevateBio, a technology-driven company focused on powering the creation of life-transforming genetic medicines, announced the appointment of Larry Lockwood, Ph.D., as Chief Commercial Officer. Dr. …
TG Announces Phase 3 Trial for Subcutaneous BRIUMVI Commenced Enrollment
GlobeNewswire
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September 8, 2025
NEW YORK, Sept. 08, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced today that enrollment has commenced in a Phase 3 trial evaluating subcutaneous BRIUMVI (ublituximab-xiiy), the company’s anti-CD20 monoclonal antibody, in people …
Angitia Biopharmaceuticals Presents First-in-Human Data on AGA2115 for Osteogenesis Imperfecta at ASBMR 2025
GlobeNewswire
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September 8, 2025
• Clinical data demonstrated administration of AGA2115 drove dose-dependent increases in bone mineral density • The Company and collaborators also presented data from non-human primate and mouse models WESTLAKE VILLAGE, Calif., Sept. 08, 2025 (GLOBE …
Insight Molecular Diagnostics Announces Positive Strategic Update and Novel Registry Database
GlobeNewswire
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September 8, 2025
5,000-participant, multi-center registry supported by iMDx’s central lab and transplant center partners New hospital-based data seeks to further differentiate pending kitted assay that measures biomarker for transplanted organ rejection (dd-cfDNA) Novel …
Kraig Biocraft Laboratories Appoints Kenneth Le as Managing Director of Prodigy Silk
GlobeNewswire
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September 8, 2025
ANN ARBOR, Mich., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) ("Company" or "Kraig Labs"), a world leader in spider silk technology*, is happy to announce the appointment of Mr. Kenneth Le as Managing Director of its …
Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025
GlobeNewswire
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September 8, 2025
Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared …