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Press releases published on September 8, 2025

Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025
EB613 Demonstrates Significant Effects on Both Trabecular and Cortical Bone Compartments After Just 6 Months of Treatment in Phase 2 Study; Cortical Improvements Comparable to Injectable Teriparatide and Abaloparatide Company Plans to Initiate Global …

Microbot Medical® Receives FDA 510(k) Clearance for Its LIBERTY® Endovascular Robotic System
Accelerated Launch Readiness Plans Position Company for Commercialization during Q4 2025 The Company’s Initial Addressable Market Includes Approximately 2.5 Million Peripheral Endovascular Procedures in the U.S. Annually CEO, President …

Belite Bio Announces Up to $275 Million Upsized Private Placement Financing by Leading Healthcare Investors
Transaction led by RA Capital Management with participation from Eventide Asset Management, Marshall Wace, RTW Investments, Soleus Capital and Vestal Point Capital $125 million financing upfront with up to an additional $150 million tied to exercise of …

Harrow Announces Offering of $250.0 Million Senior Unsecured Notes Due 2030
Announces Commitment for New $40 Million Revolving Credit Facility Issues Conditional Notice of Redemption of 11.875% Senior Notes due 2027 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease …

Sionna Therapeutics Appoints Caroline Stark Beer as Chief Business Officer
WALTHAM, Mass., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by developing novel medicines that …

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
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 …

OncoC4 to Present Global Pivotal Phase 3 Trial Design for Next-Generation CTLA-4 Antibody Gotistobart Monotherapy Being Co-Developed with BioNTech in NSCLC at the IASLC 2025 World Conference on Lung Cancer
PRESERVE-003 is evaluating gotistobart vs. docetaxel in patients with squamous non-small cell lung cancer (sqNSCLC) who have progressed on chemotherapy and immune checkpoint therapies Pivotal Stage II design was based on data from the Stage I part of the …

Alignment Healthcare Names Matt Eyles Executive Vice President of Government & Business Strategy
ORANGE, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Alignment Healthcare, Inc. (NASDAQ: ALHC) today announced that Matt Eyles will join as executive vice president of government and business strategy, effective Sept. 29. In this newly created position, …

Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment
There are currently no approved vaccines or treatments for norovirus infection Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections Phase 1b study is expected to start …

Real-World Evidence Supports Clinical Effectiveness of neffy® (epinephrine nasal spray) in Patients Experiencing Anaphylaxis
Findings accepted for publication in the official journal of the American College of Allergy, Asthma and Immunology About 9 out of every 10 patients experiencing anaphylaxis were effectively treated with a single dose of neffy Results suggest real-world …

Hydreight Technologies Signs Binding Letter of Intent to Acquire Dynamic IV Therapy Support AI Agent
Not for distribution to United States newswire services or for dissemination in the United States. VANCOUVER, British Columbia, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Hydreight Technologies Inc. (TSXV: NURS)(OTCQB: HYDTF)(FSE: SO6),("Hydreight" or the "Company …

NeuroNOS Granted FDA Orphan Drug Designation for Glioblastoma, the Most Common and Deadliest Primary Malignant Brain Cancer in Adults
BOSTON, Sept. 08, 2025 (GLOBE NEWSWIRE) -- NeuroNOS, a biopharmaceutical company focused on developing treatments for neurological disorders and neuro-oncology, and a subsidiary of Beyond Air (NASDAQ: XAIR), today announced that the U.S. Food and Drug …

Immutep Announces Data from EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma Accepted for Oral Presentation at CTOS 2025
Data to be presented in the Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers session at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting SYDNEY, AUSTRALIA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: …

Vaxart Announces Adjournment of Special Meeting of Stockholders
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
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., …

Alterity Therapeutics Raises A$20.0 million in Strategic Placement
MELBOURNE, Australia and SAN FRANCISCO, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative …

ElevateBio Appoints Larry Lockwood, Ph.D., as Chief Commercial Officer
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
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
• 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 …

Kraig Biocraft Laboratories Appoints Kenneth Le as Managing Director of Prodigy Silk
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 …