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Press releases published on September 8, 2025

Moleculin Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia
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
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 …

CorMedix Announces Strategic Minority Investment in Talphera
BERKELEY HEIGHTS, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (“CorMedix”) (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced …

Telos Corporation, an Official TSA PreCheck® Enrollment Provider, Expands Enrollment and Renewal Options by Opening New Locations
ASHBURN, Va., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Telos Corporation (NASDAQ: TLS), an authorized enrollment provider, continues to expand locations to enroll consumers in the TSA PreCheck® program by opening new TSA PreCheck enrollment locations in Colorado …

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 …

I-Mab Announces Acceleration of Givastomig Investment and Leadership Appointments
Expands investment in givastomig in 1L metastatic gastric cancers, with plans to initiate a global randomized Phase 2 study in combination with immunochemotherapy, in Q1 2026, with additional Phase 1b cohorts to follow Reiterates expectations to report …

HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Complete the Acquisition of Dura Medical; Initial Acquisition in Network of Interventional Psychiatry Clinics
Dura Medical, together with pending acquisitions of Neurospa TMS and Cohen …

OnTerra Systems Announces That Its RouteSavvy API PLUS Route Optimization API Is Now Available on Microsoft’s Azure Marketplace
DENVER, Sept. 08, 2025 (GLOBE NEWSWIRE) -- OnTerra Systems (www.OnTerraSystems.com), a provider of web mapping products, services …

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 …

OSS Receives New Platform Award from Safran Federal Systems
ESCONDIDO, Calif., Sept. 08, 2025 (GLOBE NEWSWIRE) -- One Stop Systems, Inc. (OSS or the Company) (Nasdaq: OSS), a leader in rugged Enterprise Class compute for artificial intelligence (AI), machine learning (ML) and sensor processing at the edge, today …

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 …

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
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 …

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 …

Keros Therapeutics Presents Additional Clinical Data from its KER-065 Program at the American Society of Bone and Mineral Research 2025 Annual Meeting
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 …

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: …

Refined Energy Corp. and Searchlight Resources Inc. Sign an Amendment to the Option Agreement for the Milner and Basin Properties
VANCOUVER, British Columbia, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Refined Energy Corp. (CSE: RUU | OTC: RRUUF | FRA: CWA0) ("Refined” or the "Company") announces that it has signed an amendment with Searchlight Resources Inc. ("Searchlight") on September 5, …

Spectral Medical Sponsors Unite for Sepsis Symposium, Chicago September 8 – 9, 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 …