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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
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 …
CorMedix Announces Strategic Minority Investment in Talphera
GlobeNewswire
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September 8, 2025
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 …
I-Mab Announces Acceleration of Givastomig Investment and Leadership Appointments
GlobeNewswire
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September 8, 2025
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 …
Telos Corporation, an Official TSA PreCheck® Enrollment Provider, Expands Enrollment and Renewal Options by Opening New Locations
GlobeNewswire
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September 8, 2025
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
GlobeNewswire
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September 8, 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
GlobeNewswire
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September 8, 2025
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 …
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 …
OnTerra Systems Announces That Its RouteSavvy API PLUS Route Optimization API Is Now Available on Microsoft’s Azure Marketplace
GlobeNewswire
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September 8, 2025
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
GlobeNewswire
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September 8, 2025
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
GlobeNewswire
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September 8, 2025
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
GlobeNewswire
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September 8, 2025
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 …
FOREWARN to Provide Identity Verification Services to Pacific Regional Multiple Listing Service to Promote Agent Safety
GlobeNewswire
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September 8, 2025
BOCA RATON, Fla., Sept. 08, 2025 (GLOBE NEWSWIRE) -- FOREWARN, LLC, a red violet company (NASDAQ: RDVT) and the leading provider of real-time information solutions for real estate agents, today announced that Pacific Regional Multiple Listing Service (“ …
Sionna Therapeutics Appoints Caroline Stark Beer as Chief Business Officer
GlobeNewswire
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September 8, 2025
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)
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 …
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
GlobeNewswire
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September 8, 2025
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 …
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
GlobeNewswire
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September 8, 2025
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
GlobeNewswire
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September 8, 2025
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 …
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 …
NeuroNOS Granted FDA Orphan Drug Designation for Glioblastoma, the Most Common and Deadliest Primary Malignant Brain Cancer in Adults
GlobeNewswire
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September 8, 2025
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 …