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Press releases published on September 8, 2025

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 …

Insight Molecular Diagnostics Announces Positive Strategic Update and Novel Registry Database
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
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 …

Pasithea Therapeutics Announces Enrollment of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for its Ongoing Phase 1/1b Clinical Trial of PAS-004 in Adult NF1 Patients
-- Recommendation that trial escalate to next dose level of 8mg tablet -- -- Initial interim clinical data from first two cohorts expected in Q1 2026 -- MIAMI, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the …

Picard Medical, Inc. Announces Presentation at H.C. Wainwright Global Investment Conference
TUCSON, Ariz., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), today announced that Patrick NJ Schnegelsberg, Chief Executive Officer, will present in-person at the H.C. Wainwright 27th Annual …

EDAP Receives HIFU Reimbursement for Prostate Cancer in France
Focal One Robotic HIFU procedure now covered under France’s national universal health system Reimbursement milestone allows increased patient access to Focal One Robotic HIFU AUSTIN, Texas, September 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader …

Attralus Presents New Data on Its Pan-Amyloid Diagnostic Imaging Candidates at ASNC 2025
124I-evuzamitide, the first pan-amyloid diagnostic imaging agent, demonstrated 100% sensitivity and specificity for the diagnosis of cardiac amyloidosis in patients suspected of or diagnosed with cardiac amyloidosis in ATTR, AL, and other rare types of …

IMDX Enrolls First Patient in GraftAssureDx Clinical Trial and Welcomes New Hospital Participants
iMDx’s ClinicalTrials.gov listing now names 10 leading transplant centers, up from 5 previously GraftAssureDx remains on track for FDA submission by end of 2025, commercial launch in 2026 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Insight …

Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 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 …

Dianthus Therapeutics Announces Positive Data for Claseprubart (DNTH103) from the Phase 2 MaGic Trial in Generalized Myasthenia Gravis, Supporting Its Potential Best-In-Class Profile
Claseprubart 300mg and 600mg Q2W doses both achieved statistically significant and clinically meaningful improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores at Week 13 Claseprubart …

Ocular Therapeutix™ to Host Investor Day on September 30, 2025
Company to highlight ongoing AXPAXLI™ wet AMD registrational program, strategy and next steps in NPDR and DME, and global commercial opportunity for AXPAXLI Event to feature global retinal disease experts Dr. Arshad M. Khanani MD, MA, FASRS; Professor …

Regeneron Advances Allergy Pipeline with Two Positive Phase 3 Trials Evaluating First-in-Class Antibody-Blockers of Cat and Birch Allergies
In separate cat and birch allergen-challenge trials, single doses of allergen-specific antibody blockers significantly reduced allergy symptoms compared to placebo Data from these trials will support further Phase 3 development TARRYTOWN, N.Y., Sept. 08, …

Serina Therapeutics to Present at the H.C. Wainwright 27th Annual Global Investment Conference
HUNTSVILLE, AL, Sept. 08, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, announced that Steve Ledger, Chief …

Rapport Announces Positive Topline Results from Phase 2a Clinical Trial of RAP-219 in Patients with Focal Onset Seizures
Trial met primary long episode endpoints with high statistical significance, and RAP-219 was generally well tolerated Patients achieved 77.8% reduction in clinical seizures (p=0.01), with 24% achieving seizure freedom for the 8-week treatment period (p<0. …

Stanford University Secures NIH Grant to Advance tiakis Biotech´s Elafin (Tiprelestat) Through a U.S. Phase II Trial in Pulmonary Arterial Hypertension
- Novel, disease-modifying treatment option for Pulmonary Arterial Hypertension (PAH), an orphan indication with a significant unmet medical need Kiel, GERMANY, September 8, 2025 – tiakis Biotech AG (“tiakis”), a clinical-stage biopharmaceutical company …

NRG Therapeutics Announces Oversubscribed £50m ($67m) Series B Financing to Deliver Clinical Data in Parkinson’s and Proof of Concept in ALS/MND
Oversubscribed £50m Series B led by SV Health Investors’ Dementia Discovery Fund, alongside other new investors British Business Bank, M Ventures, Novartis Venture Fund and Criteria Bio Ventures, together with existing investors Omega Funds and Brandon …

Leading Austrian Pathology Laboratory Group Chooses PathAI’s AISight® Dx to Accelerate Digital Pathology and Advanced Diagnostics
BOSTON and VIENNA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- PathAI, a global leader in artificial intelligence and digital pathology solutions, today announced multi-year partnerships with a group of pioneering Austrian pathology laboratories to deploy AISight® …