COMMUNIQUÉS West-GlobeNewswire

Entera Bio Receives Positive FDA Feedback on 12-Month Registrational Phase 3 Study for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis
22/06/2026
The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera’s plan to submit a New Drug [...]
Achieve Life Sciences Receives Complete Response Letter from FDA for Cytisinicline NDA
22/06/2026
CRL Cites Deficiencies at Third-Party Manufacturing Facility No Efficacy or Clinical Safety Deficiencies Identified SEATTLE and VANCOUVER, British Columbia, June 22, 2026 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc [...]
BridgeBio to Present Primary Results from Phase 3 PROPEL 3 Trial of Oral Infigratinib for Children Living with Achondroplasia at ICCBH 2026
22/06/2026
PALO ALTO, Calif., June 22, 2026 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for [...]
TETmedical Receives FDA Breakthrough Device Designation for NSE-FAST®, the First Rapid Test Designed to Aid in the Diagnosis of Acute Ischemic Stroke
22/06/2026
FAIR HAVEN, N.J. and ITHACA, N.Y., June 22, 2026 (GLOBE NEWSWIRE) -- TETmedical, Inc., a clinical stage medical diagnostics company developing rapid tools for diagnosing acute neurological injury based on its patented [...]
Atsena Therapeutics Doses First Patient and Reports Rapid Early Enrollment in Pivotal Trial of ATSN-201 for X-Linked Retinoschisis
22/06/2026
Enrollment expected to complete Q1 2027; topline results anticipated 1H 2028; BLA filing targeted for 2H 2028 Phase 1/2 data demonstrated ATSN-201's ability to reverse structural damage to the retina and improve vision [...]
Novel Patented Myelin Drug-Discovery Strategy Targets Massive Unmet Need in Multiple Sclerosis
22/06/2026
AUSTIN, Texas, June 22, 2026 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage : Multiple sclerosis (“MS”) robs people of control over their own bodies — slowly, relentlessly and without a cure. More than 2.9 million [...]
Route 92 Medical Announces First Commercial Cases in Canada
22/06/2026
Procedures follow Health Canada Medical Device License for the Company’s advanced neurovascular portfolio More than 100,000 patients suffer from strokes annually in Canada WEST JORDAN, Utah, June 22, 2026 (GLOBE [...]
SeaStar Medical to Present at Upcoming Investor Summit Conference
22/06/2026
DENVER, June 22, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure [...]
Catheter Precision, Inc. Announces Allowance of Key Intellectual Property
22/06/2026
Eight New Patents Issued on Heart Failure Technology Three New Patents Granted on Vascular Closure Technology FORT MILL, S.C., June 22, 2026 (GLOBE NEWSWIRE) -- Catheter Precision, Inc. (VTAK: NYSE/American), today [...]
GuideAI Health Receives FDA 510(k) Clearance for VascularAssist Occlusion Triage
22/06/2026
AI-Powered Triage Software Helps Radiologists Identify and Prioritize Peripheral Vascular Disease in Lower-Extremity CT Imaging BOSTON, June 22, 2026 (GLOBE NEWSWIRE) -- GuideAI Health Corp. (" GuideAI " or the " [...]
Prime Medicine Receives U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for PM359 for the Treatment of Chronic Granulomatous Disease (CGD)
22/06/2026
-- RMAT designation granted based on Phase 1/2 clinical data, including results previously published in The New England Journal of Medicine, demonstrating PM359’s potential to address unmet need in p47 phox -deficient [...]
Nasus Pharma to Participate in the Zacks Life Sciences Investor Forum
22/06/2026
TEL AVIV, Israel, June 22, 2026 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products [...]
FibroBiologics Receives Notice of Allowance for U.S. Patent Covering Topical Fibroblast Spheroid Therapy for Wound Healing
22/06/2026
Allowed claims directly support the Company’s ongoing Phase 1/2 clinical trial of CYWC628 in patients with diabetic foot ulcers HOUSTON, June 22, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“ [...]
InterCure Secures NIS 22 Million in Private Placement Financing Led by Leading Pharma-Focused Hedge Funds
22/06/2026
● The funding includes investments commitments from key shareholders of the Company, including the Company’s CEO Alexander Rabinovich, as well as leading pharma-focused hedge funds, including Bennu Pharma Fund Ltd., [...]
Hyperion DeFi and Blockdaemon Partner to Expand Institutional Hyperliquid Staking Infrastructure
22/06/2026
DALLAS, June 22, 2026 (GLOBE NEWSWIRE) -- Hyperion DeFi, Inc. (NASDAQ: HYPD) (“Hyperion DeFi” or the “Company”), the first U.S. publicly listed DeFi company building on Hyperliquid, today announced that it has partnered [...]
Verrica Pharmaceuticals Announces First U.S. Patient Dosed in the Second Pivotal Clinical Trial (COVE-3) of its Phase 3 Program Evaluating YCANTH® (VP-102) for the Treatment of Common Warts
22/06/2026
– Development Partner Torii Pharmaceutical also recently announced dosing of the first Japanese patient in this trial evaluating YCANTH (TO-208) in Japan – – Verrica maintains ownership of global rights to YCANTH for [...]
St. Augustine Dentist Explains Why Replacing Missing Teeth Can Support Long-Term Oral Health
22/06/2026
Educational initiative highlights treatment options that may help restore chewing function, speech, and long-term dental health for residents of St. Augustine and St. Johns County ST. AUGUSTINE, Fla., June 22, 2026 ( [...]
Taysha Gene Therapies Announces Completion of Dosing in REVEAL Pivotal Trial and Reports Longer-Term Clinical Data from Part A of REVEAL Phase 1/2 Trials Evaluating TSHA-102 for Rett Syndrome
22/06/2026
Completed dosing of 17 patients in REVEAL pivotal trial; topline data from 6 ‑ month interim analysis and FDA feedback on next steps toward BLA submission pathway expected 1H 2027 TSHA-102 was generally well-tolerated [...]
Praxis Precision Medicines Receives FDA Breakthrough Therapy Designation for Elsunersen for the Treatment of Seizures Associated with SCN2A Developmental and Epileptic Encephalopathy Caused by Gain of Function Variants
22/06/2026
The Breakthrough Therapy Designation (BTD) was granted based on the positive results from the EMBRAVE Part A trial of elsunersen Elsunersen demonstrated a 77% sham-adjusted reduction in monthly seizures (p=0.015), with [...]

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