COMMUNIQUÉS West-GlobeNewswire

Ceribell Secures CMS New Technology Add-On Payment (NTAP) for Breakthrough Point-of-Care Delirium Monitor System
03/08/2026
Incremental NTAP Reimbursement Stands to Broaden Access to First-of-Its-Kind Dual Seizure and Delirium Monitoring Platform SUNNYVALE, Calif., Aug. 03, 2026 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell” [...]
Adlai Nortye Announces Clinical Trial Notification Submission and HREC Approval for the Phase I Clinical Trial of Pan-RAS(ON) Inhibitor ADC AN4035 in Australia
03/08/2026
First-in-class pan-RAS(ON) ADC is cleared for clinical development Designed to selectively deliver pan-RAS(ON) inhibition to tumors while minimizing systemic toxicity. IND submissions to U.S. FDA and China NMPA are in [...]
Ocular Therapeutix™ Reports Second Quarter 2026 Financial Results and Business Highlights
03/08/2026
Ocular’s AXPAXLI TM wet AMD NDA submission on track for Q4 2026 following positive Type C Meeting with the U.S. FDA in May 2026 FDA Type C Meeting Minutes Formalize SOL-1 Trial with Confirmatory Evidence as Sufficient [...]
Tonix Pharmaceuticals Announces Positive Minutes from Type C FDA Meeting to Discuss Adaptive Phase 2 Field Study of TNX-4800, a Human, anti-OspA Monoclonal Antibody, to Prevent Lyme Disease in the U.S.
03/08/2026
Alignment with FDA on key elements of the study design support planned start of the Phase 2 study in the first quarter of 2027 Long-acting monoclonal antibody TNX-4800 is a rapidly acting alternative to vaccination [...]
Opus Genetics Completes Patient Enrollment in Registrational Phase 3 Trial of OPGx-LCA5 for LCA5-Associated Inherited Retinal Disease
03/08/2026
Topline six-month efficacy data expected by end of 2027 Phase 3 study follows FDA alignment on registrational trial design through Rare Disease Evidence Principles (RDEP) program Opus Genetics may submit a BLA based on [...]
Can-Fite Launches First Clinical Program for Piclidenoson in the Rare Genetic Disease Lowe Syndrome
03/08/2026
Phase 2 clinical study protocol submitted; Small Phase 2 study designed to support regulatory interactions and potential registration upon positive results Ramat Gan, Israel, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Can-Fite [...]
TG Therapeutics Reports Second Quarter 2026 Financial Results and Raises BRIUMVI® Revenue Guidance
03/08/2026
Second quarter 2026 total global revenue of approximately $240 million, including BRIUMVI U.S. net product revenue of approximately $228 million Raises full year 2026 total global revenue target to approximately $950 [...]
Eton Pharmaceuticals to Report Second Quarter 2026 Financial Results on Thursday, August 13, 2026
03/08/2026
DEER PARK, Ill., Aug. 03, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare [...]
Supernus Announces Second Quarter 2026 Financial Results
03/08/2026
Total revenues were $219.1 million in the second quarter 2026, a 32% increase compared to same period last year. Combined revenues of the Company's four growth products increased to $175.7 million in the second quarter [...]
Indivior Reports Second Quarter 2026 Financial Results and Raises Full-Year 2026 Guidance
03/08/2026
• Q2’26 Total Net Revenue of $ 343 Million, Up 14% YoY • Record Quarterly Total SUBLOCADE® Net Revenue of $ 253 Million in Q2'26, Up 21% YoY • Record Quarterly GAAP Net Income of $122 Million and Record Non-GAAP Net [...]
NRG Therapeutics Announces the Appointment of Claus Sundgreen M.D. as Chief Medical Officer
03/08/2026
STEVENAGE, United Kingdom, Aug. 03, 2026 (GLOBE NEWSWIRE) -- NRG Therapeutics Ltd. (“NRG”), a clinical stage neuroscience company developing novel disease-modifying therapeutics that rectify mitochondrial dysfunction in [...]
Aravax Awarded FDA Fast Track Designation for PVX108, a Next-Generation Immunotherapy for the Treatment of Peanut Allergy
03/08/2026
MELBOURNE, Australia and OXFORD, United Kingdom, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Aravax, a clinical-stage biotechnology company developing next-generation, disease-modifying immunotherapies for food allergy, today [...]
Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses
03/08/2026
The FDA Division of Neurology provided positive feedback supporting a regulatory pathway for Privosegtor in acute multiple sclerosis (MS) relapses, addressing a significant unmet medical need The FDA confirmed that [...]
Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses
03/08/2026
ZUG, Switzerland, Aug. 03, 2026 (GLOBE NEWSWIRE) -- The FDA Division of Neurology provided positive feedback supporting a regulatory pathway for Privosegtor in acute multiple sclerosis (MS) relapses, addressing a [...]
Klow Peptide Stack Introduced by Kylo Peptides for Laboratory Research in 2026
03/08/2026
Each vial in the stack is released after ISO/IEC 17025 testing. A lot-matched Certificate of Analysis is published on the website. Sheridan, WY, Aug. 03, 2026 (GLOBE NEWSWIRE) -- Kylo Peptides today introduced the KLOW [...]
Leads Biolabs' PD-L1/4-1BB Bispecific Antibody IND Application for Combination Therapy in Metastatic Colorectal Cancer Approved, Further Strengthening Gastrointestinal Oncology Franchise
03/08/2026
NANJING, China, Aug. 02, 2026 (GLOBE NEWSWIRE) -- Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) today announced that the Center for Drug Evaluation (CDE) of the National Medical [...]
Ascentage Pharma Appoints Dr. Faiçal Miyara as Chief Business Officer and Jim Ziegler as Chief Commercial Officer
03/08/2026
Appointments put dedicated leadership behind two separate priorities: building Ascentage Pharma’s own commercial organization in the United States, and expanding its global business development program ROCKVILLE, Md., [...]
NOX Peptides Releases Updated Quality and Testing Information for Wolverine Stack Research Blend
02/08/2026
Toronto, Canada, Aug. 02, 2026 (GLOBE NEWSWIRE) -- NOX Peptides has released updated quality assurance and testing information for the Wolverine Stack research blend, providing additional transparency regarding product [...]
We The Billions Launches Personalized Cognitive Care Focused on How Each Brain Works
02/08/2026
Speech-language pathologist Sanna Darwish says understanding how a brain works, not just what diagnosis it may carry, could reshape the future of cognitive care. Clarksville, MD, Aug. 01, 2026 (GLOBE NEWSWIRE) -- We The [...]

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