COMMUNIQUÉS West-GlobeNewswire

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 [...]
Supernus Pharmaceuticals and Indivior Pharmaceuticals to Merge, Creating a Diversified CNS Biopharmaceutical Leader with Significant Scale
03/08/2026
Combines highly complementary businesses, with a diversified portfolio of CNS medicines totaling approximately $2.2 billion in combined annual revenues Enhanced financial position and free cash flow generation enabling [...]
Leo International Precision Health AG: PC Beteiligungsgesellschaft mbH, Allocation of 3.772.368 bonus shares pursuant to the capital increase from the company’s own funds, which was resolved at the issuer’s Annual General Meeting on 12...
03/08/2026
Leo International Precision Health AG: PC Beteiligungsgesellschaft mbH, Allocation of 3.772.368 bonus shares pursuant to the capital increase from the company’s own funds, which was resolved at the issuer’s Annual [...]
Leo International Precision Health AG: Mr Leo Wang, Allocation of 78,844,000 bonus shares pursuant to the capital increase from the company’s own funds, which was resolved at the issuer’s Annual General Meeting on 12 June 2026 and...
03/08/2026
Leo International Precision Health AG: Mr Leo Wang, Allocation of 78,844,000 bonus shares pursuant to the capital increase from the company’s own funds, which was resolved at the issuer’s Annual General Meeting on 12 [...]
BioNTech Announces Appointment of Guido Oelkers to Management Board as Chief Executive Officer
03/08/2026
Mainz, Germany, August 3, 2026 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that its Supervisory Board has appointed Guido Oelkers, Ph.D., to the Management Board as Chief [...]
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 [...]

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