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Dualitas Advances Bispecific Antibodies with $65M Series A to Tackle Autoimmune Diseases
Dualitas Therapeutics secured $65 million in Series A funding to drive the development of bispecific antibodies that simultaneously engage two immune cell targets. This proximity biology-based...
Endpoints 11: Highlighting AI-Driven and Cell Therapy Startups Defining 2025 Biotech
The 2025 Endpoints 11 list spotlights 11 private biotech companies driving innovation across AI-powered drug design, in vivo CAR-T therapies, and autoimmune disease treatments. Notable recipients...
Roche to Acquire 89bio for $3.5B, Eyeing MASH and Metabolic Disease Leadership
Roche announced a definitive agreement to acquire 89bio for up to $3.5 billion, centered on 89bio’s lead candidate pegozafermin, a fibroblast growth factor 21 (FGF21) analogue in Phase III for...
Cellares and Partners to Enhance Cell Q Platform for High-Throughput Cell Therapy Quality Control
Cellares has forged partnerships with leading technology providers including Tecan, Advanced Instruments, Cytek Biosciences, and Slingshot Biosciences to expand and automate its Cell Q platform....
Regeneron’s Lynozyfic Shows 100% Response in Early Study for Smoldering Multiple Myeloma
Regeneron Incorporated reported compelling early clinical data demonstrating 100% response rate in a small study of its T cell engager drug Lynozyfic in patients with smoldering multiple myeloma,...
New Subcutaneous GLP-1 Diabetes Treatment Recommended by CHMP for EU Approval
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Bayer’s Lynkuet (elinzanetant), a dual neurokinin-1 and neurokinin-3 receptor antagonist for treating...
U.S. CDC Advisory Panel Delays Vote on Hepatitis B Birth Dose Amid Safety and Necessity Concerns
The Advisory Committee on Immunization Practices (ACIP), restructured by Health and Human Services Secretary Robert F. Kennedy Jr., postponed the vote on whether to delay the hepatitis B vaccine...
FDA Clears Stealth's Barth Syndrome Therapy: First Mitochondria-Targeted Option
The FDA has granted long-awaited approval to Stealth Therapeutics' novel treatment for Barth syndrome, marking the first mitochondria-targeted therapy available for this rare genetic disorder....
FDA Approves Subcutaneous Keytruda and Berahyaluronidase Combination
The FDA has approved a subcutaneous formulation of Merck's Keytruda (pembrolizumab) in combination with berahyaluronidase alfa-pmph, expanding administration options for this leading...
GenFleet Therapeutics' IPO Doubles on Hong Kong Debut
GenFleet Therapeutics (Shanghai) completed a successful initial public offering on the Hong Kong Stock Exchange, raising approximately $234 million. The company's shares surged over 100% on the...
Dualitas Raises $65 Million for Bispecific Antibody Autoimmune Therapies
Dualitas Therapeutics secured $65 million in Series A funding to advance its bispecific antibody platform targeting two immune cell surface proteins simultaneously. This proximity biology approach...
Cellares Expands Automated QC Platform for Commercial Cell Therapy Scale-Up
Cellares announced strategic partnerships with technology providers including Tecan, Advanced Instruments, and Cytek Biosciences to enhance its Cell Q automated quality control platform for cell...
QL Biopharm’s Monthly GLP-1 Agonist Zovaglutide Hits Phase II Obesity Trial Endpoints
Chinese biotech QL Biopharm reported that its once-monthly GLP-1 receptor agonist, zovaglutide (ZT-002), met primary and secondary endpoints in a randomized, placebo-controlled phase II obesity...
House Committee Advances Bill to Restore Rare Pediatric Disease Priority Review Vouchers
The U.S. House Energy and Commerce Committee voted unanimously (47-0) to advance the Give Kids a Chance Act of 2025, aiming to reinstate the Rare Pediatric Disease Priority Review Voucher (RPD...
Roche Completes $3.5 Billion Acquisition of 89bio for Fatty Liver Disease Treatment
Roche announced a definitive agreement to acquire 89bio for up to $3.5 billion, including upfront cash of $2.4 billion and milestone payments. 89bio's lead asset, pegozafermin, is an FGF21 analog...
Regeneron’s Lynozyfic T Cell Engager Shows 100% Response in Smoldering Multiple Myeloma
Regeneron reported promising early clinical data demonstrating a 100% response rate for Lynozyfic, its T cell engager therapy, in a study of small smoldering multiple myeloma patients. This...
Advances in AI-Driven Protein Design Secured $43.6 Million NIH Grant for Clinical Research
The University of Arizona and University of New Mexico together secured a combined $43.6 million NIH grant to support a collaborative initiative aimed at advancing translational clinical research...
FDA Approves Subcutaneous Keytruda and Other Cancer Therapies
The U.S. FDA has approved a subcutaneous formulation of Merck's Keytruda, aiming to extend the market life of the world's top-selling cancer drug by easing administration. This new approval comes...
Stealth Therapeutics Secures FDA Approval for Barth Syndrome Treatment
Stealth Therapeutics attained a long-awaited FDA approval for its mitochondrial-targeted therapy designed to treat Barth syndrome, marking a milestone for this rare genetic disorder. Barth...
Dualitas Therapeutics Raises $65M for Bispecific Antibody Development
Dualitas Therapeutics announced a $65 million Series A financing to advance its bispecific antibody platform targeting immune and inflammatory diseases. The company’s technology leverages...