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PTC Therapeutics’ Friedreich’s Ataxia Drug Rejected by FDA
PTC Therapeutics received a complete response letter from the FDA rejecting its Friedreich’s ataxia drug vatiquinone, citing insufficient evidence of efficacy in the phase III Move-FA trial....
Anocca Raises $46M to Advance Genome-Edited TCR T-cell Pancreatic Cancer Therapy
Sweden-based Anocca AB secured $46 million (SEK 440 million) to fund a phase I trial of its CRISPR-edited T-cell receptor (TCR) therapy, VIDAR-1, targeting mutant KRAS in pancreatic ductal...
Stealth BioTherapeutics Resubmits FDA Application for Rare Barth Syndrome Drug
Stealth BioTherapeutics has resubmitted its investigational drug for Barth syndrome to the FDA after a previous rejection in May. The company aims to address the agency’s concerns with new data...
George Church’s Lab Advances Creation of Human Eggs In Vitro
Researchers at Harvard University led by George Church have developed a stem cell differentiation method that induces meiosis, progressing toward the generation of human eggs in a dish. This...
Natera Reports Survival Benefit Using Signatera in Bladder Cancer Trial
Natera announced statistically significant improvement in disease-free and overall survival for Signatera-positive patients receiving Genentech’s Tecentriq in the Phase III IMvigor011 trial for...
Daewoong’s Microneedle Patch Delivers Weekly Semaglutide with High Bioavailability
Daewoong Pharmaceutical Co. Ltd. and Daewoong Therapeutics Inc. achieved 80% relative bioavailability of semaglutide via a self-developed microneedle patch in a pilot human pharmacokinetic study....
Biopharma Dealmaking Surges with Record $164 Billion Activity in 2025
In the first seven months of 2025, non-M&A biopharma deal activity soared to $164.03 billion, a 36% increase over the same period in 2024 and reaching record levels. Despite fewer transactions,...
Remegen’s Telitacicept Meets Phase III Endpoint in Sjögren's Syndrome
Remegen Co. Ltd. reported that telitacicept (RC-18) achieved the primary endpoint in a Phase III trial for primary Sjögren's syndrome, an autoimmune disease causing dry eyes and mouth. The company...
FDA Delays and Drug Approvals Shake Rare Disease and Gene Therapy Landscape
Regulatory shifts are impacting the rare disease and gene therapy sectors. The FDA has delayed its decision on Regenxbio’s gene therapy for Hunter syndrome by three months, prolonging uncertainty...
Merck KGaA and Skyhawk Team Up for $2B RNA Neurological Drug Program
Merck KGaA partnered with RNA-focused biotech Skyhawk Therapeutics in a collaboration potentially worth up to $2 billion targeting neurological diseases. Skyhawk will leverage its SkySTAR platform...
Novo Nordisk’s Wegovy Gains FDA Label Expansion for Fatty Liver Disease MASH
Novo Nordisk's GLP-1 agonist Wegovy received accelerated FDA approval for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), expanding its label to a patient population...
Viking Therapeutics’ Oral Obesity Drug Shows Mixed Phase 2 Results, Stock Falls
Viking Therapeutics reported Phase 2 data for VK2735, an oral obesity drug demonstrating up to 12.2% weight loss after 13 weeks at the highest dose. While efficacy met statistical benchmarks, high...
AI Advances Propel Drug Delivery and Protein Design Innovations
Researchers harnessed artificial intelligence to revolutionize RNA vaccine and drug delivery design, using machine learning to accelerate lipid nanoparticle (LNP) formulation, yielding candidates...
Breakthroughs in Plant Biology and Sustainable Biomaterials
Multiple studies are advancing plant science and biomaterials. Researchers at University of Missouri revealed how poplar trees dynamically regulate lignin composition in response to environmental...
New Therapeutic Strategies and Diagnostics in Oncology and Neurodegeneration
Recent oncology and neurodegenerative disease research unveiled promising findings. Moffitt Cancer Center discovered a combination therapy to overcome immunotherapy resistance in melanoma. In...
Innovations in Medical Devices and Regenerative Medicine
Innovations in medical technology and regenerative therapies are progressing. Ochsner Children’s conducted the first robotic-assisted pediatric spine surgery in Louisiana enhancing precision and...
Biotech Financing and Market Trends Reflect Sector Challenges and Opportunities
Financing activities and market analyses reveal sector dynamics. Gene therapy company Kriya Therapeutics raised $313 million to support clinical advancement amid waning investor enthusiasm in the...
Novo Nordisk Expands Wegovy Indication to Fatty Liver Disease MASH
Novo Nordisk has secured FDA accelerated approval for Wegovy, its GLP-1 drug, to treat metabolic dysfunction-associated steatohepatitis (MASH), a common variant of fatty liver disease. The new...
Kriya Therapeutics Raises $313M to Advance Gene Therapy Pipeline
Kriya Therapeutics, a U.S.-based gene therapy company, has completed a $313 million Series financing, one of the largest private biotech fundraises of the year. The company focuses on developing...
Adaptive Biotechnologies and Genentech End $2B Cancer Cell Therapy Collaboration
After over six years of partnership, Adaptive Biotechnologies and Genentech are winding down their $2 billion strategic collaboration focused on personalized cancer cell therapies using T cell...