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Biotech IPOs and public-market access
A new wave of biotech companies is lining up for public-market debut as IPO conditions appear to improve, according to recent dealflow notes. Braveheart Bio filed for a Nasdaq debut, positioning...
Regulatory: FDA credibility and pricing oversight pressures
Two regulatory storylines underscore mounting pressure on US oversight systems. In one report, BioCentury says FDA used an informal channel to disavow remarks attributed to acting commissioner...
Clinical pipeline: chronic cough setbacks and therapy reprioritization
GSK shelved its chronic cough bet camlipixant after mixed Phase 3 results in refractory chronic cough, according to company-linked reporting. Calm-1 met its primary endpoint at week 12 with cough...
Clinical trials: pancreatic cancer prevention vaccine hits early milestone
A KRAS-targeted vaccine demonstrated early safety and immunogenicity in a first-in-human pancreatic cancer interception study, reported in Cancer Discovery. The peptide vaccine (mKRAS-VAX)...
Gene therapy and neurobiology: DMD and next-step trial planning
Sarepta is preparing a second Phase 3 registration-enabling attempt for Elevidys after EMA denied marketing authorization, pushing the gene-therapy timeline back for Duchenne muscular dystrophy...
AI drug discovery: funding and platform scale-up
Chai Discovery raised $400 million in Series C to accelerate AI-powered drug design, according to the reported financing terms. The company says its models generate de novo molecular designs and...
Capital and M&A: larger deals and targeted acquisitions
Biopharma dealmaking in mid-2026 continues to set pace, with reporting citing a record-breaking first half of M&A value through June. Separately, Dimerix acquired Mission Therapeutics’ acute...
Diagnostics and precision oncology: blood test selection for radiopharmaceutical therapy
Researchers report that circulating tumor DNA profiling can help select patients for radium-223 therapy in metastatic castration-resistant prostate cancer. The analysis, published in The Journal...
Clinical updates: PAH maintenance signal in long-term extension
Insmed reported further durability data for its once-daily pulmonary arterial hypertension therapy TPIP via an open-label extension of a Phase IIb trial. The treated-arm benefits were maintained...
Compounding and shortages: GLP-1 supply chain scrutiny
A new investigation suggests compounded GLP-1 products remain widely used even as shortages for semaglutide and tirzepatide ease. Researchers, writing in JAMA Health Forum, examined compounding...
Oncology clinical update: PDAC interception immune milestone
A mutant KRAS peptide vaccine cleared its first-in-human safety and immunogenicity bar in high-risk pancreatic cancer cohorts, according to Phase I data published in Cancer Discovery....
Regulatory and development risk: GSK’s camlipixant chronic cough exit
GSK is ending development of camlipixant in refractory chronic cough after mixed results across two Phase 3 studies, the company said as it moves away from a program that had drawn blockbuster...
EU access push for Duchenne gene therapy: Sarepta adds Phase III for EMA
Sarepta Therapeutics launched an additional Phase III trial intended to address regulatory concerns from the European Medicines Agency for Elevidys in Duchenne muscular dystrophy. The EMA denied...
AAV delivery platform collaboration for stronger protein expression from gene therapy
Circio Holding and Avenue Biosciences entered a research collaboration aimed at improving long-term secretion of proteins produced using Circio’s circVec platform. The partnership focuses on...
Company financing and market momentum: Braveheart charts Nasdaq debut plan
Braveheart Bio filed for an initial public offering, setting out a path to scale its lead oral cardiac myosin inhibitor, BHB-1893, for hypertrophic cardiomyopathy. The company plans to advance...
Venture funding: Chai’s $400M Series C for AI drug discovery
Chai Discovery raised $400 million in Series C financing, pushing its valuation to $3.8 billion, the company said. The San Francisco AI platform generates de novo molecular designs and is already...
M&A and diagnostics footprint expansion: Danaher’s Leica to buy Statlab
Leica Biosystems, part of Danaher, agreed to buy Statlab Medical Products to expand Leica’s diagnostics and anatomical pathology consumables and instrument offerings. Financial terms were not...
Financing and pipeline scale-up in DMD and cardiac: Sarepta trial plus Insmed extension
Insmed added longer-term support for its pulmonary arterial hypertension therapy TPIP (treprostinil palmitil inhalation powder), reporting data from an open-label extension of a Phase IIb trial....
Regulatory and market structure: White House meeting on CMS pricing models
Midsize biotech companies met with White House and HHS officials to argue against two pending CMS pricing models they say could hinder their businesses. The companies’ outreach centers on how...
Sepsis critical-care refinement: renal resistive index guides blood pressure targets
A randomized trial tested whether renal resistive index (RRI) can refine blood pressure targets in sepsis care, with investigators reporting an approach designed to individualize mean arterial...