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Pancreatic cancer interception via KRAS-targeted vaccination
A first-in-human Phase I study of a peptide vaccine targeting common mutant KRAS variants (mKRAS-VAX) advanced pancreatic cancer prevention by showing safety and immune activation in high-risk...
Merck wins first oral PCSK9 approval in the US
The FDA approved Merck’s first oral PCSK9 inhibitor, Lipfendra (enlicitide), expanding cholesterol-lowering options beyond injectable PCSK9 antibodies. The oral macrocyclic peptide is designed to...
Lilly makes a major move into psychedelics via AtaiBeckley
Eli Lilly agreed to buy psychedelics developer AtaiBeckley for $2.8 billion upfront, adding a late-stage Phase IIb psychedelic program to its neuroscience portfolio. Under the deal, Lilly will pay...
GSK exits chronic cough program after mixed Phase 3 results
GSK ended development of camlipixant, a P2X3 receptor antagonist bought through its Bellus Health acquisition, after mixed Phase 3 outcomes in adults with refractory chronic cough. While Calm-1...
Regulatory pressure: CMS pricing rules face pushback from midsize biotechs
Midsize biotech companies pressed the White House and HHS to drop pending CMS pricing models, arguing the rules could hinder business operations. The companies’ outreach followed concerns that...
Duchenne gene therapy: Sarepta launches new Phase 3 to satisfy EMA after Elevidys denial
Sarepta launched a second Phase III clinical trial for Elevidys (delandistrogene moxeparvovec) aimed at addressing European Medicines Agency concerns. EMA previously denied marketing authorization...
Juno Bio funds and expands to CLIA sequencing for women’s vaginal microbiome
Juno Bio raised $3.8 million to support vaginal health and opened/expanded clinical testing capabilities for its sequencing-based vaginal microbiome assay. The round was backed by Ada Ventures,...
Advancements in radiopharmaceuticals and isotope supply financing
Advancell secured an oversubscribed $315 million Series D round to accelerate its radiopharma buildout, funding late-stage clinical development and expanding isotope supply and manufacturing...
AI-led drug discovery funding: Chai Discovery raises $400M
Chai Discovery raised $400 million in Series C financing, pushing the company to a $3.8 billion valuation as pharma continues adopting AI-native chemistry platforms. The company says its models...
Orum Therapeutics targets GSPT1 degradation with DACs to widen therapeutic window
Orum Therapeutics presented its strategy to extend the therapeutic window for GSPT1 degradation using antibody-mediated delivery conjugates (DACs). GSPT1 degradation has been recognized as a...
Oncology therapeutics: chronic cough pivot at GSK
GSK is ending development of camlipixant, a P2X3 receptor antagonist acquired in its $2 billion Bellus Health deal, after mixed Phase 3 results in refractory chronic cough. The company said the...
FDA approval: first oral PCSK9 option for LDL reduction
The FDA approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) to lower LDL cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. The...
Biotech IPOs: Braveheart begins Nasdaq debut runway
Braveheart Bio filed for a Nasdaq listing, setting up an IPO path for its oral cardiac myosin inhibitor program BHB-1893 in hypertrophic cardiomyopathy. The company said it will use proceeds to...
Cancer prevention immunotherapy: mutant KRAS vaccine hits Phase 1 proof-of-concept
A Phase 1 study of a peptide vaccine targeting six common mutant KRAS variants (mKRAS-VAX) reported safety and immunogenicity results in high-risk pancreatic cancer cohorts. In 20 participants,...
Regulatory / pricing: midsize biotech pushes White House on CMS payment rules
Midsize biotech companies met with White House and HHS officials to argue against pending CMS pricing models they say could constrain business. The dispute centers on how CMS will structure...
Venture funding: AdvanCell raises to scale radiopharma manufacturing and Phase 3 readiness
AdvanCell raised a $315 million Series D round to accelerate late-stage development of its radiopharmaceutical program and to expand manufacturing and isotope capabilities. The financing supports...
M&A: Leica expands pathology footprint with Statlab acquisition
Leica Biosystems agreed to buy Statlab Medical Products to broaden Danaher’s diagnostics and anatomical pathology consumables and instruments portfolio. Financial terms were not disclosed, but...
Women’s health diagnostics: Juno Bio adds funding and opens CLIA sequencing lab
Juno Bio raised $3.8 million and opened a CLIA-certified sequencing laboratory in Oakland to expand capacity for its vaginal microbiome assay. The company said the test profiles roughly 10,000...
AI drug discovery financing: Chai lands $400M Series C to scale de novo molecule design
Chai Discovery secured $400 million in Series C financing, pushing the company’s valuation to $3.8 billion and expanding its AI-first approach to generating de novo molecular designs. The company...
FDA/clinical strategy: Elevidys heads back to Europe with a second Phase 3 attempt
Sarepta launched an additional Phase 3 trial intended to address European Medicines Agency concerns about Elevidys for Duchenne muscular dystrophy. The EMA previously denied marketing...