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Migraine monetization and pipeline reshuffling
Slate Medicines announced a reverse merger with Fulcrum Therapeutics and a $245 million financing to build out a migraine pipeline after Fulcrum exited its sickle cell program. The combined plan...
Wet AMD setbacks and competitive pressure
Eyepoint’s Phase 3 program for Duravyu (vorolanib intravitreal insert) missed its primary goal, failing to show sustained vision maintenance with less frequent injections versus standard dosing....
Autoimmune myositis expansion for Vyvgart Hytrulo
Argenx reported late-stage Phase 3 top-line results for Vyvgart Hytrulo (subcutaneous efgartigimod alfa) in autoimmune myositis, with statistical significance in a combined study that included...
Cold-stored platelets approach durable storage window
A JAMA-published adaptive clinical trial from University of Pittsburgh physician-scientists found refrigerated, chilled platelets can remain effective for up to 21 days, expanding the available...
Big Pharma trial failures in lung cancer
AstraZeneca ended a Phase 3 trial of volrustomig after an interim data check indicated it was unlikely to meet survival endpoints when combined with chemotherapy. The decision adds to a series of...
Gene therapy litigation over FDA timing
A U.S. court cleared the path for a trustee suit alleging Bristol Myers Squibb delayed FDA approval of Breyanzi, a gene therapy for non-Hodgkin lymphoma, to avoid milestone payments tied to its...
Precision gene editing services: improving CRISPR off-target nomination
Integrated DNA Technologies (IDT) introduced a workflow aimed at improving CRISPR off-target site nomination, using UNCOVERseq to streamline the jump from high-throughput discovery to targeted...
Cell-free DNA toxicity monitoring
Tagomics is aiming to improve drug safety monitoring with a new cell-free DNA blood test built on its LiquiPath platform. The company’s approach uses tagging and enrichment of unmethylated genomic...
Gene-edited pets and allergy risk
Early testing suggests gene-edited beagles produce no detectable major dog allergen, Can f 1, addressing a key driver of dog allergy symptoms. The result, based on preliminary assessments, targets...
Autoimmunity and immunotherapy platform economics
Fresenius announced a €200 million corporate venture capital fund to back emerging biotech talent through its Fresenius Ventures program over the next five years. The structure is designed to...
Argenx expands Vyvgart reach in autoimmune myositis with new Phase 3 readout
Argenx reported positive late-stage results for Vyvgart Hytrulo (subcutaneous efgartigimod) in a Phase 3 program across adults with myositis, aiming to broaden use of the Vyvgart franchise. The...
AstraZeneca pulls lung cancer bispecific trial after interim survival check
AstraZeneca halted a Phase 3 lung cancer study of volrustomig after an interim data review suggested survival goals were likely to be missed. The discontinuation follows a broader pattern of...
EyePoint fails pivotal Phase 3 in wet AMD – stock reels
EyePoint reported unfavorable pivotal Phase 3 results for its experimental therapy in wet age-related macular degeneration (wet AMD), undermining the case for approval against the current standard...
Caris/CRO data infrastructure: new standardized subject ID schema aims to reduce duplication across portfolios
Researchers described a portfolio-wide standardized clinical trial subject ID schema designed to solve CRO and sponsor tracking problems caused by study-specific identifier conventions. The paper...
Systems medicine for cancer models: Jackson Laboratory promotes improved humanized platforms
The Jackson Laboratory highlighted how next-generation immuno-oncology modeling platforms aim to better reflect the tumor microenvironment for therapy development. The focus is on improving...
Precision oncology resources: tumor-derived organoid biobank maps gene dependencies across cancer types
A new tumor-derived organoid biobank created and publicly characterized 256 clinically annotated organoid models spanning colorectal, oesophageal, ovarian, pancreatic, and gastric cancers, paired...
Oncology innovation: virus-like particles expand gene engineering and pooled CRISPR screening in primary myeloid cells
Researchers reported a virus-like particle approach designed to improve gene engineering and enable pooled CRISPR screening in primary human myeloid cells, including monocytes, macrophages, and...
Regulatory and commercialization planning: Celcuity waits for FDA review on second factory for approved cancer drug
Celcuity disclosed that it is awaiting FDA review for a second manufacturing site after the company’s recently approved cancer drug’s commercial rollout progressed more slowly than investors...
Biopharma funding and market access: reverse merger wave targets public listings and trial capital
Slate Medicines agreed to combine with Fulcrum Therapeutics in a reverse merger, aiming to move toward a Nasdaq listing while financing migraine development. The deal follows Fulcrum’s earlier...
Bank coverage and commercialization momentum: Freenome initiates coverage with buy ratings as Abbott and Roche deals underpin cancer screening push
Jefferies and BTIG initiated coverage of Freenome with buy ratings, citing the scale of the addressable market for its cancer screening approach and pointing to commercialization partnerships. The...