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Phase 3 progress risk/reward in breast cancer PI3K/mTOR
Celcuity’s gedatolisib cleared a major trial milestone in Phase 3 breast cancer testing by hitting its primary endpoint, lifting the company toward a regulatory filing for a second submission. The...
Replimune’s oncolytic therapy faces FDA rejection after breakthrough designation
The FDA rejected Replimune’s oncolytic immunotherapy RP1 twice despite the program’s breakthrough therapy designation, according to reporting. The therapy is a modified herpesvirus injected...
Gene therapy startup financing to start Huntington’s and CLN2 programs
Latus Bio raised $42 million to fund its first clinical trials, aiming to work around setbacks that have hit a more advanced competitor in the gene therapy space. The startup is moving two...
Regulatory-era impact on oncology stock after reported death in trial
Erasca’s shares slid 53% after the company disclosed a patient death during ERAS-0015 development, according to StockWatch reporting. The oral pan-RAS molecular glue reported unconfirmed overall...
Clinical dataset expands evidence for selective RET inhibitor in JCO
Rigel Pharmaceuticals published final long-term results from the Phase 1/2 ARROW study of pralsetinib (GAVRETO) in Journal of Clinical Oncology, extending follow-up by an additional 42 months. The...
Protein-enrichment platform gains Wall Street focus amid throughput push
Canaccord Genuity initiated coverage of Seer with a Buy rating and a $4 price target, citing rising adoption of the firm’s proteomics technology and ongoing product improvements. Analyst Kyle...
AI-driven synbio approach trims the amino-acid toolkit in engineered E. coli
Researchers published in Science that used AI-guided design to partially eliminate isoleucine usage in engineered Escherichia coli ribosome proteins by substituting alternatives across dozens of...
Digital twins of human lungs quantify therapeutic efficacy from EVLP data
Researchers developed computational “digital twins” of ex vivo human lungs using a large clinical ex vivo lung perfusion (EVLP) dataset, and reported that the models can assess therapeutic...
Corporate M&A in immunology
UCB announced it will acquire Candid for $2.2B, placing a large bet on Candid’s antibody assets aimed at autoimmune diseases. The deal centers on a portfolio of bispecific and related biologic...
Oncology pipeline: RET+ NSCLC durability update
Rigel Pharmaceuticals published final data from its Phase 1/2 ARROW trial of pralsetinib (Gavreto) in metastatic RET fusion-positive NSCLC in the Journal of Clinical Oncology. The update adds 42...
Regulatory decision: FDA rejection of melanoma oncolytic therapy
Replimune’s RP1 oncolytic immunotherapy has faced additional regulatory setbacks after the FDA rejected the therapy twice, despite prior breakthrough-style emphasis in its clinical development....
Equity market shock: adverse-event disclosure weighs on Erasca
Erasca shares fell after the company disclosed a patient death tied to an adverse event in a previously shared dose-escalation dataset for ERAS-0015. The disclosure surfaced in investor materials...
Biotech IPO market: April fundraising surge
Four biotech IPOs raised $1.5B in April, the biggest monthly tally in more than five years, according to Renaissance Capital. The new listings included Hemab Therapeutics and Seaport Therapeutics,...
Neonatal immunology: CD44+ monocytes in BPD
Researchers reported new immunology findings implicating CD44+ monocytes in bronchopulmonary dysplasia (BPD) in very premature infants. The work focuses on hyperinflammation in BPD, a chronic lung...
Therapeutic innovation platform: digital twins for ex vivo lung therapy
A research team reported that digital twins built from ex vivo human lung perfusion (EVLP) data can model therapeutic effects with high fidelity. Using a large clinical EVLP dataset, the...
Biopharma enabling science: cost-effectiveness of AI breast screening
Researchers published an economic evaluation in the British Journal of Cancer assessing whether adding AI to the UK breast screening pathway is cost-effective. The analysis compared AI-driven...
Drug discovery tooling: data strategy for AI-driven repurposing
A technical piece on AI drug repurposing argued that performance bottlenecks often come from fragmented or inconsistent foundational data rather than insufficient model scale. The article...
Research approach: synbio AI design of altered life
Researchers reported in Science that AI helped create an engineered bacterium partially missing a universally used amino acid building block. The team used AI to propose alternatives to isoleucine...
Biotech funding and public market activity
Four biotech IPOs raised $1.5B in April, the biggest month in more than five years, according to Renaissance Capital. Hemab Therapeutics and Seaport Therapeutics joined the public markets with...
Clinical progress: solid tumor oncology
Rigel Pharmaceuticals published final 42-month follow-up from its Phase 1/2 ARROW study of pralsetinib (GAVRETO) in RET fusion-positive metastatic NSCLC in the Journal of Clinical Oncology. The...