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Pancreatic cancer (Phase 3 RAS inhibition)
Revolution Medicines reported “unprecedented” survival improvements with daraxonrasib in a Phase 3 registrational study in previously treated metastatic pancreatic ductal adenocarcinoma, setting...
CAR-T in lymphoma (off-the-shelf potential)
Allogene’s off-the-shelf CAR-T cema-cel showed strong early molecular responses in a Phase 2 futility analysis in first-line large B-cell lymphoma consolidation, with minimal residual disease...
Regulatory approval (first US therapy for FSGS)
The FDA expanded Travere Therapeutics’ Filspari label to include focal segmental glomerulosclerosis (FSGS), making it the first approved therapy in the US for the kidney disease. The update...
FDA oversight of clinical trial reporting (results transparency)
The FDA urged clinical trial sponsors and investigators to report results for registered studies after an internal review found that outcomes were missing for roughly 30% of registered clinical...
Federal funding for next-generation neuromodulation therapies (sonogenetics)
The Salk Institute announced a $41.3 million ARPA-H award to advance sonogenetics toward human clinical trials, starting with peripheral neuropathies. The grant will fund development of ultrasound...
BioNTech ADC momentum (Phase 2 success and FDA filing plans)
BioNTech reported positive Phase 2 results for trastuzumab pamirtecan (BNT323), an antibody-drug conjugate (ADC) it plans to advance with an FDA filing. The company said the clinical readout...
AI-driven drug discovery partnerships (Lilly + Insilico)
Eli Lilly signed a global R&D collaboration with Insilico Medicines worth up to $2.75 billion, expanding Lilly’s use of AI for oral therapeutic discovery. Under the agreement, Insilico receives an...
Takeda divestment in neurodegeneration (Denali rights return)
Takeda terminated its eight-year neuroscience partnership with Denali Therapeutics, returning full global rights to DNL593 to Denali. Takeda said the decision was driven by strategic...
Kidney/oncology innovation via gene editing platforms (in-body CRISPR delivery)
Researchers reported an engineered compact CRISPR system based on Al3Cas12f that is small enough for adeno-associated virus (AAV) vectors and designed for improved gene-editing performance in...
Antibiotics R&D (AI rediscovery of Halicin)
A new report on the “Halicin” story describes how an MIT machine-learning model re-screened a long-stored compound library and flagged Halicin as a potent antibiotic candidate. The compound had...
Pancreatic cancer - Phase 3 survival readout and regulatory path
Revolution Medicines reported interim and final results from its registrational Phase 3 RASolute 302 trial of daraxonrasib in metastatic pancreatic ductal adenocarcinoma, showing median overall...
Lymphoma - Allogene’s off-the-shelf CAR-T early futility analysis
Allogene Therapeutics shared early Phase 2 Alpha3 results for its off-the-shelf CAR-T cema-cel in first-line consolidation large B-cell lymphoma, reporting minimal residual disease (MRD)...
Inflammatory bowel disease - Spyre SPY001 Phase 2 ulcerative colitis results
Spyre Therapeutics reported early Phase 2 data for SPY001 in moderately to severely active ulcerative colitis, meeting the study’s primary objective after 12 weeks with a statistically significant...
Regulatory and policy - FDA leadership search and clinical trial reporting push
The FDA is moving toward leadership changes in biologics and vaccines oversight, with sources telling Endpoints News that the agency is narrowing its search for a director of the Center for...
Radiopharmaceuticals - Regeneron and Telix expand into next-gen theranostics
Regeneron entered radiopharmaceuticals through a collaboration with Telix Pharmaceuticals, agreeing to develop and co-commercialize multiple next-generation radiopharmaceutical programs. The deal...
Oncology funding - Sidewinder raises Series B for next-generation bispecific ADCs
Sidewinder Therapeutics closed a $137 million Series B to advance a pipeline of bispecific antibody-drug conjugates (ADCs) targeting multiple solid tumor indications. The round was co-led by...
Regulatory-era market access and payer pressure - Medicare Advantage spending linkage
A new analysis from the Elevance Health Public Policy Institute reports that growth in Medicare Advantage (MA) enrollment is associated with lower total Medicare spending. The research frames MA...
Clinical trial pipeline - GSK’s gynecologic cancer ADC moves into Phase 3 testing
GSK plans to launch five Phase 3 trials for a gynecologic cancer antibody-drug conjugate after sharing early promising data from the asset it licensed from Hansoh Pharma. GSK’s move signals...
IPO and capital formation - Alamar Biosciences sets pricing range for IPO
Alamar Biosciences set an IPO price range of $15 to $17 per share, targeting expected net proceeds of about $133.2 million at the midpoint. The company planned to offer 9.375 million shares, with...
Bioengineering and therapeutics platform - ARPA-H funds Salk-led sonogenetics for peripheral neuropathies
The Salk Institute secured a $41.3 million ARPA-H award to advance sonogenetics toward potential therapies, beginning with peripheral neuropathies. The funding supports development of core...