Shots:
Atavistik Bio has entered into a strategic research collaboration with Roche to discover & develop novel small molecules against multiple targets for cardiovascular, renal, and metabolic (CVRM) diseases, using Atavistik’s AMPS platform
As per the deal, Atavistik Bio will be responsible for discovery & research activities for the collaboration targets, with Roche responsible for…
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Earendil Labs has entered into a research collaboration with Genentech to discover and develop multiple therapeutic bispecific antibody programs in oncology
Earendil Labs will lead antibody discovery & research through early clinical development for programs targeting certain pre-agreed target combinations, while Genentech will take over global clinical development & commercialization
As per the deal,…
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The US FDA has granted Breakthrough Device Designation for its NET Device as an aid in reducing psychostimulant use in adults diagnosed with stimulant use disorder, incl. cocaine use disorder & amphetamine-type/ methamphetamine use disorder
NET Recovery is designing a pivotal randomized controlled trial intended to support FDA marketing authorization, which the company believes…
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Astellas has dosed the first patient in a P-III study assessing setidegrasib vs docetaxel in ~356 pts with KRAS G12D-mutated locally advanced (unresectable) or metastatic NSCLC who progressed on or after initial Pt-based CT & checkpoint inhibitor therapy
The P-III study in previously treated NSCLC builds on P-I data published in The NEJM in Mar…
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Variant Bio has expanded its multi-year research collaboration & license agreement with BI to discover and validate novel cardiovascular disease targets using its Inference platform, building on their existing kidney disease collaboration
As per the terms of the expanded agreement, Variant Bio will receive an additional upfront payment & over $250M in potential license…
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The US FDA has approved Lyrfigtu for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement; US availability is expected by Q4’26
In the P-I/II (ReFocus) trial, Lyrfigtu showed a cORR of 46%, an mDoR of 11.8mos., & 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), with a predictable and manageable safety…
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InnoCare has entered into a strategic research collaboration & license agreement with Eli Lilly to develop new medicines, using its drug discovery platform
As per the deal, InnoCare will leverage its drug discovery platform & research expertise to discover & advance compounds against up to five targets addressing critical unmet medical needs
InnoCare will…
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Genentech has reported topline P-II (CT-388-104) trial data assessing enicepatide (CT-388; QW, SC) vs PBO in 447 adults living with type 2 diabetes and overweight or obesity for 48wks.
Enicepatide met both 1EPs, with dose-dependent reductions in blood glucose & body weight at 48wks. At 24 mg, HbA1c fell 2.65% from 8.1% baseline, while…
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The EC has approved Trixeo Aerosphere(320/28.8/10μg) for the maintenance treatment of asthma in pts (≥12yrs.) who are not adequately controlled by a combination of a medium ICS & LABA
Approval was based on the P-III (LOGOS & KALOS) trials evaluating Trixeo vs two fixed-dose dual-combination therapies of ICS & LABA: Symbicort pMDI & PT009 (in an…
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The P-III (FUSION) trial met its 1EP with ulefnersen, showing improvements in functional impairment & survival in a joint rank analysis of time to death or permanent ventilation, time to rescue, & change in ALSFRS-R from baseline to Day 505 vs PBO in pts with ALS caused by mutations in the fused in sarcoma…

