Shots:
The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC
Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…
Shots:
Merck has reported ongoing P-III (KEYNOTE-B96/ENGOT-ov65) trial findings on Keytruda for the treatment of Pt-resistant recurrent ovarian cancer
Trial assessed Keytruda (400mg, IV, Q6W for ~2yrs.) with CT ± Avastin vs PBO + CT ± Avastin in pts (n=643)
Trial met its 1EP of improved PFS in overall population & 2EP of OS in pts…
Shots:
TelmyVet & PetPace have launched the Quality-of-Life Consultation, a virtual care service to support pets & their families during end-of-life stages
Service combines TelmyVet’s telemedicine platform with PetPace’s AI-powered smart collar, which tracks HRV, vital signs, mobility, & behavior to assess pain & stress. It offers a supportive space for pet parent guidance &…
Shots:
Genesys Spine has launched its Stasys-C 3DP Cervical Standalone System to simplify anterior cervical procedures
Stasys-C has a non-screw-based fixation method with quick, non-impacting anchor deployment via a direct anterior approach, plus it has Quick Turn Cam Lock, which allows visual anchor engagement & locking confirmation, while the SemaFour surface design maximizes wettability, surface…
Shots:
Septerna & Novo Nordisk to identify, develop & market oral small molecules for obesity, T2D & other cardiometabolic diseases under an exclusive global collaboration & license agreement
As per the deal, Septerna will receive ~$2.2B, incl. over $200M in upfront & near-term milestones, plus research, development, & commercial milestones, along with net sales-based tiered…
Shots:
The US FDA has approved Welireg for the treatment of pts (≥12yrs.) with advanced, unresectable, or metastatic pheochromocytoma & paraganglioma (PPGL)
Approval was based on Cohort A1 data from P-II (LITESPARK-015) trial assessing Welireg monotx. (120mg; QD) in 72 pts with unresectable or non-curable PPGL & stable blood pressure (BP <150/90 mm Hg, <135/85 mm…
Shots:
Herantis has dosed first pts with HER-096, a synthetic peptidomimetic in final arm of its P-Ib trial for Parkinson’s disease
The P-Ib trial consists of 2 parts, with the 1st assessing the safety & PK properties of 300mg HER-096 (SC) & Part 2 evaluating HER-096 vs PBO in 2 Arms along with selected biomarkers…
Shots:
The US FDA has received application for 510(k) clearance of eyonis Lung Cancer Screening (LCS) to detect & diagnose lung cancer, with clearance expected in Q3'25
Submission is backed by 2 studies, REALITY & RELIVE, both of which met their 1EP; REALITY depicted an AUC of 0.904 (vs 0.80 threshold), accurately detecting early lung…
Shots:
Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA's priority review
The trial met its 1EP, showing superior improvement in peak oxygen…
Shots:
GSK to acquire Boston’s lead asset, efimosfermin alfa, a P-III candidate for steatotic liver disease (SLD)
As per the deal, GSK will acquire BP Asset IX (Boston’s subsidiary) for ~$2B to access efimosfermin, incl. $1.2B upfront & $800M in milestones, plus GSK will also be responsible for royalties & milestone payments owed to Novartis…

