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Neurocrine’s Crenessity (Crinecerfont) Secures the US FDA’s Approval to Treat Adults and Pediatrics with Congenital Adrenal Hyperplasia (CAH)
Shots: The US FDA’s approval of Crenessity as an adjunctive treatment to glucocorticoid replacement to treat CAH was based on a global P-III (CAHtalyst Pediatric: n=103, age: 4-17yrs. & Adult: n=182, age: 18-58yrs.) trials. It has also received PRV on approval Pediatric study achieved its 1 & 2EP, depicting ~4x greater reductions in androstenedione…
GSK to Acquire IDRx for ~1.15B, Boosting its GI Cancer Portfolio
Shots: GSK to acquire IDRx incl. its lead candidate IDRX-42, for $1B upfront & ~$150M in regulatory milestones (total ~$1.15B). It will also pay success-based milestones & tiered royalties to Merck KGaA for IDRX-42 IDRX-42 (TKI, small molecule) targets key KIT mutations, responsible for proliferation & survival of tumor cells, & is under P-I/Ib…
Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders
Shots: Gilead has entered into a strategic collaboration with LEO Pharma to develop the latter’s small molecule oral STAT6 programs targeting various inflammatory disorders As per the terms, Gilead secures worldwide rights to develop, manufacture & commercialize LEO’s preclinical STAT6 inhibitors & degrading proteins, with LEO having the option to co-commercialize them for dermatology…
J&J
Johnson & Johnson’s Reports the CE Mark Approval for Dual Energy Thermocool Smarttouch SF Catheter for Cardiac Arrhythmias
Shots: The CE mark of Thermocool Smarttouch SF Catheter for cardiac arrhythmias was based on SmartfIRE trial in European patients with refractory PAF that depicted 100% acute success rate & first-pass isolation achievement in 96.8% of veins (published in Apr 2024). The Trupulse Generator hardware compatibility is anticipated in H1’25 The company has concluded…
Merus and Biohaven Join Forces to Advance Three Bispecific ADC Programs
Shots: Biohaven & Merus have entered into a research collaboration & license agreement to co-develop bispecific ADCs using the former’s ADC conjugation & payload platform plus Merus’ Biclonics tech platform As per the terms, Biohaven will develop preclinical ADCs for 3 Merus’ BsAbs (2 developed via Biclonics & 1 in preclinical) & each is…
Veralox Therapeutics to Acquire Nudge Therapeutics, Expanding its Portfolio
Shots: Veralox has signed an exclusive agreement to acquire Nudge Therapeutics & its preclinical cyclic AMP-GMP (cGAS) inhibitors. The financial terms were undisclosed As per the terms, Veralox will resume the development of acquired candidates & initiate acquisition upon achievement of downstream milestones In addition, Veralox is developing VLX-1005 (12-LOX inhibitor) for thrombosis linked…
Astellas
Astellas Reports the Health Canada’s Approval of Vyloy (Zolbetuximab) Plus Chemotherapy for Advanced G/GEJ Cancer
Shots: The Health Canada has approved Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+/HER2-ve G/GEJ adenocarcinoma, with further submissions under review. In addition, Canada’s Drug Agency (CDA-AMC) recommended reimbursement of Vyloy with conditions Approval was based on the P-III (SPOTLIGHT: n= 565 & GLOW:…