Shots:
The US FDA has granted BTD to ulixacaltamide for the treatment of patients with essential tremor (ET)
Designation was based on the topline data from the Essential3 program, consisting of Study 1 & 2, where in Study 1, ulixacaltamide improved mADL11 (1EP) by 4.3 points at Wk. 8, while Study 2 showed superior maintenance of…
Shots:
Rectify has entered into a strategic research & licensing agreement with BI to accelerate the development of small molecule therapies for CKD & other conditions
Collaboration will leverage Rectify’s positive functional modulators (PFM) platform to develop oral small molecules that restore or enhance ABCC6 function, targeting pathologic calcification to slow disease progression in CKD, Pseudoxanthoma elasticum,…
Shots:
Pfizer has entered into an exclusive global collaboration & license agreement with YaoPharma for YP05002, a GLP-1 receptor agonist for chronic weight management
As per the deal, YaoPharma will complete the ongoing P-I trial of YP05002 & grant Pfizer exclusive global rights for further development, manufacturing & commercialization, receiving $150M upfront & ~$1.935B in…
Shots:
The US FDA has granted accelerated approval to Hyrnuo (BAY 2927088; reversible TKI) under priority review for the treatment of previously treated pts with LA/M NSCLC harboring HER2 tyrosine kinase domain activating mutations; NDA under NMPA’s review
Approval was based on the ORR & DoR data from the ongoing P-I/II (SOHO-01) trial assessing Hyrnuo (PO) in…
Shots:
Transition Bio has entered into a drug discovery collaboration & license option agreement with Voyager Therapeutics to identify & develop selective small molecules targeting TDP-43 pathology in amyotrophic lateral sclerosis (ALS) & frontotemporal dementia
As per the deal, Transition Bio will discover & optimize TDP-43–targeting small molecules, after which Voyager may license exclusive global…
Shots:
BI has licensed a pre-clinical small molecule program from Kyowa Kirin to develop it as a potential treatment for autoimmune diseases
As per the deal, BI will receive exclusive rights to develop the small molecule program globally, expanding BI’s inflammatory pipeline
In contrast, Kyowa Kirin will receive up to €640M (~$744.4M), incl. an upfront payment, development,…
Shots:
Taiho Pharmaceutical has exercised its option to develop & commercialize casdatifan, pending approval in Japan & other Asian regions (excl. Greater China) under Taiho & Arcus’ 2017 option & license agreement
As per the deal, Arcus will receive an option exercise payment & clinical, regulatory, plus commercial milestone payments, with net sales-based royalties. Although…
Shots:
insitro & BMS have extended their 5yr. collaboration (2020) to discover novel small molecule therapies for ALS using insitro’s AI-enabled ChemML platform
The 1yr. extension will focus on developing therapies for a novel ALS target identified preclinically, with insitro receiving ~$20M in new funding & remaining eligible for discovery, development, regulatory, & commercial milestones…
Shots:
Variational AI has entered into a collaboration with Merck to design and optimize novel small molecule candidates against two undisclosed targets using Variational AI’s Enki platform
As per the deal, Variational AI will leverage its fine-tuned Enki platform trained on Merck’s proprietary data to generate & optimize small-molecule candidates for Merck’s targets, with Merck…
OMass has entered into an exclusive collaboration & license deal with Genentech to develop & commercialize its preclinical oral small molecule program for inflammatory bowel disease
As per the deal, OMass will receive $20M upfront & over $400M in preclinical, development, commercial, & sales milestones, with tiered royalties based on net sales
Collaboration leverages OMass’…

