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Celcuity
Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer
Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor The trial met its 1EP, with gedatolisib triplet improving PFS vs alpelisib + fulvestrant, while…
ARCHIMED to Acquire Esperion Therapeutics for ~$1.1B
Shots: Esperion Therapeutics & ARCHIMED have entered a definitive agreement under which ARCHIMED-managed funds will acquire Esperion, delisting it from NASDAQ As per the deal, Esperion’s shareholders will receive $3.16/share in cash, plus the right to participate in CVR of ~$100M tied to future sales, valuing the transaction at up to ~$1.1B in fully diluted…
UCB to Acquire Candid Therapeutics for ~$2.2B
Shots:  UCB has entered into a definitive agreement to acquire Candid Therapeutics, expanding its immunology pipeline with novel T-cell engagers (TCE) As per the deal, UCB will acquire Candid for $2B upfront & ~$200M in potential future milestone payments; closing is expected by end of Q2 or early Q3’26 Acquisition will add cizutamig, a BCMA…
Cue Biopharma Licenses Ascendant-221 from Ascendant Health Sciences in a ~$691.5M Deal
Shots: Cue Biopharma has entered into an exclusive license agreement with Ascendant Health Sciences to develop, manufacture and commercialize Ascendant-221 for the treatment of allergic diseases As per the deal, Cue will obtain global rights (excl. Greater China) to develop & commercialize Ascendant-221 in exchange for $15M upfront license fee, ~$676.5M in development, regulatory &…
Axsome
Axsome Therapeutics Reports the US FDA Approval of Auvelity to Treat Agitation Associated with Alzheimer’s Dementia
Shots: The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders In…