Shares of CG Oncology Inc. gained 25% April 28 on the back of phase III data presented at the American Urological Association meeting over the weekend showing its cretostimogene grenadenorepvec yielded durable response rates, as well as an enviable safety profile, in patients with high-risk non-muscle invasive bladder cancer unresponsive to Bacillus Calmette Guerin treatment with carcinoma in situ with or without Ta or T1 disease.
The biggest M&A activity of the year arrived in the form of Merck KGaA’s earlier-disclosed agreement to buy Springworks Therapeutics Inc. for $47 per share in cash, which represents an equity value of about $3.9 billion and an enterprise value of $3.4 billion, based on Stamford, Conn.-based Springworks’ cash in the bank as of the end of last year.
A quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter. NMEs include compounds chosen for further pharmacological evaluation or as clinical candidates; new leads whose structural optimization could provide new therapeutic agents; new additions to the structural diversity of known mechanistic classes of drugs; and new pharmacological tools for investigating drug targets.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Abbvie, Dyne, Equillium, Ferring.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bioxodes, Inmagene, Insmed, Ipsen, Mineralys, Spyglass.