Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
Early phase I data for Revolution Medicines Inc.’s RAS(ON) G12D-selective inhibitor zoldonrasib encouraged both the company and the analysts. Initial study data produced a 61% objective response rate in 11 solid tumor patients receiving the 1,200-mg dose once a day. The disease control rate for 16 patients came in at 89%.
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.
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