UCB SA anticipates submitting regulatory applications in the third quarter for IL-17-targeting bimekizumab in psoriatic arthritis and ankylosing spondylitis, after chalking up second successful phase III trials in both indications. Meanwhile, the high commercial hopes for the would-be blockbuster remain at least temporarily deferred as pandemic-related travel restrictions have delayed FDA action on the BLA for plaque psoriasis.
With the agreement to purchase Physimax Technologies Ltd. in its rearview mirror, Dariohealth Corp. passes another milestone with its third tuck-in deal in a year. Physimax, a provider of computer vision technology for musculoskeletal (MSK) screening and predictive risk assessment, joins Psyinnovations Inc. (dba Wayforward) and Upright Technologies Ltd. as tuck-ins for the rapidly growing digital health company. The latest deal is by far the smallest. The terms call for the issuance of 256,660 shares of Dariohealth’s common stock, valued at Wednesday’s closing price of $9.65 per share at just under $2.5 million, plus a cash payment of $500,000.
The FDA clapped a clinical hold on the IND for a clinical trial of Dyne Therapeutics Inc.’s DYNE-251 for treating Duchenne muscular dystrophy in patients amenable to skipping exon 51. The agency is asking for more clinical and non-clinical information on the therapy. A response, including data from existing and ongoing studies in the second quarter of 2022, is expected to be filed to the FDA sometime in mid-2022, Dyne said.
Sperogenix Therapeutics Ltd. has acquired exclusive greater China rights to Santhera Pharmaceuticals Holding AG’s glucocorticoid analogue vamorolone in a deal worth up to $124 million.
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