Riding high on dramatic phase Ib results with KIT receptor-binding monoclonal antibody CDX-0159 in urticaria (hives), Celldex Therapeutics Inc. plans to begin phase II work in the first half of next year. Shares of Hampton, N.J.-based Celldex (NASDAQ:CLDX) closed July 12 at $40.67, up $8.26, or 25%, as Wall Street reacted to favorable data from the trial in antihistamine-refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria (CindU).
A not-unexpected complete response letter (CRL) for Nexobrid, being developed by Mediwound Ltd., delayed the therapy’s approval and knocked the company’s share values backward. Nexobrid, proteolytic enzymes enriched in bromelain for treating for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns, had a June 29 PDUFA date.
More than four months after its original PDUFA date of Feb. 2, 2021, Mallinckrodt plc’s Stratagraft gained FDA approval for use in deep partial-thickness thermal burns.
Rapt Therapeutics Inc. CEO Brian Wong said RPT-193 monotherapy in atopic dermatitis (AD) “looks really promising, but there’s still quite a bit to learn” about the small molecule, designed to inhibit the migration of Th2 cells into inflamed tissues by blocking CCR4. Investors saw enough to push the shares of South San Francisco-based Rapt up 115.5%, or $21.45, to close at $40.02, after trading as high as $41.99 during the day.
Dermavant Sciences Inc. has announced a $200 million financing deal to clear the way for a potential U.S. launch of its dermatology cream tapinarof, covering a potential milestone payment to Glaxosmithkline plc following a filing in severe psoriasis.
Kyowa Kirin Co. Ltd. has partnered with Amgen Inc. to jointly develop and commercialize KHK-4083, Kyowa Kirin’s phase III-ready anti-OX40 fully human monoclonal antibody for the potential treatment of atopic dermatitis. Kyowa Kirin will receive a $400 million up front, while milestone payments could add an additional $850 million. Significant royalty payments on future global sales could sweeten the blockbuster deal.
HONG KONG – Olix Pharmaceuticals Inc. has entered an extensive research collaboration to test its RNAi therapeutic, OLX-104C, with Fimanac, PCI Biotech Holding ASA’s delivery technology for nucleic acid-based therapies, with the aim of reducing off-target effects while treating androgenic alopecia, or hair loss.
The FDA slapped Leo Pharma A/S’ BLA for IL-13 inhibitor tralokinumab with a complete response letter (CRL), making it the latest atopic dermatitis candidate to hit a regulatory setback in the U.S., following delays for three oral JAK inhibitor drugs earlier this month.
Despite stock-denting phase II data with the oral version of Korsuva (difelikefalin) for moderate to severe pruritis in patients with moderate to severe atopic dermatitis (AD), Cara Therapeutics Inc. CEO Derek Chalmers said the outcome “prioritizes moving forward. We got what we needed from the phase II trial,” which identified the patients most sensitive to the drug, nailed down a dose spectrum, and equipped the company to power a registrational effort, he said.
LONDON – C4X Discovery Holdings plc has out-licensed its preclinical oral interleukin-17 (IL-17) inhibitor to Sanofi SA in a potential €414 million (US$493.4 million) deal. Under the terms of the agreement, Sanofi is paying €7 million up front and a further €11 in short-term preclinical milestones, with the balance to follow on reaching development, regulatory and commercialization milestones.
RSS
