Mediwound Ltd. reported that the Nexobrid expanded treatment access protocol achieved complete debridement in 94.9% of adults and all children treated and removed all eschar within 24 hours. The results put more power behind a partnership with Vericel Corp. that introduced Nexobrid, an enzymatic debridement agent for severe thermal burns, into the U.S. in the fourth quarter of 2023 and increases the likelihood of an indication expansion into pediatrics.
Succeeding where others have failed in an indication with high unmet need, Celldex Therapeutics Inc. disclosed top-line data from the phase II trial with barzolvolimab (barzo) against two common forms of chronic inducible urticaria (CIndU): cold urticaria (ColdU) and symptomatic dermographism (SD).
Alumis Inc. began trading (NASDAQ:ALMS) earlier this morning, with the company’s IPO debuting at $16 per share to raise $210 million, with another $40 million coming through a concurrent private placement at the same price. That was the lower end of its previously announced price range, which had stretched as high as $18 per share.
The U.S. FDA has approved the NDA for Sofdra (sofpironium) for treating excessive underarm sweating from Botanix Pharmaceuticals Ltd. The approval was based on two pivotal phase III studies and is approved for those ages 9 and older.
South Korea’s Hanall Biopharma Co. Ltd., of Songpa-gu, Seoul, agreed to an exclusive licensing deal with San Francisco-based Turn Biotechnologies Inc. to develop novel ophthalmic and optic therapies using the latter’s mRNA-based technology.
Gaining full rights to a bispecific antibody to treat atopic dermatitis, Johnson & Johnson is paying $1.25 billion to acquire Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG. The subsidiary houses all assets related to NM-26, which targets IL-4Ra (type I and II receptors) and IL-31, and was designed with Numab’s MATCH (Multispecific Antibody-based Therapeutics by Cognate Heterodimerization) technology platform. It is ready for phase II development for atopic dermatitis, although J&J intends to develop, manufacture and commercialize the drug globally for follow-on indications as well.
Innovent Biologics Inc.’s picankibart (IBI-112) met all primary endpoints and key secondary endpoints in the phase III registrational Clear-1 trial in Chinese subjects with moderate to severe plaque psoriasis.
Johnson & Johnson is adding to its dermatology portfolio with the $850 million purchase of privately held Proteologix Inc. The Redwood City, Calif.-based company brings with it two bispecific antibodies into a space dominated by the blockbuster injectable Dupixent (dupilumab). Proteologix has PX-128, which targets IL-13 plus thymic stromal lymphopoietin for treating moderate to severe atopic dermatitis and moderate to severe asthma, and PX-130, which also targets IL-13 plus IL-22, for treating moderate to severe AD. Both are in preclinical development, but Johnson & Johnson said PX-128 is ready for its phase I close-up.
About a year after the U.S. FDA cleared Krystal Biotech Inc.’s topical gene therapy, Vyjuvek (beremagene geperpavec), as the first drug for recessive or dominant dystrophic epidermolysis bullosa, competitor Abeona Therapeutics Inc. disclosed a complete response letter (CRL) from the FDA related to its cell-based graft therapy, prademagene zamikeracel.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
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