The U.S. FDA has rejected Verrica Pharmaceuticals Inc.’s drug-device combination to treat the viral skin disease molluscum for a third time, losing more ground to a potential rival from Novan Inc., because of continued manufacturing issues. There are no FDA-approved treatments for molluscum contagiosum, which leads to skin-colored or pink lesions and affects around 6 million people in the U.S. annually.
Dermavant Sciences Inc. has received its first FDA approval with the agency’s blessing of Vtama (tapinarof) for treating plaque psoriasis in adults. The treatment is also the first FDA-approved, steroid-free topical medication in its class in addition to being the first psoriasis novel topical chemical entity introduced to the market in the past 25 years.
Concert Pharmaceuticals Inc. is on track for an NDA filing for CTP-543 in alopecia areata during the first half of 2023, following a positive read-out from the first of two phase III trials of the oral Janus kinase 1/2 inhibitor. The molecule hit the primary endpoint of the placebo-controlled Thrive-AA1 study, which was defined as the percentage of patients achieving a SALT (Severity of Alopecia Assessment Tool) score of 20 or less after 24 weeks of therapy.
Evotec AG and Almirall SA have entered a multitarget drug discovery alliance focused on severe skin disease, from which Evotec could earn up to €230 million (US$243.5 million) in per-program milestones. It is also receiving an undisclosed up-front payment, research funding and, should any products reach the market, it would also bank sales royalties in the high-single-digit percentage range.
UCB SA’s share price slumped after the U.S. FDA rejected the pharma’s filing for psoriasis drug Bimzelx (bimekizumab), citing issues with “inspection observations” that must be resolved before approval. Shares in Brussels-based UCB (Brussels:UCB) fell 13.6% following the announcement that the FDA had rejected Bimzelx for treatment of adults with moderate to severe plaque psoriasis.
Bristol Myers Squibb Co. has announced long-term data from its closely watched psoriasis pill, deucravacitinib, which it hopes will supplant Amgen Inc.’s blockbuster, Otezla (apremilast), as the main oral therapy for the disease.
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Almirall, Amryt, Aslan, Boehringer, Cara, Eli Lilly, Evelo, Incyte, Novartis, Rapt, Regeneron, Senhwa, UCB.
New and updated preclinical and clinical data presented by biopharma firms at the American Academy of Dermatology annual meeting, including: Arcutis, Dermavant, Janssen, Leo, Nimbus, Sun, Timber.
Moonlake Therapeutics AG is making headway on its mission to establish a broad dermatology and rheumatology franchise around its sole product, sonelokimab, announcing it is poised to start a phase II study in hidradenitis suppurativa.
Four years after Bristol Myers Squibb Co.’s (BMS) $1.85 billion investment in Nektar Therapeutics Inc., the pair’s collaboration has stumbled mightily with a phase III failure. A first analysis their melanoma study, PIVOT IO-001, showed it missed three primary endpoints. The study of interleukin-2-targeting NKTR-214 (bempegaldesleukin) combined with Opdivo (nivolumab) compared to Opdivo monotherapy as a first-line treatment for previously untreated, unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival and objective response rate.
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