Ducentis Biotherapeutics Ltd. has been acquired by Arcutis Biotherapeutics Inc. for up to $400 million, representing a landmark moment for seed investor Lifearc Ventures, which aims to kick-start promising biotechs in the U.K. while giving any investment returns to its parent medical charity.
Arcutis Biotherapeutics Inc. has entered into an agreement to acquire Ducentis Biotherapeutics Inc., a preclinical-stage biotechnology company focused on developing novel therapies for inflammation and autoimmune diseases.
Sidekick Health AB expanded its partnership with Pfizer Inc., adding an atopic dermatitis offering to its integrated digital therapeutics solution. The app will roll out first in the U.K., followed by Belgium, Norway, Netherlands, Sweden, France, Ireland and Japan this year.
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.
Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.
Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.
Privately held Leo Pharma Inc. has worked its way through a complete response letter issued in April to see the FDA approve Adbry (tralokinumab-ldrm) for treating moderate to severe atopic dermatitis in adults. The CRL noted FDA requests for additional data related to the device component, a prefilled syringe of tralokinumab, but it did not request new efficacy or safety data related to the drug product formulation. In April and on Dec. 28, the company did not provide details on the device-related data that were requested.
LONDON – The EMA recommended approval of Apellis Pharmaceuticals Inc.’s C3 complement inhibitor, Aspaveli (pegcetacoplan), to treat paroxysmal nocturnal hemoglobinuria, but has diverged from the FDA, excluding treatment-naïve patients adding its use should be restricted to those who have failed to respond to C5 inhibitor drugs.
Following late-stage studies in which Incyte Corp.'s topical ruxolitinib candidate significantly reduced skin inflammation and itch associated with atopic dermatitis (AD), the FDA has approved the medicine, making it the first and only topical JAK inhibitor approved in the U.S.
Shares of Forte Biosciences Inc. (NASDAQ:FBRX) touched a 52-week low, diving 82.3% to close at $5.06 on Sept. 3 after its sole candidate, FB-401, failed to make a statistically significant difference in improving the severity of atopic dermatitis. The result, contrasting starkly with a smaller positive trial, led CEO Paul Wagner to announce the company would quit development of the FDA fast-tracked asset, licensed from the U.S. National Institute of Allergy and Infectious Diseases.
