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.
Concert Pharmaceuticals Inc. CEO Roger Tung said determining who leads isn’t easy in the phase III race that pits his firm against Eli Lilly and Co. and Pfizer Inc. in alopecia areata. That’s because neither of the other companies has “been very direct about the timelines they’re on,” he told BioWorld. “We’ve been pretty clear that our goal is to have an NDA filing in early 2023.”
Anaptysbio Inc. is calling it quits for developing imsidolimab in treating moderate to severe palmoplantar pustulosis (PPP) after its phase II Poplar trial failed to hit its primary endpoint. However, the company said it would continue imsidolimab development for five other indications, including a phase III trial in treating generalized pustular psoriasis (GPP) that’s set to begin in mid-2021.
Kalvista Pharmaceuticals Inc.’s chief development officer, Christopher Yea, said the across-the-board positive phase II top-line data with KVD-900 for on-demand use against hereditary angioedema (HAE) attacks will open “a very flexible discussion with regulators” regarding the design and endpoints of the phase III study to come with the oral kallikrein inhibitor. Shares of the Cambridge, Mass.-based firm (NASDAQ:KALV) closed at $33.50, up $17.89, or 115%, after reaching a high of $45, as Wall Street digested the findings.
Concert Pharmaceuticals Inc. is scratching further work on CTP-692 after the deuterated form of D-serine missed the primary endpoint in a phase II study in schizophrenia. The news sent shares of Concert (NASDAQ:CNCE) falling 28% Feb. 1 and shifts focus to the firm’s sole remaining clinical-stage program in the competitive alopecia areata space.
The Human Skin Cell Atlas, comprising transcriptomes of 528,253 single cells, shows that cellular processes involved in skin development in embryos are reactivated in inflammatory skin diseases. In addition to suggesting potential new drug targets for atopic dermatitis and psoriasis, the transcriptomes provide a new route to understanding other inflammatory diseases.
Christmas arrived early for Athenex Inc. as the FDA approved Klisyri (tirbanibulin) for treating actinic keratosis on the face or scalp nearly two weeks before the treatment’s PDUFA date.
HONG KONG – Olix Pharmaceuticals Inc. has raised ₩41.5 billion (US$37.90 million) to support the company’s U.S. expansion and advance its pipeline globally.
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