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.
As expected, the FDA cleared Biocryst Pharmaceuticals Inc.’s oral, once-daily Orladeyo (berotralstat, formerly known as BCX-7353) for the prevention of hereditary angioedema (HAE) attacks. Last month, Biocryst, as part of its earnings report, said approvals of the compound, a kallikrein inhibitor evaluated by U.S. regulators without an advisory committee meeting, could come in Japan this month and in the EU by the first half of next year.
HONG KONG – Final results of Takeda Pharmaceutical Co. Ltd.’s phase III open-label extension study of Takhzyro (lanadelumab) showed that continued treatment with the monoclonal antibody may help with the long-term prevention of hereditary angioedema attacks as well as reducing their frequency.
Arena Pharmaceuticals Inc. CEO Amit Munshi said “a cluster of patients in a single clinical site” skewed results of the phase IIb study testing etrasimod in atopic dermatitis (AD), and caused the selective S1P modulator to miss its primary endpoint.
Bristol Myers Squibb Co. reported that its first-in-class oral selective kinase 2 inhibitor, deucravacitinib (formerly BMS-986165), beat out Otezla (apremilast) in a head-to-head phase III trial in psoriasis.
With avacopan’s PDUFA date in anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis) set for next summer, Chemocentryx Inc. rolled out long-awaited, COVID-19-delayed top-line findings from the company’s phase II, 390-patient Aurora study testing the compound for hidradenitis suppurativa (HS).
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