Ferring Pharmaceuticals A/S has notched another U.S. FDA approval, this time for the bladder cancer treatment Adstiladrin (nadofaragene firadenovec-vncg). The gene therapy’s approval comes only weeks after the FDA’s Nov. 30 approval of the privately held company’s Rebyota (fecal microbiota, live), the first fecal microbiota treatment in the U.S. Adstiladrin is another landmark, as the first FDA-approved gene therapy to treat high-risk, non-muscle-invasive bladder cancer (NMIBC). Ferring said it anticipates the product becoming commercially available in the U.S. in the second half of 2023. The product was approved for treating adults with high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors.

Investors hail big win for Madrigal, NASH field with positive phase III results

Madrigal Pharmaceuticals Inc.’s phase III study of liver-directed thyroid receptor agonist resmetirom yielded far better-than-expected top-line data from a phase III study in nonalcoholic steatohepatitis (NASH), a field littered with clinical failures even as the disease increases in global prevalence. The Maestro-NASH study achieved both liver histological improvement endpoints established by the U.S. FDA as reasonably likely to predict clinical benefit, and the company said it anticipates filing for accelerated approval in the first half of 2023. Shares of Madrigal (NASDAQ:MDGL) were up 226% at midday, for a gain of $144.

Sanofi wants more: €25M up front, €1.35B milestones for second helping of Innate Pharma’s NK cell engagers

In a show of commitment to Innate Pharma SA’s antibody-based natural killer cell engager therapeutics (Anket) platform, longstanding partner Sanofi SA is paying €25 million (US$26.5 million) up front and could pay up to €1.35 billion more in preclinical, clinical, regulatory, and commercial milestones for up to three development programs. Innate also stands to receive royalties on eventual product sales.

NXI Therapeutics reawakens interest in coronin-1 as autoimmune disease target

Dialing down the immune response remains at the heart of myriad drug development efforts in autoimmune disease. Targeting cytokines, such as tumor necrosis factor alpha (TNF-alpha) or interleukin-12 (IL-12) and IL-23, IL-6, or IL-17, or modulating immune cell trafficking by targeting sphingosine-1-phosphate receptor or integrins, are therapeutic mainstays. But chronic immunosuppression and all its attendant safety concerns is the price that many autoimmune disease patients pay to remain in remission.

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