Navacaprant

Despite Neumora Therapeutics' best efforts to salvage its major depressive disorder (MDD) programme, the biotech said it's discontinuing development of navacaprant while laying off more than a third of its workforce. The news sent its shares plummeting close to 50% on Monday. The company reported that navacaprant, an oral KOR antagonist, missed its primary and key secondary endpoints in both the Phase III KOASTAL-2 and -3 studies, which had enrolled 430 and 422 adults with MDD, respectively. On the main measure of Montgomery-Åsberg Depression Rating Scale (MADRS) score, patients taking navacaprant in KOASTAL-2 saw a similar change from baseline as the placebo arm, while navacaprant recipients in KOASTAL-3 had a numerically lower change from baseline versus the comparator. Neumora added that even when it looked only at patients enrolled following protocol changes to the KOASTAL studies implemented last year, there was no difference in MADRS score reductions between the navacaprant and placebo arms.Last March, the biotech adjusted KOASTAL-2 and KOASTAL-3 following the failure of the KOASTAL-1 trial, which showed no difference between navacaprant and placebo in improving depressive symptoms. Neumora reduced the number of clinical sites to those with "the greatest level of expertise in conducting MDD studies," improved medical monitoring and added another screening database to identify and exclude participants enrolled in multiple clinical studies.Staffing cutsWith navacaprant's development binned, the company said it's now focused on Alzheimer's disease agitation candidate NMRA-511, schizophrenia asset NMRA-898, and experimental obesity treatment NMRA-215. Neumora is hoping to hit "key catalysts" for each programme within the next 12 months, CEO Paul Berns said. A Phase IIb dose ranging study of NMRA-511, as well as a first-in-human trial of NMRA-215, are slated to launch by the end of 2026, while Phase I data for NMRA-898 are due in the second half of the year. To reach these milestones, however, the company is laying off workers to preserve cash. Neumora is trimming its headcount by about 35% to save roughly $10 million in annual costs, though it will also record $2 million in restructuring costs. With the staffing cuts, the drugmaker expects its runway to now extend into the third quarter of 2027.

Today, a brief rundown of news involving Neumora Therapeutics and enGene, as well as updates from Johnson & Johnson, Cellares and Faeth Therapeutics that you may have missed.Shares of Neumora Therapeutics lost half their value after one of the companys drugs failed a pair of Phase 3 trials in major depressive disorder. Neumoras drug navacaprant is part of a class of medicines that target kappa opioid receptors and have been hailed as potential blockbusters. But two prospects navacaprant and J&Js aticaprant have now missed key goals in depression studies, and Neumora said Monday that it plans to end development of its drug altogether. The latest findings are disappointing but not unexpected, wrote William Blair analyst Myles Minter in a Monday note to investors. Minter referred to the setback as a clearing event that shifts focus to a pipeline that now includes drugs for obesity, schizophrenia and Alzheimers disease agitation. Neumora has lost most of its value since going public in 2023. Ben FidlerEnGene will lay off half of its workforce and pare down an ongoing trial in a bid to conserve cash. In an earnings release Monday, enGene announced the layoffs as well as plans to stop enrollment in three cohorts of a trial testing its experimental gene therapy against a form of bladder cancer. The moves come ahead of a study readout that could form the basis of a U.S. approval application. Those results, and subsequent Food and Drug Administration discussions, are key determinants for enGenes regulatory and commercial outlook, wrote Mani Foroohar, an analyst at Leerink Partners. Ben FidlerCell therapy manufacturer Cellares added $50 million to whats now a $327 million Series D financing, the company said Monday. The new investment from Prime Radiant Partners will be used to support an ongoing international expansion into Europe for Cellares via a new facility in the Netherlands and comes ahead of a potential initial public offering in 2027. Cellares helps companies speed up the production of cell therapies and has already partnered with drugmakers like Bristol Myers Squibb and Cabaletta Bio. The San Francisco-area biotechnology company has raised more than $680 million since launching in 2019. Gwendolyn WuJohnson & Johnson will invest more than $1 billion in Jacksonville, Florida, as part of a $55 billion plan to onshore more drug production in the U.S. That investment includes a new distribution facility for its Acuvue contact lenses and adds to other announced commitments, such as a cell therapy plant in Pennsylvania and a biologics manufacturing hub in North Carolina. J&J is one of more than a dozen drugmakers to make a drug pricing deal with the White House in exchange for a reprieve on pharmaceutical tariffs. Gwendolyn WuFour months after acquiring Faeth Therapeutics, the biotech formerly known as Sensei Biotherapeutics is taking on the cancer drugmakers name. The new Faeth is developing a combination drug called Piktor aimed at multiple parts of a pathway, PAM, thats dysregulated in as many as half of all solid tumors. Piktor is in a Phase 2 trial in second-line endometrial cancer thatll produce data later this year. Results from a second study in breast cancer should come in 2027. The combined company will trade on Nasdaq under the ticker symbol FTH. Gwendolyn WuAtlanta-based Celltaxis has named a new CEO, promoting Eileen Heffernan, one of its co-founders and current chief business officer, to the role, according to a Monday announcement. Heffernan, who has more than three decades of experience across therapeutics and diagnostics developers, was hailed as a driving force behind Celltaxis in a statement from the company's Chief Scientific Officer Eric Springman. The company was previously led by Michael Masters. Celltaxis has a drug in mid-stage testing for lymphedema, and is developing other medicines for lymphatic diseases. Gwendolyn Wu '