Today, a brief rundown of news involving Foghorn Therapeutics and Wave Life Sciences, as well as updates from Varda Space Industries and Hatteras Venture Partners that you may have missed.
Foghorn Therapeutics is cutting 40% of its staff after a cancer drug it was developing with Eli Lilly failed to meet efficacy benchmarks to advance into further testing. In a Thursday announcement, the biotechnology firm said it is discontinuing its synthetic lethality program “FHD-909,” as well as a second unnamed experimental medicine targeting the SMARCA2 gene and is ceasing its collaboration with Lilly, which dates back to 2021. It’s the latest stumble for Foghorn, whose stock first plunged in 2022 after regulators placed a study of its leukemia drug on hold following patient deaths. Shares are now worth a fraction of their value six years ago, when Foghorn debuted on Wall Street. “This is disappointing news, given FHD-909 was the company's lead value driver and most advanced program in clinical development,” Guggenheim Securities analyst Michael Schmidt wrote in a note to clients. Shares fell 22% on Thursday.
The Food and Drug Administration gave Wave Life Sciences the all-clear for a pathway to accelerated approval following a two-year trial of its RNA editing treatment for alpha-1 antitrypsin deficiency. Wave’s Chief Medical Officer, in a Thursday announcement, said a “registrational trial design that offers an efficient path to full approval, without the need for a separate confirmatory trial, is advantageous.” In May, Wave presented data showing its treatment, called WVE-006, helped AATD patients produce “therapeutically relevant levels” of a protein their bodies don’t make. That therapy is in mid-stage testing, and additional data is expected by the end of 2026.
Samsung Bioepis and Teva Pharmaceutical have expanded their partnership to develop half a dozen biosimilar drugs, including copycats to Fasenra and Ilaris. According to a Thursday announcement, Samsung Bioepis will handle R&D and manufacturing, while Teva will commercialize those drugs globally. Previously, the South Korean and Israeli drugmakers had commercialized two biosimilars: Opuviz, a mimic of Eylea, and Epysqli, a drug similar to Soliris. Samsung Bioepis is also developing, on its own, biosimilars for cancer drugs such as Keytruda and immune drugs like Entyvio, Tremfya and Dupixent.
Drug discovery biotech Varda Space Industries announced Wednesday it added $251 million to its war chest via a Series D round led by Lux Capital and Natural Capital. Varda hypothesizes that “due to the absence of gravity, materials such as the active pharmaceutical ingredients in medicines can be crystallized in ways that would be impossible on Earth, enabling novel drug formulations that can benefit patients.” The biotech said it has more than a dozen launches and reentries planned in the next two years, but has disclosed little about the pharmaceuticals it's developing.
Hatteras Venture Partners is padding its ranks, adding former GSK and UnitedHealth Group CEO Andrew Witty as its chairman and former Acting FDA Commissioner Ned Sharpless as managing director of a drug discovery initiative. Witty is returning to the North Carolina biotech backer after spending two years as a venture partner there from 2017 to 2019. Sharpless, meanwhile, launched G1 Therapeutics with the aid of Hatteras and is coming to help run Hatteras Discovery Innovation. The venture firm also said it marked the first closing of Hatteras Opportunity Fund II, which will spread $100 million in capital across its existing biotech investments.