Roche’s Breast Cancer Treatment Gets FDA Approval; Turnstone Reduces Workforce by 60%
In this edition, we present updates from Roche and Turnstone Biologics, along with news from Sanofi, Pfizer, and Flagship Pioneering that you might have overlooked.
Turnstone Biologics has announced plans to reduce its workforce by approximately 60%, focusing efforts on a cancer cell therapy program that is currently in human testing. This significant restructuring aims to shift resources away from preclinical projects towards a cell therapy undergoing a Phase 1 trial targeting various solid tumors. An update on this trial is anticipated in the coming year, while the company expects these changes will allow operations to continue through the second quarter of 2026. Last year, Turnstone secured million during an initial public offering, but the company’s shares have significantly declined since then. — Ben Fidler
The FDA granted approval on Thursday for Roche’s new breast cancer medication, Itovebi. This drug is now authorized for use alongside Ibrance from Pfizer and endocrine therapy for individuals with HR-positive, HER2-negative breast tumors exhibiting the PIK3CA mutation. Itovebi will compete against Novartis’ drug Piqray, which also targets PIK3CA mutations. This new addition aims to enhance Roche’s offerings in breast cancer treatment, which already includes Herceptin, Perjeta, and Kadcyla. — Jonathan Gardner
In a move that underscores its struggles, vaccine developer Gritstone bio has filed for bankruptcy. The company indicated on Thursday that negotiations are underway with a potential buyer or plan sponsor, with hopes for a resolution as soon as next week. This announcement follows Gritstone’s appointment of Raymond James as its financial adviser, aimed at exploring “potential value-maximizing strategies.” Earlier this year, the company reduced its workforce significantly and subsequently reported disappointing results from a pivotal colorectal cancer vaccine study. — Jacob Bell
Denali Therapeutics disclosed in a regulatory filing on Thursday that its partner Sanofi has halted a Phase 2 trial of one of Denali’s experimental treatments for multiple sclerosis, due to the therapy failing to meet primary and secondary endpoints. This drug, oditrasertib, is part of a wider collaboration established in 2018 between Denali and Sanofi to develop therapies for autoimmune and neurological disorders. It had previously failed a study in ALS. — Delilah Alvarado
A clinical trial found that a combination of Talzenna from Pfizer and Xtandi resulted in longer survival for individuals with advanced prostate cancer compared to those who received only Xtandi, as reported on Thursday. Regardless of whether patients had certain genetic markers believed to indicate increased benefit, the dual regimen demonstrated effectiveness, according to the company’s statement. The FDA had previously authorized the Talzenna-Xtandi combination specifically for patients with these genetic markers due to safety concerns in a broader population. With these new findings, Pfizer seeks to broaden Talzenna’s usage. — Jonathan Gardner
Flagship Pioneering announced the appointment of Paul Parker as a managing partner, where he will supervise fundraising efforts and manage investor relationships. Parker previously held senior roles in the mergers and acquisitions divisions of Goldman Sachs, Barclays Group, and Lehman Brothers. His addition expands Flagship’s leadership alongside Doug Cole and Stephen Berenson. This move comes after Flagship secured .6 billion in new funding and implemented various promotions and additions to its leadership team. — Gwendolyn Wu
In another regulatory setback, the FDA has rejected an experimental hypoglycemia drug from Zealand Pharma for the second time within a year. In a statement Tuesday, Zealand reported that the drug dasiglucagon was not approved due to timing issues associated with the re-inspection of a third-party manufacturing site. An initial review identified “deficiencies” not linked to Zealand’s drug, prompting the FDA to reject dasiglucagon last December. The subsequent re-inspection occurred in August and September, but a favorable recommendation from the unnamed manufacturer has yet to be received. — Delilah Alvarado