Today, a brief rundown of news involving Pfizer and Denali Therapeutics, as well as updates from GSK, Spot Biosystems and Novocure that you may have missed.
Pfizer CFO Dave Denton will leave the company on Aug. 15 to pursue a new job he’s accepted in the consumer goods sector, the company said Thursday. He’ll be succeeded on an interim basis by Cecile Guegan, the head of finance for the company's global pharmaceutical business, while Pfizer conducts a “comprehensive internal and external search.” Denton has been Pfizer’s financial leader since May 2022, when he took over for Frank D’Amelio. Over that time, Pfizer made multiple large acquisitions, including buyouts of Seagen, Biohaven and Metsera.
Denali Therapeutics sold a fast pass that can accelerate U.S. drug reviews in a deal worth $195 million. Denali acquired that “priority review” voucher in March, when the Food and Drug Administration approved its Hunter syndrome treatment Avlayah. Denali didn’t reveal which company bought the voucher, but said the proceeds will help develop the rest of its pipeline, including other therapies for lysosomal storage disorders, Alzheimer’s and other neurodegenerative conditions.
Spot Biosystems launched with $40 million in funding and plans to develop a new kind of gene therapy for Duchenne muscular dystrophy. Spot’s treatment uses a different delivery system than many Duchenne gene therapies in development and is designed to help the body make “full-length” dystrophin, the shock-absorbing protein patients lack. Other treatments, such as Sarepta Therapeutics’ Elevidys, spur production of a shortened form of that protein. A first-in-human trial in China is ongoing. Those results could help “inform and support” a regulatory path in the U.S., the company said.
The FDA on Wednesday approved a new oral antibiotic for people with complicated urinary tract infections. Called Utebzi, the treatment was long developed by biotechnology company Spero Therapeutics as a more convenient alternative to intravenous injections and is now largely owned by GSK, which acquired most rights to the therapy four years ago. The FDA rejected Utebzi in 2022, but Spero worked with the regulator to design a new trial that could support a clearance. That study found Utebzi statistically non-inferior to an intravenous antibiotic. In a statement, GSK referred to Utebzi as the first and only oral antibiotic of its kind available in the U.S.
Novocure shares dipped by more than 20% Thursday after the company reported a setback for its electrical field-emitting device in a Phase 3 trial in brain cancer. Novocure evaluated use of that device when patients with newly diagnosed glioblastoma start receiving a combination of chemotherapy and radiation. That regimen failed to meaningfully extend survival when compared to use during the subsequent “maintenance” phase of treatment. Novocure’s device is already approved to treat glioblastoma in the “adjuvant” setting after surgery and as a monotherapy in recurrent disease. It’s also cleared for use in mesothelioma, pancreatic cancer and non-small cell lung tumors.
