J&J Submits TAR-200 for FDA Review; Lykos Therapeutics Board Shakeup

Johnson & Johnson has taken a significant step forward in the treatment of bladder cancer by submitting TAR-200 to the Food and Drug Administration (FDA) under a real-time review program. TAR-200 is a drug-device combination aimed at treating non-muscle-invasive bladder cancer that is high risk and unresponsive to the Bacillus Calmette-Guérin vaccine. The treatment delivers the chemotherapy drug gemcitabine directly into the bladder, offering a sustained release. J&J's CEO, Joaquin Duato, expressed optimism about TAR-200's potential to revolutionize bladder cancer treatment, highlighting its blockbuster sales forecast if approved.

In other news, Lykos Therapeutics, a company focused on developing psychedelic therapies, has undergone a major board reshuffle. Four board members, including chair Jeff George, are departing, following the earlier resignation of Gisselle Acevedo. This comes after the FDA rejected Lykos' application for MDMA-assisted therapy for PTSD last summer, leading to significant layoffs and the departure of CEO Amy Emerson. The company has also been in the spotlight due to reports of Antonio Gracias, an early Tesla backer, seeking to acquire a controlling stake in Lykos.

Additionally, Sarepta Therapeutics reported strong fourth-quarter sales for its Duchenne muscular dystrophy gene therapy, Elevidys, surpassing Wall Street expectations with $384 million in sales. The company's full-year revenue from Elevidys reached $820 million, maintaining its revenue guidance for the upcoming year. Bausch + Lomb's acquisition of Whitecap Biosciences was also noted, expanding its portfolio with two drugs in development for glaucoma and geographic atrophy, though the acquisition price was not disclosed.