This week, the J.P. Morgan Healthcare Conference has brought a torrent of updates from drugmakers large and small. We’re highlighting a few here, but for the rest check out our reporters’ coverage from San Francisco here and here. Also below are news from Johnson & Johnson and Lykos Therapeutics.
Johnson & Johnson on Wednesday said it has begun submitting TAR-200, a drug-device combination developed for bladder cancer, to the Food and Drug Administration under a "real-time" review program. Specifically, J&J is seeking clearance of TAR-200 for people with non-muscle-invasive bladder cancer that's considered high risk and unresponsive to treatment with the Bacillus Calmette-Guérin vaccine. The treatment, which provides sustained delivery of the chemotherapy gemcitabine into the bladder, is a top prospect for J&J, which has forecast billions of dollars of sales if approved. "We think is going to be a game change in the treatment of bladder cancer," J&J CEO Joaquin Duato told investors at the J.P. Morgan Healthcare Conference Monday. — Ned Pagliarulo
Lykos Therapeutics, a psychedelics developer that’s been trying to get MDMA approved as a therapy aid for PTSD, announced on Wednesday changes to its board of directors. A total of four board members are now leaving, including chair Jeff George. A fifth, Gisselle Acevedo, stepped down last month. The Food and Drug Administration dealt a major blow to Lykos last summer by rejecting its approval application. Soon after, the company laid off 75% of its staff and saw the departure of CEO and founder Amy Emerson. The Financial Times reported earlier this month that Antonio Gracias, an early Tesla backer and ally of Elon Musk, has in recent weeks sought to take a controlling stake in Lykos. — Jacob Bell
Fourth quarter sales of Elevidys, Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, came in ahead of both Wall Street expectations and the company's guidance, totaling some $384 million. Full year revenue from the treatment was $820 million, Sarepta said Monday. While sales were strong to end 2024, Sarepta did not change its guidance for this year and continues to predict between revenue of $2.9 billion and $3.1 billion across its entire business. "The current guidance puts Sarepta in a position of strength for potential beats in the coming year of earnings," wrote Baird analyst Brian Skorney in a Tuesday note to clients. — Ned Pagliarulo
Eye health company Bausch + Lomb has acquired Irvine, California-based Whitecap Biosciences, gaining access to two drugs in testing for glaucoma and geography atrophy. Founded in 2015, Whitecap recently completed a Phase 2 study for its glaucoma treatment and has further testing planned in geographic atrophy, which can lead to vision loss. No price was disclosed.— Delilah Alvarado
Madrigal Pharmaceuticals on Monday said net sales of its MASH drug Rezdiffra totaled between $177 million and $180 million in 2024. Approved in March for metabolic dysfunction-associated steatohepatitis, Rezdiffra has launched strongly in the U.S. Fourth quarter net sales of $100 million to $103 million were higher than the sell-side consensus figure of $91.5 million, per Leerink Partners, and nearly 12,000 people are now taking the therapy. “We expect [Madrigal] will continue building the [M]ASH market via increased prescriber penetration and [M]ASH patient uptake,” Thomas J. Smith wrote in a Monday note to clients. Madrigal expects a “country-by-country launch” in Europe in the second half of 2025, should EU regulators sign off on the medicine. “Overall, we think Rezdiffra's launch continues to look encouraging given revenues are 10-13% higher than sell side [consensus],” Akash Tewari wrote in a Jefferies note to clients. — Delilah Alvarado