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Good morning. The weather here in Chicago has been super volatile. We’ve had thunderstorms the last few days, and last night I heard for the first time a tornado warning. Truly an ominous start to the week!
With that, let’s get into the biotech news of the day.
Vertex wants U.S. permission to pay for fertility services for Casgevy patients
Vertex, one of the companies behind the gene therapy Casgevy, is suing the HHS Office of the Inspector General, aiming to get clearance to pay for fertility services for patients receiving the therapy.
To take Casgevy, sickle cell patients must undergo chemotherapy to remove bone marrow cells, a process that can cause infertility. But many insurers, including Medicaid, don’t cover fertility preservation services like freezing sperm or eggs in the context of sickle cell treatment.
Vertex has developed a program that offers financial support for these services, and it has sought to get assurance from the HHG OIG that this program doesn’t violate federal anti-kickback laws. The OIG has indicated verbally that it would not clear the program, and has missed a deadline for writing an official determination, leading Vertex to file this lawsuit.
Read more from my colleague Megan Molteni.
Trump’s pick for VP has a history of investing in drug companies
Yesterday, Donald Trump announced that he’s chosen Ohio Sen. J.D. Vance as his running mate. My colleagues Rachel Cohrs Zhang and Sarah Owermohle pored through Vance’s financial disclosures to find a history of investments in health care companies, offering a window into how he may view the biopharma industry.
Vance’s largest investments are in AmplifyBio and Kriya Therapeutics, in the range of $50,000 to $100,000, according to his 2022 financial disclosures. AmplifyBio is a contract research organization that helps drugmakers study and manufacture new medicines, while Kriya is developing gene therapies to treat conditions including eye diseases, diabetes, and epilepsy.
He also has smaller holdings in the range of $1,000 to $15,000 in a broad range of companies involved with pharmaceutical development and medical devices.
Additionally, Vance has some supporters in the industry. Former Celgene chairman Bob Hugin, who faced criticism for price hikes on a cancer drug during his failed Senate bid, donated $50,000 to a super PAC supporting Vance in 2022, according to the campaign finance tracking site OpenSecrets.
Read more on Vance’s investments and his history on health care policies.
Biotech stocks rebound as inflation cools
After plummeting earlier this year, biotech stocks have quickly rebounded. The XBI has risen 22% since its low in April, and it’s up 11% year-to-date.
The most recent surge in the XBI has been driven by cooling inflation and expectations of impending interest rate cuts. The most recent consumer price index report showed June prices dropping from the month prior, helping slow the annual inflation rate to around 3%. Federal Reserve Chair Jerome Powell said yesterday that the central bank will not wait until inflation hits 2% before cutting rates.
Roche looks to have a competitive GLP-1 drug
In an abstract for a European diabetes conferences, Roche provided some new data on an early-stage obesity drug that it got from its acquisition of Carmot Therapeutics.
Roche had earlier reported that CT-388, which targets GLP-1 and GIP receptors, led to 18.8% weight loss at 24 weeks in a placebo-controlled Phase 1 trial. The new data suggest that weight loss on the highest dose did not yet reach a plateau at the end of the trial, making it look to be a competitive candidate, Jefferies analysts said. (Note that Lilly’s Zepbound, which also targets GLP-1 and GIP, led to 21% weight loss in a 72-week Phase 3 trial.)
The Jefferies analysts noted, though, there are still questions on how much commercial success could actually be achieved with this molecule, which they expect to launch in 2029. By then, Roche may still be behind Novo and Lilly, which are both already studying next-generation candidates in late-stage studies.
More reads
- Revolution Medicines firms up Phase 3 trial plans with latest cancer drug data, BioPharma Dive
- EMA warns patients to tell doctors about GLP-1 usage before surgery, Endpoints
- At an Iowa county fair, a treasured tradition carries on despite bird flu anxiety in the dairy barn, STAT