April 16, 2024

The need-to-know this morning

Intra-Cellular Therapies reported positive results from a late-stage clinical trial seeking to expand the use of its antipsychotic medicine Caplyta to patients with major depressive disorder.
Johnson & Johnson reported first-quarter adjusted earnings of $2.71 per share on total revenue of $21.38 billion — results that were mostly in line with analyst forecasts. The diversified health care giant made a small upward change to its 2024 outlook.

Adventures in investor relations

Biohaven's data delay degrades stock price

Shares fell 16% yesterday after the company offered investors a double dose of confusing updates about BHV-1300, a closely followed drug designed to remove harmful proteins from the body, in this case an autoantibody called IgG that is implicated in a host of autoimmune diseases.

In a corporate update issued on Saturday, Biohaven said highly anticipated results from a first-in-human study of BHV-1300 would be disclosed at a company event on May 29, instead of early this quarter, per its previous guidance.

Then yesterday Biohaven dropped a second BHV-1300 update into an unexpected SEC filing, stating two lower doses of the drug led to reductions in IgG levels that were unspecified but "consistent" with a previously reported experiment in monkeys, without any safety issues.

Why didn't Biohaven simply disclose this on Saturday? Unclear.

Arguably, yesterday's update was good news for the BHV-1300 program, and the suggestion that higher dosing was being explored means the results could get better. But investors hate delays and the opaque dithering only raised concerns that something might be off. And that's how a biotech stock price falls.

drug pricing

Chuck Schumer's $35 insulin promise under fire

Two years ago, Senate Majority Leader Chuck Schumer publicly promised his Buffalo, N.Y., constituents that he'd hold a vote to cap insulin prices at $35 per month for people with all types of insurance. But the Democratic lawmaker has yet to make good on this pledge — and it's rankling the people who were once inspired by his words.

"It just feels really really gross to be used as a political prop for campaigning and then have nothing to be done to actually substantively help us," patient advocate Laura Marston said.

Democrats have achieved some progress in making insulin more affordable, such as passing a law that ensured that older adults on Medicare would pay no more than $35 for month for the medicine. Still, many people have fallen through the cracks, and it's unclear if Schumer's promises will ever come to fruition.

biosimilars

Biosimilar prescriptions for Humira spike, thanks to CVS maneuvering

The number of new prescriptions for Humira biosimilars has spiked — jumping from 5% to 36% in the first weeks of April. This is largely due to the influence CVS Health has on the prescription drug market — and a biosimilar for the blockbuster rheumatoid arthritis drug called Hyrimoz that's marketed by a CVS subsidiary.

On April 11, CVS Caremark removed Humira from its formularies — which quickly allowed Hyrimoz to gain market share. At the end of March, the number of new prescriptions for the biosimilar was about 640, but rose to nearly 8,300 within weeks.

"CVS came up with another crafty vehicle to capture money before it goes out the door," one pricing consultant told STAT's Ed Silverman. "It's very complicated and the patient should win, because it's better than offering a drug that costs $7,000 on the formularies. They are shifting market share to a lower-cost drug. But the company shouldn't get a Nobel prize."

adam's take

Taysha lawsuit questions whether PIPE deals are fair

Insiders at Taysha Gene Therapies are being sued by a shareholder, who alleges they were involved in a $150 million PIPE (private investment in public equity) deal — sharing positive gene therapy trial data with just a subset of investors and delaying the data's public release. The lawsuit alleges that a preferred group of Taysha backers held off on publicly disclosing the positive results of a gene therapy clinical trial for profit.

While there's nothing wrong or unfair about PIPEs, he said, "a case like this puts PIPEs on the SEC's radar screen," said Eric Gordon, a business and law professor at the University of Michigan. PIPEs are increasingly being used to raise money in biotech: In the first quarter of this year, biotech companies raised a record $5.7 billion via these deals.

Biotech financiers are watching the Taysha case with interest, STAT's Adam Feuerstein writes. If the SEC intervenes with these deals, that could surely make them less lucrative — but until then, it looks like investors are still all in.