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Good morning. It’s been one year since I began co-authoring this newsletter! It’s been a great time bringing you biotech news every week, and please continue to send any ideas and tips my way: [email protected].
Also, STAT has opened up nominations for our annual Wunderkinds list, which aims to honor some of the most promising early-career researchers out there. If you have someone in mind, nominate them here.
The need-to-know this morning
Akeso and Summit Therapeutics said the combination of its PD-1/VEGF-blocking antibody ivonescimab plus chemotherapy delayed tumor progression in patients with non-small cell lung cancer — achieving the primary goal of a Phase 3 study called Harmoni-6, conducted in China.
Novavax said it believes its Covid-19 vaccine is approvable, based on recent conversations with the FDA. An FDA decision on the vaccine’s final approval was expected on April 1, but has been delayed, raising concerns about political interference in regulatory decisions related to vaccines.
Bristol’s schizophrenia drug disappoints in key trial
Bristol Myers Squibb’s new treatment for schizophrenia didn’t provide additional benefits to patients when given on top of standard-of-care therapy, a setback for the company that had framed the drug as a key growth driver.
The treatment, Cobenfy, was approved last year based on data from three randomized studies comparing the drug to placebo. It was the first new mechanism-of-action approved for schizophrenia in decades.
In the new trial, Bristol tested to see whether Cobenfy could also work in combination with a generic antipsychotic to provide more relief than one drug alone. The answer, at least in this study, was no.
Read more from STAT’s Jason Mast.
A twist in Lilly’s battle against compounded GLP-1s
Eli Lilly filed new lawsuits against four telehealth firms and their affiliates, using a new line of attack than it has used previously in such cases. The pharma giant accused two of the companies of engaging in the corporate practice of medicine.
Laws governing the corporate practice of medicine, which are in place in several states including California, generally ban unlicensed corporations from owning or controlling medical practices. The laws are intended to protect patients from decisions that are influenced by the financial interests of a corporation over the clinical judgement of a health care provider.
In the lawsuits, Lilly has alleged that two telehealth companies, Mochi Health and Fella Health, engaged in the corporate practice of medicine, purportedly with the help of affiliated medical groups and compounding pharmacies.
Read more from STAT’s Ed Silverman and Katie Palmer.
Sam Waksal is caught up in more legal trouble
Remember the name Sam Waksal? The biotech entrepreneur was famously convicted of insider trading in 2003 in a case that also led to the imprisonment of Martha Stewart. Now, a new lawsuit alleges that he breached his fiduciary duties and engaged in “grossly negligent and reckless conduct” as the chairman, CEO, and largest shareholder of Equilibre Biopharmaceuticals, a biotech focused on neurological treatments.
One of Waksal’s “most reckless acts,” according to the lawsuit, was an incident in which he and other Equilibre employees smuggled into the U.S. a veterinary medicine that was unapproved for human use, and then administered it to a severely ill child “outside of approved protocols and without the Food and Drug Administration’s authorization.”
The lawsuit, filed by a trustee for Equilibre, also alleged that Waksal and other defendants inappropriately transferred proprietary company assets to another Waksal-controlled biotech company, Graviton Bioscience. Graviton said the allegations are “without merit.”
Read more from STAT’s Adam Feuerstein.
CRISPR’s CEO got a big payday
From my colleague Jason Mast: Gene-editing companies everywhere are struggling, but one of the field’s most prominent executives still just took home a significant payday. CRISPR Therapeutics disclosed last week that it awarded CEO Sam Kulkarni 400,000 new stock options last year, bringing his total compensation package for the year, for accounting purposes, to $33 million.
Those are paid out over four years, rather than all at once. (His spendable take-home last year looked something like $11.5 million, by STAT’s calculations.) But the total package puts him up with the drug industry’s highest paid executives.
Ironically, Kulkarni received the generous package in part because the gene-editing sector has been doing so poorly. In 2022, Kulkarni received a package loaded with performance-based incentives — i.e. shares he receives if CRISPR’s stock price hits a certain number. Since then, gene-editing companies have faced a minor armageddon. CRISPR’s stock is down around 50% from its 2022 peak and Kulkarni has not received any of those performance options and it’s “unlikely that all or any meaningful portion of it would vest” by this August, the company wrote. (It also argued he had previously received fewer shares than competitors, though he still took home over $30 million across 2022 and 2023).
So the board awarded Kulkarni, who has been at CRISPR since 2015 and CEO since 2017, new time-based incentives to assure he stayed at the company, it said. Under Kulkarni, CRISPR has weathered the field’s downturn relatively well, maintaining a $3.3 billion valuation and pushing several drugs into trials to follow its now approved sickle cell treatment. But he has also overseen two small layoffs over the last couple years and significant C-suite turnover. The company is now awaiting data on heart disease in the next couple months.
AstraZeneca joins PhRMA as tariffs loom
PhRMA, the lobbying group for pharmaceutical companies, announced yesterday that AstraZeneca joined as a new member.
The British company is taking this step as drugmakers face greater uncertainty around federal policies and regulation under the Trump administration, with the specter of tariffs, cuts to FDA personnel who were key to drug reviews, and potential changes to Medicare’s drug price negotiation process.
The move provides a small boost to PhRMA, which has seen membership fall in recent years after the passage of the Inflation Reduction Act in 2022 that allowed Medicare to negotiate drug prices.
Why one company hiked the price of its drug by 150%
Here’s a recent case that highlights the complexity of drug pricing in the U.S.: A small company called Eton Pharmaceuticals bought a drug for a rare growth disorder four months ago, and then quickly raised the list price by 150%. The company argues that’s the only to keep the treatment on the market and make a profit.
How so? A federal law that went into effect in 2024 requires drugmakers to pay penalties to Medicaid when they raise the price of a medicine above the inflation rate. Eton is choosing to pay that penalty and lose money on Medicaid patients, and in order to compensate for that, it’s relying on generating profits with commercial payers through a higher list price.
Read more from STAT’s Ed Silverman.
More reads
Recent FDA staff cuts to delay drug hearing decision by months, agency tells Vanda, Endpoints
Analysis signals the beginnings of a U.S. science brain drain, Nature
