Madrigal, Eli Lilly, Compass Pathways newest

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Morning! Today we discuss Madrigal’s impressive launch of its MASH drug Rezdiffra, see psychedelics player Compass Pathways shedding 30% of its workforce, and more.

Some drug launches are going very well

From STAT’s Adam Feuerstein: Add Madrigal Pharmaceuticals to that list. Yesterday, the company reported $62 million in third-quarter sales from Rezdiffra, the treatment for the serious liver disease known as MASH. Sales easily exceeded Street expectations, with the company more than tripling the number of patients taking the drug as of late June.

“While we still have a lot of work to do, we have made tremendous progress to date,” Madrigal CEO Bill Siebold said during the company’s conference call.

Rezdiffra was approved in March amid questions about whether a once-daily pill that specifically targets the liver damage caused by MASH could be successful in an era when doctors are first turning to GLP-1s to tackle obesity – often a precursor to a MASH diagnosis.

A quick launch, fueled by stronger-than-expected patient demand, should allay investor concerns that Madrigal is selling into a shrinking market. The stock rose 20% yesterday, but is still below its all-time high. So Siebold is right: there is more work and persuasion to be done.

Compass Pathways is laying off 30% of its staff

Compass Pathways, which is now further along than any other drugmaker in developing a psychedelic therapy for a mental health indication, is laying off 30% of its staff, including some in senior management positions, as clinical trials take much longer than expected.

The news follows Lykos Therapeutics’ failed bid to win FDA approval for its psychedelic PTSD treatment last summer: FierceBiotech points out that CEO Kabir Nath said in an earnings call that there was “a high degree of control regarding unblinding, which is highly relevant to our investigations.”

Phase 3 results for Compass’ psilocybin treatment COMP360, targeting treatment-resistant depression, were initially expected this summer; now that has been postponed until the second quarter of 2025. The results of another study have now been postponed until 2026.

“There have been a number of items related to the complexity of the trials that we are now learning as we go along,” Nath said. He added that the complexity of scheduling for patients and therapists “has led to inexperienced sites carefully managing patient flow as they become more skilled.”

A setback for the tau approach to Alzheimer’s

From Andrew Joseph of STAT: In an effort to expand approaches to treating Alzheimer’s disease beyond targeting amyloid, some companies have tried to target another protein thought to play a role in the disease: tau. But the approach suffered a minor setback this week.

Belgian biopharmaceutical company UCB yesterday presented data showing that its tau-targeting antibody, called bepranemab, successfully slowed the accumulation of tau versus placebo in a Phase 2 clinical trial. But the study, which included more than 450 participants, did not meet its primary endpoint of slowing the progression of Alzheimer’s disease, based on a commonly used measure known as Clinical Dementia Rating sum of boxes, CDR-SB.

UCB further sliced ​​and diced its data and found that patients who had low tau levels to begin with or who did not carry a particular genetic variant called APOE4 (or who fit into both groups) experienced a slowing of the disease saws. disease progression on bepranemab. UCB’s Matthew Barton, who presented the data at the Clinical Trials on Alzheimer’s Disease conference in Madrid, said researchers were “encouraged” by the study, and UCB said it is evaluating what steps to take next with bepranemab.

Expectations for the results were not particularly high. Last week, UCB said Roche and its subsidiary Genentech, which bought bepranemab in 2020, had returned rights to the drug.

Lilly deserves surprise and a creepy ghost story

What would a Kamala Harris or Donald Trump presidency mean for health care policy? Why have Eli Lilly sales in Mounjaro and Zepbound exceeded expectations? And does Adam believe in ghosts? We talk about all that and more in this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.

Adam, Allison and Elaine get into the Halloween spirit this week and discuss their favorite candies – and the surprising earnings reports from Eli Lilly and Pfizer. They then discuss what a Trump or Harris presidency could mean for the healthcare and biopharma industries, and what investors and biopharma executives think about both outcomes.

Listen here.

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