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Morning! Today we discuss Madrigal’s impressive launch of its MASH drug Rezdiffra, psychedelic player Compass Pathways cutting 30% of its staff, and more.

Some drug launches are going very well

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

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

Rezdiffra was approved in March amid questions about whether a once-daily pill specifically treating liver damage caused by MASH could succeed at a time when doctors are turning first to GLP-1s to combat obesity — often a precursor of a MASH diagnosis.

A rapid launch fueled by stronger-than-expected patient demand should ease investors’ fears about selling Madrigal in a contracting market. The stock rose 20% yesterday, but remains below its all-time high – so Siebold is right, there is still some work and convincing to be done.

Compass Pathways lays off 30% of its staff

Compass Pathways, which is now furthest 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 management positions, as clinical trials drag on much longer than expected.

The news follows Lykos Therapeutics’ failed attempt to gain FDA approval for its psychedelic treatment for PTSD last summer: FierceBiotech Pointing out, CEO Kabir Nath said during a conference call about the results that there was “a high degree of oversight regarding unblinding, which is very relevant to our studies.”

Phase 3 results from Compass’ COMP360 psilocybin treatment, intended to treat treatment-resistant depression, were initially expected this summer; now this has been postponed to the second quarter of 2025. The results of another study are now postponed to 2026.

“There have been a number of elements related to the complexity of the trials that we are currently learning along the way,” Nath said. He added that scheduling complexities for patients and therapists “have led inexperienced sites to carefully manage the flow of patients as they become more proficient.”

A setback for the tau approach to Alzheimer’s disease

By STAT’s Andrew Joseph: In an effort to expand treatment approaches for Alzheimer’s disease beyond targeting amyloid, some companies have sought to target another protein thought to play a role in the disease: tau. But the approach suffered a slight setback this week.

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

UCB did some further slicing of its data and found that patients who had low levels of tau at baseline or who did not carry a particular genetic variant called APOE4 (or who fell into both groups) noticed a slowdown in their data. disease progression under bepranemab. UCB’s Matthew Barton, who presented the data at the Alzheimer’s Clinical Trials Conference in Madrid, said researchers were “encouraged” by the trial, and UCB said it was evaluating the next steps to take with bepranemab.

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

Lilly Profit Surprise and Spooky Ghost Story

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

Adam, Allison and Elaine get into the Halloween spirit this week as they discuss their favorite candies and surprise earnings reports from Eli Lilly and Pfizer. Next, they discuss what a Trump or Harris presidency could mean for health care and the biopharma industry, and what investors and biopharma executives think about either outcome.

Listen here.

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