Latest Madrigal, Eli Lilly, Compass Pathways

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

Some drug launches do very well

From STAT’s Adam Feuerstein: Add Madrigal Pharmaceuticals to this list. Yesterday, the company reported $62 million in third-quarter sales of Rezdiffra, its treatment for the serious liver disease known as MASH. Sales beat Street expectations by a wide margin, with the company tripling the number of patients taking the drug since the end of the June quarter.

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

Rezdiffra was approved in March amid questions about whether a once-daily pill that specifically addresses liver damage caused by MASH could succeed in an era when doctors are turning first to GLP-1 to tackle obesity — often a precursor of a MASH diagnosis.

A fast launch fueled by stronger-than-expected patient demand should ease investor concerns that Madrigal is selling into a declining market. Shares rose 20% yesterday but are still below their all-time high – so Siebold is right, there is more work and more convincing to be done.

Compass Pathways lays off 30% of 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 positions, as clinical trials run much longer than expected wait.

The news comes after Lykos Therapeutics’ failed attempt to win FDA approval for its psychedelic PTSD treatment last summer: FierceBiotech points out, CEO Kabir Nath said in an earnings call that there was “a high degree of control over disclosure, which is very relevant to our studies.”

Phase 3 results for Compass’ psilocybin treatment COMP360, which targets treatment-resistant depression, were initially expected this summer; it has now been pushed back to the second quarter of 2025. The results of another study are now pushed back to 2026.

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

A setback for your approach to Alzheimer’s disease

From Andrew Joseph of STAT: In an effort to expand approaches to treating 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 faced a bit of a setback this week.

Belgian biopharma UCB presented data yesterday showing that its tau-targeting antibody called bepranemab successfully slowed tau build-up compared to a placebo in a phase 2 clinical trial. But the trial, which enrolled more than 450 participants, did not -met the primary endpoint of slowing Alzheimer’s progression, based on a commonly used measure known as the Clinical Dementia Score, CDR-SB.

UCB further analyzed its data and found that patients who had low levels of tau to begin with or who did not carry a certain genetic variant called APOE4 (or who fit both groups) saw a slowing of disease progression on bepranemab. UCB’s Matthew Barton, who presented the data at the Clinical Trials on Alzheimer’s Disease conference in Madrid, said the researchers were “encouraged” by the study, and UCB said it was 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 had bought bepranemab in 2020, had returned the rights to the drug.

Lilly wins surprise and a scary ghost story

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

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

Listen here.

Some drug launches do very well

Compass Pathways lays off 30% of staff

A setback for your approach to Alzheimer’s disease

Lilly wins surprise and a scary ghost story

More readings