Madrigal, Eli Lilly, Compass Pathways latest

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Morning! Today we discuss Madrigal’s impressive launch of its MASH drug Rezdiffra, see how psychedelics player Compass Pathways lost 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 sales of Resdiffra, a treatment for the serious liver disease known as MASH, of $62 million. Sales significantly exceeded Street expectations, with the company more than 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 have made amazing progress to date,” Madrigal CEO Bill Sebold said on the company’s conference call.

Rezdiffra was approved in March amid questions about whether once-daily pills specifically designed to treat liver damage caused by MASH could be successful in an era when doctors first turn to GLP-1 to combat obesity—often a precursor to a MASH diagnosis.

The quick launch, fueled by stronger-than-expected demand from patients, should ease investor concerns that Madrigal is being sold in a shrinking market. The stock was up 20% yesterday, but still below its all-time high – so Siebold is right: there is still work and convincing to be done.

Compass Pathways lays off 30% of employees

Compass Pathways, which is currently further along than any other drugmaker in developing psychedelic therapies to treat mental illness, is laying off 30% of its staff, including some in senior positions, as clinical trials take much longer than expected.

The news follows Lykos Therapeutics’ failed attempt to gain FDA approval for a psychedelic treatment for PTSD this summer: FerociousBiotechnology As noted by CEO Kabir Nath on the financial conference call, there is a “high degree of care regarding disclosure of blinding, which is very important for our research.”

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

“There were a number of questions related to the complexity of the trials that we are currently looking into,” Nath said. He added that scheduling difficulties for patients and therapists “have led to inexperienced facilities carefully managing patient flow as they become more experienced.”

Failure of the tau approach to Alzheimer’s disease

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

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

UCB analyzed its data further and found that patients who either had low levels of tau protein to begin with or were not carriers of a certain genetic variant called APOE4 (or who fit into both of these groups) did experience a slowdown in disease progression while taking bepranemab. UCB’s Matthew Barton, who presented the data at the Alzheimer’s Disease Clinical Research Conference in Madrid, said researchers were “encouraged” by the trial, and UCB said it was assessing what steps to take next with bepranemab.

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

Lilly’s Earnings Surprise and a Spooky Ghost Story

What would a Kamala Harris or Donald Trump presidency mean for health care policy? Why did Eli Lilly’s Mounjaro and Zepbound not sell as expected? And does Adam believe in ghosts? We talk about all this and more on this week’s episode of STAT’s biotech podcast, “The Readout LOUD.”

This week, Adam, Allison and Elaine got into the Halloween spirit as they discussed their favorite candies, as well as surprise earnings reports from Eli Lilly and Pfizer. They then discuss what a Trump or Harris presidency could mean for healthcare and the biopharmaceutical industry, and what investors and biopharmaceutical executives think about both outcomes.

Listen here.

Some drug launches are going very well

Compass Pathways lays off 30% of employees

Failure of the tau approach to Alzheimer’s disease

Lilly’s Earnings Surprise and a Spooky Ghost Story

More readings