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Good morning. My colleagues are hosting a virtual LinkedIn event today (at 1 p.m. ET) on how President-elect Trump’s administration could transform health care and biotechnology. Check it out here.

Today, it’s time for biotechnology news.

AbbVie’s big bet on neuroscience has yet to bear fruit

AbbVie announced yesterday that a schizophrenia treatment that was the centerpiece of its $9 billion acquisition of Cerevel has failed in two key trials. The good news is that this is not the last opportunity to make advances in neuroscience, an area the company is increasingly moving toward. The bad news is that the effort may not get any easier.

The company’s next big test will be an Alzheimer’s disease therapy that it is collaborating on with Alector Therapeutics. Results from phase 2 trials of the drug, which relies on a different mechanism than those used by existing treatments, are expected before the end of the year.

AbbVie also recently announced a $1.4 billion acquisition from a private biotech called Aliada Therapeutics, which is developing therapies that can cross the membrane known as the blood-brain barrier.

The deal “kind of reaffirmed that AbbVie is here to stay in these high-risk, high-reward neurological areas,” one analyst said.

Learn more.

AstraZeneca had to resubmit cancer drug for approval

AstraZeneca said this morning that it had to resubmit a closely watched drug for FDA approval for a different form of lung cancer, a step that will delay the drug’s arrival on the market and add questions about the extent of its use.

The drug, datopotamab deruxtecan, or Dato-DXd, is an antibody-drug conjugate that AstraZeneca is partnering on with Daiichi Sankyo. AstraZeneca cited it as one of the products that will help it achieve its goal of nearly doubling its revenue to $80 billion by 2030.

Learn more by STAT’s Drew Joseph.

23andMe ends its drug discovery dream

23andMe announced last night that it would end its drug development efforts and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the data obtained for research purposes.

In doing so, the company ends a bold bet it made nearly a decade ago: to be able to use the genetic data it had collected not only to help pharmaceutical companies, but also to become ones themselves. same one.

This comes at an incredibly tumultuous time for the company. Over the course of that year, the company’s shares fell 72%. CEO and co-founder Anne Wojcicki negotiated to secure the financing needed to take the company private, but her board resigned en masse in protest in September.

Learn more by STAT’s Matt Herper.

ALS start-up launches with $101 million

A new company called Trace Neurosciences launched today with $101 million in Series A funding led by Third Rock Ventures. Atlas Venture, GV and RA Capital Management have also joined us.

The startup is developing a treatment targeting UNC13A, a gene linked to both a higher risk of ALS and faster disease progression. While companies developing ALS therapies have struggled over the past year, Trace executives said they believe their therapy has the potential to treat the vast majority of ALS patients, as well. than those with other brain disorders, such as frontotemporal dementia and Alzheimer’s disease.

The South San Francisco biotech plans to begin testing its lead drug candidate in clinical trials by early 2026.

Learn more by STAT’s Jonathan Wosen.

When even a PIPE “above the wall” cannot help

From my colleague Adam Feuerstein: Neurogene shares fell 35% last night after revealing that a pediatric patient with Rett syndrome suffered a serious side effect after treatment with a high dose of its investigational gene therapy. No details were reported except that the toxicity was “consistent with known risks” of gene therapies delivered using adeno-associated viruses, or AAVs.

The company said it was informed of the serious side effects “just hours” before making the announcement. A week ago, Neurogene provided a group of hedge fund investors with confidential access to new data on its gene therapy for Rett syndrome, and in return, the investors provided the company with $200 million. dollars in PIPE financing, at a price of $50 per share.

After the deal was announced on November 4, Neurogene’s stock price rose more than 50% to $71 as investors outside the deal assumed the gene therapy data was positive. Neurogene said yesterday that four Rett patients treated with a low dose of its gene therapy showed steady signs of improvement, but the efficacy update was overshadowed by the revelation of the serious side effect. Neurogene shares fell to $46.

Pfizer sees promise in using wearable devices in drug trials

When Pfizer announced positive results earlier this year from its treatment for cachexia, a disease that causes muscle wasting, the company reported an intriguing secondary endpoint: Treated patients had more non-sedentary activity per day , as measured by a portable device.

Digital endpoints using wearables or other devices have been explored by more than 100 drug developers for their ability to provide new insights into how experimental treatments impact patients. But Pfizer’s latest results represent one of the most advanced efforts disclosed by a major drugmaker.

My colleague Mario Aguilar sat down with Carrie Northcott, head of digital science at Pfizer, to discuss the future of using wearable devices in drug research. The industry is close to “a revolution in the use of these measures in clinical trials,” she said.

Learn more.

More reading

• FDA lifts clinical hold on Novavax’s combined Covid flu vaccine Reuters
• OpenAI is not designed for healthcare. So why is its technology already in hospitals, pharmaceuticals and cancer care? STATUS
• The War on Recovery: The recovery community claims to offer refuge from opioid addiction. But he remains hostile to life-saving drugs for drug addiction, STATUS