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AbbVie, Pfizer, Neurogene, Novavax latest
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AbbVie, Pfizer, Neurogene, Novavax latest

This story was first published in The Readout newsletter. Sign up for The Readout and get STAT’s award-winning biotech news delivered straight to your inbox.

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

Let’s move on to today’s biotechnology news.

AbbVie’s big bet on neuroscience hasn’t yet paid off

AbbVie announced yesterday that its schizophrenia treatment, the centerpiece of its $9 billion acquisition of Cerevel, had failed in two pivotal trials. The good news is that this isn’t the last opportunity to make advances in neuroscience, an area the company is increasingly turning to. The bad news is that this effort may not get any easier.

The company’s next big test will be its readout of an Alzheimer’s treatment in which it is collaborating with Alector Therapeutics. Phase 2 trial results of the drug, which is based on a different mechanism than existing treatments, are expected before the end of the year.

AbbVie also recently announced $1.4 billion acquisition It’s from a private biotechnology company called Aliada Therapeutics, which develops treatments that can cross the membrane known as the blood-brain barrier.

One analyst said the deal “reaffirms that AbbVie is here to stay in these high-risk, high-reward neurological fields.”

Read more.

AstraZeneca had to resubmit its cancer drug for approval

AstraZeneca said this morning that it had to resubmit for FDA approval a closely watched drug for a different type of lung cancer; It’s a step that will delay the drug’s arrival on the market and add questions about how widely it can be used.

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

Read more From STAT’s Drew Joseph.

23andMe puts an end to drug discovery dreams

23andMe said late yesterday that it would halt drug development efforts and lay off 40% of its workforce, focusing instead on selling genetic tests to consumers and using the resulting data for research.

By doing so, the company is putting an end to the audacious bet it made almost a decade ago: that it could use the genetic data it collects not only to help pharmaceutical companies, but to become one of them itself.

This came during an incredibly turbulent time for the company. Over the course of this year, the company’s shares have fallen 72%. CEO and co-founder Anne Wojcicki was in talks to obtain financing to take the company private, but the board resigned en masse in protest in September.

Read more From STAT’s Matt Herper.

ALS initiative opened 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 also participated.

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

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

Read more From STAT’s Jonathan Wosen.

When not even a PIPE ‘over the wall’ can help

From my colleague Adam Feuerstein: Neurogene shares tumbled 35% last night after it was announced that a pediatric patient with Rett syndrome experienced a serious side effect following a high dose of experimental gene therapy treatment. Details were not reported, other than that the toxicity of gene therapies delivered using adeno-associated viruses, or AAVs, was “consistent with known risks.”

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

After the deal was announced on Nov. 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 patients with Rett treated with low-dose gene therapy showed consistent signs of improvement, but its efficacy update was overshadowed by the disclosure of serious side effects. Neurogene shares fell to $46.

Pfizer sees promise in using wearable tech in drug trials

When Pfizer announced positive results for its treatment for the muscle-wasting condition cachexia earlier this year, the company reported a compelling secondary endpoint: Treated patients had more sedentary activity per day, as measured by wearable devices.

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 affect patients. But Pfizer’s latest results represent one of the most advanced efforts by a major drugmaker.

My colleague Mario Aguilar spoke with Carrie Northcott, Pfizer’s head of digital sciences, to discuss the future of using wearable technologies in drug research. He said the industry is close to “a revolution in the use of these measures in clinical trials.”

Read more.

Further reading

  • FDA lifts clinical review on Novavax’s combo Covid-flu vaccine, Reuters
  • OpenAI is not designed for healthcare. So why is its technology already used in hospitals, pharmacies and cancer treatment? STATISTICS
  • Battle for Recovery: The recovery community says it offers sanctuary from opioid addiction. But he remains hostile to life-saving addiction medications. STATISTICS