April 23, 2024

The need-to-know this morning

Novartis raised its financial outlook for the year after reporting better-than-expected sales and earnings for the first quarter. The Swiss drugmaker nominated Giovanni Caforio, the former CEO of Bristol Myers Squibb, as its new chairman to replace Joerg Reinhardt when he retires next year.
The FDA approved a new immunotherapy for advanced bladder cancer made by ImmunityBio.
Incyte acquired privately held Escient Pharmaceuticals for $750 million. Escient is developing drugs to treat inflammatory skin conditions including chronic hives and liver-associated itching.
Neurocrine Biosciences reported positive results from a mid-stage study of an experimental treatment for major depressive disorder.

crispr

Researchers get one step closer to curing disease before birth

In a scientific first, a group of scientists reported yesterday that they used CRISPR to alter the DNA of laboratory monkeys in the womb, substantially reducing levels of a toxic protein that causes a fatal liver disease before the monkeys were even born.

This research paves the way for human trials and gets the field closer to the ambitious goal of curing genetic diseases before birth, STAT's Megan Molteni reports.

The study was also significant because the CRISPR machinery made it into several organs beyond the liver, which is typically where gene therapies are directed. The technology got into the kidney, diaphragm, skeletal muscles, and even the heart — an organ that scientists have long tried to find a way to get gene editing tools into.

People moves

Anthos taps ex-Karuna CEO

Anthos Therapeutics, which is developing an anti-clotting drug, named Bill Meury as its new chief executive. Meury was previously CEO of Karuna Therapeutics, the neuroscience drug developer that was bought by Bristol Myers Squibb.

Meury is joining Anthos, which is backed by Blackstone Life Sciences, at a critical stage of development for its drug abelacimab. The treatment recently showed potential to be safer than common blood thinners in a Phase 2 trial, and is now being tested in three Phase 3 trials for stroke prevention in people with atrial fibrillation and for cancer-associated vein blockages.

Abelacimab blocks the protein Factor XI, using a similar mechanism as drugs from Bayer and BMS/Janssen that are also in Phase 3 development. Bayer recently stopped one of its trials early due to lack of efficacy, but Anthos and BMS/Janssen have kept their studies going, saying they still believe in the mechanism.

Wall Street

Looking for signs of growth in Biogen's earnings

From my colleague Adam Feuerstein: New-ish Biogen CEO Chris Viehbacher has been praised for reducing operating expenses. A return to revenue growth is still on the to-do list, however, which explains why Biogen heads into tomorrow's first-quarter earnings with a stock price down 25% for the year — near the bottom of the large-cap list.

Analysts expect Biogen to report first-quarter revenue of $2.32 billion, a 6% drop from the year-ago period, according to Visible Alpha. Adjusted earnings are expected to be $3.44 per share, a decrease of 2.5% from the year-ago quarter.

For signs of growth, analysts and investors will be watching the performance of Skyclarys, the treatment for Friedreich's ataxia that was the centerpiece of Biogen's $7 billion acquisition of Reata Pharmaceuticals last year. Fourth-quarter sales of $56 million were a disappointment. The consensus estimate for Q1 is $70 million.

The commercial rollout of Leqembi, the treatment for Alzheimer's disease co-marketed with Eisai, has been slow, mostly due to the challenges of administering a drug that requires patients to undergo multiple brain scans and weekly intravenous infusions. Based on prescription data already reported for the quarter, Biogen is likely to report Q1 Leqembi sales that are short of the $30 million consensus estimate, but a number meaningfully higher than Q4 sales of $7 million might still be a sign of ramping prescriptions.

GLP-1s

Mixed data on risks of GLP-1s in medical procedures

Drugs like Ozempic can delay stomach emptying, raising concerns that patients undergoing surgeries and endoscopies may still have food in their stomach and could accidentally breathe it into their lungs during the procedures.

There's little data on how real and how big this risk is, though, and doctors have debated whether patients should stop taking GLP-1s before procedures.

New research published in JAMA yesterday analyzed a large database of health records and found that GLP-1s were not in fact linked to an increased risk of respiratory complications following emergency surgeries.

But this comes after another study published a month ago came to a different conclusion. It found that the drugs were associated with a small but heightened risk of lung infection following endoscopies.

Intro

Who is this new writer?

Real Readout fans will remember that Damian Garde, one of the previous co-authors of this newsletter, recently left STAT. I am now taking over and I'll be bringing you the biotech news every morning alongside Meghana Keshavan.

I previously covered cardiovascular and metabolic disease for STAT, and I wrote a lot about the new GLP-1 drugs for our series last year called "The Obesity Revolution." Now, as a national biotech reporter, I'll still be reporting on this class of treatments, but also many other types of drugs.

If you want to share any ideas, tips, or celebrity sightings of "The Bear" cast in Chicago (where I'm based), please do reach out: elaine.chen@statnews.com. And please fill out this survey to share your feedback on this newsletter!

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