What analysts make of Pfizer's new GLP-1 plans

From STAT's Adam Feuerstein: Pfizer's decision yesterday to move ahead with a once-daily GLP-1 pill for obesity was met with a mix of cautious praise and skepticism from Wall Street wags.

The oral drug, called danuglipron, belongs to the same class of injectable obesity medicines as Wegovy and Zepbound. Last December, Pfizer shelved a twice-daily version of the drug because its weight-loss and tolerability profile wasn't competitive. Now, Pfizer said it has selected a "modified release formulation" of danuglipron that might allow for once-daily dosing, pending the outcome of a dose-optimization study.

Evercore ISI's Umer Rafat called Pfizer's decision to conduct more preliminary work on "danu" — without committing to larger Phase 3 studies just yet — the "right move." But he noted that Pfizer might also be buying time while it susses out other backup oral GLP-1 drugs from its labs.

David Risinger of Leerink pointed out that Pfizer's dose-exploring study for the new version of danu, even if positive in early 2025, won't yield any data on weight loss or side effects in patients. "We think the company will need to subsequently initiate a Phase 1b in order to evaluate efficacy and tolerability," he wrote, adding that those data may not be ready until 2026 at the earliest.

Raymond James analyst Steven Seedhouse has a strong buy rating on Viking Therapeutics, which is developing its own obesity drug, and as such, has become a widely discussed takeover target for pharma giants like Pfizer that are falling behind Lilly and Novo Nordisk.

Commenting on the Pfizer news, Seedhouse titled his research note: "Do Bad BID Drugs Make Good QD Drugs? Pfizer Seemingly Thinks So, We Say Unlikely."

CANCER

CAR-T's complications, and benefits, become clearer

Last year, the FDA began studying whether new lymphomas were linked to CAR-T therapy — a surprise, given the fact that the therapy is used as a potent treatment for blood cancers. Despite several studies, scientists haven't yet found solid proof that CAR-T directly causes these new cancers.

It seems more likely that patients' existing risk factors and prior treatments contribute to these cases. The risk of developing a new cancer after CAR-T remains low, and the benefits of the therapy still far outweigh the risks, researchers say. And the biggest concern for CAR-T patients remains infections, not new cancers.

podcast

Biotech layoffs and a big pharma exit

Why are pharmaceutical companies cutting more staff than cash-strapped biotechs? And who will Pfizer scout out as its next science chief? STAT's West Coast biotech reporter Jonathan Wosen joins "The Readout LOUD" to discuss what's driving workforce cuts.

We also discuss a big change in Pfizer's leadership and the debate over a new side effect tied to the diabetes drug Ozempic. Plus, entrepreneurs Alexis Borisy and Zach Weinberg call in to discuss their biotech incubator Curie.Bio and how they hope to "free the founders."

Listen here.

sequencing

Element Biosciences raises another massive round

Element Biosciences, a San Diego-based rival to Illumina, just raised $277 million in Series D venture funding. The funding will help Element commercialize its Ativi benchtop genomic analyzer, and launch its next generation Ativi24 system, which will include cell profiling and multi-omics.

In May, STAT's Jonathan Wosen spoke with Element CEO Molly He, who mentioned that even when the company was raising its previous round in 2021, they weren't ready to go public — and still aren't.

"We wanted to be able to precisely predict what we're going to do in terms of revenue … that takes work and takes an understanding of our customers, of the market, and how our technology has been perceived by the market," she said. "We're getting better and better in our forecast capabilities. But we're still not quite there."

clinical trials

The case for adaptive trial design

Health care is moving toward personalized, patient-focused care, and clinical trials must follow suit with adaptive designs, opine two experts in this space. These trials adjust based on real-time data, speeding up access to new treatments, reducing exposure to ineffective therapies, enhancing patient safety, and improving understanding of drug effects.

Collaboration between tech and patient advocacy can further accelerate medical research and innovation, the experts say. Despite their complexity, advancements in machine learning are making adaptive trials more manageable. Regulatory bodies like the FDA are supporting these designs, recognizing their potential to make drug development more efficient and patient-centric.