July 14, 2023

The need-to-know this morning

Roivant Sciences could sell an experimental treatment for inflammatory bowel disease to Roche for $7 billion, according to the Wall Street Journal, citing people familiar with the deal negotiations.
Korro Bio, a startup developing drugs based on an RNA-editing technology, is going public via a merger with the shell of Frequency Therapeutics.
Acadia Pharmaceuticals pre-announced revenue for the second quarter, including preliminary sales of Daybue, its recently approved treatment for Rett Syndrome, of $21 million-$23 million — well above analysts' estimates. The company also acquired commercial rights to Daybue outside North America.
Two biotech IPOs priced overnight: Apogee Therapeutics raised $300 million at $17 per share. Sagiment Biosciences raised $85 million at $16 per share. Both stocks start trading later today.
Eli Lilly said it will acquire Versanis Bio, a privately held biotech developing drugs to treat obesity and other metabolic disorders. Deal terms were not fully disclosed, except that Versanis shareholders could receive up to $1.9 billion in cash if all development and sales milestones were achieved.

Oncology

Caribou's off-the-shelf CAR-T is gaining on the competition

Caribou Biosciences' off-the-shelf CAR-T therapy induced durable, complete remissions in patients with advanced lymphoma, the company said yesterday, data that move it closer to the benchmarks set by more established, patient-specific CAR-T therapies.

As STAT's Adam Feuerstein reports, Caribou disclosed preliminary data in which 44% of the 16 patients treated with its on-demand therapy, called CB-010, achieved a complete remission lasting a minimum of six months, a key threshold of durability. Approved CAR-T therapies, which must be custom made for each patient, have led to durable remissions of around 40% in a similar patient population.

The data suggest Caribou's approach, which uses CRISPR to edit T cells from healthy donors, could eventually compete with patient-specific CAR-T treatments from Gilead Sciences and Novartis. First the company will need to treat more patients and settle on an ideal dose of its therapy before embarking on a larger study that would support regulatory approval.

Read more.

Alzheimer's

The view from the EU

The world's biggest annual Alzheimer's disease conference, a meeting accustomed to failure and commiseration, will be decidedly different in 2023. One medicine, Eisai's Leqembi, is rolling out to patients, and another, Eli Lilly's donanemab, looks poised to follow it.

But as STAT's Andrew Joseph reports, in Europe, which is hosting this year's conference, the reception might be more muted. Experts said the continent will face some unique challenges if and when Leqembi and donanemab win approval there. For one, the European Union's fractured health system will mean companies will have to strike reimbursement deals in each member state, a process that often leaves some countries waiting years for new drugs to become available.

And that depends on whether the European providers and agencies that decide on cost-effectiveness decide that the benefits of novel Alzheimer's therapies outweigh their risks and justify their prices, which is hardly guaranteed.

Read more.

Podcast

Is Wegovy really a brain drug?

Which Alzheimer's disease treatment works best? And what's the point of Threads?

We cover all that and more this week on "The Readout LOUD," STAT's biotech podcast. Our colleague Megan Molteni joins us to explain the evolving science suggesting products like Wegovy are less weight loss drugs than treatments for human desire. We also explain why this summer is shaping up to be a pivotal moment for the treatment of Alzheimer's and discuss our befuddlement with the latest social media platform.

Listen here.

Biotech

Roche burnishes its blockbuster MS drug with new data

Roche's multiple sclerosis treatment Ocrevus, which brought in about $7 billion for the company last year, works just as well when delivered in a 10-minute injection as it does with an hours-long intravenous infusion, according to a pivotal study.

As STAT's Jonathan Wosen reports, Roche intends to submit those results to global regulators, aiming to make Ocrevus more convenient and expand the use of what has become a mainstay treatment for MS. The drug, administered every six months, is approved for patients with the relapsing and primary progressive forms of the disease.

The data might thwart challenges to Ocrevus' market share. TG Therapeutics, a biotech company that recently won FDA approval for a twice-a-year MS therapy of its own, lost about 15% of its value on the news.

Read more.

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