September 21, 2026

The need-to-know this morning

At a capital markets event today, Novo Nordisk told investors that it plans to expand its pipeline and find new products to sell more like consumer goods than traditional medicines, building off what’s occurring with its obesity treatments.
Eli Lilly has indicated an interest in purchasing up to a $100 million equity stake in Oura, according to the ring maker's updated IPO filing.

M&A

Radiopharma players merge after surprise FDA rejection

Two leading radiopharma companies are joining forces in a deal worth at least $1.65 billion, STAT’s Allison DeAngelis writes. Australia-based Telix Pharmaceuticals will acquire Germany’s ITM Isotope Technologies Munich SE for $1.65 billion upfront, with another $700 million in potential milestone payments.

The deal comes a month after the FDA unexpectedly rejected ITM-11, ITM’s treatment for gastroenteropancreatic neuroendocrine tumors. The denial was over manufacturing and facility issues from a third party, rather than concerns about the drug’s clinical data or safety.

ITM, a longtime supplier of isotopes used to make Novartis’ Pluvicto, brought in $273 million from that business last year and has been trying to expand into developing its own medicines.

mental health

Alkermes orexin agonist shows early ADHD promise

Alkermes is offering the first evidence that orexin agonists, a drug class developed for rare sleep disorders, could help allay symptoms of ADHD. In a Phase 1 study, adults taking the highest dose of ALKS 7290 saw their scores on an ADHD symptom scale fall by 19 points after two weeks, a magnitude of improvement similar to what stimulants have shown over longer trials.

The results add to growing interest in the use of orexin agonists in conditions beyond narcolepsy, STAT’s Elaine Chen writes, based on evidence that the system plays a role in attention, cognition, and mood. Alkermes has already started a Phase 2 ADHD study and is separately exploring the class in fatigue associated with Parkinson’s and multiple sclerosis.

“We're really happy on this first step,” said CEO Blair Jackson. “It's an early study, so it's not to get super excited about, but it's definitely going in the right direction.”

opinion

Reed Jobs calls for doubling NIH funding to $100B

Congress should bump NIH funding to $100 billion annually, opines Reed Jobs, founder of biotech investor Yosemite Management (and son of another famous Jobs). In a new First Opinion essay, he argues that federal investment in basic science has helped underpin breakthroughs ranging from mRNA vaccines and gene editing to obesity drugs and new cancer treatments.

Jobs notes that the recently approved pancreatic cancer drug daraxonrasib from Revolution Medicines — of which Yosemite is an investor — is an example of a discovery that would have been difficult to achieve without publicly funded research. NIH currently operates on a budget of roughly $48 billion and directs most of its funding to extramural research, while the Trump administration’s fiscal 2027 budget request proposed $41.5 billion, a $5 billion reduction from the administration’s stated fiscal 2026 baseline. Meanwhile, a House appropriations bill advanced in June would provide $48.8 billion.

“Long ago, America decided to invest heavily in an effort to lead the world in the sciences. At the time, the focus was the atomic age and soon after, the space race,” Jobs writes. “Those are still national priorities, but today the greatest opportunity is in biology.”

Oncology

Lilly's breast cancer combo wins approval

The FDA approved Eli Lilly’s Inluriyo, or imlunestrant, in combination with its cancer durg Verzenio for patients with an advanced form of breast cancer. Specifically, it’s meant for patients with advanced or metastatic ER-positive, HER2-negative breast cancer whose tumors harbor ESR1 mutations and have progressed after at least one endocrine therapy.

The approval is based on a Phase 3 study that showed the combination cut the risk of progression or death by 47% compared with imlunestrant alone. Median progression-free survival was 11.1 months with the combination, versus 5.5 months with imlunestrant alone. The response rates were 35% and 15%, respectively. The FDA also approved Guardant Health’s Guardant360 CDx as a companion diagnostic to identify eligible patients.

clinical trials

Gene therapy improved vision for patients with inherited eye disease

From STAT's Andrew Joseph: Beacon Therapeutics this morning reported that its experimental gene therapy for an inherited cause of blindness improved vision, with the company planning to submit the data to regulators this year.

The Phase 2/3 VISTA trial tested two doses of the gene therapy, known as laru-zova, as a treatment for X-linked retinitis pigmentosa, which largely affects boys and men and causes progressive vision loss. In the high-dose group, 31% of patients met the study's primary endpoint — a measure of visual improvement based on a test that involves reading letters on an eye chart under low light — while 24.1% of participants in the low-dose group did. No one in an untreated control group achieved that mark.

With the trial, Beacon, which is based in London and Cambridge, Mass., succeeded where both Biogen and Johnson & Johnson failed in their attempts to develop XLRP gene therapies.

Beacon said most adverse events were mild to moderate, though there were two ocular-related serious events in the low-dose group, tied to the surgical procedure involved in delivering the therapy.

If approved, laru-zova would be the second gene therapy to reach the market for an inherited cause of blindness. The first gene therapy ever to be approved in the U.S., Roche’s Luxturna in 2017, was for another type of retinal disease.

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