Darwin's Our Take 6.15.26: GSK grows lung cancer portfolio with $10.6 billion Nuvalent acquisition

GSK grows lung cancer portfolio with $10.6 billion Nuvalent acquisition

Among last week’s spate of Pharma-related acquisition and collaboration announcements, GSK’s deal to acquire Nuvalent is by far the largest. The transaction has an aggregate equity value of approximately $10.6 billion.

By acquiring the Cambridge, Mass.-based biopharma, GSK will add three investigational, potential best-in-class, brain-penetrant therapies for non-small cell lung cancer to its portfolio.

Nuvalent’s two lead candidates are zidesamtinib, a ROS1-selective tyrosine kinase inhibitor (TKI), and neladalkib, an ALK-selective TKI. Both are under FDA review, with approval decisions anticipated in September and November, respectively. According to the press release, both drugs could launch this year if approved, and each has “multi-blockbuster” potential.

The third therapy, NVL-330, is an HER2-selective TKI being evaluated in Phase I trials as a treatment for HER2-altered NSCLC.

Luke Miels, CEO of GSK, said the acquisition is consistent with the company’s approach to “acquire assets that have clinically proven targets and meaningfully address an efficacy and/or tolerability gap.”

Miels added that the acquisition provides GSK with “a platform in lung cancer for rapid expansion with ris-rez,” referring to risvutatug rezetecan, an investigational B7-H3-targeted antibody-drug conjugate GSK is developing to treat various solid tumors. The most advanced clinical trial of ris-rez is a Phase III study in patients with extensive-stage small cell lung cancer.

Under the agreement, GSK will pay $124 per share of outstanding Nuvalent common stock, representing a 40% premium to the stock’s closing price on the day before the acquisition was announced. Net of cash acquired, GSK’s aggregate investment will be an estimated $9.4 billion.

If customary closing conditions are met, GSK anticipates finalizing the transaction in the third quarter.

Other deals announced last week were valued, or had the potential to be valued, at $1 billion to $2 billion.

Johnson & Johnson, for instance, entered into a definitive agreement to buy Firefly Bio, a biotech based in South San Francisco, for $1 billion in cash. Through the deal, J&J would gain Firefly’s Firelink degrader antibody conjugate (DAC) platform.

The platform uses catalytic protein degraders as the payloads of antibody-drug conjugates. According to Firefly, the Firelink linker technology that connects the modalities decreases the amount of free payload in circulation and minimizes uptake in healthy cells.  

At least initially, J&J’s use of the Firelink DAC platform will center on KRAS-driven tumors, the announcement indicated.  

“KRAS has notoriously been considered an undruggable target and patients with KRAS-driven cancers continue to face limited treatment options with survival measured in months, not years,” said Dr. John Reed, executive vice president of research and development in J&J’s Innovative Medicine unit.

“We believe the proprietary Firelink platform will overcome the limitations of current treatments and diversify our pipeline with preclinical candidates for treating multiple types of solid tumors,” he said.

The deal is subject to regulatory approval and other usual closing conditions. J&J expects to complete the transaction before the end of the year.

Meanwhile, Alnylam Pharmaceuticals, an RNAi therapeutics company based in Cambridge, Mass., signed a strategic collaboration agreement with Inceptive Nucleics, a company in Palo Alto, Calif., that builds AI foundation models used to design breakthrough biological therapies.

In the press release announcing the agreement, Alnylam said it intends to integrate Inceptive’s generative AI models with Alnylam’s R&D engine to accelerate the discovery of novel RNAi therapeutics.

“Together, we have an extraordinary opportunity to accelerate the creation of transformative medicines with a speed, ingenuity, and sophistication that simply has not been possible before,” said Dr. Yvonne Greenstreet, Alnylam’s chief scientific officer.

"Most drug design still works through a process of trial and error, testing thousands of molecules and hoping something sticks,” said Jakob Uszkoreit, Inceptive’s co-founder and CEO. “Inceptive was built on a different premise: that life follows rules of such complexity that only AI can learn them.

“Alnylam’s breakthrough platform and scientific vision are an ideal match for AI,” Uszkoreit added. “Together, we’re not just accelerating drug discovery; we’re changing the way we understand and improve life.”

Uszkoreit co-invented the Transformer architecture, the “T” in ChatGPT.

Alnylam will pay $30 million up front in cash and an equity investment in Inceptive. Subsequent milestone payments to Inceptive could make the collaboration worth as much as $2 billion.

In a similarly structured deal, Eli Lilly will pay $10 million to license an investigational Alzheimer’s therapy from a Swedish company called AlzeCure Pharma — but with additional milestone payments and royalties, the overall value of the agreement could exceed $1 billion.

The drug, a gamma-secretase modulator known as Alzstatin ACD680, is in preclinical development. It aims to reduce the production of a harmful amyloid-beta protein that forms the building blocks of amyloid plaques found in the brains of people who have Alzheimer’s disease.

“In the long term, [Alzstatin] compounds may also serve as a preventive treatment to prevent the development of Alzheimer’s disease,” said Martin Jonsson, CEO of AlzeCure, in a press release.

The transaction is subject to customary closing conditions, including the approval of Swedish authorities.

And in yet another deal, Wilmington, Del.-based Incyte entered into a definitive agreement to acquire Vega Therapeutics, a subsidiary of South San Francisco-based Star Therapeutics, for an upfront sum of $1.25 billion.

Vega Therapeutics’ lead candidate, VGA039, is in Phase III testing as a treatment for von Willebrand disease, an inherited bleeding disorder. The first-in-class monoclonal antibody modulates protein S to improve hemostatis, which could make it useful in treating numerous bleeding disorders, according to the announcement.

For patients with von Willebrand disease who require frequent IV infusions, VGA039 could be the first subcutaneous prophylactic treatment with a convenient dosing regimen, Incyte noted.

If the drug is approved and certain sales milestones are achieved, Star Therapeutics could receive up to another $750 million.  

The boards of both Incyte and Star Therapeutics have approved the transaction, which is structured as an equity acquisition. It is subject to customary closing conditions and is expected to close in the third quarter.

What else you need to know

CommonSpirit is focusing on efficiency gains and cost savings through a rapid realization plan that is integral to Project Impact, a multiyear performance-improvement initiative announced last fall. CFO Michael Browning said during an earnings call in late May that the rapid realization plan “is designed to deliver immediate measurable improvements by Q1 of 2027” — which begins July 1 — and “is laying the foundation for our longer-term transformation.” The plan’s core areas include clinical capacity, care access, discretionary spending, and workforce optimization.

In October, then-CFO Dan Morissette said the Chicago-based health system still wasn’t where it needed to be financially, even though its operating loss had decreased from $875 million in FY 2024 to $225 million in FY 2025, and total operating revenue had increased $3 billion year over year. In November, CEO Wright Lassiter III said the goal of Project Impact was “to try to drive between $5 billion and $6 billion worth of value creation across the organization over the next 36 months,” Becker’s Hospital Review reported.

Although executives said on the earnings call that CommonSpirit is making progress in areas such as expanding access to care and lowering technology costs, the organization reported an operating loss of $578 million, before special charges, for the third quarter of FY 2026. This compares with an operating loss of $85 million for the same quarter of the previous year. The health system also reported a net loss of $762 million (before special charges) for Q3 of FY 2026, compared with net income of $114 million for Q3 of FY 2025.

Browning said CommonSpirit’s third-quarter performance “reflects a dynamic healthcare landscape, where we’re seeing positive demand for our services alongside persistent financial headwinds. Our focus remains firmly on long-term sustainability.”

Ascension completed its $3.9 billion acquisition of AmSurg and now has 300 ambulatory surgery centers across 35 states — making Ascension the third-largest operator of ASCs in the U.S., according to Fierce Healthcare. The nonprofit Catholic health system had to divest seven AmSurg facilities, including two in Nashville, Tenn., where AmSurg is based, to gain the Federal Trade Commission’s consent to proceed with the transaction. Six of the seven divested ASCs are now part of SC Affiliates, a subsidiary of Optum, and the seventh ASC is part of Florida Gastroenterology Center.  

The first clinical practice guideline for cardiovascular-kidney-metabolic syndrome is available to help medical professionals identify the risk, prevention, and management of the syndrome, which the American Heart Association describes in a news release as “an interconnected set of health conditions that significantly increase the risk of multiorgan complications and negative cardiovascular outcomes.” According to the AHA, almost 90% of U.S. adults have one or more CKM syndrome risk factors, including abnormal lipids, excess weight, high blood glucose, high blood pressure, and reduced kidney function.

The guideline describes the four stages of CKM syndrome and provides recommendations for tailoring prevention strategies that may slow, and in some cases reverse, its progression. Strategies include lifestyle modifications, medications — including GLP-1s — and surgical therapies. The guideline was developed by the AHA and the American College of Cardiology Joint Committee on Clinical Practice Guidelines in collaboration with the American Diabetes Association’s Obesity Association and the American Society of Nephrology. It was published June 9 in the journals Circulation and JACC.    

Humana agreed to divest “all or substantially all” of its stake in Gentiva, an Atlanta-based provider of hospice services and palliative care with more than 430 locations across 35 states. The announcement did not specify who agreed to buy Gentiva, referring only to “a consortium of investors.” Humana said the agreement values the insurer’s 40% stake at approximately $900 million. If regulators approve the transaction and other customary closing conditions are satisfied, Humana expects to close the deal in the third quarter.

Presbyterian Healthcare Services will not offer most of its Medicare Advantage plans next year, various sources reported, saying a spokesperson for the Albuquerque, N.M.-based health system had confirmed the news. As a result, approximately 30,000 health plan members will need to find other coverage. A local news outlet reported that Presbyterian will continue to offer an MA plan for those with special needs who are eligible for both Medicare and Medicaid benefits. According to Becker’s Payer Issues, Presbyterian Health Plan is New Mexico’s largest Medicaid managed care plan.

HCR #209: The State of Value: An Economist’s Perspective, with Michael Chernew, Ph.D.

U.S. health care spending keeps rising, quality scores are improving, and yet the care most Americans receive has barely improved. Dr. Michael Chernew, Professor of Health Care Policy at Harvard Medical School and former Chair of MedPAC, joins John to examine why decades of quality measurement have failed to move the needle on actual care quality, and whether value-based payment models can survive the incentive distortions they were built to fix. On Spotify, Apple, YouTube, and all other podcast platforms.

What we’re reading

Why AI Will Accelerate Health Care Inflation. Health Affairs, 6.11.26

Tracking Insurer Participation Changes in the ACA Marketplaces in 2027. KFF, 6.11.26

Former FDA Officials: There’s Opportunity to Rebuild the Agency — But Not the Way It Was. Med City News, 6.3.26