Sector Spotlight: UnitedHealth shareholder proposes split of CEO, chair role

Welcome to the latest edition of “Sector Spotlight,” where The Fly looks at a new industry every week and highlights its happenings.

HEALTHCARE NEWS: Accountability Board, a nonprofit advocacy group, filed a proposal with UnitedHealth (UNH) to separate the company’s chairman and CEO roles, John Tozzi of Bloomberg reported. “We were very disturbed to see recently that at such a trying time for UnitedHealth, the company chose to go backward and combine the CEO and chair roles,” Matt Prescott, president of the Accountability Board, told Bloomberg. The group confirmed it meets the minimum required stake to file a shareholder proposal.

Amgen (AMGN) announced the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating that Repatha significantly reduced the risk of major adverse cardiovascular events in individuals without a prior history of heart attack or stroke. The Phase 3 VESALIUS-CV trial enrolled over 12,000 patients, approximately 85% of whom were maintained on a high-intensity or moderate low-density lipoprotein cholesterol reducing therapy. Patients were followed for a median of approximately 4.5 years. VESALIUS-CV now establishes that Repatha, added to statins or other LDL-C lowering treatments, significantly reduces cardiovascular events compared with standard therapy alone as primary prevention. Results show that the primary endpoints were both statistically and clinically significant. No new safety signals were observed.

Pharmaceutical executives are getting almost daily calls from White House Staff and senior figures at agencies such as the Commerce Department, Dawn Kopecki, Jarrett Renshaw, Ernest Scheyder and Sabrina Valle of Reuters wrote, citing two sources familiar with the matter. During these calls, the White House asked Eli Lilly (LLY) to produce more insulin, Pfizer (PFE) to sell more of its cancer drug Ibrance and cholesterol drug Lipitor, and AstraZeneca (AZN) to consider a new headquarters in the U.S., the two sources added.

Pennant Group (PNTG) acquired certain operations from UnitedHealth. The operations were divested pursuant to UnitedHealth’s and Amedisys’ antitrust settlement with the United States Justice Department. Pennant is purchasing divested home health, hospice, and personal care services in Tennessee, Georgia and Alabama for a combined purchase price of $146.5M. The asset package includes 54 locations. The acquired agencies are primarily located in Tennessee, a certificate of need state.

The Trump administration issued a final plan for how it will carry out the third round of the Medicare drug price negotiations, pushing forward a Biden-era program despite ongoing opposition from the pharmaceutical industry, Bloomberg’s Nyah Phengsitthy reported. The final guidance by the U.S. Centers for Medicare & Medicaid Services outlines how the federal government plans to set the prices of up to an additional 15 drugs in the program. The negotiations for the third cycle are slated to begin in 2026 and prices will go into effect in 2028.

Enhanced subsidies for Affordable Care Act health-insurance plans are set to expire by the end of the year and decisions related to them may be crucial to end a government shutdown, Jasmin Li and Anna Wilde Matthews of The Wall Street Journal wrote. At the moment, Republicans are pushing to temporarily extend current government funding levels for extra time for negotiations, but Democrats have said they won’t vote for any bill to end a government shutdown if it excludes an extension of the ACA subsidies. These government subsidies cap the max percentage of household income an individual pays toward their ACA health coverage. About 24.3M Americans are enrolled in ACA, with 22.4M receiving subsidies.

Bristol Myers Squibb (BMY), Takeda Pharmaceuticals (TAK), and Astex Pharmaceuticals are joining a consortium that includes AbbVie (ABBV) and Johnson & Johnson (JNJ) to share data for training an AI model meant to assist with drug discovery and development, Sneha S K of Reuters reported. The companies will contribute experimentally determined protein-small molecule structures to train an AI model.

An Eli Lilly spokesperson told Bloomberg that the company is in “active discussions” with the Trump administration on drug pricing after President Donald Trump announced the “first agreement with a major pharmaceutical company,” Pfizer, to bring American drug prices in line with the lowest paid by other developed nations.

President Donald Trump announced the “first agreement with a major pharmaceutical company,” Pfizer, to bring American drug prices in line with the lowest paid by other developed nations, the White House announced. “The agreement will provide every State Medicaid program in the country access to MFN drug prices on Pfizer products, resulting in many millions of dollars in savings and continuing President Trump’s historic efforts to strengthen the program for the most vulnerable. The agreement ensures foreign nations can no longer use price controls to freeride on American innovation by guaranteeing MFN prices on all new innovative medicines Pfizer brings to market. The agreement requires Pfizer to repatriate increased foreign revenue on existing products that Pfizer realizes as a result of the President’s strong America First U.S. trade policies for the benefit of American patients. The agreement requires Pfizer to offer medicines at a deep discount off the list price when selling directly to American patients,” a White House fact sheet stated.

AbbVie announced submission of a new biologics license application to the FDA for approval of investigational Pivekimab sunirine for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm.

Merck announced results from the Phase 3 HYPERION trial evaluating Winrevair versus placebo in recently diagnosed adults with pulmonary arterial hypertension functional class II or III at intermediate or high risk of disease progression. In the study, Winrevair reduced the risk of clinical worsening events by 76% as measured by a composite endpoint of all-cause death, the need for non-planned PAH-related hospitalization greater than or equal to24 hours, atrial septostomy, lung transplantation or PAH deterioration. HYPERION included participants who were within their first year of diagnosis, with over 70% of trial participants on double background therapy. In the pivotal Phase 3 study, STELLAR, participants were WHO Group 1, FC II or III at baseline and had an average disease duration of 8.8 years from PAH diagnosis to screening. The safety profile of Winrevair was generally consistent with that observed in previous trials.

AbbVie announced plans to launch Elahere in the U.K. at a list price equal to the U.S. Elahere is the first-and-only approved FRalpha-directed antibody drug conjugate medicine.

Guardant Health (GH) announced that the FDA has approved its Guardant360 CDx as a companion diagnostic to identify advanced breast cancer patients with ESR1 mutations who may benefit from Eli Lilly and the company’s Inluriyo. Guardant360 CDx was approved in conjunction with Inluriyo for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy.

Johnson & Johnson announced that the FDA has approved Tremfya for the treatment of children six years and older who also weigh at least 40 kg with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. This milestone makes Tremfya the first and only IL-23 inhibitor approved for these pediatric indications and builds on the initial FDA approvals in adults living with moderate to severe plaque PsO in 2017 and active PsA in 2020.