Written: Katie Coffee
Photo: A scientist pipettes samples in a laboratory. Julia Koblitz / Unsplash
Sarepta closes enrollment in Elevidys Phase 3 ENVISION trial after more than a year on hold
The company will analyze blinded data from the 90 participants already enrolled rather than restart the study.
In a Nov. 5 letter to the Duchenne community, Sarepta said ENVISION, its global trial of the gene therapy Elevidys in non-ambulatory and late-ambulatory patients, will not reopen to new participants [1]. The study, on clinical hold since 2025, enrolled 64 non-ambulatory and 26 late-ambulatory participants in 14 countries [1]. Sarepta said a restart would require adding blinded sirolimus for non-ambulatory participants, combining different treatment approaches and making results hard to interpret; it gave no date for reporting data [1].
Four states sue to block Medicaid work requirements
Oregon, Minnesota, New Mexico and Washington argue the mandate in H.R. 1 exceeds Congress’s spending power.
The complaint, filed Nov. 5 in federal court in Oregon against HHS, CMS and their leaders, raises a single Spending Clause claim and asks the court to bar the government from withholding existing federal Medicaid funds from states that do not comply [2]. The states also filed motions for summary judgment and a preliminary injunction [3]. The requirement applies to expansion enrollees ages 19 to 64, with an 80-hour monthly threshold; Oregon counts about 564,177 residents in that group [2].
Amgen study links Repatha to 20% fewer heart attacks than ezetimibe
The comparison is observational, drawn from a health care database covering 544,103 adults, and was announced by the drug’s maker.
The analysis followed adults with atherosclerotic cardiovascular disease and prior statin use who started evolocumab (64,421) or ezetimibe (479,682) between 2017 and 2024 [4]. Fatal or nonfatal myocardial infarction was less frequent with evolocumab over up to four years (hazard ratio 0.80; 95% CI, 0.70–0.91) [4]. The non-interventional study, published in the American Journal of Preventive Cardiology, used weighting to balance measured baseline characteristics [4].
California lab and owner pay $1.25 million to settle kickback allegations
The government alleged commissions to marketers were disguised as flat fees.
Lab Genomics LLC of Fountain Valley and owner Leena Dalal resolved False Claims Act allegations that from January 2020 through September 2022 they paid value- and volume-based commissions to three independent marketers to generate laboratory test referrals, the Justice Department said Nov. 6 [5]. The claims are allegations only, with no determination of liability [5]. Two whistleblowers will receive $225,000 [5].
Digest references
1. Sarepta Therapeutics. “Update for the Duchenne Community: ELEVIDYS Research, ENVISION and Our Exon-Skipping Programs.” Community letter, Nov. 5, 2026, hosted by CureDuchenne. cureduchenne.org
2. State of Oregon et al. v. Oz et al. Complaint for Declaratory and Injunctive Relief, No. 6:26-cv-2435, U.S. District Court for the District of Oregon, filed Nov. 5, 2026. doj.state.or.us
3. Oregon Department of Justice. “Medicaid Work Requirements (Oregon v. Oz, D. Or.).” Federal litigation tracker, updated Nov. 6, 2026. doj.state.or.us
4. Amgen. “Repatha Lowers Risk of Heart Attacks by 20% Compared With Ezetimibe in a Large Real-World Study.” Press release, Nov. 5, 2026. amgen.com
5. U.S. Department of Justice. “California Laboratory and Its Owner Pay $1.25M to Settle Allegations of Kickbacks to Marketers.” Press release, Nov. 6, 2026. justice.gov
