Lilly’s retatrutide beats Ozempic on A1C and weight loss in head-to-head diabetes trial

-Lilly’s retatrutide beats Ozempic on A1C and weight loss in head-to-head diabetes trial

The triple agonist outperformed semaglutide’s highest approved dose over 80 weeks.

In the Phase 3 TRANSCEND-T2D-2 trial, 1,298 adults with type 2 diabetes inadequately controlled with metformin received once-weekly retatrutide 9 mg or 12 mg or Ozempic 2 mg; both retatrutide doses lowered A1C by an average of 2.2% versus 1.8% with Ozempic, from a baseline of 8.3% [1]. Retatrutide patients lost 19.5% to 20.9% of body weight versus 9.4%, while discontinuation for adverse events was 4.8% and 7.9% versus 2.7% [1]. The trial was open-label and the figures are company topline data; retatrutide is not approved anywhere, and full results await a medical meeting and peer review [1], [2].

-Artiva halts AlloNK cell therapy after two patient deaths and cuts 94% of staff

The San Diego biotech has stopped dosing and is weighing a merger, sale or liquidation.

Artiva Biotherapeutics said one participant in its Phase 2a basket trial in rheumatoid arthritis and other B-cell-driven autoimmune diseases died of a neurological event (leukoencephalopathy) that the investigator and an independent safety review assessed as likely related to fludarabine-associated neurotoxicity, and a second died suddenly about two months after treatment of a cause not yet determined, which the investigator judged unrelated to AlloNK [3]. The FDA asked the company to pause enrollment and dosing in the Phase 2a study, and Artiva said longer-term follow-up did not show the durability of response it needed to continue [3]. The company will cut roughly 94% of its workforce, has engaged Leerink Partners to evaluate strategic alternatives and reported about $319.1 million in cash and investments as of September 30 [3], [4].

-FDA proposes one BLA for individualized gene-editing products as CMS widens gene therapy access model

A draft guidance would let sponsors add patient-specific variants as manufacturing changes.

The FDA’s draft guidance introduces an “Individualized Feature Space,” a set of predefined boundaries within which a genome-editing product may vary from patient to patient while staying within the scope of a single biologics license application; a new variant inside those bounds would count as a manufacturing change rather than a new product [5], [6]. The scope is limited to products for monogenic diseases caused by known pathogenic variants, and comments are due within 30 days of Federal Register publication [5], [6]. Separately, CMS said it will invite makers of therapies beyond sickle cell disease to apply to its Cell and Gene Therapy Access Model, with a request for applications in the coming months [5].

-Single-dose psychedelic nasal spray eased treatment-resistant depression in JAMA trial

Mebufotenin, a short-acting psychedelic, beat a low-dose comparator at 29 days.

In a Phase 2b trial of 193 adults with major depression unresponsive to two to five antidepressants, a single intranasal dose of mebufotenin benzoate 12 mg reduced MADRS scores by 11.1 points at day 29 versus 5.5 points with a 0.3 mg comparator (mean difference −5.3; P = .003) [7]. Day-29 remission was 26% with 8 mg, 18% with 12 mg and 8% with the comparator; 99.7% of adverse events were mild or moderate, and most patients were ready for discharge within two hours [7]. The authors say the drug may need a shorter monitoring period than psilocybin and fewer clinic visits than esketamine [7].

Digest references

1. Eli Lilly and Company, “Lilly’s retatrutide delivered greater A1C reduction and more than double the weight loss of Ozempic’s highest approved dose in head-to-head trial,” Lilly Investors, October 28, 2026. https://investor.lilly.com/news-releases/news-release-details/lillys-retatrutide-delivered-greater-a1c-reduction-and-more

2. Elizabeth Cairns, “Lilly’s triple-G outshines Novo’s Ozempic in diabetes,” Endpoints News, October 28, 2026. https://endpoints.news/lillys-triple-g-drug-retatrutide-outshines-novos-ozempic-in-diabetes/

3. Artiva Biotherapeutics, “Artiva Biotherapeutics Announces Strategic Update and Discontinues Development of AlloNK,” GlobeNewswire, October 27, 2026. https://www.globenewswire.com/news-release/2026/10/27/3388875/0/en/artiva-biotherapeutics-announces-strategic-update-and-discontinues-development-of-allonk.html

4. Christy Santhosh, “Artiva discontinues cell therapy after two patient deaths, cuts workforce by 94%,” Reuters via Yahoo Finance, October 27, 2026. https://finance.yahoo.com/healthcare/articles/artiva-discontinues-cell-therapy-two-121511008.html

5. U.S. Department of Health and Human Services, “FDA and CMS Announce New Steps to Advance Gene Therapies and Expand Access for Patients with Rare Diseases,” HHS Press Room, October 27, 2026. https://www.hhs.gov/press-room/fda-cms-advance-gene-therapies-rare-diseases-patient-access.html

6. Joanne S. Eglovitch, “FDA issues draft guidance on individualized gene editing products to fill ‘critical gap’,” Regulatory Focus (RAPS), October 27, 2026. https://www.raps.org/resource/fda-issues-draft-guidance-on-individualized-gene-editing-products-to-fill-critical-gap.html

7. David Feifel, Mathieu Seynaeve, Wiesław Jerzy Cubała, et al., “Single Intranasal Administration of the Psychedelic Mebufotenin for Treatment-Resistant Depression: A Randomized Clinical Trial,” JAMA, published online October 26, 2026. https://jamanetwork.com/journals/jama/fullarticle/2855796