1. Former FDA medical officer urges withdrawal of Prader-Willi drug Vykat XR.
STAT reports that case reports obtained under FOIA link Neurocrine's Vykat XR to seven deaths and nearly 100 hospitalizations since its March 2025 approval. However, the reports do not prove causation, and many patients had complex conditions [1][2]. Neurocrine has said the drug has a compelling risk-benefit profile in a very serious disease [3]. See the lead article above.
2. FDA approves pritelivir, a new class of herpes antiviral, for refractory infections.
On October 9 the FDA approved Hovilpri (pritelivir) for mucocutaneous herpes simplex lesions in immunocompromised adults whose infections have not responded to other therapies [4]. The drug is a helicase-primase inhibitor. In the open-label Phase 3 PRIOH-1 trial (101 patients), 63% had complete lesion healing by day 28, compared with 34% on investigator's-choice therapy. Adverse reactions occurred in 22% vs 54% [5]. Fierce Pharma describes it as the first novel mechanism for an HSV treatment in nearly three decades [6].
3. Investigation: peptide users report harms as an FDA panel backs wider compounding access.
KFF Health News reports that users of experimental peptides such as BPC-157 describe side effects including migraines, eye pain and anxiety. A newly appointed FDA advisory committee voted in July to advise adding six such peptides to the list of substances pharmacies may compound [7]. FDA scientists told the panel there was insufficient evidence of benefit and flagged risks including liver damage. The FDA has not made a final decision [7].
4. Merck's eye drug remigromig meets non-inferiority goal but trails ranibizumab and shows a retinopathy signal.
In the 984-patient BRUNELLO trial in diabetic macular edema, mean vision gains at one year were 9.1 and 8.7 letters with two remigromig doses, compared with 11.8 with ranibizumab [8]. Proliferative diabetic retinopathy-related adverse events occurred in 6.7% and 6.1% of patients on remigromig vs 0.9% on ranibizumab. Merck says this may reflect natural disease progression, and further analyses are underway [8][9].
Digest references
Feuerstein A. "Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug." STAT, October 13, 2026. Link
Feuerstein A. "Neurocrine Biosciences rare disease drug possibly tied to safety issues, experts say." STAT, August 12, 2026. Link
Kansteiner F. "Neurocrine stands by blockbuster hopeful Vykat XR as Prader-Willi docs raise potential safety flags." Fierce Pharma, August 13, 2026. Link
US Food and Drug Administration. "Novel Drug Approvals for 2026" (entry: Hovilpri, pritelivir, approved 10/9/2026). FDA, accessed October 13, 2026. Link
Hoffman M. "FDA Approves Pritelivir for Refractory HSV in Immunocompromised Adults." Contagion Live, October 10, 2026. Link
Fierce Pharma. "Asahi Kasei makes good on AiCurus buyout with new FDA nod." October 12, 2026. Link
Maxmen A. "People Say These Peptides Hurt Them. Their Stories Are Muffled in MAHA's Push for Medical Freedom." KFF Health News, October 13, 2026. Link
Merck & Co. "Merck Presents One-Year Results from the Pivotal Phase 2b/3 BRUNELLO Study Evaluating Remigromig in Adults with Diabetic Macular Edema at AAO 2026" (press release). October 10, 2026. Link
DeFeudis N. "Merck reports mixed data for Lucentis competitor in diabetic macular edema." Endpoints News, October 12, 2026. Link
