Life Sciences Daily Summary: What Happened on October 12, 2026

FDA approves Hovilpri for hard-to-treat herpes lesions

The FDA approved Asahi Kasei Therapeutics’ oral drug Hovilpri for adults with mucocutaneous herpes simplex lesions that haven’t responded to standard antiviral drugs.1 In a 101-person Phase 3 study, lesions completely healed by day 28 in 63% of patients receiving Hovilpri and 34% receiving investigator-selected treatment.1 By day 42, response rates were 82% and 42%, respectively. Adverse reactions occurred in 22% of Hovilpri recipients and 54% of the comparison group.1 The company expects the drug to become available in the United States before the end of 2026.1

The FDA authorized Ionis Pharmaceuticals’ Zanvastro as a disease-modifying treatment for Alexander disease, a rare neurological disorder.2 The antisense oligonucleotide targets RNA that encodes GFAP, reducing excess production of a protein that can build up in brain cells and disrupt their function.2

Teva received FDA approval for Weltruza, an extended-release olanzapine injection given under the skin once a month for schizophrenia.3 Teva said the three-dose product requires no loading dose, oral supplementation, or monitoring after injection. The company expects U.S. availability in the coming weeks.3 In the Phase 3 SOLARIS trial, treatment improved symptoms, illness severity, and personal and social functioning. Discontinuations due to adverse events were consistent with placebo.3

BMS reports one significant admilparant dose and an interim RYZ101 result

Bristol Myers Squibb said the 60-mg dose of admilparant significantly improved lung function over placebo after 52 weeks in the Phase 3 ALOFT-IPF trial.4 The 120-mg dose slowed the decline in lung function but did not reach statistical significance, the company said.4 BMS said both doses were well tolerated, with few adverse-event-related discontinuations at rates similar to placebo.4

In a separate Phase 3 trial, RYZ101 met its primary endpoint of progression-free survival at a planned interim analysis in patients with advanced neuroendocrine tumors that had progressed after lutetium-177 treatment.45 The company plans to discuss regulatory steps with the FDA and present detailed findings at a future medical meeting.5

AstraZeneca’s HICKORY trial misses its main goal

Efzimfotase alfa missed the primary endpoint in the Phase 3 HICKORY trial in adolescents and adults with hypophosphatasia, a rare bone disease.67 At week 25, patients receiving the drug walked an average of 17.05 meters farther than those on placebo, but the difference was not statistically significant.7

Alexion said better-than-expected results in the placebo group largely explained the missed endpoint.7 Exploratory analyses favored treatment on fatigue and in some subgroups, but they do not change the primary-endpoint result.67 The FDA is reviewing the application under priority review and is expected to decide in the first half of 2027.7

Mirum’s Livmarli meets all six EXPAND trial endpoints

Mirum said Livmarli met the primary endpoint and all five prespecified secondary endpoints in the Phase 3 EXPAND study of itching associated with rare liver diseases.8 Among pediatric participants, itch scores improved by 0.98 points more than placebo during weeks 13 to 20. Blood bile acid levels fell 69% more than placebo across the study population.8 The trial enrolled 52 patients aged six months and older, and the company reported no new safety signals.8

Mirum plans to apply to expand Livmarli’s U.S. label in the first half of 2027.8 The drug is already approved in the United States for itching associated with Alagille syndrome and progressive familial intrahepatic cholestasis.8

Stryker invests $400 million in CMR Surgical

Stryker invested $400 million in CMR Surgical, entering the soft-tissue robotics field.9 The investment positions Stryker to compete with Johnson & Johnson and Medtronic in the field.9

GSK commits more than $800 million to Pennsylvania expansion

GSK plans to spend more than $800 million expanding its Upper Merion, Pennsylvania, operations with manufacturing and research facilities.10 The planned hub includes a biologics production site, a research-and-development pilot plant, a quality-control laboratory, and a manufacturing science center.10 Pennsylvania officials expect the project to create more than 300 jobs over five years and retain about 4,500 existing GSK positions in the state.10

Caribou pauses two CAR-T trials during strategic review

Caribou Biosciences began a strategic review on October 6, paused trials of its CAR-T candidates vispa-cel and CB-011, and announced an unspecified workforce reduction.11 CEO Rachel Haurwitz said financing conditions for allogeneic CAR-T therapies had kept the company from raising the money needed to advance its programs responsibly.11 Caribou had not enrolled anyone in its planned Phase 3 ANTLER-3 study, despite agreeing on the design with the FDA in May.11

Philips revises Lumify ultrasound instructions after four deaths

Philips updated instructions for its Lumify ultrasound system, which was linked to four deaths.12 A software issue can delay use of the system in places without Wi-Fi or cellular service.12

Also worth knowing

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  The FDA approved Revolution Medicines’ Rasonque in August for metastatic pancreatic adenocarcinoma, the most common form of pancreatic cancer.13