--- title: 'Life Sciences Daily Summary: What Happened on October 12, 2026' headline: FDA approves three treatments as trials return mixed results description: Stryker invested $400 million in CMR Surgical, GSK committed more than $800 million to Pennsylvania facilities, and Caribou paused two cell-therapy trials. url: https://thebench.bio/news/summaries/2026-10-12 topic: all date: '2026-10-12' covers: - '2026-10-12' date_published: '2026-10-13T00:04:37Z' date_modified: '2026-10-13T00:04:37Z' tags: - Clinical - Industry - Regulatory - Funding sources: 13 publisher: TheBench.Bio --- # Life Sciences Daily Summary: What Happened on October 12, 2026 **FDA approves three treatments as trials return mixed results** Stryker invested $400 million in CMR Surgical, GSK committed more than $800 million to Pennsylvania facilities, and Caribou paused two cell-therapy trials. ## Today in brief Asahi Kasei’s Hovilpri won FDA approval for hard-to-treat herpes lesions in immunocompromised adults, and Ionis’ Zanvastro became the first disease-modifying treatment for Alexander disease. [1] [2] Teva also received approval for Weltruza, a once-monthly olanzapine injection for schizophrenia. [3] Bristol Myers Squibb said one dose of its lung-disease drug met the main trial goal, while RYZ101 met its Phase 3 goal at an interim analysis. [4] [5] AstraZeneca’s efzimfotase alfa missed its Phase 3 primary endpoint, while Mirum said Livmarli met all six endpoints in a rare liver-disease study. [6] [7] [8] ## 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. [4] [5] 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. [6] [7] 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. [6] [7] 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 - The FDA approved Revolution Medicines’ Rasonque in August for metastatic pancreatic adenocarcinoma, the most common form of pancreatic cancer. [13] ## The day in numbers - **$400 million**: Stryker’s investment in CMR Surgical as it enters soft-tissue robotics. [9] - **17.05 meters**: Average week-25 walking-distance advantage for efzimfotase alfa over placebo in HICKORY. The difference was not statistically significant. [7] - **63% vs. 34%**: Share of patients receiving Hovilpri and comparison treatment, respectively, whose lesions completely healed by day 28. [1] - **69%**: Placebo-adjusted reduction in blood bile acid levels in Mirum’s EXPAND trial. [8] - **More than $800 million**: GSK’s planned investment in its Upper Merion, Pennsylvania, operations. [10] ## Sources 1. [FDA approves Asahi Kasei’s Hovilpri for refractory HSV](), Pharmaceutical Technology, 2026-10-12 2. [FDA nod for rare neurology drug](), Nature Biotechnology, 2026-10-12 3. [FDA approves Teva’s monthly injection of olanzapine for schizophrenia](), Pharmaceutical Technology, 2026-10-12 4. [BMS gains two pivotal trial wins in lung disease and rare cancer](), Clinical Trials Arena, 2026-10-12 5. [RYZ101 Meets Phase 3 Primary Endpoint in Neuroendocrine Tumors After Lutetium-177 Therapy](), BioPharm International, 2026-10-12 6. [AstraZeneca pins bone disease drug’s Phase III failure on high placebo response ](), Clinical Trials Arena, 2026-10-12 7. [Efzimfotase Alfa Misses Primary Endpoint in Phase 3 Hypophosphatasia Trial](), BioPharm International, 2026-10-12 8. [Mirum tees up Livmarli label expansion on Phase III liver disease study success ](), Clinical Trials Arena, 2026-10-12 9. [Stryker enters soft tissue robotics with $400M investment in CMR Surgical](), MedTech Dive, 2026-10-12 10. [GSK pledges $800M to add biologics production capabilities in Pennsylvania](), BioSpace, 2026-10-12 11. [StockWatch: Caribou Plunges as It Pursues Strategic Alternatives](), GEN, 2026-10-12 12. [Philips updates instructions for ultrasound system linked to 4 deaths](), MedTech Dive, 2026-10-12 13. [RevMed’s pancreatic cancer drug first](), Nature Biotechnology, 2026-10-12 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: [6]: [7]: [8]: [9]: [10]: [11]: [12]: [13]: