Life Sciences Daily Summary
Life Sciences Daily Summary: What Happened on November 3, 2026
FDA approves INOVIO’s Voceryq as Lonza adds five US sites
Teva will stop its MSA trial after a futility review, InventisBio reported positive psoriasis data, and uniQure received a May FDA decision date.
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Today in brief
INOVIO’s Voceryq won FDA approval to reduce surgery in adults with recurrent respiratory papillomatosis, a disease that causes airway growths.12 Lonza agreed to acquire five US manufacturing sites from Merck KGaA, while Stryker agreed to invest about $400 million in CMR Surgical and secured an option to buy the company.34
An interim review found a low likelihood of efficacy in Teva’s Phase II emrusolmin trial, prompting the company to plan to stop it.5 InventisBio said nomelcitinib met the primary endpoint in a Phase III psoriasis trial, and uniQure’s Huntington’s gene therapy received an FDA target action date of May 1, 2027.678
INOVIO wins accelerated approval for Voceryq, with confirmation still required
The FDA approved Voceryq to reduce the need for surgery in adults with recurrent respiratory papillomatosis, a condition that causes growths in the airway.12 In the study supporting approval, seven of 26 patients assessed for efficacy went 12 months after treatment without surgery.12
Patients use Voceryq with INOVIO’s Cellectra 5PSP delivery device, and the FDA requires a confirmatory study to verify clinical benefit.29 INOVIO expects orders and shipments to start in about 60 days and anticipates a broad commercial rollout in the first quarter of 2027.29
Lonza will take over five Merck KGaA manufacturing sites
Lonza agreed to buy five US contract development and manufacturing sites from Merck KGaA, located in St. Louis, Wisconsin, Carlsbad, and Indianapolis.3 The facilities make bioconjugates and high-potency payload-linkers, provide viral-vector and fill-finish services, and produce lipid nanoparticles and related delivery technologies.3
The acquisition is expected to add 1,100 employees and expand Lonza’s US manufacturing footprint from four locations to nine.3 Lonza estimates the sites will generate about SFr250 million in 2028 sales, with a core EBITDA margin below the company-wide level.3 The companies expect the deal to close around mid-2027, subject to customary conditions.3
Teva will end emrusolmin’s Phase II MSA trial after futility review
Teva plans to stop the TOPAS-MSA trial of emrusolmin in adults with multiple system atrophy after an independent monitoring committee recommended ending it.5 A scheduled interim review crossed the study’s futility threshold, indicating a low chance that continuing would demonstrate efficacy.5
The assessment was predictive, not a final efficacy analysis, and identified no safety concerns.5 The trial was designed to enroll nearly 350 participants, who would receive emrusolmin or placebo for about 48 weeks.5 Teva said ending the study does not decide the broader program’s future and that it plans to share findings after a full analysis.5
InventisBio reports Phase III psoriasis success for nomelcitinib
More than 70% of patients in each nomelcitinib dose group achieved at least a 90% improvement in psoriasis severity at week 16, meeting the primary endpoint in InventisBio’s China-based Phase III trial.6 The study enrolled 391 people with moderate-to-severe plaque psoriasis and compared two doses with placebo.6
More than 80% of patients taking nomelcitinib were rated clear or almost clear, and researchers reported no new safety signals.6 InventisBio is awaiting results from a separate China-based Phase III comparison with Bristol Myers Squibb’s Sotyktu and is also running a Phase II psoriasis study in the US.6
FDA sets May 2027 target for uniQure’s Huntington’s gene therapy
On November 2, the FDA accepted uniQure’s application for AMT-130 and granted it priority review, setting a May 1, 2027, target action date.710 The one-time gene therapy is delivered into the brain through MRI-guided surgery and is designed to silence the huntingtin gene.710
The application relies on results from small Phase I/II studies compared with an external control, rather than a randomized confirmatory trial.710 At four years, the reported 44% reduction in decline on a composite disease scale was not statistically significant, while the reported 61% reduction in functional-capacity decline had a nominal p-value of 0.008.710 The FDA is tentatively considering an advisory committee meeting, and uniQure plans a randomized confirmatory study of about 200 participants.710
Stryker invests $400 million in CMR Surgical and secures an acquisition option
Stryker agreed to invest about $400 million in CMR Surgical and received exclusive US commercial rights to CMR’s Versius surgical robotics portfolio.4 The agreement also gives Stryker an exclusive option to acquire all of CMR’s outstanding equity in a later transaction.4
CMR will continue developing Versius and selling it outside the US, while the current deal remains subject to regulatory approvals and customary closing conditions.4