The Priority Review

The stream · Daily digest

The stream: Thursday, October 8, 2026

6 briefs from ClinicalTrials.gov and FDA, grouped by desk. Each is two sentences from one primary source, linked to it.

Machine-summarized from primary sources; not independently reported. How we use automation

Clinical trials · 4

  1. Amgen registers Phase 3 trial of maridebart cafraglutide versus semaglutide in type 2 diabetes

    The study, NCT07866066, plans to enroll 1300 participants and start on November 2, 2026. It plans to compare maridebart cafraglutide once monthly versus semaglutide once weekly as add-on therapy to metformin with or without a sodium-glucose cotransporter-2 inhibitor.

    Source: ClinicalTrials.gov registry record, October 8, 2026

  2. Shanghai Henlius Biotech registers Phase II/III study of HLX37 in first-line NSCLC

    The study, first posted on ClinicalTrials.gov on October 8, 2026, plans to enroll 1438 participants and plans to begin recruiting on November 30, 2026. It compares two doses of HLX37 combined with chemotherapy to pembrolizumab plus chemotherapy in advanced non-small cell lung cancer.

    Source: ClinicalTrials.gov registry record, October 8, 2026

  3. DBV Technologies posts results of Phase 3 Viaskin Peanut study

    The REALISE study evaluated Viaskin Peanut 250 μg in 393 peanut-allergic children aged 4 to 11 years in a 6-month randomized, double-blind, placebo-controlled Phase III trial. The study began on October 25, 2016, with primary completion on September 22, 2017.

    Source: ClinicalTrials.gov results record, October 8, 2026

  4. PTC Therapeutics posts results of Phase 3 ataluren safety study in Duchenne muscular dystrophy

    Results for the open-label safety study of ataluren (PTC124) in 265 participants with nonsense mutation dystrophinopathy were first posted on ClinicalTrials.gov on October 8, 2026. The study, which began on November 22, 2010 and reached primary completion on February 10, 2026, was terminated before completion.

    Source: ClinicalTrials.gov results record, October 8, 2026

Approvals · 1

  1. FDA approves atezolizumab with chemotherapy for Stage III dMMR colon cancer

    On October 8, 2026, the FDA approved atezolizumab (Tecentriq, Genentech, Inc.) with fluoropyrimidine and oxaliplatin for adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient colon cancer. The approval also covers atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for patients 12 years and older who weigh 40 kg or greater.

    Source: FDA approval notification, October 8, 2026

Policy · 1

  1. CMS releases 2027 Medicare Advantage and Part D Star Ratings

    The Centers for Medicare & Medicaid Services published the 2027 Star Ratings on October 8, 2026, and the ratings will impact 2028 MA quality bonus payments. Approximately 37% of MA-PD contracts (188 contracts) earned four stars or higher, and 27% of PDPs (11 contracts) received four or more stars for 2027.

    Source: CMS fact sheet, October 8, 2026