Biopharma · FDA Approvals

INOVIO Receives FDA Accelerated Approval for VOCERYQ (INO-3107) in RRP

The FDA granted accelerated approval for VOCERYQ to reduce the frequency of surgical papilloma excisions in adults with RRP, based on complete response (no surgeries in 12 months) in the RRP-001 study. Continued approval is contingent on confirmatory study(ies), with draft protocol due by end of 2026. This is the first approved DNA medicine, with commercial availability expected in ~60 days and full launch in Q1 2027.

CGTX: FDA recognizes minocycline breakpoints for Stenotrophomonas maltophilia

The FDA has issued a rationale for its breakpoints recognition decision for minocycline against Stenotrophomonas maltophilia. This provides updated susceptibility testing guidance for the antibiotic in this indication.

Revolution Medicines receives client partnership award from Medicilon for daraxonrasib NDA

Medicilon awarded Revolution Medicines the Excellence in Client Partnership Award for their 3-year collaboration on Pan-KRAS drug discovery. The press release notes the FDA accepted the NDA for daraxonrasib in metastatic pancreatic cancer in August 2026. The companies discussed expanding their cross-border R&D partnership.

Vistagen cuts 31% workforce to focus on fasedienol Phase 3 for social anxiety disorder

Vistagen implemented a 31% workforce reduction to preserve capital and align resources with U.S. registration-directed Phase 3 development of fasedienol for social anxiety disorder. The move retains core clinical, regulatory, and technical capabilities while also supporting potential future development of itruvone and refisolone. This is a corporate restructuring with no direct change to the regulatory or clinical path for the asset.

Viatris Commences Tender Offer to Acquire Pacira BioSciences

Viatris has commenced a tender offer to acquire all outstanding shares of Pacira for $36.50 per share in cash. The offer is expected to expire on November 16, 2026, subject to conditions including a minimum tender threshold and HSR antitrust clearance. Pacira's board unanimously recommends that stockholders tender their shares.

remigromig · NCT06957080 registry update

primary_completion: 2027-03-01 → 2027-01-11; completion: 2028-03-30 → 2028-01-11

elranatamab · NCT06106945 registry update

primary_completion: 2027-08-16 → 2028-01-24; completion: 2027-08-16 → 2028-01-24; countries: {'total_sites': 43, 'us_sites': 9} → {'total_sites': 46, 'us_sites': 9}

camizestrant · NCT06380751 registry update

countries: {'total_sites': 306, 'us_sites': 60} → {'total_sites': 306, 'us_sites': 61}

YB-101 · NCT07682896 registry update

countries: {'total_sites': 29, 'us_sites': 27} → {'total_sites': 32, 'us_sites': 29}

INCB161734 · NCT07522073 registry update

countries: {'total_sites': 228, 'us_sites': 69} → {'total_sites': 230, 'us_sites': 69}

tilrekimig · NCT07772921 registry update

countries: {'total_sites': 8, 'us_sites': 7} → {'total_sites': 16, 'us_sites': 13}

EIK1001 · NCT07262619 registry update

countries: {'total_sites': 35, 'us_sites': 10} → {'total_sites': 45, 'us_sites': 10}

paxalisib · NCT03994796 registry update

primary_outcomes: ['Objective response rate in the brain'] → ['Objective Response Rate in the Brain']

belzutifan · NCT07700758 registry update

countries: {'total_sites': 4, 'us_sites': 1} → {'total_sites': 7, 'us_sites': 1}

povorcitinib · NCT06855498 registry update

countries: {'total_sites': 296, 'us_sites': 86} → {'total_sites': 306, 'us_sites': 94}

buntanetap · NCT07284784 registry update

countries: {'total_sites': 27, 'us_sites': 27} → {'total_sites': 29, 'us_sites': 29}

cemacabtagene ansegedleucel · NCT06500273 registry update

countries: {'total_sites': 85, 'us_sites': 63} → {'total_sites': 86, 'us_sites': 64}

tulisokibart · NCT06651281 registry update

primary_outcomes: ['Number of Participants Who Experience an Adverse Event (AE)', 'Number of Participants Who Discontinue Study Treatment Due to an AE'] → ['Number of Participants Who Experience an Adverse Event (AE)', 'Number of Participants Who Discontinue Study Treatment Due to an AE', 'Number of Participants Who Experience an Adverse Event (AE)', 'Number of Participants Who Discontinue Study Treatment Due to an AE']

intismeran autogene · NCT07513376 registry update

countries: {'total_sites': 119, 'us_sites': 24} → {'total_sites': 124, 'us_sites': 26}

cemsidomide · NCT07284758 registry update

countries: {'total_sites': 21, 'us_sites': 20} → {'total_sites': 60, 'us_sites': 25}