FDA Grants Fast Track Tags To Drug Candidates For Antares Pharma, Celcuity, Celularity


The FDA has granted Fast Track designation to Antares Pharma Inc's ATRS for ATRS-1902 for adrenal crisis rescue. 

  • The development program for ATRS-1902 supports a proposed indication of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using Vai proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone.
  • The agency has also granted the Fast Track tag to Celcuity Inc's CELC gedatolisib for HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy.
  • Celcuity remains on track to obtain feedback from the FDA to finalize the design and protocol of its Phase 3 trial in Q1 of 2022. Site identification and feasibility activities for the Phase 3 clinical trial are ongoing.
  • The FDA has given Fast Track status to Celularity Inc's CELU CYNK-101, an investigational genetically modified NK cell therapy.
  • CYNK-101 is being developed in combination with standard chemotherapy, trastuzumab, and pembrolizumab in patients in first-line locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction adenocarcinoma.
  • Price Action: ATRS shares are down 2.38% at $3.49, CELU stock is down 7.00% at $3.85, CELC shares are up 4.51% at $12.05 during the market session on the last check Tuesday. 
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