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

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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