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Cocrystal Pharma (COCP) FDA Events

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FDA Events for Cocrystal Pharma (COCP)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Cocrystal Pharma (COCP). Over the past two years, Cocrystal Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CC-42344 and CDI-988. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Cocrystal Pharma's Drugs in FDA Review

CC-42344 - FDA Regulatory Timeline and Events

CC-42344 is a drug developed by Cocrystal Pharma for the following indication: Seasonal and pandemic influenza A. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CDI-988 - FDA Regulatory Timeline and Events

CDI-988 is a drug developed by Cocrystal Pharma for the following indication: For Pandemic Norovirus and Coronavirus. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Cocrystal Pharma FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Cocrystal Pharma (COCP) has reported FDA regulatory activity for the following drugs: CC-42344 and CDI-988.

The most recent FDA-related event for Cocrystal Pharma occurred on December 31, 2024, involving CC-42344. The update was categorized as "Enrollment Update," with the company reporting: "Cocrystal Pharma, Inc. announces plans to extend enrollment in the Phase 2a human challenge study with its investigational, broad-spectrum, oral influenza PB2 inhibitor CDI-42344 due to unexpectedly low influenza infection among study participants who were challenged with a H3N2 viral strain."

Current therapies from Cocrystal Pharma in review with the FDA target conditions such as:

  • Seasonal and pandemic influenza A - CC-42344
  • For Pandemic Norovirus and Coronavirus - CDI-988

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:COCP) was last updated on 7/9/2025 by MarketBeat.com Staff
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