FDA rejects application for Checkpoint’s skin cancer treatment

  • Checkpoint Therapeutics shares fell by more than half after FDA issued a complete response letter
  • FDA cites findings from a multi-sponsor inspection of Checkpoint’s contract manufacturer
  • Shares of Checkpoint Therapeutics down 53% in premarket trading
  • Company aims to address feedback and resubmit application for cosibelimab next year

Shares of Checkpoint Therapeutics tumbled more than 50% after the FDA issued a complete response letter for its biologic license application for cosibelimab, an experimental treatment for skin cancer. The FDA cited findings from an inspection of Checkpoint’s contract manufacturer as the reason for the rejection. Checkpoint’s CEO, James Oliviero, expressed confidence in addressing the feedback and plans to resubmit the application next year in hopes of obtaining marketing approval for cosibelimab.

Public Companies: Checkpoint Therapeutics (N/A)
Private Companies:
Key People: James Oliviero (Chief Executive)

Factuality Level: 8
Justification: The article provides factual information about Checkpoint Therapeutics’ stock falling after receiving a complete response letter from federal regulators regarding their biologic license application for cosibelimab. It also mentions the reason for the letter, which is findings from an inspection of Checkpoint’s third-party contract manufacturer. The article includes statements from the company’s CEO about addressing the feedback and aiming for marketing approval next year. Overall, the article sticks to the facts and does not contain any obvious bias or misleading information.

Noise Level: 7
Justification: The article provides relevant information about Checkpoint Therapeutics’ stock falling after receiving a complete response letter from federal regulators. It mentions the reasons for the letter and the CEO’s response. However, it lacks in-depth analysis, scientific rigor, and actionable insights. It also does not provide evidence or data to support its claims.

Financial Relevance: Yes
Financial Markets Impacted: Shares of Checkpoint Therapeutics

Presence of Extreme Event: No
Nature of Extreme Event: No
Impact Rating of the Extreme Event: No
Justification: The article pertains to a financial topic as it discusses the impact of federal regulators’ response on the shares of Checkpoint Therapeutics.

Reported publicly: www.marketwatch.com