Serious adverse event leads to pause in zelnecirnon trials
- FDA places two RAPT Therapeutics studies on hold
- Serious adverse event of liver failure in one patient
- Studies affected: Phase 2b study in atopic dermatitis and Phase 2a trial in asthma
- Cause of adverse event unknown, potentially related to zelnecirnon
- Dosing of zelnecirnon halted in both trials
- Enrollment of new participants also stopped
- Clinical hold does not apply to tivumecirnon study in oncology
- Trading in RAPT shares halted premarket
RAPT Therapeutics announced that the FDA has placed a hold on two of its studies involving the drug candidate zelnecirnon. This decision comes after a patient experienced a serious adverse event of liver failure. The affected studies include a Phase 2b study in atopic dermatitis and a Phase 2a trial in asthma. The cause of the adverse event is currently unknown but is potentially related to zelnecirnon. As a result, dosing of zelnecirnon has been halted in both trials, and enrollment of new participants has been stopped. It’s important to note that this clinical hold does not apply to RAPT’s study of tivumecirnon in oncology. Trading in RAPT shares has been halted premarket.
Factuality Level: 9
Factuality Justification: The article provides a clear and concise report on RAPT Therapeutics’ zelnecirnon drug candidate being placed on hold by the FDA due to a serious adverse event of liver failure in one patient. It includes relevant details about the affected studies, the company’s response, and the impact on trading shares. There are no apparent digressions, misleading information, sensationalism, redundancy, or opinionated content.
Noise Level: 3
Noise Justification: The article provides relevant information about RAPT Therapeutics and the FDA placing a hold on studies of its drug candidate due to a serious adverse event. It stays on topic, presents facts with clarity, and does not contain irrelevant or misleading information. The article supports its claims with specific details and does not delve into unrelated territories. However, it lacks in-depth analysis, antifragility considerations, or accountability of powerful people, hence the lower noise level rating.
Financial Relevance: Yes
Financial Markets Impacted: Shares of RAPT
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The article pertains to a pharmaceutical company, RAPT Therapeutics, and the adverse event of liver failure in one patient. While it is a serious event, it does not qualify as an extreme event.
Public Companies: RAPT Therapeutics (RAPT)
Key People: Colin Kellaher (Author)
Reported publicly:
www.marketwatch.com 
