FDA rejects supplemental license application for Trogarzo
- Theratechnologies shares sink after FDA refusal to file letter
- FDA rejects supplemental license application for Trogarzo
- Stock price drops 30% in premarket trading
- Application deemed incomplete by FDA
- Data required to establish pharmacokinetic bridge missing
- Company disappointed but aware of challenges
- Assessing options for the application
Theratechnologies shares are expected to open significantly lower after the Food and Drug Administration (FDA) rejected the company’s supplemental biologics license application for an intramuscular method of administering a maintenance dose of Trogarzo, an HIV-1 inhibitor. The stock price dropped 30% in premarket trading following the news. The FDA determined that the application was incomplete and did not contain the necessary data to establish the pharmacokinetic bridge between the intramuscular and intravenous infusion route of administration of Trogarzo. Theratechnologies expressed disappointment but acknowledged the challenges based on previous study results. The company is now evaluating its options for the application.
Factuality Level: 9
Factuality Justification: The article provides a clear and concise report on the FDA’s rejection of Theratechnologies’ supplemental biologics license application for an intramuscular method of administering Trogarzo. It includes relevant details such as the stock’s significant drop in premarket trading, the reason for the FDA’s decision, and a statement from the company’s chief medical officer. There are no apparent digressions, misleading information, sensationalism, redundancy, or bias in the article.
Noise Level: 3
Noise Justification: The article provides relevant information about Theratechnologies’ shares facing a sharp decline due to the FDA rejecting a supplemental license application. It includes details about the reasons for the rejection and quotes from the company’s chief medical officer. The article stays on topic and does not contain irrelevant information. However, it lacks in-depth analysis, antifragility considerations, and accountability of powerful people. It could benefit from more data or evidence to support the claims and provide actionable insights for readers.
Financial Relevance: Yes
Financial Markets Impacted: Theratechnologies shares
Presence Of Extreme Event: No
Nature Of Extreme Event: No
Impact Rating Of The Extreme Event: No
Rating Justification: The article pertains to the rejection of a supplemental biologics license application by the FDA for Theratechnologies’ HIV-1 inhibitor. This news is relevant to financial markets as it will likely impact the company’s stock price.
Public Companies: Theratechnologies (NASDAQ: THTX)
Key People: Christian Marsolais (Chief Medical Officer at Theratechnologies)
Reported publicly:
www.marketwatch.com 
