Citius Pharmaceuticals Received Complete Response Letter From The FDA For LYMPHIR For The Treatment Of Patients With Relapsed Or Refractory Cutaneous T-Cell Lymphoma
Portfolio Pulse from Charles Gross
Citius Pharmaceuticals (NASDAQ:CTXR) has received a Complete Response Letter from the FDA regarding its Biologics License Application for LYMPHIR, a treatment for patients with relapsed or refractory cutaneous T-cell lymphoma. The FDA has asked Citius to incorporate enhanced product testing and additional controls. No concerns were raised about the safety and efficacy of the clinical data package submitted with the application.
July 29, 2023 | 8:32 pm
News sentiment analysis
Sort by:
Descending
NEUTRAL IMPACT
Citius Pharmaceuticals has received a response from the FDA requiring additional product testing and controls for LYMPHIR. No concerns were raised about the safety and efficacy of the product.
The FDA's response is a mixed bag for Citius. While it requires additional work, it does not raise concerns about the safety or efficacy of LYMPHIR. This could delay the approval process, but does not necessarily indicate a negative outcome. Therefore, the short term impact on the stock price is likely to be neutral.
CONFIDENCE 90
IMPORTANCE 75
RELEVANCE 100