Regulatory Hurdle For Innate Pharma's Blood Cancer Studies
Portfolio Pulse from Vandana Singh
The FDA has placed a clinical hold on Innate Pharma SA's (NASDAQ:IPHA) lacutamab Investigational New Drug (IND), leading to a pause in new patient enrollment in ongoing lacutamab trials. The hold follows a fatal case of a rare blood disorder. However, patients already on the study treatment may continue after being reconsented. Despite the hold, Innate Pharma does not anticipate any delay for the Phase 2 TELLOMAK study as all patients have been recruited. IPHA shares are down 9.72% in premarket trading.
October 05, 2023 | 12:19 pm
News sentiment analysis
Sort by:
Descending
NEGATIVE IMPACT
Innate Pharma's lacutamab IND has been put on clinical hold by the FDA, causing a pause in new patient enrollment. Despite this, the company does not expect any delay in the Phase 2 TELLOMAK study. IPHA shares have dropped 9.72% in premarket trading.
The FDA's clinical hold on Innate Pharma's lacutamab IND is a significant regulatory hurdle for the company, causing a pause in new patient enrollment. This could potentially delay the progress of the drug's trials and impact the company's future revenues. However, the company has stated that it does not expect any delay in the Phase 2 TELLOMAK study as all patients have been recruited. The news has negatively impacted the company's stock price, with shares down 9.72% in premarket trading.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100