The FDA has authorized the use of Tekmira Pharmaceuticals’ (NASDAQ:TKMR; TSX:TKM) TKM-Ebola therapy under expanded access and compassionate use protocols to treat Ebola virus infected individuals.
“As we have suggested in our previous notes, we believed that Tekmira has been working to establish the appropriate framework and associated protocols to govern the use of its limited therapeutic inventories,” writes Clarus Securities analyst David Novak.
“The present event confirms that such framework has now been established with both the FDA and Health Canada,” he added.
Mr. Novak reiterated his “buy” recommendation and $22.50 price target on Tekmira, which was quoted at $23.56, up $3.40, near the close on Monday.
He said Tekmira is approaching compassionate use with an approved regulatory framework and treatment protocol. “In the absence of a controlled clinical trial, this has the potential to generate meaningful clinical data, which could be utilized to solidify a complete response to the FDA aiding in the resolution of the partial hold in the fourth quarter.”
TKM-Ebola has already been used in a number of patients and has been well tolerated, “potentially de-risking future development and further supporting its position as the front running candidate to be the first approved Ebola therapeutic,” he added.
If TKM-Ebola efficacy is supported by objective clinical data, he said the implications for RNA interference as a viable medical approach are significant.
“Such data would represent the first in man evidence of a disease indication being cured by RNA interference,” he added. “This would bode favorable on our perceived potential for the success of Tekmira’s blockbuster preclinical Hepatitis B candidate.”
(BioTuesdays)