Shares of Tekmira Pharmaceuticals were up more than 14% on Monday after the company announced that it reached a “regulatory framework” with the FDA for using its TKM-Ebola treatment to treat Ebola.
In a press release, Tekmira said:
Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference (RNAi) therapeutics, today announced that the FDA has authorised Tekmira to provide TKM-Ebola for treatment under expanded access protocols to subjects with confirmed or suspected Ebola virus infections.
“Tekmira is reporting that an appropriate regulatory and clinical framework is now in place to allow the use of TKM-Ebola in patients. We have worked with the FDA and Health Canada to establish this framework and a treatment protocol allowing us to do what we can to help these patients,” said Dr. Mark J. Murray Tekmira’s President and CEO.
“We have insisted on acting responsibly in the interest of patients and our stakeholders,” added Dr. Murray. “Today we are reporting that, working closely with regulators in the United States and Canada, we have established a framework for TKM-Ebola use in multiple patients. In the US, the FDA has granted expanded access use of TKM-Ebola under our Investigational New Drug application (IND) and Health Canada has established a similar framework, both of which allow the use of our investigational therapeutic in more patients.”
This summer, shares of Tekmira were all over the place on hopes that the company’s Ebola treatment would get expanded approval from the FDA.
The latest update from the company, which came on August 13, said it was “evaluating” options with regard to expanded use of its Ebola treatment.
This chart shows the rally in shares of Tekmira over the last three months, with the stock gaining more than 65% over that period.