Milestone Pharmaceuticals (NASDAQ:MIST) news for Thursday includes new guidelines for a clinical study pushing MIST stock higher.
According to the Milestone Pharmaceuticals news release, the company has reached an agreement with the U.S. Food and Drug Administration (FDA) concerning its NODE-301B study. This has it changing the name to RAPID and adopting guidelines that will allow it to be used for a future New Drug Application (NDA).
RAPID is an ongoing study testing the use of MIST’s etripamil nasal spray in patients suffering from paroxysmal supraventricular tachycardia (PSVT). This has the study focusing on a new endpoint time of conversion within 30 minutes.
As part of this guideline change news, Milestone Pharmaceuticals is reopening enrollment into the RAPID trial. It’s also now expecting to see results from the study in late 2021 or early 2022.
Adding to this, Milestone Pharmaceuticals notes that it has received a $25 million investment from RTW Investments. This is a shareholder in the company. MIST says that this will provide the company with enough funding to operate into the second quarter of 2022.
Joseph Oliveto, president and CEO of Milestone Pharmaceuticals, said this about the news.
“We are pleased with the outcome of our recent interactions with the FDA, as they outline an efficient path to registration for etripamil which eliminates the need to start a new Phase 3 study. This study, together with our recently completed NODE-301 study, which will also now use a 30 minute endpoint, will serve to fulfill the efficacy requirements for a New Drug Application (NDA) for etripamil in PSVT.”
MIST stock was up 114.4% as of Thursday afternoon.
As of this writing, William White did not hold a position in any of the aforementioned securities.
