- The stock price of Axsome Therapeutics Inc (NASDAQ: AXSM) increased over 5% pre-market today. This is why it happened.
The stock price of Axsome Therapeutics Inc (NASDAQ: AXSM) – a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders – increased over 5% pre-market today. Investors are responding positively to Axsome Therapeutics announcing that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine and has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2022 for the NDA.
AXS-07 (MoSEIC meloxicam-rizatriptan) is known as a novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for migraine. And the NDA is supported by results from two Phase 3 randomized, double-blind, controlled trials of AXS-07 in the acute treatment of migraine, the MOMENTUM and INTERCEPT trials — which demonstrated statistically significant elimination of migraine pain with AXS-07 compared to placebo and active controls.
KEY QUOTE:
“The FDA’s acceptance of the NDA for AXS-07 is an important milestone for Axsome as it brings us closer to potentially making this multi-mechanistic treatment available to migraine patients in need. We look forward to continued interactions with the FDA during the review process.”
— Herriot Tabuteau, MD, Chief Executive Officer of Axsome
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.
