Axsome Therapeutics Says On Jul. 30 Received FDA Letter Regarding NDA For AXS-05 Stating FDA Has ‘identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time’
AXS-05
AXS-05 (dextromethorphan-bupropion) is Axsome's novel, oral, investigational NMDA receptor antagonist with multimodal activity being developed for the following indications: major depressive disorder (MDD),
Axsome Therapeutics Q2 EPS $(0.86) Beats $(0.97) Estimate
Axsome Therapeutics (NASDAQ:AXSM) reported quarterly losses of $(0.86) per share which beat the analyst consensus estimate of $(0.97) by 11.34 percent. This is a 75.51 percent decrease over losses of $(0.49) per share
Earnings Scheduled For August 9, 2021
Companies Reporting Before The Bell
• Privia Health Group (NASDAQ:PRVA) is projected to report quarterly loss at $1.57 per share on revenue of $215.17 million.
The Week Ahead In Biotech (Aug. 8-14): Jazz Pharma FDA Decision, Earnings Deluge and IPOs In The Spotlight
Biopharma stocks ended higher for the week ending Aug. 6, as the sector latched on to the optimism that was evident in the broader markets. Earnings continued to flow in, triggering stock-specific moves, while clinical readouts also moved stocks during the week.
Understanding Axsome Therapeutics’s Unusual Options Activity
Shares of Axsome Therapeutics (NASDAQ:AXSM) saw some unusual options activity on Friday. Following the unusual option alert, the stock price moved up to $50.74.
Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
The month of July was disappointing from the perspective of Food and Drug Administration decisions, as the agency handed down mostly negative verdicts.
Axsome Therapeutics Targets Submission Of US Application For Fibromyalgia Candidate By 2022
After a pre-NDA meeting with FDA, Axsome Therapeutics Inc (NASDAQ:AXSM) has announced its plan to submit a marketing application seeking approval for…