Tonix Pharma's Drug Gets FDA Nod For Chronic Pain Condition, First New Therapy In Over 15 Years FDA approves Tonmya, a non-opioid fibromyalgia therapy from Tonix, with strong trial data and U.S. launch expected in late 2025.
Axsome Therapeutics Inc (NASDAQ:AXSM) Reports Q2 2025 Revenue Beat and Narrower EPS Loss, Shares Surge 6% in Pre-Market Trading Axsome Therapeutics beats Q2 2025 revenue estimates with $150M, driven by Auvelity's 84% YoY growth. Shares rise 6% pre-market on improved EPS.
FDA Pushes Pause On Axsome Fibromyalgia Drug, New Trial Required The FDA rejected Axsome's AXS-14 fibromyalgia, prompting a new trial and pushing the expected drug launch to 2028.
Axsome Stock Slips Pre-Market After FDA Issues Refusal-To-File Letter: Retail’s Skeptical On Likelihood Of Year-End Profitability The regulator said that upon preliminary review, it found that the new drug application for AXS-14 was not sufficiently complete to permit a substantive review.
Why Is Teva Stock Trading Higher On Tuesday? Teva starts IND-enabling studies for BD9, a dual-target therapy for asthma and atopic dermatitis, under license from Biolojic Design.
Axsome Therapeutics Clocks Around 60% Topline Growth In Q1 Axsome beat Q1 expectations with $121.5 million in revenue and strong Auvelity sales as it prepares Symbravo's U.S. launch and advances key drug programs.
