SEC Form 10-Q filed by Axsome Therapeutics Inc.
$AXSM
Biotechnology: Pharmaceutical Preparations
Health Care
Unavailable
Unavailable
Save time and jump to the most important pieces.
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 12/31/2024 | $124.00 → $122.00 | Outperform | Mizuho |
| 9/3/2024 | $140.00 | Overweight | Wells Fargo |
| 8/6/2024 | $95.00 → $106.00 | Neutral → Buy | BofA Securities |
| 7/22/2024 | $130.00 | Buy | Needham |
| 4/29/2024 | $90.00 → $115.00 | Equal-Weight → Overweight | Morgan Stanley |
| 3/19/2024 | $108.00 | Outperform | Robert W. Baird |
| 2/6/2024 | $111.00 | Buy | UBS |
| 1/25/2024 | $126.00 | Outperform | RBC Capital Mkts |
Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively NEW YORK, Jan. 13, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced preliminary net product revenue for the fourth quarter and full year ended December 31, 2024. "We delivered strong revenue growth in 2024 and significantly advanced our industry leading neuroscience pipeline, including achievement of positive Phase 3 results for AXS-
ACCORD-2 Phase 3 trial in Alzheimer's disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer's disease agitation) AXS-05 reduced worsening of Alzheimer's disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer's disease overall clinical status) ADVANCE-2 trial did not demonstrate statistical significance on primary endpoint; numerically greater improvements with AXS-05 over placebo (primary and secondary endpoints) Long-term safety trial completed with required number of patients treated for 6 and 12 mo
AXS-12 statistically significantly reduced the frequency of cataplexy attacks compared to placebo (p=0.017, primary endpoint) Statistically significant improvement in cognition compared to placebo (p=0.011, NSAQ) Statistically significant improvement in narcolepsy overall compared to placebo (p=0.024, PGI-C) Cataplexy response (≥50% improvement) achieved by 72% of patients at 1 month and 82% at 6 months Improvement in excessive daytime sleepiness (EDS), assessed by the CGI-C, achieved by 84% of patients at 1 month and 78% at 6 months Improvement in narcolepsy overall, assessed by the CGI-C, achieved by 90% of patients at 1 month and 90% at 6 months Well-tolerated with long-term safety
Mizuho reiterated coverage of Axsome Therapeutics with a rating of Outperform and set a new price target of $122.00 from $124.00 previously
Wells Fargo initiated coverage of Axsome Therapeutics with a rating of Overweight and set a new price target of $140.00
BofA Securities upgraded Axsome Therapeutics from Neutral to Buy and set a new price target of $106.00 from $95.00 previously
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
8-K - Axsome Therapeutics, Inc. (0001579428) (Filer)
ACCORD-2 Phase 3 trial in Alzheimer's disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared to placebo (p=0.001, prevention of relapse of Alzheimer's disease agitation) AXS-05 reduced worsening of Alzheimer's disease overall compared to placebo in ACCORD-2 Phase 3 trial (p<0.001, CGI-S Alzheimer's disease overall clinical status) ADVANCE-2 trial did not demonstrate statistical significance on primary endpoint; numerically greater improvements with AXS-05 over placebo (primary and secondary endpoints) Long-term safety trial completed with required number of patients treated for 6 and 12 mo
Total 3Q 2024 net product revenue of $104.8 million, representing 81% year-over-year growth Auvelity® 3Q 2024 net product sales of $80.4 million, representing 113% year-over-year growth Sunosi® 3Q 2024 net product revenue of $24.4 million representing 21% year-over-year growth Second expansion of Auvelity psychiatry sales force planned for 1Q 2025 NDA resubmission for AXS-07 for the treatment of migraine accepted by the FDA with PDUFA goal date of January 31, 2025 Topline results of ADVANCE-2 and ACCORD-2 Phase 3 trials of AXS-05 in Alzheimer's disease agitation on track for 4Q 2024 Topline results of ENCORE Phase 3 trial of AXS-12 in narcolepsy on track for 4Q 2024 Topline results of
NEW YORK, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, will report its financial results for the third quarter of 2024 on Tuesday, November 12, 2024, before the opening of the U.S. financial markets. Axsome management will then host a conference call at 8:00 a.m. Eastern Time to discuss these results and provide a business update. To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851 (international). A live webcast of the conference call can be accessed on the "Webcasts
SC 13G/A - Axsome Therapeutics, Inc. (0001579428) (Subject)
SC 13G/A - Axsome Therapeutics, Inc. (0001579428) (Subject)
SC 13G/A - Axsome Therapeutics, Inc. (0001579428) (Subject)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
4 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
3 - Axsome Therapeutics, Inc. (0001579428) (Issuer)
Submission status for AXSOME THERAPEUTICS, INC.'s drug AUVELITY (ORIG-1) with active ingredient DEXTROMETHORPHAN HYDROBROMIDE AND BUPROPION HYDROCHLORIDE has changed to 'Approval' on 08/18/2022. Application Category: NDA, Application Number: 215430, Application Classification: Type 3 - New Dosage Form and Type 4 - New Combination
Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, Nov. 28, 2023 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Axsome Therapeutics, Inc. ("Axsome" or "the Company") (NASDAQ:AXSM) investors that a lawsuit filed on behalf of investors that purchased Axsome securities between May 10, 2021 and April 22, 2022, inclusive (the "Class Period") Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email: [email protected], to discuss their legal rights, or click here to join the case via www.portnoylaw.com. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors' options fo
NEW YORK, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ:AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that Susan Mahony, PhD, has been appointed to Axsome's board of directors, effective immediately. Dr. Mahony most recently served on the board of directors of Horizon Therapeutics from 2019 until its acquisition by Amgen in October 2023. She was formerly Senior Vice President of Eli Lilly and Company and President of Lilly Oncology, where under her leadership, the business unit evolved from one to five marketed medicines. At Lilly, she held leadership position