Axsome's NDA for AXS-12 in Narcolepsy Gets FDA Acceptance
AXSM advances AXS-12 toward potential approval after the FDA accepts its NDA for cataplexy in narcolepsy and sets a May 2027 decision date.
AXSM - Axsome Therapeutics, Inc.
Price:
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CONSENSUS:
Buy
DETAILS
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PRICE TARGET:
$262.50
DETAILS
HIGH:
$380.00
LOW:
$200.00
MEDIAN:
$259.50
CONSENSUS:
$262.50
UPSIDE:
14.13%
Stock News
Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy
FDA sets PDUFA target action date of May 1, 2027 NEW YORK, July 15, 2026 (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 that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
Axsome Therapeutics to Report Second Quarter 2026 Financial Results on August 10
NEW YORK, July 14, 2026 (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 it will report its financial results for the second quarter of 2026 on Monday, August 10, 2026, 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.
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Axsome Begins Phase III Study on Solriamfetol for ADHD in Children
AXSM doses the first patient in the phase III FOCUS-2 study of solriamfetol for treating ADHD in children aged six to under 12 years.
Axsome Therapeutics Initiates FOCUS-2 Phase 3 Trial of Solriamfetol in Children with Attention Deficit Hyperactivity Disorder (ADHD)
The FOCUS-2 trial in children complements the recently announced FOCUS-3 trial in adolescents with ADHD NEW YORK, July 07, 2026 (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 that the first patient has been dosed in the FOCUS-2 Phase 3 trial evaluating solriamfetol as a treatment for children with attention deficit hyperactivity disorder (ADHD). FOCUS-2 (Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol in children aged 6 to less than 12 years with ADHD.
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Axsome specializes in central nervous system disorders, including depression, migraine, and fibromyalgia. Axsome's Auvelity recently won approval to treat agitation associated with Alzheimer's disease.
Why Axsome Stock Has Doubled In Nine Months
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Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)
NEW YORK, June 26, 2026 (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 that the first patient has been dosed in the FOCUS-3 Phase 3 trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder (ADHD).
Axsome Therapeutics Highlights the Importance of Brain Health During Alzheimer's & Brain Awareness Month
NEW YORK, June 18, 2026 (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 it is joining patients, caregivers, and advocacy organizations in raising awareness of brain health and the impact of Alzheimer's disease during Alzheimer's & Brain Awareness Month. “Nearly everyone knows brain health is important, but many people aren't sure what steps to take to protect it,” said Wendy Vizek, Senior Vice President, Community Engagement and Field Operations at the Alzheimer's Association.
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Axsome Therapeutics Presents New Data Highlighting its Innovative Sleep Medicine Portfolio at SLEEP 2026
NEW YORK, June 15, 2026 (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 presentations of new data on AXS-12 and solriamfetol at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 14-17, 2026, in Baltimore, Maryland.
Axsome Therapeutics, Inc. (AXSM) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Axsome Therapeutics, Inc. (AXSM) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
Axsome Therapeutics Readies Auvelity Alzheimer's Agitation Launch, Expands CNS Pipeline
Axsome Therapeutics NASDAQ: AXSM executives said the company is preparing to launch Auvelity in Alzheimer's disease agitation this month while continuing to expand the drug's use in major depressive disorder and advance a broad central nervous system pipeline.
Axsome Therapeutics Presents New SYMBRAVO® Data at the Americal Headache Society (AHS) 68th Annual Scientific Meeting
NEW YORK, June 04, 2026 (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 presentations of new SYMBRAVO® data at the Americal Headache Society (AHS) 68th Annual Scientific Meeting being held from June 4-7 in Orlando, FL.
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Axsome Therapeutics Announces Settlement Resolving All SUNOSI® (solriamfetol) Patent Litigation
NEW YORK, June 03, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has resolved all patent litigation related to Axsome's product SUNOSI (solriamfetol). The litigations resulted from submission of Abbreviated New Drug Applications to the U.S. Food and Drug Administration by companies seeking approval to market a generic version of SUNOSI in the United States.
Axsome Therapeutics Partners with the Headache Alliance to Highlight the Impact of Migraine During Migraine and Headache Awareness Month
NEW YORK, June 01, 2026 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today highlighted its commitment to the migraine community by supporting educational initiatives during Migraine and Headache Awareness Month this June.
Price Targets
Axsome Therapeutics price target raised to $304 from $302 at RBC Capital
$304.00
(was $242.60)
Leonid Timashev
·
RBC Capital
Axsome Therapeutics (AXSM) PT Raised to $380 at Jefferies
$380.00
(was $246.34)
Andrew Tsai
·
Jefferies
Axsome Therapeutics price target lowered to $280 from $281 at Deutsche Bank
$280.00
(was $230.10)
David Hoang
·
Deutsche Bank
Axsome Therapeutics price target raised to $242 from $217 at Morgan Stanley
$242.00
(was $230.11)
Morgan Stanley
Axsome Therapeutics price target raised to $267 from $255 at Needham
$267.00
(was $230.63)
Needham
Axsome Therapeutics price target raised to $302 from $242 at RBC Capital
$302.00
(was $231.00)
Leonid Timashev
·
RBC Capital
Axsome Therapeutics price target raised to $246 from $241 at Baird
$246.00
(was $223.70)
Brian Skorney
·
Robert W. Baird
Axsome Therapeutics price target raised to $290 from $270 at H.C. Wainwright
$290.00
(was $223.70)
H.C. Wainwright
Axsome Therapeutics price target raised to $280 from $250 at Oppenheimer
$280.00
(was $223.34)
Oppenheimer
Axsome Therapeutics price target raised to $260 from $245 at Guggenheim
$260.00
(was $227.31)
Yatin Suneja
·
Guggenheim
Axsome Therapeutics price target raised to $258 from $223 at Piper Sandler
$258.00
(was $227.26)
Piper Sandler
Axsome Therapeutics price target raised to $272 from $234 at Cantor Fitzgerald
$272.00
(was $227.39)
Cantor Fitzgerald
Axsome Therapeutics price target raised to $275 from $245 at Jefferies
$275.00
(was $227.92)
Andrew Tsai
·
Jefferies
Axsome Therapeutics price target raised to $281 from $245 at Deutsche Bank
$281.00
(was $227.35)
David Hoang
·
Deutsche Bank
Axsome Therapeutics price target raised to $270 from $250 at H.C. Wainwright
$270.00
(was $206.53)
Raghuram Selvaraju
·
H.C. Wainwright
Axsome Therapeutics price target raised to $250 from $220 at Oppenheimer
$250.00
(was $201.03)
Oppenheimer
Axsome Therapeutics price target raised to $217 from $207 at Morgan Stanley
$217.00
(was $207.75)
Morgan Stanley
Axsome Therapeutics price target raised to $259 from $251 at UBS
$259.00
(was $179.25)
UBS
Axsome Therapeutics price target raised to $222 from $219 at RBC Capital
$222.00
(was $168.35)
RBC Capital
Axsome Therapeutics price target raised to $251 from $248 at UBS
$251.00
(was $170.81)
UBS