StreetInsider.com News Articles

BMO Capital Starts Axsome Therapeutics (AXSM) at Outperform

Mon, 20 Jul 2026 16:13:55 -0400

BMO Capital analyst Malcolm Hoffman initiates coverage on Axsome Therapeutics (NASDAQ: AXSM) with a Outperform rating and a price target of $310.00.

For an analyst ratings summary and ratings history on Axsome Therapeutics click here. For more ratings news on Axsome Therapeutics click here.

Shares of Axsome Therapeutics closed at $230.00 yesterday.

H.C. Wainwright Reiterates Buy Rating on Axsome Therapeutics (AXSM)

Thu, 16 Jul 2026 06:47:39 -0400

H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $290.00 price target on Axsome Therapeutics (NASDAQ: AXSM).

The analyst commented: "AXS-12 regulatory submission accepted for review, with potential approval and market entry next year. This morning, Axsome Therapeutics reported that the FDA has accepted for filing the New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027. The FDA also indicated that it does not currently plan to hold an advisory committee meeting (AdCom) to discuss the application.

Form 8-K Axsome Therapeutics, For: Jul 15

Wed, 15 Jul 2026 07:05:00 -0400

si-local-file:///var/storage/secattach/20260715/26770754.html

Form 8-K Axsome Therapeutics, For: Jul 15

Wed, 15 Jul 2026 07:05:00 -0400

si-local-file:///var/storage/secattach/20260715/26770754.html

FDA accepts Axsome drug application for cataplexy treatment

Wed, 15 Jul 2026 07:00:25 -0400

Axsome Therapeutics (NASDAQ: AXSM) announced that the U.S. Food and Drug Administration has accepted for filing the company's New Drug Application for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy, according to a press release issued July 15, 2026.

The FDA set a Prescription Drug User Fee Act target action date of May 1, 2027. The agency also indicated it does not currently plan to hold an advisory committee meeting to discuss the application.

AXS-12 is a norepinephrine reuptake inhibitor and cortical dopamine modulator. The drug has previously received FDA Orphan Drug Designation for the treatment of narcolepsy. It has not

Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy

Wed, 15 Jul 2026 07:00:00 -0400

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. The FDA also indicated that it does not

Axsome Therapeutics Announces FDA Acceptance of New Drug Application for AXS-12 for the Treatment of Cataplexy in Narcolepsy

Wed, 15 Jul 2026 07:00:00 -0400

FDA sets PDUFA target action date of May 1, 2027

Piper Sandler Reiterates Overweight Rating on Axsome Therapeutics (AXSM)

Tue, 14 Jul 2026 07:55:52 -0400

Piper Sandler analyst David Amsellem reiterated an Overweight rating and $258.00 price target on Axsome Therapeutics (NASDAQ: AXSM).

The analyst commented: "Perspectives On Auvelity in AD-Agitation; We hosted a webinar with a leading neurologist who manages a significant number of patients with Alzheimer's disease (AD) (~300-350 patients under his care) as part of a larger academic network consisting of ~3,000 AD patients. In the ~40% of his AD patients with agitation (AD-agitation), our expert historically has relied on reuptake inhibitors and atypical antipsychotics in more severe cases (of the atypical antipsychotics, he leans into Rexulti (brexpiprazole), no surprise given its approval

Axsome Therapeutics to Report Second Quarter 2026 Financial Results on August 10

Tue, 14 Jul 2026 07:00:00 -0400

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.

To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851

Axsome Therapeutics to Report Second Quarter 2026 Financial Results on August 10

Tue, 14 Jul 2026 07:00:00 -0400

To participate in the live conference call, please dial (877) 405-1239 (toll-free domestic) or +1 (201) 389-0851

H.C. Wainwright Reiterates Buy Rating on Axsome Therapeutics (AXSM)

Wed, 08 Jul 2026 06:40:59 -0400

H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $290.00 price target on Axsome Therapeutics (NASDAQ: AXSM).

The analyst commented: "We note that Axsome recently reported the initiation of the FOCUS-2 and FOCUS-3 pivotal trial programs with solriamfetol in children and adolescents with attention deficit/hyperactivity disorder (ADHD), respectively. 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 between 6 and 12 years of age with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of

Axsome Therapeutics (AXSM) PT Raised to $304 at RBC Capital

Tue, 07 Jul 2026 07:59:45 -0400

RBC Capital analyst Leonid Timashev raised the price target on Axsome Therapeutics (NASDAQ: AXSM) to $304.00 (from $302.00) while maintaining a Outperform rating.

Axsome starts Phase 3 trial of solriamfetol in children with ADHD

Tue, 07 Jul 2026 07:00:12 -0400

Axsome Therapeutics (NASDAQ: AXSM) announced that the first patient has been dosed in its FOCUS-2 Phase 3 clinical trial evaluating solriamfetol as a treatment for children with attention deficit hyperactivity disorder (ADHD), according to a company statement.

The trial is a randomized, double-blind, placebo-controlled, multicenter study enrolling children aged 6 to under 12 years with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo over six weeks. The primary endpoint is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.

The FOCUS-2 trial follows

Axsome Therapeutics Initiates FOCUS-2 Phase 3 Trial of Solriamfetol in Children with Attention Deficit Hyperactivity Disorder (ADHD)

Tue, 07 Jul 2026 07:00:00 -0400

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

Axsome Therapeutics Initiates FOCUS-2 Phase 3 Trial of Solriamfetol in Children with Attention Deficit Hyperactivity Disorder (ADHD)

Tue, 07 Jul 2026 07:00:00 -0400

The FOCUS-2 trial in children complements the recently announced FOCUS-3 trial in adolescents with 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

Form 4 Axsome Therapeutics, For: Jul 01 Filed by: TABUTEAU HERRIOT

Wed, 01 Jul 2026 19:30:00 -0400

si-local-file:///var/storage/secattach/20260701/26722575.html

Form 4 Axsome Therapeutics, For: Jul 01 Filed by: TABUTEAU HERRIOT

Wed, 01 Jul 2026 19:30:00 -0400

si-local-file:///var/storage/secattach/20260701/26722575.html

Form 144 Axsome Therapeutics, Filed by: TABUTEAU HERRIOT

Wed, 01 Jul 2026 17:35:00 -0400

si-local-file:///var/storage/secattach/20260701/26722266.html

Form 144 Axsome Therapeutics, Filed by: TABUTEAU HERRIOT

Wed, 01 Jul 2026 17:35:00 -0400

si-local-file:///var/storage/secattach/20260701/26722266.html

Axsome starts Phase 3 trial of solriamfetol for adolescent ADHD

Fri, 26 Jun 2026 07:00:27 -0400

Axsome Therapeutics (NASDAQ: AXSM) announced that the first patient has been dosed in its FOCUS-3 Phase 3 clinical trial evaluating solriamfetol as a treatment for adolescents with attention deficit hyperactivity disorder (ADHD), according to a company statement.

The trial is a randomized, double-blind, placebo-controlled, multicenter study enrolling adolescents aged 12 to under 18 years with ADHD. Approximately 468 patients will be randomized in a 1:1:1 ratio to receive one of two doses of solriamfetol or placebo over six weeks. The primary endpoint is the change from baseline to week 6 in the ADHD Rating Scale (ADHD-RS-5) total score.

Solriamfetol is a dopamine

Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

Fri, 26 Jun 2026 07:00:00 -0400

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).

FOCUS-3 (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 adolescents aged 12 to less than 18 years with ADHD.

Axsome Therapeutics Initiates FOCUS-3 Phase 3 Trial of Solriamfetol in Adolescents with Attention Deficit Hyperactivity Disorder (ADHD)

Fri, 26 Jun 2026 07:00:00 -0400

Axsome Therapeutics Highlights the Importance of Brain Health During Alzheimer's & Brain Awareness Month

Thu, 18 Jun 2026 07:00:00 -0400

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. “That’s why Alzheimer’s & Brain

Axsome Therapeutics Highlights the Importance of Brain Health During Alzheimer's & Brain Awareness Month

Thu, 18 Jun 2026 07:00:00 -0400

Axsome Therapeutics Highlights the Importance of Brain Health During Alzheimer's & Brain Awareness Month

Thu, 18 Jun 2026 07:00:00 -0400