AXSM — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-04

• We are a biopharmaceutical company focused on the development and commercialization of innovative medicines for people living with central nervous system (“CNS”) conditions. Our operations are primarily directed toward the commercialization of our marketed products, AUVELITY®, SUNOSI®, and SYMBRAVO®…

• Our commercial products represent our primary sources of revenue and are expected to be key contributors to future revenue growth.

• AUVELITY (dextromethorphan and bupropion) was developed by Axsome and approved by the FDA for the treatment of MDD (as defined below) in adults in August 2022. We launched AUVELITY in the U.S. in October 2022 as the first and only oral, N-methyl-D-aspartate (NMDA) receptor antagonist approved for MD…

• SUNOSI (solriamfetol) is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT1A agonist approved in the United States, the European Union, and Canada for the treatment of EDS in adult patients with obstructive sleep apnea o…

• SYMBRAVO (MoSEICTM meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist that was developed by us and approved by the FDA in January 2025 for the acute treatment of migraine with or without aura in adults. We launched SYMBRAVO i…

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• We are a biopharmaceutical company dedicated to the development and commercialization of innovative medicines for people living central nervous system (“CNS”) conditions.

• Auvelity®. Auvelity (dextromethorphan-bupropion) is a novel, oral, N-methyl-D-aspartate (NMDA) receptor antagonist, sigma-1 receptor agonist, aminoketone, and CYP2D6 inhibitor. Auvelity was developed by the Company and approved by the FDA for the treatment of major depressive disorder (MDD) in adult…

• Sunosi®. Sunosi (solriamfetol) is a novel, oral, dopamine and norepinephrine reuptake inhibitor (DNRI), trace amine-associated receptor 1 (TAAR1) agonist, and 5-HT1A agonist. Sunosi was approved for the treatment of EDS in adult patients with narcolepsy or obstructive sleep apnea (OSA) by the FDA in…

• Symbravo®. Symbravo (MoSEICTM meloxicam-rizatriptan) is a novel, oral, rapidly absorbed, multi-mechanistic, selective COX-2 inhibitor and 5-HT1B/1D agonist. Symbravo was developed by the Company and approved by the FDA for the acute treatment of migraine with or without aura in adults in January 202…

• We are advancing a diversified, late-stage pipeline of novel product candidates for serious neurological and psychiatric conditions.

Text added vs the prior filing · source: 10-Q · 2026-05-04

• Certain matters discussed in this report, including matters discussed under the caption “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” may constitute forward-looking statements for purposes of the Securities Act of 1933, as amended, or the Securities Act, an…

• our expectations for the clinical and preclinical development, manufacturing and regulatory approval of our product candidates, and commercialization of our pharmaceutical products or any other products that we may acquire or in-license;

• our estimates of the sufficiency of our existing capital resources combined with future anticipated cash flows to finance our operating requirements;

• our expectations for incurring capital expenditures to expand our research and development and manufacturing capabilities;

• unforeseen circumstances or other disruptions to normal business operations arising from or related to geopolitical conflicts or pandemics;

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• Except as described herein, we, and our subsidiaries, are currently not a party to, and our property is not currently the subject of, any material pending legal proceedings; however, we may also become involved in various claims and legal actions arising in the ordinary course of business.

• On May 13, 2022, Evy Gru filed a putative class action complaint captioned Gru v. Axsome Therapeutics, Inc., et al. in the U.S. District Court for the Southern District of New York, or the SDNY District Court, against the Company and certain of its current and former officers and one director, which…

• On October 13, 2023, plaintiffs’ counsel filed a letter seeking leave to file an amended complaint and to substitute new plaintiffs. On January 22, 2024, the SDNY District Court granted that motion and ordered that the case name be changed to In re Axsome Therapeutics, Inc. Securities Litigation. On…

• On July 21, 2022, Daniel Engel filed a stockholder derivative complaint captioned Engel v. Herriot Tabuteau, et al. in the SDNY District Court against the Company’s current directors, certain of the Company’s current and former officers, and the Company (as nominal defendant). On January 27, 2023, K…

• On September 23, 2025, John Wickstrom filed a stockholder derivative complaint captioned Wickstrom v. Herriot Tabuteau, et al. in the Court of Chancery of the State of Delaware against the Company’s current directors, certain of the Company’s current and former officers, and the Company (as nominal …

Text added vs the prior filing · source: 10-Q · 2026-05-04

• U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions, including the military conflict between Russia and Ukraine and heightened instability in the Middle East involving Iran. Since Russia’s full-scale invasion of Ukraine in February 202…

• Additionally, the military conflict in Ukraine has led to sanctions and other penalties being levied by the United States, European Union and other countries against Russia. Additional potential sanctions and penalties have also been proposed and/or threatened. Most recently, in December 2025, the E…

• In addition, the United States and other countries maintain extensive sanctions and trade restrictions with respect to Iran. These measures could be broadened in scope or subject to more rigorous enforcement in response to future developments involving Iran or the broader Middle East.

• General political uncertainty may have an adverse impact on our operating performance and results of operations. In particular, the U.S. continues to experience significant political events that cast uncertainty on the U.S. and global financial and economic markets. For example, from October 1, 2025…

• Furthermore, in April 2025, the U.S. administration imposed increased tariffs on all countries and individualized “reciprocal” higher tariffs on certain countries with which the U.S. has the largest trade deficits, which were subsequently paused, modified, and ultimately terminated in February 2026 …

Text removed vs the prior filing · source: 10-Q · 2025-11-03

• U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Russia and Ukraine. On February 24, 2022, a full-scale military invasion of Ukraine by Russian troops was reported. Although the length …

• Additionally, the military conflict in Ukraine has led to sanctions and other penalties being levied by the United States, European Union and other countries against Russia. Additional potential sanctions and penalties have also been proposed and/or threatened. Russian military actions and the resul…

• In addition, on October 7, 2023, Hamas militants and members of other terrorist organizations infiltrated Israel’s southern border from the Gaza Strip and conducted a series of terror attacks on civilian and military targets. Shortly following the attack, Israel’s security cabinet declared war again…

• General political uncertainty may have an adverse impact on our operating performance and results of operations. In particular, the U.S. continues to experience significant political events that cast uncertainty on the U.S. and global financial and economic markets. For example, on October 1, 2025, …

• Furthermore, in April 2025, the U.S. administration imposed increased tariffs on all countries and individualized “reciprocal” higher tariffs on certain countries with which the U.S. has the largest trade deficits. Certain countries responded by announcing retaliatory tariffs on U.S. imports. A few …