Earnings summaries and quarterly performance for Axsome Therapeutics.
Executive leadership at Axsome Therapeutics.
Board of directors at Axsome Therapeutics.
Research analysts who have asked questions during Axsome Therapeutics earnings calls.
CC
Cerena Chen
Wells Fargo & Company
4 questions for AXSM
Also covers: AMPH, HALO
David Amsellem
Piper Sandler Companies
4 questions for AXSM
Also covers: ABBV, ALKS, AMGN +27 more
Graig Suvannavejh
Mizuho Securities
4 questions for AXSM
Also covers: ADAP, ADVM, ALEC +11 more
Jason Gerberry
Bank of America Merrill Lynch
4 questions for AXSM
Also covers: ALKS, AMPH, ARWR +21 more
Leonid Timashev
RBC Capital Markets
4 questions for AXSM
Also covers: ADCT, ALKS, CMPS +8 more
MG
Marc Goodman
Leerink Partners
4 questions for AXSM
Also covers: ACAD, ALDX, ALKS +14 more
MM
Myles Minter
William Blair & Company
4 questions for AXSM
Also covers: ALEC, ARCT, ARGX +11 more
Ami Fadia
Needham & Company, LLC
3 questions for AXSM
Also covers: ACAD, ALKS, AVDL +10 more
CD
Charles Duncan
Cantor Fitzgerald & Co.
3 questions for AXSM
Also covers: ACAD, ALKS, ATAI +12 more
Joseph Thome
TD Cowen
3 questions for AXSM
Also covers: ALKS, AMLX, ARDX +12 more
RS
Raghuram Selvaraju
H.C. Wainwright & Co.
3 questions for AXSM
Also covers: ABEO, ACOG, AQST +20 more
Yatin Suneja
Guggenheim Partners
3 questions for AXSM
Also covers: ACAD, ARGX, CLDX +10 more
AV
Ashwani Verma
UBS Group AG
2 questions for AXSM
Also covers: ACAD, ALKS, ALVO +12 more
AR
Asim Rana
Truist Securities
2 questions for AXSM
Also covers: CORT, CPRX, SAGE +2 more
DH
David Hoang
Citigroup
2 questions for AXSM
Also covers: ACAD, ALKS, AVDL +8 more
JB
Joel Beatty
Baird
2 questions for AXSM
Also covers: ACAD, ALKS, AMLX +11 more
JL
Joon Lee
Truist Securities
2 questions for AXSM
Also covers: ADVM, CNM, CORT +14 more
CC
Chris Coetzee
Baird
1 question for AXSM
EH
Eddie Hickman
Guggenheim Securities
1 question for AXSM
Also covers: OTLK, TARS, ZVRA
Linda Tsai
Jefferies
1 question for AXSM
Also covers: ADC, AKR, AMH +31 more
Matthew Hershenhorn
Oppenheimer & Co. Inc.
1 question for AXSM
Also covers: SKYE
MK
Matthew Kaplan
Ladenburg Thalmann
1 question for AXSM
Also covers: ARDX, CORT, ELDN +8 more
Parth Patel
Morgan Stanley
1 question for AXSM
Also covers: KYMR
PS
Pete Stavropoulos
Cantor Fitzgerald
1 question for AXSM
Also covers: ABOS, ALEC, ARCT +7 more
PK
Poorna Kannan
Needham & Company
1 question for AXSM
Also covers: NMRA, RVMD
Sam Beck
Deutsche Bank
1 question for AXSM
Sean Laaman
Morgan Stanley & Co.
1 question for AXSM
Also covers: ACAD, ARGX, BGNE +8 more
TL
Troy Langford
TD Cowen
1 question for AXSM
Also covers: ALKS, JAZZ, NTLA
VP
Vikram Purohit
Morgan Stanley
1 question for AXSM
Also covers: ABSI, ARGX, ARQT +11 more
Recent press releases and 8-K filings for AXSM.
Axsome Therapeutics Announces Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue
AXSM
Earnings
Revenue Acceleration/Inflection
Product Launch
- Axsome Therapeutics reported preliminary total net product revenue of $196.0 million for the fourth quarter of 2025, representing 65% annual growth, and $638.5 million for the full year 2025, an increase of 66% annually.
- AUVELITY preliminary net product sales were $155.1 million for Q4 2025 and $507.1 million for the full year 2025.
- SUNOSI preliminary net product revenue was $36.7 million for Q4 2025 and $124.8 million for the full year 2025.
- SYMBRAVO, which commercially launched in June 2025, generated preliminary net product sales of $4.1 million for Q4 2025 and $6.6 million for the full year 2025.
13 hours ago
Axsome Therapeutics Provides Preliminary Q4 and Full Year 2025 Net Product Revenue
AXSM
Earnings
Guidance Update
Revenue Acceleration/Inflection
- Axsome Therapeutics, Inc. announced preliminary Fourth Quarter and Full Year 2025 net product revenue on January 12, 2026.
- Preliminary total net product revenue for Q4 2025 is expected to be approximately $196.0 million, representing 65% annual growth compared to Q4 2024.
- Preliminary total net product revenue for Full Year 2025 is expected to be approximately $638.5 million, representing 66% annual growth compared to Full Year 2024.
- Key product sales for Full Year 2025 include AUVELITY at $507.1 million, SUNOSI at $124.8 million, and SYMBRAVO at $6.6 million following its June 2025 launch.
13 hours ago
Axsome Therapeutics Announces FDA Pre-NDA Meeting Minutes for AXS-12 in Narcolepsy
AXSM
Product Launch
New Projects/Investments
- Axsome Therapeutics received formal pre-New Drug Application (NDA) meeting minutes from the FDA for AXS-12 in narcolepsy.
- The FDA feedback confirmed that the regulatory data package is sufficient for NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy.
- Axsome anticipates completing the NDA submission in January 2026.
- AXS-12 has been granted Orphan Drug Designation for narcolepsy, which may entitle Axsome to seven years of marketing exclusivity and a waiver of FDA application user fees upon approval.
Dec 31, 2025, 12:10 PM
Axsome Therapeutics Receives FDA Priority Review for AXS-05 sNDA
AXSM
New Projects/Investments
Product Launch
- The FDA has accepted Axsome Therapeutics' supplemental New Drug Application (sNDA) for AXS-05 for the treatment of Alzheimer’s disease agitation and granted it Priority Review designation.
- The Prescription Drug User Fee Act (PDUFA) target action date for AXS-05 is set for April 30, 2026.
- This Priority Review designation indicates the FDA's goal to act on the application within 6 months, compared to the standard 10 months, for medicines that could provide significant improvements for serious conditions.
- AXS-05 previously received Breakthrough Therapy designation for Alzheimer’s disease agitation in June 2020, addressing a significant unmet medical need as agitation affects up to 76% of Alzheimer's patients.
Dec 31, 2025, 12:00 PM
Axsome Therapeutics Announces FDA Support for AXS-12 Narcolepsy NDA Submission
AXSM
Product Launch
New Projects/Investments
- Axsome Therapeutics has received formal pre-New Drug Application (NDA) meeting minutes from the FDA, supporting the NDA submission of AXS-12 for the treatment of cataplexy in narcolepsy.
- The company anticipates completing the NDA submission in January 2026.
- AXS-12 has been granted Orphan Drug Designation for narcolepsy, which may entitle Axsome to seven years of marketing exclusivity in the U.S. upon FDA approval.
Dec 31, 2025, 11:55 AM
Axsome Therapeutics Provides Updates on Auvelity, Elyxyb, and Pipeline at Piper Sandler Conference
AXSM
Product Launch
Guidance Update
New Projects/Investments
- Axsome Therapeutics is awaiting an acceptance decision for the Supplemental New Drug Application (SNDA) for Auvelity in Alzheimer's disease (AD) agitation, with an expected standard review process and a projected peak sales opportunity of $1.5-$3 billion for this indication alone.
- For Auvelity in Major Depressive Disorder (MDD), new-to-brand prescriptions (NBRXs) have increased to approximately 2,750 per week following a direct-to-consumer (DTC) campaign launch in September. Monotherapy usage is now over 50%, with 15% first-line and 35% second-line usage.
- Auvelity's gross-to-net improved to the high 40s% in Q3 from the mid-50s% in Q1 and Q2, achieving 85% total covered lives. The company anticipates 100% access in the government channel for AD agitation upon approval.
- The early launch of Elyxyb for migraine has achieved 52% total covered lives as of Q3, with a 100-rep sales force focused on headache centers.
- Axsome's Solriamfetol pipeline includes studies for shift work disorder and binge eating disorder, both with top-line data expected next year, and studies for pediatric adolescent ADHD and MDD with excessive daytime sleepiness starting this quarter.
Dec 3, 2025, 9:00 PM
Axsome Provides Updates on Auvelity Filings, Commercialization, and Pipeline
AXSM
Product Launch
New Projects/Investments
Guidance Update
- Axsome submitted a Supplemental New Drug Application (SNDA) for Auvelity in Alzheimer's disease (AD) agitation, anticipating a standard review and a $1.5-$3 billion peak sales opportunity for this indication.
- The Auvelity national TV DTC campaign for Major Depressive Disorder (MDD), launched in September, has driven new-to-brand prescriptions (NBRx) from 2,500 to approximately 2,750 per week.
- Auvelity's gross-to-net (GTN) improved from the mid-50s% in Q1 and Q2 to the high 40s% in Q3, with a slight uptick to the low 50s% projected for Q4.
- Axsome plans a meaningful expansion of its 300-rep commercial team upon Auvelity's approval for AD agitation, including a dedicated long-term care field force.
- Pipeline updates include Solriamfetol studies for shift work disorder, ADHD, MDD with excessive daytime sleepiness, and binge eating disorder, with top-line data expected next year for several trials.
Dec 3, 2025, 9:00 PM
Axsome Provides Updates on Auvelity, Symbrava, and Pipeline Development
AXSM
Product Launch
New Projects/Investments
Guidance Update
- Axsome has submitted the SNDA for Auvelity in Alzheimer's disease (AD) agitation, awaiting an acceptance decision, with an expectation of a standard review. Commercial plans include leveraging the existing 300 reps and expanding the field force, including a dedicated long-term care team, targeting peak sales of $1.5-$3 billion for this indication.
- For Auvelity in Major Depressive Disorder (MDD), a DTC campaign launched in September has helped increase weekly new-to-brand prescriptions (NBRx) from 2,000 to 2,750-2,800. Monotherapy use is now over 50%, with 15%+ as first-line and 35% as second-line therapy. Gross-to-net improved to the high 40s% in Q3, with 85% total covered lives.
- The Symbrava launch is receiving positive clinician feedback, with 52% total covered lives as of Q3. Axsome launched with 100 reps focusing on headache centers.
- Axsome is advancing its Solriamfetol pipeline, with shift work disorder and binge eating disorder trials expected to topline next year , and has in-licensed a GABA-A alpha 2/3 positive allosteric modulator for early-stage development.
Dec 3, 2025, 9:00 PM
Fortress Biotech Reports Third Quarter 2025 Financial Results and Strategic Highlights
AXSM
Earnings
M&A
New Projects/Investments
- Fortress Biotech reported total net revenue of $17.6 million for the third quarter ended September 30, 2025, a 20.5% increase compared to the third quarter of 2024.
- The company achieved consolidated net income attributable to common stockholders of $3.7 million, or $0.13 per share basic, for Q3 2025, a significant improvement from a net loss of $(15.0) million, or $(0.76) per share basic, in Q3 2024.
- As of September 30, 2025, Fortress' consolidated cash and cash equivalents totaled $86.2 million, an increase of $28.9 million year-to-date from December 31, 2024.
- Strategic monetization updates include the acquisition of Fortress subsidiary Checkpoint Therapeutics by Sun Pharma, which provided Fortress with approximately $28 million at closing and potential for additional contingent value rights and a 2.5% royalty on future net sales of UNLOXCYT™. Additionally, the acquisition of Baergic by Axsome makes Avenue, a Fortress subsidiary, eligible for an upfront payment, milestone payments, and tiered royalties.
- The company's late-stage pipeline continues to progress, with dotinurad advancing in two Phase 3 clinical trials for gout, supported by Crystalys Therapeutics' $205 million Series A financing.
Nov 14, 2025, 1:30 PM
Axsome Therapeutics Discusses Q3 Performance, Product Pipeline, and Financial Milestones
AXSM
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
- Axsome Therapeutics reported strong Q3 2025 performance, with Auvelity achieving $136 million in net sales, representing 69% year-over-year growth and 14% quarter-over-quarter growth. The company also noted the positive early impact of its direct-to-consumer (DTC) campaign on new-to-brand prescriptions (NBRx), which recently surpassed 2,800 per week.
- The gross-to-net discount for Auvelity improved to the high 40s in Q3, with 85% total covered lives and 28 million additional lives gaining first-line or first-switch access.
- Sunosi recorded $33 million in Q3 sales, showing 35% year-over-year growth, while Elyxyb generated $2.1 million in its first full quarter post-launch. The company maintains peak sales guidance of $300 million-$500 million for Sunosi and $500 million-$1 billion for Elyxyb.
- Axsome achieved cash flow positive for the first time in Q3 2025, with approximately $1 million positive cash flow from operations. The company is progressing with its NDA-stage programs for AXS-05 in AD agitation and AXS-12 in narcolepsy, with an expansion of the sales force anticipated upon ADA approval.
Nov 10, 2025, 4:00 PM
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