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Axsome Therapeutics

Axsome Therapeutics, Inc. · New York, NY · founded 2012

Axsome Therapeutics is a New York commercial-stage CNS biotech. It markets AUVELITY, a once-daily oral combination drug for major depressive disorder, and SUNOSI for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea. The pipeline includes solriamfetol for ADHD, AXS-05 for Alzheimer's-related agitation, and AXS-07 for acute migraine.

Lead asset
AUVELITY · Approved · Major Depressive Disorder
small molecule · NMDA antagonist + sigma-1 agonist
Pipeline
1 drug · 1 program
1 Neurology
Modalities
small molecule×1
FocusNeurology
0.58
Reliability
Mixed
8/11
hits
13d
Next catalyst
readout
Last refresh · 5d ago · PR
$87.00+1.55%1Y
AXSM · daily close · illustrative · 2 catalysts marked
$72$78$84$90$97Apr '25Aug '25Dec '25Apr '26
Interim+18%AdCom-28%
1Y high$94.591Y low$74.13range$20.46(28%)past catalysts

Peers in this space

same sector or modality · sorted by match strength + market cap
Pipeline & catalysts

Pipeline & catalysts

1 drug · 1 programs · 2 upcoming catalysts
Pipeline by phase1programs
  • Preclin0
  • Ph10
  • Ph20
  • Ph30
  • Filed0
  • Approved1

AUVELITY

dextromethorphan-bupropion
small moleculeNMDA antagonist + sigma-1 agonist
Major Depressive Disorder
1 program·0 trials·View drug →
Upcoming catalysts2
ReadoutMAY 082026·8 daysEXACT

AUVELITY Adolescent MDD Phase 3 Topline

Phase 3 efficacy readout for AUVELITY in adolescents (12–17) with major depression. AUVELITY is currently approved only in adults. Watch: CDRS-R change at week 6 vs. placebo, suicidal ideation signal.

Cited“Topline results from the Phase 3 study of AUVELITY in adolescent major depressive disorder are expected on May 8, 2026.”
Topline Readout·PR·disclosed 5d ago
CMCAUG2026·3 monthsMONTH

AUVELITY Adolescent MDD sNDA Filing

Filing of the supplemental NDA for AUVELITY in adolescent major depressive disorder. Procedural step in the path to extend the label beyond adults.

Cited“Axsome plans to file a supplemental NDA for AUVELITY in adolescent MDD in August 2026.”
CMC Milestone·PR·disclosed 5d ago

Past catalyst impact

4 historical events · % change vs announcement
DateKindEventOutcome+1W+1M+6M
Oct 27, 2025InterimAUVELITY — Phase 3 Interim — Stopped for EfficacyPositive+18.2%+21.2%+18.6%
Apr 30, 2025AdComAUVELITY — Advisory Committee — 12–2 Vote in FavorNegative-27.6%-33.3%-19.2%
Aug 3, 2024AdComAUVELITY — Advisory Committee — 12–2 Vote in FavorPositive+34.8%+29.7%+17.9%
Feb 5, 2024InterimAUVELITY — Phase 3 Interim — Stopped for EfficacyPositive+23.3%+15.1%+10.2%
% change vs ticker close on the announcement date · backtest illustrative
Smart money

Insider activity

SEC EDGAR Form 4 · last 90 days
Insider activity · last 90 days
Form 4 trail · 3 transactions · 3 insiders
1 near a catalyst
Net flow
−$276.2K
Buys
$0
0 txns
Sells
$276.2K
1 txns
Largest
−$276.2K
SVP sell
Net flow per quarter · last 8Q
6 txns · sum −$3.09M
24Q325Q125Q326Q126Q2
buys · $0sells · $3.09M
Insider · roleActionSharesPriceValueDate
N. Walsh
SVP
Sell8,154$33.87−$276.2K
Mar 23, 2026
46d to catalyst
B. Hassan
CMO
Option ex.2,742$28.69$78.7K
Feb 12, 2026
E. Park
CFO
Award10,215$31.33$320.0K
Feb 9, 2026

Congressional trading

STOCK Act PTRs · House & Senate
Congressional trading · STOCK Act · last 365d
2 trades · 2 members
1 near a catalyst
Est. net flow
+$200K
midpoint · brackets only
Buys
1
Sells
1
Party mix
1 D1 R
Member · chamberActionBracket~ midpointOwnerDate · disclosure
R
Rep. G. Ostrom
House · OH
Sell$100K–$250K~$175Kself
Apr 8, 2026
filed +28d
30d to catalyst
D
Rep. P. Bowen
House · NJ
Buy$250K–$500K~$375Kself
Jan 4, 2026
filed +13d
Source: Senate eFD & House Clerk PTR feeds

Top ETF holders

ETF NAV disclosures · 13F filings
ETF holders · NAV disclosures
2 ETFs hold the position
Held by ETFs
$26.2M
aggregate position
Of market cap
0.62%
aggregate ETF share
Top holder
IBB0.29%
iShares Biotechnology ETF
TickerETF · familyThemeNAV% of NAVPosition
IBB
iShares Biotechnology ETF
iShares
Broad biotech$8.40B0.29%$24.4M
BBC
Virtus LifeSci Biotech Clinical Trials
WisdomTree
Small-cap biotech$60.0M3.14%$1.9M
Source: ETF NAV disclosures + quarterly 13F filings

KOL network

CMS OpenPayments · 2024 – 2025
KOL network · CMS OpenPayments
8 physicians paid · 42 disclosed records
Total 2025+2024
$3.35M
YoY
+31%
Co-Investigator$2.09MEquity / Ownership$603.7KResearch Grant$450.6KConsulting$150.8KSpeaking$40.0KTravel & Lodging$20.4KFood & Beverage$1.1K
Physician · affiliationSpecialtyTop categoryTotalRecords
Dr. Daniel Walsh
Mayo Clinic
Hematology / OncologyCo-Investigator$640.0K7
Dr. Tomás Kowalski
UCSF
GeneticsCo-Investigator$618.5K4
Dr. Sarah Singh
Cedars-Sinai
Hematology / OncologyCo-Investigator$555.1K6
Dr. Kavya Park
University of Washington
Pediatric GeneticsResearch Grant$539.2K7
Dr. Rebecca Nakamura
Mass General Hospital
Hematology / OncologyCo-Investigator$434.3K6
Dr. Theo Romano
UCSF
Pediatric GeneticsCo-Investigator$355.8K6
Dr. James Greene
University of Michigan
Hematology / OncologyCo-Investigator$180.0K4
Dr. Henry Tanaka
Stanford Medicine
Pediatric GeneticsConsulting$31.4K2
Source: CMS OpenPayments
Government & IP

Federal lobbying

Senate LDA disclosures · last 8 quarters
Federal lobbying · LDA · last 8 quarters
$365K disclosed · 3 firms engaged
YoY change
+9%
last 4Q vs prior 4Q
24Q3Q425Q1Q2Q3Q426Q1Q2
Top lobbying firms · last 8Q
Invariant$134K
5 quarters active
Tiber Creek Group$117K
5 quarters active
Squire Patton Boggs$114K
5 quarters active
Top issues lobbied
  • Prescription Drug User Fee programs$231K
  • Cardiovascular drug review guidance$58K
  • FDA user fee reauthorization (PDUFA / BsUFA)$38K
  • CMS Quality Reporting Program$38K
Source: Senate LDA database (lda.senate.gov)

Government contracts

USAspending.gov · BARDA · NIH · DoD · HHS · VA
Federal contracts · USAspending.gov
2 awards · 2 agencies
Total awarded
$14.1M
across all programs
Active
$14.1M
option periods incl.
Top agency
NIH / NCI$10.1M
largest active: Rare Cancer Translational Research Grant
AgencyTitle · type · award IDStatusValueAwarded → ends
NIH / NCI
Rare Cancer Translational Research Grant
Grant · NIH-34133110
active$10.1MMar 2026→ Jan 2029
CDC
Vaccine Adverse Event Surveillance
Contract · CDC-63813916
active$4.1MJan 2026→ Feb 2028
Source: USAspending.gov · SAM.gov

U.S. Patents

USPTO PEDS & Patent Public Search
U.S. Patents · USPTO
2 granted · 2 pending
Total in portfolio
4
Granted in last 12mo
2
Expiring < 2yr
0
Nearest expiry
Apr 2043
Patent #Title · inventor · drugTypeStatus · filedExpiry
11,322,324
Genome editing constructs encoding AUVELITY
E. Walsh + 3 · AUVELITY
Composition of Matter
grantedfiled Apr 2023
exp. Apr 2043
17.0y left
10,663,503
Pediatric methods of use for AUVELITY
F. Voss · AUVELITY
Method of Use
grantedfiled Apr 2023
exp. Apr 2043
17.0y left
US 2026/0927788 A1
Genome editing constructs encoding AUVELITY
A. Hoffman + 1 · AUVELITY
Composition of Matter
pendingfiled Apr 2026
in prosecution
US 2023/5015922 A1
Lipid nanoparticle formulations comprising AUVELITY
A. Goldstein + 3 · AUVELITY
Composition of Matter
pendingfiled Apr 2023
in prosecution
Source: USPTO PEDS & Patent Public Search
News

News

PR wires · biotech trades · company IR · last 90 days
News · last 90 days
8 items from 3 categories
analyst3corporate3clinical2
just now
Bank reiterates Outperform rating on AXSM
STAT$·analyst
11d ago
Sell-side raises price target on AXSM after pipeline review
STAT$·analyst
24d ago
AXSM expands manufacturing capacity at lead facility
Business Wire·corporate
1mo ago
AXSM adds independent director to Board
Business Wire·corporate
2mo ago
AXSM completes enrollment in AUVELITY Phase 2 trial
FierceBiotech·clinical
3mo ago
AXSM provides corporate update at investor conference
Business Wire·corporate
3mo ago
AXSM reports topline results from Phase 2 trial of AUVELITY
Endpoints News$·clinical
3mo ago
Bank reiterates Outperform rating on AXSM
Reuters·analyst
Sources: PR wires + biotech-trade publications + company IR
Financials

Financials

snapshot · sourced to filings · refreshed at next 10-Q
Trading
Previous close
$87.00
Open
$87.35
Day Δ
-0.35
-0.40%
Day range
$86.43 – $87.92
52W range
$74.13 – $94.59
Avg daily volume
560K
Valuation & ownership
Enterprise value
$4.0B
Shares out
48.28M
Float
41.52M
Insider %
1.33%
Institutional %
51.33%
Beta
2.33
vs SPY · 52w
Balance sheet & burn
Cash + invest
$425M
Total debt
$33M
Debt / equity
4.33
Cash burn / Q
$60M
R&D spend TTM
$228M
54% of cash
ATM available
None
no active facility
Earnings
EPS latest
$-0.78
EPS Δ vs prior
+0.13
EPS estimate
$-0.75
next quarter
EPS prior
$-0.91
Next earnings
Jun 30, 2026
Rev guidance
$76M

All values reflect the most recent 10-Q / 10-K filing or seeded equivalent. Beta, IV, short interest, and borrow availability are derived from broker-feed conventions. Upgrade to Pro for live updates.

Recent disclosure activity

last 2 observations
5d agoAUVELITYAUVELITY Adolescent MDD sNDA FilingMedPR
5d agoAUVELITYAUVELITY Adolescent MDD Phase 3 ToplineHighPR

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