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Axsome Therapeutics (AXSM)

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                                                                          Axsome Therapeutics

                                                                                                                                                                                             https://axsome.com

We aim to become a fully integrated biopharmaceutical company that develops and commercializes differentiated medicines that expand the treatment options available to caregivers and improve the lives of patients living with CNS disorders.


Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome's core CNS product candidate portfolio includes four clinical-stage candidates, which we are developing for six different CNS indications. The Axsome Pain and Primary Care business unit (Axsome PPC) houses Axsome's pain and primary care assets and intellectual property which includes three clinical-stage product candidates, which are being developed for multiple pain and primary care indications.

Our proprietary medicinal chemistry and formulation technologies allow us to continue to design new and innovative medicines to treat CNS conditions. These technologies and capabilities include:
 

Chiral and Formulation Chemistry. Our AXS-09 product candidate was developed using our chiral chemistry and formulation capabilities to identify, isolate and stabilize chirally pure enantiomers.
 
 
MoSEIC™ Technology. Our AXS-06 and AXS-07 product candidates incorporate our MoSEIC™ technology which is designed to substantially increase the solubility and speed the absorption of target drug molecules.

Learn more about our science

 
Metabolic Inhibition Technology. Our AXS-05 and AXS-09 product candidates incorporate our technology of using metabolic inhibition as a novel drug delivery method to increase the bioavailability and prolong the half-life of target drug molecules.

Learn more about our science

 
Proprietary Synthesis and Analysis. Our AXS-02 product candidate was generated using proprietary chemical synthesis and analysis to increase the solubility and enable the oral delivery of the target drug molecule. 
 



AXS-05

AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. We are initially developing AXS-05 for the treatment of the following conditions: treatment resistant depression (TRD), agitation associated with Alzheimer’s Disease (AD), and smoking cessation. AXS-05 is an investigational drug product not approved by the FDA.

Learn more about AXS-05 and our target indications.

**On Jan. 7, 2019 Axsome Therapeutics reported that its lead drug candidate, AXS-05, hit its primary endpoint in a phase 2 trial evaluating it as a treatment for major depressive disorder (MDD).

AXS-05

Treatment Resistant Depression (TRD)

TRD occurs in individuals suffering from major depression who fail to respond to initial antidepressant treatments. AXS-05 is a novel, oral, investigational drug product, incorporating multiple mechanisms of action, under development for the treatment of TRD.

Learn more about TRD and AXS-05

AXS-05

Agitation Associated with Alzheimer's Disease

Individuals diagnosed with Alzheimer’s Disease typically experience behavioral and psychological symptoms including agitation and aggression. AXS-05 is a novel, oral, investigational drug product, incorporating multiple mechanisms of action, under development for the treatment of Alzheimer’s disease agitation.

Learn more about Agitation Associated With Alzheimer's Disease and AXS-05

AXS-07

AXS-07 is an oral, fixed-dose combination of MoSEIC™ meloxicam and rizatriptan being developed for the acute treatment of migraine. Meloxicam is a new molecular entity for migraine enabled by Axsome’s  proprietary MoSEIC™ (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug  with potent pain-relieving efficacy while rizatriptan is a 5-HT1B/D agonist currently approved as a single agent for the acute treatment of migraine. AXS-07 is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence

Learn more about AXS-07 and our target indications.

AXS-09

AXS-09 is a novel, oral medicine consisting of chirally pure esbupropion and dextromethorphan being developed for the treatment of central nervous system disorders. Esbupropion is the S-enantiomer of bupropion, a dopamine and norepinephrine reuptake inhibitor and nicotinic acetylcholine receptor antagonist which also serves to increase the bioavailability of dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, an inhibitor of the serotonin and norepinephrine transporters, and a nicotinic acetylcholine receptor antagonist.

Learn more about AXS-09 and our target indications.

AXS-12

AXS-12 (reboxetine) is a novel, oral, investigational medicine in development for the treatment of the symptoms of narcolepsy. AXS-12 is a highly selective and potent norepinephrine reuptake inhibitor. AXS-12 is an investigational drug not approved by the FDA.

Learn more about AXS-12 and our target indications.


 


Management Team

Herriot Tabuteau, MD

Chief Executive Officer

Dr. Tabuteau has served as our founder, Chief Executive Officer, and Chairman of our board of directors since our founding in January 2012. Prior to founding our company, Dr. Tabuteau was a Senior Analyst and Partner at Healthco/S.A.C. Capital (now known as HealthCor) where he was responsible for the biotechnology, genomics, and instrumentation portfolios. Previously, Dr. Tabuteau was the healthcare analyst at Kingdon Capital. Prior to that position, Dr. Tabuteau was a Senior Research Analyst at Banc of America Securities covering the hospital supplies sector. Prior to Banc of America, Dr. Tabuteau was part of the healthcare investment banking group at Goldman Sachs. Dr. Tabuteau earned his M.D. from Yale University School of Medicine and his Bachelor of Arts in molecular biology and biochemistry from Wesleyan University.

Nick Pizzie, CPA, MBA

Chief Financial Officer

Mr. Pizzie has served as our Chief Financial Officer since May 2018. Prior to joining Axsome, Mr. Pizzie was the Vice President and Chief Financial Officer of Pierre Fabre USA, the U.S. affiliate of Pierre Fabre. Previously, he was Senior Finance Director at Immucor. Prior to Immucor, he held positions of increasing responsibility in finance and accounting at Merck and Pfizer. Mr. Pizzie began his career at Arthur Andersen, where he served as staff auditor. He earned his BS in Accounting, BA in Economics, and MBA in Finance, and Supply Side Logistics, from Rutgers University.

Cedric O’Gorman, MD, MBA

SENIOR VICE PRESIDENT, CLINICAL DEVELOPMENT AND MEDICAL AFFAIRS

Dr. O’Gorman has served as our Senior Vice President, Clinical Development and Medical Affairs since September 2017. Prior to joining Axsome, Dr. O’Gorman was the Vice President of Medical Affairs at Intra-Cellular Therapies since December 2014. Before that, he was the U.S. medical lead for psychiatry at Genentech/Roche. Prior to Genentech/Roche, he spent 5 years at Pfizer representing medical affairs on several branded neuroscience products including Geodon for schizophrenia and bipolar disorder, and Pristiq for major depressive disorder. Dr. O’Gorman received his medical degree from the National University of Ireland, in Galway, Ireland, trained at the Institute of Psychiatry, in London, England, and earned his Master of Business Administration from the New York University Stern School of Business.

Mark Jacobson

SENIOR VICE PRESIDENT, OPERATIONS

Mr. Jacobson has served as our Senior Vice President, Operations since September 2017 and has been a member of the Axsome team since April 2014. Prior to joining Axsome, he was Director of Corporate Development at Stemline Therapeutics, Inc., where he played a critical role in advancing the company from a 3-person team in 2010 to the successful completion of an initial public offering and secondary public offering in 2013, which together raised approximately $100 million for the company. While at Stemline, Mr. Jacobson’s responsibilities spanned investor relations, public relations, corporate operations, and intellectual property. Mr. Jacobson began his career in healthcare communications at Publicis Healthcare Communications Group. Mr. Jacobson earned a Master of Arts in Biotechnology from Columbia University and a Bachelor of Science in Biology from Iowa State University.




Anticipated Near-Term Clinical Milestones
 
Clinical Trial Readouts

•Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (late December 2017 to early January 2018)

•Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (late December 2017 to early January 2018)

•Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1H 2018)




7 x Phase 3 Programs in Pipeline 

AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions in Phase 3 (SPA & Fast Track) ---7M patients in the U.S.


AXS-02 CREATE-1 Complex regional pain syndrome (CRPS) in Phase 3 (Orphan+Fast Track Status) ---No approved drug = high unmet need. 80,000 new cases per year in the U.S.


AXS-02 Chronic Low Back Pain Associated with Modic Changes in Phase 3 ---1.6M patients in the U.S.


AXS-05 Agitation in patients with Alzheimer’s disease(AD) in Phase 2/3 ---No approved medication = unmet medical need. 2M patients in the U.S.


AXS-05 STRIDE-1 Treatment resistant depression in Phase 3 ---Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.


AXS-06(MoSEIC™ Mx + Eso) Acute and Chronic Pain Phase 3 Ready = 120M NSAID TRx per year in the U.S.



AXS-07 (meloxicam and rizatriptan) for the Treatment of Migraine Phase 3 Ready = Migraine attacks are disabling and affect more than 37 million Americans
 

Share Structure

Market Cap    
226,580,077       01/14/2019
Authorized Shares
150,000,000       09/28/2018
Outstanding Shares   
29,813,168         11/02/2018

https://axsome.com/company/about/




 
AXSM
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AXSM News: Current Report Filing (8-k) 09/24/2020 07:07:12 AM
AXSM News: Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced... 09/24/2020 06:00:10 AM
AXSM News: Current Report Filing (8-k) 09/21/2020 07:11:49 AM
AXSM News: Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Thera... 09/21/2020 07:00:10 AM
AXSM News: Axsome Therapeutics Announces AXS-07 Phase 3 Migraine Trial Results Selected by the American Academy of Neurology Science Com... 09/17/2020 07:00:10 AM
PostSubject
#359   I bought at 3, problem is I sold bigarena 06/29/20 04:20:04 PM
#358   Stock is a beast, to bad I didn't Johnny_C 04/29/20 01:45:10 PM
#357   This was a very very impressive comeback ... Johnny_C 04/28/20 03:56:30 PM
#356   Premarket is pretty bonkers. Trader's dream. chainma1l 04/27/20 09:27:13 AM
#355   AXSM > “I am very pleased to see crudeoil24 04/27/20 07:03:27 AM
#354   Going to be an extraordinary day. Great Basil22 04/27/20 06:31:03 AM
#353   Once again same old same old.....Great Day!! Basil22 04/24/20 03:45:28 PM
#352   Hate to be repetitive but another great day Basil22 04/17/20 06:50:43 PM
#351   Great day. Fighting to get back over $100. Basil22 04/08/20 02:51:13 PM
#350   Great news today for migraine sufferers and longs. Basil22 04/06/20 06:44:40 AM
#349   This stock will be back over $100 in Basil22 04/03/20 06:35:05 PM
#348   Great day following another great day. Go AXSM Basil22 03/20/20 01:31:53 PM
#347   Seeking Alpha article: chainma1l 02/12/20 11:52:28 AM
#346   Short volume over 5 million Seems to be Flying Albatross 01/10/20 01:57:29 PM
#344   Just bought into $AXSM February options. Very excited flyonthewall 01/06/20 12:44:13 PM
#343   "Results showed that AXS-07 met the two regulatory, chainma1l 12/31/19 11:48:49 AM
#342   Axsome Therapeutics Inc. AXSM topped the list of Paullee 12/31/19 10:50:40 AM
#341   Check out QBIO lets me know thoughts on Chrism0000 12/31/19 08:58:01 AM
#340   If the saga of mother Theresa provides hope 2H2 12/22/19 09:22:27 PM
#339   What is TDS? and Mother Theresa is not Cuppy 12/22/19 08:12:26 PM
#338   DYAI Paullee 12/22/19 10:06:08 AM
#337   PKTX SPORT19 12/22/19 07:51:43 AM
#336   I got into AXSM late--but at least I voisybay123 12/21/19 09:13:09 PM
#335   I only bought this thing because of millions pokerman000222 12/20/19 09:17:36 AM
#334   All I can say is WOW. What this Cuppy 12/19/19 11:27:24 AM
#333   Damn this exceeded my expectations. Congrats to all. grich1 12/19/19 11:10:07 AM
#332   Is today's offering part of the $80M mixed smallbio 12/18/19 04:14:10 PM
#331   Were they waiting for lunchtime to let it go? chainma1l 12/18/19 12:44:43 PM
#330   * * $AXSM Video Chart 12-16-2019 * * ClayTrader 12/16/19 05:24:09 PM
#329   I know you wish you would have waited kelskb 12/16/19 04:15:55 PM
#328   Can't even fathom what would happen if they chainma1l 12/16/19 09:59:16 AM
#327   Thx for the detail Incredible yr in this Whalatane 12/16/19 09:30:25 AM
#326   Wow. Gr8 results Congrats to all who stuck Whalatane 12/16/19 09:06:32 AM
#325   out is crazy overbought,make money people m1999 12/16/19 09:00:11 AM
#324   AXSM $86.00 going m1999 12/16/19 08:50:52 AM
#323   Oops the question marks were meant to be exclamations Manonb 12/16/19 08:24:34 AM
#322   Thank you for posting something meaningful ?? Manonb 12/16/19 08:23:43 AM
#321   This is really good news not only for smallbio 12/16/19 08:21:12 AM
#320   $80.00 on the table m1999 12/16/19 07:48:32 AM
#319   AXSM~~$79.00 m1999 12/16/19 07:41:24 AM
#318   who cares lol m1999 12/16/19 07:40:50 AM
#317   Too much posting! Manonb 12/16/19 07:30:55 AM
#316   AXSM 66%% up ,nice morning here m1999 12/16/19 07:22:25 AM
#315   AXSM 77.50 lets see $80.00 m1999 12/16/19 07:20:35 AM
#314   AXSM~~$73.00 baby,looks awesome m1999 12/16/19 07:03:16 AM
#313   AXCM~~$73.00 baby,looks awesome m1999 12/16/19 07:02:52 AM
#312   AXCM $47.00 m1999 12/16/19 06:49:49 AM
#311   Nothing like waiting until the last minute. chainma1l 12/11/19 06:03:05 PM
#310   This thing ain't exactly boring to me........... pokerman000222 12/03/19 07:34:20 PM
#309   I bought for $4 and sold for $28 rkrudt 12/03/19 11:23:11 AM
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