|Bid||9.20 x 1800|
|Ask||9.47 x 2900|
|Day's Range||9.21 - 9.89|
|52 Week Range||1.94 - 10.80|
|Beta (3Y Monthly)||3.55|
|PE Ratio (TTM)||N/A|
|Earnings Date||Mar 5, 2019 - Mar 11, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||23.25|
Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design, endpoints, and statistical approach of the planned MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase 3 trial of AXS-07 (MoSEIC™ meloxicam and rizatriptan) in the acute treatment of migraine. MOMENTUM will enroll only patients with a history of inadequate response to prior migraine treatments.
Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, has initiated the CONCERT (Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment) study, a Phase 2, randomized, controlled trial of AXS-12 (reboxetine) in narcolepsy. AXS-12 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. Topline results from the CONCERT trial are expected in the second quarter of 2019.
The tiny pharma company splashed onto the radar of investors this week with great trial results, but a maturing drug pipeline has one inescapable downside.
HENDERSON, NV / ACCESSWIRE / January 9, 2019 / Markets are rallying in first full market week of 2019 and the biotech sector is responding as many oversold small caps are starting to rebound. We've found ...
The move to get patients out of doctors offices and hospitals quickly using virtual care and remote monitoring is underway. Technology is enabling the switch, and few subsectors have benefitted more than remote cardiac care. Companies like Biotelemetry (BEAT) have grown by leaps and bounds in the last few years as their proprietary remote cardiac monitoring devices have gained traction.
As of January 8, Axsome Therapeutics (AXSM) is trading at $8.24, 19.87% higher than its previous closing price. On January 7, Axsome Therapeutics issued a press release announcing positive results from its Phase 2 ASCEND trial, which evaluated the investigational therapy AXS-05 compared to bupropion in major depressive disorder indications. Based on its closing price on January 7, the company had reported returns of 215.14% in the last week, 114.69% in the last month, and 95.17% in the last quarter.
The tiny pharma company reported promising results in a study for its lead drug candidate, eliciting comparisons to a reputable high-flying peer.
For a year, shares of Axsome Therapeutics, Inc. (NASDAQ:AXSM) traded in a range of between of between $2.00 to $3.00. That changed on Jan. 7 when the stock rallied by 161%, closing at $6.87. On Jan. 8, AXSM stock is trading hands at $8.22 per share, as of this writing. Markets reacted to the company's positive Phase 2 results. The big question for those who missed the rally is: Could AXSM end up like so many other small-cap biotech stocks and drop? To answer that, investors need to dig into the trial results, the potential of a product launch to market and Axsome's balance sheet health. Axsome reported results of AXS-05, a study distributing two different doses to patients suffering from major depressive disorder ranging from moderate to severe. Subjects had a 17.2 point drop in the Montgomery-Asbert Depression Rating Scale. The statistically significant superiority over active comparator had a six-week treatment period and involved 80 adult patients. InvestorPlace - Stock Market News, Stock Advice & Trading Tips To put it simply, this is just an orally available combination of bupropion and dextromethorphan. ### Market Size for Treating Depression Investors buying AXSM stock and sending it sharply higher have a good reason to be bullish. The market size of the global anxiety disorder and depression market could reach $18.3 billion by 2023. TAM, or Total Addressable Market, is massive relative to Axsome Therapeutics' current market cap size of $208.71 million. And this is after the stock's surge. * The 7 Best Stocks in the Entrepreneur Index TAM is also a fallacy that could trick investors into believing the revenue potential for the company will ever reach 100% of that $18.3 billion. The upside potential is not even gaining a small fraction of that share. The realistic upside for Axsome is getting an approved drug to market and consistently growing the patient base prescribed for treatment. Professor Maurizio Fava, Harvard Medical School said "Data show currently marketed antidepressants fail to provide adequate treatment response in about two-thirds of treated patients. An estimated 16 million Americans suffer from major depressive disorder each year. As an oral NMDA receptor antagonist with multimodal activity, AXS-05 could provide a new approach to treating this potentially life-threatening condition." ### How The Drug Works AXS-05 is a glutamate receptor modulator that is thought to help enhance synaptic connections. If communication between brain cells improves, brain levels of key chemicals will go up. This includes serotonin, noradrenaline and dopamine. ### Study Results Promising The study measured patient response through a rating depression rating scale and did not look at any chemical levels in the body or brain. Still, the results allow the company to build on the Phase 3 trial that studies treatment-resistant depression. It also benefits the Phase 2/3 trial of the drug in Alzheimer's disease agitation. ### Financial Risks Cash balance and cash flow are the two key metrics investors should look at for companies like Axsome Therapeutics. The company raised cash levels in FY 2015 by $48 million. In its most recent September quarter, that cash level fell to $15 million. Axsome made no meaningful revenue from FY 2013, so cash flow from operations was negative. Losses increased steadily in that time, probably due to the higher costs from running clinical studies: In $ millions 13-Dec 14-Dec 15-Dec 16-Dec 17-Dec LTM 17-Sep 18-Sep Net Income / (Loss) -2 -6 -12 -27 -29 -29 -22 -21 Source: finbox.io After the market closed, the company announced it raised $23.3 million. This is through a 2.88 million share sale. ### Your Takeaway Axsome Therapeutics is a high-risk play, especially after the stock's run-up. Shareholders who held the stock for years may sell to lock in the quick gains. And speculators that caught wind of the study's positive results may trade the stock's bounce in the next few sessions. With higher volatility ahead, buying the stock now is risky. Yet if buying momentum does not drop and selling is absent, then Axsome could reward traders holding the stock. The biggest potential headwind for AXSM stock is the 2.88 million share sale. Management clearly capitalized on the stock's rally to raise funds. As a value investor in the biotech space, there is nothing wrong with buying only companies that are cash flow positive. This usually means that the conservative investor type would avoid AXSM stock at this time. As of this writing, Chris Lau did not hold a position in any of the aforementioned securities. ### More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 Stocks to Buy Down 20% in December * 5 Chinese Stocks to Avoid Now (But Buy Later) * 3 Big Gainers That Easily Could Be the Best Stocks to Buy Compare Brokers The post Axsome Therapeutics: Do Not Buy AXSM Stock After Its Monster Rally appeared first on InvestorPlace.
HENDERSON, NV / ACCESSWIRE / January 8, 2019 / Celgene's major deal with Bristol-Myers Squibb seems to have woken up the sleeping giant that is the biotech market. Axsome announced positive trial data ...
Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peak (Biotech Stocks Hitting 52-week highs on Jan. 7) Axsome Therapeutics Inc (NASDAQ: AXSM ) ( reported positive ...
Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, announced that today it raised approximately $23.3 million through the sale of 2,881,066 shares under its existing at-the-market (ATM) facility with Leerink Partners LLC. Axsome intends to use the proceeds from this offering to continue to fund the ongoing clinical development of its late stage product candidates and for other general corporate purposes, including funding existing and potential new clinical programs and product candidates.
Axsome Therapeutics (NASDAQ:AXSM) stock was flying high on Monday following some good AXSM news. The new bit of AXSM news from the company that has Axsome Therapeutics stock on the rise today has to do with recent results from a study. This comes from a Phase 2 trail of using its AXS-05 to treat major depressive disorder. The Phase 2 trail saw Axsome Therapeutics distributing two different doses of AXS-05 to patients with major depressive disorder ranging from moderate to severe. This includes 45 mg dextromethorphan or 105 mg of the active comparator bupropion twice a day for six weeks. InvestorPlace - Stock Market News, Stock Advice & Trading Tips The good AXSM news from the Phase 2 trial is that AXS-05 was able to meet its primary endpoints. This saw 17.2 point reduction on the the Montgomery-Åsberg Depression Rating Scale. In comparison, patients on bupropion saw a 12.1 point reduction on the same scale. Axsome Therapeutics also notes that AXS-05 also worked more quickly in patients that bupropion did. This includes patients seeing significant improvement as soon as the second week of taking the drug. Also among the AXSM news is that patients taking AXS-05 didn't suffer from any serious adverse events during the trial. Side effects of the drug that did occur were nausea, dizziness, dry mouth, decreased appetite, and anxiety. * 9 A-Rated Safety Stocks for a Grossly Oversold Market "These results build on the positive interim futility analyses for the Phase 3 trial of AXS-05 in treatment resistant depression and the Phase 2/3 trial of AXS-05 in Alzheimer's disease agitation," Herriot Tabuteau, MD, CEO of Axsome Therapeutics, said in a statement. AXSM stock was up 185% as of Monday afternoon. ### More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 10 Top Stock Picks From the Street's Best Analysts * 7 Tech Stocks Without China Exposure * 5 Strong-Buy Stocks That Crushed 2018 As of this writing, William White did not hold a position in any of the aforementioned securities. Compare Brokers The post AXSM News: Why Axsome Therapeutics Stock Is Skyrocketing Today appeared first on InvestorPlace.
CORAL GABLES, FL / ACCESSWIRE / January 7, 2019 / The healthcare industry is predicated on the notion that as diseases become more advanced and difficult to treat, companies responsible for creating treatment options will rise to the occasion to assist patients suffering from said ailments. Given that the world's population is consistently increasing, and resources are diminishing, access to healthcare presents a dire need for consumers on a global scale. As healthcare companies work to develop new methods for bettering the care provided to their patients, the industry, in its entirety, will unite to meet the demands and needs of consumers in the space looking for qualitative healthcare.
Shares of Axsome Therapeutics Inc. rocketed 164% in very active premarket trade Monday, after the biopharmaceutical company developing therapies to treat central nervous system disorders said a phase 2 trial of its AXS-05 met its primary endpoint, and "significantly improved symptoms of depression." Trading volume ballooned to about 1.5 million shares, already about 5-times the full-day average of about 306,000 shares, and enough to make the stock the most actively traded ahead of the open. The company said AXS-05 met the primary endpoint by demonstrating a "highly statistically significant reduction" in the Montgomery-Asberg Depression Rating Scale total score. The company said ASX-05 was also safe and well tolerated, with no serious adverse events. The stock had tumbled 28% over the past three months through Friday, while the iShares Nasdaq Biotechnology ETF had lost 12.0% and the S&P 500 had declined 12.3%.
Demonstrated statistically significant improvement in MADRS scores compared to active comparator (p
CORAL GABLES, FL / ACCESSWIRE / December 31,2018 / This year has been a year which has seen significant market volatility, but the healthcare sector has managed to remain above the curve by constantly working to design and implement innovative approaches to medical care for patients suffering from a variety of serious illnesses. As experts and professionals in the field have worked on developing technologies to improvequality of care available for consumers, the healthcare industry, as a whole, has seen tremendous growth. Premier Health Group (PHGRF) (PHGI), Axsome Therapeutics Inc (AXSM), Marimed Inc (MRMD), and Marker Therapeutics Inc (MRKR) are 4 healthcare companies worth keeping tabs on as we head into the new year.
NEW YORK, Dec. 31, 2018 -- In new independent research reports released early this morning, Fundamental Markets released its latest key findings for all current investors,.
CORAL GABLES, FL / ACCESSWIRE / December 27, 2018 / With the new year less than one week away, the healthcare industry is effervescent with excitement as companies work towards designing new methods and technologies to dramatically improve care options available to consumers. Premier Health Group (OTC:PHGRF) (CSE:PHGI), BioXcel Therapeutics Inc (BTAI), Axsome Therapeutics Inc (AXSM), and Adial Pharmaceuticals are 4 healthcare stocks representing companies dead-set on fostering the best possible care options and products in their sector. Premier Health Group (OTC:PHGRF) (CSE:PHGI) is a company you may not have heard of, but may want to look into as they break new ground on inventive approaches to products and treatments previously determined to be unchangeable.
FDA clearance of IND received for Phase 2 trial of AXS-12 in narcolepsy Phase 2 results of AXS-05 in major depressive disorder on track for early January 2019 Phase 3 results.
Axsome Therapeutics, Inc. (AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will present a corporate overview at Biotech Showcase 2019 on Wednesday, January 9, 2019 at 10:00 AM Pacific Time. A live webcast and archive of the event can be viewed on the Company's website at www.axsome.com. 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.
NEW YORK, NY / ACCESSWIRE / December 11, 2018 / Wall Street bounced on Monday as optimism outweighed earlier losses caused by the U.S. - China trade dispute. Analysts expect the Federal Reserve to raise ...
Shares of Axsome Therapeutics Inc. surged about 24% premarket Monday, after the biotech, which specializes in therapies for central nervous system disorders, reported positive results in an interim analysis of a trial of a treatment for the agitation associated with Alzheimer's disease. An independent data monitoring committee (IDMC) recommended continuing the Phase 1/2 trial of AXS-05 and did not indicate any safety concerns. The company intends to follow the committee's recommendation. "We anticipate that implementation of the IDMC's recommendations may provide greater flexibility to our operating plans and timelines which we will evaluate in the coming weeks," Chief Executive Herriot Tabuteau said in a statement. Roughly 70% of Alzheimer's patients suffer from agitation, which can be highly upsetting for patients and caregivers. There is currently no approved treatment for the condition. Axsome shares have fallen 47% in 2018, while the S&P 500 has fallen 1.5%.