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Ladenburg Thalmann raised its price target on Axsome Therapeutics (NASDAQ: AXSM) to $31.00 (from $28.00) while maintaining a Buy rating. July 26, 2017 6:48 AM EDT
https://www.streetinsider.com/Analyst+Comments/Axsome+Therapeutics+(AXSM)+PT+Raised+to+%2431+at+Ladenburg+Thalmann/13129605.html
Analyst Matt Kaplan comments "Interim Phase 3 data for CRPS is expected in 4Q17, with AXS-02 potentially being initially launched in the US in 2019, and other indications following in later years. We estimate AXS-02 can achieve $150 million in revenue in CRPS, with other pain indications also adding materially. At peak, we estimate AXS-02 can reach $600 million."
Good News out today
AXSM = Market Cap $134 Million / $50 Million Cash / Low foat / 6x Phase 3 Programs in different indications targeting large markets 4 of them are active and the other 2 are ready for Phase 3 = very attractive Investment = Strong Buy
up she goes again
Hit $2 today and market cap is still very low with $22 milion which is close to cash balance of $17 million
The $2 Mark is coming closer and closer
KTOV = Mcap $16 Mil/Cash $17 Mil / O/S 10.6 M / NDA submission for an attracive Drug this Quarter = Could be the next 10 Bagger here
Kitov Pharma (KTOV)
Market Cap: $17 M
Cash $17 M
Price: $1.50
Shares Out: 10.6 Million
Presentation June 2017
http://kitovpharma.investorroom.com/download/KitovPresentation+June+2017+FINAL.pdf
Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
https://baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdf
Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Products
Kitov’s current pipeline products, KIT-301 and KIT-302, are combination drugs that treat OA pain and HTN simultaneously. In December 2015, KIT-302 successfully achieved the primary efficacy endpoint for its Phase III clinical trial. In August 2016, the United States Patent Office issued a patent covering KIT-302.
Market
Of the 27 million Americans with OA, 50% also suffer from HTN, which is also a common side effect of stand-alone OA drugs. With no single medication currently treating both conditions, KIT-301 and KIT-302 are targeting this multi-billion dollar market.
look at unknown KTOV if you like another FDA play that could jump even higher than AEZS
KTOV = Market cap $17 M // Cash $17 M // NDA Submission for an attractive drug this quarter (more infos on KTOV board)
Up 7% looking good so far
Watch AEZS move today after NDA resubmission thats how KTOV could move and we have much better fundamentals and the way better product .
fully diluted O/S is 12 million so even at $10 per share this stock would havea market cap of around $100 million which is still ridiculous the most biotechs are valued at much higher valued with nothing to show for it .
looks like another great day and market cap isstillat laughable $17 million what a joke
i think this time they are on track with the support by parexel .
"The stock’s most recent catalyst was its announcement that it has begun the process of digitizing its New Drug Application (NDA) for KIT-302, its lead drug candidate, through Parexel International Corporation, a clinical research organization, which has been engaged by Kitov for the preparation of the NDA into the standard, accepted electronic format of the U.S. Food and Drug Administration (FDA)."
$10++ stock with fda approval in 2018 ,and there are in discussion with pharmas who are interested in the drug so any new partnerships could also push the sp higher .
KTOV (MC $16 M) (Cash $17 M) US-NDA Submission for their osteoarthritis pain and hypertension drug exptected this Quarter. This ultra low float stock will be one of the hottest and most underpriced FDA play i ever have seen in last 20 years in stock trading. KTOV has really more than 10 bagger potential the stock is trading at cash level and the valuation is ONLY $16 Million i cant believe it but please do your own dd and realize the brutal potential here .Im so in and GL
Kitov Pharma (KTOV)
Market Cap: $16 Million
Cash $17 Million
Price: $1.44
Shares Out: 10.6 Million
Kitov Updates on KIT-302 New Drug Application http://kitovpharma.investorroom.com/news-releases?item=50
Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.
Presentation June 2017
http://kitovpharma.investorroom.com/download/KitovPresentation+June+2017+FINAL.pdf
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
https://baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdf
Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
Kitov Received a $2 Million Filing Waiver from FDA http://kitovpharma.investorroom.com/news-releases?item=46
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
KTOV (MC $16 M) (Cash $17 M) US-NDA Submission for their osteoarthritis pain and hypertension drug exptected this Quarter. This ultra low float stock will be one of the hottest and most underpriced FDA play i ever have seen in last 20 years in stock trading. KTOV has really more than 10 bagger potential the stock is trading at cash level and the valuation is ONLY $16 Million i cant believe it but please do your own dd and realize the brutal potential here .GL
Kitov Pharma (KTOV)
Market Cap: $16 Million
Cash $17 Million
Price: $1.44
Shares Out: 10.6 Million
Kitov Updates on KIT-302 New Drug Application http://kitovpharma.investorroom.com/news-releases?item=50
Kitov expects that the formal filing of the NDA by the FDA will occur by the end of the third quarter of 2017.
Presentation June 2017
http://kitovpharma.investorroom.com/download/KitovPresentation+June+2017+FINAL.pdf
KIT-302 is a combination drug that treats osteoarthritis pain and hypertension simultaneously
Primary efficacy endpoint achieved Lead drug candidate KIT-302 achieved its primary efficacy endpoint in a pivotal Phase III trial
Marketing potential Pipeline candidates address large, multi-billion dollar markets
Kitov Pharmaceuticals Initiates NDA Filing for KIT-302 as a Treatment for Osteoarthritis and Hypertension
https://baystreet.ca/articles/research_reports/lifesci/Kitov062717.pdf
Kitov Expects to Submit an NDA for KIT-302 in the Third Quarter 2017.Kitov announced that it began the process of compiling the documents necessary to file an NDA for its lead asset KIT-302 as a treatment for patients who experience both osteoarthritis and hypertension. The Company hired Parexel International Corporation, a clinical research organization, to digitalize and formally submit its NDA application. Kitov expects the filing to occur during the third quarter of 2017, with a potential FDA approval during the second quarter of 2018.
Kitov Received a $2 Million Filing Waiver from FDA http://kitovpharma.investorroom.com/news-releases?item=46
Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV, TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
ACRX Gains On Coming Catalyst
As mentioned above, AcelRx is having an incredibly strong day in the market today, and for good reason. A report pointed out that the company is undervalued and has a massive catalyst on the horizons.
On the valuation side of the equation, the argument is a very simple one. While the company has an average price of under $3 per share, they have assets worth far more than that. In fact, the company actually has $1.59 per share in cash alone.
Perhaps most importantly, there are two big catalysts coming surrounding the stock. First and foremost, the company has a treatment known as Dsuvia that is pending approval by the FDA. The PDUFA date for this potential approval comes in October. On top of that, there's Phase 3 data that will soon be released surrounding Zalviso. That data is expected to be released by the end of July. The value of these treatments, if they make it to the market, is incredibly high. In fact, it is estimated that ACRX could reach peak revenue from these treatments in the amount of $1.7 billion annually if all goes well.
Any dip is a great buying opp here before the bigmilestones hit the wire
Nice jump in Pre-Mkt and we are just days away before phase 3 results will be released and 3 months before FDA decision so there is good chance for a run close or maybe even over $10 .GL
Upcoming Major Milestones
Zalviso Phase 3 Results in July 2017
DSUVIA PDUFA Date October 12, 2017
Zalviso NDA Resubmission in Q4 2017
DSUVIA CHMP Opinion in 1H 2018 (EU Approval)
Zalviso FDA approval expected in Q2 2018
AcelRx: Undervalued Heading Into A Phase 3 Catalyst....Jul.16.17
https://seekingalpha.com/article/4087901-acelrx-undervalued-heading-phase-3-catalyst
Summary
AcelRx is a relatively unknown biotech company focused on the development and eventual commercialization of treatments for moderate-severe acute pain.
Shares are trading at $2.40 while the company has $1.59/share in cash alone, assuming they maintain their cash burn rate, they should have enough cash to last until early 2019.
Peak annual sales for both Dsuvia and Zalviso could exceed $1.7 billion annually, both drugs have near-term binary catalysts which will decide the fate of AcelRx.
Zalviso has already conducted three positive phase 3 trials and will be reporting topline data from a 4th by the end of July, Zalviso is already approved in the EU.
With such a low market cap of 100 million and annual drug sales which could potentially exceed $1.5 billion in the future, AcelRx offers an asymmetric risk/reward ratio for investors.
Investment Thesis
AcelRx (ACRX) shares are deeply undervalued, the true potential of their pipeline is not being priced into the share. Shares are currently trading at $2.40 giving AcelRx a market cap of $104.07 million while they have over $72 million in cash and cash equivalents alone. Their pipeline consists of two drugs which are in late stage development, Zalviso and Dsuvia. Dsuvia is pending FDA approval in October and there is a phase 3 data readout for Zalviso due by the end of July, these two drugs have combined annual peak sales revenue of $1.7 billion. It simply makes no sense for AcelRx shares to be trading at such a low valuation when both drugs are so close to approval; if both catalysts go well, shareholders will be greatly awarded. If the Zalviso data is not good, then there is still the upcoming FDA approval decision on Dsuvia to look forward to, AcelRx's strong cash position should also provide cushion for shareholders in case of bad news. The bottom line is that AcelRx shares are deeply undervalued and overlooked by the market, the current valuation of AcelRx by the market has created a very compelling opportunity which has low risk relative to the potential return for investors.
AcelRx Pharmaceuticals: Blockbuster Potential Makes This $2 Stock A Strong Buy For 2017
https://seekingalpha.com/article/4035751-acelrx-pharmaceuticals-blockbuster-potential-makes-2-stock-strong-buy-2017
In a research report issued Friday, Jefferies analyst Matthew Andrews assumed coverage on shares of AcelRx Pharmaceuticals Inc (NASDAQ:ACRX), with a Buy rating and a $7.00 price target, which implies an upside of 208% from current levels.
In early June 2017, the FDA canceled a tentative joint Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management Advisory Committee meeting in connection with its review of the Company’s New Drug Application (NDA) for DSUVIA for the treatment of moderate-to-severe acute pain. Andrews believes the reason in part has to do with the uncontroversial product profile; thus the analyst believes Dsuvia will be approved on its October 12, 2017, PDUFA date.
"While the FDA under Dr. Gottlieb is focused on addressing the U.S.’s opioid crisis, we believe this will largely focus on the appropriate use and duration of chronic (not acute) opioid therapy. The CHMP’s decision on the Dsuvia MAA in Europe is expected in H1 2018, and the EMA has already approved Zalviso (a 15mcg tablet of sufentanil). We probability weight our U.S. and Europe Dsuvia estimates at 75% and 80%, respectively," Andrews said.
The analyst concluded, "ACRX is under-valued due to potent oral opioid Dsuvia's promise in medicallysupervised acute pain markets (~92M patients) and we see high likelihood of U.S./EU approvals in Q4'17/H1'18. Risk/reward is favorable into H1'18 with floor of ~$1.25 (no approvals) vs. $12/share (upside scenario)."
https://finance.yahoo.com/news/jefferies-sees-strong-upside-acelrx-145225845.html
$3-4.50 on positive phase 3 reults which expected this month and could run to $10 with FDA approval in october .
FDA Decision in October for potential Blockbuster and Phase 3 readout this month for another Drug = SUPER HOT AND DIRRT CHEAP FDA GEM
ACRX (MC $97 M) Cash $72 M / FDA Decision on Oct 12 / P3 results this month...Im in as well guys love it .
Very attractive and dirt cheap FDA Play .....
ACRX has 2 Products including potential Blockbuster under review by FDA and MAA (Europe) . Upcoming Milestones : Zalviso (Pain) final Phase 3 results this month // DSUVIA (Pain) with FDA Decision on October 12 and EU approval likely in 1H 2018 . If everything goes well this low float stock could move close or above $10 in the coming months . GL
AcelRx Pharma (ACRX)
Market Cap $97.5 Million
Cash: $72 Million
Price $2.15
Shares Out: 45 Million (more than half of that held alone by insiders and institutions)
Anticipated Upcoming 2017 Milestones:
Top-line data results from the IAP312 clinical study in mid-2017.
Joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee for DSUVIA this summer.
FDA decision on the NDA for DSUVIA this fall.
Resubmission of ZALVISO® NDA by year-end.
Biotech Catalyst Play: AcelRx Pharmaceuticals Inc (NASDAQ:ACRX)
https://insiderfinancial.com/biotech-catalyst-play-acelrx-pharmaceuticals-inc-nasdaqacrx
There is what we are watching out for.
So, the first catalyst, the July catalyst, derives from an ongoing phase 3 study of a drug called Zalviso.
So that is the first catalyst; for the second one we have to move to the start of the final quarter, specifically, October.
In parallel to Zalviso, AcelRx is also trying to get a drug called DSUVIA approved in the US. This one is also a pain drug, this time designed for the treatment of moderate-to-severe pain in a medically supervised setting. The company submitted an NDA for the asset at the end of last year and, in February this year, the FDA accepted the submission for consideration. On acceptance, the agency set a PDUFA day of October 12, 2017, meaning it will make a decision as to whether it is willing to approve the drug before or on that date.
While Zalviso is our near-term catalyst, the DSUVIA decision probably holds more weight from a valuation perspective. Why? Because peak sales for this one are estimated at a little over $1.1 billion in the US alone. If FDA gives a green light for commercialization to the asset, therefore, the company could have a blockbuster drug on its hands. Combine that with the close to $400 million in revenues potential from Zalviso, and AcelRx could very justifiably become a multibillion-dollar biotech company before the end of the decade.
Investor Presentation (Juni)
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjczNjExfENoaWxkSUQ9MzgxNTY1fFR5cGU9MQ==&t=1
STRONG Insider & Institutional Ownership:
Three Arch Partners 9 367 041
Perceptive Advisors LLC 4 533 728
BlackRock Fund Advisors 2 032 631
The Vanguard Group, Inc. 1 539 535
Palo Alto Investors LLC 1 032 715
SSgA Funds Management, Inc. 512 877
Pamela Pierce Palmer MD, PhD 405 801
Northern Trust Investments, Inc. 366 387
Bridgeway Capital Management, Inc. 244 150
Oppenheim Asset Management Services SARL 232 341
ACRX (MC $97 M) Cash $72 M / FDA Decision on Oct 12 / P3 results this month...Im in as well guys love it .
Very attractive and dirt cheap FDA Play .....
ACRX has 2 Products including potential Blockbuster under review by FDA and MAA (Europe) . Upcoming Milestones : Zalviso (Pain) final Phase 3 results this month // DSUVIA (Pain) with FDA Decision on October 12 and EU approval likely in 1H 2018 . If everything goes well this low float stock could move close or above $10 in the coming months . GL
AcelRx Pharma (ACRX)
Market Cap $97.5 Million
Cash: $72 Million
Price $2.15
Shares Out: 45 Million (more than half of that held alone by insiders and institutions)
Anticipated Upcoming 2017 Milestones:
Top-line data results from the IAP312 clinical study in mid-2017.
Joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee for DSUVIA this summer.
FDA decision on the NDA for DSUVIA this fall.
Resubmission of ZALVISO® NDA by year-end.
Biotech Catalyst Play: AcelRx Pharmaceuticals Inc (NASDAQ:ACRX)
https://insiderfinancial.com/biotech-catalyst-play-acelrx-pharmaceuticals-inc-nasdaqacrx
There is what we are watching out for.
So, the first catalyst, the July catalyst, derives from an ongoing phase 3 study of a drug called Zalviso.
So that is the first catalyst; for the second one we have to move to the start of the final quarter, specifically, October.
In parallel to Zalviso, AcelRx is also trying to get a drug called DSUVIA approved in the US. This one is also a pain drug, this time designed for the treatment of moderate-to-severe pain in a medically supervised setting. The company submitted an NDA for the asset at the end of last year and, in February this year, the FDA accepted the submission for consideration. On acceptance, the agency set a PDUFA day of October 12, 2017, meaning it will make a decision as to whether it is willing to approve the drug before or on that date.
While Zalviso is our near-term catalyst, the DSUVIA decision probably holds more weight from a valuation perspective. Why? Because peak sales for this one are estimated at a little over $1.1 billion in the US alone. If FDA gives a green light for commercialization to the asset, therefore, the company could have a blockbuster drug on its hands. Combine that with the close to $400 million in revenues potential from Zalviso, and AcelRx could very justifiably become a multibillion-dollar biotech company before the end of the decade.
Investor Presentation (Juni)
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjczNjExfENoaWxkSUQ9MzgxNTY1fFR5cGU9MQ==&t=1
STRONG Insider & Institutional Ownership:
Three Arch Partners 9 367 041
Perceptive Advisors LLC 4 533 728
BlackRock Fund Advisors 2 032 631
The Vanguard Group, Inc. 1 539 535
Palo Alto Investors LLC 1 032 715
SSgA Funds Management, Inc. 512 877
Pamela Pierce Palmer MD, PhD 405 801
Northern Trust Investments, Inc. 366 387
Bridgeway Capital Management, Inc. 244 150
Oppenheim Asset Management Services SARL 232 341
Here Are Three Near Term Catalysts To Watch From IntelGenx Technologies Corp
https://insiderfinancial.com/intelgenx-technologies-corp-otcmktsigxt-has-a-july-full-of-catalysts
With 2 NDA submissions within weeks + Partnership and FDA approvals in 1H 2018 this stock could run to minimum $3 and thats a conservative number .
i see the fair vaulue right now at around $4-5 with FDA approvals the sky is the limit .
hmm RALLYYYYYYYYYYYYYYYYYYYYYy
Looks like big breakout is around the corner ----
IntelGenx Receives USPTO Notice of Allowance for Oral Film Dosage Form Technology Patent
http://www.marketwired.com/press-release/intelgenx-receives-uspto-notice-allowance-oral-film-dosage-form-technology-patent-otcqx-igxt-2223907.htm
IGXT (MC $54 M) 2 NDA submission + Partnership imminent / Profitable in 2018 /well financed untill profitability expected next year /Lots of BIG News on the way (see below) = 10 Bagger Gem .GL
Upcoming Milestones:
NDA submission for tadalafil (erectile dysfunction) thin-film version of Blockbuster drug Cialis in June or July
NDA resubmission for Rizaport (migraine) in early Q3
Start Phase 2a of Montelukast (Alzheimer Disease ) potential Blockbuster
Partnership for Tadalafil could come anytime now
Partnership for Rizaport for EU and USA could also happen anytime now
Monster Pipeline
http://s2.q4cdn.com/790425727/files/design/IntelGenx-Product-Portfolio-and-Pipeline-June-2017.xlsx.jpg
IntelGenx has multi-faceted BD approach for its oral films May 16, 2017
http://www.biotuesdays.com/features/2017/5/11/intelgenx-has-multi-faceted-bd-approach-for-its-oral-films
IntelGenx previously confirmed the bioequivalence of Tadalafil to Eli Lilly’s Cialis, which had sales of $1.5-billion in 2016 but faces generic competition in 2020. IntelGenx has an exclusive license for oral films from Lilly for its dosing patent, which would allow Tadalafil to enter the ED market in the U.S. free from patent litigation from Lilly. Dr. Matzen explains that Tadalafil, which offers a discrete dosing alternative, could enter the market in 2018, with up to three years of market exclusivity before Cialis is hit with generic competition.
just a few cents and we will break the $1 mark which is a multiple year high
it wouldnt only a catalyst it will be a monster catalyst because the suboxone film has huge market potential .
looks like breakout is in the making ,looking great so far
Heavily undervalued stock and with so many big milestones on the way
Market cap $55 million
Upcoming Milestones:
NDA submission for tadalafil (erectile dysfunction) thin-film version of Blockbuster drug Cialis in June or July
NDA resubmission for Rizaport (migraine) in early Q3
Start Phase 2a of Montelukast (Alzheimer Disease ) potential Blockbuster
Partnership for Tadalafil could come anytime now
Partnership for Rizaport for EU and USA could also happen anytime now
nice consolidation after the move in last days next leg up could drive it $1+
$5 is coming very close , good results will push this low float gem close or above $10 in the blink of an eye .GL
Should You Invest In Axsome Therapeutics? Monday, May 8, 2017
http://www.talkmarkets.com/content/stocks--equities/should-you-invest-in-axsome-therapeutics?post=134346
Final Thoughts
Axsome is very interesting to me. The company has four active Phase 3 clinical trials with two drug candidates. AXS-05 targets a host of mechanisms in the CNS that are clinically and commercially proven to be effective for the treatment of depression and agitation. The concept with AXS-05 is that dextromethorphan is pretty darn effective in treating depression, but has such poor bioavailability that it is hardly used. Bupropion synergistically improves the uptake of BM while providing baseline antidepressant effects. AXS-02 is an oral formulation of a well know bisphosphonate known to improve pain in CRPS and knee OA.
I like the fact that Axsome has good insider ownership, plenty of cash, drugs with proven mechanisms of action, strong IP, and plenty of catalysts. Data from COAST-1 is expected in the Q3-2017. That's the first catalyst up for the company. CREATE-1 and STRIDE-1 are up in the Q4-2017 and Q1-2018, respectively. If the company goes 3-for-3, this stock will be north of $15.
-------------------
Recommendation by Aegis (TGT $20):
Aegis Capital has reiterated a ‘Buy’ rating and price target of $20 on Axsome Therapeutics (NASDAQ: AXSM) after the company reported financial results for the quarter ended March 31, 2017. The analyst noted that although Axsome reported revenue in-line with consensus estimates, the focus remains on upcoming catalysts such as the company’s ongoing clinical trials. Since February 2017, the company’s AXS-05 has received fast track designation from the FDA for the treatment of Alzheimer’s disease (AD) agitation and treatment resistant depression (TRD). Topline data from the TRD treatment study is expected in the first quarter of 2018. Additionally, Axsome is developing AXS-02 in three separate phase 3 clinical programs, including chronic low back pain associated with modic changes and complex regional pain syndrome, with interim data expected in the fourth quarter of 2017, as well as knee osteoarthritis associated with bone marrow lesions, with interim data expected in the third quarter of 2017.
-----
Recommendation by BTIG (TGT $14 ):
Axsome Therapeutics initiated with a Buy at BTIG BTIG analyst Robert Hazlett started coverage of Axsome with a $14 price target and a Buy rating. The analyst says that the company's AXS-05 combination is unique and could treat a number of disorders. He notes that data on the combination's impact on treatment-resistant depression is due in early 2018. Tgh analyst adds that the company's AXS-02 drug "is a novel approach to the treatment of pain," and reports that data on the drug is due out in Q3 and Q4.
-----
Axsome Therapeutics: ~$4 Biotech Stock A Worthy Investment? May 15 ,2017
https://seekingalpha.com/instablog/498952-bret-jensen/4989021-axsome-therapeutics-4-biotech-stock-worthy-investment
$1++ coming
the market like the news
There are NO approved drugs for AD agitation if AXS-05 is successfull in phase 3 then it is a potential Blockbuster . Acadia (ACAD) which has a valuation of above $3 billion also working on this indication but there 2-3 years behind Axsome .
http://axsome.com/axs-05/agitation-in-patients-with-alzheimers-disease-ad/
There are currently no therapies approved by the FDA for the treatment of agitation in patients with AD.
Alzheimer’s Disease Agitation (AD Agitation)
According to the Alzheimer’s Association, around 5.4 million people in the United States are living with Alzheimer’s disease and approximately half are diagnosed with the disease. Studies suggest that 40 to 50 percent of patients diagnosed with Alzheimer’s disease in the United States exhibit agitation. AD Agitation is characterized by verbal aggression, physical aggression, and excessive motor activities. These behavioral symptoms have been associated with more rapid cognitive decline, greater caregiver burden, and earlier institutionalization.
Great new Director, she really must like what she sees at Axsome ...
Axsome Therapeutics Appoints Myrtle Potter to its Board of Directors
https://finance.yahoo.com/news/axsome-therapeutics-appoints-myrtle-potter-110000754.html
Ms. Potter was President, Commercial Operations and Chief Operating Officer of Genentech from 2000 to 2005, where she also served on the Executive Committee and was Co-Chair of the Product Portfolio Committee. At Genentech Ms. Potter led the commercialization of a number of products including Avastin™, Rituxan™, Herceptin™, Tarceva™, Xolair™, Nutropin™, Activase™, and TNkase™. Prior to joining Genentech, Ms. Potter was President of Bristol-Myers Squibb’s $3.5 billion, 3,500-person U.S. Cardiovascular and Metabolic Business. Before Bristol-Myers Squibb, Ms. Potter worked at Merck & Co. for fourteen years in roles of increasing responsibility, including Vice President of an $800 million U.S. pharmaceutical business unit. While at Merck, she started the joint venture entity Astra Merck, which through merger, later became AstraZeneca. She began her career with Procter and Gamble Patient Care Products.
About Myrtle Potter
http://myrtlepotterconsulting.com/myrtle-potter-and-company/myrtle-potter/