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its sanofi who has the license for the otc ,i think if there were a chance of otc approval then lilly would do it alone . Im sure that pfizer is wachting this so IF sanofi gets approval then i think pfizer will file a lawsuit .
the US pharma giant pfizer also tried to bring viagra on otc but they fail so why should the french company sanofi get approval ?
And even then intelgenx will do very well with their thin film version which is light years better than the tablets .
Wafer Viagra For Instant Results One of the big challenges for erectile dysfunction medicine manufacturers is to quicken the time between the application of the medicine and its response. Men want instant results when they take Viagra, Cialis or Levitra and complain that having to wait as much as thirty minutes before the active ingredient is effective can burst the bubble of spontaneity and passion which are often essential requirements of good sex. Well a solution could be at hand following research done by a Canadian research company called IntelGenx who have developed wafers [like the common breath freshness ones] that are designed to melt on your tongue which they say will get the medicine into your bloodstream around 30% faster than by using conventional tablets. IntelGenx say that because the mouth is lined with tiny blood vessels applying the wafer Viagra here can give a very fast application of the drug directly into the bloodstream. IntelGenx said that they would be conducting more clinical trials to corroborate this and they hoped to develop a whole range of fast acting wafer medications to treat not only erectile dysfunction but also pain relief, depression and hypertension. Sometimes men complain that if they have eaten a large meal it can take an even longer time for the Viagra, Cialis and Levitra to take effect. If on the other hand they made use of erectile dysfunction medication in a wafer form applied directly to the mouth and therefore bypassing their digestive system this problem would disappear. Using a wafer type of Viagra would also mean that you wouldn't have to go and get a glass of water in the middle of a passionate encounter in order to swallow your pill.
With a great partner for tadalafil then the numbers could be higher easily .
hi there
the $150 million was an estimate by ceo which he did i think 2 years ago but at that time there was no patent deal with eli lilly so maybe the sales potential is much much higher now . Partnership for Tadalafil could happen anytime now then we will know what IGXT will get of milestones and royalties .
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http://s2.q4cdn.com/790425727/files/doc_financials/2017/Q1/final-051117-intelgenx-corp-q1-2017-financial-results-18899915.pdf
Some of the ANDA applicants have already settled with Lilly, settled in the sense that they have greed to launch their generic product only at the expiry of this third patent, the dosing patent that we obtained a license for. That means that we have a pretty good chance to enjoy an extended period of excessivity once we’ve launched our product. Several companies have expressed interest in licensing the product. Term sheets(phon)have been submitted and are currently being reviewed and the due-diligence process has commenced.
yes once they submit the NDA to FDA in the coming days then it will start to attract new investors who will buy for the runup to the FDA decision .
Nice move today , News like Patent ruling regarding Par Pharma drug and NDA submission of Tadalafil expected within next 2-3 Weeks .
NDA submission for Tadalafil (erectile dysfunction) in June or July >> FDA approval in 1H 2018 (Peak Sales $120-150 Million)
NDA REsubmission for Rizaport(Migraine) in July or early August >>
FDA approval 1Q 2018 (Peak Sales $50-60 Million)
Patent ruling regarding the Par Pharma Drug (opioid dependence) in June 2017 >> Market Launch expected in 1H 2018 (Peak Sales $70-80 Million)
Start Phase 2a for Montulukast (Alzheimer disease) in June >> Phase 2a Results in 4Q 2017 (BLOCKBUSTER Candidate)
then what are you doing here just move on look for a better stock where is the problem .
Good News and more to come
IntelGenx Announces Issuance of US Patent for Topical Oral Film Technology
June 08, 2017
http://www.intelgenx.com/investors/press-releases/press-release-details/2017/IntelGenx-Announces-Issuance-of-US-Patent-for-Topical-Oral-Film-Technology/default.aspx
IntelGenX on the way to take some of the $16bn thin films market
https://investorintel.com/sectors/biotech/biotech-intel/intelgenx-thin-film-market/
IGXT ($46 M) 2 NDA Submission within 2 months this will make IGXT as one of the most attractive and underpriced fda play you can get at this time .
Market Cap $46 Million
Cash untill 2021+ (including convertible debt)
Price: 0.70
Patent ruling regarding Par project this month
NDA submission for tadalafil in June or July
NDA resubmission for Rizaport in early Q3
Partnership for Tadalafil in 2H 2017
Most people still not realize the signifance of this news below ..Tadalafil could be up to 2 years on market before the generics enter the Market THATS MEGA NEWS for Intelgenx they will earn a lot of money .
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.
http://s2.q4cdn.com/790425727/files/doc_financials/2017/Q1/final-051117-intelgenx-corp-q1-2017-financial-results-18899915.pdf
The trial with the ANDA applicants that submitted applications for generic copies, is scheduled for July. Some of the ANDA applicants have already settled with Lilly, settled in the sense that they have greed to launch their generic product only at the expiry of this third patent, the dosing patent that we obtained a license for. That means that we have a pretty good chance to enjoy an extended period of excessivity once we’ve launched our product. Several companies have expressed interest in licensing the product. Term sheets(phon)have been submitted and are currently being reviewed and the due-diligence process has commenced.
Now a few words on our Par project for the indication of opioids dependency. That product is entirely driven by litigation. We had a paragraph 4 case ongoing last year, and as we reported previously, we won on two patents and lost on a third patent. In addition, there was a court proceeding in November of last year on a non-Orange Book patent. We expect the ruling on that case and on that patent very soon in June.
Lot of buying alone in may by Institutional investors
https://fintel.io/sob/us/axsm
another nice move and stock is still flying under the radar .Phase 3 results in early Q3 could change this .
they didnt know this stock but this will change once the results start coming in
RALLLLLLLLLLLLLLLLLLLY i love it hehe
and another buy rating with tgt $14
https://thefly.com/landingPageNews.php?id=2555207&headline=AXSM-Axsome-Therapeutics-initiated-with-a-Buy-at-BTIG
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.
look at the performance of the entire stock market and you will have your answer
Another Guy likes AXSM ...more and more people discover this stock and realize the mega potential here
https://seekingalpha.com/instablog/498952-bret-jensen/4989021-axsome-therapeutics-4-biotech-stock-worthy-investment
Aegis Capital has reiterated a ‘Buy’ rating and price target of $20 on Axsome Therapeutics (NASDAQ: AXSM) May 10, 2017
https://www.networknewswire.com/networknewsbreaks/networknewsbreaks-aegis-capital-reiterates-buy-rating-axsome-therapeutics-inc-nasdaq-axsm/
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.
I say this heavily underpriced stock could run to $1 this year and you say not before next year . you have a opinion and i have mine but fact is we both can only speculate and not more . So stop repeating the same garbage over and over again .
AXSM ..Nice Article out by Napodano
Should You Invest In Axsome Therapeutics? Monday, May 8, 2017
talkmarkets.com
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.
AXSM ..Nice Article out by Napodano
AXSM(MC $99 M) $55 M Cash/ 5x Phase3 programs in various indications some of them targeting ver large markets with NO approved drugs .
Should You Invest In Axsome Therapeutics? Monday, May 8, 2017
talkmarkets.com
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.
Ceo bought another 95000 shares holding now over 4.7 million shares he knows why ...
https://www.canadianinsider.com/company?menu_tickersearch=aqs
May 5/17 May 5/17 Janzen, Doug Direct Ownership Common Shares 10 - Acquisition in the public market 50,000 $0.250
May 5/17 May 3/17 Janzen, Doug Direct Ownership Common Shares 10 - Acquisition in the public market 45,500 $0.230
Fantastic News out today...
Axsome Therapeutics Receives FDA Fast Track Designation for AXS-05 for Alzheimer’s Disease Agitation
https://globenewswire.com/news-release/2017/05/08/980006/0/en/Axsome-Therapeutics-Receives-FDA-Fast-Track-Designation-for-AXS-05-for-Alzheimer-s-Disease-Agitation.html
then you should avoid this stock and move on and come back next year .plain and simple
NEW Interview out
insert-text-here
Thats your opinion and i respect it but thats irrelevant ,for me its important what management says and does and nothing else .
you forget that they are very close to acquire many new revenue generating products which will drive the company to profitability (see chart below).Another big milestone is the US-NDA submission for AQS1301 likely before year end and the NDS submission for trokendi ER by mid this year . We are talking about a company which is valued at laughable $11 Million you will not find a cheaper stock than this one. Any good news like the product acqusition and this stock is back over 0.30 and higher .
here is the volume from the main listing toronto under the aqs.v ticker :
http://us.finance.qa1p.global.media.yahoo.com/q/hp?s=AQS.V+Historical+Prices
the selling has to do with the share offering they did a few weeks ago , the washout is still ongoing but close to finish . I asked the ceo who is selling this stock at this massive bargain level below is his answer .
Hello xxxxx. It has been frustrating to see canaccord selling. We issued 17m shares to them on the recent financing and have traded more than 20m since then so I think we are close to the end. We have a few deals pending. People buying at these levels will do well.
Doug
Sent from my iPhone
GREAT NEWS indeed
New Investor bought a MASSIVE stake of 1.3 Million shares 5.5% , now the majority of the 22.9 million shares outstanding held by Insiders and Institutions which is a very good sign .GL
13g filing
http://ih.advfn.com/p.php?pid=nmona&article=74443449
New Email reply by Ceo .. This Stock has is now valued at ridiculous US$ 11 million which is a pure gift .
------
Company well financed and not needing capital;
2 press releases this month already regarding programs and opportunities in the medical cannabis space We have a number of product discussions underway and hope to have additional revenue generating assets for Canada to announce.
We expect at least 2 revenue product deals per year, similar to what we did last year We are waiting for Health Canada to send back the meeting minutes from our recent meeting. Expect to see progress and announcements on the Trokendi XR file once we receive the official minutes. As disappointing as the share price performance was last year we outperformed the majority of CDN specialty pharma companies.
The damage that Valeant and Concordia did to companies in our space was significant in 2016 and we suffered as well. I bought close to 1Million shares last year and look forward to adding more this year.
Best, Doug
Someone tried to push the stock down on very low volume maybe to scare the weak shareholders out of the stock to get their shares .
There is absolute no reason to sell this stock with a terrible low marketcap of $14 million . they have enough cash untill mid 2018 and there is a lot of news on the way like the new product acquisitions . This is a strong buy aggressive .
Need to break the MA(50) at $4.24 then $5+ coming
Load up guys while its still heavily underpriced but not for long thats for sure
Earnings coming later this month
Bigger jump in share price coming once it breaks the MA(50) at $4.36 .
looks like only a few people realize the fantastic potential on this undiscovered gem .
AXSM (MC $90M)(Cash $50M) 5x Phase3 Programms , get some of this terrible undervalued and unknown gem guys .
Marketcap: $90 Million
Cash: $50 Million
Price: $3.95
New Presentation
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjY0Mzk1fENoaWxkSUQ9MzcyMTk4fFR5cGU9MQ==&t=1
AXS-02 COAST-1 Knee Osteoarthritis Associated with Bone Marrow Lesions Phase 3 Phase 3 commenced March 2016. Interim analysis due 3Q 2017.
AXS-02 CREATE-1 Complex regional pain syndrome (CRPS) Phase 3 Initiated July 2015. Expect to complete trial by end of 2017 with interim efficacy analysis due 4Q 2017.
AXS-02 Chronic Low Back Pain Associated with Modic Changes Phase 3
AXS-05 Agitation in patients with Alzheimer’s disease (AD) Phase 2/3 Phase 2/3 to be initiated 2Q 2017.
AXS-05 STRIDE-1 Treatment resistant depression Phase 3 Phase 3 initiated March 2016. Top-line data due 1Q 2018.
Up she goes $5 coming guys
AXSM (MC $85 M)(Cash $50 M) 5x BIG Phase 3 in various indications targeting large Markets with first interim results in 2H 2017 = 2000% POTENTIAL..UNKNOWN LOW FLOAT GEM !!!
Undiscovered and massive undervalued Biotech Stock with lots of Big News on the way.This Stock is brutally undervalued with a Market cap of just $85 million and $50 million in cash .Founder and Ceo is the larget shareholder holding over 7 million shares (30%) more than 50% of O/S is owned by Insider and Institutions which is a great sign .
This undiscovered stock could be the next 10 bagger gem if just one of their 5 ongoing Phase 3 programs is successful .GL
Axsome (AXSM)
Market-Cap: $85 Million
Cash: $50.6 Million(cash runway into the first quarter of 2019.)
Price:$3.70
Shares Out: 23 Million
Anticipated Near-Term Clinical Milestones
Clinical Trial Initiations: -- Phase 2/3 clinical trial of AXS-05 in AD agitation (2Q 2017)
Clinical Trial Readouts:
-- Phase 3 COAST-1 trial of AXS-02 in knee OA associated with BMLs, interim analysis (3Q 2017)
-- Phase 3 CREATE-1 trial of AXS-02 in CRPS, interim efficacy analysis (4Q 2017)
-- Phase 3 STRIDE-1 trial of AXS-05 in TRD, top-line data (1Q 2018)
New Presentation April
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NjY0Mzk1fENoaWxkSUQ9MzcyMTk4fFR5cGU9MQ==&t=1
HUGE Pipeline targeting Billion Dollar Markets:
http://axsome.com/wp-content/uploads/2016/11/Axsome_Dec2016_Pipeline.png
AXS-05 Treatment Resistant Depression in Phase 3 -(Only 1 approved drug for TRD = unmet medical need. 3M patients in the U.S.)
AXS-05 Agitation in Alzheimer’s Disease in Phase 2/3 -(No approved medication = unmet medical need. 2M patients in the U.S.)
AXS-02 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 Knee Osteoarthritis (OA) with Bone Marrow Lesions (BMLs) in Phase 3 (SPA & Fast Track) -(7M patients in the U.S.)
AXS-02 Chronic Low Back Pain(CLBP) with Modic Changes (MCs) in Phase 3 -(1.6M patients in the U.S.)
Major Shareholders
Herriott Tabuteau, MD 7 351 729 38,4%
Fidelity Management & Research Co. 2 361 625 12,3%
JPMorgan Asset Management (UK) Ltd. 1 432 456 7,48%
Mark Coleman, MD 647 998 3,38%
BlackRock Fund Advisors 426 837 2,23%
Stifel Trust Co., NA 415 279 2,17%
The Vanguard Group, Inc. 272 189 1,42%
Lombard Odier Asset Management (USA) Corp. 250 000 1,31%
JPMorgan Investment Management, Inc. 156 625 0,82%
SSgA Funds Management, Inc. 134 688 0,70%