VistaGen Therapeutics Inc (VTGN)

[Richard2]

Close e fucking nough, of course if it had been ketamine it wouldn’t still be without a product

[Richard2]

I’ve been watching for years, not new.

[whosjohngalt]

thanks

good to see new people here, we work our way thru this phase 3 successfully and it's off to the races here. Takes alot of patience these little biomeds.

best regards
who

[Richard2]

I’m giving you a follow just because of your username lol

[whosjohngalt]

new big hitter added to board

almost makes you think we are going places

best

[whosjohngalt]

nice

good to see you back then, and I'm acutely aware of the imminent eua piece wouldn't rule that sleeping dog out yet, but nonetheless it is sleepy. Hopefully we continue to roll here we may be a bit over our skis now tough to tell short term, but longer term vistagen has a legitimate shot at being a big dog. phase 3 94B gets us out of the gate.

best

[TurdBlossom]

Greetings to all. I was here with an initial entry at $0.70 but sold out to transfer funds to another stock which I thought would have an ‘imminent EUA’ and wound up still waiting on that EUA a year later. Re-entered VTGN at $2.60 and thought I would have plenty of time to add since ph3 trial would take approx a year with top line data out approx 30-60 days after the trial concludes. Did not expect the rapid jump to $3+ so quickly. Congrats to all you longs who have been holding this hidden gem- this is going to be a blockbuster. GLTA

[whosjohngalt]

new 52 week high

and closed at the high of the day, that never gets old to see

[whosjohngalt]

3's up

a new frontier, keep up the good work team.

[whosjohngalt]

new exchange Monday

conference call Tuesday. Exciting future ahead.

[whosjohngalt]

Russell 2000 index done

https://finance.yahoo.com/news/vistagen-therapeutics-set-join-russell-120000528.html

best

[whosjohngalt]

nice week

[Johnny_C]

1 yr for a phase 3 trial is not long at all, then there is the submission process.

From what I understand this is similar to simply duplicating the phase 2 trial which was successful. There is a lot of optimism on this trial and now you see analysts sticking there neck out putting a nearly $2 bil valuation on just that drug if it meets end points.

Looks like VTGN is heading to Russell 2000 according to all the chatter.

Incredible turnaround since last November.

And the new patent on AV101 means the clock starts again.

[whosjohngalt]

figured that was coming really

groups seem to know what's coming a few days in advance of us getting the pr on this stock every time.
Happy to see us getting started on time though, I am a bit surpised top line results will take an estimated year; didn't think it would be that long.

patience it is
best
who

[JohnLocke101]

A sell of the news - ouch.

[JohnLocke101]

VistaGen Therapeutics Initiates PALISADE Phase 3 Trial of PH94B in Social Anxiety Disorder

PALISADE Phase 3 Program focused on acute treatment of anxiety in adults with Social Anxiety Disorder

FDA Fast Track designation granted

Topline results anticipated in mid-2022

VistaGen Therapeutics Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, today announced the initiation of its PALISADE Phase 3 clinical program with the PALISADE-1 Phase 3 trial, a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of PH94B for the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD). PH94B is an odorless, rapid-onset, investigational pherine nasal spray with a unique mechanism of action, working differently than all existing therapies for SAD. There is currently no U.S. Food and Drug Administration (FDA) approved acute treatment of anxiety for adults with SAD.

PALISADE-1 is being conducted across approximately 18 sites in the U.S., with a target of approximately 200 randomized subjects. Dr. Michael Liebowitz, a Columbia University psychiatrist, former director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), is serving as Principal Investigator of the trial. Topline results from PALISADE-1 are anticipated in mid-2022.

"Initiation of PALISADE-1 is a major milestone for our PALISADE Phase 3 clinical program for PH94B, a program aimed at supporting a potential New Drug Application to the FDA. The trial is an essential next step in our efforts to confirm the positive efficacy and safety results we have seen in all PH94B Phase 2 trials to date," stated Shawn Singh, Chief Executive Officer of VistaGen. "PH94B has the potential to be a life-changing acute, as-needed treatment of anxiety for adults with SAD, similar to how a rescue inhaler is used to prevent an asthma attack. At a time of continuing increase in the number of Americans suffering from SAD and other anxiety disorders, and a current treatment paradigm that falls short of delivering necessary relief, a new fast-acting treatment alternative is imperative. Initiation of our PALISADE-1 trial further reflects our commitment to go beyond the current standard of care for SAD. If successfully developed, PH94B has the potential to be the first fast-acting, non-systemic, non-sedating acute treatment of anxiety for more than 23 million Americans who suffer from SAD."

"Social Anxiety Disorder is the third most common mental health disorder among Americans, and it can turn everyday social interactions into debilitating, fearful experiences for people who continue to suffer from this growing mental health condition," said Dr. Liebowitz. "Existing treatments, such as approved antidepressants, have not been effective acute treatment solutions for this large patient population. In addition, the negative side effects and safety concerns associated with benzodiazepines prescribed off-label are a significant cause for concern, as demonstrated by the FDA's Drug Safety Communication detailing the risks of benzodiazepines issued last Fall. The start of this Phase 3 trial is a major step forward in the clinical development of PH94B, an investigational drug with the potential to displace antidepressants and benzodiazepines in the treatment paradigm for SAD, as well as several other anxiety disorders."

[whosjohngalt]

nice week

maybe an announce of the start of phase 3 94b sad testing at the June conferences? can hope

best
who

[ClayTrader]

* * $VTGN Video Chart 05-20-2021 * *

Link to Video - click here to watch the technical chart video

[crudeoil24]

MAY 12....IT'S A SHELF PLACEMENT > READ THE FILING, DILUTION IS STILL IN PROCESS.

[Johnny_C]

This is old news and is part of the $250 mil shelve registration previously filed. There has been significant share dilution over the past year yet the price per share is much higher that 6 months ago when the stock was trading in the 70 cent range.

In fact, not long ago the market cap here was $40 million and now it is $400 million.

Baird has put a $9.00 price target on the company, and they issued a comprehensive 30-page report. What is significant is that would give VTGN a market cap in the $2.5 billion dollar range. That is only considering one drug, the nasal anxiety SAD PH10.

The phase 3 trial is basically a mirror of the phase 2 trial, so I think the massive institutional buying is based on the thought the odds are well in favor of success.

VTGN has 3 other potential blockbuster drugs as well as offshoot indications for smaller markets.

It has been a long haul with VTGN, but CEO Shawn Singh hard work, locating and buying additional assets for the portfolio has put the Company in excellent shape for success

[crudeoil24]

$75M > dilution > SEC filing 424B5 We have entered into an Open Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) relating to the sale of shares of our common stock, par value $0.001 per share, offered by this prospectus supplement. In accordance with the terms of the Sales Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $75,000,000 from time to time through Jefferies, acting as sales agent.

Our common stock is listed on the Nasdaq Capital Market under the trading symbol “VTGN.” On May 12, 2021, the last reported sale price of our common stock on the Nasdaq Capital Market was $2.33 per share.

[whosjohngalt]

everyone settle down


we haven't even gotten started here yet.

[whosjohngalt]

another solid week going on here

congratulations me

[whosjohngalt]

appointment today

suggests they feel pretty confident about how this phase 3 test will turn out, set to commence 'soon'.

best
who

[whosjohngalt]

nice week

good job everyone

[whosjohngalt]

190k

buy today at 2.54, that ain't no beanie baby.

best
who

[whosjohngalt]

nice bounce back

new board member and we got a 'soon' on phase 3 ph94b starting so I'll take that.

[Johnny_C]

True, I think that is the timeline but i am hoping for some milestone announcements between now and then

[whosjohngalt]

I see

still a bit concerning they mentioned q2 2022 twice.

best
who

[Johnny_C]

I am not sure if it is to post the whole research report as it goes to people paying for the service.

Long and short they have an $8.00 target and $1.5 bil valuation just based on the SAD drug.

Patiently waiting for them to announce enrollment and then dosing.


If AV-101 also comes in with good phase 2 as early as Q1 things will get very interesting.

[whosjohngalt]

sorry

is that an insider type report? Don't see it on the Jeffries website.

Also in fear of sounding naive who is KOL?, and the phase 3 for 94B SAD starts in q2 2021 (or now), not next year.

Appreciate the post, thanks for any assistance.

best
who

[Johnny_C]

Interesting report from Jeffries.

Vistagen Therapeutics
KOL Thinks Novel Anxiety Spray Will Work in Phase III, Has Real-World Use Case

April 18, 2021
Key Takeaway
We spoke to a psychiatrist who thinks VTGN has generated compelling Phase II data for social anxiety, leading him to believe the Phase III studies in 2022 "will be successful." We reiterate our view that the setup at $2/share ($375M cap) looks attractive, as pivotal data starting in Q2:22 could push the stock towards $8/sh ($1.5B+ cap) versus
downside to mostly cash ($100M cap), implying a positive expected value with a 65% PoS assumption. KOL believes existing therapies for social-anxiety disorder (SAD) have serious limitations. He treats over 50+ SAD
patients a month, and his patient breakdown currently includes 60% on SSRIs, 20% benzodiazepines, 10% beta-blockers, and 10%untreated. He affirms: (1) antidepressants..........


Interesting market cap this analyst predicts...

[whosjohngalt]

new fiscal year

today, should be a good one.

2nd quarter calendar year today, let's fire up the phase 3 testing.

best
who

[Johnny_C]

I think oral ketamine is not going to be a winner as tested. Maybe they can redo trials like VTGN is doing with AV-101. Intravenous ketamine has short term benefits but the delivery method and then wait time after dosage makes that a hard sell.

Drug trials are very risky, especially trials trying to treat depression and anxiety. VTGN oral and nasal seem to have a fantastic safety profile. If Av-101 new compound meets data points in a new phase 2 trial and the nasal SAD meets data points the sky is the limit here. It will be great to be part of a drug without side effects that can help millions with mental health issues, whether it is anxiety or depression.

As a recent example of how difficult drug trials are my old neighbor protected and tried to reincarnate a non opiod drug that Pfizer tried numerous times to get approved over a 16 year period. He must be bummed out now.

VTGN AV-101 originally was tested for pain and met endpoints in early studies. It may be on the shelf now but that is another potential blockbuster indication VTGN has in the portfolio.

A pair of FDA advisory committees has rejected a risk mitigation proposal from Pfizer for its NGF-blocker tanezumab, stating it would fail to ensure the drug's benefits outweigh its risks for patients with osteoarthritis

[whosjohngalt]

not

ketamine

best
who

[Richard2]

I thought that the other year. The oral ketamine I was really hoping was going to be something. Maybe this time.

[whosjohngalt]

yup

easily 12-24 months but I see this phase 3 as finally loading the horse in the gate, exciting time here.

Emailed them a few days back, but no response. Not surprised, we'll know when they let us know things are fired up.

best

[Johnny_C]

Hopefully we here news phase 3 clincal trial has enrolled soon. Still, I think another 12 to 24 month hold here.

[whosjohngalt]

short

sellers love this ticker, hopefully we can kick um right in the proverbial noogies one day.

best

[JohnLocke101]

“ VistaGen’s Poster Presentation at the Anxiety and Depression Association of America’s 2021 Annual Conference Differentiates PH94B’s Mechanism of Action from Highly-Addictive Benzodiazepines

SOUTH SAN FRANCISCO, Calif., March 22, 2021 (GLOBE NEWSWIRE) -- VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, announced today that data highlighting the proposed mechanism of action (MOA) of its Phase 3 investigational drug candidate, PH94B nasal spray, were recently presented in a poster session at the Anxiety and Depression Association of America’s 2021 Virtual Annual Conference. PH94B is designed with potential to provide rapid-onset acute treatment of anxiety for millions of individuals suffering from social anxiety disorder (SAD) without directly activating gamma-amino butyric acid (GABA-A) receptors. PH94B’s MOA is, therefore, fundamentally differentiated from the MOA of benzodiazepines such as alprazolam, diazepam and lorazepam, which are direct GABA-A receptor positive modulators. Among VistaGen’s core goals is for PH94B to displace these and other widely-used but highly-addictive benzodiazepines in the acute treatment paradigm for SAD and other anxiety disorders and phobias.“

Read In Full Here

[JohnLocke101]

Nabbed a big chunk this time at 212

[JohnLocke101]

I’ll take more at 2.22 - thank you.

[JohnLocke101]

Continuing to build position as it dips to low 2.20’s

Good Luck!

[Johnny_C]

Timing seems odd, I thought they had plenty of money to get phase 3 done and start other trials. All Biotechs raise money though, considering where we were a year ago $250 mil is impressive.

Nothing changed as far as VTGN having 4 potential blockbusters. Maybe they are looking at other assets or just want this in place for the future. It is 3 yrs I think

[JohnLocke101]

Thanks. Here’s the filing.

[Johnny_C]

S3 refreshed. I think they will always have one ready in the event of an opportunity presenting itself. I would think they still have north of $100 mil banked until trials starts.

Looks like VTGN north of 50percent being institutionally owned

[pzottkpz]

Thanks for the great find Fress!

[whosjohngalt]

phase 3

ph94b to start soon for SAD, fast tracked. Big deal to get us out of the gate.

best to you
who

[JohnLocke101]

Took some more at 2.26

[JohnLocke101]

Adding on the dips.

Good Luck!