Viewmont
1 day ago
Any New News could hit anytime Now! A reminder of Jan 8, 2025 Press release!
Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Gary Ainsworth as Vice President of Market Access
Mr. Ainsworth brings over two decades of industry and market access experience to Tonix
U.S. Food and Drug Administration (FDA) recently assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for U.S. marketing authorization of TNX-102 SL for the management of fibromyalgia
CHATHAM, N.J., January 8, 2025 (GLOBE NEWSWIRE) – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the appointment of Gary Ainsworth as Vice President, Market Access, effective immediately. Mr. Ainsworth is an accomplished executive with leadership in market access strategies from both large pharmaceutical companies and healthcare consultancies.
“Gary has a significant track record of success building market access functions, developing launch-ready access and reimbursement strategies and payer-focused resources, including those for fibromyalgia and migraine treatment options,” said Thomas Englese, EVP Commercial of Tonix Pharmaceuticals. “His extensive experience will be especially valuable as we work towards the potential approval and commercial launch of TNX-102 SL for the management of fibromyalgia this year.”
Most recently, Mr. Ainsworth was Managing Director, Head of Market Access at Eversana Intouch, where he led the agency function and the efforts to optimize the Company’s vast market access capabilities and services. Prior to that, he was the founder and Managing Director at Havas Gemini, the Market Access Business Unit of Havas Health & You that developed innovative market access strategies and solutions for their clients. Mr. Ainsworth also had a distinguished career leading pharmaceutical organizations’ market access functions. Mr. Ainsworth was the Vice President of Corporate Accounts and Customer Operations for Baxter International within the Anesthesia, Critical Care and Oncology Division where he led a team of national account managers and a patient services telemarketing center. Mr. Ainsworth also led the National Accounts and Managed Care Marketing function at Roche Laboratories and held a variety of market access leadership positions with the predecessor companies to Sanofi. Mr. Ainsworth holds a Master of Business Administration from Rockhurst University and a Bachelor of Arts in Business Administration and a Bachelor of Arts in Public Relations from William Jewell College.
“Joining the Tonix team presents an exciting and fulfilling opportunity to help advance a treatment for the millions of individuals with fibromyalgia,” said Mr. Ainsworth. “I look forward to providing additional expertise to a seasoned leadership team with the goal of bringing meaningful therapeutics to patients in need.”
At the end of December 2024, Tonix announced that the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing authorization for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia. TNX-102 SL is a non-opioid, centrally-acting analgesic. Fibromyalgia is a common chronic pain condition that affects mostly women.
Dumb&dumber4long
2 days ago
This, I am sure it’ll not be to your liking!
But you asked for my opinions, so here it is,
I don’t think of the list/delist scenario often mentioned on this board.
It will not change the forward looking potential for tnxp.
What difference does it make where it trades.
Holding tnxp for reasons that will not change, regardless where it trades.
It’s the same on RS, what matters is the market cap.
Acquisitions are not based on the numbers of outstanding shares, it’s on forward valuation.
You don’t find acquisitions of companies expected to forward lose money.
Good luck.
timberwolf7
2 days ago
Hate to say it, but when it comes to the fda and drug companies,
its pretty apparent the drug industry has more power than folks
realize.
And in this case, as mentioned, it will be interesting to see what
the labeling says with respect to 'who' can use it, and for 'what'
conditions.
Or as I tell those I chat with about drug developments.. There is some
that are getting approved that make you wonder how many were bought
off to get it approved.
Dumb&dumber4long
2 days ago
Looked into it a bit more, the Study leading to the FDA, highlighted some concerns earlier this year & noted again in today’s news article.
I am surprised they claim it to be for moderate & severe acute pain. The severe acute part is,
Wholesale acquisition cost for VX-548, is $15.50 per 50 mg tablet, implying daily cost of $31. In a pivotal study, VX-548 helped patients with acute pain after surgery but did not show superiority to opioids, raising concerns about its widespread use. The drug reduced pain more than a placebo in the first 48 hours after surgery, but secondary analysis showed no better results than opioids. Analysts, such as Brian Abrahams from RBC Capital Markets, view the drug's effects as modest, potentially limiting its use to niche markets. Paul Matteis from Stifel noted the drug’s efficacy could complicate prescribing decisions in acute settings. VX-548 was studied in patients after tummy tuck or bunion surgery and for chronic nerve pain caused by diabetes.
timberwolf7
2 days ago
When TNXP announced they submitted and then the fda accepted their submission?
The chart that was BASED on what WAS?? The conditions that helped shape
the chart before these fundamental changing events?? That just reshaped
the companies prospects and the way the market will NOW look at the company?
To me, the chart prior to the fda acceptance and announcement of the PDUFA date??
No longer matters to me..
Now I am focused on the 'new' chart cause it will start to reflect the new conditions,and
what the market thinks about the company NOW.
Thats why I use/rely on a much shorter timeframe, and my 'chart' for TNXP starts when
the fda announced it accepted the submission and gave a PDUFA date. Could care less
what it did before that. Cause again, the dynamics have radically changed.
And I do this for all of my trades be it short term or long term.. Only focus on what
IS happening..
disclaimer: in this for the long haul... with $3 as my first goal, adjusting it as the
conditions justify.. (conservative market cap based on existing share count)
timberwolf7
2 days ago
I use as mentioned before a SHORT moving average. At 36 cents, its sitting right
on this MA line.
Unfortunately, given the 'negative momentum of the last 3 days, won't be surprised if it
dips below the MA line (MA line went 'neutral' today, lost its positive slope) and has to
wrestle its way back over it Pattern looks similar to what took place when it peaked
back in mid-Dec before it then ran down for almost a month.
Have to remember, we are still 7 months out from Aug. So it has time to be jerked
around for the next few plus months barring any news from the company itself to renew
interest..
timberwolf7
2 days ago
Share price vs its moving average line
One thing I pay attention to is and why I advocate/hope for a 'slow and steady'
movement in the share price vs rapid/chaotic. Is the relationship between its MA
and the SP.
7 days ago, this shot up in price, and for the next 5 days, it ran 'up'. Peaked out
at around 47 cents with the MZ line around 35. One heck of a gap. And an observation
of mine is, when that kind of 'gap' develops, the SP & MA line get 'lonely' for
each other. They want to 'find' each other and the expectation goes like this:
-if they stay 'close/tight' to each other during a move up (nice and slow),
they may pause, but the pullback isn't as dramatic when
-they get far apart like they just did. Makes it easy for the share price to be
dropped back down to the MA line like it did this morn.
Just did an update and the MA line is around 36 to 37 cents, and the share price
just nibbled on 36.12..
Called recognizing the PATTERNS and BEHAVIORS
seen in the charts, that are REPEATABLE because its
the masses called investors, their psychology that create
these patterns. And we as humans, for most of us, tend to
think in patterns, never consider 'varying' what we do, how we
think. Function like predictable 'robots'... So those that think
outside of the box?? Can take advantage of this awareness (smile)
timberwolf7
3 days ago
Naked shorting:
mentioned it before, its common, wall street is doing it
its being done blatantly cause there is very little enforcement
and the reward vs penalties make it worthwhile.
Biggest problem is, the ones caught don't go to jail.
Listening to the Kash Patel fiasco this morning? One of the
questions I didn't hear him asked was, will those behind the
J6 hoax, those that abused their power to persecute the J6ers,
the ones that killed Ashli Babbit and beat the other lady to death..
Face prosecution and an appropriate jail sentence.
Yep, the biggest problem we have is we have laws, regs, but 'select'
accountability if any at all.
timberwolf7
3 days ago
They aren't ALL dilution scams.
Yes, there are many that have no chance of success, but end up
lining the pockets of those 'runing things'. Create a lot of 'losers' in the
process (venture capitalists, investors)
But anyone that invests in a company before the PH 2s CONFIRMS that
it has a chance of being successful is placing a VERY risky bet. And anyone
that invests in something that didn't confirm with its PH2, before its Ph 3 does is
playing Russian roulette.
But you try to find a baby bio that goes thru the clinical trial process that
didn't have to DILUTE to raise cash, and you will be lucky to find 'some'. For it
is an expensive process, and DILUTION is likely the only viable option beyond
'loans/venture capital' they have to raise money.
And reverse splits? Far too common and the primary reason why I avoid
investing before the end of the PH 2 at the earliest. Call them an EVIL necessity...
And if they announce a major one, and with no revenue generation in the near future?
You have to expect the share price is going 'down'
So to call a company a 'scam' just cause they do a r/split or dilute is actually libelous
isn't it. Unless you can prove it is scam rather than just part of the normal baby bio
development process. Disagree??
Dumb&dumber4long
3 days ago
According to MSFT Copilot, if your tnxp shares are paid for in full (cash account) then your brokerage is not allowed to lend them.
If your position is on margin, your brokerage account contract gives the broker the right to lend, you have no choice in the matter.
Tnxp current share price doesn’t qualify for a margin trade.
So, all shorts are naked shorts.
Checked & confirmed with Schwab.
Too many brokerages are in violation of the SEC, judging by the volume of short interest.