Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Unreal!
congratulations to those who believed in it and held out for so long!
Nice to see the shorts burning each other!
Now the question is: Who will be next?
ISRG $ 97.280 milion
TMDI $ 408 milion
If TMDI will still be listed, what will the difference be in two years?
Huge market for Enos
Tomorrow
Title Effect of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) on PTSD Sleep-Dependent Emotional Memory Processing: Retrospective Analysis of Phase 2 and 3 Trial Results in Military-Related and Civilian PTSD
Session Poster Session II
Date June 3, 2021
Time 10:00 a.m. – 11:00 a.m. ET
The poster, titled, “Efficacy and Safety of TNX-102 SL (Sublingual Cyclobenzaprine) for the Treatment of Fibromyalgia in the RELIEF Study: Positive Results of a Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Trial” shows that TNX-102 SL met its pre-specified primary endpoint in the Phase 3 RELIEF trial, significantly reducing daily pain compared to placebo (p=0.01) and was associated with a higher rate than placebo of ≥30% pain responders in participants with fibromyalgia (p=0.006).
TNX-102 SL at 5.6 mg also showed activity in key secondary endpoints measuring improvements in sleep quality, mitigation of fatigue, and fibromyalgia-specific functional recovery. In addition, TNX-102 SL was well tolerated and was not associated with side-effects seen with other approved oral fibromyalgia treatments, including weight gain, insomnia, nausea or sexual dysfunction.
Beware of the traps!
Doesn't seem like a bear year to me!
Things like AMC happen!
Better not to make big shots
anyway thanks
hehehehehehehehehehe
https://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=%22titan+medical%22&OS=%22titan+medical%22&RS=%22titan+medical%22
https://pdfaiw.uspto.gov/.aiw?PageNum=0&docid=20210161558&IDKey=98FAA414DC25&HomeUrl=http%3A%2F%2Fappft.uspto.gov%2Fnetacgi%2Fnph-Parser%3FSect1%3DPTO2%2526Sect2%3DHITOFF%2526p%3D1%2526u%3D%25252Fnetahtml%25252FPTO%25252Fsearch-bool.html%2526r%3D1%2526f%3DG%2526l%3D50%2526co1%3DAND%2526d%3DPG01%2526s1%3D%252522titan%252Bmedical%252522%2526OS%3D%252522titan%252Bmedical%252522%2526RS%3D%252522titan%252Bmedical%252522
Very interesting!
well if it goes up slowly! there is no rush!
25% of incy
how is perky today!
I like it!
I t’s tyme for happy days!
1K Thanks,
but if the inspector does not find anything they will know immediately the same day of the inspection, I think I understand!
at best!
ok the goodies have been distributed!
we hope with good reason
is this what they want us to think?
Patents are the basis!
But even Enos is tempting!
I also think MDT needs a development worklab for robotic surgery!
me 3k
and 3K wait
Buy zone
Is the appointment set for 31st?
Who knows how long it takes since the visit to know they're okay?
Do not forget!
76 US and international patents issued
87 (or more) Applications Pending
Oppenheimer
Bloom Barton
Huge market!
Gold cross
Gold mine
MDT 66/67
milestone 3
Timely manner
Enos
OTB
Hehehehehe
1.77
nice number
woman legs
in the end it got there!
Will it be a coincidence?
Greeting!
Hello people!
I'm piling up!
Time to go up !!
I feel I have to buy a lot of TMDI!
I was hoping to get back at a better price to be honest!
you want to see shorts take slaps up to 15!
enough for me
it looks like a bear trap ... at least for now!
I took a handful yesterday!
Floating thin!
5.2
I think that with a little bit of FOMO it goes up a lot!
Many will go up in the opening
The Publication Only abstracts are under embargo until 5:00 p.m. ET on May 19, 2021.
I'm thinking about what to sell to buy here!
12 days and ends May! The wait will soon be over!
The visit should be a formality for SPPI!
Fly baby
Recognizes $8.2 Million of Revenue from XpresCheck™ in the First Quarter of 2021, Including $3.2 Million Related to 2020
Net Loss Narrows to $0.8 Million Compared to Net Loss of $10.7 Million
Strong Liquidity Position with Cash Balance of $103 Million
total current assets of $91.8 million
MC 130 milion
considering the substantial buy back, shorty look very bad!
So much meat on the fire or so it seems!
Our most advanced CNS product candidate is TNX-102 SL*, a proprietary sublingual tablet formulation of cyclobenzaprine, or CBP, designed for bedtime administration. TNX-102 SL has active investigational new drug applications, or IND?s, for FM, posttraumatic stress disorder, or PTSD, agitation in Alzheimer?s disease, or AAD, and alcohol use disorder, or AUD. TNX-102 SL is in mid-Phase 3 development for the management of FM which is a pain disorder characterized by chronic widespread pain, non-restorative sleep, fatigue and impaired cognition. We reported positive results from its Phase 3 RELIEF study in December 2020 and expect interim analysis data from a second Phase 3 study, RALLY, in the third quarter of 20211, followed by topline data in the first quarter of 2022. We completed enrollment of 50% of participants in the RALLY study in March 2021. For TNX-102 SL in PTSD, we completed the Phase 3 RECOVERY trial and reported topline results in the fourth quarter of 2020 in which TNX-102 SL did not meet the primary efficacy endpoint. As a next step, we intend to meet with the U.S. Food and Drug Administration, or FDA, to discuss potential new endpoints for the indication of treatment of PTSD. We expect to begin enrolling a Phase 3 study of TNX-102 SL in police in Kenya in the third quarter of 2021. PTSD is a serious psychiatric condition that develops in response to experiencing a traumatic event. The AAD program is Phase 2 ready with an active IND and FDA Fast Track designation. AAD, which includes emotional lability, restlessness, irritability, and aggression, is one of the most distressing and debilitating of the behavioral complications of Alzheimer?s disease. The AUD program is also Phase 2 ready with an active IND. AUD is a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and a negative emotional state when not using alcohol.
Other CNS candidates in development include TNX-1900* (intranasal potentiated oxytocin), which is in development as a candidate for prophylaxis of chronic migraine and for the treatment of craniofacial pain, insulin resistance and related conditions. TNX-1900 was acquired from Trigemina, Inc. in 2020 and licensed from Stanford University in 2020. We intend to submit an IND to the FDA in the third quarter of 2021 and initiate a Phase 2 study in migraine in the third quarter of 2021. Tonix also licensed technology to use TNX-1900 for the treatment of insulin resistance from the University of Geneva. TNX-2900* is another intranasal oxytocin-based therapeutic in development for the treatment of Prader-Willi syndrome, or PWS. The technology for TNX-2900 was licensed from the French National Institute of Health and Medical Research. PWS, an orphan condition, is a rare genetic disorder of failure to thrive in infancy, associated with uncontrolled appetite later in life.
TNX-601 CR* (tianeptine oxalate and naloxone controlled-release tablets) is another CNS product candidate in development as a treatment for major depressive disorder, or depression, as well as for PTSD and neurocognitive dysfunction associated with corticosteroid use. We completed a Phase 1 trial for formulation development outside of the U.S. Based on official minutes from a pre-IND meeting with the FDA, we expect to be in a position to initiate a Phase 2 study for the treatment of depression in the fourth quarter of 2021, pending results of toxicology studies.
TNX-1300** (double-mutant cocaine esterase) is also in Tonix?s CNS portfolio and is in Phase 2 development for the treatment of life-threatening cocaine intoxication. TNX-1300 has been granted Breakthrough Therapy designation, or BTD by the FDA. TNX-1300 was licensed from Columbia University in 2019 after a Phase 2 study showed that it rapidly and efficiently disintegrates cocaine in the blood of volunteers who had received intravenous, or i.v., cocaine. We expect to initiate a Phase 2 open-label safety study of TNX-1300 in an emergency room setting in the third quarter of 2021.
Our immunology portfolio includes vaccines to prevent infectious diseases and biologics to address organ rejection, cancer, and autoimmune diseases. Our lead vaccine candidate, TNX-1800**, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell immune response. We reported positive immune response data in non-human primates in the fourth quarter of 2020 and reported positive efficacy data from animal challenge studies using live SARS-CoV-2 in the first quarter of 2021. TNX-801**, a live horsepox virus vaccine for percutaneous administration, is in the pre-IND stages of development to protect against smallpox and monkeypox. Both TNX-1800 and TNX-801 are based on the proprietary horsepox viral vector platform. We expect to initiate a Phase 1 safety study of TNX-1800 for COVID-19 in the first half of 2022.
TNX-2100** is a skin test we are developing to measure SARS-CoV-2 exposure and T cell immunity. It is an intradermal test to measure delayed-type hypersensitivity (DTH) response to SARS-CoV-2. We have manufactured GMP peptides designed to stimulate SARS-CoV-2 specific T cells and expect to submit an IND to the FDA in the third quarter of 2021 and initiate a first-in-human clinical study in the fourth quarter of 2021.
TNX-3500* (sangivamycin) is an antiviral inhibitor of SARS-CoV-2. It has demonstrated broad-spectrum activity in laboratory-based assays against the coronaviruses SARS-CoV-2 and MERS-CoV. Tonix licensed this compound from OyaGen, Inc. and intends to develop it as a treatment for COVID-19 and potentially other viral disorders. The active ingredient of TNX-3500 has been studied for safety in humans in prior studies on cancer patients at the U.S. National Cancer Institute but has not been approved for marketing in any jurisdiction. Tonix intends to conduct further animal studies and submit an IND in the first half of 2022.
TNX-1500** is a humanized monoclonal antibody, or mAb, directed against CD40-ligand, or CD40L, engineered to modulate binding to Fc receptors, that is being developed to prevent and treat organ transplant rejection as well as to treat autoimmune conditions. We expect to have GMP TNX-1500 product ready in the third quarter of 2021. In experiments at the Massachusetts General Hospital, a teaching hospital of Harvard Medical School, TNX-1500 product candidate is being studied as monotherapy or in combination with mycophenolate mofetil in heart and kidney organ transplants in non-human primates. Preliminary results from an ongoing experiment in heart transplants indicated that TNX-1500 appeared to have comparable efficacy to historical experiments using the chimeric mouse-human anti-CD40L monoclonal antibody (mAb) hu5c8 and no evidence of thrombosis has been observed.
Finally, our preclinical pipeline includes TNX-1600*, TNX-1700**, TNX-701* and TNX-2300**. TNX-1600 is an inhibitor of the reuptake of neurotransmitters serotonin, norepinephrine and dopamine (a triple reuptake inhibitor). TNX-1600 was licensed from Wayne State University in 2019 and is being developed as a treatment for PTSD, depression and attention-deficit/hyperactivity disorder, or ADHD. TNX-1700 is a recombinant modified form of Trefoil Family Factor 2, or rTFF2, that was licensed from Columbia University in 2019, and is a biologic being developed to treat gastric and pancreatic cancers. TNX-701 is an undisclosed small molecule, which is being developed to prevent deleterious effects of radiation exposure which has the potential to be used as a medical countermeasure to improve biodefense. Tonix is also developing TNX-2300** as a second COVID-19 vaccine under an option agreement with Kansas State university. TNX-2300 is a live replicating viral vector based on the bovine parainfluenza virus.
AS OF MARCH 31, 2021, TONIX HAD $164.2 MILLION OF CASH AND CASH EQUIVALENTS
Tonix Pharmaceuticals Says Entered Purchase Agreement Pursuant To Which Lincoln Park Has Committed To Purchase Up To $80.0 Mln Of Shares!
OK I m in!
nice price!
tomorrow or the stars or the stables
A little more and I'm in!
Buy the dip!
Will they cover up to $ 5?
https://biotuesdays.com/2021/05/06/stifel-starts-cti-biopharma-at-buy-pt-5-50/
Tnxp
You gotta get up... try try try
At December 31, 2020, Cash and Cash Equivalents Totaled $77.1 Million;
In January 2021, the Company sold 50,000,000 shares of common stock at $0.80 per share, priced at-the-market, for gross proceeds of approximately $40 million, and net proceeds of approximately $36.9 million, after deducting the underwriting discount and other offering expenses. In February 2021, the Company sold 58,333,334 shares of common stock at $1.20 per share in a registered direct public offering, priced at-the-market, for gross proceeds of approximately $70 million, and net proceeds of approximately $65.0 million, after deducting the underwriting discount and other offering expenses.
77
37
70=
184
MC 320
April 19 (Reuters) - Tonix Pharmaceuticals Holding Corp (TNXP.O):
* TONIX PHARMACEUTICALS - INCREASED OFFERING PRICE OF SHARES ISSUABLE UNDER SALES AGREEMENT DATED AS OF APRIL 8, 2020, FROM $100 MILLION TO $170 MILLION
they are full of money but they will spend a lot of it!
NVAX MC 17.000
I had NVAX at 7 sold at 82
Tonix have big potential
I don't sell it I don't look at it at least until next year
See you next year
I'm going in today!
great potential