Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) is making a run for the top in the market this morning, and for good reason. The comapny announced that it would be expanding a late-stage clinical development program.
As you could imagine, the news excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The expanded Phase 3 clinical development program;
- what we’re seeing from TNXP stock as a result; and
- what we’ll be watching for ahead.
TNXP Announces Expanded Phase 3 Development Program
As mentioned above, Tonix Pharmaceuticals is having an incredibly strong start to the trading session this morning after the comapny announced that it has expanded a Phase 3 clinical development program. The announcement came by way of press release early this morning.
In the release, TNXP said that it will be expanding the TNX-102 SL 5.6 mg program beyond PTSD to include Phase 3 development for the treatment in fibromyalgia. TNX-102 SL, also known as Tonmya, is the company’s lead Phase 3 program in PTSD. Currently, the Phase 3 RECOVERY trial is actively enrolling military and civilian PTSD participants.
In a recent meeting with the FDA, the comapny received guidance and support to advance the development of TNX-102 SL for the management of fibromyalgia. Previously, the company studied a lower dose, bed time treatment with TNX-102 SL, showing clinical benefits.
In the lower dose, the drug led to quality of sleep improvements, but did not show any statistically significant changes in pain level. However, additional data developed by TNXP in the PTSD program with a high dose, showed acceptable tolerability with a benefit of pain reduction.
As a reuslt, the company believes that by increasing the dose of TNX-102 SL from 2.8 mg to 5.6 mg, it will be able to be used as a treatment to address pain in fibromyalgia patients.
In a statement, Seth Lederman, M.D., President and CEO at TNXP, had the following to offer:
We are very pleased with the outcomes of our recent discussion with the FDA to advance the fibromyalgia Phase 3 clinical program with TNX-102 SL 5.6 mg with the potential to expand the product labeling beyond PTSD. The FDA’s acceptance of the well-established safety information of currently-marketed oral cyclobenzaprine products and their agreement that TNX-102 SL 5.6 mg long-term exposure data from our PTSD studies may support the fibromyalgia indication are very reassuring. We are looking forward to submitting a final Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation.
We have extensive clinical experience and data collected over the past seven years with TNX-102 SL in fibromyalgia and PTSD studies. In addition to the synergy between these two development programs, we are very pleased with the FDA’s clear guidance and support to help advance our lead product candidate, TNX-102 SL, in fibromyalgia and PTSD toward NDA approvals.
There is a pressing need for new drugs to treat patients with fibromyalgia, especially considering that approximately one-third of fibromyalgia patients are on chronic opiates. Tonix could potentially address this need for a non-opiate, non-addictive analgesic for fibromyalgia and possibly other indications in which improvement in sleep quality can indirectly provide clinical benefit to the primary symptoms.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that the news leads to moves. When it comes to Tonix Pharmaceuticals, the news proved to be overwhelmingly positive.
After all, the expansion of the TNX-102 SL program to address fibromyalgia means that the company may have yet another potential New Drug Application on the horizons. If all goes well, the door will be opened to yet another revenue stream.
So, it’s not surprising to see that excited investors are pushing the stock on a run for the top in the market this morning. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:06), TNXP is trading at $2.79 per share after a gain of $0.46 per share or 19.74% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on TNXP. In particular, we’re interested in following the story surrounding the company’s continued work to bring Tonmya to market for both PTSD and fibromyalgia. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!