Ampio Pharmaceuticals Inc (NYSEAMERICAN: AMPE) is having a great day in the market today after announcing a regulatory update with regard to its lead candidate, Ampion. Of course, the update excited investors, sending the stock on a run for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from AMPE; and
- what we’ll be watching for ahead.
AMPE Is Rocketing On A Regulatory Update
As mentioned above, Ampio is having a strong day in the market today after the company announced a regulatory update with regard ot the status of Ampion. Ampion is a treatment currently under development by AMPE for pain due to osteoarthritis of the knee.
In the release, the company said that staticians representing it and the FDA recently met to discuss the clinical pathway for the treatment. During this meeting, all KL-4 patients that took part in each single injection trial, were sugjected to a statistical review.
Following the review, the FDA scheduled an additional, internal meeting that will include reviewers from the Office of Tissue and Advanced Therpaies (OTAT). Since then, OTAT has indicated that it will provide final guidance by mid-December. OTAT will also determine whether the clinical trial portion of the Ampion BLA process is complete or will require an additional trial.
At the moment, chances seem positive. In fact, AMPE even pointed to a recent comprehensive review article that was published in Current Rheumatology Reviews. The article, titled “On the mechanisms of action of the low molecular weight fraction of commercial human serum albumin in osteoartheritis,” the reviewer describes inflammation and healing biochemical pathways. These pathways were relevant to OA and are affected by at least three of the well characterized chemical components within Ampion.
It is also worth mentioning that AMPE said that Scientific Advisory Board members, David Bar-Or MD, Edward Brody MD, Ph.D. and Pablo Rubinstein MD, stated that
…available in vitro and in vivo data are highly suggestive of Ampion being a safe and effective disease-modifying drug for OAK (DMOAD).
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 Ampio, the news proved to be incredibly positive. After all, the company will be finding out if the clinical trials side of development for Ampion is complete, and the strong data produced in trials and comments from members of the Scientific Advisory Board suggest that this may just be the case. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (11:50), AMPE is trading at $0.65 per share after a gain of $0.07 per share or 12.05% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on AMPE. In particular, we’re interested in following the story surrounding the company’s continued work to bring Ampion to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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