Arch Therapeutics Inc (OTCMKTS:ARTH) has been back on the warpath in recent action, ripping as much as 40% higher in the past month on several new catalysts. The most important recent move for ARTH is captured by its announcement this week that the Company made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its AC5 Topical Gel on July 17, 2017.
If the Company’s 510(k) application is cleared by the FDA, it is expected that the AC5 Topical Gel will be used for external wounds. “This is an important milestone for Arch,” said Terrence W. Norchi, President and CEO of Arch Therapeutics, Inc. “As previously shared, we planned to request 510(k) clearance in the middle of 2017 for the external use AC5, which is a significant acceleration from original expectations of seeking U.S. regulatory approval through the PMA process, and we have met that goal. This achievement illustrates the ability of our team to execute on our development and regulatory strategies.”
Arch Therapeutics Inc (OTCMKTS:ARTH) bills itself as a company that operates as a life science medical device maker. The company focuses on developing products based on a novel technology to stop bleeding and control leaking during surgery and trauma care.
Its lead product candidate is AC5 Surgical Hemostatic Device, a biocompatible synthetic peptide comprising naturally occurring amino acids to achieve hemostasis in minimally invasive and open surgical procedures. It’s an innovative self-assembling peptide technology platform but is still in development at this point.
The company was founded in 2006 and is based in Framingham, Massachusetts.
According to company materials, “Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care. Arch is developing products based on an innovative self-assembling materials technology platform with the goal of making care faster and safer for patients. Arch’s initial development stage product candidates are the AC5 Surgical Hemostatic Device and AC5 Topical Hemostatic Device.”
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As noted above, the company recently announced that it made a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its AC5 Topical Gel last week. The stock has been red hot over the past month. The last couple days have seen a strong hold of support at a rising 200-day simple moving average, which is the definitive technical signal, traditionally, for a bull trend move.
According to the release, as previously disclosed, the Company still plans to seek regulatory approval to market other AC5 products for internal use through the PMA process. Arch will continue to concentrate resources on the rest of its development and regulatory objectives. The Company is also working to scale up production and at the present time expects to have commercial product available in the second half of 2018. In the interim, Arch will continue to evaluate its commercialization options and it will provide further guidance as appropriate.
Dr. Norchi added, “This 510(k) submission, which incorporates recommendations provided by the FDA during pre-submission communications, is the culmination of the collective effort and success of our team in completing important biocompatibility, toxicology, preclinical, and clinical studies. Simultaneously, we continue to make progress on our preclinical pipeline, including several product applications with high unmet medical needs.”
We’ve witnessed 10% piled on for shareholders of the company during the trailing month. This is emblematic of the stock. ARTH has a track record that includes a number of dramatic bounces. What’s more, the name has seen an influx in interest of late, with the stock’s recent average trading volume running 57% over what the stock has registered over the longer term.
At this time, carrying a capital value in the market of $99.5M, ARTH has a significant war chest ($7.2M) of reported cash on the books, which compares with virtually no total current liabilities. The company is pre-revenue at this point. This is an exciting story, and we look forward to a follow-up chapter as events transpire. For continuing coverage on shares of $ARTH stock, as well as our other breakout picks, sign up for our free newsletter today and get our next hot stock pick!
Disclosure: we hold no position in $ARTH, either long or short, and we have not been compensated for this article.