Palatin Technologies, Inc. (NYSEAMERICAN: PTN) is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced news surrounding an accepted New Drug Application (NDA). Of course, the news led to excitement among investors, sending the stock on a run for the top. Today, we’ll talk about:
- The NDA acceptance;
- what we’re seeing from PTN as a result; and
- what we’ll be watching with regard to the stock ahead.
PTN Announces NDA Acceptance
As mentioned above, Palatin Technologies is having an incredibly strong start to the trading session this morning after the company announced that it has received news from the United States Food and Drug Administration (FDA). According to a press release issued by the company early this morning, the FDA has accepted the NDA of bremelanotide for filing. Bremelanotide is being developed as a treatment for hypoactive sexual desire disorder in premenopausal women. In the release, PTN said that the NDA was filed by AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), its exclusive North American licensee.
In the release, PTN said that the Prescription Drug User Fee Act (PDUFA) goal date for completion of the review is March 23, 2019. This is a key catalyst, as, if the treatment is approved, it will be the only as-desired pharmacologic option in the United States that is indicated for the treatment of this condition.
The news also means that Palatin Technologies will be receiving a decent chunk of funding. In fact, the acceptance of the FDA triggers a $20 million milestone payment under the agreement with AMAG minus agreed upon deductions for expenses incurred by AMAG. Moving forward, PTN is eligible to receive up to an additional $60 million upon regulatory approval of the treatment by the FDA. Once approved, the company is entitled to royalties of high single-digit to low double-digit percentages as well as up to $300 million in milestone payments based on sales. In a statement, Carl Spana, Ph.D., President and CEO at PTN, had the following to offer:
We are very pleased with the FDA’s acceptance of the NDA filing for bremelanotide… This is an important milestone for Palatin and reflects our drive and commitment to the development of novel therapies to treat conditions with significant unmet medical need and commercial potential. We look forward to assisting AMAG during the FDA review process. HSDD is an underserved medical condition and, if approved, bremelanotide has significant potential as an as-desired treatment of HSDD in premenopausal women.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In the case of Palatin Technologies, the news proved to be overwhelmingly positive. After all, acceptance of the NDA brings bremelanotide one step closer to the commercial stage, which could drive revenue. Not to mention the revenue generated through the acceptance of the NDA. So, it’s no surprise that excited investors are sending the stock screaming for the top. Currently (8:01), PTN is trading at $1.29 per share after a gain of $0.10 per share (8.40%) 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 PTN. In particular, we’re interested in following the story surrounding the bremelanotide NDA, as the approval of the NDA could be a strong value driver for the company and its investors. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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