AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) is having an incredibly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced the acceptance of an NDA resubmission by the FDA. Of course, the news excited investors, sending the stock on a tear for the top. Today, we’ll talk about:
- The NDA;
- what we’re seeing from ACRX;
- and what we’ll be watching for ahead.
ACRX Heads For The Top On NDA Acceptance
As mentioned above, AcelRx Pharmaceuticals is having an incredibly strong start to the trading session this morning after the company announced FDA news. In a press release issued early this morning, the company announced that the United States Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) surrounding DSUVIA™. In the release, ACRX said that the FDA considers the DSUVIA NDA resubmission to be a complete class 2 response to their action letter sent back in October of 2017. As a result, the application is under review with a decision expected to be seen no later than November 3, 2018. In a statement, Vince Angotti, CEO at ACRX, had the following to offer:
The acceptance of the DSUVIA NDA resubmission is yet another important milestone achieved by the Company this year… We are one step closer to potentially delivering a new, non-invasive treatment option for the management of moderate-to-severe acute pain for adult patients in medically supervised settings. We believe DSUVIA, if approved, also has the opportunity to help U.S. hospitals manage through the intravenous opioid shortage1 they are currently experiencing in their facilities.
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 AcelRx Pharmaceuticals, the news proved to be overwhelmingly positive. With the acceptance of the NDA for DSUVIA by the United States FDA, the company is one step closer to bringing this product to market, and generating revenue in the process. So, it comes as no surprise that excited investors are sending the stock screaming for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:23), ACRX is trading at $3.30 per share after a gain of $0.15 per share or 4.76% 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 ACRX. In particular, we’re interested in following the story surrounding the company’s ongoing work to bring DSUVIA to the market and the FDA’s review of the treatment. Nonetheless, we’ll continue to follow the news closely and bring the updates to you as they break!
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