AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) is having an overwhelmingly rough day in the market today, and for good reason. The United States Food and Drug Administration (FDA) has rejected the company’s painkilling drug. Of course, this is causing fear among investors, sending the stock spiraling down to the bottom. As is normally the case, our partners at Trade Ideas were the first to alert us to the declines. Currently (9:42), ACRX is trading at $2.22 per share after a loss of $3.13 per share (58.48%) thus far today.
ACRX Falls On FDA Rejection
As mentioned above, AcelRx Pharmaceuticals is having a rough start to the trading session this morning after the company announced that it has received a Complete Response Letter from the FDA with regard to the New Drug Application for DSUVIATM. As we know, CRLs are never a good thing, as they mean that the FDA has rejected the application.
In the CRL, the FDA said that it has determined that it cannot approve the NDA in its present form. The FDA has provided two recommendations to the company for what it expects to see upon resubmission. First and foremost, while the safety database was suitable in a number of patients, the FDA wants to see the collection of additional data on at least 50 patients to further assess the safety of DSUVIA at the maximum amount described in the proposed labeling for the treatment.
The FDA also said that it wants to ensure proper administration of the tablet with the single-dose applicator. As a result, the FDA recommended certain changes to the Directions for Use to address use-related errors, including dropped tablets, to be validated through a human factors study. In a statement, Vincent J. Angotti, CEO at ACRX, had the following to offer:
“We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings.”
In their press release, ACRX said that it plans to request a meeting with the FDA in order to discuss topics covered in the CRL as well as confirm its plan to move forward with the resubmission of the NDA. The company also informed its investors that it ended the third quarter with about $67.9 million in cash and it plans to provide further financial updates on its third quarter earnings call.
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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 ongoing work to bring DSUVIA to market. Considering the requests by the FDA, while work is needed, the rejection can be overturned in time, and it is possible that the treatment will make it to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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