scPharmaceuticals Inc (NASDAQ: SCPH) is having an incredibly rough start to the trading session this morning after the United States Food and Drug Administration decided not to approve the company’s 505(b)(2). Of course, the news upset investors, leading to big declines in the value fo the stock. Today, we’ll talk about:
- The FDA rejection;
- what we’re seeing from SCPH as a result;
- and what we’ll be watching with regard to the stock ahead.
SCPH Sinks On FDA Rejection
As mentioned above, scPharmaceuticals is having an incredibly rough start to the trading session this morning after the company announced that it has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA). In a press release issued early this morning, the company said that the CRL was with regard to the company’s 505(b)(2) application surrounding FUROSCIX®. FUROSCIX® is a treatment in development by the company as a candiate for edema, or fluid overload, in patients with heart failure.
In the release, SCPH announced that the CRL indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study. The comapny said that it plans to request a meeting with the FDA to further evaluate the regulatory agency’s concerns. In a statement, John Tucker, President and CEO at SCPH, had the following to offer:
While we are disappointed with the outcome of the review, we are committed to addressing the issues of the CRL and bringing this important product to market… Our team will continue to work closely with the FDA to determine an appropriate path forward regarding product performance, appropriate patient identification, and risk mitigation strategies that ultimately enable a timely resubmission of the FUROSCIX NDA.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to invest is that the news moves the market. In the case of scPharmaceuticals, the news proved to be overwhelmingly negative. After all, with this rejection, the company will need to spend a massive amount of money on further trials and adjustments at best. At worse, the company will need to scrap the product and cut its losses. So, it’s no surprise that upset investors are sending the stock spiraling for the bottom. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:27), SCPH is trading at $5.60 per share after a loss of $2.01 per share or 26.41% 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 SCPH. In particular, we’re interested in following the story surrounding the company’s plans with regard to FUROSCIX® following the news of the rejection from the FDA. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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