AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) could see some very strong times ahead, and for good reason. While the company reported an earnings report that missed the mark on Friday, something else happened that made it so that investors weren’t concerned. The company received FDA approval for Dsuvia, an incredibly powerful pain killer. Today, we’ll talk about:
- The approval and how it changes the game;
- what we’re seeing from ACRX stock; and
- what we’ll be watching for ahead.
How the Dsuvia Approval Changes The Game For ACRX
As mentioned above, AcelRx earnings didn’t hit the mark investors were hoping it would, but with the announcement of an FDA approval on the same day, earnings were the last concern on investor’s minds, and for good reason. Regulatory approvals are always a great thing for biotech stocks, but for ACRX, this approval really changes the game.
First and foremost, while the company has received two approvals in the EU, the Dsuvia approval marks the first time the company has received authorization to market a drug in the United States. This is key as prices for treatments are higher in the United States, giving ACRX a stronger ability to improve upon revenue.
However, the approval of Dsuvia and what it means for the company go far further than that. Sure, it’s the company’s first US approval and yes, it’s the opportunity to break into the world’s largest healthcare market that the company has been waiting for. However, it also shows the strength of the team at AcelRx.
The truth of the matter is that Dsuvia is a massively potent opiod. In fact, it is considered to be 1,000 times stronger than morphine and 10 times stronger than fentanyl. The disolvable pill is a fast-acting alternative to IV painkillers often used in hospitals. However, at the moment, we’re going through an opiod epidemic and even politicians were pushing for the FDA to reject the treatment. One of the biggest opponents to the ACRX pain killer was Democratic Senator, Ed Markey of Massachusetts. In fact, Markey urged the FDA not to approve the pain killer last month, stating:
…an opioid that is a thousand times more powerful than morphine is a thousand times more likely to be abused, and a thousand times more likely to kill.
Nonetheless, even through the political backlash, ACRX was able to show meaningful reasons for the treatment to be approved, and the FDA agreed. At the end of the day, if that’s not a show of strength in this relatively small biotechnology company, I don’t know what would be!
What We’re Seeing From The Stock
With the recent approval of Dsuvia, it only makes sense that investors and traders alike are watching AcelRx incredibly closely. As you can imagine, even early in the pre-market session, the stock is seeing gains. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:42), ACRX is trading at $4.93 per share after a gain of $0.13 per share or 2.71% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
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 commercialization of Dsuvia, now that the treatment has been approved for marketing in the United States. With this approval, the company has the opportunity to expand revenue like it has not had in the past. So, this could be a very strong opportunity ahead. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!