2 Hot Biotechs With Major FDA Catalysts

TM editors’ note: This article discusses a penny stock and/or microcap. Such stocks are easily manipulated; do your own careful due diligence.

Biotech stocks can soar or plunge depending on FDA decisions. Both biotechs below have a fast-approaching PDUFA date. This stands for the Prescription Drug User Fee Act- and the PDUFA date is the deadline by which the FDA must approve or reject new drug applications (NDAs).

There’s no doubt that buying ahead of PDUFA dates is a risky call. That’s why turning to analyst reports can help. 

Let’s take a closer look at some key dates to track now. And for those risk-tolerant investors who decide to take a shot, good luck. Because when you get it right, the returns for biotech stocks can be very lucrative indeed. For example, Madrigal Pharmaceuticals sparked 135% in May following successful mid-stage trial data for fatty liver disease.

November 3- AcelRX (ACRX)

On November 3 the FDA will approve or reject AcelRx Pharmaceuticals Inc.’s (ACRX – Research Report) tablet Dsuvia for acute pain. Note that Dsuvia has already been rejected once. Last year shares crashed over 50% following a request from the FDA for additional safety information. However shares are already back up 105% year-to-date.

This is an opioid sublingual drug so powerful it will only be administered to adult patients in a medically supervised setting — and where other treatments are inadequate.

But now ACRX is back for round two. Encouragingly the drug has already received thumbs up from a positive Advisory Committee vote on 12 October 2018. The committee voted 10-3 in favor of the drug’s approval. Although this vote isn’t binding, the FDA does tend to follow the committee’s advice.

“Following [the vote] we expect ACRX’s lead product Dsuvia to gain approval by its PDUFA date of 11/3/2018. If approved we believe Dsuvia peak sales could be in excess of $350MM,” cheers Cantor Fitzgerald’s Louise Chen (Track Record & Ratings).