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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).

Meanwhile HC Wainwright’s Ed Arce calls approval “nearly certain.” As a result, this top-performing analyst bumps up his price target from $7 to $8 (93% upside potential).

If priced right the drug could capture a significant market share — with some analysts looking at 2026E peak Dsuvia revenue of over $300MM.

The stock boasts 6 recent buy ratings vs just 1 hold rating. This is with a $7.83 average price target, suggesting shares could surge 89%.

(Click on image to enlarge)

View ACRX Price Target & Analyst Ratings Detail

November 28- Catalyst Pharma (CPRX)

This is a biopharma developing therapies for rare debilitating neuromuscular and neurological diseases. Right now Catalyst Pharmaceuticals Inc’s (CPRX – Research Report) lead candidate is Firdapse for several rare disorders including Lambert-Eaton myasthenic syndrome (LEMS). This is an autoimmune disease that interferes with the ability of nerve cells to send signals to muscle cells.

The FDA has set the PDUFA date for Firdapse at November 28, 2018. And so far the outlook is very optimistic. “Physicians with whom we spoke who treat LEMS and are familiar with Firdapse uniformly expect approval on/around the 11/28 PDUFA date” cheers Oppenheimer’s Leland Gershell (Track Record & Ratings).

“Key opinion leaders expressed few reservations around Firdapse’s approval prospects based on its Phase 3 efficacy data and safety profile. They also added supportive anecdotes from their personal clinical experience” the analyst said.

As a result, he has a $6 price target on the stock (84% upside potential).

Gershell believes the drug will generate sales revenue for CPRX by early 2019, and ultimately achieve ~$475M in 2025E sales. Indeed, preparations for an early January launch are already well underway with senior level hires and payor discussions.

“We are encouraged by management’s confidence in approval and in its strategy to transition the existing patient base onto its drug within the first year” adds Cantor Fitzgerald’s Charles Duncan.

In total five analysts have published recent buy ratings on CPRX. With an average price target of $6.80, the Street is expecting prices to double from current levels.

(Click on image to enlarge)

View CPRX Price Target & Analyst Ratings Detail

Also keep an eye out for:

TherapeuticsMD, Inc. (TXMD)- With only a few days to go, all eyes are on TXMD. Earlier this year, the FDA set the PDUFA date for TX-001HR as October 28. If approved, TX-001 would be the first FDA-regulated estrogen plus progesterone (E+P) product. The drug is designed to reduce the frequency and severity of hot flashes.

Ocular Therapeutix, Inc. (OCUL) OCUL has a clear goal: to pioneer a new era of drug delivery in ophthalmology. The big hitter here is Dextenza for the treatment of post-surgery eye pain and inflammation. And if all goes smoothly the FDA could approve Dextenza on or before the December 28 PDUFA date.