Stocks that receive approval from the FDA for their new drugs can often rocket to new highs. These three microcaps have upcoming PDUFA (Prescription Drug User Fee Act) dates that will impact their underlying stocks.
Tetraphase Pharmaceuticals, Inc. (NASDAQ: TTPH) learned earlier this year what it’s like to have the FDA not approve your crown jewel drug. The stock had traded as high as $9.93 last year before dropping to almost $2 on the negative FDA news.
The company now has a new date, and new hope, for it’s once-daily intravenous (IV) eravacycline drug, designed for hard-to-treat urinary tract infections. The FDA is reviewing the drug and has set a tentative date of August 28, 2018 for a decision.
On June 11th the company presented positive data on two trials of the drug that it had conducted. CEO and President of Tetraphase Pharmaceuticals, Guy MacDonald, stated they were “pleased to show that favorable clinical and microbiological responses were observed for eravacycline…” Holders of the stock will be rewarded if these favorable responses carry through to FDA approval.
EyePoint Pharmaceuticals (NASDAQ: EYPT) is developing sustained release products to treat retinal diseases and other eye conditions. The company has a November 5, 2018 PDUFA for it’s Durasert and Durasert micro-insert products.
The Durasert product is already marketed in the U.K, Germany and Portugal, and is awaiting approval in 13 other countries in addition to the United States.
The product is superior to others on the market in that it treats a hard to reach areas of the eye, where for certain conditions, medicine must be delivered on a regular basis.
Instead of eye injections every few months, the Durasert product is inserted and delivers the needed medicine without injections. If EYPT receives FDA approval in November the stock’s investors may be “eyeing” a hefty profit.
Trevena, Inc. (NASDAQ: TRVN) develops pain relievers for moderate-to-severe acute pain, such as that associated with a migraine.
Trevena’s Oliceridine injection has been designated a Breakthrough Therapy by the FDA, and has a PDUFA date of November 2, 2018.
The stock has been range bound this year, trading between $1.50 and $2.30. With the stock trading in the $1.60s, now may be a good time to establish a position.
The company also recently added three experienced marketing and medical affairs members to their staff, perhaps in anticipation of getting an approved drug into patient’s hands.
FDA approval of their product may positively impact one or more of these microcaps in the next few months. Taking a position now may prove to be a prudent investment headed into year-end.
Disclaimer: The author and Spotlight Growth has no positions in any of the stocks mentioned in this article. Nor does either party currently have any relationship, or any other conflicts of interest, with any of the companies mentioned in this article. This content is meant for informational and entertainment purposes only and should not be meant as a recommendation to buy or sell any securities. Please visit a licensed financial representative to determine what investments are right for you.
Article By: Steven Adams