4 Top Small-Cap Biotech Stocks Approaching FDA Approval

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In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), which allows the US Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the drug review and approval process. The act required the FDA to reach approval decisions on novel treatments within certain deadlines in order to accelerate patient access.

These PDUFA dates can have huge implications on the performance of biotech stocks and are often make or break deadlines for smaller pharmaceutical firms whose entire business may depend on that very decision. Huge swings in stock prices are very common for biotech stocks, particularly those classed as penny stocks, at the PDUFA stage, and that can be excellent news for investors in the know. Let’s take a look at four companies with PDUFA deadlines arriving in the next few months.

But while you’re here, you might also want to check out our piece from last month on four biotech stocks that are racing to develop a coronavirus vaccine.

IntelGenx Technologies Corp (TSXV:IGX) (OTCQX:IGXT)

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Established in 2003 in Montreal, IntelGenx is an oral drug delivery company that specializes in developing oral soluble films for the treatment of a variety of illnesses. IGXT announced in October that the FDA had assigned a PDUFA deadline of March 26 to approve its Rizaport treatment, which is the first oral disintegrating film for the treatment of migraines to achieve marketing approval in the EU.

This treatment has specific benefits for patients who suffer from migraine-related nausea, estimated to be approximately 80% of migraine sufferers, and patients suffering from dysphagia (difficulty swallowing). Global migraine sales are estimated to reach US$8.7 billion by 2026, and so this treatment could be the first of its kind to tap into a hugely underserved market.

This biotech penny stock has seen some interesting movements over the last couple of months. Valued as high as $0.70 just under a year ago, IGXT has fallen to around the $0.40 mark after the FDA issued a Complete Response Letter (CRL) in response to the Rizaport application, which is just a request for more information relating to the Chemistry, Manufacturing, and Controls section of the application. IGXT’s current valuation of $0.40 could be a huge bargain ahead of that March 26 deadline.

Rockwell Medical Inc (NASDAQ:RMTI)

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Rockwell Medical is a biotech stock dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD) and chronic kidney disease (CKD). Rockwell’s exclusive renal drug therapy, Triferic, supports disease management initiatives to improve the quality of life and care of dialysis patients and is intended to deliver safe and effective treatment while decreasing drug administration costs and improving patient convenience.

>> TLSA Stock Soars to 52-Week High on Potential Coronavirus Treatment

Triferic currently comes in two forms, Dialysate Triferic and IV Triferic. The dialysate version of the treatment is already FDA approved and commercially available as of last May and has helped drive a steady 80% gain for the biotech stock despite limited availability at the minute. The IV version of the drug is currently at the PDUFA stage with a decision expected on March 28, and if those gains in its sister treatment are anything to go by, RMTI could soon move well above its current value of just $3.33.

Durect Corporation (NASDAQ:DRRX)

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Durect is in a slightly different position to the other biotech penny stocks mentioned here, but the upside remains equally impressive. The company manufactures Posimir, which is a post-operative pain relief treatment designed to be administered directly into the surgical site to deliver bupivacaine for up to three days after surgery. The company has completed 16 trials for Posimir involving over 1,600 patients, which have shown a significant decrease in pain and opioid consumption over the 72 hour period following surgery as compared to placebo.

This is where things get interesting for Posimir. The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) actually reached a split decision on approving the treatment in January, with six in favor and six opposed. The AADPAC’s decisions are simply recommendations, with no definitive date set for the FDA’s final approval. However, the authority has been pushing for a substitute for opioid painkillers for years, so Posimir’s potential in that field could tip the scales in favor of Durect.

This biotech stock is currently trading for $1.88, having spiked to $3.80 ahead of the AADPAC’s recommendation. However, the stock is still up a massive 268% since the beginning of 2019 as the market warms to the potential of Posimir.

Correvio Pharma Corp (NASDAQ:CORV)

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This biotech penny stock is focused on providing treatments for the in-hospital, acute care market segment. Its treatments specialize in hospital-acquired diseases such as acute bacterial skin and skin structure infections, pneumonia, and acute coronary diseases, among others. The company is currently in the PDUFA stage for Treyvent, a drug-device combination product that combines two-day, single-use, disposable PatchPump technology with treprostinil, for the subcutaneous treatment of Pulmonary arterial hypertension (PAH).

PAH is a type of high blood pressure that occurs in the right side of the heart and in the arteries that supply blood to the lungs. There is no cure for PAH, but several medications are available to treat symptoms, such as the market-leading therapy, Remodulin (treprostinil) Injection, which is manufactured by United Therapeutics Corporation and brought in almost US$600 million in revenue in 2018. Treyvent has a PDUFA deadline of April 27, and with CORV stock currently trading at just $0.44, it could take off very quickly.

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