Will The Regulatory Catalyst Impact These 3 Small-cap Pharma Stocks This Month?

With just seven trading days left in this month, the following 3 small-cap pharma stocks are worth keeping an eye on.

Here’s why…

1. Eton Pharmaceuticals

Shares of Eton Pharmaceuticals Inc. (ETON) have nearly doubled in value from their 52-week low price of $4.38 to trade around $8.50.

Eton Pharma is a pharmaceutical company focused on developing and commercializing treatments for rare diseases.

The FDA decision on two of the company’s products – Dehydrated Alcohol Injection and Zonisamide Oral Suspension – is expected this month.

Dehydrated Alcohol Injection is proposed to counter methanol poisoning, which is often characterized by a decreased level of consciousness, poor or no coordination, vomiting, and abdominal pain. The incidence of methanol poisoning has increased significantly in 2020 due to COVID-19, as unprecedented demand for hand sanitizers has led some manufacturers to improperly use methanol in their products.

The regulatory decision on Dehydrated Alcohol Injection is expected on May 27, 2021.

The second product candidate Zonisamide Oral Suspension is proposed for the treatment of partial seizures in patients with epilepsy. Zonisamide is widely used as a capsule to treat partial seizures, but the molecule is not FDA approved in liquid form.

The FDA decision on Zonisamide Oral Suspension is expected on May 29, 2021.

In the first quarter ended March 31, 2021, the financial results of which were reported last week, the total revenue was $11.9 million compared to $99 thousand in the year-ago quarter.

ETON closed Wednesday’s trading at $8.56, up 1.54%.

2. Provention Bio

Shares of Provention Bio Inc. (PRVB) are well off their 52-week high of $20.05 and trade around $7.

Provention Bio is a biopharmaceutical company developing investigational therapies for debilitating and life-threatening immune-mediated diseases.

On May 27, 2021, an FDA panel will securitize the company’s investigational drug Teplizumab, proposed for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals.

The regulatory agency’s final decision was originally set for July 2, 2021. However, earlier this month, the company announced that there could be a delay in the FDA decision on Teplizumab.

If approved, Teplizumab could achieve peak global sales of $691 million in 2027, according to a GlobalData consensus.

PRVB closed Wednesday’s trading at $7.77, up 5.43%.

3. Lantheus Holdings

Shares of Lantheus Holdings Inc. (LNTH) have gained nearly 57% year-to-date to trade around $20.

Lantheus is an integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions.

The company’s lead investigational drug is PyL, a prostate specific membrane antigen-targeted positron emission tomography imaging agent for prostate cancer, under FDA review, with a decision expected on May 28, 2021.

PyL, also known as 18F-DCFPyL, enables visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.

Prostate cancer is the second most common cancer in American men and over 3.1 million people are living with it today.

If approved, PyL will compete with Bracco’s Axumin (fluciclovine F 18), which is already on the market and Telix Pharmaceuticals’ PSMA-targeted prostate cancer PET diagnostic imaging agent Illuccix, which is under FDA review, with a decision expected in September of this year.

LNTH closed Wednesday’s trading at $20.82, up 0.10%.

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