These 3 Biotech Stocks are Facing a Key US FDA Decision

Some of the best opportunities can be found in biotech.

Especially if they’re heading into a potential US FDA approval. 

Here are just a few you may want to consider as we get deeper into the new year.

Aldeyra Therapeutics (SYM: ALDX)

In early April, the US FDA will make its decision on Aldeyra Therapeutics’ Reproxalap for the treatment of the signs and symptoms of dry eye disease, which impacts about 300 million people all over the world. Just in the U.S., there are about 16.4 million people. So, there’s a sizable market out there.  

Helping, “Reproxalap has demonstrated a significantly faster onset of action compared to other treatments in the dry eye space, with notable improvements in ocular discomfort within 30 to 35 minutes in a controlled trial,” as noted by Investing.com.

Even better, company Chairman David Mott recently bought about $1 million worth of the stock following a significant buy in December. 

Soleno Therapeutics (SYM: SLNO)

On March 27, the US FDA will decide on approving Soleno Therapeutics’ Diazoxide Choline Controlled-Release tablet (DCCR) for the treatment of Prader-Willi syndrome in individuals four years and older who have hyperphagia.

As noted by the company, “The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening feeling of intense, persistent hunger, food pre-occupation, extreme drive to food seek and consume food that severely diminish the quality of life for patients with PWS and their families.”

In the PWS Phase 3 clinical development program, DCCR showed promise in addressing hyperphagia, the hallmark symptom of PWS, as well as several other symptoms such as aggressive/destructive behaviors, fat mass and other metabolic parameters.

Milestone Pharmaceuticals (SYM: MIST)

On March 26, the US FDA will decide on approving Milestone Pharmaceuticals’ CARDAMYST nasal spray for the management of paroxysmal supraventricular tachycardia (PSVT) – a type of abnormal heartbeat characterized by rapid, regular heartbeats that originate in the upper chamber of the heart. These can start and stop without warning.

As noted by the company, “Milestone’s New Drug Application (NDA) for CARDAMYST nasal spray, its lead investigational product, for the management of PSVT, is under review at the U.S. Food and Drug Administration (FDA). The FDA has communicated that an advisory committee is not planned. Launch in PSVT targeted for mid-2025. Milestone is currently preparing for a commercial launch of CARDAMYST in mid-2025 pending FDA approval. 

Further Reading: We just released Our #1 AI Biotech Stock…

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  • Why Big Pharma signed over $3 billion in deals with this tiny AI-biotech.
  • And why Bill Gates owns over 10% of this company.

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