Skip to content

FDA

Get A Leg Up From “The Novel Drug Craze”

Although a controversial decision, the FDA has approved Biogen’s Alzheimer’s drug, Aduhelm – and the decision caused Biogen’s stock to surge more than 60% in one day. On the heels of this, and with novel drug approvals on the rise, the contributors to today’s article discuss Biogen’s approval “and how ‘novel’ drugs can give biotech stocks a leg up …… 

A Short Biotech Idea

The small-cap biotech company featured in today’s article experienced a remarkable rally over the last few months. However, with the FDA having just approved its most advanced asset, a treatment for ADHD, the author believes that this “exhausts the company’s largest catalyst, and [they] do not see any material new catalysts any time soon.” With that, and with doubts about… 

These Biotechs Are Awaiting FDA Decisions In January

While the most important decisions made by the FDA in December were undoubtedly the Emergency Use Authorizations for two COVID-19 vaccines, the month also saw a number of firsts on the regulatory front, including the authorization of the first test allowing for at-home collection of patient samples to detect both COVID-19 and influenza A and B. Now, today’s article takes… 

What Could Cause These 3 Biotech Stocks To Explode Higher Next Year – And What Could Go Wrong

Compelling clinical trial data and decisions from the FDA could send one, two, or all three of the biotech stocks highlighted in today’s article through the roof next year. For a look at each of these three biotech stocks and their respective catalysts – as well as a consideration of the potential pitfalls associated with each of them – CLICK… 

Bad News For Its Competitor Could Be Great News For This Small-Cap Biotech – And Its Shareholders

In January, the small-cap biotech highlighted in today’s article received FDA approval for its treatment for childhood peanut allergy – and with peanut allergy being the most common food allergy in the U.S. (with cases of the condition rising rapidly) and the fact that this is currently the only FDA-approved treatment for the condition (thanks to a competitor encountering some… 

A Look At One Of The Newest COVID-19 Stocks

Joining the ever-expanding list of COVID-19 stocks is this biotech that has filed an application with the FDA for initiation of Phase 2/Phase 3 clinical trials for its experimental monoclonal antibody therapy for the disease. The safety and tolerability of the therapy has already been demonstrated and, as today’s article explains, the company believes that its modulating effect “could reduce…