FSD Pharma Jumps 200% After FDA Nod For Initiating Proof-Of-Concept Study Of COVID-19 Treatment

Comments
Loading...

Shares of FSD Pharma Inc HUGE are advancing strongly Wednesday following an announcement regarding a potential COVID-19 drug.

What Happened?

FSD said the FDA has approved its IND application for studying FSD-201 for the treatment of SARS-CoV-2, the virus that causes COVID-19. FSD-201, according to the company, is ultramicronized palmitoylethanolamide, or PEA.

The company clarified that it's focused on developing the investigational asset for its anti-inflammatory properties to avoid the cytokine storm associated with acute lung injury in hospitalized COVID-19 patients.

"We contacted the FDA in late-March 2020 after becoming aware that several Italian physicians and scientists were advocating for use of ultramicronized PEA for patients suffering from symptoms of COVID-19, based on the drug's mechanism of action as a potent and safe anti-inflammatory agent that reduces the production of pro-inflammatory cytokines," said Raza Bokhari, co-chairman and CEO of the company.

Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates

What's Next?

Based on the feedback from the FDA, FSD plans to conduct the proof-of-concept, or Phase 2a study, to assess the safety and efficacy of FSD-201, dosed 600mg or 1,200mg, twice-daily, plus standard-of-care, compared to standard-of-care alone in symptomatic COVID patients.

The company said the primary endpoint would be a significant improvement in clinical status – shorter time to symptom relief.

FSD said it expects the treatment period to be 14 days.

In pre-market trading, FSD shares were jumping 222.58% to $10.

Market News and Data brought to you by Benzinga APIs

Posted In:

Cannabis is evolving—don’t get left behind!

Curious about what’s next for the industry and how to stay ahead in today’s competitive market?

Join top executives, investors, and industry leaders at the Benzinga Cannabis Capital Conference in Chicago on June 9-10. Dive deep into market-shaping strategies, investment trends, and brand-building insights that will define the future of cannabis.

Secure your spot now before prices go up—this is where the biggest deals and connections happen!

Get your tickets today!