E Protalix BioTherapeutics Pipeline Progress

Protalix Biotherapeutics (PLX) offers great potential in the coming months. The NYSE-traded, Israel-based biopharma has a pipeline of "proprietary, potentially clinically superior versions of recombinant therapeutic proteins that target established pharmaceutical markets" that is looking increasingly robust - particularly its lead candidate, PRX-102 (Pegunigalsidase alfa). Even amidst the pandemic, the company has managed to stay on track - the fast track, in fact, that was granted in 2018 by the FDA - submitting its Biologics Licensing Application (BLA) for accelerated approval in late May 2020, as well as completing one Phase III study.

PRX-102 is a therapy for Fabry Disease, a rare genetic disorder that nonetheless generates $1B for Sanofi with its drug Fabrazyme. Not only is PRX-102 years newer than Fabrazyme, but new standards are in place for approval that should give prescribers more confidence with the newer medication. 

According to the company:

"Fabry disease is an X-linked inherited disease that results from abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person’s body. Fabry disease occurs in one person per 40,000. Fabry patients inherit a deficiency of the enzyme alpha-galactosidase-A, which is normally responsible for the breakdown of Gb3. The abnormal storage of Gb3 increases with time and, accordingly, Gb3 accumulates, primarily in the blood and in the blood vessel walls. The channels of blood vessels narrow, leading to decreased blood flow and decreased tissue nourishment. The ultimate consequences of Gb3 deposition range from episodes of pain and impaired peripheral sensation to end-organ failure—particularly of the kidneys, but also of the heart and the cerebrovascular system. Fabry disease is generally treated with enzyme replacement therapy (ERT), meaning the replacement of the missing alpha-Galactosidase-A enzyme with a recombinant form of the protein via intravenous infusion once every two weeks."

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Disclosure: This article is part of a new “UnderCovered” series of exclusive articles featuring companies with limited coverage. Authors are compensated by TalkMarkets for their time, and ...

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Richard M. Clark 1 year ago Member's comment

Just read another good article about $PLX out today:

There Is Beta In Protalix Stock Due To PRX-102


Harry Goldstein 1 year ago Member's comment

#Protalix clearly has a lot of potential but there's a limited number of people who will need this drug. So the real question is how much of a dent will they put into #Sanofi's market share. $PLX $SNY

Terrence Howard 1 year ago Member's comment

@[Moon Kil Woong](user:5208), what's your take on this company?

Moon Kil Woong 1 year ago Contributor's comment

Unfortunately there is already a drug to treat this, so it is less likely to get accelerated approval and until it shows itself to be more effective than the existing drug adoption may be in question. I'd look to the financials on this company which I don't know much about.

That said, there is no guarantee it will be markedly better in phase III vs the existing drug. The good news is the FDA is now more open to allowing competing drugs with the same effect to lower costs.

Dave Schneider 1 year ago Member's comment

Thanks for your thoughts. I'm interested in this company but would like to see more info about $PLX before investing. However, good coverage seems to be sparse.

Moon Kil Woong 1 year ago Contributor's comment


There are also reports out by Jeffries and HC Wainwright on this.

Andrew Armstrong 1 year ago Member's comment

True but it does sound promising. Like you, I'd be curious to see more info about the actual financials. But there is risk with every investment, and the greater the risk, the greater the potential payout.

Adam Reynolds 1 year ago Member's comment

What's the market size for this new PRX-102 drug? How many people have Fabry disease? I had never heard of it.

Old Time Investor 1 year ago Member's comment

It's actually more common than you'd think. According to the article, Fabry disease occurs in one person per 40,000. But from my own research (ala Google), I know it affects about one in every 40,000 to 60,000 men worldwide. It can affect women as well but the prevalence is unknown.

Adam Reynolds 1 year ago Member's comment

Thank you! I was wondering why the author, @[Terry Chrisomalis](user:5023), never responded, so appreciate that you did.

Old Time Investor 1 year ago Member's comment

My pleasure. What's more important than how prevalent the disease is, is how much money #Protalix can make on its new drug. It's competitor, #Sanofi ($SNY) makes $1 billion in revenue annually on their drug. Protalix's sounds like a more promising alternative. I'd definitely rate $PLX a buy.

William K. 1 year ago Member's comment

Interesting article indeed.

Getting any drug or treatment approved without using that horribly cruel double blind test would certainly be a benefit to those afflicted. It seems that the FDA would much rather let hundreds of folks die that pass up their testing process. I would rather such people were not in authority at all.

Andrew Armstrong 1 year ago Member's comment

Good article, nicely done. I will be checking out $PLX.

John Doee 1 year ago Member's comment

Thank you for this article. Are there any other recombinant therapeutics that are in the pipeline for them? $PLX

Wendell Brown 1 year ago Member's comment

Good Q.

Terry Chrisomalis 1 year ago Author's comment

PRX-110 for cystic fibrosis and OPRX-106 for irritable bowel syndrome are other pipeline products.

John Doee 1 year ago Member's comment

Thank you!

Barry Glassman 1 year ago Member's comment

Sounds like some very promising progress! $PLX