E PLX Upcoming Volatility Creates Opportunity

Protalix (PLX) was up on FDA notice last year on a CRL postponement that its PDUFA review of PRX-102. In the meantime, phase III trials continue to provide more positive results.  

Then, on June 2, the company reported more interim data on its Phase III Balance study, and Protalix came out with this statement:

The initial top-line results show that the lower boundary of the confidence interval for the mean difference between the two treatments was below the non-inferiority margin pre-specified for this interim analysis in the ITT analysis set and above such limit in the PP analysis set. At the time of this analysis, two patients discontinued participation due to treatment emergent adverse events (TEAEs). Of these two patients, one discontinued participation due to a related adverse event.

The potential advantages of PRX-102 over Fabrazyme are two. First, in the frequency of dosing, and second, in immunogenicity. With an enzyme replacement therapy like Fabrazyme, an immune reaction against the enzyme tends to eventually develop. With PRX-102, the formulation of the enzyme is designed to inhibit an immune response, and the data show it. Of 30 patients enrolled, 20 patients remained negative for anti-drug antibodies, and of the 10 patients who were initially positive, four became negative at 12 months.

A Class A meeting with the FDA should be upcoming with regard to the next steps to clear the inspection hurdle that brought the CLR. The timeline for commercial launch now moves to Europe for the first half of 2023. With the FDA timeline delay due to the final inspection of their lab in Isreal the FDA results are important and have increased importance Protalix. With this event upcoming shortly there is a potential for serious movement into the stock price in the next month. 

Protalix shares well in April on a CRL received from the FDA. The CRL made no mention of any data but was most likely a logistics issue as an FDA team could not travel to Israel to inspect Protalix Facilities, but Israel is opening up travel again.

1 2 3
View single page >> |

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 ...

more
How did you like this article? Let us know so we can better customize your reading experience.

Comments

Leave a comment to automatically be entered into our contest to win a free Echo Show.
Moon Kil Woong 1 month ago Author's comment

There is plenty of potential in this small cap. Unfortunately like all the small caps there has been negative sentiment for term for quite some time. Hopefully this will go away along with positive news.

Roland Murphy 1 month ago Member's comment

Agreed.

IB Trading 1 month ago Member's comment

Had our eyes on $PLX for a while now. I think big things are coming for this company.