The share price of Protalix BioTherapeutics (NYSEMKT:PLX) is off more than 43% in pre-market trading on Wednesday morning after the Israeli biopharma got word that the U.S. Food and Drug Administration found deficiencies in an application for accelerated approval on its Fabry disease treatment.
Protalix is a biotechnology company that has developed plant cell culture technology and a bioreactor system. The Fabry disease treatment is under development in collaboration with a unit of Italy’s Chiesi Farmaceutici.
The review of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease had been extended until April 27 by the FDA. PLX stock had gained 61% between the Nov. 27 extension announcement and today’s update.
“While disappointing, we remain confident in the strength of our data and in the depth of our program,” said Dror Bashan, Protalix’s president and chief executive officer. “We remain committed to the program and to working with the FDA and Chiesi toward the approval of PRX‑102.”
PLX Stock Shows Volatility of Biotech
People who have Fabry disease don’t have the enzymes that break down lipids or fats, according to the Cleveland Clinic. These fats collect in blood vessels and tissue, raising the risk of heart attack, stroke and kidney failure. This genetic condition is passed from parent to child. Approximately one out of every 40,000 males has classic Fabry disease. Late-onset or atypical Fabry disease is more common. It affects about one in every 1,500 to 4,000 males.
Protalix’s development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets. In addition to the Fabry disease treatment, it is developing an orally delivered anti-inflammatory treatment and alidornase alfa for the treatment of cystic fibrosis.
As InvestorPlace analyst Louis Navellier wrote last month, there’s plenty to like in the biotech sector besides potential catalysts caused by the coronavirus pandemic.
Thanks to the incredible innovations in recent decades, the biotechnology space has offered both hope for patients and profitability potential for stakeholders. At the same time, biotech stocks are not an appropriate arena for every investor, particularly when you’re dealing with speculative names. Still, very few sectors offer the astounding potential of biotech penny stocks, which is why — though it’s terribly risky — people continue to flock to this market.
On the date of publication, Robert Lakin did not have (either directly or indirectly) any positions in the securities mentioned in this article.
InvestorPlace contributor Robert Lakin is a veteran financial writer and editor, including previous stints with Bloomberg News, McKinsey & Co. and McDonald & Company Investments.