Protalix BioTherapeutics, Inc. (NYSE American: PLX) a biopharmaceutical company focused on manufacturing recombinant therapeutic proteins with clinically improved profiles, confirmed receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) concerning the Biologics License Application (BLA) attempting to fast-track approval for use of pegunigalsidase alfa (PRX‑102) for the potential treatment of adults effected with Fabry disease. PLX stock declined immensely adjacent to the news.
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At last check-in premarket trading, shares of Protalix BioTherapeutics Inc. (PLX) were down -43.57% at $3.79. Protalix BioTherapeutics Inc.’s stock subtracted -4.74% to finish last trading session at $5.83. Shares of the company fluctuated between $5.51 and $6.19 throughout the day. For the last six months, the stock has gained a total of 65.16%.
ProtalixBioTherapeutics Regulatory Approach
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The PRX-102 BLA was initially given priority review by FDA due to its potential to provide immense advancement in treatment of serious diseases. It was submitted under the accelerated approval to fast-track approval and be used in serious conditions with no alternative medicines.
The Biological license application submission for PRX‑102 was inclusive of detailed preclinical, clinical, and manufacturing data compiled from the concluded Phase I and II clinical trial of PRX‑102. The data also included the extension study after the Phase I/II clinical trial, and interim clinical data from the Phase III BRIDGE switch-over study and safety.
“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.”Protalix is currently studying the complete response letter from FDA to provide adequate date for regulatory advancement and understand the actions required to further obtain approval of PRX 102.
Fabry disease is an X-linked genetic disease caused due to decreased activity of the lysosomal α‑Galactosidase‑A enzyme, as a result abnormal deposits of a fatty substance in the blood vessel walls is present. Symptoms include periods of pain, gastrointestinal (GI) symptoms, tiredness, random sweating and can climb up to serious problems such as cardiovascular, renal, and cerebrovascular events.
Protalix has partnered with ChiesiFarmaceuticifor manufacturing and development of pegunigalsidase alfa, and with SarcoMed USA, Inc. for the global commercialization of PRX-110 to treat any human respiratory disease or condition including, sarcoidosis and pulmonary fibrosis.
Disapproval by FDA has set back research and lowered investor expectation with ProtalixBioTherapeutics stock plummeting immensely. However strategic collaborations combined with adequate actions to fulfil regulatory requirements can be beneficial for the company in the long run.