Protalix BioTherapeutics Stock Tumbled 28% Today: Why The Latest CHMP Opinion Is Sparking Concerns Among Investors?

Protalix BioTherapeutics (PLX) and Chiesi Global Rare Diseases announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion on the request to approve a new dosing regimen for Elfabrio.

The company was seeking approval of a dosing regimen of 2 mg/kg body weight infused every four weeks for Elfabrio. The currently approved dosing regimen in the European Union is 1 mg/kg body weight infused every two weeks for the treatment of adults with confirmed Fabry disease, a rare genetic disorder leading to the buildup of a fatty substance called globotriaosylceramide in cells throughout the body.

Fabry disease can cause a range of serious signs and symptoms, including fatigue, chronic pain, gastrointestinal issues, decreased ability to sweat, progressive kidney failure, heart complications, and increased risk of stroke. It affects both males and females and is caused by a deficiency of the enzyme alpha-galactosidase A.

However, Protalix CEO said that the results of the review do not change the priority of the company to reduce treatment burden for patients with Fabry disease. The two companies also clarified that they intend to keep working together.

Shares of PLX dropped 28% in the pre-market session at the time of writing. On Stocktwits, retail sentiment around PLX stock rose from ‘neutral’ to ‘bullish’ territory over the past 24 hours while message volume stayed at ‘high’ levels.

Protalix submitted the data to the committee for review, which included two new studies and analyses from prior studies. However, the data was not deemed sufficient to conclude on efficacy, the company said

PLX stock is up by 28% this year and by 120% over the past 12 months. 

Read also: Boston Scientific To Acquire Privately-Held Pain Solutions Developer Nalu Medical For About $533M

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