Protalix Biotherapeutics PLX Stock News

Protalix BioTherapeutics Inc (NYSEAMERICAN: PLX) is headed for the top in premarket trading this morning, and for good reason. The company announced that it has submitted a Biologics License Application, or BLA, to the United States Food and Drug Administration. Here’s what’s going on:

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PLX Stock Runs After Submitting BLA

In the press release, Protalix BioTherapeutics announced that it and its partner, Chiesi Global Rare Disease, submitted a BLA to the FDA. The submission surrounded pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease.

Importantly, PLX said that the submission was done under the Accelerated Approval pathway. This was made possible in January of 2018, when pegunigalsidase alfa, or PRX-102, was granted Fast Track designation by the FDA.

In the release, the company said that the BLA submission includes a comprehensive set of preclinical, clinical and manufacturing data from multiple clinical studies, completed and ongoing.

Should the BLA be approved by the FDA, the company will be eligible to receive a milestone payment from Chiesi. In a statement, Dror Bashan, President and CEO at PLX, had the following to offer:

We are grateful for the assistance the FDA provided leading up to the submission of this BLA via the Accelerated Approval pathway, and we look forward, together with Chiesi, to working with the FDA as we seek marketing approval for PRX‑102. Together with Chiesi, we thank the investigators and study participants who have made reaching this milestone possible and have supported Protalix in our commitment to bringing this new treatment option to the Fabry patient community.

The above statement was followed up by Giacomo Chiesi, head of Chiesi Global Rare Disease. Here’s what he had to offer:

The submission of this BLA to the FDA represents a significant milestone for our Global Rare Diseases division that was established earlier this year to strengthen Chiesi’s focus on making a difference for patients living with rare diseases around the world. Our partnership and active collaboration with Protalix are a great example showing how we can leverage Chiesi’s global reach and decades of experience in drug development to support patients and their families living with Fabry disease and many other devastating rare diseases.

This News Is Huge

Ultimately, the news issued by Protalix BioTherapeutics this morning is overwhelmingly positive for the company and its investors. After all, should the FDA approve the BLA, the company will have a potentially blockbuster treatment option on the market.

By the year 2025, it is expected that the Fabry disease market will be worth about $3.12 billion. That’s a massive market for a company with a market cap of just over $100 million to dive into. Moreover, it could quickly become the leader.

The treatment was granted Fast Track designation and is being reviewed under the Accelerated Approval pathway. This only happens when treatments address conditions that have little to no effective options already on the market. So, should the biologic agent be approved, the revenue opportunity here could be incredible, making PLX stock one to watch closely.

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