Protalix Biotherapeutics Inc (NYSEAMERICAN: PLX) is taking off like a rocket early on in today’s trading session after announcing a planned application. In a press release issued early this morning, the ocmpany said that it plans on filing a biologics license agreement with the FDA as soon as early 2020. As the excitement hits, the stock is trading up more than 20%.
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PLX Plans On Filing A BLA In The Near Term
In the press release, Protalix Biotherapeutics said that it plans on filing the BLA for pegunigalsidase in the first quarter of 2020. The company will be filing the BLA under the FDA’s Accelerated Approval pathway following a series of meetings and communication with the FDA.
Pegunigalsidase alfa is an experimental treatment under development as a potential option for Fabry disease. The company said that throughout the past several months, it and its partner Chiesi, have engaged the FDA regarding the potential eligibility of the treatment for accelerated approval based on readily available data.
PLX said that as a result of the feedback in conversations and a recent letter from the FDA, it and its partner have initiated preparations for submission. In a statement, Moshe Manor, President and CEO at PLX, had the following to offer:
We are very excited to be one step closer to an approved product to help a patient population that desperately needs a better option than those currently available on the market. This regulatory approval path is a significant achievement as it means that we can start the application process and potentially attain market approval significantly earlier than the initial plan of data from our ongoing phase III BALANCE clinical trial. We plan to continue the BALANCE study to further strengthen the profile of pegunigalsidase alfa.
Approval will depend on the formal FDA review, but based on communications with the agency, Protalix remains optimistic that the FDA will approve pegunigalsidase alfa on the accelerated basis.
The Market Potential Here Is Incredible
This is great news for Protalix Biotherapeutics and its investors as the fabry disease market is a massive and growing one. Moreover, if approved, the treatment could quickly become the leading option.
Looking at estimates surrounding the fabry disease market, it is expected that the market will grow with a CAGR of 9.6% to reach an annual value of $3.12 billion by the year 2025. For a company like PLX, with a market cap around $60 million, tapping into even a small percentage of this market would be a big deal. However, there’s a chance that the company’s treatment could become the leader in the space.
The current standard of care fo fabry disease is enzyme replacement therapy. Patients must undergo this therapy about every two weeks to maintain the right levels of enzymes, avoiding damage to the kidney, heart, brain and other vital organs.
Pegunigalsidase alfa is an enzyme replacement therapy. However, the therapy has proven in clinical studies to be just as effective with far less infusions. In fact, at an infusion rate of once per month, patients with fabry disease can cut infusions by 50%!
Considering this, should pegunigalsidase alfa be approved by the FDA, it could quickly become a blockbuster treatment option.
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Final Thoughts
With the biologics license application just around the corner, investors have good reason to be excited. This, combined with the efficacy remaining static with less infusions suggests that this treatment could quickly become a meaningful stream of revenue for the company, generating strong value for PLX investors.
What Do You Think?
Where do you think PLX stock is headed moving forward? Join the discussion in the comments below!