Dova Pharmaceuticals DOVA Stock News

Dova Pharmaceuticals Inc (NASDAQ: DOVA) is climbing in the market today after announcing a European regulatory approval. With the approval in mind, excited investors have the stock trading on 17% gains as we near mid-day. Here’s what’s happening.

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DOVA Stock Rockets On DOPTELET Approval!

In a premarket press release issued on Thursday morning, Dova Pharmaceuticals announced that the European Commission has granted it marketing authorization for DOPTELET. As a reasult, the drug is now ready for marketing in Europe and indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.

Ultimately, this is a significant approval. The market authorization means that DOVA can now sell the treatment in 28 European Union member states as well as Iceland, Norway, and Liechtenstein.

The approval is the result of strong efficacy and safety data from a global Phase 3 clinical trial in adults with thrombocytopenia and chronic liver disease. In the study, the treatment proved to be superior to placebo when it comes to reducing the risk of need for platelet transfusions or rescue procedures for bleeding.

In the study, the drug also proved to be superior to placebo in patients achieving a stronger platelet count and the magnituted of change in platelet counts from baseline to procedure day.

In a statement, Dr. Davide Zaccardelli, President and CEO at DOVA, had the following to offer:

Receiving the European marketing authorization for DOPTELET marks another significant milestone for Dova and our growing leadership in the treatment of thrombocytopenia.

As an oral thrombopoietin receptor agonist that can raise platelet levels in CLD patients with thrombocytopenia ahead of an invasive procedure, DOPTELET offers a safe and effective alternative to platelet transfusions. Conversations with potential commercial partners are ongoing to make DOPTELET available in Europe.

Considerable Market Potential

At the moment, thrombocytopenia is a major global issue. A big part of this issue is that before today, there were few options, generally including steroids that largely lack efficacy and blood transfusions that are incredibly costly. With the approval of DOPTELET, there is a new, effective option available in a large market.

In fact, according to GlobalData, the thrombocytopenia market is already generating nearly $930 million in annual value. Moreover, these same experts expect that the market will grow to be worth $985 million by the year 2025.

This is a significant win for Dova Pharmaceuticals. At the end of the day, the treatment has the potential to become a leader in the market. Moreover, the company’s market cap is sub-$350 million, showing that there’s strong potential for value growth ahead.

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