U.S. Markets closed

Dova Receives Approval for Doptelet in Europe, Stock Up

Zacks Equity Research

Shares of Dova Pharmaceuticals, Inc. DOVA gained 3.3% on Jun 26 after the company’s lead drug, Doptelet, received marketing authorization from the European Commission for treating severe thrombocytopenia in adult patients with chronic liver disease (“CLD”) who are scheduled to undergo an invasive procedure. The authorization allows the company to market the drug in 28 countries constituting the European Union, plus Iceland, Norway, and Liechtenstein.

The company is currently seeking partnerships for commercialization of the drug in Europe. The drug has been available in the United States since last year. The company has a co-promotion agreement with the Salix division of Bausch Health Companies BHC, for commercialization of Doptelet in the United States.

Shares of Dova have increased 39.8% so far this year compared with the industry’s rise of 8.5%.

 

 

The approval of the drug in Europe was based on data from two phase III studies, which evaluated two doses of Doptelet — 40 mg and 60 mg — in patients with thrombocytopenia and CLD. Treatment with the drug increased the proportion of patients who did not require platelet transfusions or rescue procedures for bleeding up to seven days following a scheduled procedure. The increase in the number of patients was superior compared to a placebo. The drug also achieved superior results compared to placebo in increasing the proportion of patients with platelet count equal to or greater than 50,000/µL and increase in platelet count from baseline.

The drug has generated sales of $11.7 million since its approval in May 2018 in the United States. The recent approval in Europe is expected to increase the sales of the drug following a successful launch.

Dova is also developing Doptelet as a treatment for chronic immune thrombocytopenia (“ITP”) and chemotherapy-induced thrombocytopenia (“CIT”). A supplemental new drug application is under review in the United States seeking label expansion of the drug to include ITP patients. A decision is expected shortly. An approval will boost the prospects of the drug. A phase III study is evaluating the drug in CIT patients. Top-line data is expected in the first half of 2020.

Doptelet faces competition from Shionogi's Mulpleta (lusutrombopag) for its approved indication in the United States and Europe. Moreover, there are several drugs approved for treating ITP including Rigel Pharmaceuticals RIGL Tavalisse, Novartis’ NVS Promacta and Amgen’s Nplate. Several other companies including Bristol-Myers are developing their candidate for ITP indication.

There is no approved drug for the treatment of CIT. Amgen is evaluating Nplate in a late-stage study in CIT patients.

Dova Pharmaceuticals, Inc. Price

 

Dova Pharmaceuticals, Inc. Price

Dova Pharmaceuticals, Inc. price | Dova Pharmaceuticals, Inc. Quote

Zacks Rank

Dova currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Breakout Biotech Stocks with Triple-Digit Profit Potential

The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.

Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.

See these 7 breakthrough stocks now>>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Novartis AG (NVS) : Free Stock Analysis Report
 
Rigel Pharmaceuticals, Inc. (RIGL) : Free Stock Analysis Report
 
Bausch Health Cos Inc. (BHC) : Free Stock Analysis Report
 
Dova Pharmaceuticals, Inc. (DOVA) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research