New Products

Newcomer Dova hustles a pharma castoff through to an FDA approval, shares sink anyway

Less than a year after little Dova Pharmaceuticals popped up on Nasdaq to raise $75 million from an IPO, the biotech has raced ahead to an FDA approval of its lead drug.

Durham-based Dova picked up avatrombopag from Eisai for a song — plus $5 million up front. It was already Phase III ready at the time, allowing Dova to quick march to the marketplace.

Richard Pazdur

The FDA offered a green light to use the drug — to be marketed as Doptelet — for a set of chronic liver disease patients suffering from low blood platelet counts.

The news brought only a temporary lift to its shares $DOVA, though, which ended the day down 13% as a number of biotech stocks went on a roller coaster ride. Nevertheless, at a little north of $24, the stock is still well up from its $17 launch price, which hit on the high end of the range.

Leerink’s Geoffrey Porges has been crunching the numbers and believes that Dova is looking at $350 million in annual sales by 2025, with a European approval possible next summer along with some label extensions to help boost its revenue. He notes:

This approval of Dova’s first and only drug is exactly on the FDA’s priority review PDUFA date and matched investors’ generally positive views of the likelihood of the approval. The label reflects the efficacy and safety of the two pivotal trials, ADAPT-1 and ADAPT-2, does not include a Black Box warning for hepatotoxicity, and lists the clinical experience of thrombotic complications (0.2% of patients) as a warning for high-risk patients. Dova has hired all sales, marketing, and reimbursement support resources and is ready to launch in June, and the price will not be disclosed until that time (we anticipate $6,000).

“Doptelet was demonstrated to safely increase the platelet count,” said the FDA’s Richard Pazdur, stepping in as acting director of the Office of Hematology and Oncology Products. “This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions.”

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,900+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->