UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 27, 2017

 

Dova Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

 

001-38135

 

81-3858961

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

 

240 Leigh Farm Road, Suite 245

 

 

Durham, North Carolina

 

27707

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (919) 748-5975

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

 

 



 

Item 8.01          Other Events.

 

On November 27, 2017, Dova Pharmaceuticals, Inc. announced that the New Drug Application for avatrombopag has been accepted for filing and has been granted Priority Review by the United States Food and Drug Administration.

 

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K, the contents of which are incorporated herein by reference.

 

Item 9.01          Financial Statements and Exhibits.

 

(d)         Exhibits

 

Exhibit No.

 

Description

99.1

 

Press Release titled “Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review” dated November 27, 2017.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Dova Pharmaceuticals, Inc.

 

 

 

 

Date: November 28, 2017

/s/ Douglas Blankenship

 

Douglas Blankenship

 

Chief Financial Officer

 

3


Exhibit 99.1

 

 

Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review

 

PDUFA date of May 21, 2018

 

DURHAM, NC, November 27, 2017 — Dova Pharmaceuticals, Inc. (NASDAQ: DOVA) today announced the New Drug Application (NDA) for avatrombopag has been accepted for filing and has been granted Priority Review by the United States Food and Drug Administration (FDA).  Dova is seeking FDA approval of avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. The submission is based on two identically-designed Phase 3 clinical trials, ADAPT 1 and ADAPT 2, in which avatrombopag met all primary and secondary endpoints with high statistical significance. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is May 21, 2018.

 

Alex Sapir, President and Chief Executive Officer of Dova, commented, “We are extremely pleased that FDA has accepted our NDA submission with Priority Review.  We believe that avatrombopag represents a novel treatment option with robust efficacy as well as an improved safety profile when compared to platelet transfusions, today’s current standard of care.  We look forward to working closely with FDA through the review process.”

 

The FDA’s Priority Review status accelerates the review time from ten months to a goal of six months from the date of acceptance of filing and is granted to applications for drugs that, if approved, would provide significant improvements in safety or effectiveness in the treatment of a serious condition over available therapies.

 

About Avatrombopag

 

Avatrombopag is a second generation orally administered TPO-RA which is intended to address the limitations of other existing treatments for thrombocytopenia. In two identically-designed Phase 3 clinical trials, ADAPT 1 and ADAPT 2, avatrombopag met all primary and secondary endpoints with high statistical significance.  Avatrombopag is initially being studied for its potential for the acute treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure. Dova is also planning to explore the potential use of avatrombopag in a broader population of patients with thrombocytopenia, including in patients undergoing surgical procedures associated with a high risk of bleeding, and patients who develop thrombocytopenia after receiving chemotherapy. In addition, Dova is exploring a potential regulatory approval pathway for avatrombopag for the treatment of adults with chronic immune thrombocytopenic

 



 

purpura (ITP) based on results from a completed Phase 3 trial in this patient population. Dova holds the worldwide rights to avatrombopag for all current and future indications.

 

About Dova Pharmaceuticals, Inc.

 

Dova is a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, with an initial focus on addressing thrombocytopenia. Dova’s lead drug candidate, avatrombopag, has successfully completed two pivotal Phase 3 clinical trials for the treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure and an NDA has been submitted to the FDA for this initial indication.

 

Cautionary Note Regarding Forward-Looking Statements

 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.  These statements may be identified by words such as “anticipated”, “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Dova’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential U.S. launch for avatrombopag in patients with CLD who are scheduled to undergo a procedure and the clinical development of avatrombopag for other indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, increased regulatory requirements, Dova’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Dova’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on November 9, 2017, and Dova’s other periodic reports filed with the SEC.  Any forward-looking statements speak only as of the date of this press release and are based on information available to Dova as of the date of this release, and Dova assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

###

 

Contacts

 

Doug Blankenship

(919) 748-5975

dblankenship@dova.com

 

Westwicke Partners

John Woolford

(443) 213-0506

john.woolford@westwicke.com