Current Report Filing (8-k)

Date : 07/23/2019 @ 6:09PM
Source : Edgar (US Regulatory)
Stock : Durect Corp (DRRX)
Quote : 1.825  -0.095 (-4.95%) @ 6:01PM

Current Report Filing (8-k)





Washington, D.C. 20549


Form 8-K


Current Report

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

July 23, 2019

Date of Report

July 19, 2019

(Date of earliest event reported)



(Exact name of Registrant as specified in its charter)








(State or other jurisdiction of

incorporation or organization)



File Number)


(I.R.S. Employer

Identification No.)

10260 Bubb Road

Cupertino, CA 95014

(Address of principal executive offices) (Zip code)

(408) 777-1417

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)


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:

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

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

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

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

Securities registered pursuant to Section 12(b) of the Act:





Title of Each Class

Trading Symbol

Name of Each Exchange on Which Registered



Common Stock $0.0001 par value per share

Preferred Share Purchase Rights


The NASDAQ Stock Market LLC

(The Nasdaq Capital Market)


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 

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. 




Item 1.01

Entry into a Material Definitive Agreement

On July 19, 2019, DURECT Corporation (“DURECT” or the “Company”) entered into a license agreement (the “Agreement”) with Gilead Sciences, Inc.  (“Gilead”). Pursuant to the Agreement, the Company has granted Gilead the exclusive worldwide rights to develop and commercialize a long-acting injectable HIV product utilizing DURECT’s SABER® technology.    Gilead also received exclusive access to the SABER® platform for HIV and Hepatitis B Virus (HBV) and the exclusive option to license additional SABER-based products directed to HIV and HBV.

Under the terms of the Agreement, Gilead will make an upfront payment to DURECT of $25 million, with the potential for up to an additional $75 million in development and regulatory milestones, up to an additional $70 million in sales-based milestones, as well as tiered single-digit royalties on product sales for a defined period. Gilead has the exclusive option to license additional SABER-based products directed to HIV and HBV for an additional $150 million per product in upfront, development, regulatory and sales-based milestones as well as tiered single-digit royalties on sales.  The parties will collaborate on specified development activities with Gilead controlling and funding the development programs.  The Agreement contains customary representations, warranties and indemnification provisions.  The term of the Agreement is for the duration of Gilead’s obligation to pay royalties for product sales under the Agreement. The Agreement provides each party with specified termination rights, including the right of Gilead to terminate at will with advance notice to DURECT and each party to terminate the Agreement upon material breach of the Agreement by the other party. The description of the Agreement is qualified in its entirety by the full text of the Agreement which will be filed as an exhibit to the Company’s Form 10-Q for the quarter ended September 30, 2019.

Item 8.01 Other Events

The Company issued a press release announcing this event on July 22, 2019, a copy of which is attached hereto as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits

( d) Exhibits







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.




DURECT Corporation






Date: July 23, 2019




/s/ James E. Brown





    James E. Brown





    President and Chief Executive Officer



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