8-K

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

July 8, 2019

Date of report (Date of earliest event reported)

_______________________

Valeritas Holdings, Inc.

(Exact name of registrant as specified in its charter)

________________________

Delaware	001-38038		46-5648907
(State or other jurisdiction of incorporation)	(Commission File Number)		(IRS Employer Identification No.)
750 Route 202, Suite 600 Bridgewater, NJ (Address of principal executive offices)		08807 (Zip Code)
Registrant's telephone number, including area code (908) 927-9920 (Former name or former address, if changed since last report) ________________________

Check the appropriate box below if the Form 8‑K 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))

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

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

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.001 per value	VLRX	The Nasdaq Capital Market

Item 8.01. Other Events.

On July 8, 2019, Valeritas Holdings, Inc. issued a press release announcing positive data from a retrospective study using the HealthCore Integrated Research Database (HIRD) comparing patients using V-Go® to patients using multiple daily injection (MDI) therapy.

The full text of the press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d)Exhibits.

Exhibit No.	Description
99.1	Press release dated July 8, 2019.

SIGNATURES

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

Valeritas Holdings, Inc.

Dated: July 8, 2019                     By: s/ John E. Timberlake

Name: John E. Timberlake

Title: Chief Executive Officer

EX-99.1

Valeritas’ V-Go® Wearable Insulin Delivery Device Demonstrates Economic Advantages Compared to Multiple Daily Injection Therapy for Insulin Dependent Type 2 Diabetes Population

BRIDGEWATER, N.J., July 08, 2019 (GLOBE NEWSWIRE) -- Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology company and maker of the V-Go^®Wearable Insulin Delivery device, announced today positive data from a retrospective study using the HealthCore Integrated Research Database (HIRD) comparing patients using V-Go to patients using multiple daily injection (MDI) therapy. The study demonstrates V-Go users experienced lower insulin dose requirements and lower diabetes-related medication cost while lowering average blood sugar levels, as measured by A1c.

“We view this study as a confirmation of both the clinical and economic benefits V-Go provides patients,” said John Timberlake, President and Chief Executive Officer of Valeritas. “V-Go has always offered the improvements in insulin adherence associated with removing multiple daily injections for patients with type 2 diabetes requiring daily insulin, and this study provides additional long-term data demonstrating the economic advantages of our cost-effective alternative.”

Results from the study demonstrate that despite similar baseline insulin Rx fills and diabetes medication costs, V-Go users required fewer insulin Rx fills (mean change: -0.8 vs. +1.8 fills, p<0.001; -17% vs. +38%), had a smaller increase in diabetes medication costs (mean change in 2016 USD: $341 vs. $1,628, p=0.012; +10% vs. +47%), and a decrease in insulin total daily dose (TDD) (mean change in insulin units/day: -29.2 vs. +5.8, p<0.001; -21% vs. +4%), compared to MDI users, during the last six months of follow-up.

About Valeritas Holdings, Inc.

Valeritas is a commercial-stage medical technology company focused on improving health and simplifying life for people with diabetes by developing and commercializing innovative technologies. Valeritas’ flagship product, V-Go^®Wearable Insulin Delivery device, is a simple, affordable, all-in-one basal-bolus insulin delivery option for patients with type 2 diabetes that is worn like a patch and can eliminate the need for taking multiple daily shots. V-Go administers a continuous preset basal rate of insulin over 24 hours, and it provides discreet on-demand bolus dosing at mealtimes.  It is the only basal-bolus insulin delivery device on the market today specifically designed keeping in mind the needs of type 2 diabetes patients. Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D functions in Marlborough, Massachusetts.

More information is available at www.valeritas.com and our Twitter feed @Valeritas_US, www.twitter.com/Valeritas_US.

Forward-Looking Statements

This press release may contain forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Valeritas technologies, business and product development plans and market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue Valeritas’ business and product development plans, Valeritas' expected cash burn rate and its ability to continue to increase new and total prescription growth, the effects of the reverse stock split on the trading price of Valeritas’ common stock, in both the

short and long-term, the inherent uncertainties associated with developing new products or technologies, the ability to continue to commercialize the V-Go® Wearable Insulin Delivery device with limited resources, competition in the industry in which Valeritas operates and overall market conditions. Statements or claims made by third parties regarding the efficacy or functionality of V-Go as compared to other products are statements made by such individual and should not be taken as evidence of clinical trial results supporting such statements or claims. Any forward-looking statements are made as of the date of this press release, and Valeritas assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.  Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Valeritas files with the SEC available at www.sec.gov.

Investor Contacts:

Lynn Pieper Lewis or Greg Chodaczek

Gilmartin Group

646-924-1769

ir@valeritas.com

Media Contact:

Kevin Knight

Knight Marketing Communications, Ltd.

206-451-4823

pr@valeritas.com