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
  May 22, 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 May 22, 2019, Valeritas Holdings, Inc. issued a press release announcing that it presented additional results from its VERDICT study at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting.

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



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: May 22, 2019
 
 
By: s/ John E. Timberlake

 
 
 
 
Name: John E. Timberlake

 
 
 
 
Title: Chief Executive Officer

 
 
 
 
 
 







ART1591REVAISPORPRESS_IMAGE1.GIF

Valeritas’ V-Go® Demonstrates Positive Impact in Diabetes Quality Performance Measures
in an Older Adult Population

BRIDGEWATER, New Jersey, May 22, 2019 --- Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology company and maker of V-Go® Wearable Insulin Delivery device , today announced additional data from the VERDICT study at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual Meeting. The data demonstrated that V-Go therapy resulted in better glycemic control and improved attainment of Quality Performance Measures (QPM) and was well tolerated.

The data used in this analysis was taken from the VERDICT study, a real-world retrospective analysis of electronic health records from a large specialized diabetes center.  According to HEDIS, which sets QPMs, A1c >9% is considered poor diabetes control.  After 5 months of V-Go use, significant reductions in A1c of 1.5% were observed, and nearly twice as many patients achieved evaluated A1c QPM.  

“The VERDICT study demonstrates that significantly more patients achieved better control and attained improved quality metrics. We will continue to partner with clinicians to improve patient outcomes and quality of care delivered using V-Go as a standard way to deliver basal-bolus insulin therapy,” said John Timberlake, President and Chief Executive Officer of Valeritas.

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