Current Report Filing (8-k)
June 27 2016 - 4:18PM
Edgar (US Regulatory)
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): June 27, 2016
Regulus Therapeutics Inc.
(Exact name of registrant as specified in its charter)
|
|
|
|
|
Delaware
|
|
001-35670
|
|
26-4738379
|
(State
of incorporation)
|
|
(Commission
File No.)
|
|
(IRS Employer
Identification No.)
|
|
|
10614 Science Center Drive
San Diego, CA
|
|
92121
|
(Address of principal executive offices)
|
|
(Zip Code)
|
Registrants telephone number, including area code: (858) 202-6300
N/A
(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 (see General Instruction A.2. below):
¨
|
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))
|
On June 27, 2016, we issued a press release announcing we received
verbal notice from the U.S. Food and Drug Administration (FDA) that our Investigational New Drug (IND) for RG-101 for the treatment of chronic hepatitis C virus (HCV) infection has been placed on full clinical hold. We anticipate we will receive a
formal clinical hold letter from the FDA within 30 days and plan to work diligently with the agency to seek the release of the clinical hold.
The FDA initiated the clinical hold after we reported a second serious adverse event (SAE) of jaundice. The SAE occurred in a HCV patient with
end-stage renal disease on dialysis enrolled in its on-going Phase I US study 117 days after receiving a single dose of RG-101.
Timelines
for our three on-going studies of RG-101 are not expected to be impacted as all patients have been enrolled and completed their dosing of RG-101 and will continue with protocol scheduled visits. We remain on track to deliver follow-up results from
these studies at upcoming scientific meetings.
Conference Call Information
Regulus will host a conference call and webcast today at 5:00p.m. Eastern time to discuss todays announcement. A live webcast of the call will be
available online at
www.regulusrx.com
. To access the call, please dial (877) 257-8599 (domestic) or (970) 315-0459 (international) and refer to conference ID 41706266. To access the telephone replay of the call, dial
(855) 859-2056 (domestic) or (404) 537-3406 (international), passcode 41706266. The webcast and telephone replay will be archived on the companys website following the call.
Forward-Looking Statements
Statements
contained in this report regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with our expected ability
to undertake certain activities and accomplish certain goals, including with respect to development related to RG-101, the projected timeline of clinical development activities related to RG-101, and expectations regarding future therapeutic and
commercial potential of our business plans, technologies and intellectual property related to RG-101. Words such as believes, anticipates, plans, expects, intends, will,
goal, potential and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may
prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with
the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning our financial position and
programs are described in additional detail in our filings with the Securities and Exchange Commission. All forward-looking statements contained in this report speak only as of the date on which they were made. We undertake no obligation to update
such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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.
|
|
|
|
|
|
|
Regulus Therapeutics Inc.
|
|
|
|
Date: June 27, 2016
|
|
By:
|
|
/s/ Paul Grint, M.D.
|
|
|
|
|
Paul Grint, M.D.
|
|
|
|
|
President and CEO
|
Regulus Therapeutics (NASDAQ:RGLS)
Historical Stock Chart
From Jun 2024 to Jul 2024
Regulus Therapeutics (NASDAQ:RGLS)
Historical Stock Chart
From Jul 2023 to Jul 2024