Current Report Filing (8-k)
September 08 2020 - 8:16AM
Edgar (US Regulatory)
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2020-09-08
2020-09-08
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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): September 8, 2020
CORBUS
PHARMACEUTICALS HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
001-37348
|
|
46-4348039
|
(State
or other jurisdiction
of
incorporation)
|
|
(Commission
File
Number)
|
|
(IRS
Employer
Identification
No.)
|
500
River Ridge Drive, Norwood, MA
|
|
02062
|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
Registrant’s
telephone number, including area code: (617) 963-0100
Not
Applicable
(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))
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Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Common
Stock
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CRBP
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The
Nasdaq Global 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
7.01.
|
Regulation
FD.
|
On
September 8, 2020, Corbus Pharmaceuticals Holdings, Inc. (the “Company”) issued a press release announcing results
from its Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous systemic sclerosis. A copy of the press
release is attached hereto as Exhibit 99.1.
The
information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being
furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
Item
8.01
|
Other
Information.
|
On
September 8, 2020, the Company announced results from its Phase 3 RESOLVE-1 study of lenabasum in patients with diffuse cutaneous
systemic sclerosis (“SSc”).
The
RESOLVE-1 study tested the efficacy and safety of lenabasum in 365 patients with diffuse cutaneous SSc in a multi-national, double-blind,
randomized, placebo-controlled study, with dosing of lenabasum at 20 mg twice daily, lenabasum at 5 mg twice daily, or placebo
twice daily for 52 weeks. The primary endpoint of the RESOLVE-1 study was the American College of Rheumatology Combined Response
Index for Systemic Sclerosis (“ACR CRISS”) score, a composite endpoint that reflects the probability of patient improvement.
Topline data showed no significant differences in the primary and secondary endpoints when comparing lenabasum to placebo, both
added to background drug therapy. For the primary endpoint at Week 52, median ACR CRISS scores were 0.887 in the placebo arm and
0.888 in the lenabasum 20 mg twice daily arm. The maximum achievable ACR CRISS score is 1.0.
Similar
proportions of placebo-treated and lenabasum-treated subjects had at least one treatment emergent adverse event (“AEs”),
86.2% in the placebo arm and 91.7% in the lenabasum 20 mg twice daily arm. Serious AEs occurred in 14.6% of subjects in the
control arm and 9.2% of subjects in the lenabasum 20 mg twice daily arm. Severe adverse events occurred in 13% of subjects in
the control arm and 5.8% of subjects in the lenabasum arm. No subjects receiving lenabasum withdrew from the study because of
an AE related to study drug. Lenabasum treatment was well-tolerated in this study. No evidence of lenabasum-related immunosuppression
or new safety signals for lenabasum were observed.
Item
9.01
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Financial
Statements and Exhibits.
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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.
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CORBUS
PHARMACEUTICALS HOLDINGS, INC.
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|
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Dated:
September 8, 2020
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By:
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/s/
Yuval Cohen
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Name:
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Yuval
Cohen, PhD
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Title:
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Chief
Executive Officer
|
Corbus Pharmaceuticals (NASDAQ:CRBP)
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