CIDARA THERAPEUTICS, INC. (NASDAQ:CDTX) Files An 8-K Regulation FD Disclosure
Item7.01
| Regulation FD Disclosure |
On February 21, 2017, Cidara Therapeutics, Inc. (the Company)
issued a press release relating to the results of its Phase 2
clinical trial of CD101 topical, called the RADIANT study. A copy
of the press release is attached as Exhibit 99.1 to this report.
The information contained in this Item7.01 and in Exhibit 99.1 of
this Current Report on Form 8-K shall not be deemed filed for
purposes of Section18 of the Securities Exchange Act of 1934, as
amended (the Exchange Act), or incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as expressly set forth by specific reference
in such a filing.
| Item8.01 | Other Events |
On February 21, 2017, the Company reported results from its Phase
2 clinical trial of CD101 topical, called the RADIANT study,
which was designed to evaluate gel and ointment topical
formulations of CD101 in women with moderate-to-severe acute
vulvovaginal candidiasis (VVC).
The RADIANT study was a multicenter, randomized, open-label,
active-controlled, dose-ranging trial that enrolled 125 patients
into three treatment cohorts. In the first cohort, 50 patients
were treated with CD101 gel; a second cohort of 50 patients was
treated with CD101 ointment. The third cohort comprised 25
patients treated with oral fluconazole.
The study found that while the gel and ointment topical
formulations of CD101 were well tolerated, both formulations were
similar in efficacy to each other but lower in clinical and
mycological cure rates compared to oral fluconazole. As a result,
the Company has discontinued the CD101 topical development
program for VVC.
| Item9.01. | Financial Statements and Exhibits |
(d)Exhibits.
|
Exhibit No. |
Description |
|
| 99.1 | Press Release, dated February 21, 2017. |
1
About CIDARA THERAPEUTICS, INC. (NASDAQ:CDTX)
Cidara Therapeutics, Inc., formerly K2 Therapeutics, Inc., is a clinical-stage biotechnology company. The Company is engaged in the discovery, development and commercialization of anti-infectives. It is developing a pipeline of product and development candidates with a focus on serious fungal infections. Its product portfolio consists of over two formulations of its echinocandin, CD101. CD101 IV is a long-acting therapy for the treatment and prevention of serious, invasive fungal infections. CD101 topical, its second product candidate, is being developed for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. Its immunotherapy technology platform, Cloudbreak, is used to create compounds designed to direct a patient’s immune cells to attack and eliminate pathogens that cause infectious disease. CIDARA THERAPEUTICS, INC. (NASDAQ:CDTX) Recent Trading Information
CIDARA THERAPEUTICS, INC. (NASDAQ:CDTX) closed its last trading session up +0.25 at 11.70 with 32,894 shares trading hands.