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December 2014
Exhibit 99.1
Receptos Reports Fourth Quarter and Year End 2013 Operational and Financial Results
- Favorable interim results from Phase 2 trial of RPC1063 in relapsing multiple sclerosis consistent with differentiated profile; top-line data expected mid-2014 -
- Phase 3 trial of RPC1063 in relapsing multiple sclerosis has begun enrolling patients -
- Top-line data from Phase 2 trial of RPC1063 in ulcerative colitis expected in mid-2014 -
- Conference Call Today at 5 p.m. Eastern Time -
San Diego, CA, March 5, 2014 Receptos, Inc. (Nasdaq: RCPT) today provided development program updates and announced financial results for the fourth quarter and year ended December 31, 2013.
The data from the interim analysis of the Phase 2 portion of our RADIANCE trial was consistent with our differentiation thesis, and provided support to continue to advance the program, said Faheem Hasnain, President and Chief Executive Officer of Receptos. Our initiation of the Phase 3 portion of our RADIANCE trial positions RPC1063 as the potential next-to-market oral agent for the treatment of relapsing multiple sclerosis. We look forward to mid-2014 for the top-line results of the Phase 2 portion of RADIANCE, as well as top-line results of TOUCHSTONE, our Phase 2 study of RPC1063 in ulcerative colitis, and continued progress with our pipeline programs.
Receptos is developing RPC1063, a small molecule sphingosine 1-phosphate 1 (S1P1) receptor modulator administered orally for immunology indications. The Company has initiated a Phase 3 trial of RPC1063 in relapsing multiple sclerosis (RMS) and is currently conducting separate Phase 2 trials in RMS and ulcerative colitis (UC), with top-line data expected for both trials in mid-2014. The Company is also developing RPC4046, an anti-interleukin-13 (IL-13) antibody for an immune-mediated orphan disease, eosinophilic esophagitis (EoE), and is in preclinical development of oral, small molecule, positive allosteric modulators of the GLP-1 receptor for the treatment of Type 2 diabetes.
Development Program Updates
RPC1063 in Relapsing Multiple Sclerosis
· In Q4 2013, Receptos completed enrollment in the Phase 2 portion of RADIANCE, its Phase 2/3 trial of RPC1063 in RMS. The primary objective of the Phase 2 portion of the study is to demonstrate the superior clinical efficacy of RPC1063 compared to placebo as measured by a reduction in the cumulative number of total gadolinium-enhancing lesions determined by MRI from week 12 to week 24 of study treatment. Top-line data for this trial is expected in mid-2014.
· In Q4 2013, Receptos completed a pre-planned interim analysis of the Phase 2 portion of RADIANCE. The interim analysis focused on several potential product attributes that may be important for differentiation from other S1P receptor modulators on the market or in development. These included the overall adverse event profile; cardiovascular profile; liver enzyme effects; and preliminary clinical activity and reduction in lymphocyte count.
· In December 2013, based on these interim results and with the recommendation of the studys Data Monitoring Committee, the Company initiated enrollment of the Phase 3 portion of RADIANCE This is a randomized, double-blind, double-dummy study designed to compare 0.5 mg and 1.0 mg of orally administered RPC1063 against injected interferon beta-1a (Avonex®) in 1,200 patients with RMS. It is being conducted under a Special Protocol Assessment (SPA) with the FDA.
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Ticker: RCPT
CIK: 1463729
Form Type: 10-K Annual Report
Accession Number: 0001047469-14-001911
Submitted to the SEC: Thu Mar 06 2014 4:43:31 PM EST
Accepted by the SEC: Thu Mar 06 2014
Period: Tuesday, December 31, 2013
Industry: Pharmaceutical Preparations