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News Breaks
May 13, 2014
07:03 EDTIDRAIdera Pharmaceuticals reports Q1 EPS (12c), two estimates (8c)
Reports Q1 revenue $3,000, two estimates $3,000. The company anticipates enrolling up to approximately 30 patients in a Phase 1/2 trial of IMO-8400 in patients with trial DLBCL who harbor the MYD88 L265P mutation and have relapsed or were refractory to prior therapy. The company expects to initiate patient treatment in the second half of 2014. A Phase 1/2 clinical trial of IMO-8400 in patients with Waldenström’s macroglobulinemia, who have relapsed or were refractory to prior therapy, is ongoing. This trial is designed to evaluate safety, tolerability and clinical activity of escalating IMO-8400 dose levels. The Company anticipates enrolling up to approximately 30 patients in this trial. In March, the company announced positive top-line data from a randomized, double-blind, placebo controlled Phase 2 trial of IMO-8400 in 32 patients with moderate-to-severe plaque psoriasis. The trial met the primary objective of demonstrating safety and tolerability, as well as a secondary objective of clinical activity of IMO-8400. The company intends to submit the full data set, including data from an additional higher dose cohort, for presentation at a medical meeting in 2014.
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April 1, 2015
08:40 EDTIDRAIdera Pharmaceuticals granted ODD by FDA for IMO-8400
Idera Pharmaceuticals announced that the FDA has granted orphan drug designation for IMO-8400, an antagonist of the endosomal Toll-like receptors, or TLRs, 7, 8 and 9, for the treatment of diffuse large B-cell lymphoma, or DLBCL. Idera is currently conducting a clinical trial of IMO-8400 in patients with relapsed or refractory DLBCL harboring MYD88 L265P oncogenic mutation. Preclinical studies have shown that in B]cell lymphomas characterized by the MYD88 L265P oncogenic mutation, including DLBCL, TLR signaling is over-activated, thereby enabling tumor cell survival and proliferation. As a TLR antagonist, IMO-8400 inhibits TLR signaling. The objectives of the trial are to evaluate the compound's safety, tolerability and clinical activity. The protocol includes three dose-escalation cohorts of IMO-8400 administered subcutaneously.
March 31, 2015
14:49 EDTIDRAIdera adds DLBCL to other orphan designation for IMO-8400, says Piper Jaffray
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11:03 EDTIDRAIdera Pharmaceuticals granted orphan status for lymphoma treatment
The FDA granted Idera Pharmaceuticals orphan status for its treatment of diffuse large B-cell lymphoma.
March 23, 2015
09:27 EDTIDRAIdera Pharmaceuticals Chief Medical Officer resigns
Idera Pharmaceuticals disclosed in a regulatory filing that Louis Brenner, M.D. resigned his positions as senior VP and Chief Medical Officer of Idera to accept a new role as the Chief Operating Officer of a privately-held biotechnology company. This change will become effective April 3.

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