|Over a week ago|
Iveric bio doses first patient in second Zimura Phase 3 clinical trial » 07:3306/3006/30/20
IVERIC bio announced the…
IVERIC bio announced the first patient has been dosed in GATHER2, also known as ISEE2008, the second Phase 3 clinical trial for Zimura, a novel complement C5 inhibitor, in development for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration, or AMD. IVERIC said in a release, "The Company announced previously that Zimura met its pre-specified primary efficacy endpoint and reached statistical significance in GATHER1, also known as OPH2003, the first Phase 3 clinical trial for Zimura for the treatment of GA secondary to AMD. There are no FDA or EMA approved treatments available for patients with GA secondary to AMD."
Fly Intel: Pre-market Movers » 09:0806/1806/18/20
ORN, ENPH, CMC, FRAN, FLWS, KR, CCL, DBI, CBIO, ISEE
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Iveric bio 24.536M share Spot Secondary priced at $4.099 » 06:1506/1806/18/20
Cowen and Credit Suisse…
Cowen and Credit Suisse acted as joint book running managers for the offering.
Fly Intel: After-Hours Movers » 19:0206/1706/17/20
ABM, ELOX, IBTX, NDLS, NLTX, TMUS, HUD, TISI, QUIK, LPTX, ADMS, CBIO, ISEE, KTOS, X, KIDS, FOXF
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Iveric bio announces $50M common stock offering, concurrent private placement » 16:0406/1706/17/20
Iveric bio announced that…
Iveric bio announced that it is commencing an underwritten public offering of $50M of shares of its common stock Concurrent with the public offering, the company has agreed to sell, subject to the consummation of the public offering and other customary conditions, in a private placement, $35Mof its common stock to affiliates of Vivo Capital and Samsara BioCapital, at a sale price equal to the price of the common stock sold to the public in the public offering. The consummation of the public offering is not contingent on the consummation of the concurrent private placement. Cowen and Credit Suisse are acting as the book-running managers for the public offering and as placement agents for the concurrent private placement. Wedbush PacGrow is acting as lead manager for the public offering.
Fly Intel: Pre-market Movers » 08:5806/1506/15/20
CTLT, MRNA, SHOP, BYSI, ISEE, AZN, IRBT, JKS, BP, HTZ, CBIO, XOG
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Iveric bio announces 18-month Zimura trial data » 06:2206/1506/15/20
Iveric bio announced…
Iveric bio announced 18-month results from the company's first Phase 3 clinical trial for Zimura, a novel complement C5 inhibitor, for the treatment of geographic atrophy, or GA, secondary to age-related macular degeneration, or AMD. The 18-month data supports the previously announced 12-month data from this trial, at which time point Zimura met the pre-specified primary efficacy endpoint with statistical significance. The reduction in the mean rate of GA growth over 18 months was 28.11% for the Zimura 2 mg group as compared to the corresponding sham control group and 29.97% for the Zimura 4 mg group as compared to the corresponding sham control group. The pre-specified efficacy analysis for the primary endpoint was performed at month 12 using all of the power in the trial to detect a statistically significant difference. Therefore, the p-values for the 18 month statistical analyses are descriptive in nature. The descriptive p-values for the treatment effects at month 18 were 0.0014 for the Zimura 2 mg group and 0.0021 for the Zimura 4 mg group. In this trial, the treatment effect was observed as early as six months, with an increase in the absolute difference of the mean change in GA growth for treatment with either Zimura 2 mg or Zimura 4 mg, as compared to sham, at each subsequent time point, suggesting the progressive benefit of continuous treatment with Zimura. Zimura maintained its favorable safety profile at 18 months with no reported Zimura related adverse events, no cases of endophthalmitis and a lower rate of choroidal neovascularization, or CNV, than reported for C3 inhibition. The overall 18 month data may suggest a dose response relationship. Mean rate of change in GA growth over 18 months, was measured by fundus autofluorescence, or FAF, based on readings at four time points (baseline, month 6, month 12 and month 18) and was calculated using the square root transformation of the GA area. The FAF images were assessed by an independent masked reading center. The prespecified statistical analysis plan used a model of repeated measures, or MRM, to compare data for the Zimura 2 mg and Zimura 4 mg groups to the corresponding sham groups. Zimura was generally well tolerated after 18 months of administration. There was no Zimura-related inflammation, no Zimura-related discontinuations from the trial, no cases of endophthalmitis and no Zimura-related adverse events. Through month 18, the reported incidence of CNV in the untreated fellow eye was 11 patients and in the study eye was 3 patients in the sham control group, 8 patients in the Zimura 2 mg group and 13 patients in the Zimura 4 mg group. The most frequently reported ocular adverse events were related to the injection procedure.
|Over a quarter ago|
Iveric bio announces fast track designation for Zimura from FDA » 08:0304/0304/03/20
Iveric bio announced that…
Iveric bio announced that the FDA has granted fast track designation to Zimura, a novel complement C5 inhibitor, in development for the treatment of geographic atrophy, or GA, secondary to dry age-related macular degeneration, or AMD.
Iveric bio names Pravin U. Dugel chief strategy and business officer » 16:0303/2303/23/20
Iveric bio announced the…
Iveric bio announced the appointment of Pravin U. Dugel, MD, as Executive Vice President and Chief Strategy and Business Officer, effective April 1, 2020. In this role, Dr. Dugel will help shape IVERIC bio's business development strategy going forward. "We are excited to add Pravin to our management team," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "In addition to being a globally recognized retinal specialist, Pravin brings an extensive network and long-standing relationships with the biotech/pharma ophthalmic industry. With IVERIC bio's portfolio of multiple ongoing retinal disease therapeutic and gene therapy R&D programs, Pravin's experience will be instrumental in helping us build alliances with potential future collaborators and other stakeholders. We look forward to Pravin's input and perspective as we move the Company forward." Dugel was previously Managing Partner, Retinal Consultants of Arizona and the Retinal Research Institute; Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California; and Founding Member, Spectra Eye Institute in Sun City, Arizona.
Iveric bio delays initiation of enrollment for Zimura pivotal clinical trial » 08:1403/1803/18/20
Iveric bio announced that…
Iveric bio announced that due to the threat of the coronavirus (COVID-19) global pandemic, the company has decided to delay the initiation of enrollment of patients in the second pivotal clinical trial for Zimura, a novel complement C5 inhibitor, in development for the treatment of geographic atrophy, or GA, secondary to dry age-related macular degeneration, or AMD. "In light of the COVID-19 pandemic and out of an abundance of caution for the safety and well-being of our elderly patients and participating physicians and their staffs, we have decided to delay the initiation of enrollment in our second pivotal trial of Zimura in geographic atrophy secondary to dry AMD, the ISEE2008 trial, which was on track to begin this month," stated Glenn Sblendorio, CEO and President of IVERIC bio. "It is critically important that we heed the warnings from the U.S. Centers for Disease Control, World Health Organization and national, state and local governments during this time of uncertainty. We will continue to closely monitor the situation in the United States and abroad to determine when enrollment should begin." Kourous Rezaei, M.D., Chief Medical Officer of IVERIC bio said, "Our first priority is to ensure the best interest of our patients, caregivers, and physicians. We want to thank clinical investigators and their teams for their enthusiasm and support in completing the activities necessary to begin enrolling patients at a number of clinical sites, including identification of potential patients for this trial. We will continue our efforts to prepare additional clinical sites, so that we can begin enrolling patients expeditiously, once the COVID-19 threat dissipates."