Iveric bio completes patient enrollment in clinical trial of Zimura » 07:3407/2607/26/21
IVERIC bio announced the…
IVERIC bio announced the early completion of patient enrollment of GATHER2, the Company's second pivotal clinical trial of Zimura, avacincaptad pegol in development for the treatment of geographic atrophy GA secondary to age-related macular degeneration, AMD. The Company expects topline GATHER2 data to be become available during the second half of 2022, approximately one year after the enrollment of the last patient, plus the time needed for database lock and analysis. "The time to complete enrollment in the Zimura GATHER2 clinical trial was four months ahead of our original timeline. That we were able to accomplish this during the unprecedented challenges stemming from the global COVID-19 pandemic, we believe highlights the unmet need of patients and physicians for a treatment of GA secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "Patient retention continues to exceed our expectations in GATHER2. We look forward to sharing the topline results of GATHER2 in the second half of 2022 and to the potential opportunity to bring Zimura therapy to GA secondary to AMD patients around the world." The Company also announced earlier this month that it received written agreement from the U.S. Food and Drug Administration under a Special Protocol Assessment for the overall design of GATHER2. The agreement further solidifies the Company's plans to file an application with the FDA for marketing approval of Zimura for GA secondary to AMD, if the ongoing GATHER2 clinical trial meets its primary endpoint at 12 months. Zimura met its pre-specified primary efficacy endpoint at 12 months and reached statistical significance in the previously completed GATHER1 pivotal clinical trial. "The successful completion of enrollment ahead of schedule and on-going patient retention in GATHER2 reflect the tremendous work and innovative programs our clinical team has executed and are a tribute to our patients, investigators and their study staff," stated Pravin U. Dugel, President of Iveric Bio. "This milestone would have been impressive at any time however it is more impressive during a global pandemic. We continue to focus on retention, not only to protect the integrity of our data, but also with the goal of demonstrating Zimura's early and continuous treatment effect over time, similar to what we observed previously in GATHER1."
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Iveric bio appoints Christopher Simms as Chief Commercial Officer » 07:3507/1907/19/21
IVERIC announced the…
IVERIC announced the appointment of Christopher Simms to Senior Vice President and Chief Commercial Officer, effective August 2. Mr. Simms joins Iveric Bio from Novartis, where he successfully managed commercial operations for the U.S. Ophthalmics Franchise, launching BEOUV,brolucizumab injection, for wet age-related macular degeneration. Before Novartis, he served as marketing lead for the Genentech ophthalmology business which included creating a new brand positioning and launching a new campaign for Lucentis, ran ibizumab injection. "In this newly created position, Chris's responsibilities include developing and implementing the Company's commercial strategy and establishing our commercial infrastructure as we complete our GATHER2 clinical trial, prepare for a potential new drug application and begin to prepare for a potential launch of Zimura for the treatment of geographic atrophy secondary to AMD," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited about a potential launch of Zimura and our strategy to develop multiple, complementary assets to establish an AMD franchise. We believe Chris's deep understanding of the retinal space and highly accomplished commercial experience with launching retinal products of blockbuster potential will serve us well."
Piper Sandler biotech analysts hold an analyst/industry conference call » 09:5107/1507/15/21
RGNX, ROG, ADVM, SNY, JNJ, BIIB, AGTC, ISEE, GSGTF
Biotechnology Analysts Rahimi & Raymond, along with Roger A. Goldberg, MD, MBA, Ophthalmologist at Bay Area Retina Associates discuss gene therapy for ocular disease on an Analyst/Industry conference call to be held on July 15 at 10 am. Webcast Link
Cantor Fitzgerald technology analyst to hold an analyst/industry conference call » 08:5307/1307/13/21
ISEE, GMTX, LCTX, APLS
Biotech Analyst Young,…
Biotech Analyst Young, along with Key Opinion Leader Dr. Roger Goldberg, Partner and Vitreoretinal Surgeon at Bay Area Retina Associates, discuss Apellis' Pegcetacoplan and other emerging therapies in geographic atrophy such as Gemini's (GMTX) GEM103, Iveric's (ISEE) Zimura, and Lineage's (LCTX) OpRegen, on an Analyst/Industry conference call to be held on July 13 at 10:30 am.
Iveric bio 11.65M share Spot Secondary priced at $8.60 » 06:3907/1307/13/21
The deal range was…
The deal range was $8.50-$8.75. Cowen, Credit Suisse and Stifel acted as joint book running managers for the offering.
Iveric bio files to sell common stock, no amount given » 16:0707/1207/12/21
Cowen, Credit Suisse and…
Cowen, Credit Suisse and Stifel are acting as the book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.
Iveric bio price target raised to $16 from $14 at Credit Suisse » 10:4007/0607/06/21
Credit Suisse analyst…
Credit Suisse analyst Tiago Fauth raised the firm's price target on Iveric bio to $16 from $14 and keeps an Outperform rating on the shares after the company announced receipt of written agreement from the FDA under a Special Protocol Assessment, or SPA, for the overall design of the pivotal clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration. The SPA helps clear a potential regulatory overhang and helps to confirm his view that a positive GATHER2 outcome, in addition to the GATHER1 dataset, would likely suffice for a potential approval, Fauth tells investors.
Fly Intel: Pre-market Movers » 08:5407/0607/06/21
ISEE, CANO, MNOV, AXLA, OCGN, BLIN, DIDI, YMM, BZ, PRVB, AHT
Check out this morning's…
Iveric bio jumps over 20% after FDA agreement for GATHER2 Phase 3 trial » 07:3007/0607/06/21
Shares of IVERIC bio are…
Shares of IVERIC bio are up over 20% at $9.61 in pre-market trading after the company announced that it received FDA agreement under SPA for GATHER2 Phase 3 trial.
Iveric bio receives FDA agreement under SPA for GATHER2 Phase 3 trial » 06:1607/0607/06/21
IVERIC bio announced that…
IVERIC bio announced that the Company received written agreement from the U.S. Food and Drug Administration under a Special Protocol Assessment for the overall design of GATHER2, the Company's pivotal clinical trial of Zimura in development for the treatment of geographic atrophy secondary to age-related macular degeneration. As previously announced, the Company expects to complete enrollment in GATHER2 in late July of this year. Based on this timeline, the Company expects topline GATHER2 data to be available in the second half of 2022, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis. Similar to the Company's completed GATHER1 clinical trial, GATHER2 is designed to be an adequate and well-controlled clinical trial which, if positive, would support a New Drug Application for Zimura in the treatment of GA secondary to AMD. The SPA agreement further solidifies the Company's plans to file an application with the FDA if the ongoing GATHER2 clinical trial meets its primary efficacy endpoint at 12 months. In connection with the SPA, the FDA recommended, and the Company accepted, modifying the primary efficacy endpoint for the GATHER2 trial from the mean rate of change in GA area over 12 months measured by fundus autofluorescence at three timepoints: baseline, month 6 and month 12, to the mean rate of growth estimated based on GA area measured by FAF in at least three timepoints: baseline, month 6 and month 12. In connection with the SPA, the Company submitted, and the FDA reviewed, a revised clinical trial protocol and statistical analysis plan for the GATHER2 trial reflecting the revised primary efficacy endpoint and agreed upon statistical analysis method. The original primary efficacy endpoint estimated the mean rate of change in GA area from baseline to month 12, as measured by FAF readings at three time points, without assuming a constant rate of growth over the period. Using the same raw data, the FDA preferred method estimates the mean rate of growth of GA area from baseline to month 12, based on FAF readings at the same three time points, assuming a constant rate of growth over the period, essentially fitting a straight line based on the data. In parallel discussions with those for the GATHER2 SPA, the FDA indicated to the Company that, as part of a future NDA submission for Zimura, the GATHER1 results will be considered using the original prespecified primary efficacy endpoint analysis, together with a post-hoc analysis using the same FDA preferred method that will be used for the GATHER2 trial.