Zimura® GATHER2 Topline Data Expected in the Third Quarter of this Year
GATHER2 Trial Completion at 94% for Year One; Patient Retention Continues to Exceed Expectations with a Target 12-Month Injection Fidelity Rate of Greater than 90%
U.S. Patent Covering Methods of Treating GA with Zimura Granted by USPTO
@Howard, Mazen, and Josh: Told you cheerleaders/pumpers. See you @ $7.
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Meaningful move up today.....looks ready to challenge $20++
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IVERIC bio is down 9.11% to 11.28
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What happened to be down by 10.9%????
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IVERIC bio is down 8.49% to 13.68
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What’s got you thinking that Jason?
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3/22/22 Jefferies Initiated IVERIC bio, Inc. (ISEE) $27.00 Buy
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IVERIC bio is up 7.93% to 16.34
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IVERIC bio is down 8.10% to 15.43
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3/3/22 Baird Initiates IVERIC bio, Inc. (ISEE) $27.00 Outperform
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IVERIC bio is up 7.33% to 16.89
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IVERIC bio is down 7.47% to 15.37
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IVERIC bio is up 6.92% to 16.06
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IVERIC bio is down 7.08% to 13.79
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(Nasdaq: ISEE) today announced financial and operating results for the fiscal quarter ended September 30, 2020 and provided a general business update.
“It has been a landmark year as we have achieved several major milestones for Zimura,” stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. “Over the past year, we announced positive 12-month and 18-month results from our GATHER1 Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration. We initiated patient enrollment in GATHER2, our second Phase 3 clinical trial for the treatment of GA secondary to AMD. Additionally, we strengthened our balance sheet, advanced our two lead gene therapy product candidates to be on track to enter into the clinic next year and identified a lead compound for our HtrA1 inhibitor program.”
Pravin U. Dugel, M.D., Chief Strategy and Business Officer of IVERIC bio added, “We are excited about the momentum generated with Zimura as a potential treatment for GA and, based on scientific data, Zimura‘s potential impact in wet (neovascular) AMD and in earlier stages of dry AMD. We are also encouraged by our HtrA1 inhibitor, IC-500, which we believe could be another important target in the treatment of AMD. Looking forward, our goal is to expand our footprint in multiple stages and types of AMD, dry and wet. We intend to do this by potentially studying Zimura in additional indications and by advancing the development of IC-500. We expect to make great strides in 2021, as we continue to move our pipeline of therapeutics and gene therapy product candidates forward.”
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Wedbush Initiates Coverage IVERIC bio, Inc. (ISEE) Outperform $13.00 Wedbush’s David Nierengarten initiated coverage of Iveric Bio with an Outperform rating and a price target of $13.
The Thesis
Geographic atrophy is estimated to represent a market opportunity of over $1 billion, with the current patient population at more than 1 million, Nierengarten said in the note.
In October, Iveric Bio had announced Zimura showed positive results in slowing the growth of lesions in its Phase 2 study. The company’s lead asset is also being investigated in Stargardt disease and data from this study could come as early as in the back half of 2002, the analyst noted.
Nierengarten expects more details of the trial design for Zimura’s pivotal study to be disclosed at Iveric Bio’s R&D investor symposium on Jan. 14.
He further wrote, “The company is also building a portfolio of gene therapy candidates, with the first program in autosomal dominant retinitis pigmentosa (adRP) likely to enter the clinic late this year.”
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IVERIC bio Announces Positive Zimura 18 Month Data Supporting the 12 Month Efficacy Findings: Continuous Positive Treatment Effect with Favorable Safety Profile in Geographic Atrophy Secondary to Age-Related Macular Degeneration in a Phase 3 Trial
GATHER2 Trial Completion at 94% for Year One; Patient Retention Continues to Exceed Expectations with a Target 12-Month Injection Fidelity Rate of Greater than 90%
U.S. Patent Covering Methods of Treating GA with Zimura Granted by USPTO
Credit Suisse Raises Price IVERIC bio, Inc. (ISEE) $21.00 -> $22.00
Jefferies Initiated IVERIC bio, Inc. (ISEE) $27.00 Buy
Baird Initiates IVERIC bio, Inc. (ISEE) $27.00 Outperform
“It has been a landmark year as we have achieved several major milestones for Zimura,” stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. “Over the past year, we announced positive 12-month and 18-month results from our GATHER1 Phase 3 clinical trial of Zimura for the treatment of geographic atrophy secondary to age-related macular degeneration. We initiated patient enrollment in GATHER2, our second Phase 3 clinical trial for the treatment of GA secondary to AMD. Additionally, we strengthened our balance sheet, advanced our two lead gene therapy product candidates to be on track to enter into the clinic next year and identified a lead compound for our HtrA1 inhibitor program.”
Pravin U. Dugel, M.D., Chief Strategy and Business Officer of IVERIC bio added, “We are excited about the momentum generated with Zimura as a potential treatment for GA and, based on scientific data, Zimura‘s potential impact in wet (neovascular) AMD and in earlier stages of dry AMD. We are also encouraged by our HtrA1 inhibitor, IC-500, which we believe could be another important target in the treatment of AMD. Looking forward, our goal is to expand our footprint in multiple stages and types of AMD, dry and wet. We intend to do this by potentially studying Zimura in additional indications and by advancing the development of IC-500. We expect to make great strides in 2021, as we continue to move our pipeline of therapeutics and gene therapy product candidates forward.”
Wedbush’s David Nierengarten initiated coverage of Iveric Bio with an Outperform rating and a price target of $13.
The Thesis
Geographic atrophy is estimated to represent a market opportunity of over $1 billion, with the current patient population at more than 1 million, Nierengarten said in the note.
In October, Iveric Bio had announced Zimura showed positive results in slowing the growth of lesions in its Phase 2 study. The company’s lead asset is also being investigated in Stargardt disease and data from this study could come as early as in the back half of 2002, the analyst noted.
Nierengarten expects more details of the trial design for Zimura’s pivotal study to be disclosed at Iveric Bio’s R&D investor symposium on Jan. 14.
He further wrote, “The company is also building a portfolio of gene therapy candidates, with the first program in autosomal dominant retinitis pigmentosa (adRP) likely to enter the clinic late this year.”