공시 • Sep 07

Iveric Bio Announces Positive Topline Data from Zimura® Gather2 Phase 3 Clinical Trial in Geographic Atrophy

IVERIC bio, Inc. announced positive topline results from GATHER2, the Company’s second Phase 3 clinical trial of Zimura® (avacincaptad pegol), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA). GATHER2 met its prespecified primary endpoint of mean rate of growth (slope) in GA area at 12 months with statistical significance and a favorable safety profile. In GATHER2, there were no events of endophthalmitis, no intraocular inflammation events, and no ischemic optic neuropathy events through month 12. The most frequently reported ocular adverse events were related to the injection procedure. The incidence of choroidal neovascularization (CNV) in the study eye through month 12 was 15 patients (6.7%) in the Zimura 2 mg group and 9 patients (4.1%) in the sham control group. Similar to GATHER1, the Company’s first Phase 3 clinical trial of Zimura in GA, an independent masked reading center assessed the CNV cases in GATHER2 at the 12-month timepoint for exudative macular neovascularization (eMNV) and non-exudative macular neovascularization (neMNV). The pre-specified primary endpoint, mean rate of growth (slope) in GA area over 12 months, was measured by fundus autofluorescence (FAF) based on readings at three time points (baseline, month 6, and month 12) and was calculated using the square root transformation of the GA area. The FAF images were assessed by an independent masked reading center. The Company also analyzed the mean rate of growth (slope) in GA area without square root transformation (observed GA area). The Company also analyzed the mean change in GA area from baseline to month 12 in GATHER2 using a point analysis, which was the pre-specified primary endpoint in GATHER1. This analysis was performed based on FAF readings at the same three time points as the primary efficacy analysis (baseline, month 6, and month 12) using the square root transformation and the observed GA area. The results for the 12-month point analysis were consistent with the slope analysis. Details are provided in the accompanying supplement. As part of the pre-specified statistical analysis plan for GATHER2, the Company also analyzed the mean rate of growth (slope) in GA area for Zimura 2 mg as compared to sham for pre-specified patient subgroups based on baseline lesion size, baseline visual acuity, baseline autofluorescence pattern, age, and gender. Zimura 2 mg showed a reduction in the mean rate of growth (slope) in GA area for all analyzed subgroups. The pre-specified supportive endpoints in GATHER2 included the mean change in best corrected visual acuity (BCVA) and the mean change in low luminance best corrected visual acuity (LL BCVA) from baseline to month 12. For BCVA, a favorable trend for Zimura 2 mg was observed consistent with GATHER1. For LL BCVA, a favorable trend was not observed.

공시 • Apr 06

IVERIC bio, Inc. Completes Retrospective Review of Choroidal Neovascularization

IVERIC bio, Inc. working with an independent reading center, recently completed a retrospective review of the cases of choroidal neovascularization ("CNV") in the Zimura® (avacincaptad pegol) 2 mg group (n=67) from GATHER1, the Company's first pivotal clinical trial evaluating the safety and efficacy of Zimura for the treatment of geographic atrophy ("GA") secondary to age-related macular degeneration ("AMD"). As previously reported, the incidence of investigator reported CNV in the study eye in the Zimura 2 mg group in the completed GATHER1 clinical trial was six (6) patients (9.0%) at 12 months and eight (8) patients (11.9%) at 18 months. GATHER2, the Company's second pivotal clinical trial evaluating the safety and efficacy of Zimura 2 mg for the treatment of GA remains ongoing, with topline data expected to be available during the second half of 2022. The retrospective review was performed by the Center for Ocular Research and Evaluation (CORE) at Cole Eye Institute of the Cleveland Clinic (the "Reading Center"). As part of the retrospective review, the Reading Center read optical coherence tomography ("OCT") images for the eight (8) patients in the Zimura 2 mg group who developed CNV in the study eye. OCT is an ultra-high resolution imaging technology commonly used to visualize the retinal tissue. OCT is capable of rendering images in multiple dimensions and from multiple perspectives, including a cross-sectional view of the retina showing clearly defined layers of retinal tissue. OCT is the dominant imaging modality used by retinal specialists in the United States to diagnose, treat and follow patients with CNV. OCT images were read to determine the number of CNV cases that were (1) macular neovascularization ("MNV") (versus peripapillary neovascularization, where the neovascularization is located around the optic nerve and not encroaching on the macula) and (2) exudative MNV (versus non-exudative MNV). T he Reading Center classifies cases of MNV as exudative or non-exudative based on the following OCT criteria: Exudative MNV ("eMNV") is MNV that presents with new onset fluid in either the subretinal space or the intraretinal space. The subretinal space is the area on OCT between the retinal pigment epithelium ("RPE") and photoreceptor cells. The intraretinal space is the area on OCT containing the photoreceptors and other neurosensory cells of the retina. Non-exudative MNV ("neMNV") is neovascularization located in the macula but which does not present with new onset fluid in the subretinal or intraretinal spaces. In some cases, isolated fluid may be present in the sub-RPE space, which is the area between the RPE and Bruch's membrane, a layer of tissue directly beneath the RPE separating the RPE from the choroid. A case is also considered to be neMNV when the MNV may not be visible but both a double-layer sign and sub-RPE fluid are present. A double-layer sign is characterized by a shallow elevation of the RPE typically caused by the accumulation of fluid or debris in the sub-RPE space. The Reading Center also reviewed the baseline OCT images for all eight (8) patients looking for the presence of a double-layer sign at baseline. A study published in 2019 in the peer-reviewed journal Ophthalmology Retina found that the presence of a double-layer sign is correlated with the presence or development of neMNV in eyes with AMD, and clinical experience has shown that this type of neMNV often progresses to eMNV. Based on scientific literature and clinical understanding among the retinal community, the Company believes the presence of a double-layer sign on OCT is a useful biomarker to predict the future onset of cases of eMNV. In this retrospective review, the Reading Center found that among the six (6) GATHER1 patients who developed eMNV over 18 months, five (5) of those patients had a double-layer sign at baseline. The Reading Center also found that neither of the two GATHER1 patients who had neMNV at the 12-month and 18-month timepoints had a double-layer sign at baseline. For this retrospective review, OCT images were graded at the Reading Center by two masked, independent readers, with the gradings confirmed by two additional masked, independent senior readers. All OCT gradings for these patients were consistent among all readers. All of the readers remained masked to treatment condition throughout the review. The Company does not plan to report data comparing the growth of GA area in the study eye to the growth of GA area in the fellow eye among patients in the GATHER1 trial. The study eye is the eye that received study drug or sham during the trial, while the fellow eye is the patient's other eye. In the GATHER1 trial, one of the key ophthalmic inclusion criteria was the presence of GA in the study eye located in whole or in part within 1,500 microns of the fovea, the central portion of the macula, but which did not enter the foveal center point. These criteria did not apply to the fellow eye, and the Company has not collected measurements of the fellow eye that would enable it to determine which patients' fellow eyes would have met the study eye inclusion criteria. As the Company has previously discussed, it has been widely reported in scientific literature and observed in clinical trials that GA that is non-subfoveal (that has not impacted the foveal center), is positively correlated with a higher rate of GA area progression and growth as compared to GA that has reached the foveal center. For these reasons, the Company does not believe that a valid comparison between the growth of GA area in the study eye versus that in the fellow eye can be made for the GATHER1 trial.

이자보상배율	n/a
현금	US$599.92m
자본	US$477.05m
총부채	US$136.36m
총자산	US$613.41m

데이터	최종 업데이트 (UTC 시간)
기업 분석	2023/07/12 06:28
종가	2023/07/10 00:00
수익	2023/03/31
연간 수익	2022/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
Yuan Zhi	B. Riley Securities, Inc.
Ling Wang	BTIG
Gbolahan Amusa Benz	Chardan Capital Markets, LLC

This company has been acquired

IVERIC bio 대차대조표 건전성

재무 건전성 기준 점검 5/6

핵심 정보

최근 재무 건전성 업데이트

IVERIC bio, Inc. Files Form 15

IVERIC bio's Common Stock Delisted from NASDAQ

Recent updates

IVERIC bio, Inc. Announces Positive 24-Month Topline Results from Phase 3 Study of IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

European Medicines Agency Accepts Iveric Bio's Marketing Authorization Application for Avacincaptad Pegol for Geographic Atrophy

Iveric Bio Receives U.S. FDA Approval for IZERVAY™ (avacincaptad pegol intravitreal solution), a New Treatment for Geographic Atrophy

IVERIC bio, Inc. Files Form 15

IVERIC bio, Inc.(NasdaqGS:ISEE) dropped from NASDAQ Composite Index

IVERIC bio's Common Stock Delisted from NASDAQ

Senior VP & COO exercised options and sold US$730k worth of stock

Senior VP & COO notifies of intention to sell stock

Consensus EPS estimates fall by 12%

Forecast to breakeven in 2025

Senior VP exercised options and sold US$2.2m worth of stock

Price target increased by 10% to US$35.09

Forecast to breakeven in 2025

Senior VP notifies of intention to sell stock

Senior VP & COO exercised options and sold US$940k worth of stock

Consensus revenue estimates fall by 13%

Senior VP & COO exercised options and sold US$299k worth of stock

No longer forecast to breakeven

Senior VP & COO exercised options and sold US$314k worth of stock

IVERIC bio, Inc. Announces U.S. Food and Drug Administration Accepts New Drug Application for Avacincaptad Pegol for the Treatment of Geographic Atrophy

Senior VP & COO notifies of intention to sell stock

CEO & Director exercised options and sold US$350k worth of stock

Iveric Bio Announces the Addition of Pravin U. Dugel to Its Board of Directors

Forecast to breakeven in 2025

Iveric Bio, Inc. Announces Completion of Rolling NDA Submission to FDA for Avacincaptad Pegol for the Treatment of Geographic Atrophy

Senior VP & COO exercised options and sold US$259k worth of stock

Senior VP & COO exercised options to buy US$109k worth of stock.

IVERIC bio, Inc. has completed a Follow-on Equity Offering in the amount of $300.375 million.

President exercised options to buy US$179k worth of stock.

IVERIC bio, Inc. Announces FDA Has Granted Breakthrough Therapy Designation for Avacincaptad Pegol for Geographic Atrophy

Price target increased to US$30.17

Senior VP & COO exercised options and sold US$964k worth of stock

IVERIC bio, Inc. Announces Submission of First Part of NDA for Rolling Review of Avacincaptad Pegol for the Treatment of Geographic Atrophy

IVERIC bio, Inc. to Report Q3, 2022 Results on Nov 03, 2022

Iveric Bio Announces Positive Topline Data from Zimura® Gather2 Phase 3 Clinical Trial in Geographic Atrophy

Price target increased to US$26.36

Iveric drives Apellis lower as Street reacts to Phase 3 data for GA candidate

Senior VP & Chief Commercial Officer exercised options and sold US$138k worth of stock

IVERIC bio Q2 2022 Earnings Preview

IVERIC bio, Inc. to Report Q2, 2022 Results on Jul 26, 2022

Iveric Bio Announces Post-Hoc Analysis from GATHER1 Clinical Trial of Zimura® At American Society of Retina Specialists Meeting

Insider exercised options and sold US$73k worth of stock

Iveric bio pay DelSiTech €1.25M upfront to develop new formulations of eye disorder drug Zimura

IVERIC bio, Inc.(NasdaqGS:ISEE) dropped from Russell Microcap Value Index

IVERIC bio: A First Take

Independent Director recently bought US$241k worth of stock

IVERIC bio, Inc. Announces Presentation of Post-Hoc Analysis At Macula Society from Gather1 Clinical Trial of Zimura® in Patients with Geographic Atrophy

Price target increased to US$24.38

IVERIC bio, Inc. Completes Retrospective Review of Choroidal Neovascularization

IVERIC bio, Inc., Annual General Meeting, May 12, 2022

Senior VP exercised options and sold US$261k worth of stock

Senior VP notifies of intention to sell stock

IVERIC bio, Inc. to Report Q4, 2021 Results on Feb 24, 2022

Iveric Bio Announces Foveal Anatomy Post-Hoc Analysis from GATHER1 Clinical Trial of Zimura® in Patients with Geographic Atrophy

IVERIC bio, Inc. Announces in GATHER2, the Company's Phase 3 Clinical Trial Evaluating the Safety and Efficacy of Zimura (Avacincaptad Pegol) for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration

CEO & Director exercised options and sold US$882k worth of stock

CEO & Director exercised options and sold US$122k worth of stock

Insider recently bought US$50k worth of stock

Apellis' Loss Is Iveric Bio's Gain In Lucrative Eye Disease Field

Price target increased to US$16.50

IVERIC Bio, Inc. Provides Updates on Clinical Trails

Price target increased to US$14.67

IVERIC bio, Inc. Updates on Its Phase 3 Clinical Trails Zimura

New 90-day low: US$5.58

IVERIC bio, Inc. to Report Q4, 2020 Results on Feb 25, 2021

Senior VP & COO exercised options and sold US$81k worth of stock

Executive Chairman exercised options and sold US$67k worth of stock

New 90-day high: US$6.91

New 90-day high: US$6.48

IVERIC bio, Inc. to Report Q3, 2020 Results on Nov 02, 2020

New 90-day high: US$6.38

IVERIC bio Announces Successful Advancement of LCA10 Minigene Program and Expansion of Orphan Gene Therapy Portfolio with USH2A-Related Inherited Retinal Diseases Program