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Hot Stocks
Iveric bio completes patient enrollment in clinical trial of Zimura » 07:34
07/26/21
07/26
07:34
07/26/21
07:34
ISEE

Iveric bio

$8.94 /

+0.05 (+0.56%)

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."

ShowHide Related Items >><<
ISEE Iveric bio
$8.94 /

+0.05 (+0.56%)

ISEE Iveric bio
$8.94 /

+0.05 (+0.56%)

07/06/21 Credit Suisse
Iveric bio price target raised to $16 from $14 at Credit Suisse
08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
ISEE Iveric bio
$8.94 /

+0.05 (+0.56%)

  • 13
    Jul
ISEE Iveric bio
$8.94 /

+0.05 (+0.56%)

Over a week ago
Hot Stocks
Iveric bio appoints Christopher Simms as Chief Commercial Officer » 07:35
07/19/21
07/19
07:35
07/19/21
07:35
ISEE

Iveric bio

$9.74 /

-0.04 (-0.41%)

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."

ShowHide Related Items >><<
ISEE Iveric bio
$9.74 /

-0.04 (-0.41%)

ISEE Iveric bio
$9.74 /

-0.04 (-0.41%)

07/06/21 Credit Suisse
Iveric bio price target raised to $16 from $14 at Credit Suisse
08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
ISEE Iveric bio
$9.74 /

-0.04 (-0.41%)

  • 13
    Jul
ISEE Iveric bio
$9.74 /

-0.04 (-0.41%)

Conference/Events
Piper Sandler biotech analysts hold an analyst/industry conference call » 09:51
07/15/21
07/15
09:51
07/15/21
09:51
RGNX

Regenxbio

$35.60 /

-0.36 (-1.00%)

, ROG

Rogers Corporation

$193.11 /

-1.44 (-0.74%)

, ADVM

Adverum Biotechnologies

$3.08 /

-0.075 (-2.38%)

, SNY

Sanofi

$51.63 /

-0.74 (-1.41%)

, JNJ

Johnson & Johnson

$169.40 /

-0.8 (-0.47%)

, BIIB

Biogen

$338.50 /

-13.56 (-3.85%)

, AGTC

Applied Genetic

$3.56 /

-0.02 (-0.56%)

, ISEE

Iveric bio

$9.34 /

-0.08 (-0.85%)

, GSGTF

Gensight Biologics

$9.90 /

+ (+0.00%)

Biotechnology Analysts…

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

ShowHide Related Items >><<
SNY Sanofi
$51.63 /

-0.74 (-1.41%)

ROG Rogers Corporation
$193.11 /

-1.44 (-0.74%)

RGNX Regenxbio
$35.60 /

-0.36 (-1.00%)

JNJ Johnson & Johnson
$169.40 /

-0.8 (-0.47%)

ISEE Iveric bio
$9.34 /

-0.08 (-0.85%)

BIIB Biogen
$338.50 /

-13.56 (-3.85%)

AGTC Applied Genetic
$3.56 /

-0.02 (-0.56%)

ADVM Adverum Biotechnologies
$3.08 /

-0.075 (-2.38%)

RGNX Regenxbio
$35.60 /

-0.36 (-1.00%)

07/09/21 Chardan
Regenxbio coverage transferred at Chardan
04/29/21 Chardan
Chardan downgrades Adverum after serious adverse reaction disclosure
04/05/21 Morgan Stanley
Regenxbio AAV9 patent challenged by Passage Bio, says Morgan Stanley
02/09/21 Morgan Stanley
Sarepta denied motion to dismiss 'Wilson Wolf' case, says Morgan Stanley
ROG Rogers Corporation
$193.11 /

-1.44 (-0.74%)

06/09/21 Wolfe Research
Rogers Corporation initiated with an Outperform at Wolfe Research
05/26/21
Fly Intel: Top five analyst initiations
05/26/21 Canaccord
Canaccord starts Rogers with Buy on electrification benefits
05/26/21 Canaccord
Rogers Corporation initiated with a Buy at Canaccord
ADVM Adverum Biotechnologies
$3.08 /

-0.075 (-2.38%)

07/09/21 Chardan
Adverum Biotechnologies coverage transferred at Chardan
05/03/21 SVB Leerink
Adverum Biotechnologies downgraded to Market Perform at SVB Leerink
05/03/21 SVB Leerink
Adverum Biotechnologies downgraded to Market Perform from Outperform at SVB Leerink
SNY Sanofi
$51.63 /

-0.74 (-1.41%)

05/25/21 JPMorgan
Olema selloff brings 'compelling' entry point, says JPMorgan
04/30/21 Deutsche Bank
Sanofi price target raised to EUR 75 from EUR 70 at Deutsche Bank
04/29/21 Barclays
Sanofi price target raised to EUR 90 from EUR 85 at Barclays
04/28/21 Stifel
Protalix, Sanofi updates may signal headwinds for Avrobio, Amicus, says Stifel
JNJ Johnson & Johnson
$169.40 /

-0.8 (-0.47%)

07/08/21 Stifel
Vor Biopharma, Janssen collaboration benefits both parties, says Stifel
07/02/21 Cantor Fitzgerald
J&J vaccine shows 'strong' activist against Delta, says Cantor Fitzgerald
06/28/21 Cantor Fitzgerald
J&J opioid settlement removes share overhang, says Cantor Fitzgerald
06/22/21 JPMorgan
Opioid settlement would be best case for manufacturers, says JPMorgan
BIIB Biogen
$338.50 /

-13.56 (-3.85%)

07/13/21 Oppenheimer
Prothena price target raised to $76 from $54 at Oppenheimer
07/09/21 Stifel
FDA call for probe 'noise' for Biogen, unlikely to impact Aduhelm, says Stifel
07/08/21 Deutsche Bank
Roche upgraded to Buy from Hold at Deutsche Bank
06/28/21 RBC Capital
Biogen price target lowered to $354 from $400 at RBC Capital
AGTC Applied Genetic
$3.56 /

-0.02 (-0.56%)

07/09/21 Chardan
Applied Genetic coverage transferred at Chardan
06/14/21 BTIG
Applied Genetic initiated with a Buy at BTIG
04/19/21 Roth Capital
Roth Capital 'bullish' on Applied Genetic's technology, pipeline outlook
04/13/21 Roth Capital
Roth Capital sees Applied Genetic's XLRS licensing as vote of confidence
ISEE Iveric bio
$9.34 /

-0.08 (-0.85%)

07/06/21 Credit Suisse
Iveric bio price target raised to $16 from $14 at Credit Suisse
08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
GSGTF Gensight Biologics
$9.90 /

+ (+0.00%)

07/09/21 Chardan
Gensight Biologics coverage transferred at Chardan
02/19/21 Chardan
Chardan doubles Gensight target, makes top pick for 2021
09/15/20 Chardan
Gensight Biologics price target raised to EUR 10 from EUR 8.50 at Chardan
SNY Sanofi
$51.63 /

-0.74 (-1.41%)

ROG Rogers Corporation
$193.11 /

-1.44 (-0.74%)

RGNX Regenxbio
$35.60 /

-0.36 (-1.00%)

JNJ Johnson & Johnson
$169.40 /

-0.8 (-0.47%)

ISEE Iveric bio
$9.34 /

-0.08 (-0.85%)

BIIB Biogen
$338.50 /

-13.56 (-3.85%)

AGTC Applied Genetic
$3.56 /

-0.02 (-0.56%)

ADVM Adverum Biotechnologies
$3.08 /

-0.075 (-2.38%)

  • 13
    Jul
  • 28
    Jan
  • 08
    Jan
  • 13
    Aug
SNY Sanofi
$51.63 /

-0.74 (-1.41%)

JNJ Johnson & Johnson
$169.40 /

-0.8 (-0.47%)

BIIB Biogen
$338.50 /

-13.56 (-3.85%)

SNY Sanofi
$51.63 /

-0.74 (-1.41%)

JNJ Johnson & Johnson
$169.40 /

-0.8 (-0.47%)

ISEE Iveric bio
$9.34 /

-0.08 (-0.85%)

BIIB Biogen
$338.50 /

-13.56 (-3.85%)

AGTC Applied Genetic
$3.56 /

-0.02 (-0.56%)

ADVM Adverum Biotechnologies
$3.08 /

-0.075 (-2.38%)

JNJ Johnson & Johnson
$169.40 /

-0.8 (-0.47%)

BIIB Biogen
$338.50 /

-13.56 (-3.85%)

Conference/Events
Cantor Fitzgerald technology analyst to hold an analyst/industry conference call » 08:53
07/13/21
07/13
08:53
07/13/21
08:53
ISEE

Iveric bio

$9.00 /

-0.6 (-6.25%)

, GMTX

Gemini Therapeutics

$5.70 /

-0.19 (-3.23%)

, LCTX

Lineage Cell Therapeutics

$2.75 /

-0.01 (-0.36%)

, APLS

Apellis

$65.81 /

-1.19 (-1.78%)

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.

ShowHide Related Items >><<
LCTX Lineage Cell Therapeutics
$2.75 /

-0.01 (-0.36%)

ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

GMTX Gemini Therapeutics
$5.70 /

-0.19 (-3.23%)

APLS Apellis
$65.81 /

-1.19 (-1.78%)

ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

07/06/21 Credit Suisse
Iveric bio price target raised to $16 from $14 at Credit Suisse
08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
GMTX Gemini Therapeutics
$5.70 /

-0.19 (-3.23%)

06/23/21 Stifel
Gemini's negative stock reaction to GEM103 data overdone, says Stifel
04/08/21 SVB Leerink
SVB Leerink bullish on Gemini Therapeutics, initiates with an Outperform
04/08/21 SVB Leerink
Gemini Therapeutics initiated with an Outperform at SVB Leerink
03/03/21 Jefferies
Gemini Therapeutics initiated with a Buy at Jefferies
LCTX Lineage Cell Therapeutics
$2.75 /

-0.01 (-0.36%)

03/30/21 Cantor Fitzgerald
Lineage Cell Therapeutics initiated with an Overweight at Cantor Fitzgerald
09/17/20 Noble Capital
Lineage Cell Therapeutics initiated with an Outperform at Noble Capital
08/31/20 H.C. Wainwright
Lineage Cell extends cash runway to over two years, says H.C. Wainwright
APLS Apellis
$65.81 /

-1.19 (-1.78%)

07/08/21 BMO Capital
Apellis price target raised to $89 from $68 at BMO Capital
07/07/21 Piper Sandler
NGM executing on fully owned assets in oncology, says Piper Sandler
07/02/21 Citi
Citi opens '90-day catalyst watch' on Apellis ahead of trial readouts
07/02/21 JPMorgan
Apellis price target raised to $101 from $91 at JPMorgan
LCTX Lineage Cell Therapeutics
$2.75 /

-0.01 (-0.36%)

ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

APLS Apellis
$65.81 /

-1.19 (-1.78%)

  • 13
    Jul
LCTX Lineage Cell Therapeutics
$2.75 /

-0.01 (-0.36%)

ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

GMTX Gemini Therapeutics
$5.70 /

-0.19 (-3.23%)

APLS Apellis
$65.81 /

-1.19 (-1.78%)

GMTX Gemini Therapeutics
$5.70 /

-0.19 (-3.23%)

APLS Apellis
$65.81 /

-1.19 (-1.78%)

Syndicate
Iveric bio 11.65M share Spot Secondary priced at $8.60 » 06:39
07/13/21
07/13
06:39
07/13/21
06:39
ISEE

Iveric bio

$9.00 /

-0.6 (-6.25%)

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.

ShowHide Related Items >><<
ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

07/06/21 Credit Suisse
Iveric bio price target raised to $16 from $14 at Credit Suisse
08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

  • 13
    Jul
ISEE Iveric bio
$9.00 /

-0.6 (-6.25%)

Syndicate
Iveric bio files to sell common stock, no amount given » 16:07
07/12/21
07/12
16:07
07/12/21
16:07
ISEE

Iveric bio

$9.06 /

-0.54 (-5.63%)

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.

ShowHide Related Items >><<
ISEE Iveric bio
$9.06 /

-0.54 (-5.63%)

ISEE Iveric bio
$9.06 /

-0.54 (-5.63%)

07/06/21 Credit Suisse
Iveric bio price target raised to $16 from $14 at Credit Suisse
08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
ISEE Iveric bio
$9.06 /

-0.54 (-5.63%)

ISEE Iveric bio
$9.06 /

-0.54 (-5.63%)

Recommendations
Iveric bio price target raised to $16 from $14 at Credit Suisse » 10:40
07/06/21
07/06
10:40
07/06/21
10:40
ISEE

Iveric bio

$7.68 /

-0.24 (-3.03%)

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.

ShowHide Related Items >><<
ISEE Iveric bio
$7.68 /

-0.24 (-3.03%)

ISEE Iveric bio
$7.68 /

-0.24 (-3.03%)

08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
ISEE Iveric bio
$7.68 /

-0.24 (-3.03%)

ISEE Iveric bio
$7.68 /

-0.24 (-3.03%)

On The Fly
Fly Intel: Pre-market Movers » 08:54
07/06/21
07/06
08:54
07/06/21
08:54
ISEE

Iveric bio

$7.92 /

+0.88 (+12.50%)

, CANO

Cano Health

$12.04 /

+0.275 (+2.34%)

, MNOV

MediciNova

$4.12 /

-0.045 (-1.08%)

, AXLA

Axcella Health

$3.95 /

-0.04 (-1.00%)

, OCGN

Ocugen

$7.30 /

-0.54 (-6.89%)

, BLIN

Bridgeline Digital

$8.92 /

+3.19 (+55.67%)

, DIDI

DiDi

$15.53 /

-0.81 (-4.96%)

, YMM

Full Truck Alliance

$18.99 /

+0.45 (+2.43%)

, BZ

Kanzhun

$36.32 /

-0.94 (-2.52%)

, PRVB

Provention Bio

$8.29 /

-0.03 (-0.36%)

, AHT

Ashford Hospitality

$3.97 /

-0.375 (-8.64%)

Check out this morning's…

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YMM Full Truck Alliance
$18.99 /

+0.45 (+2.43%)

PRVB Provention Bio
$8.29 /

-0.03 (-0.36%)

OCGN Ocugen
$7.30 /

-0.54 (-6.89%)

MNOV MediciNova
$4.12 /

-0.045 (-1.08%)

ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

DIDI DiDi
$15.53 /

-0.81 (-4.96%)

CANO Cano Health
$12.04 /

+0.275 (+2.34%)

BZ Kanzhun
$36.32 /

-0.94 (-2.52%)

BLIN Bridgeline Digital
$8.92 /

+3.19 (+55.67%)

AXLA Axcella Health
$3.95 /

-0.04 (-1.00%)

AHT Ashford Hospitality
$3.97 /

-0.375 (-8.64%)

ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
CANO Cano Health
$12.04 /

+0.275 (+2.34%)

11/19/20 Compass Point
Compass Point upgrades PennantPark to Buy after Cano Health 'game changer'
MNOV MediciNova
$4.12 /

-0.045 (-1.08%)

03/10/21
Fly Intel: Top five analyst initiations
03/10/21 Maxim
MediciNova initiated with a Buy at Maxim
03/10/21 Maxim
MediciNova initiated with a Buy at Maxim
AXLA Axcella Health
$3.95 /

-0.04 (-1.00%)

07/06/21 H.C. Wainwright
Axcella Health initiated with a Buy at H.C. Wainwright
06/03/21 Chardan
Axcella Health price target raised to $16 from $10 at Chardan
04/13/21 Piper Sandler
Piper says IND clearance sets up Axcella Health for potential NASH 'home run'
03/22/21 Wedbush
Axcella Health price target lowered to $11 from $19 at Wedbush
OCGN Ocugen
$7.30 /

-0.54 (-6.89%)

06/11/21
Fly Intel: Top five analyst downgrades
06/11/21 H.C. Wainwright
Ocugen price target lowered to $10 from $12 at H.C. Wainwright
06/10/21 Roth Capital
Ocugen downgraded to Neutral from Buy at Roth Capital
06/10/21 Chardan
Ocugen price target lowered to $4.50 from $8 at Chardan
BLIN Bridgeline Digital
$8.92 /

+3.19 (+55.67%)

DIDI DiDi
$15.53 /

-0.81 (-4.96%)

YMM Full Truck Alliance
$18.99 /

+0.45 (+2.43%)

BZ Kanzhun
$36.32 /

-0.94 (-2.52%)

PRVB Provention Bio
$8.29 /

-0.03 (-0.36%)

05/28/21 Chardan
Provention Bio price target lowered to $22.50 from $35 at Chardan
05/25/21 SVB Leerink
Provention Bio briefing documents a positive, says SVB Leerink
05/07/21 Cantor Fitzgerald
Provention Bio price target lowered to $19 from $25 at Cantor Fitzgerald
04/12/21 Chardan
Provention Bio price target lowered to $22.50 from $35 at Chardan
AHT Ashford Hospitality
$3.97 /

-0.375 (-8.64%)

06/15/21 B. Riley
Ashford Hospitality price target raised to $5 from $3 at B. Riley
02/01/21 B. Riley
Ashford Hospitality price target raised to $3 from $2.50 at B. Riley Securities
12/02/20 B. Riley
Ashford Hospitality price target lowered to $2.50 from $3.50 at B. Riley
11/16/20 B. Riley
Ashford Hospitality price target lowered to $3.50 from $5 at B. Riley Securities
PRVB Provention Bio
$8.29 /

-0.03 (-0.36%)

OCGN Ocugen
$7.30 /

-0.54 (-6.89%)

ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

CANO Cano Health
$12.04 /

+0.275 (+2.34%)

AXLA Axcella Health
$3.95 /

-0.04 (-1.00%)

  • 30
    Jun
  • 22
    Jun
  • 11
    Jun
  • 14
    Jan
OCGN Ocugen
$7.30 /

-0.54 (-6.89%)

DIDI DiDi
$15.53 /

-0.81 (-4.96%)

YMM Full Truck Alliance
$18.99 /

+0.45 (+2.43%)

PRVB Provention Bio
$8.29 /

-0.03 (-0.36%)

OCGN Ocugen
$7.30 /

-0.54 (-6.89%)

MNOV MediciNova
$4.12 /

-0.045 (-1.08%)

DIDI DiDi
$15.53 /

-0.81 (-4.96%)

CANO Cano Health
$12.04 /

+0.275 (+2.34%)

BZ Kanzhun
$36.32 /

-0.94 (-2.52%)

AHT Ashford Hospitality
$3.97 /

-0.375 (-8.64%)

PRVB Provention Bio
$8.29 /

-0.03 (-0.36%)

OCGN Ocugen
$7.30 /

-0.54 (-6.89%)

CANO Cano Health
$12.04 /

+0.275 (+2.34%)

AXLA Axcella Health
$3.95 /

-0.04 (-1.00%)

AHT Ashford Hospitality
$3.97 /

-0.375 (-8.64%)

Hot Stocks
Iveric bio jumps over 20% after FDA agreement for GATHER2 Phase 3 trial » 07:30
07/06/21
07/06
07:30
07/06/21
07:30
ISEE

Iveric bio

$7.92 /

+0.88 (+12.50%)

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.

ShowHide Related Items >><<
ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

Hot Stocks
Iveric bio receives FDA agreement under SPA for GATHER2 Phase 3 trial » 06:16
07/06/21
07/06
06:16
07/06/21
06:16
ISEE

Iveric bio

$7.92 /

+0.88 (+12.50%)

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.

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ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

08/13/20 Credit Suisse
Iveric bio initiated with an Outperform at Credit Suisse
ISEE Iveric bio
$7.92 /

+0.88 (+12.50%)

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