IVERIC bio Inc (ISEE) 銘柄情報

News> PARSIPPANY, N.J.--(BUSINESS WIRE)--IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for avacincaptad pegol (ACP, also known as Zimura®), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). To date, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation status for this indication, which was granted based on the 12-month pre-specified primary endpoint data in the GATHER1 and GATHER2 pivotal clinical trials.

“In both GATHER1 and GATHER2, avacincaptad pegol consistently showed a treatment effect with the first measurement at month 6 that was persistent and continued to increase over time, with observed efficacy rates of up to 35%”

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Breakthrough Therapy designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to show preliminary clinical evidence that the drug may demonstrate substantial improvement in effectiveness or safety over available therapies on a clinically significant endpoint and in general, should show a clear advantage.1

“We believe this Breakthrough designation reflects the fact that both GATHER1 and GATHER2 met their primary endpoint with a safety profile that meets the stringent criteria required,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “We are now focused on the execution of our full NDA submission and launch preparation, with the possibility of being first to market. We look forward to working collaboratively with the FDA to expedite the review timeline for avacincaptad pegol and to potentially bringing a new therapy to AMD patients impacted by GA.”

Recently, Iveric Bio announced the submission of the first part of its New Drug Application (NDA) for rolling review, which included the full clinical data package from the GATHER1 and GATHER2 pivotal trials. The company is on track to complete the final part of the NDA submission by the end of this year.

“In both GATHER1 and GATHER2, avacincaptad pegol consistently showed a treatment effect with the first measurement at month 6 that was persistent and continued to increase over time, with observed efficacy rates of up to 35%,” said Pravin U. Dugel, MD, President of Iveric Bio. “We believe ACP has the potential to safely and effectively preserve central vision by saving photoreceptor cells for patients living with this life-changing disease that leads to irreversible blindness.”

The FDA’s Breakthrough Therapy designation decision was based on the 12-month primary efficacy endpoint data from the GATHER1 and GATHER2 pivotal studies which evaluated the safety and efficacy of ACP in patients with GA located inside and/or outside of the clinical fovea. Per the special protocol assessment (SPA) agreement for GATHER2, the FDA required the mean rate of growth (slope) in GA area from baseline to month 12. These results showed a significant treatment difference of 35% (p=0.0050; GATHER1) and 18% (p= 0.0039, GATHER2) compared to sham using observed (non-transformed) data; and 28% (p=0.0063; GATHER1) and 14% (p= 0.0064; GATHER2) using square root transformation. In both GATHER1 and GATHER2 there were no events of serious intraocular inflammation, vasculitis, or endophthalmitis.

About Geographic Atrophy

Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. FDA or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy secondary to AMD.

they dumping hard now. 16 today

hey bud

10:25 EST > this morning ISEE presentation:

Sept. 9 > Wells Fargo 2022 Healthcare Conference Date: September 9, 2022 Time: 10:25 a.m. Easter

$ISEE going to run again today

Investors are forward looking. > Iveric said it plans to submit a new drug application for Zimura by the end of the first quarter of 2023.

ISEE

19.15 in AH > Let's run the 20's tomorrow!!!!!

18.88

ISEE it now

PT > $35.00 > IVERIC Bio shares are trading higher after Stifel maintained a Buy rating on the stock and raised its price target from $28 to $35.

Sep 8, 2022 11:02a ETBenzinga Stock Analysis

Tomorrow Sept. 9 > Wells Fargo 2022 Healthcare Conference Date: September 9, 2022 Time: 10:25 a.m. Eastern Time Morgan Stanley 20th Annual Global Healthcare Conference Date: September 12, 2022 Time: 2:50 p.m. Eastern Time

17.25

$15.70 CLOSE > $WEET!!!!!

ISEE

LET'S GO ISEE !!!!! @(@

iSEE 15.40's feels like NHOD coming...the volume is staggering

Now check out this analyst > what an absolute knucklehead : B. Riley Securities Downgrades IVERIC bio to Sell, Lowers Price Target to $8
11:47 am ET September 6, 2022 (Benzinga) Print
B. Riley Securities analyst Yuan Zhi downgrades IVERIC bio (NASDAQ:ISEE) from Neutral to Sell and lowers the price target from $12 to $8.

Latest Ratings for ISEE DateFirmActionFromTo

Mar 2022BairdInitiates Coverage OnOutperform Feb 2022Morgan StanleyInitiates Coverage OnOverweight Nov 2021HC Wainwright & Co.MaintainsBuy

View More Analyst Ratings for ISEE

View the Latest Analyst Ratings

Yup both are green! Shuttle moving up fast now.

ISEE
shph flying

Should hit all PT's in upcoming weeks. Solid FDA phase III trial results!

ISEE

Damn. Someone's dumping. I thought this was going to break $20.00 today.

another NEW HIGH $15.50 and so quiet here

May 6, 2022 high of the week was 14.97

14 again lets see if it holds and consolidates this round

https://www.nasdaq.com/articles/iveric-bios-gather-2-phase-3-trial-meets-primary-endpoint-for-zimura

13 already from that sub 12 dip

good to know

Message in reply to:
BlackRock is largest shareholder follow the big dogs

Aug-02-22 Initiated UBS Buy $20
Jun-08-22 Initiated Guggenheim Buy $30
Jun-08-22 Initiated BofA Securities Buy $18
May-12-22 Initiated B. Riley Securities Neutral $12
Mar-22-22 Initiated Jefferies Buy $27
Mar-03-22 Initiated Robert W. Baird Outperform $27
Feb-07-22 Initiated Morgan Stanley Overweight $25

i just saw ISEE 11.91

you thinK it will retest the pm high of 14.31


https://finviz.com/quote.ashx?t=ISEE&ty=c&ta=1&p=d

finshizzle shows 115M float

Iveric Bio Reports Positive Zimura Trial Results, Shares Soar
6:33 am ET September 6, 2022 (Dow Jones) Print
By Dean Seal


Iveric Bio Inc. said Tuesday that a second Phase 3 clinical trial for its geographic atrophy treatment Zimura met its primary endpoint with statistical significance and a favorable safety profile.

The biopharmaceutical company said the two trials have shown a significant reduction in the rate of geographic atrophy progression at the 12-month endpoint.

Iveric said it plans to submit a new drug application for Zimura by the end of the first quarter of 2023.

Shares soared 42% to $13.38 in premarket trading.


ISEE

ISEE 17 did come through as expected

I think we see 18 tomorrow and still looking for 2o on Friday.

BlackRock is largest shareholder follow the big dogs

Institutions are still buying ISEE

266k buy at 16.7 for $4.5mil

All ISEE is green

ISEE 17 tomorrow 20 on Friday

Shorty is sweating cause the bulls are still in charge ISEE it do you

Lol…every ignorant trader says the same thing then nothing happens

ISEE said the blind man

ISEE green dreams tonight

Iveric Bio (ISEE) PT Raised to $21 at Wedbush

ISEE 85% Institution owned

This going to be the greatest short squeeze ever. ISEE up up and away

ISEE said the blind man to his deaf dog! > BLINDED BY THE GOLD $$$$$ .

14.24

13.73

ISEE $10 coming

"We are excited to receive this SPA agreement from the FDA," stated Pravin U. Dugel, MD, President of Iveric Bio. "We thank the FDA for their collaborative interactions and valuable input on the primary efficacy endpoint for the GATHER2 trial, which we believe reflects the FDA's current thinking. The modification of the primary efficacy endpoint does not require collecting any new data but instead reflects a change in how the data are analyzed. We look forward to continuing to work with the FDA and following their guidance as we work toward preparing the eventual NDA submission for Zimura."

Moving strooooong

Really nice buys last week. Hoping for a long term rally here.