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Opthea finalizes design for ShORe, COAST clinical trials of OPT-302 » 05:45
02/24/21
02/24
05:45
02/24/21
05:45
OPT

Opthea

$10.90 /

-0.2 (-1.80%)

Opthea announced that it…

Opthea announced that it has finalized the protocol study designs and start-up activities in readiness for the initiation of the Phase 3 ShORe and COAST pivotal clinical trials of OPT-302 in wet age-related macular degeneration, or AMD. Finalization of the Phase 3 trial protocols follows productive consultations with the FDA, EMA and key opinion leaders, or KOLs, in wet AMD. The trial protocols have also been submitted to relevant regulatory agencies, institutional review boards and human research ethics committees. The global, multi-center, double-masked, sham-controlled, pivotal Phase 3 clinical trials will each enroll approximately 990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab or 2.0 mg aflibercept, compared to ranibizumab or aflibercept monotherapy, respectively. In addition, extended durability of the OPT-302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT-302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor. If effective in these Phase 3 studies, OPT-302 could be adopted for administration with either Eylea or Lucentis which had combined sales for retinal diseases of $11.9B in 2019. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy. Each patient will continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period. Opthea remains on track to initiate the trials in Q1 and to report top-line data in the second half of 2023. If the results at the completion of the primary efficacy phase at week 52 of the Phase 3 clinical trials are favorable, the company intends to submit biologics license and marketing authorization applications with the FDA and EMA respectively for marketing approval for OPT-302 for the treatment of wet AMD in the United States, European Union and other global territories.

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OPT Opthea
$10.90 /

-0.2 (-1.80%)

11/17/20 Citi
Opthea initiated with a Buy at Citi
11/11/20 SVB Leerink
SVB Leerink bullish on Opthea, initiates with an Outperform
11/11/20 SVB Leerink
Opthea initiated with an Outperform at SVB Leerink
11/11/20 Oppenheimer
Opthea initiated with an Outperform at Oppenheimer
  • 16
    Oct
OPT Opthea
$10.90 /

-0.2 (-1.80%)

Over a month ago
Conference/Events
Opthea management to meet virtually with Oppenheimer » 04:55
01/28/21
01/28
04:55
01/28/21
04:55
OPT

Opthea

$12.00 /

-0.125 (-1.03%)

Virtual Meetings to be…

Virtual Meetings to be held January 27-28 hosted by Oppenheimer.

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OPT Opthea
$12.00 /

-0.125 (-1.03%)

11/17/20 Citi
Opthea initiated with a Buy at Citi
11/11/20 SVB Leerink
SVB Leerink bullish on Opthea, initiates with an Outperform
11/11/20 SVB Leerink
Opthea initiated with an Outperform at SVB Leerink
11/11/20 Oppenheimer
Opthea initiated with an Outperform at Oppenheimer
  • 16
    Oct
OPT Opthea
$12.00 /

-0.125 (-1.03%)

Conference/Events
Opthea management to meet virtually with Oppenheimer » 04:55
01/27/21
01/27
04:55
01/27/21
04:55
OPT

Opthea

$12.13 /

-0.39 (-3.12%)

Virtual Meetings to be…

Virtual Meetings to be held January 27-28 hosted by Oppenheimer.

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OPT Opthea
$12.13 /

-0.39 (-3.12%)

11/17/20 Citi
Opthea initiated with a Buy at Citi
11/11/20 SVB Leerink
SVB Leerink bullish on Opthea, initiates with an Outperform
11/11/20 SVB Leerink
Opthea initiated with an Outperform at SVB Leerink
11/11/20 Oppenheimer
Opthea initiated with an Outperform at Oppenheimer
  • 16
    Oct
OPT Opthea
$12.13 /

-0.39 (-3.12%)

Conference/Events
Opthea management to meet virtually with Oppenheimer » 11:09
01/26/21
01/26
11:09
01/26/21
11:09
OPT

Opthea

$12.52 /

+ (+0.00%)

Virtual Meetings to be…

Virtual Meetings to be held January 27-28 hosted by Oppenheimer.

ShowHide Related Items >><<
OPT Opthea
$12.52 /

+ (+0.00%)

11/17/20 Citi
Opthea initiated with a Buy at Citi
11/11/20 SVB Leerink
SVB Leerink bullish on Opthea, initiates with an Outperform
11/11/20 SVB Leerink
Opthea initiated with an Outperform at SVB Leerink
11/11/20 Oppenheimer
Opthea initiated with an Outperform at Oppenheimer
  • 16
    Oct
OPT Opthea
$12.52 /

+ (+0.00%)

Over a quarter ago
Initiation
Opthea initiated with a Buy at Citi » 06:41
11/17/20
11/17
06:41
11/17/20
06:41
OPT

Opthea

$12.60 /

-0.01 (-0.08%)

Citi analyst Yigal…

Citi analyst Yigal Nochomovitz initiated coverage of Opthea with a Buy rating and $48 price target. The company is developing OPT-302, a first-in-class VEGF-C/-D inhibitor designed to drive improved visual acuity outcomes over the current standard of care in wet age-related macular degeneration, Nochomovitz tells investors in a research note. The analyst models a 70% probability of success with peak risk-adjusted revenues of $1.2B in the U.S.

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OPT Opthea
$12.60 /

-0.01 (-0.08%)

11/11/20 SVB Leerink
SVB Leerink bullish on Opthea, initiates with an Outperform
11/11/20 SVB Leerink
Opthea initiated with an Outperform at SVB Leerink
11/11/20 Oppenheimer
Opthea initiated with an Outperform at Oppenheimer
11/11/20 Truist
Opthea initiated with a Buy at Truist
  • 16
    Oct
OPT Opthea
$12.60 /

-0.01 (-0.08%)

Initiation
SVB Leerink bullish on Opthea, initiates with an Outperform » 08:59
11/11/20
11/11
08:59
11/11/20
08:59
OPT

Opthea

$13.00 /

+0.2 (+1.56%)

As previously reported,…

As previously reported, SVB Leerink analyst Geoffrey Porges initiated coverage of Opthea with an Outperform rating and $33 price target. The analyst cites his forecast for revenue from the company's only product, OPT-302, which will soon enter two large phase III trials in wet AMD, and has the potential to be a meaningful participant in the growing $11B market for direct retinal medicines for diseases of neovascularization, including wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. Over time, Porges expects Opthea to establish the activity of OPT-302 in combination with biosimilar VEGF A antibodies, and to also develop a co-formulated product or products that can reduce the burden of additional injections with the current presentation.

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OPT Opthea
$13.00 /

+0.2 (+1.56%)

11/11/20 SVB Leerink
Opthea initiated with an Outperform at SVB Leerink
11/11/20 Oppenheimer
Opthea initiated with an Outperform at Oppenheimer
11/11/20 Truist
Opthea initiated with a Buy at Truist
11/11/20 Truist
Opthea initiated with a Buy at Truist
  • 16
    Oct
OPT Opthea
$13.00 /

+0.2 (+1.56%)

Initiation
Opthea initiated with an Outperform at SVB Leerink » 08:18
11/11/20
11/11
08:18
11/11/20
08:18
OPT

Opthea

$13.00 /

+0.2 (+1.56%)

SVB Leerink analyst…

SVB Leerink analyst Geoffrey Porges initiated coverage of Opthea with an Outperform rating and $33 price target.

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OPT Opthea
$13.00 /

+0.2 (+1.56%)

11/11/20 Oppenheimer
Opthea initiated with an Outperform at Oppenheimer
11/11/20 Truist
Opthea initiated with a Buy at Truist
11/11/20 Truist
Opthea initiated with a Buy at Truist
  • 16
    Oct
OPT Opthea
$13.00 /

+0.2 (+1.56%)

Initiation
Opthea initiated with an Outperform at Oppenheimer » 08:06
11/11/20
11/11
08:06
11/11/20
08:06
OPT

Opthea

$13.00 /

+0.2 (+1.56%)

Oppenheimer analyst…

Oppenheimer analyst Hartaj Singh initiated coverage of Opthea with an Outperform rating and $36 price target. The analyst argues that with a strong scientific rationale, good early/mid-stage clinical data, and an execution-focused management team, Opthea could be well on its way to creating a robust ophthalmology franchise around OPT-302, its lead asset in combination with currently approved anti-VEGF A inhibitors in wAMD and DME. Two Phase 3 trials expect to initiate in the first half of 2021, finalize recruitment in the first half of 2022, and read out in the second half of 2023, positioning Opthea, an October IPO, well to capitalize on the potential of OPT-302, Singh contends. The analyst is "bullish on the approach."

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OPT Opthea
$13.00 /

+0.2 (+1.56%)

11/11/20 Truist
Opthea initiated with a Buy at Truist
11/11/20 Truist
Opthea initiated with a Buy at Truist
  • 16
    Oct
OPT Opthea
$13.00 /

+0.2 (+1.56%)

Initiation
Opthea initiated with a Buy at Truist » 07:50
11/11/20
11/11
07:50
11/11/20
07:50
OPT

Opthea

$13.00 /

+0.2 (+1.56%)

, REGN

Regeneron

$559.22 /

-8.85 (-1.56%)

, RHHBY

Roche

$0.00 /

+ (+0.00%)

Truist analyst Robyn…

Truist analyst Robyn Karnauskas initiated coverage of Opthea (OPT) with a Buy rating and $25 price target. The analyst notes that the company is developing a novel add-on drug to current treatments - including EYLEA (REGN) and Lucentis (RHHBY) - for common diseases that cause blindness. Karnauskas adds that with many patients still losing their vision on current drugs, there continues to be a "high unmet need", as she models a 35% probability of success of OPT-302 with peak 2030 adjusted sales estimate of $0.6B in U.S. / E.U. markets.

ShowHide Related Items >><<
RHHBY Roche
$0.00 /

+ (+0.00%)

REGN Regeneron
$559.22 /

-8.85 (-1.56%)

OPT Opthea
$13.00 /

+0.2 (+1.56%)

11/11/20 Truist
Opthea initiated with a Buy at Truist
REGN Regeneron
$559.22 /

-8.85 (-1.56%)

11/10/20 SVB Leerink
Regeneron price target lowered to $643 from $653 at SVB Leerink
11/06/20 Truist
Regeneron price target raised to $770 from $750 at Truist
11/05/20 Piper Sandler
Regeneron shares will continue moving higher, says Piper Sandler
10/28/20 Piper Sandler
Piper Sandler says would be 'hard pressed' to see Regeneron cocktail not get EUA
RHHBY Roche
$0.00 /

+ (+0.00%)

10/16/20 UBS
Roche price target lowered to CHF 370 from CHF 390 at UBS
10/06/20 Goldman Sachs
Goldman reiterates $34 target on Kiniksa after 'impressive' data
09/29/20 Berenberg
Roche initiated with a Hold at Berenberg
09/28/20 Societe Generale
Roche price target raised to CHF 420 from CHF 365 at Societe Generale
RHHBY Roche
$0.00 /

+ (+0.00%)

REGN Regeneron
$559.22 /

-8.85 (-1.56%)

  • 16
    Oct
  • 27
    May
RHHBY Roche
$0.00 /

+ (+0.00%)

REGN Regeneron
$559.22 /

-8.85 (-1.56%)

RHHBY Roche
$0.00 /

+ (+0.00%)

REGN Regeneron
$559.22 /

-8.85 (-1.56%)

OPT Opthea
$13.00 /

+0.2 (+1.56%)

REGN Regeneron
$559.22 /

-8.85 (-1.56%)

Initiation
Opthea initiated with a Buy at Truist » 06:46
11/11/20
11/11
06:46
11/11/20
06:46
OPT

Opthea

$13.00 /

+0.2 (+1.56%)

Truist analyst Robyn…

Truist analyst Robyn Karnauskas initiated coverage of Opthea with a Buy rating and $25 price target.

ShowHide Related Items >><<
  • 16
    Oct
OPT Opthea
$13.00 /

+0.2 (+1.56%)

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