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OTLK

Outlook Therapeutics

$2.40

-0.24 (-9.09%)

, FUJIY

Fujifilm

$0.00

(0.00%)

08:10
06/03/19
06/03
08:10
06/03/19
08:10

Outlook Therapeutics signs manufacturing supply agreement with Fujifilm Diosynth

Outlook Therapeutics (OTLK) announced that it has signed a master services agreement with FUJIFILM Diosynth Biotechnologies (FUJIY, MSBHY) for the production of ONS-5010. Under the terms of this agreement, FDB will provide global manufacturing of ONS-5010 to Outlook in support of the commercialization strategy for the drug. Additional terms of the agreement were not disclosed. "Our master services agreement with FDB secures a world class manufacturing facility for the potential commercial launch of ONS-5010. Most importantly, FDB has the ability to rapidly scale manufacturing of ONS-5010 while maintaining the quality controls that meet or exceed regulatory requirements," said Terry Dagnon, COO at Outlook Therapeutics, Inc. "Identifying a highly-regarded manufacturing partner for ONS-5010 is an important part of our commercialization strategy and is a required part of the Biologics License Application, or BLA, submission in wet AMD." Outlook Therapeutics is currently conducting two Phase 3 clinical studies for ONS-5010. If successful, these studies will support the Company's plan to submit for regulatory approval in multiple markets in 2020. ONS-5010, if approved, has potential to mitigate risks associated with off-label use of Avastin or other drugs. Off-label use of Avastin is currently estimated to account for at least 50% of all wet AMD prescriptions in the United States.

OTLK

Outlook Therapeutics

$2.40

-0.24 (-9.09%)

FUJIY

Fujifilm

$0.00

(0.00%)

MSBHY

Mitsubishi Corp

$0.00

(0.00%)

OTLK Outlook Therapeutics
$2.40

-0.24 (-9.09%)

04/22/19
ASCN
04/22/19
INITIATION
Target $4
ASCN
Buy
Outlook Therapeutics initiated with a Buy at Ascendiant
Ascendiant analyst Edward Woo initiated Outlook Therapeutics with a Buy and $4 price target.
05/16/19
OPCO
05/16/19
INITIATION
Target $12
OPCO
Outperform
Outlook Therapeutics initiated with an Outperform at Oppenheimer
Oppenheimer analyst Leland Gershell started coverage of Outlook Therapeutics with an Outperform rating and $12 price target. Assuming a late 2021-2022 FDA approval in wet age-related macular degeneration that he views as low-risk, ONS-5010 stands to take Avastin's about 50% unit share in this multibillion-dollar indication as physicians and payors adopt it as the preferred step-edit ahead of expensive anti-VEGF alternatives, he contends. The analyst believes the health risks posed by sterile injectable compounding provide a regulatory tailwind, and sees the shares as "undervalued."
FUJIY Fujifilm
$0.00

(0.00%)

MSBHY Mitsubishi Corp
$0.00

(0.00%)

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AMZN

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TLF

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AAPL

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TECK

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OSK

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OVLY

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FTNW

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TNXP

Tonix Pharmaceuticals

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RLMD

Relmada Therapeutics

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NWSA

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NWS

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FB

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WAIR

Wesco Aircraft

$11.01

0.01 (0.09%)

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