FDA Response: Outlook Therapeutics' stock fell significantly after the FDA issued a complete response letter (CRL) for its biologics license application (BLA) for ONS-5010, indicating it cannot be approved in its current form due to insufficient evidence of effectiveness.
Clinical Trial Findings: The FDA noted that while the NORSE TWO trial met its primary efficacy endpoint, the NORSE EIGHT trial did not, leading to the request for additional confirmatory evidence to support the application.
Future Plans: Outlook Therapeutics plans to meet with the FDA for further clarification on approval requirements and aims to expand into European markets, where its product Lytenava has already received regulatory approval.
Stock Impact: Following the FDA's announcement, Outlook Therapeutics' stock price dropped by over 57%, reflecting investor concerns regarding the drug's approval prospects.
OTLK
$2.27+Infinity%1D
Analyst Views on OTLK
Wall Street analysts forecast OTLK stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OTLK is 4.00 USD with a low forecast of 1.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
Wall Street analysts forecast OTLK stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for OTLK is 4.00 USD with a low forecast of 1.00 USD and a high forecast of 8.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Buy
3 Hold
0 Sell
Hold
Current: 2.470
Low
1.00
Averages
4.00
High
8.00
Current: 2.470
Low
1.00
Averages
4.00
High
8.00
H.C. Wainwright
Douglas Tsao
NULL -> Sell
downgrade
$3 -> $1
2025-08-29
Reason
H.C. Wainwright
Douglas Tsao
Price Target
$3 -> $1
2025-08-29
downgrade
NULL -> Sell
Reason
H.C. Wainwright analyst Douglas Tsao downgraded Outlook Therapeutics with a price target of $1, down from $3. The firm is "disappointed "that the FDA issued a complete response letter for ONS-5010 in wet age-related macular degeneration. It downgraded Outlook after removing all future U.S. revenues for ONS-5010 from its valuation.
Guggenheim
Buy
to
Neutral
downgrade
2025-08-29
Reason
Guggenheim
Price Target
2025-08-29
downgrade
Buy
to
Neutral
Reason
As previously reported yesterday, Guggenheim downgraded Outlook Therapeutics to Neutral from Buy and removed the firm's price target after the company received another complete response letter from the FDA regarding their BLA resubmission for ONS-5010 for the treatment of wetAMD. The firm, which previously thought there was "a small chance of approval," now has "serious doubts" on the company's ability to get ONS-5010 approved in the U.S.
Guggenheim
Buy
to
Neutral
downgrade
2025-08-28
Reason
Guggenheim
Price Target
2025-08-28
downgrade
Buy
to
Neutral
Reason
Guggenheim downgraded Outlook Therapeutics to Neutral from Buy.
Guggenheim
Eddie Hickman
Buy
downgrade
$10 -> $8
2025-05-20
Reason
Guggenheim
Eddie Hickman
Price Target
$10 -> $8
2025-05-20
downgrade
Buy
Reason
Guggenheim analyst Eddie Hickman lowered the firm's price target on Outlook Therapeutics to $8 from $10 and keeps a Buy rating on the shares after having caught up with management following the company's Q2 earnings release. The cash position continues to be an overhang, but management is confident they have a runway to get to the Lytenava PDUFA date of August 27, the analyst tells investors.
About OTLK
Outlook Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on developing and commercializing ONS-5010/LYTENAVA (bevacizumab-gamma), an ophthalmic formulation of bevacizumab for use in retinal indications. It is advancing ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO). Bevacizumab-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. ONS-5010/LYTENAVA, consisted of three clinical trials which it refers to as NORSE ONE, NORSE TWO and NORSE THREE.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
