Outlook Therapeutics Inc. experienced a significant price drop of 17.86%, hitting a 52-week low, following the FDA's Complete Response Letter regarding its ONS-5010 application.
The FDA rejected the biologics license application for ONS-5010, indicating that additional confirmatory evidence of efficacy is required. This decision negatively impacts the company's competitiveness in the wet age-related macular degeneration treatment market, particularly in the U.S., and reflects broader market sentiment as the Nasdaq-100 and S&P 500 showed gains of 1.00% and 0.68%, respectively, suggesting sector rotation.
The rejection poses challenges for Outlook Therapeutics as it seeks to navigate regulatory hurdles while planning to expand into European markets. CEO Bob Jahr emphasized the company's commitment to providing effective treatment options, but the uncertainty surrounding ONS-5010's approval could hinder future growth prospects.
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 3.83 USD with a low forecast of 0.50 USD and a high forecast of 10.00 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.
3 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 3.83 USD with a low forecast of 0.50 USD and a high forecast of 10.00 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
2 Hold
0 Sell
Moderate Buy
Current: 0.508
Low
0.50
Averages
3.83
High
10.00
Current: 0.508
Low
0.50
Averages
3.83
High
10.00
H.C. Wainwright
H.C. Wainwright
Neutral
maintain
$1
2026-01-02
Reason
H.C. Wainwright
H.C. Wainwright
Price Target
$1
AI Analysis
2026-01-02
maintain
Neutral
Reason
H.C. Wainwright lowered the firm's price target on Outlook Therapeutics to 50c from $1 and keeps a Neutral rating on the shares after the company received another complete response letter for ONS-5010. "This is not the first time that the company has misread FDA's feedback and what the Agency needed to approve ONS-5010," the analyst tells investors in a research note. H.C. Wainwright is not even sure there's much of a commercial opportunity for ONS-5010 anymore. It is concerned about the company's path forward.
Chardan
Daniil Gataulin
Neutral
downgrade
$3 -> $1
2026-01-02
Reason
Chardan
Daniil Gataulin
Price Target
$3 -> $1
2026-01-02
downgrade
Neutral
Reason
Chardan analyst Daniil Gataulin lowered the firm's price target on Outlook Therapeutics to $1 from $3 and keeps a Neutral rating on the shares. The company received a complete response letter from the FDA for Lytenava, Outlook's ophthalmic formulation of bevacizumab, in wet age-related macular degeneration, the analyst tells investors in a research note. The firm said this is yet another setback for the company following a CRL for Lytenava on August 28 and BLA resubmission shortly thereafter. While the news is disappointing, the firm said it is not surprised by the decision, as it believed the approval would be unlikely in the absence of additional studies.
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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.
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.
