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OTLK Overview

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ET
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ET
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Intellectia

Loading chart...

High
0.448
Open
0.410
VWAP
0.43
Vol
1.67M
Mkt Cap
34.39M
Low
0.406
Amount
726.61K
EV/EBITDA(TTM)
--
Total Shares
83.07M
EV
62.37M
EV/OCF(TTM)
--
P/S(TTM)
--
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.
Show More

Events Timeline

(ET)
2026-03-05
17:00:00
Outlook Therapeutics Updates ONS-5010 Application Progress
select
2026-02-19 (ET)
2026-02-19
09:10:00
Outlook Therapeutics Signs Exclusive Distribution Agreement with Mediconsult for Switzerland
select
2026-02-17 (ET)
2026-02-17
08:20:00
Outlook Therapeutics Sees Sales Growth in Europe
select
2026-02-11 (ET)
2026-02-11
08:50:00
Outlook Therapeutics Submits FDA Meeting Request in Response to CRL
select
2026-01-07 (ET)
2026-01-07
08:50:00
Latest Data Shows Sealsq Corp Borrow Rate at 59.18%
select
2026-01-06 (ET)
2026-01-06
08:50:00
Latest Data Shows Outlook Therapeutics Borrow Rate at 81.97%
select
2026-01-06
08:50:00
Outlook Therapeutics Appoints Laura Cantrell as VP of Corporate Strategy and Business Development
select
2026-01-02 (ET)
2026-01-02
09:00:00
U.S. Stock Futures Rise, Ironwood Issues Better-Than-Expected FY26 Guidance
select

News

NASDAQ.COM
9.0
03-06NASDAQ.COM
Outlook Therapeutics Discusses FDA Response on ONS-5010 Approval Pathway
  • FDA Meeting Progress: Outlook Therapeutics recently held a Type A meeting with the U.S. FDA to discuss the Complete Response Letter issued in December 2025 for ONS-5010/LYTENAVA™, highlighting the need for additional confirmatory evidence of effectiveness, indicating regulatory pathway complexities.
  • Clinical Trial Results: ONS-5010 demonstrated statistically significant vision improvements in the NORSE TWO Phase 3 trial, supported by evidence from the NORSE EIGHT study; while the FDA raised no safety concerns, more data is required to advance the approval process.
  • Market Authorization Dynamics: ONS-5010 received European Commission marketing authorization for wet AMD treatment in May 2024, subsequently launching in Germany, the UK, and Austria, showcasing its potential for market expansion across Europe.
  • Sales and Financial Status: Despite unit sales more than doubling last quarter, reported revenue was negative at $(1.2) million, primarily due to short-dated product returns from UK distributors; Outlook expects demand to continue rising as launches expand to major markets like Ireland and the Netherlands.
Newsfilter
9.0
03-05Newsfilter
Outlook Therapeutics Provides FDA Meeting Update on ONS-5010
  • FDA Meeting Progress: Outlook Therapeutics held a Type A meeting with the FDA to clarify key issues regarding evidence of effectiveness identified in the December 30, 2025 Complete Response Letter, demonstrating the company's ongoing commitment to regulatory approval.
  • Clinical Trial Results: ONS-5010 showed clinically meaningful improvements in visual acuity in the NORSE TWO Phase 3 trial, successfully meeting its primary and key secondary endpoints, further supporting its potential as a treatment for wet AMD.
  • Safety Assessment: ONS-5010 demonstrated a favorable safety profile with no safety concerns identified by the FDA, laying the groundwork for future market approval and potentially becoming the first FDA-approved ophthalmic formulation of bevacizumab.
  • Manufacturing Supply Chain Advantage: The product candidate is supported by a fully domestic end-to-end U.S. manufacturing supply chain, ensuring standardized production and robust pharmacovigilance capabilities, enhancing its competitive position in the market.
moomoo
7.5
02-19moomoo
OUTLOOK THERAPEUTICS INC - MEDICONSULT TO PROMOTE AND DISTRIBUTE LYTENAVA IN SWITZERLAND
  • Market Overview: The therapeutic market is experiencing significant changes, with a focus on innovative treatments and their distribution strategies.

  • Consultation Insights: Recent consultations highlight the importance of adapting to market demands and regulatory environments to enhance therapeutic offerings.

moomoo
7.5
02-19moomoo
OUTLOOK THERAPEUTICS: COLLABORATION BOOSTS EUROPEAN GROWTH PLAN, LYTENAVA SET TO DEBUT IN SWITZERLAND IN 2027
  • Therapeutics Partnership Advances: The article discusses advancements in therapeutic partnerships aimed at enhancing healthcare solutions.

  • European Commercial Expansion Strategy: It outlines a strategy for expanding commercial operations in Europe, focusing on new market opportunities.

  • Lytena's Launch Plans: Lytena is expected to launch its services in Switzerland in 2027, marking a significant step in its European expansion.

  • Future Outlook: The article emphasizes the potential impact of these developments on the healthcare landscape in Europe.

Newsfilter
8.5
02-11Newsfilter
Outlook Therapeutics Requests FDA Meeting Following CRL for ONS-5010
  • FDA Meeting Request: Outlook Therapeutics has submitted a Type A meeting request regarding its ONS-5010 after receiving a Complete Response Letter (CRL) from the FDA on December 30, 2025, which cited a lack of substantial evidence of effectiveness, indicating a communication gap with the FDA.
  • Clinical Data Support: The Biologics License Application (BLA) for ONS-5010 is backed by data from the NORSE TWO trial, which demonstrated significant visual acuity improvements at 12 months, achieving its primary endpoint, thus reinforcing the reliability of the treatment effect despite the FDA's request for additional evidence.
  • Favorable Safety Profile: ONS-5010 exhibited a safety profile consistent with the control arm (ranibizumab), and the FDA has never expressed any safety concerns, laying a foundation for future market approval and potentially providing patients with a high-quality treatment option.
  • European Market Expansion: LYTENAVA™ has received marketing authorization in the EU and UK and has been commercialized in Germany and the UK, with Outlook Therapeutics planning to expand its commercial presence in additional European countries, demonstrating a proactive global strategy.
Benzinga
4.5
01-05Benzinga
U.S. Stocks Close Higher on Friday, Nasdaq Slightly Declines, Market Sentiment Neutral
  • Stable Market Sentiment: The CNN Money Fear & Greed Index remained at 44.6 on Friday, indicating a neutral market sentiment with minimal change from the previous reading of 44.8, suggesting that investor emotions are stable without significant fluctuations.
  • Positive Stock Performance: The Dow Jones gained approximately 319 points to close at 48,382.39, while the S&P 500 rose 0.19% to 6,858.47, reflecting an overall positive trend in the market, despite the Nasdaq Composite slightly declining by 0.03%.
  • Strong Chip Stock Rebound: Key chip stocks, including Nvidia (NASDAQ: NVDA) and Micron Technology (NASDAQ: MU), showed strong gains during the session, reflecting ongoing investor confidence in tech stocks, even as overall market sentiment remains neutral.
  • Economic Data Decline: The S&P Global manufacturing PMI fell from 52.2 to 51.8 in December, indicating a slowdown in manufacturing activity that could pose risks to future economic growth, prompting investors to closely monitor subsequent economic indicators.
Wall Street analysts forecast OTLK stock price to rise
3 Analyst Rating
Wall Street analysts forecast OTLK stock price to rise
1 Buy
2 Hold
0 Sell
Moderate Buy
Current: 0.000
sliders
Low
0.50
Averages
3.83
High
10.00
Current: 0.000
sliders
Low
0.50
Averages
3.83
High
10.00
H.C. Wainwright
H.C. Wainwright
Neutral
maintain
$1
AI Analysis
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.
Unlock Full Analyst Thesis, Get the complete breakdown of rating reason for OTLK
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Valuation Metrics

The current forward P/E ratio for Outlook Therapeutics Inc (OTLK.O) is -0.89, compared to its 5-year average forward P/E of -4.15. For a more detailed relative valuation and DCF analysis to assess Outlook Therapeutics Inc's fair value, Click here.

Forward PE

The forward P/E ratio is a valuation metric that divides a company's current stock price by its estimated future earnings per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PE
-4.15
Current PE
-0.89
Overvalued PE
-1.48
Undervalued PE
-6.81

Forward EV/EBITDA

The forward EV/EBITDA ratio is a valuation metric that divides a company's enterprise value (EV) by its estimated future earnings before interest, taxes, depreciation, and amortization (EBITDA) over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average EV/EBITDA
0.00
Current EV/EBITDA
0.00
Overvalued EV/EBITDA
0.00
Undervalued EV/EBITDA
0.00

Forward PS

The forward P/S ratio is a valuation metric that divides a company's current stock price by its estimated future sales (or revenue) per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PS
267.58
Current PS
1.72
Overvalued PS
735.22
Undervalued PS
-200.06

Financials

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Frequently Asked Questions

What is Outlook Therapeutics Inc (OTLK) stock price today?

The current price of OTLK is 0.4476 USD — it has increased 8.21

What is Outlook Therapeutics Inc (OTLK)'s business?

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.

What is the price predicton of OTLK Stock?

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 is3.83 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.

What is Outlook Therapeutics Inc (OTLK)'s revenue for the last quarter?

Outlook Therapeutics Inc revenue for the last quarter amounts to -1.21M USD, decreased

What is Outlook Therapeutics Inc (OTLK)'s earnings per share (EPS) for the last quarter?

Outlook Therapeutics Inc. EPS for the last quarter amounts to -0.38 USD, decreased -152.78

How many employees does Outlook Therapeutics Inc (OTLK). have?

Outlook Therapeutics Inc (OTLK) has 17 emplpoyees as of March 09 2026.

What is Outlook Therapeutics Inc (OTLK) market cap?

Today OTLK has the market capitalization of 34.39M USD.