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OTLK Overview

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0.000(0.000%)
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0.000(0.000%)Aft-market
ET
$
0.000
0.000(0.000%)
At close
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ET
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Intellectia

Loading chart...

High
1.660
Open
1.620
VWAP
1.55
Vol
20.62M
Mkt Cap
253.03M
Low
1.400
Amount
31.90M
EV/EBITDA(TTM)
--
Total Shares
160.15M
EV
283.47M
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.
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Events Timeline

(ET)
2026-06-16
08:30:00
Outlook Therapeutics ONS-5010 Application Acknowledged by FDA
select
2026-06-01 (ET)
2026-06-01
09:20:00
Outlook Therapeutics Resubmits BLA for ONS-5010 to FDA
select
2026-05-29 (ET)
2026-05-29
09:00:00
Liquid Option Names See Borrow Rate Increases
select
2026-05-28 (ET)
2026-05-28
16:10:00
Outlook Therapeutics Sells 8.54M Shares at $0.5855 Each
select
2026-05-28
16:10:00
Outlook Therapeutics Sells 8.54M Shares at $0.5855 Each
select
2026-05-26 (ET)
2026-05-26
07:10:00
Outlook Therapeutics Receives FDA Approval for Lytenava to Treat nAMD
select
2026-05-15 (ET)
2026-05-15
16:20:00
Outlook Therapeutics Q2 Revenue $128,000
select
2026-04-22 (ET)
2026-04-22
09:20:00
Outlook Therapeutics to Offer 16.129M Shares at $0.31 Each
select
2026-04-21 (ET)
2026-04-21
09:10:00
Outlook Therapeutics Completes Federal Dispute Resolution Meeting with FDA
select

News

seekingalpha
8.5
06-16seekingalpha
PinnedFDA Reconsiders ONS-5010 Marketing Application for Wet AMD
  • FDA Review Restart: The U.S. FDA has agreed to reconsider Outlook Therapeutics' marketing application for ONS-5010, potentially opening new market opportunities for the company, particularly in the treatment of wet age-related macular degeneration (wet AMD).
  • Stock Price Recovery: Following the FDA's announcement to review the application, Outlook Therapeutics' shares rose in premarket trading on Tuesday, reflecting market optimism regarding the potential approval of the drug, despite the company's earlier stock crash due to application rejection.
  • Application Resubmission: Outlook Therapeutics has resubmitted its Biologics License Application (BLA) for ONS-5010, which has received a Class 1 review from the FDA, with a target action date set for July 29, 2026, providing a potential pathway for future revenue growth.
  • Market Potential: As an ophthalmic formulation aimed at treating wet AMD, ONS-5010 could open new revenue streams for Outlook Therapeutics if approved, enhancing its competitive position in the biopharmaceutical market.
stocktwits
8.5
06-16stocktwits
Outlook Therapeutics Expects Approval for LYTENAVA
  • FDA Application Acceptance: Outlook Therapeutics announced that the FDA has accepted its biologics license application for LYTENAVA, with a decision expected by July 29, 2026, leading to a 28% surge in the company's stock on Tuesday, indicating strong market anticipation for the drug.
  • Regulatory Journey Overview: Although the FDA initially rejected LYTENAVA in December, the agency determined that no additional clinical trials were necessary following the company's appeal, suggesting that substantial evidence of effectiveness has been established, thereby accelerating the approval process.
  • Positive Market Reaction: According to Stocktwits data, retail sentiment around OTLK has remained in the 'extremely bullish' territory over the past 24 hours, with message volume increasing from 'high' to 'extremely high', reflecting investor optimism regarding the drug's approval.
  • Analyst Ratings Optimistic: Among the four analysts covering OTLK, two have rated it as 'Buy' and two as 'Hold', with a 12-month average price target of $5.50, representing a potential upside of 374% from the stock's last close, showcasing confidence in the company's future prospects.
Newsfilter
9.0
06-16Newsfilter
Outlook Therapeutics' FDA Resubmission Acknowledged for ONS-5010
  • FDA Submission Progress: Outlook Therapeutics announced that the FDA has acknowledged the resubmission of its Biologics License Application (BLA) for ONS-5010/LYTENAVA™, classified as a Class 1 review with a target action date of July 29, 2026, presenting a significant market opportunity for the company.
  • First Ophthalmic Formulation: Upon approval, ONS-5010/LYTENAVA™ will be the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, marking a major breakthrough in the treatment of retinal diseases and potentially enhancing the company's competitive edge in the market.
  • Pre-Launch Activities: Outlook Therapeutics has initiated pre-launch activities in anticipation of the pending BLA approval, indicating the company's proactive approach to market entry and its commitment to meeting patient needs swiftly.
  • International Authorization Status: ONS-5010/LYTENAVA™ has received centralized marketing authorization in the EU and UK, showcasing its international market potential, while requiring pricing and reimbursement approvals in certain EU member states, which will influence its market strategy.
stocktwits
8.5
06-01stocktwits
Outlook Therapeutics Resubmits Lytenava Application to FDA for Approval
  • FDA Resubmission: Outlook Therapeutics has resubmitted its application for Lytenava, with the FDA confirming that no additional trials are necessary, indicating substantial evidence of effectiveness, which could expedite the drug's market entry as the only FDA-approved ophthalmic formulation of bevacizumab if approved.
  • Stock Surge: Following the announcement of the resubmission, shares of Outlook Therapeutics jumped 21% on Monday, reflecting market optimism regarding FDA approval and significantly boosting investor confidence in the company's future growth potential.
  • Regulatory Journey: The path to approval for Lytenava has faced multiple challenges, with the FDA initially rejecting the application in August 2023 due to manufacturing deficiencies and insufficient evidence of effectiveness; however, Outlook addressed these issues and engaged in a Formal Dispute Resolution process, leading to the current resubmission opportunity.
  • Positive Market Sentiment: On Stocktwits, retail sentiment around OTLK has remained in the “extremely bullish” territory, with users expressing optimism about FDA approval, showcasing strong market confidence in the company's future prospects despite a 50% decline in stock price over the past 12 months.
Newsfilter
8.5
06-01Newsfilter
Outlook Therapeutics Resubmits BLA for ONS-5010/LYTENAVA™ Approval
  • FDA Resubmission Progress: Outlook Therapeutics announced the resubmission of its Biologics License Application (BLA) for ONS-5010/LYTENAVA™, with the FDA confirming the drug's effectiveness for neovascular age-related macular degeneration (nAMD) and stating that no additional trials are required, which accelerates the path to market.
  • Significant Milestone Achieved: CEO Bob Jahr noted that this resubmission represents a success achieved through rigorous review and appeal processes in close collaboration with the FDA, with a decision expected within 60 days, potentially providing new treatment options for patients.
  • Market Potential: If approved, ONS-5010/LYTENAVA™ will be the first FDA-approved ophthalmic formulation of bevacizumab, significantly improving patient access to treatment and offering an attractive alternative for anti-VEGF therapies, addressing the market's demand for new options.
  • International Authorization Status: ONS-5010/LYTENAVA™ has received marketing authorization in the EU and UK, with Outlook Therapeutics launching commercial efforts in Germany, Austria, and the UK, demonstrating its potential for global market expansion and solidifying its leadership in the ophthalmic pharmaceutical sector.
NASDAQ.COM
8.5
05-29NASDAQ.COM
Outlook Therapeutics Prices $5 Million Stock Offering
  • Offering Details: Outlook Therapeutics announced a registered direct offering of 8,539,709 shares at $0.5855 each to its largest shareholder, GMS Ventures, expected to close around May 29, 2026, aiming to raise $5 million for working capital and general corporate purposes.
  • Existing Registration Statement: The securities are sold under an existing shelf registration statement on Form S-3, originally filed in March 2024 and effective in April 2024, indicating the company's compliance and transparency in capital markets, which enhances investor confidence.
  • Warrant Amendment: As part of the transaction, Outlook Therapeutics agreed to amend previously issued warrants held by GMS Ventures, reducing the exercise price to $0.5855 per share, aimed at improving shareholder returns and facilitating future financing.
  • Stock Performance Review: Over the past year, Outlook Therapeutics' stock has traded between $0.16 and $3.39, closing at $0.74, up 26.39% from the previous trading day, reflecting positive market expectations for the company's future developments.
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
BTIG
analyst
Buy
to
Neutral
downgrade
AI Analysis
2026-05-18
Reason
BTIG
analyst
Price Target
AI Analysis
2026-05-18
downgrade
Buy
to
Neutral
Reason
BTIG downgraded Outlook Therapeutics to Neutral from Buy with no price target. While the firm believes Lytenava has inherent benefits over compounded bevacizumab in wet age-related macular degeneration, it needs to see confirmation of a clear path to potential approval in the U.S. and/or signs of commercial momentum in Europe in order to get more constructive, the analyst tells investors.
Ascendiant
Buy
downgrade
$10 -> $6
2026-03-11
Reason
Ascendiant
Price Target
$10 -> $6
2026-03-11
downgrade
Buy
Reason
Ascendiant lowered the firm's price target on Outlook Therapeutics to $6 from $10 and keeps a Buy rating on the shares following the Q1 report.
Unlock Full Analyst Thesis, Get the complete breakdown of rating reason for OTLK
Unlock Now

Valuation Metrics

The current forward P/E ratio for Outlook Therapeutics Inc (OTLK.O) is 2.85, compared to its 5-year average forward P/E of -3.22. 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
-3.22
Current PE
2.85
Overvalued PE
0.07
Undervalued PE
-6.50

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
-1.16
Current EV/EBITDA
-0.05
Overvalued EV/EBITDA
11.22
Undervalued EV/EBITDA
-13.55

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
231.25
Current PS
5.36
Overvalued PS
693.37
Undervalued PS
-230.87

Financials

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Frequently Asked Questions

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

The current price of OTLK is 1.58 USD — it has decreased -4.24

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 127.44K 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 -0.05 USD, decreased -96.67

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

Outlook Therapeutics Inc (OTLK) has 17 emplpoyees as of June 19 2026.

What is Outlook Therapeutics Inc (OTLK) market cap?

Today OTLK has the market capitalization of 253.03M USD.