Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $0.1652W HIGH $2.54
Volume
3.69 M
Value Traded
11.42 M
Short % Float
16.38%
+0.57%Week
-6.11%1 Month
-61.36%3 Month
+135.42%6 Month
-99.35%5 Year
-99.95%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
145.80 M
EPS (TTM)
-0.25
P/E Ratio
-
Ent. Value
134.56 M
Total Shares
243.45 M
Float Shares
196.67 M
Insiders
19.21%
Institutions
18.46%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
PoA blends historical approval base rates, trial design score and FDA review track record.
OTLK Catalyst Timeline
Dated clinical, regulatory and corporate events for Outlook Therapeutics, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Outlook Therapeutics, Inc.
344Total events
12Upcoming
100Tier-1 (high impact)
2016 to 2030Coverage
Upcoming catalysts 2
Event history 50
●Management ChangeCorporate
Greg DiPasquale named Chief Commercial Officer of Outlook Therapeutics
◆Reimbursement / PricingONS-5010ApprovedPost-Market
Outlook Therapeutics submits HCPCS Level II application to CMS for permanent J-code for LYTENAVA
wet age-related macular degeneration (wet AMD)source ↗
▼Equity OfferingCorporate
Pricing of $55.0 million public offering of common stock and warrants
▲FDA ApprovalONS-5010ApprovedFDA Decision
FDA approval of LYTENAVA (bevacizumab-vikg) for wet AMD
wet AMDsource ↗
▲Product LaunchONS-5010ApprovedPost-Market
Commercial launch of LYTENAVA in the U.S.
neovascular age-related macular degeneration (wet AMD)source ↗
▲Exclusivity GrantedONS-5010ApprovedIP / Competition
Anticipated 12 years of Reference Product Exclusivity under BPCIA
neovascular age-related macular degeneration (wet AMD)source ↗
▲FDA Filing AcceptedONS-5010ApprovedRegulatory Filing
FDA accepts resubmitted BLA for ONS-5010/LYTENAVA for wet AMD
neovascular age-related macular degeneration (wet AMD)source ↗
▲Product LaunchONS-5010ApprovedPost-Market
Commercial launch of LYTENAVA in Germany, Austria, and UK
wet AMDsource ↗
▲EU ApprovalONS-5010ApprovedEx-US Regulatory
European Commission Marketing Authorization for LYTENAVA
wet AMDsource ↗
▲MHRA MilestoneONS-5010ApprovedEx-US Regulatory
MHRA Marketing Authorization for LYTENAVA in UK
wet AMDsource ↗
●Timing GuidanceONS-5010ApprovedPresentation
Planned resubmission of BLA for ONS-5010/LYTENAVA to FDA
neovascular age-related macular degeneration (nAMD)source ↗
▲BLA SubmissionONS-5010ApprovedRegulatory Filing
Resubmission of BLA to FDA for ONS-5010
neovascular age-related macular degenerationsource ↗
▼Equity OfferingCorporate
Pricing of $5.0 million registered direct offering at $0.5855 per share
▲Formal Dispute ResolutionONS-5010ApprovedFDA Meeting
FDA grants appeal following Formal Dispute Resolution process for ONS-5010/LYTENAVA
neovascular age-related macular degeneration (nAMD)source ↗
▲Partnership / LicenseONS-5010ApprovedCorporate
Commercial Distribution Agreement with Mediconsult AG for LYTENAVA in Switzerland
wet AMDsource ↗
●Trial InitiationONS-5010ApprovedTrial
Launched real-world evidence study in Germany for LYTENAVA
wet AMDsource ↗
◆FDA Feedback ReceivedONS-5010ApprovedFDA Meeting
Formal feedback from FDA expected
neovascular age-related macular degenerationsource ↗
◆FDA Feedback ReceivedONS-5010ApprovedFDA Meeting
FDA formal decision expected for ONS-5010
wet AMDsource ↗
◆Formal Dispute ResolutionONS-5010ApprovedFDA Meeting
Completed Federal Dispute Resolution (FDR) meeting with FDA
neovascular age-related macular degenerationsource ↗
◆Formal Dispute ResolutionONS-5010ApprovedFDA Meeting
FDA accepted Formal Dispute Resolution Request (FDRR) and granted meeting with deciding official
neovascular age-related macular degenerationsource ↗
◆Formal Dispute ResolutionONS-5010ApprovedFDA Meeting
Completed formal dispute resolution meeting with FDA regarding CRL for ONS-5010
wet AMDsource ↗
▼Equity OfferingCorporate
Registered direct offering of common stock and warrants for $4.2M net proceeds
▲Product LaunchONS-5010ApprovedPost-Market
Commercial launch of LYTENAVA (bevacizumab gamma) in Germany, Austria, and UK
wet AMDsource ↗
▼Equity OfferingCorporate
Closing of $5.0 million public offering of common stock and warrants
▼Equity OfferingCorporate
Pricing of $5.0 million public offering of 20,000,000 shares and warrants at $0.25
▲Product LaunchONS-5010ApprovedPost-Market
Commercial launch of LYTENAVA (bevacizumab gamma) in Germany, Austria, and UK
wet AMDsource ↗
▲EU ApprovalONS-5010ApprovedEx-US Regulatory
Marketing authorization from European Commission for ONS-5010/LYTENAVA for wet AMD
wet age-related macular degenerationsource ↗
▲MHRA MilestoneONS-5010ApprovedEx-US Regulatory
Marketing authorization from UK MHRA for ONS-5010/LYTENAVA for wet AMD
wet age-related macular degenerationsource ↗
●ATM ProgramCorporate
Sale of shares under at-the-market sales program since December 31, 2025, net proceeds $2.4 million
●Debt Royalty FinancingCorporate
Entered into Note Purchase Agreement with Atlas Sciences for $18.36 million March 2026 Note
◆Type A MeetingONS-5010ApprovedFDA Meeting
Type A meeting with FDA to discuss CRL for ONS-5010 BLA
wet AMDsource ↗
●Type A MeetingONS-5010ApprovedFDA Meeting
Type A meeting with FDA regarding CRL
neovascular age-related macular degenerationsource ↗
▼Equity OfferingCorporate
Public offering of common stock and warrants for ~$4.0M net proceeds
●Type A MeetingONS-5010ApprovedFDA Meeting
Type A meeting request submitted to FDA following CRL
wet age-related macular degenerationsource ↗
▲Formal Dispute ResolutionONS-5010ApprovedFDA Meeting
Successfully appealed CRL; FDA Office of New Drugs concluded substantial evidence of effectiveness
neovascular age-related macular degenerationsource ↗
◆Timing GuidanceONS-5010ApprovedPresentation
FDA decision on ONS-5010 BLA expected in a few weeks
wet AMDsource ↗
▲Product LaunchONS-5010ApprovedPost-Market
Commercial launch of LYTENAVA™ in Germany, Austria, and the UK
wet AMDsource ↗
▼Complete Response LetterONS-5010ApprovedFDA Decision
FDA issues Complete Response Letter for ONS-5010 BLA resubmission
wet age-related macular degenerationsource ↗
Past FDA Catalysts and PDUFA Decisions
How OTLK actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-07-24 | ONS-5010/LYTENAVA™ (bevacizumab-vikg) | PDUFA Date Approved | PDUFA |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
F11 / 100
Pipeline Score
$0M
Pipeline Value
Not rated
Valuation Signal
2
Drugs Scored
-
rNPV / MCap
Top 100%
Micro Cap(rank 657 of 657)
Percentile Rank
Outlook Therapeutics, Inc. has significant pipeline risk (11/100), with 2 assets in development, but cash runway is a concern.
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| ONS-5010 Monoclonal antibodyMarketedNCT05112861 | Age-Related Macular Degeneration | Phase 3 | ACTIVE NOT_RECRUITING | 606 | Dec 1, 2027 |
Clinical Trial Results
Readouts, endpoints and source filings for every OTLK program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ONS-5010 | wet AMD | 2024-11-27 | -2.257 BCVA letters; 95% confidence interval of (-4.044, -0.470); -3.5 at a 95% confidence interval; +4.2 letter improvement in BCVA in the ONS-5010 arm; +6.3 letter improvement in BCVA in the ranibizumab armRead More | Outlook Therapeutics Announces Preliminary Topline Results of NORSE EIGHT Clinical Trial Final efficacy data expected in January 2025 Anticipate resubmission of BLA in calendar Q1 2025 ISELIN, N.J.Read More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| KENYON LAWRENCE ADirector, Officer (Chief Financial Officer) | Buy | 101,010 101,010 held | $0.00 | 08/14/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in OTLK
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| PERCEPTIVE ADVISORS LLC | 0.1 % | 4.99 M | 3.14 M |
OTLK Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How OTLK ranks across every disease it competes in
Competitive Position is a premium feature
See how OTLK ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialOTLK News
OTLK▲ +6.2%on this news
Outlook Therapeutics Names Greg DiPasquale Chief Commercial Officer
Outlook Therapeutics has appointed Greg DiPasquale as Chief Commercial Officer to lead the commercialization of LYTENAVA, the first FDA-approved ophthalmic formulation of bevacizumab for wet AMD. DiPasquale, who has over 30 years of experience in commercial leadership, aims to leverage his background to successfully launch LYTENAVA in the U.S. by the end of 2026.
Read more →OTLKOutlook Therapeutics Highlights What the Appointment of New CFO Kevin Lundquist Means for the Company’s Next Chapter in Virtual Investor Discussion
Outlook Therapeutics has appointed Kevin Lundquist as CFO, coinciding with the FDA approval of LYTENAVA, an ophthalmic formulation for treating wet AMD. Lundquist emphasizes the importance of this transition as the company prepares for the commercial launch of LYTENAVA. The approval positions Outlook Therapeutics for significant growth in the retinal disease market.
Read more →OTLKOutlook Therapeutics Submits HCPCS Level II Application to CMS for Permanent J-Code for LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics has submitted an application to CMS for a permanent J-code for LYTENAVA, its FDA-approved treatment for wet AMD. This submission is part of their strategy to ensure market access and reimbursement ahead of a planned U.S. launch by the end of 2026. The company emphasizes the importance of this J-code in facilitating billing and improving patient access to the treatment.
Read more →OTLKOutlook Therapeutics Fireside Chat from H.C. Wainwright Conference Now Available On-Demand
Outlook Therapeutics announced that a pre-recorded fireside chat featuring CEO Bob Jahr is now available for on-demand viewing. The chat, part of the H.C. Wainwright 28th Annual Global Investment Conference, discusses the company's recent developments. The conference will also host in-person meetings with investors from September 14-16, 2026.
Read more →OTLKOutlook Therapeutics CEO, Bob Jahr, Discusses FDA Approval and Commercial Opportunity for LYTENAVA™ in Virtual Investor CEO Connect Segment
Outlook Therapeutics has received FDA approval for LYTENAVA, the only ophthalmic formulation of bevacizumab for wet AMD. CEO Bob Jahr discussed the commercial opportunities and the company's plans for a U.S. launch by the end of 2026, aiming for significant market penetration. The company expects to achieve over $500 million in annual sales by 2030.
Read more →OTLKOutlook Therapeutics Appoints Kevin Lundquist as Chief Financial Officer as It Prepares for U.S. Commercial Launch of LYTENAVA™
Outlook Therapeutics has appointed Kevin Lundquist as Chief Financial Officer, effective September 1, 2026, to enhance its financial and operational capabilities ahead of the U.S. launch of LYTENAVA. The FDA's approval of LYTENAVA marks a significant milestone for the company, and Lundquist's expertise in finance and operations is expected to support its growth strategy. He succeeds Lawrence Kenyon, who will transition to a non-executive role.
Read more →OTLKOutlook Therapeutics CEO, Bob Jahr, Participates in the Virtual Investor “Why Now” On-Demand Conference
Outlook Therapeutics CEO Bob Jahr participated in the Virtual Investor 'Why Now' conference, discussing the company's transition following the FDA approval of LYTENAVA for wet AMD. He emphasized the unique position of LYTENAVA as the only FDA-approved ophthalmic formulation of bevacizumab, highlighting the potential to redefine treatment standards. The company is preparing for a commercial launch in the U.S. and has an established presence in Europe.
Read more →OTLK▼ -14.9%on this news
Outlook Therapeutics Reports Third Quarter Fiscal Year 2026 Financial Results and Provides Business Update Highlighting FDA Approval of LYTENAVA™
Outlook Therapeutics announced the FDA approval of LYTENAVA, the only ophthalmic bevacizumab for wet AMD, marking a pivotal opportunity for the company. The U.S. launch is planned before the end of 2026, with expectations of exceeding $500 million in annual sales by 2030. The company is building a commercial team and strategy to ensure broad patient access and reimbursement. Financial results show a net loss of $20.3 million for Q3 2026.
Read more →OTLK▼ -19.2%on this news· ran to -36% by day 3shared move
Outlook Therapeutics Announces Pricing of $55.0 Million Public Offering of Common Stock and Warrants
Outlook Therapeutics announced a public offering of 55,555,556 shares of common stock and warrants, priced at $0.99 per share. The offering aims to raise approximately $55 million to support the launch of LYTENAVA™ in the U.S. and for general corporate purposes. The offering is set to close on August 14, 2026, pending market conditions.
Read more →OTLK▼ -19.2%on this news· ran to -36% by day 3shared move
Outlook Therapeutics Announces Proposed Public Offering of Common Stock and Warrants
Outlook Therapeutics, Inc. has announced a proposed public offering of common stock and warrants. This move aims to raise capital to support the development and commercialization of LYTENAVA™ for retinal diseases. The announcement reflects the company's ongoing commitment to advancing its therapeutic pipeline.
Read more →OTLK▼ -5.6%on this news
Outlook Therapeutics to Report Third Quarter Fiscal Year 2026 Financial Results and Host a Corporate Update Conference Call and Webcast on August 14, 2026
Outlook Therapeutics will report its third quarter fiscal year 2026 financial results and host a corporate update conference call on August 14, 2026. The call will feature CEO Bob Jahr and CFO Lawrence A. Kenyon. The company focuses on LYTENAVA™, an FDA-approved treatment for retinal diseases, which has begun its commercial launch in select European countries.
Read more →OTLK▼ -14.1%on this news· ran to -39% by day 3
Outlook Therapeutics Announces LYTENAVA™ FDA Approval as the First and Only FDA-Approved Ophthalmic Bevacizumab for the Treatment of Wet AMD
Outlook Therapeutics has received FDA approval for LYTENAVA™ (bevacizumab-vikg), marking it as the first ophthalmic formulation of bevacizumab specifically developed for treating wet age-related macular degeneration (AMD). This approval is expected to set a new benchmark in retina care, providing physicians and patients with a reliable treatment option. The company anticipates a 12-year market exclusivity period, positioning LYTENAVA™ to become a leading therapy in the $8.5 billion U.S. retina market.
Read more →OTLK▲ +35.3%on this news· ran to +58% by day 3
Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD
Outlook Therapeutics announced that the FDA has accepted its resubmitted Biologics License Application for ONS-5010/LYTENAVA™ for the treatment of wet AMD. This resubmission is classified as a Class 1 review, with a target action date set for July 29, 2026. If approved, ONS-5010/LYTENAVA™ will be the first FDA-approved ophthalmic formulation of bevacizumab, enhancing treatment options for patients.
Read more →OTLK▲ +15.5%on this news
Outlook Therapeutics Announces Resubmission of Biologics License Application to U.S. FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
Outlook Therapeutics has resubmitted its Biologics License Application for ONS-5010/LYTENAVA™ to the FDA for treating neovascular age-related macular degeneration. The FDA has determined that substantial evidence of effectiveness exists, eliminating the need for additional trials. The resubmission is classified as Class 1, with a decision expected within 60 days.
Read more →OTLKOutlook Therapeutics Announces Pricing of $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Outlook Therapeutics announced a $5 million registered direct offering priced at $0.5855 per share. The offering involves the sale of 8,539,709 shares to GMS Ventures, the company's largest stockholder. Proceeds will be used for working capital and corporate purposes. The company also plans to amend existing warrants to a lower exercise price.
Read more →OTLK▲ +29.1%on this news· ran to +136% by day 3shared move
Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA (bevacizumab-vikg)
Outlook Therapeutics has successfully won an appeal from the FDA regarding its ONS-5010/LYTENAVA (bevacizumab-vikg) product after a Formal Dispute Resolution process. The FDA now recognizes substantial evidence for the drug's effectiveness in treating neovascular age-related macular degeneration (nAMD). As a result, the company plans to resubmit its Biologics License Application (BLA) in June 2026. If approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab.
Read more →OTLKOutlook Therapeutics Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update
Outlook Therapeutics reported its financial results for Q2 FY 2026, showing a significant reduction in net loss compared to the same period last year. The company continues to advance its commercialization of LYTENAVA in Europe, with plans to expand into Switzerland and other markets. Outlook is also waiting for the FDA's decision regarding the ONS-5010 application, having conducted a formal dispute resolution meeting to clarify its path forward. Overall, the company remains optimistic about its prospects in both European launches and U.S. regulatory approval.
Read more →OTLKOutlook Therapeutics Announces Closing of $5.0 Million Registered Direct Offering
Outlook Therapeutics has successfully closed a $5 million registered direct offering, selling over 16 million shares at $0.31 each. The company also issued unregistered warrants for the same number of shares, which could generate an additional $5 million if exercised. Proceeds will support working capital and corporate initiatives. The company’s product, LYTENAVA™, has received marketing authorization in Europe, enhancing its market position.
Read more →OTLK▼ -13.7%on this newsshared move
Outlook Therapeutics Completes Federal Dispute Resolution (FDR) Meeting with FDA for ONS-5010/LYTENAVA (bevacizumab-vikg)
Outlook Therapeutics has completed its Federal Dispute Resolution meeting with the FDA regarding ONS-5010/LYTENAVA. This meeting follows a previous Type A meeting related to a Complete Response Letter for the drug. The company is hopeful for constructive feedback from the FDA, which is expected in May 2026. ONS-5010/LYTENAVA aims to enhance the treatment of neovascular age-related macular degeneration, pending regulatory approval.
Read more →OTLK▲ +6.2%on this news· ran to +25% by day 1
Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA
Outlook Therapeutics has submitted a formal dispute resolution request to the FDA regarding the Complete Response Letter for ONS-5010/LYTENAVA™. The FDA has accepted this request and scheduled a meeting for April 2026. The company believes that the data from clinical trials supports the efficacy and safety of the treatment for neovascular age-related macular degeneration.
Read more →About Outlook Therapeutics, Inc.
Headquarters111 S. WOOD AVENUE, ISELIN, NJ, 08830
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