Outlook Therapeutics Inc Dossier
Outlook & Key Dates
Estimates, guidance, catalysts, and upcoming events
Analyst Estimates Learn more →
Analyst Coverage
3analysts covering
FY EPS (est.)
-$0.51next fiscal year
Monitoring Framework
Key Performance Indicators
U.S. FDA Regulatory Approval Status for ONS-5010 (Lytenava) QuarterlyTarget: FDA Approval of Biologics License Application (BLA)
European Commercial Unit Sales Growth Quarterly-1,000.0%Target: Continued quarter-over-quarter unit sales growth
Cash and Cash Equivalents Quarterly7.7MTarget: Secure additional financing to extend runway beyond September 2026
Watch Items
- FDA PDUFA Target Action Date for ONS-5010 (Lytenava)Trigger: July 29, 2026Action: Monitor FDA decision on Class 1 BLA resubmission; prepare for immediate U.S. commercial launch if approved.
- Capital Structure and Share DilutionTrigger: Special Stockholder Meeting on July 16, 2026Action: Track shareholder votes on proposals to increase authorized common shares to 600 million and authorize a 1-for-10 to 1-for-50 reverse stock split.
- European Commercial Expansion and Reimbursement ApprovalsTrigger: Launches in Ireland, Netherlands, and Switzerland in 2026Action: Monitor local pricing and reimbursement approvals in individual EU member states to drive European revenue.
Research as of 19 Jun 2026