Highest-materiality recent filing
Outlook Therapeutics regains Nasdaq minimum bid price compliance, delisting risk removed
Received Nasdaq letter on June 26, 2026 confirming compliance with bid price rule 5550(a)(2).
FDA accepts resubmitted BLA for Outlook's ONS-5010; PDUFA date July 29, 2026
FDA acknowledged receipt of resubmitted BLA for ONS-5010 (bevacizumab-vikg) to treat wet AMD.
Outlook Therapeutics resubmits BLA for ONS-5010 to FDA; Class 1 review, PDUFA in 60 days
Resubmitted BLA for ONS-5010 (bevacizumab-vikg) for neovascular AMD under Class 1 review.
Outlook Therapeutics sells 8.54M shares to GMS Ventures in registered direct offering
8,539,709 shares of common stock sold to GMS Ventures and Investments under a securities purchase agreement dated May 28, 2026.
Outlook Therapeutics raises ~$5M in registered direct offering at $0.5855/share; warrants repriced
Gross proceeds of ~$5.0M from sale of 8,539,709 shares at $0.5855 per share.
FDA grants Outlook Therapeutics appeal; BLA resubmission planned for June 2026
FDA concluded substantial evidence of effectiveness for LYTENAVA (bevacizumab-vikg) for nAMD after FDR appeal.
Outlook Therapeutics Q2 FY2026 net loss narrows to $4.5M; FDA decision on ONS-5010 expected May 2026
Net loss of $4.5M ($0.05/sh) vs $46.4M ($1.50/sh) YoY; adjusted net loss $14.1M ($0.16/sh).
Outlook Therapeutics enters new $100M ATM with H.C. Wainwright; cash at $7.7M
Entered into $100M at-the-market offering agreement with H.C. Wainwright & Co. as sales agent.
Outlook Therapeutics raises ~$5M in registered direct offering and private placement at $0.31/unit
Offering of 16,129,033 shares of common stock and accompanying Common Warrants at $0.31 per unit.
Completed Federal Dispute Resolution meeting with FDA Office of New Drugs to appeal Dec 30, 2025 Complete Response Letter for ONS-5010 BLA.
Outlook Therapeutics closes $5.0M offering of common stock and warrants
20M shares + 20M warrants sold at $0.25/unit; gross proceeds ~$5.0M, net ~$4.0M.
Issued $18.36M unsecured note (net $17M after OID) to Atlas Sciences; proceeds used to repay $17M of $33.1M Avondale Note.
Outlook Therapeutics receives Nasdaq minimum bid price deficiency notice; 180-day cure period
Received Nasdaq letter on Feb 18, 2026, for closing bid price below $1.00 for 30 consecutive business days.
Outlook Therapeutics Q1 FY2026 net loss $23.1M; unit sales of LYTENAVA double in Europe
Net loss of $23.1M ($0.38/share) vs net income of $17.4M ($0.72/share) in prior-year quarter.
Outlook Therapeutics requests Type A FDA meeting after CRL for wet AMD drug ONS-5010
CRL dated Dec 30, 2025 cited lack of substantial evidence; company believes it contradicts alignment from Sept 2025 meeting.
FDA issues Complete Response Letter for Outlook Therapeutics' ONS-5010 BLA for wet AMD
FDA CRL states additional mechanistic/natural history data does not alter prior conclusion; confirmatory efficacy evidence needed but not defined.
Outlook Therapeutics FY2025 net loss $62.4M; $1.4M revenue from LYTENAVA launch in Europe
Net loss $62.4M ($1.79/share) vs $75.4M ($4.06/share) prior year; revenue $1.4M from initial EU sales.
FDA accepts Outlook Therapeutics' BLA resubmission for ONS-5010; PDUFA date Dec 31, 2025
FDA acknowledged receipt of BLA resubmission for ONS-5010 (bevacizumab-vikg) and assigned Class 1 review.
Outlook Therapeutics resubmits BLA for ONS-5010 (wet AMD) to FDA after Sept 2025 Type A meeting
Resubmitted BLA on Nov 3, 2025 for ONS-5010 (LYTENAVA) to treat wet AMD.
Outlook Therapeutics completes FDA Type A meeting for ONS-5010 BLA; plans resubmission in 2025
Type A meeting with FDA discussed August 27, 2025 CRL for ONS-5010 BLA (bevacizumab for wet AMD).
Chief Commercial Officer Jeff Evanson departs Outlook Therapeutics effective immediately
Jeff Evanson stepped down as Chief Commercial Officer on September 5, 2025.
CRL cites lack of substantial evidence of effectiveness; ONS-5010 did not meet primary endpoint in NORSE EIGHT trial.
Outlook Therapeutics reports first LYTENAVA sales, $20.2M net loss for Q3 FY2025
First commercial sales of LYTENAVA (bevacizumab gamma) in Germany and UK; $1.5M revenue recognized.
Outlook Therapeutics appoints Robert C. Jahr as President and CEO, replacing interim CEO
Robert C. Jahr appointed President & CEO effective July 1, 2025; replaces interim CEO Lawrence Kenyon, who remains CFO and board member.
Outlook Therapeutics launches LYTENAVA (bevacizumab gamma) in Germany and UK for wet AMD
Commercial launch of LYTENAVA (bevacizumab gamma) in Germany and UK announced on June 2, 2025.
Outlook Therapeutics Q2 FY2025 net loss $46.4M; cash $7.6M; PDUFA Aug 27
Net loss $46.4M ($1.50/share) vs $114.3M ($8.01) YoY; adjusted net loss $12.5M ($0.40) vs $22.1M ($1.55).
FDA accepts resubmission of OTLK's BLA for ONS-5010; PDUFA date set for August 27, 2025
FDA acknowledged receipt of resubmission of BLA for ONS-5010 (bevacizumab-vikg).
Outlook Therapeutics closes $33.1M convertible note, increases authorized shares to 260M
Issued $33.1M convertible note to Avondale Capital on March 13, 2025; proceeds used to repay $32.91M Streeterville note.
Outlook Therapeutics resubmits BLA for ONS-5010 to FDA
Resubmitted Biologics License Application for ONS-5010 to FDA on February 28, 2025.
Outlook Q1: GAAP EPS $0.72 (fair value gains), adj EPS -$0.89; BLA resubmission on track
GAAP net income $17.4M ($0.72/sh) vs net loss $11.2M; adj net loss $21.6M ($0.89/sh) vs $10.1M ($0.78 loss) prior year.
Issued $33.1M unsecured convertible note to Avondale Capital; proceeds primarily used to repay $32.37M Streeterville note.
Exercised existing warrants for ~$17.8M gross (including $8.7M from GMS Ventures) and ~$2.7M from Syntone.
Outlook Therapeutics reports FY2024 net loss of $75.4M; LYTENAVA launch plans for H1 2025
Net loss of $75.4M ($4.06 per share) vs $59.0M ($4.72 per share) in prior fiscal year.
Outlook Therapeutics CEO Russell Trenary resigns effective Dec 3; CFO Kenyon named interim CEO
C. Russell Trenary III stepped down as President, CEO and Board member on Dec 3, 2024, effective immediately.
ONS-5010 did not meet non-inferiority endpoint at week 8 vs ranibizumab (difference -2.257 BCVA letters, margin -3.5).
Outlook Therapeutics reports Q3 FY2024 adjusted net loss $19.2M; EU/UK approval for LYTENAVA
GAAP net income $44.4M ($1.91 basic EPS), but diluted loss $0.89; adjusted net loss $19.2M ($0.83).
Outlook Therapeutics gets UK MHRA approval for LYTENAVA (bevacizumab gamma) for wet AMD
UK MHRA granted Marketing Authorization for LYTENAVA (bevacizumab gamma) to treat wet age-related macular degeneration.
European Commission granted Marketing Authorization for LYTENAVA (bevacizumab gamma) for wet AMD in the EU.
Outlook Therapeutics reports Q2 FY2024 net loss of $114.3M; positive CHMP opinion for ONS-5010 in EU
Net loss of $114.3M ($8.01/sh); adjusted net loss of $22.1M ($1.55/sh) vs $6.7M loss year ago.
Outlook Therapeutics submits UK MAA for ONS-5010 (bevacizumab gamma) for wet AMD
Submitted MAA to UK MHRA via International Recognition Procedure, relying on March 2024 positive CHMP opinion.
Outlook Therapeutics closes $5M private placement to Syntone Ventures
Issued 714,286 shares and warrants to purchase 1,071,429 shares at $7.00 per share+ warrant.
Terry Dagnon ceased to serve as the Company’s Chief Operations Officer and an executive officer of the Company and was appointed as Senior Advisor.
appointed Dr. Julia A. Haller to fill the newly created vacancy
Mr. Trenary replaces Lawrence Kenyon, who resigned as President and Chief Executive Officer of the Company concurrently with Mr. Trenary’s appointment.
On July 6, 2021, the Board of Directors (the “Board”) of Outlook Therapeutics, Inc. (the “Company”) appointed C. Russell Trenary III as President and Chief Executive Officer of the Company and as a director, effective immediately.
Max materiality 0.85 · Median 0.70 · Most common event regulatory