Outlook Therapeutics Submits Type A Meeting Request to FDA Following Complete Response Letter

Rhea-AI Summary

Outlook Therapeutics (Nasdaq: OTLK) submitted a Type A meeting request to the FDA on Feb 11, 2026 after receiving a Complete Response Letter (Dec 30, 2025) for its BLA for ONS-5010/LYTENAVA (bevacizumab-vikg) in wet AMD. The CRL cited a single deficiency alleging lack of substantial evidence of effectiveness and requested additional confirmatory evidence.

The company cites positive Phase 3 NORSE TWO results at 12 months, complementary data from NORSE EIGHT, mechanistic/pharmacodynamic evidence, favorable safety findings, and existing EU and UK marketing authorizations.

Positive

• NORSE TWO met primary endpoint with statistically significant visual acuity gains at 12 months
• Comprehensive confirmatory package includes mechanistic and pharmacodynamic VEGF inhibition data
• Favorable safety profile comparable to ranibizumab with no FDA safety concerns noted
• LYTENAVA granted Marketing Authorization in EU and UK; commercially available in Germany and UK

Negative

• FDA issued a Complete Response Letter dated Dec 30, 2025 citing insufficient substantial evidence of effectiveness
• NORSE EIGHT did not meet its primary endpoint at 8 weeks, requiring additional confirmatory evidence

Key Figures

Primary endpoint: 3 lines (15 letters) visual acuity gain NORSE TWO duration: 12 months NORSE EIGHT primary endpoint: 8 weeks +5 more

8 metrics

Primary endpoint 3 lines (15 letters) visual acuity gain NORSE TWO Phase 3 primary endpoint met at 12 months

NORSE TWO duration 12 months Phase 3 trial visual acuity assessment period

NORSE EIGHT primary endpoint 8 weeks Primary endpoint not met at 8 weeks in Phase 3 study

NORSE EIGHT trajectory 12 weeks Positive trajectory consistent with NORSE TWO through 12 weeks

Secondary endpoints 1-line and 2-line gains Additional visual acuity gains in NORSE TWO

Vision preservation Loss of fewer than 3 lines Secondary endpoint supporting treatment effect

CRL date December 30, 2025 FDA Complete Response Letter on resubmitted BLA

Commercial launch timing June 2025 LYTENAVA became commercially available in Germany and UK

Market Reality Check

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Technical Shares at $0.4209 are trading below the 200-day MA of $1.51 and 87.58% under the 52-week high.

Peers on Argus

OTLK is up 4.03% while close biotech peers are mixed, with moves from -12.23% (V...

OTLK is up 4.03% while close biotech peers are mixed, with moves from -12.23% (VRCA) to +9.12% (CALC). This pattern points to a stock-specific reaction rather than a broad sector rotation.

Historical Context

5 past events · Latest: Jan 06 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Executive appointment	Positive	-2.4%	New VP of Corporate Strategy and Business Development hired to lead partnerships.
Dec 31	Regulatory setback	Negative	-15.3%	FDA issued CRL for resubmitted ONS-5010 BLA, requesting more efficacy evidence.
Dec 26	Equity inducement grants	Neutral	+8.8%	Stock options for 150,000 shares granted to new employees as inducement awards.
Dec 19	Earnings results	Negative	-2.9%	Fiscal 2025 net loss of $62.4M with modest initial LYTENAVA revenue and limited cash.
Nov 24	Conference participation	Neutral	-4.3%	CEO scheduled for fireside chat at Piper Sandler healthcare conference.

Pattern Detected

Regulatory setbacks like the December CRL have coincided with notable declines, while corporate or administrative updates often show muted or contrary price reactions.

Recent Company History

Over the past few months, Outlook Therapeutics has been driven largely by regulatory milestones for ONS-5010 and corporate updates. A December 31, 2025 CRL requesting additional confirmatory evidence triggered a sharp -15.28% move, contrasting with smaller declines around the FY 2025 results and a conference appearance. Administrative items such as stock option inducement grants on December 26, 2025 saw a positive +8.79% reaction. Today’s Type A FDA meeting request fits into this ongoing effort to address U.S. regulatory hurdles after the resubmitted BLA CRL.

Market Pulse Summary

This announcement outlines Outlook Therapeutics’ next regulatory step after the December 2025 Comple...

Analysis

This announcement outlines Outlook Therapeutics’ next regulatory step after the December 2025 Complete Response Letter by requesting a Type A meeting with the FDA. The company highlights that NORSE TWO met its 12‑month primary endpoint and that European approvals have enabled commercialization since June 2025. Historically, U.S. regulatory updates have driven sizable moves, so investors may focus on forthcoming FDA feedback and any clarity on what additional confirmatory evidence is required.

Key Terms

type a meeting, complete response letter, biologics license application, wet age-related macular degeneration, +3 more

7 terms

type a meeting regulatory

"it has submitted a Type A meeting request to the U.S. Food and Drug"

A Type A meeting is an urgent, short-notice session requested between a company and a regulatory agency (for example, the FDA in the U.S.) to resolve critical issues that block a development program, such as a clinical hold or safety concern. Investors care because the outcome can immediately affect whether a clinical trial or approval process resumes, changing timelines, costs and the company’s near-term value — like calling an emergency mechanic when a car won’t start so a trip can continue.

complete response letter regulatory

"following receipt of a Complete Response Letter (CRL) dated December 30,"

A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.

biologics license application regulatory

"regarding the Company’s Biologics License Application (BLA) for ONS-5010"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

wet age-related macular degeneration medical

"for the treatment of wet age-related macular degeneration (wet AMD). The"

A severe eye condition in which abnormal, fragile blood vessels grow beneath the macula — the small central part of the retina responsible for sharp, detailed vision — and leak fluid or blood, causing rapid loss of central sight. Investors care because the condition drives demand for high-cost therapies, medical devices and ongoing care; successful treatments can create sizable markets, affect healthcare spending and influence regulatory and reimbursement decisions, much like fixing a leaking camera lens restores image quality and value.

phase 3 trial medical

"NORSE TWO, a single adequate and well-controlled Phase 3 trial that"

A Phase 3 trial is a large, late-stage test of a new drug or medical treatment done on many people to make sure it really works and is safe. For investors, it matters because a successful Phase 3 usually means the company can ask regulators to sell the product and could earn lots of money, while failure can sharply reduce the company’s value.

best-corrected visual acuity medical

"NORSE EIGHT showed consistent gains in best-corrected visual acuity across"

The sharpest level of sight a person can reach when using the best possible glasses or contact lenses; think of it as how well a camera can resolve detail once its lens is perfectly focused. It matters to investors because it is a common clinical measure and regulatory endpoint for eye drugs, procedures and devices, so changes in best-corrected visual acuity indicate whether a treatment works and can drive approval, market size and sales potential.

pharmacodynamic medical

"functional and mechanistic/pharmacodynamic evidence of efficacy. Specifically,"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

AI-generated analysis. Not financial advice.

ISELIN, N.J., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that it has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Based on prior discussions with the FDA in September 2025, during which Outlook Therapeutics understood that it had aligned with FDA on the requirements for resubmission of the BLA, the issuance of an additional CRL was unexpected. Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL.

“Outlook Therapeutics remains confident in the strength of the clinical evidence supporting ONS-5010 and firmly believes the totality of data meets the FDA’s substantial evidence standard,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “We are committed to working constructively with the FDA to resolve these issues and to bringing this important therapy to patients with wet AMD in the United States.”

The BLA for ONS-5010 is supported by clinically meaningful data, including results from NORSE TWO, a single adequate and well-controlled Phase 3 trial that demonstrated statistically significant and clinically relevant improvements in visual acuity at 12 months. NORSE TWO met its primary endpoint - patients gaining three lines (15 letters) of visual acuity - and a key secondary endpoint of mean change from baseline in visual acuity. Additional secondary endpoints, including gains of one line, two lines, and preservation of vision (loss of fewer than three lines), further reinforce the robustness and consistency of the treatment effect.

At FDA’s request, Outlook Therapeutics also conducted NORSE EIGHT, a second adequate and well-controlled Phase 3 study. While NORSE EIGHT did not meet its primary endpoint at 8 weeks, the study demonstrated a positive trajectory consistent with NORSE TWO through 12 weeks of treatment and provided important functional and mechanistic/pharmacodynamic evidence of efficacy. Specifically, NORSE EIGHT showed consistent gains in best-corrected visual acuity across all measured timepoints, low variability, and results aligned with the established anti-VEGF mechanism of action.

In addition to NORSE TWO and NORSE EIGHT, Outlook Therapeutics submitted a comprehensive package of confirmatory evidence, including mechanistic and pharmacodynamic data demonstrating VEGF inhibition and natural history data showing that the observed improvements with ONS-5010 represent a clear departure from the expected progression of untreated wet AMD. Outlook Therapeutics believes the resubmitted BLA fully satisfied the substantial evidence standard for demonstrating effectiveness, and intends to continue to work with the FDA on a path forward for resolving the FDA’s request for additional confirmatory evidence.

ONS-5010 also demonstrated a favorable safety profile, with ocular adverse reactions consistent with both the control arm (ranibizumab) and with intravitreal injections generally and the FDA has never expressed any safety concerns with ONS-5010. The availability of an FDA-approved bevacizumab product for wet AMD would provide patients and physicians with a consistent, high-quality, commercially manufactured option supported by FDA-approved labeling, standardized manufacturing, and robust pharmacovigilance.

ONS-5010/LYTENAVA™ (bevacizumab-vikg) is supported by a fully domestic, end-to-end U.S. manufacturing supply chain, enhancing reliability of supply and aligning with long-term public health and national resilience objectives.

As previously announced, LYTENAVA™ (bevacizumab gamma) was granted Marketing Authorization by the European Commission in the EU and Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In June 2025, LYTENAVA™ (bevacizumab gamma) became commercially available in Germany and the UK for the treatment of wet AMD. In addition to current plans to expand its commercial presence in select countries in Europe, Outlook Therapeutics continues to speak with and explore collaborations with potential commercial and distribution partners in additional European countries, as well as outside of Europe. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.

In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “on track,” “plan,” “potential,” “target,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, expectations concerning Outlook Therapeutics’ plans to conduct a Type A meeting with the FDA and the ability to remediate or otherwise resolve the deficiency identified in the CRL, expectations concerning decisions of regulatory bodies and the timing thereof, the potential to receive approval from the FDA, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD and to mitigate certain risks associated with the current off-label use of repackaged bevacizumab, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that Outlook Therapeutics is not able to provide sufficient evidence to support the approval by the FDA of the ONS-5010 BLA, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 19, 2025, and in future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs and trade tensions, fluctuations in interest rates and inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
OTLK@jtcir.com

FAQ

What did Outlook Therapeutics announce about its FDA interaction for ONS-5010 (OTLK) on Feb 11, 2026?

They submitted a Type A meeting request to the FDA after a Dec 30, 2025 Complete Response Letter. According to the company, the CRL identified a single deficiency and requested additional confirmatory evidence despite their submitted Phase 3 and supportive data.

Did the Phase 3 trials for ONS-5010 support effectiveness for OTLK's wet AMD submission?

Yes for NORSE TWO; results showed significant visual acuity improvements at 12 months. According to the company, NORSE TWO met its primary and key secondary endpoints, while NORSE EIGHT provided supportive mechanistic and functional evidence despite missing its 8-week primary endpoint.

What reason did the FDA give in the Complete Response Letter for OTLK's BLA rejection?

The CRL cited a single deficiency alleging a lack of substantial evidence of effectiveness and asked for additional confirmatory evidence. According to the company, this determination conflicts with the totality of clinical and mechanistic data submitted in the BLA.

How does Outlook describe the safety profile of ONS-5010 in their Feb 11, 2026 release?

Outlook reports a favorable safety profile with ocular adverse reactions consistent with ranibizumab and standard intravitreal injections. According to the company, the FDA has never expressed safety concerns with ONS-5010.

What regulatory progress has LYTENAVA achieved outside the U.S. relevant to OTLK investors?

LYTENAVA secured Marketing Authorization in the EU and UK and became commercially available in Germany and the UK in June 2025. According to the company, it is the first authorized ophthalmic bevacizumab formulation for wet AMD in those jurisdictions.

What next steps did Outlook Therapeutics say it will take after the CRL for ONS-5010?

They requested a Type A meeting and held informal FDA discussions to resolve the CRL and additional evidence request. According to the company, they intend to work constructively with the FDA to identify a path forward and potentially resubmit confirmatory data.