Outlook Therapeutics
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2011-01-01
- Employees
- 24
- Market Cap
- $176.7M
- Introduction
Outlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of ONS-5010/LYTENAVA. Its pipeline includes unmet patient needs, repackaged IV bevacizumab, and anti-VEGF. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Iselin, NJ.
FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications
• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar.
• JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others.
• The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.
Outlook Therapeutics' ONS-5010 BLA Resubmission Progresses Amid Price Target Adjustment
• Guggenheim maintains Buy rating on Outlook Therapeutics while adjusting price target from $12 to $10 following fiscal Q1 earnings report.
• Company confirms timeline for ONS-5010 Biologics License Application (BLA) resubmission within calendar Q1, marking a crucial regulatory milestone.
• FDA's upcoming review will focus on evaluating ONS-5010's complete clinical package to determine adequacy of controlled studies.
Phase 3 Trial Shows Promising Results for Novel Encapsulated Cell Therapy in MacTel Treatment
• Phase 3 clinical trials of NT-501, an encapsulated cell therapy delivering CNTF, demonstrated significant reduction in disease progression for macular telangiectasia type 2 patients, with up to 52% reduction in ellipsoid zone loss.
• The innovative implantable device, developed by Neurotech, maintains long-term viability with CNTF production documented for up to 14.5 years, offering a potential alternative to frequent intravitreal injections.
• FDA review of the therapy is currently underway with a PDUFA date set for March 18, 2025, marking a potential breakthrough in MacTel treatment.
Nektar's Rezpegaldesleukin Receives FDA Fast Track for Atopic Dermatitis Treatment
• The FDA has granted Fast Track designation to rezpegaldesleukin for moderate-to-severe atopic dermatitis in patients 12 years and older.
• Rezpegaldesleukin targets the interleukin-2 receptor complex, stimulating regulatory T cell proliferation to restore immune balance.
• Phase 2b REZOLVE-AD study has completed enrollment, with topline data expected in Q2 2025, evaluating EASI score improvements.
• Fast Track designation allows for more frequent interactions with the FDA, potentially accelerating the drug's development and approval.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
Outlook Therapeutics' ONS-5010 Shows Non-Inferiority to Ranibizumab in Wet AMD Trial
• Outlook Therapeutics' ONS-5010 demonstrated non-inferiority to ranibizumab (Lucentis) at week 12 in the NORSE EIGHT trial for wet AMD.
• The company plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025 based on the trial results.
• ONS-5010/LYTENAVA has already been granted marketing authorization in the EU and UK, with a commercial launch planned for H1 2025.
• The NORSE EIGHT trial showed a mean 5.5 letter improvement in BCVA in the ONS-5010 arm, compared to a 6.5 letter improvement in the ranibizumab arm.
LYTENAVA Receives NICE Recommendation for Wet AMD Treatment in the UK
• LYTENAVA (bevacizumab gamma) has been recommended by NICE for treating wet AMD, marking the first positive reimbursement decision worldwide for this ophthalmic formulation.
• This decision allows LYTENAVA to be available on the NHS and for Independent Sector Providers, offering a cost-effective anti-VEGF treatment option for approximately 40,000 new wet AMD patients each year in the UK.
• Outlook Therapeutics anticipates launching LYTENAVA in the UK in the first half of 2025 and is progressing with pricing and reimbursement processes in EU countries for subsequent launches.
• LYTENAVA is the first and only authorized ophthalmic formulation of bevacizumab for treating wet AMD in the EU and UK, holding an initial 10 years of market exclusivity.
Outlook Therapeutics Announces Executive Leadership Transition
• Russell Trenary has stepped down as President and CEO of Outlook Therapeutics, effective immediately, after the company achieved EU and UK regulatory approval for LYTENAVA™.
• Lawrence Kenyon, the current Executive Vice President and CFO, has been appointed as the Interim CEO to guide the company through this transitional period.
• Outlook Therapeutics remains on track to resubmit the BLA for ONS-5010 in Q1 2025 and launch LYTENAVA™ in Europe during the first half of 2025.
• The company has initiated a search for a permanent CEO to lead Outlook Therapeutics in its future endeavors and strategic goals.
Outlook Therapeutics' Lytenava Fails to Meet Endpoint in Phase III Wet AMD Trial
• Outlook Therapeutics' Lytenava (bevacizumab-vikg) did not meet the pre-specified non-inferiority endpoint in the NORSE EIGHT Phase III trial for wet AMD at eight weeks.
• Despite the setback, Outlook Therapeutics plans to resubmit its biologics license application (BLA) to the FDA in Q1 2025 with complete NORSE EIGHT trial analysis.
• The NORSE EIGHT trial showed a smaller improvement in best corrected visual acuity (BCVA) with Lytenava compared to Roche's Lucentis (ranibizumab) at eight weeks.
• Outlook Therapeutics is considering launching Lytenava in the UK and Germany in 2025, where it is already approved, and is exploring partnerships for global markets.
ONS-5010 Fails to Meet Non-Inferiority Endpoint in NORSE EIGHT Trial for Wet AMD
• Outlook Therapeutics' ONS-5010 did not meet the primary endpoint of non-inferiority compared to ranibizumab in the NORSE EIGHT trial for wet AMD.
• The ONS-5010 arm showed a +4.2 letter improvement in BCVA, while ranibizumab showed a +6.3 letter improvement from baseline.
• Despite not meeting the primary endpoint, ONS-5010 demonstrated vision improvement and a favorable safety profile, according to preliminary data.
• Outlook Therapeutics plans to resubmit the BLA for ONS-5010 in Q1 2025, pending full analysis of the month 3 data.
Outlook Therapeutics Completes Enrollment in NORSE EIGHT Wet AMD Trial
• Outlook Therapeutics has completed enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in patients with wet age-related macular degeneration (AMD).
• The NORSE EIGHT trial is a randomized, controlled, masked, non-inferiority study comparing ONS-5010 to ranibizumab in newly diagnosed wet AMD patients.
• Topline results from the NORSE EIGHT trial are expected in the fourth quarter of calendar year 2024, with a BLA resubmission planned for Q1 2025.
• If approved, ONS-5010/LYTENAVA™ would be the first ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.
Outlook Therapeutics Advances ONS-5010 Toward Potential First Approved Ophthalmic Bevacizumab for Retinal Diseases
• Outlook Therapeutics received a positive opinion from the European Medicines Agency's CHMP for ONS-5010/LYTENAVA™ (bevacizumab gamma) for wet AMD treatment, with European Commission decision expected in Q2 2024.
• The company has submitted a Marketing Authorization Application in the UK and is progressing with the NORSE EIGHT clinical trial in the US, with over 30% of subjects enrolled and topline results expected in Q4 2024.
• If approved, ONS-5010 would be the first authorized ophthalmic formulation of bevacizumab for treating retinal diseases, potentially launching in the EU and UK in early 2025 and in the US later that year.
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