Outlook Therapeutics

Outlook Therapeutics develops an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration, diabetic macular edema, and branch retinal vein occlusion. Their ophthalmic formulations also use in treating retinal diseases.

Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of retinal diseases, including wet age-related macular degeneration (AMD). The company's lead product candidate, ONS-5010, is designed to be the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases. ONS-5010 is a recombinant humanized monoclonal antibody that selectively binds to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF's biologic activity through steric blocking.

Outlook Therapeutics Grants Stock Options to Top Executives

Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2024

Q2 2024 Outlook Therapeutics Inc Earnings Call

Outlook Therapeutics regains Nasdaq compliance with stock price By Investing.com

Outlook Therapeutics, Inc.

Outlook Therapeutics stock undergoes 1-for-20 reverse stock split

Buy Rating Affirmed for Outlook Therapeutics: European Endorsement and Pivotal US Study Progress Signal Strong Market Potential

Outlook Therapeutics® Provides Update on Type A Meetings with FDA

Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million

Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD

Outlook Therapeutics® Receives European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

Outlook Therapeutics recupera el cumplimiento del precio de oferta del Nasdaq Por Investing.com

Outlook Therapeutics: Analysts Forecast Over 500% Stock Upside

Outlook Therapeutics® Doses First Subject in NORSE EIGHT

FDA issues CRL for Outlook Therapeutics’ ONS-5010

Outlook Therapeutics® to Present at the Retina World Congress 2024

Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

Outlook Therapeutics requests Type A meeting with FDA

Bringing Life-Saving Biologics to More Patients

Biosimilars

Outlook Therapeutics (OTLK) Streamlines Operations

Cencora

To bolster Outlook Therapeutics' forthcoming launch of Lytenava in European markets by early 2025, potentially aiding in introducing ONS-5010 across diverse global markets.

Outlook Therapeutics is a biopharmaceutical company focused on developing and commercializing ONS-5010/LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of retinal diseases, including wet age-related macular degeneration (AMD). The company's lead product candidate, ONS-5010, is designed to be the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases. ONS-5010 is a recombinant humanized monoclonal antibody that selectively binds to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF's biologic activity through steric blocking. Outlook Therapeutics has completed three clinical trials for ONS-5010 - NORSE ONE, NORSE TWO, and NORSE THREE. The pivotal NORSE TWO trial met its primary and secondary endpoints with high statistical significance and clinical relevance. In March 2024, Outlook Therapeutics received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for ONS-5010/LYTENAVA (bevacizumab gamma) to treat wet AMD in the European Union. The company is also conducting the NORSE EIGHT trial, a 90-day non-inferiority study comparing ONS-5010 to ranibizumab, with top line data expected in the fourth quarter of 2024.

Coherus BioSciences is a commercial-stage biopharmaceutical company focused on developing and commercializing innovative immunotherapies for cancer treatment. The company's strategy revolves around building a leading immuno-oncology franchise funded by cash generated from its portfolio of FDA-approved therapeutics. Coherus markets several biosimilar products in the US, including UDENYCA (pegfilgrastim-cbqv), a biosimilar of Neulasta, CIMERLI (ranibizumab-eqrn), a biosimilar of Lucentis, and YUSIMRY (adalimumab-aqvh), a biosimilar of Humira.
In July 2023, Coherus launched YUSIMRY at a list price of USD 995 per carton for two 40 mg/0.8 mL autoinjectors, representing a discount of more than 85% compared to Humira. This pricing strategy aims to improve patient access to adalimumab treatment by offering significant cost savings. YUSIMRY is indicated for various autoimmune conditions, including rheumatoid arthritis, psoriatic arthritis, and Crohn's disease.
Coherus is also developing toripalimab, an anti-PD-1 antibody, for the US and Canadian markets through a licensing agreement with Shanghai Junshi Biosciences Ltd. A Biologics License Application (BLA) for toripalimab in combination with chemotherapy for treating recurrent or metastatic nasopharyngeal carcinoma was under FDA review.
In March 2024, Coherus reported net revenue of USD 91.5 million for Q4 2023 and USD 257.2 million for the full year 2023, driven by sales of UDENYCA and CIMERLI. However, the company faced challenges, including a net loss of USD 79.7 million in Q4 and USD 237.9 million for the full year 2023. To address these challenges, Coherus initiated a workforce reduction of 30% to streamline operations and focus on oncology.

Coherus Biosciences

Custom Biologics is a Canadian contract research organization (CRO) specializing in bioanalytical services for biopharmaceuticals, vaccines, and cell and gene therapy products. With over 20 years of experience, the company focuses on designing and validating regulatory compliant assays for functional characterization, potency/bioactivity assessments, clinical pharmacokinetics, and immunogenicity of biotherapeutic drugs. Custom Biologics' genomics group develops molecular genetic assays for gene and genome analysis, measuring genetic inserts and transgenes in gene therapy vectors, oncolytic viruses, and nucleic acid-based vaccines. The company has also developed a proprietary isothermal nucleic acid amplification technology called DASL-RAPID for rapid identification of human and food-borne pathogens. Custom Biologics maintains a Health Canada cGMP Drug Establishment License and operates under a quality system based on FDA and EMEA GLP guidelines. The company's services are utilized in preclinical research and development programs, as well as for validated GMP-compliant assays suitable for stability analysis, clinical analysis, and clinical/market lot release testing. Custom Biologics employs state-of-the-art bioanalytical laboratory equipment and sophisticated statistical software to generate data for submissions to regulatory agencies worldwide.

Custom Biologics

CuriRx, Inc., founded in 2012, is a contract development and manufacturing organization (CDMO) based in Wilmington, Massachusetts. The company specializes in providing end-to-end support for biotherapeutic drug developers, focusing on complex molecules such as recombinant proteins, monoclonal antibodies, bispecific antibodies, vaccines, antibody drug conjugates, oligonucleotides, and gene therapy products. CuriRx's services encompass upstream and downstream process development, optimization, characterization, scale-up and scale-down, analytical development, formulation development, and lyophilization.
In January 2022, CuriRx launched its Advanced Bioprocessing and Analytical Center, which combines state-of-the-art bioprocessing laboratories with the CuriLytics Platform's high-resolution analytical instrumentation. This center aims to accelerate biotherapeutic drug development by leveraging the team's extensive bioprocessing experience and employing the latest methods in upstream and downstream process development. The CuriLytics Platform utilizes high-resolution mass spectrometry and various orthogonal characterization methods to further de-risk drug development.
CuriRx has the capacity to produce non-GMP vials for animal studies and non-GMP stability support studies. The company's key personnel have been involved in successful development projects for notable drugs such as HUMIRA, SYNAGIS, BLINCYTO, and GATTEX. In September 2013, CuriRx was awarded a five-year contract by the National Cancer Institute for the development and production of oncology products, demonstrating its expertise in the field.

CuriRx

Paras Biopharmaceuticals Finland Oy is a biopharmaceutical technology development company based in Oulu, Finland. Founded in 2012, the company specializes in the development and manufacturing of complex biologics and biosimilars using microbial expression systems. Paras Biopharmaceuticals operates a state-of-the-art 25,000 square foot biologics production facility in Finland, which includes 4,300 square feet of classified cleanroom space. The facility is equipped for media and buffer preparation, fermentation, harvest and extraction, purification, final filtration, and freeze-drying.
The company's core activities are divided into two main divisions: Paras Biopharma, which focuses on biologics Contract Development and Manufacturing Organization (CDMO) services, and Paras Biologics, which handles biosimilar development and licensing. Paras Biopharmaceuticals has developed proprietary technology platforms including Biomultifold, Noblecleav, and Cytofold StructQuant to achieve high productivity and quality in biologics manufacturing. These technologies enable the company to produce complex proteins and biosimilars cost-effectively at scale.
As of December 2022, Paras Biopharmaceuticals reported achieving success with "Continuous Biomanufacturing" for high-value onco-immunology and urology biosimilars. The company has also made advancements in maximizing recombinant protein expression in microbial systems, reporting expression levels of up to 12g/L or more of fully folded, biologically active protein in fermentation broth as of July 2023.

Paras Biopharmaceuticals

Kashiv Biosciences, LLC is a fully integrated biopharmaceutical company focused on developing biosimilars and specialty biopharmaceutical products. The company has global research and development, clinical, regulatory, and manufacturing capabilities. Kashiv utilizes its MayaBio reactor technology to develop biosimilars. The company's product portfolio includes biosimilars targeting conditions such as asthma, chronic idiopathic urticaria, and neutropenia. Kashiv's lead biosimilar candidate, ADL018, is a proposed biosimilar to Xolair (omalizumab) currently in Phase III clinical trials for chronic spontaneous urticaria. In March 2022, Kashiv received FDA approval for its first biosimilar RELEUKO (filgrastim-ayow), a biosimilar referencing Neupogen. The company has a robust pipeline of seven biosimilars and multiple 505(b)(2) and complex peptide generic products in development. Kashiv operates FDA-approved GMP manufacturing facilities in Chicago, Illinois and has state-of-the-art R&D infrastructure in Ahmedabad, India. The company is headquartered in Piscataway, New Jersey.
Key customers and partnerships
Kashiv has established strategic partnerships to commercialize its products globally. In October 2023, Kashiv entered into an exclusive licensing agreement with Alvotech for the development and commercialization of ADL018 in Europe, the UK, Australia, Canada, and New Zealand. In July 2024, Kashiv signed an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of ADL018 in the US. Kashiv has also collaborated with Amneal on the development and commercialization of other biosimilars, including RELEUKO and FYLNETRA. These partnerships allow Kashiv to leverage its partners' commercial expertise and global reach to bring its biosimilar products to market.

Kashiv Biosciences

Biotechnology companies that focus on the research, development, production, and commercialization of prescription drugs including biosimilars.

Biotechnology companies that focus on the research, development, production, and commercialization of biosimilars based on original biological medicine.

Companies offering R&D capabilities and production facilities to biosimilar companies on contracts or partnerships.

Biopharmaceutical technology development and support service companies that offer specialized solutions to biosimilar companies.

Companies offering testing solutions to support the biological characterization, comparability, and other clinical assessments required in the biosimilar development process.

AI/ML-driven technology platforms support drug design and development process and integration of drug substance development

Outlook Therapeutics

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