Welcome to our dedicated page for Harrow Health news (Ticker: HROW), a resource for investors and traders seeking the latest updates and insights on Harrow Health stock.
Company Overview
Harrow Health Inc (HROW) is an innovative eyecare pharmaceutical company focused on addressing unmet medical needs through the discovery, development, production, and commercialization of specialized ophthalmic formulations and therapeutic products across the United States. Operating at the intersection of advanced research and clinical application, the company brings together deep industry expertise, rigorous R&D, and a commitment to improving patient care.
Business Model and Operations
At its core, Harrow Health provides a comprehensive portfolio that blends ophthalmology-based drug development with non-intravenous sedation and anesthesia therapeutics for a variety of medical procedures. Its operations are structured around:
- Ophthalmic Therapeutics: Focusing on the management of ocular surface diseases, the company develops topical eye drop formulations that serve both preventative and therapeutic roles.
- Compounded Medications: Offering both sterile and non-sterile formulations, it meets the needs of physicians seeking tailored solutions for diverse clinical scenarios.
- Non-Intravenous Sedation: Developing products designed to facilitate conscious sedation during procedures such as cataract surgery, thereby enhancing patient comfort and procedural efficiency.
This multi-pronged approach not only diversifies its product portfolio but also creates a resilient business model that appeals to healthcare professionals and institutions across outpatient, in-office, and hospital settings.
Market Position and Competitive Landscape
Harrow Health Inc has carved a niche within the highly regulated US pharmaceutical market. Its strategic focus on ocular and sedation therapeutics differentiates it from broader scale pharmaceutical companies, while its commitment to advanced research and quality production standards reinforces its reputation among eyecare professionals. In a competitive landscape where precision and safety are paramount, Harrow Health’s integration of clinical insights with innovative drug formulations positions it as a noteworthy player devoted to addressing specific medical challenges effectively.
Product Portfolio and Therapeutic Solutions
The company has developed an extensive range of products that address conditions related to the ocular surface and procedural sedation. Its portfolio includes:
- Topical Ophthalmic Formulations: Designed to manage diseases affecting the ocular surface and support rehabilitation of vision-related functions.
- Compounded Medications: Both sterile and non-sterile, these are tailored to meet precise medical requirements across various treatment settings.
- Sedation Therapeutics: Products intended for sublingual administration provide non-intravenous sedation, enabling safe and effective patient management during surgical procedures.
Research, Development, and Quality Assurance
The foundation of Harrow Health Inc’s operations lies in robust research and development. The company continually refines its product offerings through comprehensive clinical research and adherence to stringent quality assurance protocols. Its approach underscores a commitment to safety and efficacy while addressing the evolving needs of healthcare providers and patients. This rigorous scientific methodology exemplifies the company’s dedication to maintaining high standards of regulatory compliance and industry best practices.
Commitment to Scientific Integrity and Patient Care
Across its diverse operations, Harrow Health demonstrates a sustained commitment to improving patient outcomes. The company’s emphasis on continuous innovation, strategic R&D, and quality-focused manufacturing processes helps ensure that its pharmaceutical solutions not only meet but often exceed industry benchmarks. This dedication to scientific integrity and patient well-being has established Harrow Health as a trusted entity within the field of eyecare therapeutics.
Strategic Value Proposition
Harrow Health Inc’s value proposition is rooted in its specialized expertise in ophthalmic formulations and sedation therapies. By addressing critical gaps in current medical treatments, the company supports healthcare providers in delivering effective and accessible care. Its balanced focus on innovation, quality, and clinical relevance positions it as a vital contributor to the pharmaceutical landscape, particularly within the realms of eye care and procedural sedation.
Overall, Harrow Health Inc exemplifies a dedicated, research-driven approach to pharmaceutical development that leverages deep industry expertise to meet unmet medical needs. Through its integrated operations and commitment to quality, it remains a significant, unbiased source of therapeutic solutions for healthcare professionals nationwide.
Harrow (Nasdaq: HROW) announced that the Centers for Medicare & Medicaid Services has issued a permanent J-code (J2403) for its ocular anesthetic IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%, effective April 1, 2023. This code will simplify the billing process for eyecare professionals. CEO Mark L. Baum expressed gratitude for CMS's support, emphasizing IHEEZO's clinical advantages and the commitment to accessibility. IHEEZO, approved by the FDA on September 26, 2022, is the first branded ocular anesthetic in the U.S. in nearly 14 years, protected by a patent valid until 2038.
Harrow (Nasdaq: HROW) has successfully closed its acquisition of U.S. commercial rights to five branded ophthalmic products for
Harrow (Nasdaq: HROW) has made its compounded antibiotic formulation, Fortisite (Tobramycin 1.5% + Vancomycin 5%), available for immediate in-office use by eyecare professionals. This product, sourced from its FDA-registered ImprimisRx 503B facility, marks a significant advancement in treating sight-threatening infections. Fortisite is distinguished by its high concentration and stability, allowing for improved patient care. The company also offers a robust access program and a 100% replacement guarantee for expired products, enhancing its service to healthcare providers.
Melt Pharmaceuticals has announced positive top-line results from its Phase 2 study of MELT-300, a novel sublingual formulation for procedural sedation during cataract surgery. The study demonstrated that MELT-300 was statistically superior in efficacy compared to both midazolam (P=0.0129) and ketamine (P=0.0096), and patients treated with MELT-300 were significantly less likely to require rescue sedation (50% less than midazolam, P=0.0198). The company plans to approach the FDA to discuss further development plans.
Harrow Health has announced the pricing of an underwritten public offering of
Harrow Health, Inc. (Nasdaq: HROW) has launched a public offering of $100 million in senior notes due 2027. The offering is subject to market conditions, with underwriters potentially acquiring an additional 15%. The proceeds will fund a previously announced acquisition and support other corporate activities. Egan-Jones Ratings Company has rated the notes as 'BB'. The notes will be offered under an SEC effective shelf registration statement. Harrow focuses on innovative ophthalmic prescription therapies in the U.S. market.
Harrow Health, Inc. (NASDAQ: HROW) announced a priced underwritten offering of 2,376,426 shares at $10.52 per share, yielding gross proceeds of $25 million. This offering is expected to close around December 16, 2022. Funds will be utilized primarily for a recent acquisition and general corporate purposes, including product acquisitions and capital expenditures. The offering is conducted under Harrow's Form S-3 shelf registration. B. Riley Securities is the sole book-running manager for this offering.
Harrow (Nasdaq: HROW) has announced a binding agreement to acquire exclusive U.S. commercial rights to five FDA-approved ophthalmic products from Novartis. This acquisition is expected to enhance Harrow's portfolio and contribute to revenue growth. The deal, valued at $130 million at closing with an additional $45 million contingent on future sales, will allow Harrow to enter the U.S. ophthalmic market more competitively. Revenue projections for 2023 are estimated between $135 million and $143 million, with adjusted EBITDA between $44 million and $50 million.
Harrow (Nasdaq: HROW) has expanded its national product supply agreement with iOR Partners, enhancing the availability of its ophthalmic products across the U.S. This collaboration aims to support the growing trend of office-based cataract surgeries, allowing surgeons to deliver personalized care. Mark L. Baum, CEO of Harrow, emphasized their mission to ensure accessibility and affordability in eyecare. iOR Partners praised Harrow for its high-quality compounded formulations, including the MKO Melt®, which minimizes the need for opioids during procedures.
Harrow (NASDAQ: HROW) reported third-quarter 2022 revenues of $22.8 million, a 22% increase from $18.7 million in Q3 2021. The company achieved FDA approval for IHEEZO™ and launched Fortisite™, a new line of antibiotics. With a cash reserve of $45 million and a backlog of nearly $1 million, Harrow is focusing on its ophthalmic products. Despite a net loss of $6.5 million, adjusted EBITDA reached $2.5 million, indicating operational progress. CEO Mark Baum highlighted the company's strategic shift towards being a pure-play ophthalmic pharmaceutical entity.
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