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.
Harrow, Inc. (Nasdaq: HROW) is an ophthalmic-focused pharmaceutical company that regularly issues news and updates related to its portfolio of eye-care products, development programs, and corporate activities. The company describes itself as a leading provider of ophthalmic disease management solutions in North America, with products that address conditions such as dry eye disease, wet age-related macular degeneration, cataracts, refractive errors, glaucoma, ocular surface conditions, and retina diseases.
News about Harrow commonly covers financial results and investor communications, including quarterly earnings releases, letters to stockholders, and conference call announcements. The company also announces participation in investor conferences and Investor & Analyst Day events, where it provides overviews of its commercial portfolio, pipeline, and long-term vision.
Another key theme in Harrow’s news flow is business development and pipeline progress. Recent press releases have described the agreement to acquire, and subsequent closing of the acquisition of, Melt Pharmaceuticals, Inc., a clinical-stage company developing non-opioid, non-IV sedation therapies such as MELT-300 and MELT-210. Harrow has used these announcements to explain the strategic rationale for expanding into procedural sedation and to outline regulatory and development milestones for these product candidates.
Harrow’s news also highlights access and affordability initiatives, such as the launch of the VEVYE Access for All (VAFA) program for VEVYE (cyclosporine ophthalmic solution) 0.1% and the broader Harrow Access for All (HAFA) program, which is intended to extend a unified access model across its branded, authorized generics, and compounded ophthalmic medications. Additional releases address leadership changes at ImprimisRx, debt offerings and related credit facilities, and other corporate matters.
Investors and eyecare professionals reviewing Harrow’s news page can expect updates on earnings, capital markets transactions, acquisitions, development milestones for ophthalmic and procedural sedation candidates, and initiatives aimed at improving patient access to the company’s ophthalmic therapies.
Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, will attend the 2024 American Society of Retina Specialists (ASRS) Annual Meeting in Stockholm, Sweden, from July 17-20, 2024.
The meeting gathers top retina specialists, researchers, and industry leaders to discuss the latest advancements in retinal health.
Harrow plans to showcase its expanding portfolio, including IHEEZO®, a novel anesthetic gel for ocular surface anesthesia, and provide updates on the relaunch of TRIESENCE®, used for vitrectomy and treating posterior uveitis.
The company's participation aims to build a strong retina franchise and demonstrate its commitment to serving the U.S. retina community.
Harrow (Nasdaq: HROW) has entered into an agreement with Apexus to offer its products, including IHEEZO® (chloroprocaine hydrochloride ophthalmic gel) 3%, through the 340B Prime Vendor Program starting July 1, 2024. The 340B PVP, managed by Apexus, aims to enhance purchasing power for U.S. hospitals and ensure access to discounted medications. Additional Harrow products included are VIGAMOX®, a bacterial conjunctivitis treatment, and ILEVRO®, an NSAID for ocular pain and inflammation. This agreement aims to open access to Harrow's products for the U.S. hospital market, significantly impacting the 44% of hospitals participating in the program.
Harrow (Nasdaq: HROW) has successfully manufactured the first of three commercial-scale process performance qualification (PPQ) batches of TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, an FDA-approved corticosteroid for ocular surgeries and inflammatory conditions. The remaining two PPQ batches are scheduled, and if all batches meet specifications, TRIESENCE will relaunch in 2024. TRIESENCE has been on the FDA Drug Shortage List for over five years, with no inventory available in the U.S. for over two years. Harrow is committed to quickly building commercial inventories, though initial supplies may not meet market demand. Pre-commercial activities and discussions with strategic accounts for pre-orders are underway.
Melt Pharmaceuticals has dosed the first patient in its Phase 3 clinical trial for MELT-300, a non-IV, non-opioid sedation tablet, targeting procedural sedation during cataract surgery. MELT-300 combines midazolam and ketamine in a sublingual, fast-dissolving format. The trial is a randomized, double-blind study involving 528 patients across 14 clinical sites, comparing MELT-300 to sublingual midazolam and a placebo. Previous Phase 2 trials showed MELT-300's superior efficacy. Topline results are expected in Q4 2024. CEO Dr. Larry Dillaha highlighted the innovation in sedation and potential expansion to over 100 million annual procedures in various medical fields.
Harrow (Nasdaq: HROW) announced results from its ESSENCE-2 open-label extension (OLE) clinical study for VEVYE® (cyclosporine ophthalmic solution) 0.1%, aimed at treating dry eye disease (DED). The 52-week study, involving 202 patients, demonstrated sustained safety and efficacy of VEVYE, with significant improvements in corneal staining, tear production, and symptomatology. Mild instillation site pain and reduced visual acuity were the most common adverse events. Only one patient withdrew due to mild ocular discomfort. 33.1% of patients rated the eye drop satisfaction at 10, and 91% rated it 5 or higher. Investigators highlighted VEVYE’s tolerability and long-term potential. Harrow’s CEO emphasized the product’s unique formulation and clinical benefits.
Harrow (Nasdaq: HROW), a prominent North American eyecare pharmaceutical company, will participate in two investor conferences in May. The company will attend the B. Riley Securities 24th Annual Institutional Investor Conference at the Beverly Hilton Hotel in Beverly Hills, CA, on May 22-23, 2024. The event includes an in-person Fireside Chat and 1x1 investor meetings.
Harrow will also be present at the Craig-Hallum 21st Annual Institutional Investor Conference at the Depot Renaissance Hotel in Minneapolis, MN, on May 29, 2024, featuring 1x1 and small group investor meetings. Interested investors should contact their B. Riley or Craig-Hallum representative for meeting arrangements. Neither event will be webcast.
Harrow (Nasdaq: HROW) reported its first quarter 2024 financial results, with revenues reaching $34.6 million, a 33% increase from the prior-year quarter. Gross margin was steady at 69%, while net loss increased to $13.6 million from $6.6 million in Q1 2023. Key highlights include IHEEZO's new CMS reimbursement approval, seven new supply agreements, and new patent claims valid through 2039. VEVYE's coverage expanded to 150 million lives, and ImprimisRx returned to quarterly growth. Cash reserves totaled $76 million as of March 31, 2024, with an additional $5.5 million from recent Eton Pharmaceuticals stock sales. Harrow remains focused on expanding its dry eye and retina franchises and stabilizing ImprimisRx.
Harrow, a U.S. eyecare pharmaceutical company, appoints Greg DiPasquale as Senior Vice President, Head of Commercial. DiPasquale brings extensive experience from companies like Regeneron and Novartis, with a track record of growing sales and revenue in the ophthalmic pharmaceutical industry. Harrow aims to leverage DiPasquale's expertise to enhance its leadership structure and drive growth in the North American market.
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