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 Health Inc (HROW) is a leading developer of ophthalmic pharmaceuticals and non-intravenous sedation therapies, addressing critical needs in eyecare and procedural medicine. This dedicated news hub provides investors and healthcare professionals with timely access to official announcements and objective updates about the company's progress.
Our curated collection features earnings reports, regulatory milestones, and product development updates, offering a comprehensive view of HROW's strategic direction. Users will find essential information on FDA approvals, clinical trial results, and partnership announcements that shape the company's position in the pharmaceutical sector.
Key content categories include financial disclosures, research breakthroughs, and manufacturing updates related to compounded medications and sedation therapeutics. All materials are sourced from verified channels to ensure accuracy and relevance for decision-makers.
Bookmark this page for streamlined access to HROW's latest developments. Check back regularly for authoritative updates on innovations in ocular surface disease treatments and non-IV sedation solutions that demonstrate the company's commitment to advancing patient care.
Melt Pharmaceuticals has announced the completion of patient dosing in its pivotal Phase 3 study for MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. The study, conducted at 13 clinical sites with over 525 patients, compares MELT-300 to sublingual midazolam and placebo. Topline results are expected by the end of 2024.
The FDA has agreed to a Special Protocol Assessment (SPA) for the MELT-300 Phase 3 study, establishing a binding agreement on key elements for a future marketing application. Additionally, a cardiac safety study showed MELT-300 does not alter normal heart rhythm.
MELT-300 combines fixed doses of midazolam (3mg) and ketamine (50mg) in a sublingual tablet using Catalent's Zydis® delivery technology. Previous Phase 2 results showed MELT-300 was statistically superior for procedural sedation compared to placebo, midazolam, and ketamine individually.
Harrow (Nasdaq: HROW) has relaunched TRIESENCE®, a preservative-free synthetic corticosteroid approved by the FDA for visualization during vitrectomy and treating ocular inflammatory conditions unresponsive to topical corticosteroids. This relaunch comes after more than five years on the FDA Drug Shortage List and two years of inventory depletion.
Key points:
- TRIESENCE provides a white backdrop against the retina, enhancing visibility during vitrectomy
- It's critical for office-based and surgical procedures
- The relaunch addresses the need for a reliable alternative to less ideal, off-label solutions
- TRIESENCE can be ordered through major pharmaceutical specialty distributors
Ophthalmologists and retina specialists have expressed enthusiasm for the return of this trusted product, highlighting its importance in improving surgical outcomes and patient care.
Harrow Inc. (Nasdaq: HROW), a leading U.S. ophthalmic pharmaceutical company, has announced a significant expansion of its corporate headquarters in Nashville, Tennessee. The expansion will create nearly 150 new jobs in the area. Harrow, originally founded in San Diego in 2012, relocated its headquarters to Nashville in 2019.
Since the relocation, Harrow has invested in Nashville by building a state-of-the-art analytical chemistry lab, expanding its sales and marketing organization, and hiring for other critical business operations. The company has also recently expanded its total leased square footage in Nashville to approximately 30,000 square feet.
Tennessee Governor Bill Lee and other state officials praised the expansion, highlighting the state's growing economy and business-friendly environment. Harrow's CEO, Mark L. Baum, cited Nashville's advantageous location, beneficial tax environment, and dynamic culture as key factors in the company's decision to expand in the city.
Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, has announced its participation in three investor conferences in New York this September. The events include:
- H.C. Wainwright 26th Annual Global Investment Conference (Sept 9-11, 2024)
- Lake Street 8th Annual Best Ideas Growth Conference (Sept 12, 2024)
- Cantor 2024 Global Healthcare Conference (Sept 17-19, 2024)
Harrow will present at the H.C. Wainwright conference on Sept 10 at 8:00 a.m. ET and host a Fireside Chat at the Cantor conference on Sept 18 at 2:30 p.m. ET. The company will conduct one-on-one meetings at all three events. Audio webcasts for the H.C. Wainwright and Cantor conferences will be available on Harrow's website.
Harrow (Nasdaq: HROW) reported record Q2 2024 revenues of $48.9 million, a 46% increase year-over-year and 42% quarter-over-quarter. The company saw significant growth across all business segments, particularly in IHEEZO and VEVYE sales. Key highlights include:
- GAAP net loss of $(6.5) million
- Adjusted EBITDA of $8.8 million
- Cash and cash equivalents of $71.0 million as of June 30, 2024
- IHEEZO customer unit demand volume increased by 98% from Q1 2024
- VEVYE total prescriptions increased by 212% from Q1 2024
- Anterior Segment revenues up over 40% from Q1 2024
Harrow is progressing with the relaunch of TRIESENCE®, with positive initial analytical test results for the second process performance qualification batch.
Novaliq has received a positive opinion from the European Medicines Agency's CHMP for Vevizye®, a treatment for moderate to severe dry eye disease in adults. Vevizye® is a clear ciclosporin 0.1% solution based on Novaliq's unique EyeSol® water-free technology. The recommendation is based on comprehensive data from over 1,500 patients, showing clinically meaningful improvements in ocular surface conditions as early as two weeks, with excellent tolerability.
In clinical trials, Vevizye® demonstrated statistically significant improvements across various endpoints, with up to 71.6% of patients responding within four weeks. The therapy showed continued improvement in both signs and symptoms over 56 weeks. If approved, Vevizye® would be the first medicinal therapy approved to treat dry eye disease in both the US and EU.
Harrow (HROW), a leading U.S. eyecare pharmaceutical company, has announced it will release its second quarter 2024 financial results on August 7, 2024, after market close. The company will also publish its Q2 Letter to Stockholders on its website. A conference call and live webcast are scheduled for August 8, 2024, at 8:00 a.m. Eastern Time to discuss the results and provide a business update.
Investors can access the live conference call via webcast on Harrow's website or register in advance for telephone participation. A replay of the call and webcast will be available on the company's website for one year.
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.
