Harrow Health Inc Stock Price, News & Analysis

Harrow (HROW) has executed a five-year strategic supply and development agreement for TRIESENCE®, a preservative-free synthetic corticosteroid approved by the FDA for visualization during vitrectomy and treatment of certain ocular inflammatory conditions. The agreement is with the current contract manufacturing organization that has over 15 years of experience with TRIESENCE manufacturing.

The company aims to ensure continuous supply of TRIESENCE, which had previously been on the FDA's Drug Shortage List for over five years. Additionally, Harrow has initiated development of a next-generation version of TRIESENCE, with plans to submit a new drug application (NDA) to the FDA by the end of 2027.

Harrow (HROW), a leading North American eyecare pharmaceutical company, has scheduled its fourth quarter and year-end 2024 financial results announcement for March 17, 2025, after market close. The company will simultaneously release its fourth quarter Letter to Stockholders on its website.

A conference call and live webcast are planned for March 18, 2025, at 8:00 a.m. Eastern Time to discuss the results and provide a business update. Investors can access the conference call through the company's website or register for telephone participation, which will provide them with a unique dial-in number and PIN.

Harrow (HROW) has announced a strategic partnership with Cencora (COR) to launch the 'Harrow Cares' program, aimed at improving accessibility and affordability of IHEEZO® and TRIESENCE® for retina specialists and their patients. The program offers comprehensive support services through a state-of-the-art patient support hub.

The initiative includes multiple key features: streamlined enrollment through various channels, real-time benefit verifications for rapid treatment access, flexible affordability options including commercial copay assistance with patients paying as little as $0, and ongoing support services including patient welcome calls and prior authorization denial assistance.

This partnership represents Harrow's strategic focus on expanding its presence in the U.S. retina market and demonstrates the company's commitment to improving healthcare accessibility while driving better patient outcomes.

Harrow (HROW) has appointed Amir H. Shojaei, PharmD, PhD as Chief Scientific Officer (CSO). Dr. Shojaei brings 28 years of life sciences experience, specializing in clinical development, regulatory affairs, and commercialization of biopharmaceutical products. He previously served as CSO at AsclepiX Therapeutics and held executive roles at TherOptix , Novartis, and Shire Pharmaceuticals.

Notable achievements include his instrumental role in the FDA approval of Xiidra® at Shire Pharmaceuticals in 2013, the first product approved for both signs and symptoms of dry eye disease. Dr. Shojaei succeeds Dennis E. Saadeh, who is retiring after nearly a decade of service to Harrow.

OSRX expressed disappointment with the jury verdict in ImprimisRx v. OSRX trademark infringement case. The jury found OSRX and Ocular Science guilty of willful trademark infringement and unfair competition, awarding $34.9 million in damages. OSRX disputes ImprimisRx's claims about trademark ownership of pharmaceutical abbreviations like 'Pred,' 'moxi,' 'dex' and 'brom.' The company argues that these are generic terms in ophthalmology, citing a survey showing 70% of eye care professionals consider them generic. OSRX plans to challenge the verdict, with pending legal issues to be decided in December, including laches, unclean hands, and fraud on the USPTO.

Harrow (HROW) announced a favorable jury verdict in a trademark infringement case where its subsidiary ImprimisRx sued OSRX, Inc. and Ocular Science, Inc. The eight-person jury unanimously found the defendants guilty of willful trademark infringement and unfair competition, awarding $34.9 million in damages. The verdict includes $20.4 million in punitive damages and $14.5 million in actual damages. The case was tried in the United States District Court for the Southern District of California, where the jury validated ImprimisRx's trademark estate and found the defendants acted with malice, fraud, or oppression.

Melt Pharmaceuticals announced positive Phase 3 topline results for MELT-300, a non-IV, non-opioid sublingual tablet for procedural sedation during cataract surgery. The study, involving over 530 patients across 13 U.S. clinical sites, demonstrated MELT-300's statistical superiority over both sublingual midazolam (P=0.009) and placebo (P<0.001). The tablet combines midazolam (3mg) and ketamine (50mg), dissolving in 3 seconds using Catalent's Zydis® technology. Patients receiving midazolam alone required nearly twice the rescue sedation compared to MELT-300 (P=0.003), while MELT-300 showed a favorable safety profile comparable to placebo.

Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, has announced its participation in three upcoming investor conferences. The company will attend the Craig-Hallum 15th Annual Alpha Select Conference on November 19, 2024, the BTIG 4th Annual Ophthalmology Day on December 2, 2024, and the Piper Sandler 36th Annual Healthcare Conference from December 3-5, 2024.

Management will conduct one-on-one meetings at all conferences. A Fireside Chat is scheduled for December 4, 2024, at 8:00 a.m. ET during the Piper Sandler conference, which will be the only event featuring an audio webcast available on Harrow's website.

Harrow (HROW) reported strong Q3 2024 results with revenues increasing 44% year-over-year to $49.3 million. The company posted a GAAP net loss of $(4.2) million and Adjusted EBITDA of $8.8 million. Key highlights include a 55% increase in VEVYE prescriptions over Q2 2024, 15% growth in IHEEZO customer unit demand, and operating cash flow of $3 million. The company maintained strong cash position with $72.6 million in cash and equivalents. Despite Q3 seasonal challenges, management expects Q4 revenue to meaningfully exceed 2024 guidance, driven by positive demand trends for VEVYE, IHEEZO, and TRIESENCE products.