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Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it has entered into an agreement to acquire Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company pioneering non-opioid, non-IV therapies for sedation for medical procedures in the hospital, outpatient, and in-office settings. The closing of this acquisition is subject to customary closing conditions, including approval by Melt stockholders, excluding Harrow and Harrow-affiliated parties.
Melt's lead investigational therapy, MELT-300, is a patented, sublingually delivered formulation of a fixed dose of midazolam (3mg) and ketamine (50mg) designed to provide rapid, predictable sedation and analgesia without the need for intravenous administration. This innovative approach has the potential to transform patient experiences across a wide range of office-based and outpatient procedures and address the healthcare system's growing demand to reduce exposure to opioids.
In November 2024, Melt announced positive topline results from its pivotal LOUISE (Lower Opioid Use and Improve the Sedation Experience) Phase 3 Study, which demonstrated that MELT-300 was statistically superior to both sublingual midazolam alone (P=0.009) and placebo (P=<0.0001) in providing successful procedural sedation. In addition, the proportion of patients requiring rescue sedation was nearly twice as high for sublingual midazolam compared with MELT-300 (P=0.003).
The LOUISE Phase 3 Study was conducted under a Special Protocol Assessment ("SPA") agreement with the U.S. Food and Drug Administration ("FDA"), which confirmed the study design would adequately support a future regulatory submission. Further, results from a recently completed cardiac safety study indicated that MELT-300 did not alter normal heart rhythm, supporting the therapy's safety profile.
Harrow plans to submit a New Drug Application ("NDA") to the FDA in 2027, with a potential U.S. commercial launch in 2028.
Posted In: HROW
