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INVERSAGO PHARMA: Receives Rare Pediatric Disease Designation from the FDA for INV-101 for the Treatment of Prader-Willi Syndrome

Inversago Pharma Inc. (“the Company” or “Inversago”), the peripheral CB1 blockade company, today announced the U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease (RPD) designation to the Company’s lead compound, INV-101, for the treatment of Prader-Willi syndrome (PWS).

GEMINI THERAPEUTICS: Announces FDA Fast Track Designation Granted for GEM103 for the Treatment of Dry Age-Related Macular Degeneration (AMD) in Patients With Complement Factor H (CFH) Loss of Function Gene Variants

Gemini Therapeutics, a clinical stage precision medicine company developing innovative treatments for genetically defined age-related macular degeneration (AMD), announced that GEM103, the Company’s investigational treatment for dry AMD, has been granted Fast Track designation by the United States Food and Drug Administration (FDA).

MEDICURE: Announces Pivotal Phase 3 Trial IND Filing with FDA for Treatment of Seizures Associated with Pyridox(am)ine 5'-phosphate oxidase (PNPO) Deficiency

Medicure Inc. ("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a cardiovascular pharmaceutical company, today announced that through its Barbados subsidiary, Medicure International Inc., it intends to file an Investigational New Drug ("IND") application with the U.S. Food and Drug Administration ("FDA") pertaining to its legacy product Pyridoxal 5′-phosphate ("P5P", also referred to as "MC-1") for the treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase ("PNPO") deficiency.

UNION THERAPEUTICS A/S: Receives FDA Approval for Ind of Oral Next Generation Pde4-inhibitor (Orismilast) for Investigation in Plaque Psoriasis

Orismilast is a next generation oral PDE4-inhibitor with an improved therapeutic window compared to other PDE4-inhibitors

REDHILL BIOPHARMA: RHB-204 Granted FDA Fast Track Designation for NTM Disease

U.S. Phase 3 study underway to evaluate RHB-204 as a first-line, stand-alone, oral treatment for pulmonary NTM disease - a rare condition with no FDA-approved first-line therapy

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