Tag: Regulatory

SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio^®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 53,000 people in the U.S. alone, and there are currently no approved treatment options for the disease.

MONTREAL, June 12, 2026 (GLOBE NEWSWIRE) -- Prime Drink Group Corp. (CSE: PRME) (“Prime” or the “Company”) announces that it is proceeding with a non-brokered private placement offering of units of the Company (the “Units”) to raise minimum gross proceeds of $1,200,000 and maximum gross proceeds of $2,200,000 (the “Unit Offering”).

NEWTOWN, Pa., June 12, 2026 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW, the Company), a clinical-stage biopharmaceutical company developing novel therapies for critical global viral threats, today announced that the planned test of tivoxavir marboxil (TXM) in a Phase 2a human influenza challenge study has been deferred due to a negative review of the program by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA).