Tag: candidates

 -- Patients with PWS treated with setmelanotide therapy (N=17) achieved clinically meaningful BMI or BMI z-score reductions, reductions in fat mass with preservation of lean mass, and improvements in hyperphagia and anxiety measures --   

-- Positive results reinforce rationale for Phase 3 development of MC4R agonism in PWS --

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.

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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).

CALGARY, Alberta, June 12, 2026 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease, announces that the Company has elected to voluntarily delist its common shares from the TSX Venture Exchange (“TSXV”). The Company will provide additional information on timing for the completion of the delisting of its common shares in a separate press release.

TAIPEI, Taiwan, June 12, 2026 (GLOBE NEWSWIRE) -- SL BIO Ltd. (“SL Bio” or the “Company”), a Taiwan-headquartered biomedical company specializing in developing innovative cellular and gene therapies, today announced the closing of its previously announced business combination with Horizon Space Acquisition II Corp. (Nasdaq: HSPT) (“Horizon Space”), a publicly traded special purpose acquisition company.

CINCINNATI, June 12, 2026 (GLOBE NEWSWIRE) -- The Jared Kamrass Scholarship for Public Service today announces its 2027 award cycle, inviting undergraduate students across the United States to apply for a one-time $1,000 scholarship. The initiative, created by political strategist and public service advocate Jared Kamrass, seeks to support young leaders who demonstrate a deep commitment to community impact and civic leadership.

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Responder rate of 57% at one year in open-label extension (OLE) comparable to 63% at 12 weeks in Phase 2 Avail™ trial

COPENHAGEN, Denmark, June 12, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, has been awarded the 2026 Prix Galien UK Award for Best digital health solution for AI-Immunology™.