Tag: approval

BEERSE, BELGIUM, June 13, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced results from the investigational Phase 3 MonumenTAL-3 study.¹ The results showed that TALVEY^® (talquetamab), a GPRC5D bispecific antibody, in combination with daratumumab with or without pomalidomide demonstrated significant reduction in the risk of disease progression or death of up to 72.0%, and clinically meaningful reduction of up to 53.0% in the risk of death, compared to the standard regimen of daratumumab, pomalidomide, and dexamethasone (DPd) in patients with relapsed or refractory multiple myeloma (RRMM).¹ Results showed a progression-free survival (PFS) rate of up to 81.3% versus standard of care (51.2%) and an overall survival (OS) rate of up to 89.2% versus standard of care (79.1%) at 24 months.¹  

DALLAS, June 12, 2026 (GLOBE NEWSWIRE) -- Arcadia Biosciences, Inc.^® (Nasdaq: RKDA), a producer and marketer of innovative wellness products, announced today the closing of its previously announced private placement priced at-the-market under Nasdaq rules for the purchase and sale of 3,883,496 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 preferred investment options to purchase up to an aggregate of 3,883,496 shares of common stock and Series A-2 preferred investment options to purchase up to an aggregate of 3,883,496 shares of common stock at a purchase price of $1.03 per share of common stock (or pre-funded warrant in lieu thereof) and associated preferred investment options.

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.

New vertical extends ROMA’s sustainable-finance mandate into energy-efficient, behind-the-meter-powered digital infrastructure; Company is evaluating a pipeline of distributed, sub-50 MW AI/HPC investment opportunities, subject to diligence, definitive documentation, and board approval.

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).

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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.