Tag: therapy

Media Release

COPENHAGEN, Denmark; June 13, 2026

 -- 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 --

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  

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.

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).

FREDERICK, Md., June 12, 2026 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a late clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced the granting of an inducement award to one new employee. On June 8, 2026, the Company issued to this employee an option to purchase an aggregate of 6,100 shares of the Company’s common stock with an exercise price of $5.86, the closing trading price of the Company’s common stock on the Nasdaq Global Market on the date of grant. The option was granted pursuant to the Company’s Amended and Restated 2018 Employment Inducement Incentive Award Plan and was approved by the Company’s board of directors. The option vests as to 25% on June 8, 2027, and then in thirty-six substantially equal monthly installments thereafter such that the option will be fully vested on June 8, 2030. The option has a ten-year term. The option was granted under Rule 5635(c)(4) of the Nasdaq Listing Rules as an inducement material to the employee’s entry into employment with the Company.