Tag: trial

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.

LOS ANGELES, June 12, 2026 (GLOBE NEWSWIRE) -- The Law Offices of Frank R. Cruz reminds investors that class action lawsuits have been filed on behalf of shareholders of the following publicly-traded companies.  Investors have until the deadlines listed below to file a lead plaintiff motion.

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

FREMONT, Calif., June 12, 2026 (GLOBE NEWSWIRE) -- Dmitry Shubov Consulting, an advisory firm helping Southeast Asian startups scale into the U.S., is telling founders to watch out for what it calls the 2026 U.S. “pilot trap.” The warning stems from a recent LegalBooks article, “How to Structure Enterprise Pilots That Show Traction,” which highlighted why clear success metrics and a direct path to full adoption are so vital. Looking at this issue through a cross-border lens, Dmitry Shubov Consulting notes that many Southeast Asian startups can misread early U.S. pilot projects, software trials, or enterprise testing as a sign of market readiness. The trouble is, they are rarely prepared for the complex pricing, contracting, procurement, and rollout demands needed to turn that initial interest into a lasting commercial deal.

For many founders, getting a U.S. company to test a product feels like a major breakthrough. And in some ways, it is. But Dmitry Shubov Consulting says a pilot only matters if the company knows how to carry that momentum forward once the trial period ends.

“Too many founders see a pilot in the U.S. as proof that they’ve already gained real traction, when often it only shows that a company is willing to test something new,” said Dmitry Shubov, founder of Dmitry Shubov Consulting. “If there’s no clear plan for pricing, internal ownership, decision-makers, and what happens after the pilot ends, that momentum can fade very quickly.”

The firm says this is where many promising expansion efforts begin to lose steam. Startups may focus heavily on product performance during a pilot but spend too little time thinking through what comes next — who owns the budget, how success will be measured, what legal review may be required, and what would need to happen for the customer to move from a short-term test to a paid relationship.

Rather than treating a pilot as a simple sign that the product works, Dmitry Shubov Consulting says founders should look at it as the beginning of a much bigger business process. That means being clear on what success looks like, who inside the customer’s organization is actually making the decision, what issues might come up during legal or procurement review, and what needs to happen for the relationship to continue after the pilot wraps up. With funding still tight in 2026, the firm says startups cannot rely on early interest alone — they need to show they can follow through.

By raising this pressing issue now, Dmitry Shubov Consulting hopes to encourage founders to look at pilot activity more carefully and more strategically. Early U.S. interest can be valuable, but only if a startup is prepared to turn that opening into something lasting. Reach out to Dmitry Shubov Consulting for more information.