PHAR News & Events

Pharming Group earlier announced that Japan's Ministry of Health, Labour and Welfare has approved Joenja, an oral, selective phosphoinositide 3-kinase delta inhibitor, for the treatment of activated PI3K delta syndrome in adult and pediatric patients aged 4 years and older. "With this approval, Joenja becomes the first treatment approved in Japan specifically for APDS and the first approved treatment anywhere globally, for children aged 4 to 11 with the disease. Under an agreement with Pharming, OrphanPacific, Inc. serves as the Marketing Authorization Holder for Joenja in Japan and in collaboration with Pharming, is responsible for supply and distribution of the product. The launch of Joenja is expected following agreement with the MHLW on its National Health Insurance drug price," the company stated.

Stock futures are weaker in pre-market action, pressured by a dramatic reversal in precious metals, triggering broader selling across risk assets as leveraged positions and safe-haven bets unwind. U.S. markets are starting the week on a soft and unsettled note as investors grapple with lingering volatility and a sharp unwind in previously crowded trades.  That metals selloff has bled into equities, with tech stocks in particular showing pressure amid renewed uncertainty around the trajectory of AI demand and monetary policy expectations. This mood has been reinforced by unease over the nomination of Kevin Warsh as the next Federal Reserve chair, with markets recalibrating around how a more hawkish or independent Fed could influence rates and liquidity.The broader backdrop of trading reflects elevated nervousness ahead of a busy week of data and earnings. Key economic releases like the ISM manufacturing index and upcoming U.S. jobs figures are on traders' radar, and central bank decisions in Europe, Australia and the U.K. are also in focus. Cryptocurrencies have also slumped along with broader risk assets, further highlighting the risk-off tone.In pre-market trading, S&P 500 fell 0.43%, Nasdaq futures fell 0.71% and Dow futures rose 0.05%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Oracleup 4% after announcing that it expects to raise $45B to $50B of gross cash proceeds during the 2026 calendar yearUP AFTER EARNINGS -Twist Bioscienceup 7%Napco Securityup 5%Tyson Foodsup 1%DOWN AFTER EARNINGS -Disneydown 2%Revvitydown 2%Aptivdown 1%LOWER -Pharmingdown 16% after the FDA raised an issue with the potential for underexposure in lower weight pediatric patient in a complete response letter to its supplemental new drug application for JoenjaStrategydown 7% after bitcoin fell below $80,000Coterra Energyand Devon Energydown 4% and 3%, respectively, after the companies announced the signing of a definitive agreement to merge in an all-stock transaction