PHAR News & Events

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

Catch up on the weekend's top five stories with this list compiled by The Fly: 1) Ford (F) held discussions with Xiaomi (XIACF) over a partnership to help Chinese carmakers gain a foothold in the U.S., Demetri Sevastopulo, Christian Davies, Kana Inagaki, and Gloria Li of The Financial Times reports, citing four people familiar with the matter. During preliminary discussions, Ford explored forming a joint venture with Xiaomi to create EVs in the U.S., the sources added. Ford has also discussed with BYD (BYDDF) about a potential U.S. collaboration. 2) Oracle (ORCL) announced its full calendar year 2026 plan to fund the expansion of its Oracle Cloud Infrastructure business. Oracle is raising money in order to build additional capacity to meet the contracted demand from its largest Oracle Cloud Infrastructure customers. Oracle expects to raise $45 to $50 billion of gross cash proceeds during the 2026 calendar year. The company plans to achieve its funding objective by using a balanced combination of debt and equity financing to maintain a solid investment-grade balance sheet. 3) Pharming (PHAR) announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, to its supplemental New Drug Application, sNDA, for Joenja, an oral, selective phosphoinositide 3-kinase delta inhibitor, as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome, APDS, a rare primary immunodeficiency. The FDA raised an issue with the potential for underexposure in lower weight pediatric patients. As a result, the FDA has requested additional pediatric pharmacokinetic data to reassess the proposed pediatric doses and confirm that children in the lower weight dose groups can achieve exposure levels comparable to the approved adult and adolescent regimen. The letter also identified an issue with one of the analytical methods used for production batch testing, and the FDA requested additional data and clarification on this point. 4) Carlyle (CG) has started exploratory talks with UAE investors to bring in partners should its agreement to purchase Lukoil's international assets proceed, Shadia Nasralla and Anna Hirtenstein of Reuters reports, citing three sources with knowledge of the process. 5) Bain Capital (BCSF) has finalized plans to acquire FineToday in a deal set to be worth $1.29B, Reuters reports, citing Nikkei. CVC Capital Partners intends to divest all of FineToday's shares.

Pharming Group announced that the U.S. Food and Drug Administration, FDA, has issued a Complete Response Letter, CRL, to its supplemental New Drug Application, sNDA, for Joenja, an oral, selective phosphoinositide 3-kinase delta inhibitor, as a treatment for children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome, APDS, a rare primary immunodeficiency. The FDA raised an issue with the potential for underexposure in lower weight pediatric patients. As a result, the FDA has requested additional pediatric pharmacokinetic data to reassess the proposed pediatric doses and confirm that children in the lower weight dose groups can achieve exposure levels comparable to the approved adult and adolescent regimen. The letter also identified an issue with one of the analytical methods used for production batch testing, and the FDA requested additional data and clarification on this point.