

FDA approved Novartis's Pluvicto for PSMA-positive metastatic hormone-sensitive prostate cancer, cutting progression or death risk 33%. "Having a radioligand therapy available at this stage meaningfully expands the options for physicians and represents real progress for patients," Michael Morris, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center and principal investigator of the study, said. The approval is based on the Phase III PSMAddition trial, which randomized more than 1,100 patients with PSMA-positive hormone-sensitive prostate cancer. At primary analysis, Pluvicto plus standard of care (an androgen receptor pathway inhibitor and androgen deprivation therapy) reduced the risk of progression or death by 28% (HR 0.72; 95% CI: 0.58-0.90) versus standard of care alone. An updated analysis showed a 33% reduction (HR 0.67; 95% CI: 0.55-0.82) with a positive overall survival trend (HR=0.80; 95% CI: 0.63-1.01). Grade 3 or higher adverse events occurred in 50.7% of Pluvicto-treated patients versus 43.0% in the standard-of-care arm. The approval extends Pluvicto across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the eligible patient population. More than 186,000 men are diagnosed with mHSPC globally each year, and about half progress to castration-resistant disease within 20 months. The PSMA biomarker is present in more than 80% of prostate cancer patients. Pluvicto is an intravenous radioligand therapy combining a targeting ligand with the therapeutic radionuclide lutetium-177. Once in the bloodstream, it binds to PSMA-expressing prostate cancer cells, delivering targeted radiation that disrupts replication and triggers cell death. The drug was previously approved for metastatic castration-resistant prostate cancer in both post-chemotherapy and pre-chemotherapy settings. "This approval signals a new era in the treatment of prostate cancer, representing a shift toward more targeted, early intervention," Gina Carithers, CEO and President of the Prostate Cancer Foundation, said. "This milestone redefines prostate cancer care, ensuring that from day one of their metastatic diagnosis, men have a precision option." The ARPI comparator arms in PSMAddition included Johnson & Johnson's Zytiga (abiraterone), Astellas/Pfizer's Xtandi (enzalutamide), Bayer's Nubeqa (darolutamide), and Johnson & Johnson's Erleada (apalutamide). Patients in both arms received a gonadotropin-releasing hormone agonist or antagonist or underwent bilateral orchiectomy. Novartis said it has five US radioligand therapy manufacturing sites operational or under construction, with delivery to treatment sites within five days. The company's patient support program offers insurance coverage assistance and financial aid options. Novartis is also investigating Pluvicto in oligometastatic prostate cancer (PSMA-DC trial, NCT05939414). The approval positions Pluvicto as a first-line precision option in mHSPC, expanding Novartis's radioligand therapy franchise beyond the castration-resistant setting. Investors will watch the final overall survival analysis from PSMAddition and commercial uptake in the newly approved earlier-stage indication. This article is for informational purposes only and does not constitute investment advice.

Rosen Law Firm opened a securities investigation into Alibaba Group Holding Ltd. after its shares fell 2.7 percent on June 24. The firm is preparing a class action seeking recovery of investor losses on behalf of shareholders who bought Alibaba securities, Rosen Law Firm said in a statement Thursday. The probe follows a June 24 Financial Times report that Anthropic accused the Chinese e-commerce giant of obtaining illicit access to its Claude AI model by creating fake accounts designed to access the model, which the American company does not offer to Chinese groups. Alibaba American Depositary Shares fell 2.7 percent on that news. Rosen Law Firm is investigating whether Alibaba issued materially misleading business information to the investing public. The allegations come as Alibaba competes directly with Anthropic and other US labs through its Qwen family of open-source models. The Hangzhou-based company has made AI a core growth driver, investing heavily in cloud and model development to counter slowing e-commerce growth. A finding that it misrepresented its business operations could weigh on investor confidence in that strategy and pressure the stock further, while also raising questions about how Chinese firms access frontier US models. Rosen Law Firm has recovered billions of dollars for investors and was ranked No. 1 by ISS Securities Class Action Services for the number of securities class action settlements in 2017, with a top-four ranking each year since 2013. In 2019 alone the firm secured more than $438 million for investors. The firm said it achieved the largest-ever securities class action settlement against a Chinese company. Shareholders who want to serve as lead plaintiff must file motions with the court within the window set by the court, while those who take no action can remain absent class members and still be eligible for any recovery. All representation is on a contingency fee basis, with shareholders paying no fees or expenses. The investigation adds to scrutiny of Chinese ADR-listed technology companies and could pressure BABA shares if the allegations are substantiated. Investors who purchased Alibaba securities may be eligible for compensation without out-of-pocket fees through a contingency arrangement; the firm is accepting inquiries via attorney Phillip Kim at 866-767-3653. The next catalyst is the court's scheduling of lead plaintiff motions, which will determine how the case proceeds. This article is for informational purposes only and does not constitute investment advice.

Federal Reserve Chairman Kevin Warsh floated cutting the central bank's policy meetings below the current eight per year, a structural shift that would reduce communication touchpoints for markets already adjusting to his pared-back guidance. "I believe the statute requires a minimum of four meetings, but four is not enough," Warsh said at his Senate confirmation hearing in April, before he took the helm of the Fed in May. Warsh raised the proposal to change the frequency of rate-setting meetings at this week's gathering of the Federal Open Market Committee, the New York Times reported Friday. A Fed spokesperson declined to comment. The committee voted 9-3 on Wednesday to hold interest rates steady during Warsh's second meeting presiding over the panel — a widely expected decision that drew investor criticism when Warsh declined to explain the outcome or commit to raising rates should inflation fail to slow. Reducing the number of meetings would mark one of the most significant operational changes at the US central bank in decades. With fewer scheduled decision points, each remaining meeting would carry outsized weight for rate expectations across equities, bonds, and other rate-sensitive assets. A decision on the revised calendar could come before the Fed's next scheduled meeting in mid-September, according to officials familiar with the discussions. ## Five Task Forces, Fewer Press Conferences Warsh's proposal is part of a broader push to reshape how the Fed conducts monetary policy. He has said he intends to reduce the number of press conferences he holds after policy decisions, and he announced the creation of five internal task forces to review areas ranging from communications strategy to data analytics and balance sheet management. The task forces represent the most extensive internal review of Fed operations in years, touching on nearly every aspect of how the central bank formulates and communicates policy. The current schedule has the Fed convening eight times per year for two-day gatherings, after which policymakers announce their rate decision. Under the FOMC's rules of procedure, the committee meets at least four times a year in Washington. The Fed has already scheduled its meetings for the remainder of 2026 — with gatherings set for September, October and December — and for 2027, though each date is tentative until confirmed at the meeting immediately preceding it. Any change to the meeting calendar would require the FOMC to amend its rules of procedure, a process that would likely involve formal notice and deliberation. ## Fewer Decision Points, Higher Stakes For financial markets, a reduction in meeting frequency would alter how rate expectations are priced. With fewer scheduled opportunities for the Fed to adjust policy or communicate its outlook, each remaining decision date would carry greater weight, potentially increasing volatility around those events. Traders who currently position across eight decision points per year would need to concentrate their risk management around a smaller number of dates, increasing the market impact of each individual meeting. The proposal comes at a moment when investors have criticized Warsh's attempt to limit guidance to markets on the direction of interest rates. At this week's meeting, Warsh declined to explain the rate decision or say whether he would support raising rates should inflation fail to slow, leaving markets without a clear forward path. This approach marks a departure from the communication style of recent Fed chairs, who used press conferences and forward guidance to anchor market expectations. The combination of fewer meetings and less forward guidance would represent a fundamental shift in how the Fed manages market expectations. The Fed faces mounting pressure to do more to curb inflation, and the 9-3 vote to hold rates steady reflects internal divisions over the appropriate policy stance. Reducing the frequency of meetings would give policymakers fewer opportunities to recalibrate, making each decision more consequential. If inflation remains elevated and the Fed meets less often, the gap between policy adjustments could widen, potentially forcing larger moves at each meeting. This dynamic could be particularly challenging for rate-sensitive sectors such as housing and financials, which depend on predictable policy signals. If the revised calendar is adopted, the change would likely take effect in 2027 or later, given that the Fed has already scheduled its meetings for the remainder of 2026. The next scheduled FOMC gathering is set for mid-September, when officials could provide further clarity on the proposed changes. Market participants will be watching closely for any administrative guidance on the timeline for implementation. This article is for informational purposes only and does not constitute investment advice.