Brazil's government said on Friday that Vietnam has been formally admitted as a "partner country" of the BRICS group of major emerging economies.
Friday, June 13, 2025
UroGen’s Bladder Cancer Drug Wins FDA Approval Over Adcomm’s Objections
The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.
Despite failing to secure the backing of an external panel of advisors, UroGen won the FDA’s approval on Thursday for its intravesical drug mitomycin for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer. UroGen will market the drug under the brand name Zusduri.
Zusduri is the first FDA-approved therapy for this indication and is meant for use in adults with recurrent disease, according to UroGen’s announcement. The drug, which is administered via a catheter directly into the bladder in an out-patient procedure, will be available “on or around” July 1.
UroGen was up nearly 52% when markets closed on Thursday. Zusduri is the company’s second commercial product, following the low-grade upper tract urothelial cancer drug Jelmyto, which was approved in April 2020.
The Phase III ENVISION study, which is still ongoing, supported the regulatory decision with a 79.6% complete response rate at 3 months. The single-arm pivotal trial documented an 80.6% duration of response at 18 months, according to the latest data, released in April.
Despite the promising data, Zusduri’s approval comes as a bit of a surprise, given that the FDA’s Oncologic Drugs Advisory Committee last month recommended against the drug—though only narrowly so. With a 5–4 split, the independent panel of experts pointed to several issues with UroGen’s application package, including the lack of a completely randomized study and the short follow-up in ENVISION.
Perhaps to address these concerns, UroGen has come to a post-marketing commitment agreement with the FDA, the company said in its announcement. UroGen will see the ENVISION trial through to completion “to further characterize the clinical benefit of Zusduri.” The company will also provide the FDA with yearly updates regarding the drug’s duration of response for all treated patients with ongoing complete responses.
On a more sour note, the New York-based Gross Law Firm on Thursday issued a reminder to UroGen shareholders that if they purchased company stock from July 27, 2023 to May 15, 2025 they are eligible to join a class-action lawsuit, which alleges that during that period, UroGen “issued materially false and/or misleading statements” regarding ENVISION.
The lawsuit claims that UroGen did not make it clear to investors that ENVISION “was not designed to demonstrate substantial evidence of effectiveness” of Zusduri and that, as a result, the company “would have difficulty demonstrating that the duration of response endpoint was attributable” to the drug. The company also “failed to heed the FDA’s warning about the study design,” as per the complaint.
The oversight, the lawsuit contends, exposed the company and its shareholder to “substantial risk” that Zusduri would not get approved.
https://www.biospace.com/fda/urogens-bladder-cancer-drug-wins-fda-approval-over-adcomms-objections
Visa, Mastercard stocks fall after stablecoin report
Visa (NYSE:V) stock fell 5.4%, Mastercard (NYSE:MA) dropped 4.6%, and American Express (NYSE:AXP) declined 2% after a Wall Street Journal report revealed major retailers are exploring stablecoin options to bypass traditional card payment fees. Other payment processors also suffered, with Capital One (NYSE:COF) down 3%, PayPal (NASDAQ:PYPL) falling 2.6%, and Block dropping 2.4%.
According to the report, retail giants including Walmart (NYSE:WMT) and Amazon.com (NASDAQ:AMZN) have recently explored issuing their own stablecoins in the U.S., a move that could potentially save them billions in transaction fees by shifting payment processing outside the traditional financial system. Expedia (NASDAQ:EXPE) Group and several major airlines have reportedly engaged in similar discussions.
Stablecoins, which maintain a one-to-one exchange ratio with government currencies and are backed by cash reserves or cash-like assets such as Treasury securities, are currently primarily used for cryptocurrency transactions. However, their potential application in everyday retail transactions poses a significant threat to established payment networks.
The retailers’ final decisions reportedly hinge on the Genius Act, pending legislation that would establish a regulatory framework for stablecoins. While the bill has cleared a procedural hurdle, it still requires approval from both the Senate and House.
The potential entry of major retailers into the payment processing space with their own digital currencies could significantly disrupt the business model of traditional payment networks, which generate substantial revenue from transaction fees charged to merchants.
https://finance.yahoo.com/news/visa-mastercard-stocks-fall-stablecoin-143514621.html
OpenAI to maintain Scale AI partnership despite Meta’s stake
OpenAI will continue its working relationship with Scale AI even after Meta (NASDAQ:META) acquired a 49% stake in the artificial intelligence startup for $14.8 billion on Friday, according to OpenAI’s CFO Sarah Friar.
Speaking at the VivaTech conference in Paris, Friar emphasized the importance of maintaining collaboration within the AI ecosystem despite ownership changes.
"We don’t want to ice the ecosystem because acquisitions are going to happen," Friar said. "And if we ice each other out, I think we’re actually going to slow the pace of innovation."
Scale AI provides essential services for AI development, specializing in labeled and curated training data that is critical for sophisticated AI tools like OpenAI’s ChatGPT.
GSK Seeks EMA Approval to Broaden Use of RSV Vaccine
GSK (GSK, Financial) has submitted an application to the European Medicines Agency (EMA) to extend the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, to adults aged 18 years and older. Initially, Arexvy was the first vaccine approved in the European Economic Area for preventing lower respiratory tract disease caused by RSV in individuals 60 years and older, as well as those aged 50-59 at higher risk. The EMA is expected to make a decision on this proposal in the first half of 2026. In addition to Europe, GSK is actively pursuing regulatory approval for expanded indications of its RSV vaccine in markets such as the US and Japan.
Bausch Health ticks higher following large director stock purchase
Bausch Health shares rise ~5% as director John Paulson purchases ~$15M worth of stock.
Tiziana Expands Phase 2 of Foralumab at Weill Cornell Multiple Sclerosis Center
Tiziana Life Sciences (NASDAQ: TLSA) has expanded its Phase 2 clinical trial of intranasal foralumab by initiating patient dosing at Weill Cornell Multiple Sclerosis Center, marking the fifth site in their study. The trial evaluates foralumab, a first-in-class fully human anti-CD3 monoclonal antibody, in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This site joins existing locations at Yale University, Johns Hopkins University, Brigham and Women's Hospital, and the University of Massachusetts. The study includes a six-month open-label extension phase following the blinded phase, allowing all participants to receive foralumab. The treatment's innovative intranasal delivery method aims to engage regulatory T cells and promote immune tolerance while minimizing systemic immune suppression.
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