Clene Eyes Q4 NDA for ALS Drug After FDA-Requested Biomarker Analyses

Clene Inc. (CLNN) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 ex_967804.htm EXHIBIT 99.1 ex_967804.htm Exhibit 99.1 CLENE REPORTS Second QUARTER 2026 FINANCIAL RESULTS AND RECENT OPERATING HIGHLIGHTS ● Clene expects to submit a New Drug Application for CNM-Au8 ® in ALS under the accelerated approval pathway in early fourth quarter

Taiwan indicted nine people, including an Nvidia manager, for illegally exporting 130 AI servers to China. Prosecutors allege the Nvidia employee certified a fraudulent inspection. Nvidia and Super Micro, whose products were involved, are cooperating with the investigation. The B300 servers are restricted for export to China due to their dual-use capabilities. The scheme involved fake documentation and routing through intermediaries, with proceeds totaling approximately $21.2 million. (350 chara

Ultragenyx Pharmaceutical's Genglycos, a gene therapy for glycogen storage disease type Ia, received FDA accelerated approval on August 19, 2026. Approval was based on reduced cornstarch intake, not hypoglycemia prevention. The therapy showed a 3% increase in hypoglycemic readings. Safety concerns include immune-mediated liver enzyme elevations and adrenal insufficiency. The company's ticker is RARE.

The FDA approved Johnson & Johnson's drug Imaavy for treating warm autoimmune hemolytic anemia in patients aged 12+. The approval covers those treated with steroids and is based on a study showing improved hemoglobin levels. Imaavy blocks harmful antibodies and is infused every four weeks. Common side effects include swelling, diarrhea, and fever. According to the company, the drug offers important advances for patients.

The SEC has subpoenaed Goldman Sachs, JPMorgan, Citigroup, and Bank of America regarding their ties to AI hedge fund Situational Awareness, which faced losses in July. The regulator seeks details on the fund's trades and communications with the banks, per the New York Times.

The SEC subpoenaed major banks, including Goldman Sachs, JPMorgan Chase, Citigroup, and Bank of America, for information on their dealings with the AI-focused hedge fund Situational Awareness, which nearly collapsed in July. The fund, which managed $45 billion at its peak, lost $35 billion after margin calls. Its portfolio was heavily concentrated in AI infrastructure stocks like Sandisk and Micron. Citadel purchased the fund's portfolio at a discount and has since unwound most of the risk.