Clene Inc. announced it will submit a New Drug Application (NDA) for its ALS treatment CNM-Au8 to the FDA in the third quarter of 2026 under the accelerated approval pathway. The FDA indicated that biomarker data on neurofilament light (NfL) may support this submission, recognizing NfL as a potential surrogate endpoint predicting clinical benefits. This marks a significant step for CNM-Au8, a first-in-class therapy addressing a critical unmet need in ALS treatment. Clene is also preparing to start a Phase 3 confirmatory trial in early 2027, continuing its efforts to bring this therapy to patients urgently needing new options.
BlackRock, Inc. has reported that its direct and indirect ownership in Orion Oyj has dropped below the 5% threshold as of June 15, 2026. This change requires a formal disclosure under Finnish securities law. The reduction in BlackRock's stake may aff...
On June 15, 2026, BlackRock, Inc. and its funds reduced their total holdings in Orion Corporation to below 5% of the company's shares and voting rights. This change was disclosed under the Finnish Securities Market Act, indicating a decrease from a p...
US stock futures showed mixed results with the S&P 500 slightly down while the Dow Jones and Nasdaq 100 edged higher following a recent rally. The market reacted to a preliminary US-Iran agreement aimed at extending a ceasefire and reopening the Stra...
MindWalk Holdings Corp. emphasizes the importance of a connected, trustworthy biological data layer over AI model size in drug discovery. The company launched ReefIQ™, a biological context layer, and LensAI™, a reasoning platform, aiming to reduce co...
Space Exploration Technologies Corp. (SpaceX) saw its shares surge over 11% in premarket trading, pushing its market capitalization close to $3 trillion, surpassing Amazon to become the fifth-largest company globally. This rapid valuation increase ha...
