Galderma Expands Relfydess Reach With China Approval For Frown Lines

Galderma Group (GDERF) said the EU approved Restylane Shaype, a hyaluronic acid injectable for temporary chin augmentation under the EU Medical Device Regulation. The company cited clinical results showing 83% improved structure at 3 months and 66% at 12 months. Galderma noted Restylane Shaype uses NASHA HD and that its stock closed at $228.55, up 3.91%.

Galderma said the U.S. FDA issued a Complete Response Letter for its BLA submission for relabotulinumtoxinA (Relfydess). The FDA cited manufacturing site inspection observations and requests to optimize analytical methods; Galderma said safety/efficacy sections had no deficiencies. Galderma plans corrective actions and continued FDA dialogue. GDERF shares closed at $238.05, up 12.95% Tuesday.

Ripple supported the SEC's proposed crypto regulation while seeking changes to how digital assets and investment contracts are treated. The company cited $150M in legal costs due to regulatory uncertainty. The OCC finalized GENIUS Act rules for stablecoin issuers, setting standards for reserves, risk management, and capital. Both developments could impact digital asset operations in the U.S.

Unicycive Therapeutics (UNCY) announced the FDA accepted its resubmitted NDA for oxylanthanum carbonate, setting a PDUFA date of Mar 25, 2027. The resubmission includes new CMC data from a third-party manufacturer. According to the company, this follows a previous CRL related to manufacturing issues, not efficacy.

The FDA approved GSK's Hibsago (bepirovirsen), a new chronic hepatitis B treatment that may allow some patients to stop therapy. It's used with existing antivirals in adults without cirrhosis. Clinical trials showed 19% of patients maintained viral control after stopping treatment. GSK expects peak sales over £2 billion. The drug was licensed from Ionis Pharmaceuticals.

Boeing received FAA certification for the 737 MAX 10, completing its MAX family lineup. The aircraft has 1,555 firm orders, including from United Airlines, Alaska Airlines, and Ryanair. Deliveries are expected to begin in early 2027. The MAX 10 competes with Airbus's A321neo in the high-capacity single-aisle segment.