Gold Ticks Lower, US Inflation Data in Spotlight

Sanofi (NASDAQ:SNY) said it withdrew its Europe regulatory application for Dupixent (dupilumab) to treat adults with moderate-to-severe bullous pemphigoid. The EMA cited unresolved efficacy issues, including failure to meet the primary trial endpoint and limited secondary results, concluding risks outweighed benefits. FDA approved the indication in June 2025. SNY was up 1.58% to $45.11.

Pfizer Korea’s RSV vaccine Abrysvo received MFDS marketing authorization on Aug. 13 for adults 60+ and high-risk adults 18-59. The article says this adds to competition with GSK’s Arexvy and Moderna’s mRESVIA. For infants, it contrasts maternal Abrysvo (MATISSE: 81.8% risk reduction to day 90) with Sanofi’s Beyfortus and MSD’s Enflonsia, and notes policy talks on NIP and reimbursement.

Biotech roundup reports multiple FDA and EU approvals: Replimune’s TUDRIQEV with Bristol Myers Squibb’s nivolumab for advanced melanoma, Takeda’s ORZEYFUL for narcolepsy type 1, Moderna’s mFLUSIVA flu vaccine for adults 50+, Sanofi’s MenQuadfi expanded EU use, and Novartis’ Pluvicto combo for PSMA+ mHSPC. It also covers Lisata layoffs, Emergent restructuring and Q2 results, and deals including Tarsus-Alkeus and Evotec-Odyssey.

Sanofi said the European Commission approved an expanded indication for its MenQuadfi (MenACWY) vaccine in the EU, extending use to infants from six weeks of age against invasive meningococcal disease from serogroups A, C, W and Y. The change follows a positive CHMP opinion on June 25, 2026, and is supported by the MET58 study and a 2+1 infant schedule.

Sanofi said Dupixent sales rose 37.6% to €5.154 billion, while vaccines sales fell 4.7% to €1.15 billion. Beyfortus sales increased 54.2% to €108 million. Adjusted EPS was €2.09 per share ($1.21 per ADS), above consensus. Sanofi raised Dupixent and 2026 sales outlook but warned second-half growth may moderate; SNY shares were down 5.65% to $42.31.

Sanofi shares fell 1.6% to €78.62 after the company’s Q2 2026 earnings. Sanofi reported revenue of €11.6B vs €11.2B consensus and raised full-year 2026 revenue growth to ~10% at constant FX. Vaccine sales missed (€1.15B vs €1.20B), and pipeline sentiment was pressured by abandoning global filings for amlitelimab. Macro caution also weighed.