Moderna (MRNA) announces US FDA will initiate review of its investigational seasonal influenza vaccine submission; FDA assigned a prescription drug user fee act goal date of August 5th, 2026
Newsquawk Staff ·
Moderna (MRNA) announces US FDA will initiate review of its investigational seasonal influenza vaccine submission; FDA assigned a prescription drug user fee act goal date of August 5th, 2026.
What it means
Moderna's FDA submission review for its seasonal influenza vaccine is a notable development in the biotechnology space, indicating progress in diversifying its vaccine portfolio. With a PDUFA goal date set for August 5, 2026, investors should monitor not just the approval process but also how this aligns with the company's overall strategic direction and revenue potential in a competitive market.
- US EQUITY OPEN: Indices rangebound ahead of FOMC and major earnings
- Verisk (VRSK) integrates insurance intelligence with Amazon (AMZN) and Microsoft (MSFT) AI platforms
- Senior US Treasury trade official Eric Ettorre will leave to join Netflix (NFLX), reports Axios
- Daily US Conference Calendar - 28th October 2026: JNJ, BA, CAT
- Biogen Inc. (BIIB) Q3 2026 (USD): Adj. EPS 2.62 (exp. 1.98), Revenue 2.8bln (exp. 2.63bln). Raises lower end of FY26 diluted EPS guidance to USD 12.20-13.00 (exp. 12.23, prev. 12.00-13.00)
Related headlines
- T-Mobile (TMUS) CEO to step down from the board2 hours ago
- US PRE-MARKET MOVERS: SKHY, NXPI, ENPH, APH, GOOGL, HOOD, PPG, VRT, GEV, GEHC, BSX, ETSY, WEN, V2 hours ago
- US Broker Moves: ENPH and DYN downgraded at Oppenheimer; FFIV downgraded at Piper Sandler3 hours ago
- GE Healthcare Technologies Inc. (GEHC) Q3 (USD): Adj. EPS 1.34 (exp. 1.20), Revenue 5.5bln (exp. 5.35bln), Adj. EBIT 913mln (exp. 838.8mln)4 hours ago
- Apple (AAPL) is set to unveil 14‑inch and 16‑inch touch MacBooks on Wednesday and discussed charging USD 2,899 for the new 14-inch touch Mac, while touch-screen Macs will be its priciest laptops17 hours ago
- Baker Hughes (BKR) Q3 (USD) EPS 0.70 (exp. 0.64), rev. 8.03bln (exp. 7.78bln)18 hours ago
- Major US technology company selects Baker Hughes’ (BKR) power generation and cooling solutions to scale high-density AI compute18 hours ago
- Canada's Competition Bureau says proposed arrangements between Air Canada and United Airlines (UAL) would lead to higher prices, with the Transport Minister set to review the findings of its investigation46 min ago
- JPMorgan Chase (JPM) reportedly faces an additional GBP 100-150mln tax bill following the UK government's decision to double the corporation tax surcharge on banks, potentially jeopardising plans for its new London headquarters, Sky News reports48 min ago
- Amphenol (APH) Q3 2026 (USD): Adj. EPS 0.80 (exp. 0.73), Sales 10.2bln (exp. 9.49bln)3 hours ago
- GE Vernova (GEV) expects USD 50-100mln of annual cost synergies from Trench by 2030, according to the conference call3 hours ago
- Etsy Inc. (ETSY) Q3 2026 (USD): EPS 1.00 (exp. 0.77), Revenue 692mln (exp. 668mln)4 hours ago
- Etsy (ETSY) CFO Baker is to leave on March 1st 2027, will remain an advisor through July 1st 20274 hours ago
- Garmin Ltd. (GRMN) Q3 2026 (USD): Adj. EPS 2.76 (exp. 2.41), Revenue 1.99bln (exp. 1.99bln)4 hours ago
- Phillips 66 (PSX) Q3 2026 (USD): Adj. EPS 14.08 (exp. 11.73)4 hours ago