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A Run of FDA Target Dates Fills the Biotech Calendar From Late November to Year End

  • Five biotech companies have FDA PDUFA target action dates scheduled between November 27 and December 27, 2026.
  • BridgeBio Pharma (NASDAQ: BBIO) has a November 27, 2026 PDUFA date for BBP-418 to treat limb-girdle muscular dystrophy type 2I/R9.
  • Vertex Pharmaceuticals (NASDAQ: VRTX) has a November 30, 2026 PDUFA date for povetacicept to treat IgA nephropathy.
  • Gilead Sciences (NASDAQ: GILD) has a December 23, 2026 PDUFA date for anitocabtagene autoleucel to treat relapsed or refractory multiple myeloma.
  • Viatris Inc. (NASDAQ: VTRS) has a December 27, 2026 PDUFA date for MR-107A-02 to treat moderate-to-severe acute pain.
  • Praxis Precision Medicines (NASDAQ: PRAX) has a December 27, 2026 PDUFA date for relutrigine to treat SCN2A and SCN8A developmental and epileptic encephalopathies.
  • BridgeBio, Vertex, Gilead, Viatris, and Praxis all reported third-quarter 2026 financial results or pipeline updates between October 29 and November 9.
  • BridgeBio reported $353.2 million in Q3 2026 revenue, primarily from acoramidis sales.
  • Vertex raised its full-year 2026 revenue guidance to $13.15 billion–$13.25 billion after acquiring Crinetics Pharmaceuticals in September.
  • Gilead raised its full-year 2026 product sales guidance to $31.0 billion–$31.3 billion after receiving FDA approval for Bixlenvo.
  • Viatris reported flat Q3 2026 revenue of $3.75 billion, raised its 2026 financial guidance, and expects to close its Pacira BioSciences acquisition by late November.
  • Praxis reported $1.3 billion in cash and investments as of September 30, 2026, with top-line EMERALD study results expected in Q4 2026.
  • Additional PDUFA dates for other candidates include February 4, 2027 for BridgeBio, May 8, 2027 for BridgeBio, and January 29, 2027 for Praxis.
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