BMRNEarningsAnnounced
BioMarin: Q3 earnings & rare-disease sales
Q3 results and guidance for BioMarin’s rare-disease portfolio. Watch product sales, profitability and operating cash flow.
BioMarin announces November 2 earningsCatalyst calendar
The next decision. The next data release. The companies exposed.
Sponsor targetAnnounced eventTargets can move. Study-completion estimates live in Study windows.
AMGNEarningsAnnounced
Amgen: Q3 earnings & pipeline update
Q3 results, guidance and pipeline commentary. Watch reported earnings, key product sales and changes to the clinical outlook.
Amgen announces November 3 earningsUTHREarningsAnnounced
United Therapeutics: Q3 earnings & TYVASO sales
Q3 results with TYVASO franchise sales in focus. Compare the reported release with prior sales, guidance and company commentary.
United Therapeutics announces November 4 earningsCYTKFDA decisionTarget date
Aficamten: MAPLE-HCM supplemental FDA decision
The FDA accepted the MAPLE-HCM supplemental application for aficamten, with a November 14, 2026 target. This concerns an additional label supported by MAPLE-HCM, not initial approval of MYQORZO and not the separate ACACIA-HCM non-obstructive program.
Cytokinetics · MAPLE-HCM sNDA acceptanceCAPRFDA decisionTarget date
Deramiocel: DMD upper-limb FDA decision
Capricor reconfirmed a November 22, 2026 FDA target in its October HOPE-3 extension update. A major amendment moved the review from August 22. The proposed indication focuses on upper limb function in Duchenne muscular dystrophy; the actual label scope matters.
Capricor · review extensionSVRAFDA decisionTarget date
Molgramostim: autoimmune PAP FDA decision
Savara lists November 22, 2026 for the MOLBREEVI BLA after a three-month extension. Its August business update confirms the target; October materials still describe molgramostim as investigational. FDA approval is separate from EMA/MHRA reviews and presentation of IMPALA analyses.
Savara · review extensionBBIOFDA decisionTarget date
BBP-418: LGMD2I/R9 FDA decision
BridgeBio reports BBP-418 under FDA priority review for LGMD2I/R9, with a November 27, 2026 target, reconfirmed in its October FORTIFY update. The regulatory event is separate from already reported clinical and exploratory cardiac findings.
BridgeBio · October target confirmation and FORTIFY contextCOGTFDA decisionTarget date
Bezuclastinib: GIST FDA decision
Cogent states that its GIST NDA is under review with a November 30, 2026 target. Its September update explicitly separates this application from nonadvanced systemic mastocytosis on December 30 and advanced systemic mastocytosis on June 29, 2027.
Cogent · September update distinguishes all three applicationsVRTXFDA decisionTarget date
Povetacicept: IgAN accelerated-approval decision
Vertex confirmed November 30, 2026 as the FDA target for potential accelerated approval of povetacicept in adult IgAN in its October RAINIER update. This is the IgAN BLA, not a primary membranous nephropathy application or a question about already published interim trial success.
Vertex · BLA acceptance and exact indicationLooking beyond the calendar? Follow public and private biotech milestones before a date is announced.
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