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Research candidates, not listed markets or live prices. Undated records are monitors, not a promise of an upcoming event. Candidate questions require final rules before trading.
Q3 results and guidance for BioMarin’s rare-disease portfolio. Watch product sales, profitability and operating cash flow.
Q3 results, guidance and pipeline commentary. Watch reported earnings, key product sales and changes to the clinical outlook.
Q3 results with TYVASO franchise sales in focus. Compare the reported release with prior sales, guidance and company commentary.
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.
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.
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.
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.
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.
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.
Exelixis reconfirmed March 3, 2027 for FDA review of zanzalintinib plus atezolizumab in previously treated metastatic colorectal cancer in its October 29 update. A September extension superseded December 3, 2026 after additional safety and efficacy data were submitted.
HAELO met its primary endpoint in April 2026; that trial-success question is already answered. The pending next catalyst is the FDA BLA review of lonvoguran ziclumeran (lonvo-z), with priority review and a March 10, 2027 target confirmed in the September acceptance filing.
Axsome announced FDA acceptance of the AXS-12 NDA for cataplexy in narcolepsy with a May 1, 2027 target. Its August SEC-filed update retains that target. This is reboxetine, distinct from AUVELITY and from AXS-14 in fibromyalgia.
AbbVie’s October 30 outlook raises adjusted diluted EPS to $13.95–$13.99, including year-to-date acquired-IPR&D and milestone expense. Future charges can still affect delivery.
ADRX-0405 is a STEAP1-directed ADC in Phase 1a/b trial NCT06710379. The company’s June 2026 update targets Phase 1a completion in Q4 2026.
Adcentrx reported initial dose-escalation data for its Nectin-4 ADC ADRX-0706 in 2025. Expansion-cohort results would provide different clinical evidence from that earlier presentation.
Adcytherix dosed the first ADCX-020 participant in March 2026. Its first-in-human ADC study includes escalation followed by dose optimization and selected expansion cohorts.
AIRNA says AIR-001 was in the clinic by June 2026. The RNA-editing candidate is designed to repair the disease-driving AATD variant and restore functional alpha-1 antitrypsin.
CSL agreed to fund RENAL completion and a planned Phase 3 AAV-RPGN trial. A later pivotal first dose would be distinct from the already signed collaboration.
CSL’s October 2026 partnership identifies lixudebart, formerly ALE.F02, in the ongoing RENAL Phase 2 AAV-RPGN study. Claudin-1 targeting is intended to address inflammatory/fibrotic kidney injury.
Alnylam’s Q3 release gives net product revenue guidance of $4.7B–$5.1B. Collaborations and royalties are guided separately and must stay outside this measure.
Alnylam guides TTR net product revenue to $4.2B–$4.5B for AMVUTTRA and ONPATTRO. The franchise question excludes GIVLAARI, OXLUMO and collaboration income.
The sponsor started PERFORMA in August 2026 and anticipates 52-week data in 2029. Histology findings and the longer-term clinical-outcomes endpoint must not be conflated. pemvidutide — phase 3 study in Metabolic Dysfunction-Associated Steatohepatitis (MASH). NCT07795164 lists Clinical Outcome Event as a primary outcome (Baseline through end of study (approximately Month 60)). Registry status: recruiting.
Amgen identifies MARITIME-CV as enrolling in its 2026 update. Cardiovascular outcome success is distinct from previously reported weight-loss results. maridebart cafraglutide — phase 3 study in Atherosclerotic Cardiovascular Disease, Overweight, Obesity. NCT07037433 lists Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE]) as a primary outcome (Up to approximately 35 months). Registry status: active not recruiting.
The sponsor continues the Phase 3 cardiovascular outcomes program. Lp(a)-lowering biomarker results are not proof of benefit on its coronary event endpoint. olpasiran — phase 3 study in Atherosclerotic Cardiovascular Disease. NCT05581303 measures Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first (Approximately 5 years). Registry status: active not recruiting.
ABO-101 uses LNP-delivered Cas12i2 editing to disrupt hepatic HAO1 in primary hyperoxaluria type 1. The Phase 1/2 redePHine study is identified as NCT06839235.
Arbor lists ABO-201 for C9ORF-related ALS and FTD using AAV-delivered nuclease excision. Its financing announcement funds progression of CNS programs toward IND/CTA filings.
Arbor identifies ABO-202 as an AAV-delivered nuclease-excision program for STMN2-related ALS. It is distinct from its C9ORF and UNC13A programs.
SHASTA-5 tests adjudicated acute pancreatitis as the primary endpoint. SHASTA-3/4 triglyceride and pooled pancreatitis results are already disclosed and do not settle this separate event-driven trial. plozasiran — phase 3 study in Severe Hypertriglyceridemia. NCT06880770 measures Time to First Occurrence of Positively Adjudicated AP Event (Event Occurring More Than 10 Days After First Dose of Study Drug) (Randomization up to end of Double Blind Treatment Period compared to placebo (Approximate Maximum 50 Months)]). Registry status: recruiting.
ARTBIO’s Series B announcement funds AB001 through Phase II development. Moving into that phase is distinct from its existing ARTISAN Phase 1 dosing.
ARTISAN evaluates a lead-212 PSMA-targeted alpha radioligand in metastatic castration-resistant prostate cancer. ARTBIO announced dosing of Lu-177-PSMA-naive and experienced cohorts in January 2026.