Upcoming biotech catalysts

FDA decision dates, advisory-committee meetings, and trial-readout windows — so you know which stocks have a catalyst coming. Estimated and subject to change.

Upcoming catalysts are extracted from companies' own SEC 8-K filings (EDGAR). Dates are estimates and frequently change. This is a research tool, not investment advice, and is not a prediction that any event will occur or produce any particular outcome. Always verify against the company's filings and consult a licensed financial advisor.

QTTBQ32 Bio Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
AURAAura Biosciences, Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
TTRXTurn Therapeutics Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
TRDAEntrada Therapeutics, Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
CNTBConnect Biopharma Holdings Ltd
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
EYPTEyePoint, Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
KPTIKaryopharm Therapeutics Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
TVRDTvardi Therapeutics, Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
NGNENeurogene Inc.
Trial readout (estimated)
June 2026 · Estimated — subject to change
Source
SPROSpero Therapeutics, Inc.
FDA decision date
Jun 18, 2026 · Confirmed
Source
MRKMerck & Co., Inc.
FDA decision date
Jun 19, 2026 · Confirmed
Source
UNCYUnicycive Therapeutics, Inc.
FDA decision date
Jun 29, 2026 · Confirmed
Source
VRDNViridian Therapeutics, Inc.\DE
FDA decision date — veligrotug
Jun 30, 2026 · Confirmed
Source
EVMNEvommune, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
CRVOCervoMed Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
BHVNBiohaven Ltd.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
AMLXAmylyx Pharmaceuticals, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
SPTXSeaport Therapeutics, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
AXSMAxsome Therapeutics, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
QNRXQuoin Pharmaceuticals, Ltd.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
MANEVeradermics, Inc
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
NMRANeumora Therapeutics, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
SNSESensei Biotherapeutics, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
ALTAltimmune, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
IVVDInvivyd, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
TENXTENAX THERAPEUTICS, INC.
Trial readout (estimated) — TNX-103
Q3 2026 · Estimated — subject to change
Source
HRMYHarmony Biosciences Holdings, Inc.
Trial readout (estimated)
Q3 2026 · Estimated — subject to change
Source
KPTIKaryopharm Therapeutics Inc.
Trial readout (estimated) — SENTRY-2
Q3 2026 · Estimated — subject to change
Source
VERAVera Therapeutics, Inc.
FDA decision date
Jul 7, 2026 · Confirmed
Source
CORTCORCEPT THERAPEUTICS INC
FDA decision date
Jul 11, 2026 · Confirmed
Source
MNKDMANNKIND CORP
FDA decision date
Jul 26, 2026 · Confirmed
Source
SLNSilence Therapeutics plc
Trial readout (estimated)
August 2026 · Estimated — subject to change
Source
PFEPFIZER INC
FDA decision date
Aug 17, 2026 · Confirmed
Source
CAPRCAPRICOR THERAPEUTICS, INC.
FDA decision date
Aug 22, 2026 · Confirmed
Source
JAZZJazz Pharmaceuticals plc
FDA decision date
Aug 25, 2026 · Confirmed
Source
ZYMEZymeworks Inc.
FDA decision date
Aug 25, 2026 · Confirmed
Source
KODKodiak Sciences Inc.
Trial readout (estimated)
September 2026 · Estimated — subject to change
Source
NUVLNuvalent, Inc.
FDA decision date
Sep 18, 2026 · Confirmed
Source
RAREUltragenyx Pharmaceutical Inc.
FDA decision date
Sep 19, 2026 · Confirmed
Source
IONSIONIS PHARMACEUTICALS INC
FDA decision date
Sep 22, 2026 · Confirmed
Source
MIRMMirum Pharmaceuticals, Inc.
FDA decision date
Sep 26, 2026 · Confirmed
Source
PRAXPraxis Precision Medicines, Inc.
FDA decision date
Sep 27, 2026 · Confirmed
Source
BFRIBiofrontera Inc.
FDA decision date
Sep 28, 2026 · Confirmed
Source
SRRKScholar Rock Holding Corp
FDA decision date
Sep 30, 2026 · Confirmed
Source
VIRVir Biotechnology, Inc.
Trial readout (estimated)
Q4 2026 · Estimated — subject to change
Source
GPCRStructure Therapeutics Inc.
Trial readout (estimated)
Q4 2026 · Estimated — subject to change
Source
SNDXSyndax Pharmaceuticals Inc
Trial readout (estimated)
Q4 2026 · Estimated — subject to change
Source
IRONDisc Medicine, Inc.
Trial readout (estimated)
Q4 2026 · Estimated — subject to change
Source
BMEABiomea Fusion, Inc.
Trial readout (estimated)
Q4 2026 · Estimated — subject to change
Source
ZURAZura Bio Ltd
Trial readout (estimated)
Q4 2026 · Estimated — subject to change
Source
CLDXCelldex Therapeutics, Inc.
Trial readout (estimated)
Q4 2026 · Estimated — subject to change
Source
IONSIONIS PHARMACEUTICALS INC
FDA decision date
Oct 26, 2026 · Confirmed
Source
INOINOVIO PHARMACEUTICALS, INC.
FDA decision date
Oct 30, 2026 · Confirmed
Source
BTAIBioXcel Therapeutics, Inc.
FDA decision date
Nov 14, 2026 · Confirmed
Source
CYTKCYTOKINETICS INC
FDA decision date — maple-hcm
Nov 14, 2026 · Confirmed
Source
SMMTSummit Therapeutics Inc.
FDA decision date
Nov 14, 2026 · Confirmed
Source
BBIOBridgeBio Pharma, Inc.
FDA decision date
Nov 27, 2026 · Confirmed
Source
VNDAVanda Pharmaceuticals Inc.
FDA decision date
Dec 12, 2026 · Confirmed
Source
MLYSMineralys Therapeutics, Inc.
FDA decision date
Dec 22, 2026 · Confirmed
Source
GILDGILEAD SCIENCES, INC.
FDA decision date
Dec 23, 2026 · Confirmed
Source
VIRVir Biotechnology, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
TARSTarsus Pharmaceuticals, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
HRMYHarmony Biosciences Holdings, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
DYNDyne Therapeutics, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
OCULOCULAR THERAPEUTIX, INC
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
SPTXSeaport Therapeutics, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
RNACCartesian Therapeutics, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
ZURAZura Bio Ltd
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
OCGNOcugen, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
ANROAlto Neuroscience, Inc.
Trial readout (estimated)
Q1 2027 · Estimated — subject to change
Source
PRAXPraxis Precision Medicines, Inc.
FDA decision date
Jan 29, 2027 · Confirmed
Source
CGEMCullinan Therapeutics, Inc.
FDA decision date
Feb 27, 2027 · Confirmed
Source
AKBAAkebia Therapeutics, Inc.
Trial readout (estimated)
March 2027 · Estimated — subject to change
Source
PROKPROKIDNEY CORP.
Trial readout (estimated)
Q2 2027 · Estimated — subject to change
Source
ALXOALX ONCOLOGY HOLDINGS INC
Trial readout (estimated)
June 2027 · Estimated — subject to change
Source
VSTMVerastem, Inc.
Trial readout (estimated)
June 2027 · Estimated — subject to change
Source
AVLNAvalyn Pharma Inc.
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
LBRXLB PHARMACEUTICALS INC
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
AURAAura Biosciences, Inc.
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
NGNENeurogene Inc.
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
LONALeonaBio, Inc.
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
NERVMinerva Neurosciences, Inc.
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
ANROAlto Neuroscience, Inc.
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
TVTXTravere Therapeutics, Inc.
Trial readout (estimated)
Q3 2027 · Estimated — subject to change
Source
IMRXImmuneering Corp
Trial readout (estimated)
October 2027 · Estimated — subject to change
Source
EYPTEyePoint, Inc.
Trial readout (estimated)
Q4 2027 · Estimated — subject to change
Source
IMAImageneBio, Inc.
Trial readout (estimated)
Q4 2027 · Estimated — subject to change
Source
AVLNAvalyn Pharma Inc.
Trial readout (estimated)
October 2027 · Estimated — subject to change
Source
AVLNAvalyn Pharma Inc.
Trial readout (estimated)
December 2027 · Estimated — subject to change
Source
QNCXQuince Therapeutics, Inc.
Trial readout (estimated)
Q1 2028 · Estimated — subject to change
Source
SPTXSeaport Therapeutics, Inc.
Trial readout (estimated)
March 2028 · Estimated — subject to change
Source
SNDXSyndax Pharmaceuticals Inc
Trial readout (estimated)
March 2028 · Estimated — subject to change
Source
IMRXImmuneering Corp
Trial readout (estimated)
June 2028 · Estimated — subject to change
Source
LBRXLB PHARMACEUTICALS INC
Trial readout (estimated)
Q1 2029 · Estimated — subject to change
Source

Compiled from SEC EDGAR 8-K filings. Not affiliated with or endorsed by the SEC or FDA.