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Sep 28 - Oct 4, 2026

This Week's Biotech Catalysts

All FDA decisions, clinical trial readouts, and key events happening this week.

43

Total Events

6

PDUFA Dates

30

Trial Readouts

Monday

September 288
Sep '26
INCYPhase 2
✓Positive

INCB099280 Phase 2 Est. Readout

INCB099280
Sep 2026~
CT.gov
Sep '26
TVTXPDUFA
NDA

FDA PDUFA Date undisclosed drug candidate (standard)

undisclosed drug candidate
Sep 2026~STALE
SEC
00%
Sep '26
OCGNPhase 3

OCU410ST Phase 3 Est. Readout

OCU410ST
Sep 2026~STALE
CT.gov
00%
Past
days
CSTLData Readout
✓Positive

Data Readout - TissueCypher® Barrett's Esophagus Test

Sep 28
Source
Past
days
ETONRegulatory
✓Positive

Regulatory Decision - IMPAVIDO®

Sep 28
Source
Past
days
KODPhase 3
✓Positive

KSI-101 Phase 3 Est. Readout

KSI-101
Sep 28
CT.gov
Past
days
BNTCEarnings

BNTC Earnings Report

Sep 28
Source
Sep '26
MLTXPhase 3

Sonelokimab Phase 3 Est. Readout

Sonelokimab
Sep 2026~
CT.gov
00%

Tuesday

September 294
Past
days
NVOData Readout
✓Positive

Data Readout - Ozempic

Sep 29
Source
Past
days
LXEOM&A

Acquisition

Sep 29
Source
Sep '26
SNYPhase 2

Amlitelimab Phase 2 Est. Readout

Amlitelimab
Sep 2026~
CT.gov
00%
Past
days
BYSIOffering

BYSI — Stock Offering (424B5)

Sep 29
Source

Wednesday

September 3030
Past
days
ZEALData Readout
✓Positive

Data Readout - petrelintide

Sep 30
Source
Sep '26
RPTXPhase 2

RP-3500 Phase 2 Est. Readout

RP-3500
Sep 2026~
CT.gov
00%
Sep '26
AZNCFPhase 2

Rosuvastatin Phase 2 Est. Readout

Rosuvastatin
Sep 2026~
CT.gov
00%
Sep '26
NBPEarnings

NBP Earnings Report

Sep 2026~
Source
Sep '26
RZLTEarnings

RZLT Earnings Report

Sep 2026~
Source
Sep '26
AZNCFPhase 3

Durvalumab Phase 3 Est. Readout

Oleclumab
Sep 2026~
CT.gov
00%
Past
days
SYREData Readout
✓Positive

Data Readout

Sep 30
Source
Past
days
VNDAPDUFA
NDA✅Approved

FDA PDUFA Date Hetlioz (standard)

Sep 30
SEC
Past
days
IVVDPhase 3
✓Positive

Phase 3 — VYD2311

Sep 30
Source
Past
days
AZNM&A

Acquisition ($2B)

Sep 30
Source
Sep '26
HLUYYPhase 2

Lu AG13909 Phase 2 Est. Readout

Lu AG13909
Sep 2026~
CT.gov
00%
Sep '26
DSKYFPhase 2
✗Negative

Ifinatamab deruxtecan Phase 2 Est. Readout

Ifinatamab deruxtecan
Sep 2026~
CT.gov
Past
days
QUREBLA Filing
✓Positive

BLA Filing

Sep 30
Source
Sep '26
HGZDYPhase 3

IBI112 Phase 3 Est. Readout

IBI112
Sep 2026~STALE
CT.gov
00%
Sep '26
MRTXPhase 2

Adagrasib oral dose of 400 mg twice daily tablets Phase 2 Est. Readout

Adagrasib oral dose of 400 mg twice daily tablets
Sep 2026~
CT.gov
00%
Sep '26
TPTXPhase 2

Oral repotrectinib (TPX-0005) Phase 2 Est. Readout

Oral repotrectinib (TPX-0005)
Sep 2026~
CT.gov
00%
Sep '26
HNPHYPhase 3

Topotecan Phase 3 Est. Readout

Topotecan
Sep 2026~
CT.gov
00%
Sep '26
QUREPhase 2

AMT-162 Phase 2 Est. Readout

AMT-162
Sep 2026~STALE
CT.gov
00%
Sep '26
DSKYFPhase 3

Dato-DXd Phase 3 Est. Readout

Dato-DXd
Sep 2026~
CT.gov
00%
Sep '26
RHHBYPhase 3

Crizotinib Phase 3 Est. Readout

Crizotinib
Sep 2026~
CT.gov
00%
Past
days
CRBPPhase 1

Phase 1 — CRB-913

Sep 30
Source
00%
Sep '26
CGTXPhase 2

golexanolone Phase 2 Est. Readout

golexanolone
Sep 2026~
CT.gov
00%
Sep '26
HNSA.STPhase 2

GNT0003 Phase 2 Est. Readout

GNT0003
Sep 2026~
CT.gov
00%
Sep '26
AMGNPhase 3

Pegaspargase Phase 3 Est. Readout

Pegaspargase
Sep 2026~
CT.gov
00%
Sep '26
RYTMPhase 3

Setmelanotide Phase 3 Est. Readout

Setmelanotide
Sep 2026~STALE
CT.gov
00%
Past
days
SRRKPDUFA
NDA

PDUFA

Sep 30
Source
00%
Sep '26
NVSPhase 2

Iptacopan (LNP023) Phase 2 Est. Readout

Iptacopan (LNP023)
Sep 2026~
CT.gov
00%
Past
days
RVMDRegulatory
Phase 3✓Positive

Regulatory Decision - daraxonrasib

daraxonrasib
Sep 30
Source
Past
days
TLSAPhase 2
✓Positive

Phase 2 — intranasal foralumab

Sep 30
Source
Sep '26
BEIGFPhase 3

Oxaliplatin Phase 3 Est. Readout

Oxaliplatin
Sep 2026~
CT.gov
00%

Thursday

October 112
Past
days
ABBVData Readout
✓Positive

Data Readout

Oct 1
Source
Oct '26
IONSPDUFA
NDA

FDA PDUFA Date drug candidate (standard)

drug candidate
Oct 2026~
SEC
00%
Past
days
GSKPDUFA
NDA✅Approved

FDA PDUFA Date Belumosudil (priority)

Belumosudil
Oct 1
SEC
Past
days
TARSConference

Conference — XDEMVY

Oct 1
Source
Past
days
SGPM&A

Acquisition ($13M)

Oct 1
Source
Oct '26
ARGXPhase 3
✓Positive

Efgartigimod PH20 SC Phase 3 Est. Readout

Efgartigimod PH20 SC
Oct 2026~
CT.gov
Oct '26
BAYRYPhase 2

Larotrectinib monotherapy Phase 2 Est. Readout

Larotrectinib monotherapy
Oct 2026~
CT.gov
00%
Oct '26
NVSPhase 2

Iptacopan (LNP023) Phase 2 Est. Readout

Iptacopan (LNP023)
Oct 2026~
CT.gov
00%
Past
days
NUVBPDUFA
NDA

FDA PDUFA Date NUV-868 (priority)

NUV-868
Oct 1STALE
SEC
00%
Past
days
INCYConference

Conference

Oct 1STALE
Source
Oct '26
COCPPhase 2

CDI-988 Phase 2 Est. Readout

CDI-988
Oct 2026~
CT.gov
00%
Past
days
FMCQFM&A

Acquisition

Oct 1
Source

Friday

October 26
Oct '26
CELUEarnings

CELU Earnings Report

Oct 2026~
Source
Past
days
CNTBConference

Conference — ATTR

Oct 2STALE
Source
Past
days
SMMTM&A

Acquisition — AstraZeneca ($2B)

Oct 2
Source
Past
days
IARTEarnings
?Unknown

CORP Reports Financial Results

Oct 2
Source
Past
days
NVSM&A

Acquisition ($7.8B)

Oct 2
Source
Past
days
QGENM&A

Acquisition

Oct 2
Source

Saturday

October 31
Oct '26
NUVBNDA Filing
✓Positive

NDA Filing — IBTROZI

Oct 2026~
Source

SundayToday

October 4

No events scheduled

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Why Track Weekly Biotech Catalysts?

Biotech stocks are driven by binary events - FDA decisions, clinical trial results, and regulatory milestones. Knowing which catalysts are coming this week helps investors prepare for potential volatility and trading opportunities.

Key Events to Watch

  • PDUFA Dates: FDA target action dates for drug approvals
  • Clinical Trials: Phase 1, 2, and 3 data readouts
  • AdCom Meetings: FDA Advisory Committee votes
  • Conferences: Medical conference presentations

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