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May 11 - May 17, 2026

This Week's Biotech Catalysts

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

49

Total Events

1

PDUFA Dates

45

Trial Readouts

Monday

May 1113
Past
days
ALPMYPhase 2

enfortumab vedotin (EV) Phase 2 Results Expected

enfortumab vedotin (EV)348
May 11
CT.gov
00%
Past
days
MLTXEarnings

MoonLake Reports Financial Results

May 11
Source
Past
days
DYNEarnings

Dyne Reports Financial Results

May 11
Source
Past
days
CRONEarnings

Cronos Reports Financial Results

May 11
Source
Past
days
COCHEarnings

Envoy Reports Financial Results

May 11
Source
Past
days
XGNEarnings

EXAGEN Reports Financial Results

May 11
Source
Past
days
BCAXEarnings

Bicara Reports Financial Results

May 11
Source
Past
days
ADILEarnings

ADIAL Reports Financial Results

May 11
Source
Past
days
LXEOEarnings

Lexeo Reports Financial Results

May 11
Source
Past
days
CSDXEarnings

HERON Reports Financial Results

May 11
Source
Past
days
AGENEarnings

INC Reports Financial Results

May 11
Source
Past
days
DSKYFEarnings

Earnings

May 11
Source
Past
days
NVSPhase 2

CPK850 Phase 2 Results Expected

CPK85012
May 11
CT.gov
00%

Tuesday

May 1224
Past
days
COYAEarnings

Coya Reports Financial Results

May 12
Source
Past
days
UNCYEarnings

Unicycive Reports Financial Results

May 12
Source
Past
days
ADGMEarnings

Adagio Reports Financial Results

May 12
Source
Past
days
PRLDEarnings

Prelude Reports Financial Results

May 12
Source
Past
days
OLMAEarnings

Olema Reports Financial Results

May 12
Source
Past
days
KURAEarnings

Kura Reports Financial Results

May 12
Source
Past
days
ABOSEarnings

Acumen Reports Financial Results

May 12
Source
Past
days
HCMPhase 2

HMPL-760 planned dose 1 Phase 2 Results Expected

HMPL-760 planned dose 161
May 12
CT.gov
00%
Past
days
TEVAConference

Conference Presentation

May 12
Source
Past
days
VRCAEarnings

Verrica Reports Financial Results

May 12
Source
Past
days
ARVNEarnings

Earnings

May 12
Source
Past
days
TECHConference

Conference Presentation

May 12
Source
Past
days
SVAPhase 3

Sinovac PCV13 Phase 3 Results Expected

Sinovac PCV133,080
May 12
CT.gov
00%
Past
days
AGIOPDUFA
NDAApproved

FDA PDUFA Date Pyrukynd (standard)

May 12
SEC
Past
days
BKYIOther

BIO Corporate Update

May 12
Source
Past
days
OLMAData Readout

Olema Oncology Reports First Quarter 2026 Financial and Operating Results

May 12
Source
00%
Past
days
RLMDEarnings

RELMADA Reports Financial Results

May 12
Source
Past
days
BBOTEarnings

BridgeBio Reports Financial Results

May 12
Source
Past
days
SIONEarnings

Sionna Reports Financial Results

May 12
Source
Past
days
XLOEarnings

Xilio Reports Financial Results

May 12
Source
Past
days
KLRSEarnings

Kalaris Reports Financial Results

May 12
Source
Past
days
PMVPEarnings

PMV Reports Financial Results

May 12
Source
Past
days
ACHVEarnings

LIFE Reports Financial Results

May 12
Source
Past
days
MANEEarnings

Veradermics, Reports Financial Results

May 12
Source

Wednesday

May 1325
Past
days
PBHEarnings

Prestige Reports Financial Results

May 13
Source
Past
days
MRMDEarnings

MARIMED Reports Financial Results

May 13
Source
Past
days
NHPAPEarnings

National Reports Financial Results

May 13
Source
Past
days
ALTEarnings

Earnings

May 13
Source
Past
days
KMDARegulatory

Kamada Reports First Quarter 2026 Financial Results and Affirms 2026 Annual Guidance; Expecting Significantly Stronger Remainder of the Year

May 13
Source
00%
Past
days
SPRBEarnings

SPRUCE Reports Financial Results

May 13
Source
Past
days
XBIOEarnings

Xenetic Reports Financial Results

May 13
Source
Past
days
EYEEarnings

National Reports Financial Results

May 13
Source
Past
days
AZTREarnings

Azitra, Reports Financial Results

May 13
Source
Past
days
AVTXEarnings

Avalo Reports Financial Results

May 13
Source
Past
days
BYSIEarnings

BeyondSpring Reports Financial Results

May 13
Source
Past
days
VERUEarnings

VERU Reports Financial Results

May 13
Source
Past
days
CODXEarnings

COMPASS Reports Financial Results

May 13
Source
Past
days
ZBIOEarnings

Zenas Reports Financial Results

May 13
Source
Past
days
RVPHEarnings

REVIVA Reports Financial Results

May 13
Source
Past
days
TYRAEarnings

Tyra Reports Financial Results

May 13
Source
Past
days
ABEOEarnings

ABEONA Reports Financial Results

May 13
Source
Past
days
PDSBEarnings

PDS Reports Financial Results

May 13
Source
Past
days
ANROEarnings

Alto Reports Financial Results

May 13
Source
Past
days
TXGConference

Conference Presentation

May 13
Source
Past
days
REGNPhase 2

Placebo Phase 2 Results Expected

Dupilumab180
May 13
CT.gov
00%
Past
days
VRCAConference

Conference Presentation - VP-315

May 13
Source
Past
days
REGNPhase 2

Fianlimab Phase 2 Results Expected

Fianlimab180
May 13
CT.gov
00%
Past
days
REGNPhase 2

Pemetrexed Phase 2 Results Expected

Pemetrexed180
May 13
CT.gov
00%
Past
days
REGNPhase 2

Cemiplimab Phase 2 Results Expected

cemiplimab180
May 13
CT.gov
00%

ThursdayToday

May 146
Today
AZNCFPhase 3

Ramucirumab+ paclitaxel Phase 3 Results Expected

Ramucirumab+ paclitaxel572
May 14
CT.gov
00%
Today
AZNPhase 3

Eplontersen Phase 3 Results Expected

Eplontersen64
May 14
CT.gov
00%
Today
RHHBYPhase 2

Entrectinib Phase 2 Results Expected

Entrectinib534
May 14
CT.gov
00%
Today
BIIBPhase 2

BIIB080 Phase 2 Results Expected

BIIB080416
BTDFTOrphan
May 14
CT.gov
00%
Today
AZNCFPhase 3

AZD0901 Phase 3 Results Expected

AZD0901572
May 14
CT.gov
00%
Today
CLRBEarnings

Cellectar Reports Financial Results

May 14
Source

Friday

May 1532
Tomorrow
ALCPhase 3

Netarsudil 0.02%/latanoprost 0.005% ophthalmic solution Phase 3 Results Expected

AR-17043 Ophthalmic Solution489
May 15
CT.gov
00%
Tomorrow
GILDPhase 2

Sacituzumab Govitecan-hziy Phase 2 Results Expected

Sacituzumab Govitecan-hziy135
May 15
CT.gov
00%
Tomorrow
TNGXPhase 2

TNG462 Phase 2 Results Expected

TNG462225
May 15
CT.gov
00%
Tomorrow
LLYPhase 3
Positive

Retatrutide Phase 3 Results Expected

Retatrutide1,000
May 15
CT.gov
Tomorrow
LLYPhase 3
Positive

Mirikizumab IV Phase 3 Results Expected

Mirikizumab IV60
May 15
CT.gov
Tomorrow
ARWRPhase 3

Plozasiran Injection Phase 3 Results Expected

Plozasiran Injection1,456
May 15
CT.gov
00%
Tomorrow
GNFT.PAPhase 2

GNS561 + Trametinib Phase 2 Results Expected

GNS561 + Trametinib74
May 15
CT.gov
00%
Tomorrow
SNYPhase 3

Venglustat (GZ402671) Phase 3 Results Expected

Venglustat (GZ402671)104
May 15
CT.gov
00%
Tomorrow
CODXPhase 3

ELIXCYTE Phase 3 Results Expected

ELIXCYTE165
May 15
CT.gov
00%
Tomorrow
ALCPhase 3

Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution Phase 3 Results Expected

Netarsudil 0.01%/latanoprost 0.005% ophthalmic solution489
May 15
CT.gov
00%
Tomorrow
ABBVPhase 3
Positive

Risankizumab IV Phase 3 Results Expected

risankizumab IV1,336
May 15
CT.gov
Tomorrow
EVMNPhase 2

EVO756 Phase 2 Results Expected

EVO756160
May 15
CT.gov
00%
Tomorrow
ALTPhase 2

Pemvidutide Phase 2 Results Expected

Pemvidutide100
May 15
CT.gov
00%
Tomorrow
LLYPhase 3
Positive

Tirzepatide Phase 3 Results Expected

Tirzepatide150
May 15
CT.gov
Tomorrow
EXELPhase 3

Regorafenib Phase 3 Results Expected

Regorafenib901
May 15
CT.gov
00%
Tomorrow
ITCIPhase 3

Lumateperone Phase 3 Results Expected

Lumateperone350
May 15
CT.gov
00%
Tomorrow
AGIOPhase 2

Tebapivat Phase 2 Results Expected

Tebapivat56
May 15
CT.gov
00%
Tomorrow
GILDPhase 2

Lenacapavir Injection Phase 2 Results Expected

Lenacapavir Injection268
May 15
CT.gov
00%
Tomorrow
LLYPhase 2

Mevidalen Phase 2 Results Expected

Mevidalen300
May 15
CT.gov
00%
Tomorrow
BHVNPhase 3

BHV-7000 Phase 3 Results Expected

BHV-7000390
May 15
CT.gov
00%
Tomorrow
BLCOPhase 2

BL1107 Low dose Phase 2 Results Expected

BL1107 Low dose228
May 15
CT.gov
00%
Tomorrow
ENTXPhase 2

EBP05 Phase 2 Results Expected

EBP0545
May 15
CT.gov
00%
Tomorrow
GRFSPhase 3

Xembify Phase 3 Results Expected

Xembify386
May 15
CT.gov
00%
Tomorrow
GILDPhase 2

Emtricitabine/tenofovir disoproxil fumarate (F/TDF) Phase 2 Results Expected

Emtricitabine/tenofovir disoproxil fumarate (F/TDF)268
May 15
CT.gov
00%
Tomorrow
EXELPhase 3

XL092 Phase 3 Results Expected

XL092901
May 15
CT.gov
00%
Tomorrow
JNGHFPhase 3

SHR2554; Chidamide analog tablets Phase 3 Results Expected

SHR2554; Chidamide analog tablets130
May 15
CT.gov
00%
Tomorrow
WSTPhase 2

RVU120 (SEL120) Phase 2 Results Expected

RVU120 (SEL120)41
May 15
CT.gov
00%
Tomorrow
GLUEPhase 2

Oral MRT-2359 Phase 2 Results Expected

Oral MRT-2359174
May 15
CT.gov
00%
Tomorrow
ABBVPhase 3
Positive

Risankizumab SC Phase 3 Results Expected

Risankizumab SC1,336
May 15
CT.gov
Tomorrow
ABBVPhase 3

Ubrogepant Phase 3 Results Expected

Ubrogepant1,059
May 15
CT.gov
00%
Tomorrow
NMRAPhase 3

NMRA-335140 Phase 3 Results Expected

NMRA-335140332
May 15
CT.gov
00%
Tomorrow
SKBBYPhase 3

BL-B01D1 Phase 3 Results Expected

BL-B01D1432
May 15
CT.gov
00%

Saturday

May 16

No events scheduled

Sunday

May 17

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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