Aug 17 - Aug 23, 2026

This Week's Biotech Catalysts

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

Total Events

PDUFA Dates

Trial Readouts

Monday

August 1720

Past

days

AKTSEarnings$1.4B

AKTS Earnings Report

Aug 17Confirmed

Source

Past

days

FVNNUM&A

?Unknown

II M&A / Acquisition

Aug 17Confirmed

Source

Aug '26

PFEPhase 2$143.7B

✓Positive

ATM-AVI Phase 2 Est. Readout

ATM-AVI• Complicated Intra-Abdominal Infections, cIAIs48

Aug 2026~Confirmed

CT.gov

Past

days

NRXPPDUFA$157M

NDA?Unknown

FDA PDUFA Date NRX-101 (standard)

NRX-101• bipolar depression and suicidal ideation

Aug 17AI-detectedSTALE

SEC

Past

days

COSMEarnings$24M

COSM Earnings Report

Aug 17ConfirmedSTALE

Source

Past

days

NRXPEarnings$157M

NRXP Earnings Report

Aug 17Confirmed

Source

Aug '26

ARGXPhase 3$56.5B

✓Positive

efgartigimod administration Phase 3 Est. Readout

efgartigimod administration• Myasthaenia Gravis30

Aug 2026~Confirmed

CT.gov

Aug '26

BIOA-B.STPhase 2$2.6B

exidavnemab Phase 2 Est. Readout

exidavnemab• Parkinson Disease38

Aug 2026~Confirmed

CT.gov

00%

Past

days

AURXEarnings$65M

?Unknown

Nuo Reports Financial Results

Aug 17Confirmed

Source

Past

days

NRXPWEarnings

?Unknown

NRX Reports Financial Results

Aug 17Confirmed

Source

Past

days

BPMCM&A

Acquisition — Sanofi

Aug 17AI-detected

Source

Past

days

OSTXEarnings$81M

OSTX Earnings Report

Aug 17Confirmed

Source

Past

days

NTHIEarnings$189M

NTHI Earnings Report

Aug 17Confirmed

Source

Past

days

SNYM&A$100.0B

Acquisition — Blueprint Medicines

Aug 17AI-detected

Source

Aug '26

VRNAPhase 2$1.1B

Ensifentrine 3 mg Phase 2 Est. Readout

Glycopyrrolate 21.25 mcg• Chronic Obstructive Pulmonary Disease1,119

Aug 2026~Confirmed

CT.gov

00%

Past

days

ELOXEarnings$106M

ELOX Earnings Report

Aug 17Confirmed

Source

Past

days

GRFSEarnings$5.0B

GRFS Earnings Report

Aug 17Confirmed

Source

Past

days

EIKNEarnings$520M

EIKN Earnings Report

Aug 17Confirmed

Source

Past

days

FDMTEarnings$481M

FDMT Earnings Report

Aug 17Confirmed

Source

Past

days

CAPREarnings$1.6B

CAPR Earnings Report

Aug 17Confirmed

Source

TuesdayToday

August 1814

Today

NNOXEarnings$113M

NNOX Earnings Report

Aug 18Confirmed

Source

Today

ANABM&A$1.7B

Acquisition — GlaxoSmithKline

Aug 18AI-detected

Source

Today

KLAREarnings$6.8B

KLAR Earnings Report

Aug 18Confirmed

Source

Today

GSKM&A$101.7B

Acquisition — AnaptysBio

Aug 18AI-detected

Source

Today

CUEEarnings$115M

CUE Earnings Report

Aug 18Confirmed

Source

Today

AVXLEarnings$253M

AVXL Earnings Report

Aug 18Confirmed

Source

Today

TVGNEarnings$41M

TVGN Earnings Report

Aug 18Confirmed

Source

Today

QCLSEarnings$31M

QCLS Earnings Report

Aug 18ConfirmedSTALE

Source

Today

CINGEarnings$66M

CING Earnings Report

Aug 18Confirmed

Source

Today

WGRXEarnings$426M

WGRX Earnings Report

Aug 18Confirmed

Source

Today

GOSSEarnings$39M

GOSS Earnings Report

Aug 18Confirmed

Source

Aug '26

MRKPhase 2$281.2B

~Mixed

Raludotatug Deruxtecan (R-DXd) Phase 2 Est. Readout

Raludotatug Deruxtecan (R-DXd)• Gastrointestinal Cancer160

Aug 2026~Confirmed

CT.gov

Today

ANVSEarnings$61M

ANVS Earnings Report

Aug 18Confirmed

Source

Today

HRMYEarnings$1.9B

✓Positive

Harmony Reports Financial Results

Aug 18Confirmed

Source

Wednesday

August 1913

Tomorrow

AAPGEarnings$6.4B

AAPG Earnings Report

Aug 19Confirmed

Source

Tomorrow

ANTAEarnings$156M

ANTA Earnings Report

Aug 19Confirmed

Source

Tomorrow

NBPEarnings$177M

NBP Earnings Report

Aug 19Confirmed

Source

Tomorrow

ASMBEarnings$388M

ASMB Earnings Report

Aug 19Confirmed

Source

Tomorrow

NMRAEarnings$280M

NMRA Earnings Report

Aug 19Confirmed

Source

Tomorrow

ANABEarnings$1.7B

ANAB Earnings Report

Aug 19Confirmed

Source

Tomorrow

NCNAEarnings$39.7B

NCNA Earnings Report

Aug 19Confirmed

Source

Tomorrow

MRKPhase 3$281.2B

✓Positive

pembrolizumab/vibostolimab Phase 3 Results Expected

Pembrolizumab/Vibostolimab• Lung Neoplasms611

Aug 19Confirmed

CT.gov

Aug '26

AMGNPhase 3$182.2B

Dazodalibep Phase 3 Est. Readout

Dazodalibep• Sjögren's Syndrome (SS)651

Aug 2026~Confirmed

CT.gov

00%

Tomorrow

PHGEEarnings$63M

PHGE Earnings Report

Aug 19Confirmed

Source

Tomorrow

PURREarnings$1.2B

PURR Earnings Report

Aug 19Confirmed

Source

Tomorrow

IMTXEarnings$1.3B

IMTX Earnings Report

Aug 19Confirmed

Source

Tomorrow

ALVOEarnings$1.2B

ALVO Earnings Report

Aug 19Confirmed

Source

Thursday

August 2012

days

OCSEarnings$1.8B

OCS Earnings Report

Aug 20Confirmed

Source

days

EXOZEarnings$66M

EXOZ Earnings Report

Aug 20Confirmed

Source

days

EXOZConference$66M

Conference

Aug 20AI-detected

Source

days

REPLEarnings$841M

REPL Earnings Report

Aug 20Confirmed

Source

days

PRQREarnings$198M

PRQR Earnings Report

Aug 20Confirmed

Source

days

PMVPEarnings$60M

PMVP Earnings Report

Aug 20Confirmed

Source

days

NMADEarnings$77M

NMAD Earnings Report

Aug 20Confirmed

Source

Aug '26

AZNPhase 2$273.6B

AZD7798 Phase 2 Est. Readout

AZD7798• Crohn's Disease24

Aug 2026~Confirmed

CT.gov

00%

Aug '26

TAKPhase 2$48.9B

✓Positive

TAK-360 Phase 2 Est. Readout

TAK-360• Idiopathic Hypersomnia88

Aug 2026~Confirmed

CT.gov

days

EVAXEarnings$29M

EVAX Earnings Report

Aug 20ConfirmedSTALE+IMMINENT

Source

days

ARGXPDUFA$56.5B

Phase 3✅Approved

FDA PDUFA Date efgartigimod alfa (priority)

Efgartigimod IV• Generalized Myasthenia Gravis

Aug 20AI-detected

SEC

days

COAGEarnings$1.4B

COAG Earnings Report

Aug 20Confirmed

Source

Friday

August 216

days

NGENEarnings$175M

NGEN Earnings Report

Aug 21Confirmed

Source

days

LNAIEarnings$137M

LNAI Earnings Report

Aug 21Confirmed

Source

Aug '26

NVOPhase 3$203.2B

✓Positive

Oral semaglutide Phase 3 Est. Readout

Oral semaglutide• Diabetes Mellitus, Type 2264

Aug 2026~Confirmed

CT.gov

Aug '26

NVOPhase 2$203.2B

✓Positive

CagriSema (Cagrilintide B and Semaglutide I) Phase 2 Est. Readout

CagriSema (Cagrilintide B and Semaglutide I)• Obesity142

Aug 2026~Confirmed

CT.gov

days

SLGLEarnings$241M

SLGL Earnings Report

Aug 21Confirmed

Source

Aug '26

MRKPhase 2$281.2B

Pembrolizumab Phase 2 Est. Readout

Vibostolimab/Pembrolizumab• Carcinoma, Renal Cell400

Aug 2026~Confirmed

CT.gov

00%

Saturday

August 223

CAPRRegulatory$1.6B

Regulatory — deramiocel

Aug 22AI-detected

Source

00%

Aug '26

RHHBYPhase 2$316.4B

✗Negative

RO7204239 Phase 2 Est. Readout

RO7204239• Obesity285

Aug 2026~Confirmed

CT.gov

Aug '26

RHHBYPhase 3$316.4B

RO7204239 Phase 3 Est. Readout

RO7204239• Obesity259

Aug 2026~Estimated

CT.gov

00%

Sunday

August 231

Aug '26

PFEPhase 2$143.7B

PF-07220060 + PF-07104091 combination dose escalation Phase 2 Est. Readout

PF-07220060 + PF-07104091 combination dose escalation• Breast Cancer192

Aug 2026~ConfirmedSTALE+IMMINENT

CT.gov

00%

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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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