How many FDA decisions (PDUFA dates) are in April 2027?

9 PDUFA dates fall in April 2027: 9 with a confirmed day. Updated November 6, 2026.

What is the next FDA decision in April 2027?

Pitolisant GR from Harmony Biosciences Holdings, Inc. (HRMY), PDUFA target date Apr 1, for Narcolepsy (gastro-resistant formulation).

What is a PDUFA date?

The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

March 2027

PDUFA Dates April 2027: 9 FDA Decisions

Updated November 6, 2026

May 2027

These dates are public. The filterable calendar, alerts, exports and AI research are in the app — free account: the next 7 days and 3 companies you track. Plans →

9 FDA decisions (PDUFA target action dates) fall in April 2027: 9 with a confirmed day. Next: Pitolisant GR (HRMY) on Apr 1. Each row shows the drug, company, indication, status and how firm the date is.

FDA decisions in April 2027
Date	Company	Drug	Indication	Event	Status	Date
Apr 1	HRMY	Pitolisant GR	Narcolepsy (gastro-resistant formulation)	PDUFA	Pending	Confirmed · source
Apr 1	ALCOX.PA	NCX 470	Glaucoma	PDUFA	Pending	Confirmed · source
Apr 9	JHPCY	—	—	PDUFA	Pending	AI-detected · source
Apr 14	INBX	Ozekibart (INBRX-109)	Unresectable or metastatic conventional chondrosarcoma	PDUFA	Pending	Confirmed · source
Apr 16	JAZZ	Cannabidiol	Sturge-Weber Syndrome	PDUFA	Pending	Confirmed · source
Apr 22	MRK	IDVYNSO	HIV-1 infection in certain virologically suppressed adults	PDUFA	Pending	Confirmed · source
Apr 23	RPRX	deucrictibant	on-demand treatment of hereditary angioedema attacks	PDUFA	Pending	Confirmed · source
Apr 23	PHVS	Deucrictibant	On-demand treatment of hereditary angioedema (HAE) attacks	PDUFA	Pending	Confirmed · source
Apr 28	IMNM	AL102	adults with desmoid tumors	PDUFA	Pending	Confirmed · source

113

Total Catalysts

PDUFA Dates

103

Trial Results

Companies

Week 1Mar 29 - Apr 4(11 catalysts)

HRMY$2.4BPDUFA

5mo

FDA PDUFA Date Pitolisant GR

Pitolisant GRNDA

Narcolepsy (gastro-resistant formulation)

Apr 1Confirmed

00%

Source

Pitolisant GR FDA decision page →

ALCOX.PA$35MPDUFA

5mo

FDA PDUFA Date NCX 470

NCX 470Phase 3

Glaucoma

Apr 1Confirmed

00%

Source

Apr 2027~TLSAForalumab Nasal Phase 2 Est. ReadoutPhase 2
Apr 2027~NVSRibociclib Phase 2 Est. ReadoutPhase 2
Apr 2027~LLYAbemaciclib Phase 2 Est. ReadoutPhase 2
Apr 2027~SNYIsatuximab SC-OBDS Phase 2 Est. Readout (SubQSA)Phase 2
Apr 2027~INCYItacitinib Phase 2 Est. ReadoutPhase 2
Apr 2027~PBLSFOG-001 Phase 2 Est. ReadoutPhase 2
Apr 2027~NVOOther - WegovyOther
Apr 2027~PFETucatinib Phase 2 Est. ReadoutPhase 2
Apr 2027~INCYAxatilimab Phase 2 Est. ReadoutPhase 2

Week 2Apr 5 - Apr 11(12 catalysts)

JHPCY$38.2BPDUFA

6mo

FDA PDUFA Date - rivoceranib

Apr 9AI-detected

00%

Source

Apr 2027~ITCILumateperone Phase 3 Est. ReadoutPhase 3
Apr 2027~SNYIsatuximab SAR650984 Phase 3 Est. Readout (IMROZ)Phase 3
Apr 2027~VRTXSuzetrigine Phase 3 Est. ReadoutPhase 3
Apr 2027~VRTXELX/TEZ/IVA Phase 3 Est. ReadoutPhase 3
Apr 2027~AZNOlaparib Phase 3 Est. Readout (ROSY-O)Phase 3
Apr 2027~ESALYPerampanel Oral Suspension Phase 2 Est. ReadoutPhase 2
Apr 2027~AGENBalstilimab Phase 2 Est. ReadoutPhase 2
Apr 2027~MRKPembrolizumab Phase 2 Est. ReadoutPhase 2
Q2 2027~QSNYSAR444336 Phase 2 Est. ReadoutPhase 2
Apr 2027~BAYRYFinerenone (Kerendia, BAY94-8862) Phase 3 Est. Readout (FIONA)Phase 3
Apr 2027~DSKYFU3-1402 Phase 2 Est. Readout (ICARUS BREAST)Phase 2

Week 3Apr 12 - Apr 18(47 catalysts)

INBX$1.5BPDUFA

6mo

FDA PDUFA Date Ozekibart (INBRX-109)

Ozekibart (INBRX-109)NDA

Unresectable or metastatic conventional chondrosarcoma

Apr 14Confirmed

00%

Source

Ozekibart (INBRX-109) FDA decision page →

JAZZ$15.3BPDUFA

6mo

FDA PDUFA Date oral cannabidiol capsule

CannabidiolPhase 2

Sturge-Weber Syndrome

Apr 16Confirmed

00%

SEC

Cannabidiol FDA decision page →

Q2 2027~QNVSianalumab Phase 3 Est. ReadoutPhase 3
Apr 2027~AMGNInebilizumab Phase 2 Est. ReadoutPhase 2
Apr 2027~TAKTDV Phase 3 Est. ReadoutPhase 3
Q2 2027~QNVS[68Ga]Ga-NeoB Phase 2 Est. Readout (NeoB-Cap1)Phase 2
Apr 2027~BMRNBMN 351 Phase 2 Est. ReadoutPhase 2
Apr 2027~VSTMAvutometinib Phase 2 Est. Readout (CHAMELEON)Phase 2
Apr 2027~PFEBrentuximab vedotin Phase 2 Est. ReadoutPhase 2
Apr 2027~RHHBYAtezolizumab Phase 2 Est. Readout (ANTONIO)Phase 2
Apr 2027~SKBBYSKB264 Phase 3 Est. ReadoutPhase 3
Apr 2027~ESALYLenvatinib Phase 2 Est. Readout (Ta-Len-Tra)Phase 2
Apr 2027~MRKPembrolizumab Phase 2 Est. ReadoutPhase 2
Apr 2027~VSTMLetrozole Phase 2 Est. Readout (CHAMELEON)Phase 2
Apr 2027~BMYNivolumab + Ipilimumab Phase 2 Est. ReadoutPhase 2
Apr 2027~PFEVinblastine Phase 2 Est. ReadoutPhase 2
Apr 2027~MRKPlacebo Phase 3 Est. ReadoutPhase 3
Apr 2027~AZNCapivasertib Phase 2 Est. ReadoutPhase 2
Apr 2027~MRKLY3537982 Phase 2 Est. ReadoutPhase 2
Apr 2027~WXID3S-001 Phase 2 Est. ReadoutPhase 2
Apr 2027~JHPCYirinotecan liposome (II) + temozolomide + fluzoparib Phase 2 Est. ReadoutPhase 2
Apr 2027~4151.TKK2430 Phase 2 Est. ReadoutPhase 2
Apr 2027~PCYCIbrutinib Phase 2 Est. ReadoutPhase 2
Apr 2027~IONSION717 Phase 2 Est. ReadoutPhase 2
Apr 2027~ALCAR-14034 SR implant lower dose Phase 2 Est. ReadoutPhase 2
Apr 2027~NKTXFludarabine, Cyclophosphamide Phase 2 Est. ReadoutPhase 2
Apr 2027~SVAexperimental vaccine Phase 3 Est. ReadoutPhase 3
Apr 2027~GSKRPT904 Phase 2 Est. ReadoutPhase 2
Apr 2027~NVSMODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO Phase 2 Est. ReadoutPhase 2
Apr 2027~RHHBYPHESGO Phase 2 Est. ReadoutPhase 2
Apr 2027~LLYLY3537982 Phase 2 Est. ReadoutPhase 2
Apr 2027~KYTXKYV-101 Phase 2 Est. ReadoutPhase 2
Apr 2027~SNYIsatuximab Phase 3 Est. Readout (GEM21menos65)Phase 3
Apr 2027~LLYAbemaciclib Phase 2 Est. ReadoutPhase 2
Apr 2027~COYACOYA 302 Phase 3 Est. Readout (ALSTARS)Phase 3
Apr 2027~XENEXEN1101 Phase 3 Est. Readout (X-ACKT)Phase 3
Apr 2027~MNOVMN-166 Phase 3 Est. Readout (COMBAT-ALS)Phase 3
Apr 2027~KODKSI-101 Phase 3 Est. Readout (PEAK)Phase 3
Apr 2027~LONALasofoxifene in combination with abemaciclib Phase 3 Est. Readout (ELAINEIII)Phase 3
Apr 2027~RCUSQuemliclustat Phase 2 Est. Readout (AIRPanc)Phase 2
Apr 2027~ALCAR-14034 SR implant Phase 2 Est. Readout (NOVA-1)Phase 2
Apr 2027~IXHLIHL-42X: dronabinol + acetazolamide Phase 2 Est. Readout (DReAMzz)Phase 2
Apr 2027~KPTISelinexor Phase 2 Est. Readout (STOMP)Phase 2
Apr 2027~VTVTCadisegliatin Phase 3 Est. Readout (CATT1)Phase 3
Apr 2027~RHHBYAfimkibart Phase 2 Est. ReadoutPhase 2
Apr 2027~RHHBYCrovalimab Phase 3 Est. Readout (COMMODORE 1)Phase 3
Apr 2027~4519.TEculizumab Phase 3 Est. Readout (COMMODORE 1)Phase 3

Week 4Apr 19 - Apr 25(14 catalysts)

MRK$364.4BPDUFA

6mo

FDA PDUFA Date IDVYNSO (standard)

IDVYNSONDA

HIV-1 infection in certain virologically suppressed adults

Apr 22Confirmed

00%

SEC

IDVYNSO FDA decision page →

RPRX$22.7BPDUFA

6mo

FDA PDUFA Date deucrictibant (standard)

deucrictibantNDA

on-demand treatment of hereditary angioedema attacks

Apr 23Confirmed

00%

SEC

deucrictibant FDA decision page →

PHVS$2.2BPDUFA

6mo

FDA PDUFA Date deucrictibant (immediate-release, 20 mg) (standard)

DeucrictibantPhase 3

On-demand treatment of hereditary angioedema (HAE) attacks

Apr 23Confirmed

00%

SEC

Deucrictibant FDA decision page →

Q2 2027~QAMGNOcrelizumab (US) Phase 3 Est. ReadoutPhase 3
Apr 2027~AMGNABP 692 Phase 3 Est. ReadoutPhase 3
Apr 2027~AZNAZD5148 Phase 2 Est. Readout (PRISM)Phase 2
Q2 2027~QAZNCamizestrant Phase 3 Est. ReadoutPhase 3
Apr 2027~BNTXBNT162b2 Phase 3 Est. ReadoutPhase 3
Apr 2027~GSKBepirovirsen Phase 2 Est. Readout (B-Focus)Phase 2
Q2 2027~QNVSMAS825 Phase 2 Est. ReadoutPhase 2
Apr 2027~MRKIntismeran autogene Phase 2 Est. ReadoutPhase 2
Q2 2027~QGSKRTS,S/AS01E vaccine Phase 2 Est. ReadoutPhase 2
Q2 2027~QPFEATM-AVI Single Dose, Cohorts 1-4 Phase 2 Est. ReadoutPhase 2
Apr 2027~ALM.MCLebrikizumab Phase 3 Est. Readout (ADhope 2)Phase 3

Week 5Apr 26 - May 2(29 catalysts)

IMNM$2.8BPDUFA

6mo

FDA PDUFA Date varegacestat

AL102Phase 3

adults with desmoid tumors

Apr 28Confirmed

00%

SEC

AL102 FDA decision page →

Q2 2027~QNVSDII235 Phase 2 Est. ReadoutPhase 2
Q2 2027~QINCYINCB123667 Phase 2 Est. Readout (MAESTRA 1)Phase 2
Apr 2027~AMGNMaridebart cafraglutide Phase 3 Est. Readout (MARITIME-3-J)Phase 3
Q2 2027~QJNJAmivantamab IV Phase 2 Est. Readout (OrigAMI-1)Phase 2
Q2 2027~QNVSQCZ484 Phase 2 Est. ReadoutPhase 2
Apr 2027~ALNYALN-2232 Phase 2 Est. ReadoutPhase 2
Q2 2027~QSNYFrexalimab Phase 2 Est. Readout (FABULINUS)Phase 2
Q2 2027~QMRKBelzutifan Phase 2 Est. ReadoutPhase 2
Q2 2027~QSNYBrivekimig Phase 2 Est. Readout (T1D OBTAIN)Phase 2
Apr 2027~IDYADarovasertib Phase 2 Est. ReadoutPhase 2
Apr 2027~RCUSEtrumadenant Phase 2 Est. ReadoutPhase 2
Apr 2027~ARGXEfgartigimod PH20 SC Phase 2 Est. Readout (ADHERE+)Phase 2
Apr 2027~RNAAOC 1044 Phase 2 Est. Readout (EXPLORE44OLE)Phase 2
Apr 2027~IVBXFTigulixostat Phase 3 Est. ReadoutPhase 3
Apr 2027~IOVAAldesleukin Phase 2 Est. ReadoutPhase 2
Apr 2027~AIMEC Aspirin Phase 2 Est. ReadoutPhase 2
Q2 2027~QNVSIptacopan Phase 3 Est. ReadoutPhase 3
Q2 2027~QIVBXFFebuxostat Phase 3 Est. ReadoutPhase 3
Q2 2027~QRNAAOC 1044 Phase 2 Est. ReadoutPhase 2
Q2 2027~QJHPCYCamrelizumab+Fluzoparib Phase 2 Est. ReadoutPhase 2
Q2 2027~QINCYRuxolitinib Cream Phase 3 Est. ReadoutPhase 3
Q2 2027~QRHHBYvon Willebrand Factor (VWF) Concentrates Phase 3 Est. ReadoutPhase 3
Q2 2027~QAZNChemoimmunotherapy Phase 3 Est. ReadoutPhase 3
Q2 2027~QREGNCemiplimab Phase 2 Est. ReadoutPhase 2
Apr 2027~AZNAcalabrutinib Phase 3 Est. Readout (AMPLIFY)Phase 3
Apr 2027~RHHBYEmicizumab Phase 3 Est. Readout (WILL-EMI)Phase 3
Apr 2027~DSKYFIfinatamab deruxtecan (I-DXd) Phase 2 Est. ReadoutPhase 2
Apr 2027~GMABEpcoritamab Phase 2 Est. ReadoutPhase 2

March 2027 Full Calendar May 2027

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PDUFA dates April 2027: questions

How many FDA decisions (PDUFA dates) are in April 2027?: 9 PDUFA dates fall in April 2027: 9 with a confirmed day. Updated November 6, 2026.
What is the next FDA decision in April 2027?: Pitolisant GR from Harmony Biosciences Holdings, Inc. (HRMY), PDUFA target date Apr 1, for Narcolepsy (gastro-resistant formulation).
What is a PDUFA date?: The FDA's target date to complete its review of a new drug (NDA) or biologic (BLA) application. On or before it, the FDA approves the application, issues a complete response letter (CRL), or extends the review.

About PDUFA Dates in April 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for April 2027. PDUFA dates represent FDA's target action dates for reviewing new drug applications (NDAs) and biologics license applications (BLAs).

Biotech investors and traders closely monitor these dates as FDA decisions can significantly impact stock prices. Our calendar includes PDUFA dates, clinical trial results, advisory committee meetings, and other regulatory milestones.

Learn more about PDUFA dates or view the full biotech catalyst calendar.