February 2027 Catalysts

FDA Decisions & PDUFA Dates

March 2027

Total Catalysts

PDUFA Dates

Trial Results

Companies

Week 1Feb 1 - Feb 7(11 catalysts)

Feb 2027~AMGNDiphenhydramine Phase 2 Est. ReadoutPhase 2
Feb 1PPCBPhase 1 — PRPPhase 1
Feb 2027~AZNCFGC012F Injection Phase 2 Est. ReadoutPhase 2
Feb 2027~TVRDTTI-101 Phase 2 Est. ReadoutPhase 2
Feb 2027~EPZMTazemetostat Phase 2 Est. ReadoutPhase 2
Feb 2027~NVSLEE011 Phase 2 Est. ReadoutPhase 2
Feb 2027~PHM.MCBasimglurant Phase 3 Est. ReadoutPhase 3
Feb 2027~VRTXVX-670 Phase 2 Est. ReadoutPhase 2
Feb 2027~NVSLXH254 Phase 2 Est. ReadoutPhase 2
Feb 2027~NVSSoC (Coartem) Phase 2 Est. ReadoutPhase 2
Feb 2027~RHHBYRanibizumab Phase 3 Est. ReadoutPhase 3

Week 2Feb 8 - Feb 14(12 catalysts)

RHHBY$351.3BBLA Filing

5mo

BLA Filing — Lunsumio VELO

Feb 9AI-detected

00%

Source

RHHBY$351.3BPDUFA

5mo

FDA PDUFA Date Lunsumio VELO (mosunetuzumab) in combination with Polivy (polatuzumab vedotin) (accelerated review)

MosunetuzumabPhase 3

Non-Hodgkin Lymphoma

Feb 9Confirmed

00%

Source

Mosunetuzumab FDA decision page →

BLTE$6.7BPDUFA

Feb '27

FDA PDUFA Date Tinlarebant (priority review)

TinlarebantPhase 3

STGD1

Feb 2027~AI-detected

00%

Source

DCPHPDUFA

Feb '27

FDA PDUFA Date Tirabrutinib

TirabrutinibPhase 3

Relapsed/Refractory Primary Central Nervous System Lymphoma

Feb 2027~Confirmed

00%

Source

QURE$2.7BPDUFA

Feb '27

FDA PDUFA Date uniQure Huntington's disease gene therapy (accelerated review)

uniQure Huntington's disease gene therapyNDA

Huntington's disease

Feb 2027~AI-detected

00%

Source

Feb 2027~REGNREGN9933 Phase 2 Est. ReadoutPhase 2
Feb 2027~SNYBrivekimig Phase 2 Est. ReadoutPhase 2
Feb 2027~TAKTeduglutide Phase 3 Est. ReadoutPhase 3
Feb 2027~AZNCFAZD4144 Phase 2 Est. ReadoutPhase 2
Q1 2027~QRHHBYRanibizumab Phase 2 Est. ReadoutPhase 2
Feb 2027~EPZMTazemetostat Phase 3 Est. ReadoutPhase 3
Feb 2027~ESALYE2086 Phase 2 Est. ReadoutPhase 2

Week 3Feb 15 - Feb 21(33 catalysts)

HRMY$2.4BPDUFA

Q1 '27

FDA PDUFA Date

Q1 2027~QAI-detected

00%

Source

TEVA$46.0BPDUFA

Feb '27

FDA PDUFA Date olanzapine extended-release injectable suspension (standard review)

Feb 2027~AI-detected

00%

Source

MLTX$1.1BPDUFA

Feb '27

FDA PDUFA Date

inflammatory arthritis

Feb 2027~AI-detected

00%

Source

RGNX$506MPDUFA

Feb '27

FDA PDUFA Date RGX-121 (accelerated review)

RGX-121NDA

Hunter syndrome

Feb 2027~AI-detected

00%

Source

Feb 2027~DAWNEmi-Le Phase 2 Est. ReadoutPhase 2
Feb 2027~BAVA.COMVA-BN-WEV Phase 2 Est. ReadoutPhase 2
Feb 2027~JNGHFFH-006 for Injection Phase 2 Est. ReadoutPhase 2
Feb 2027~AZNCFTremelimumab Phase 2 Est. ReadoutPhase 2
Feb 2027~IPIXGI-108 Phase 2 Est. ReadoutPhase 2
Feb 2027~IQVER004 Phase 2 Est. ReadoutPhase 2
Feb 2027~MGNXLorigerlimab Phase 2 Est. ReadoutPhase 2
Feb 2027~ARWRARO-ALK7 Phase 2 Est. ReadoutPhase 2
Feb 2027~ABCLABCL635 Phase 2 Est. ReadoutPhase 2
Feb 2027~ALM.MCLAD328 Phase 2 Est. ReadoutPhase 2
Feb 2027~GNLXPlatinum chemotherapy: carboplatin or cisplatin Phase 2 Est. ReadoutPhase 2
Feb 2027~RHHBYVenetoclax Phase 2 Est. ReadoutPhase 2
Feb 2027~ENLVAllocetra Phase 2 Est. ReadoutPhase 2
Feb 2027~MRNAmRNA-1403 Phase 3 Est. ReadoutPhase 3
Feb 2027~BAYRYFOLFOX chemotherapy with oxaliplatin Phase 2 Est. ReadoutPhase 2
Feb 2027~TXMDYL201 for Injection Phase 2 Est. ReadoutPhase 2
Feb 2027~RHHBYVenetoclax Phase 3 Est. ReadoutPhase 3
Feb 2027~KRYSKB707 Phase 2 Est. ReadoutPhase 2
Feb 2027~ABBVRavagalimab Phase 2 Est. ReadoutPhase 2
Feb 2027~REC.MIPasireotide Phase 2 Est. ReadoutPhase 2
Feb 2027~CADLaglatimagene besadenovec + valacyclovir Phase 2 Est. ReadoutPhase 2
Feb 2027~TKPHFTAK-279 Phase 2 Est. ReadoutPhase 2
Q1 2027~QAZNZibotentan/Dapagliflozin Phase 3 Est. ReadoutPhase 3
Q1 2027~QREGNREGN7508 Phase 2 Est. ReadoutPhase 2
Feb 2027~REGNEnoxaparin Phase 3 Est. ReadoutPhase 3
Feb 2027~JHPCYPD-1 blocking antibody Phase 3 Est. ReadoutPhase 3
Feb 2027~SKBBYSKB518 Phase 2 Est. ReadoutPhase 2
Feb 2027~MRKR-CHOP Protocol Phase 2 Est. ReadoutPhase 2
Feb 2027~REGNREGN7508 Phase 3 Est. ReadoutPhase 3

Week 4Feb 22 - Feb 28(20 catalysts)

RARE$1.5BPDUFA

5mo

FDA PDUFA Date (standard)

Feb 24AI-detected

00%

SEC

LRMR$393MPDUFA

Feb '27

FDA PDUFA Date nomlabofusp (accelerated review)

CTI-1601Phase 2

Friedreich Ataxia

Feb 2027~Confirmed

00%

Source

SRPT$2.0BRegulatory

5mo

Regulatory — exon skipping drugs

Feb 28AI-detected

00%

Source

BMRN$12.0BNDA Filing

5mo

NDA Filing — VOXZOGO

Feb 28AI-detected

00%

Source

BMRN$12.0BPDUFA

5mo

FDA PDUFA Date

Feb 28AI-detected

00%

Source

Feb 2027~AZNCFOsimertinib Phase 3 Est. ReadoutPhase 3
Q1 2027~QPFEtofacitinib Phase 3 Est. ReadoutPhase 3
Feb 2027~AZNAnifrolumab Phase 3 Est. ReadoutPhase 3
Q1 2027~QUCBJYBrivaracetam Phase 3 Est. ReadoutPhase 3
Feb 2027~RHHBYCevostamab Phase 2 Est. ReadoutPhase 2
Feb 2027~ARDXTenapanor 5 mg BID Phase 3 Est. ReadoutPhase 3
Feb 2027~NVSPertuzumab Phase 3 Est. ReadoutPhase 3
Feb 2027~NVSAlpelisib Phase 2 Est. ReadoutPhase 2
Feb 2027~NVSEFLEE011 Phase 2 Est. ReadoutPhase 2
Q1 2027~QFBRXFB102 Phase 2 Est. ReadoutPhase 2
Feb 2027~IONSPhase 1Phase 1
Q1 2027~QREGNREGN5715 Phase 3 Est. ReadoutPhase 3
Feb 28TRAXPhase 3 — zipalertinibPhase 3
Feb 2027~HNSA.STImlifidase Phase 2 Est. ReadoutPhase 2
Feb 2027~IVBXFAflibercept Ophthalmic Phase 3 Est. ReadoutPhase 3

January 2027 Full Calendar March 2027

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About PDUFA Dates in February 2027

This page tracks all FDA Prescription Drug User Fee Act (PDUFA) dates and biotech catalyst events scheduled for February 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.