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Recent FDA Drug Approval Process News

Biotechnology and pharmaceutical stocks often move sharply in response to FDA decisions, so knowing what’s coming can give you a critical edge.

MarketBeat’s FDA Drug Approval Calendar is your go-to resource for staying ahead of critical biotech catalysts. This tool helps you navigate the high-stakes world of drug development by tracking key milestones like Prescription Drug User Fee Act (PDUFA) dates, New Drug Applications (NDAs), Biologics License Applications (BLAs), Complete Response Letters (CRLs), and special designations like Breakthrough Therapy or Orphan Drug status.

The calendar makes it easy to filter by company, drug, event type, or date. Whether you're anticipating a market-moving approval or reviewing past decisions, this resource puts the FDA pipeline in sharp focus, allowing you to make investment decisions with confidence.

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Main Company Current Price 30-Day Price Change Drug Status Event
Sight Sciences, Inc. stock logo
SGHT
Sight Sciences
$3.49
0.0%
-16.7%
The price history of SGHT in the last 30 days
OMNI Surgical System Pseudophakic Eyes with Open-Angle Glaucoma 9/17/2025 - Published Results Sight Sciences, Inc. announced the results as published in the European Journal of Ophthalmology of …
Full Summary
Nurix Therapeutics, Inc. stock logo
NRIX
Nurix Therapeutics
$8.66
+2.6%
-15.1%
The price history of NRIX in the last 30 days
GS-6791/NX-0479 Novel IRAK4 Degrader for Inflammatory Conditions 9/17/2025 - Data Presentation Nurix Therapeutics, Inc. announced the presentation of preclinical data from GS-6791/NX-0479, a no…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$77.62
+0.1%
-1.9%
The price history of AZN in the last 30 days
TULIP-SC in patients with systemic lupus erythematosus based on an interim analysis 9/17/2025 - Positive Results Astrazenca announced Positive high-level results from a pre-specified interim analysis of the Phase …
Full Summary
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$28.01
+3.3%
-30.1%
The price history of TNXP in the last 30 days
TNX-4800 Lyme Disease 9/17/2025 - Provided Update Tonix Pharmaceuticals announced the in-licensing of worldwide rights to TNX-4800 (formerly known as…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$583.69
+1.5%
+1.7%
The price history of REGN in the last 30 days
garetosma Fibrodysplasia Ossificans Progressiva (FOP)
Phase 3
9/17/2025 - Endpoint Met Regeneron Pharmaceuticals, Inc announced the primary endpoint was met in the Phase 3 OPTIMA trial i…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$763.36
-0.2%
+9.2%
The price history of LLY in the last 30 days
orforglipron Orforglipron for the treatment of obesity and overweight
Phase 3
9/17/2025 - Positive Results Eli Lilly and Company announced positive topline results from ACHIEVE-3, an open-label randomized P…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$583.69
+1.5%
+1.7%
The price history of REGN in the last 30 days
Semaglutide (GLP-1 receptor agonist) induced Weight Loss by Preserving Lean Mass
Phase 2
9/17/2025 - Analysis Regeneron Pharmaceuticals, Inc announced updated analyses from the ongoing Phase 2 COURAGE trial in…
Full Summary
Roivant Sciences Ltd. stock logo
ROIV
Roivant Sciences
$15.52
+9.5%
+31.4%
The price history of ROIV in the last 30 days
Brepocitinib Systemic Lupus Erythematosus
Phase 3
9/17/2025 - Positive Results Roivant and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study eval…
Full Summary
Lexicon Pharmaceuticals, Inc. stock logo
LXRX
Lexicon Pharmaceuticals
$1.08
-2.3%
-11.2%
The price history of LXRX in the last 30 days
pilavapadin For the treatment of diabetic peripheral neuropathic pain (DPNP)
Phase 2b
9/17/2025 - Data Presentation Lexicon Pharmaceuticals, Inc announced the presentation of clinical data from the company's Phase 2…
Full Summary
Innate Pharma S.A. Sponsored ADR stock logo
IPHA
Innate Pharma
$2.03
-2.6%
-9.2%
The price history of IPHA in the last 30 days
Lacutamab Treatment of patients with relapsed or refractory Sézary syndrome 9/17/2025 - Provided Update Innate Pharma SA provided Business Update
Full Summary
Astria Therapeutics, Inc. stock logo
ATXS
Astria Therapeutics
$7.56
+4.0%
+11.5%
The price history of ATXS in the last 30 days
STAR-0310 Treatment of Atopic Dermatitis
Phase 1a
9/17/2025 - Positive Results Astria Therapeutics, Inc announced positive initial results from the Phase 1a trial of STAR-0310, a…
Full Summary
Oruka Therapeutics, Inc. stock logo
ORKA
Oruka Therapeutics
$15.87
+6.5%
+4.0%
The price history of ORKA in the last 30 days
ORKA-001 Inhibitor IL-23p19
Phase 1
9/17/2025 - Interim Data Oruka Therapeutics announced interim data from its Phase 1 trial of ORKA-001, the Company's long-act…
Full Summary
Arcutis Biotherapeutics, Inc. stock logo
ARQT
Arcutis Biotherapeutics
$17.37
+2.3%
+3.7%
The price history of ARQT in the last 30 days
ZORYVE™ (roflumilast) Inhibitor of phosphodiesterase-4 (PDE4) 9/17/2025 - New Data Arcutis Biotherapeutics, Inc. announced that new data on ZORYVE (roflumilast) efficacy across three …
Full Summary
Incyte Corporation stock logo
INCY
Incyte
$85.62
+2.0%
+0.8%
The price history of INCY in the last 30 days
povorcitinib AK1 inhibitor
Phase 3
9/17/2025 - Interim Data Incyte announced new 24-week interim data evaluating the safety and efficacy of povorcitinib (INCB54…
Full Summary
Kymera Therapeutics, Inc. stock logo
KYMR
Kymera Therapeutics
$49.33
+1.1%
+13.1%
The price history of KYMR in the last 30 days
KT-621 A potential oral treatment for asthma and other TH2 respiratory diseases.
Phase 1
9/17/2025 - Positive Results Kymera Therapeutics announced that the positive results from the Phase 1 healthy volunteer clinical …
Full Summary
Protagonist Therapeutics, Inc. stock logo
PTGX
Protagonist Therapeutics
$60.01
+2.4%
+6.8%
The price history of PTGX in the last 30 days
PN-881 oral peptide antagonist blocking the three dimeric forms of IL-17
Phase 3
9/17/2025 - New Data Protagonist Therapeutics, Inc. announced new data from the Phase 3 ICONIC-ADVANCE 1 and 2 studies w…
Full Summary
Aileron Therapeutics, Inc. stock logo
ALRN
Aileron Therapeutics
LTI-03 In Idiopathic Pulmonary Fibrosis 9/17/2025 - Data Publication Rein Therapeutics announced the publication of novel data on its lead drug candidate, LTI-03, in iS…
Full Summary
Cidara Therapeutics, Inc. stock logo
CDTX
Cidara Therapeutics
$65.37
+1.0%
+3.4%
The price history of CDTX in the last 30 days
CD388 Universal Prevention and Treatment of Influenza
Phase 2b
9/17/2025 - Presentation Cidara Therapeutics, Inc. announced two presentations during the International Society for Respirato…
Full Summary
Celldex Therapeutics, Inc. stock logo
CLDX
Celldex Therapeutics
$24.87
+1.2%
+1.6%
The price history of CLDX in the last 30 days
Barzolvolimab For Prurigo Nodularis
Phase 2
9/17/2025 - New Data Celldex announced today new data demonstrating rapid and strong efficacy regardless of baseline immu…
Full Summary
Candel Therapeutics, Inc. stock logo
CADL
Candel Therapeutics
$4.92
+1.5%
-17.4%
The price history of CADL in the last 30 days
CAN-2409 Prostate cancer 9/17/2025 - Abstract Candel Therapeutics, Inc. announced that an abstract was accepted for an oral presentation at the 2…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$46.18
-0.3%
-4.2%
The price history of BMY in the last 30 days
Deucravacitinib Moderate to severe plaque psoriasis
Phase 3
9/17/2025 - Data J&J Announces Data From Phase 3 ICONIC-ADVANCE 1 And 2 Studies Showing Icotrokinra Demonstrated Supe…
Full Summary
Brainsway Ltd. Sponsored ADR stock logo
BWAY
Brainsway
$16.03
-5.1%
+7.9%
The price history of BWAY in the last 30 days
Deep TMS Decreasing Anxiety Symptoms in Depressed Patients 9/16/2025 - FDA GRANT BrainsWay Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted an expansion o…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.30
-1.1%
-12.5%
The price history of MIRA in the last 30 days
Ketamir-2 To treat depression and treatment-resistant depression (TRD). 9/16/2025 - Positive Results MIRA Pharmaceuticals, Inc announced positive results demonstrating that its oral drug candidate Ket…
Full Summary
Cyclo Therapeutics, Inc. stock logo
CYTH
Cyclo Therapeutics
$0.72
Trappsol® Cyclo™ For the treatment of Niemann-Pick Disease Type C1 (NPC1)
Phase 3
9/16/2025 - Data Rafael Holdings, Inc. announced today that data from Cyclo Therapeutics' Phase 3 TransportNPC™ open…
Full Summary
Arcutis Biotherapeutics, Inc. stock logo
ARQT
Arcutis Biotherapeutics
$17.37
+2.3%
+3.7%
The price history of ARQT in the last 30 days
ZORYVE™ (roflumilast) Inhibitor of phosphodiesterase-4 (PDE4) 9/16/2025 - Presentation Arcutis Biotherapeutics, Inc announced that ZORYVE was presented with a 2025 Best of Beauty Breakt…
Full Summary
Jyong Biotech Ltd. stock logo
MENS
Jyong Biotech
$54.19
-0.4%
+30.6%
The price history of MENS in the last 30 days
MCS‑8 Prostate Cancer Prevention
Phase 2
9/16/2025 - Enrollment Update Jyong Biotech Ltd. announced that it has completed patient enrollment in its Phase II clinical trial…
Full Summary
Verona Pharma PLC American Depositary Share stock logo
VRNA
Verona Pharma PLC American Depositary Share
$106.28
+0.0%
+0.5%
The price history of VRNA in the last 30 days
Ensifentrine Chronic obstructive pulmonary disease (COPD) 9/16/2025 - Poster Presentation Verona Pharma plc announces two posters on additional analyses from its Phase 3 ENHANCE studies with…
Full Summary
Moderna, Inc. stock logo
MRNA
Moderna
$25.12
+1.1%
-10.6%
The price history of MRNA in the last 30 days
SPIKEVAX (COVID-19 Vaccine, mRNA) COVID-19 in individuals 18 years of age and older 9/16/2025 - Positive Data Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of Spikev…
Full Summary
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$1.33
+4.3%
+31.2%
The price history of ONCY in the last 30 days
Pelareorep In Breast Cancer 9/16/2025 - Enrollment Update ncolytics Biotech® Inc. nnounced updates on enrollment progress, U.S. site expansion, and expected d…
Full Summary
Biomea Fusion, Inc. stock logo
BMEA
Biomea Fusion
$2.00
-1.2%
+14.7%
The price history of BMEA in the last 30 days
icovamenib For 2 diabetes 9/16/2025 - Presentation Biomea Fusion, Inc. announced the presentation of preclinical data from its investigational menin in…
Full Summary
Lantern Pharma Inc. stock logo
LTRN
Lantern Pharma
$4.01
-2.3%
-9.8%
The price history of LTRN in the last 30 days
LP-184 Prostate cancer
Phase 1a
9/16/2025 - Provided Update Lantern Pharma Inc. announced the successful completion of its Phase 1a clinical trial (NCT05933265…
Full Summary
Cytosorbents Corporation stock logo
CTSO
Cytosorbents
$0.91
+0.4%
-17.0%
The price history of CTSO in the last 30 days
DrugSorb-ATR Antithrombotic Removal System 9/16/2025 - Regulatory Update CytoSorbents Corporation today provided a regulatory update on DrugSorb™-ATR.
Full Summary
Corbus Pharmaceuticals Holdings, Inc. stock logo
CRBP
Corbus Pharmaceuticals
$11.60
+12.9%
+25.4%
The price history of CRBP in the last 30 days
CRB-701 Targets the expression of Nectin-4 on cancer cells
Fast Track
9/16/2025 - Designation Grant Corbus Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) has granted …
Full Summary
Viridian Therapeutics, Inc. stock logo
VRDN
Viridian Therapeutics
$18.91
+1.3%
+4.4%
The price history of VRDN in the last 30 days
VRDN-003 for patients with moderate-to-severe TED.
Phase 3
9/15/2025 - Enrollment Update Viridian Therapeutics, Inc announced that enrollment is complete in REVEAL-1 and REVEAL-2, phase 3 …
Full Summary
BioAge Labs, Inc. stock logo
BIOA
BioAge Labs
$5.03
+2.7%
+11.3%
The price history of BIOA in the last 30 days
BGE-102 For the treatment of obesity.
Phase 1
9/15/2025 - Primary Endpoint Shanghai Stock Exchange listed company HitGen Inc congratulates its partner BioAge Labs, Inc on t…
Full Summary
Krystal Biotech, Inc. stock logo
KRYS
Krystal Biotech
$155.29
+0.6%
+6.1%
The price history of KRYS in the last 30 days
VYJUVEK Designed to treat DEB at the molecular level by providing the patient's skin cells the template to make normal COL7 protein, 9/15/2025 - FDA approved Krystal Biotech, Inc announced today that the United States Food and Drug Administration (FDA) appr…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$81.08
0.0%
-3.7%
The price history of MRK in the last 30 days
R-DXd for Patients with CDH6
Breakthrough Therapy
9/15/2025 - Designation Grant Merck announced that Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designati…
Full Summary
Kodiak Sciences Inc. stock logo
KOD
Kodiak Sciences
$9.36
+0.3%
-16.8%
The price history of KOD in the last 30 days
KSI-101 in patients with MESI 9/15/2025 - New Data Kodiak Sciences Inc. announced today new data from the APEX study of KSI-101 presented at the Reti…
Full Summary
Entera Bio Ltd. stock logo
ENTX
Entera Bio
$1.80
-1.4%
-10.3%
The price history of ENTX in the last 30 days
OPK-8801003 For Short Bowel Syndrome Patients 9/15/2025 - Presentation Entera Bio Ltd. announced the presentation of a poster titled "A First-in-Class Oral GLP-2 Analog fo…
Full Summary
aTyr Pharma, Inc. stock logo
LIFE
aTyr Pharma
Efzofitimod Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD)
Phase 3
9/15/2025 - Top-line results aTyr Pharma, Inc. announced topline results from the Phase 3 EFZO-FIT™ study of efzofitimod in 268 p…
Full Summary
NovoCure Limited stock logo
NVCR
NovoCure
$12.72
+0.3%
+5.2%
The price history of NVCR in the last 30 days
Optune Lua For the Treatment of Metastatic Non-Small Cell Lung Cancer MHLW Approval 9/15/2025 - Approved Novocure announced today that Japan's Ministry of Health, Labour and Welfare (MHLW) approved Optune…
Full Summary
Forte Biosciences, Inc. stock logo
FBRX
Forte Biosciences
$11.92
-3.3%
+0.1%
The price history of FBRX in the last 30 days
FB102 In celiac disease 9/15/2025 - Additional data Forte Biosciences, Inc announced additional details from the oral presentation "FB102 prevents histo…
Full Summary
Forte Biosciences, Inc. stock logo
FBRX
Forte Biosciences
$11.92
-3.3%
+0.1%
The price history of FBRX in the last 30 days
FB102 In celiac disease 9/15/2025 - Additional data Forte Biosciences, Inc announced additional details from the oral presentation "FB102 prevents his…
Full Summary
Alterity Therapeutics Limited - Sponsored ADR stock logo
ATHE
Alterity Therapeutics
$4.40
-1.1%
-15.7%
The price history of ATHE in the last 30 days
ATH434-201 Investigation of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare neurodegenerative disease with no approved treatments to slow or stop its progression.
Phase 2
9/15/2025 - Data Alterity Therapeutics announced that data from the ATH434-201 randomized, double-blind Phase 2 cli…
Full Summary
Kalaris Therapeutics Inc. stock logo
KLRS
Kalaris Therapeutics
$4.47
-10.8%
+78.8%
The price history of KLRS in the last 30 days
TH103 in Neovascular Age-Related Macular Degeneration
Phase 1b/2
9/15/2025 - Enrollment Update Kalaris Therapeutics, Inc. announced that it is now enrolling a Phase 1b/2 multiple ascending dose (…
Full Summary
Belite Bio, Inc. Sponsored ADR stock logo
BLTE
Belite Bio
$72.57
+8.5%
+11.7%
The price history of BLTE in the last 30 days
Tinlarebant In Stargardt Disease
Phase 3
9/12/2025 - Provided Update Belite Bio Inc announced the completion of the last subject visit in the Phase 3 DRAGON clinical tri…
Full Summary
Precision BioSciences, Inc. stock logo
DTIL
Precision BioSciences
$4.63
-0.9%
-6.5%
The price history of DTIL in the last 30 days
ARCUS Eliminate DNA of living cells and organisms.
Phase 1
9/12/2025 - Clinical Data Precision BioSciences, Inc announced that the Company presented clinical data from the Phase 1 ELIM…
Full Summary
Maze Therapeutics, Inc. stock logo
MAZE
Maze Therapeutics
$23.83
+1.6%
+78.5%
The price history of MAZE in the last 30 days
MZE782 first-in-class therapy for patients with CKD.
Phase 1
9/11/2025 - Positive Results Maze Therapeutics, Inc. announced positive clinical results from the Phase 1 healthy volunteer stud…
Full Summary
Liquidia Technologies, Inc. stock logo
LQDA
Liquidia Technologies
$25.63
-1.6%
-7.6%
The price history of LQDA in the last 30 days
LIQ861 (Treprostinil) Pulmonary arterial hypertension (PAH) 9/11/2025 - Poster Presentation Liquidia Corporation announced today that the company will present four posters at the Pulmonary Hyp…
Full Summary
FibroBiologics Inc. stock logo
FBLG
FibroBiologics
$0.53
-0.8%
-14.9%
The price history of FBLG in the last 30 days
Human dermal fibroblast in Chronic-Relapse Psoriasis Treatment 9/11/2025 - Positive Data FibroBiologics, Inc. announced positive IND-enabling updates from its psoriasis research program de…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$81.08
0.0%
-3.7%
The price history of MRK in the last 30 days
CAPVAXIVE For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
Phase 3
9/11/2025 - Positive Results Merck announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococca…
Full Summary
Lexicon Pharmaceuticals, Inc. stock logo
LXRX
Lexicon Pharmaceuticals
$1.08
-2.3%
-11.2%
The price history of LXRX in the last 30 days
pilavapadin For the treatment of diabetic peripheral neuropathic pain (DPNP) 9/11/2025 - Presentation Lexicon Pharmaceuticals, Inc. announced the presentation of clinical data for its investigational, …
Full Summary
Enlivex Therapeutics Ltd. stock logo
ENLV
Enlivex Therapeutics
$1.07
-1.4%
-14.8%
The price history of ENLV in the last 30 days
Allocetra Sepsis 9/11/2025 - Provided Update Enlivex Therapeutics Ltd. today issued the following update to shareholders from Chief Executive Off…
Full Summary
Apogee Therapeutics Inc. stock logo
APGE
Apogee Therapeutics
$38.46
+4.4%
+4.2%
The price history of APGE in the last 30 days
APG777 For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases
Phase 2
9/11/2025 - Data Apogee Therapeutics, Inc. announced data from the Phase 2 APEX trial of APG777 for moderate-to-seve…
Full Summary
Inspira Technologies OXY B.H.N. Ltd. stock logo
IINN
Inspira Technologies OXY B.H.N.
$1.16
+1.0%
-7.1%
The price history of IINN in the last 30 days
HYLA™ Blood Sensor 9/11/2025 - Positive Results Inspira™ Technologies announced pivotal results for its HYLA blood sensor, achieving 97.35% accurac…
Full Summary
PureTech Health PLC Sponsored ADR stock logo
PRTC
PureTech Health
$14.92
+1.5%
-24.8%
The price history of PRTC in the last 30 days
SPT-320 to treat generalized anxiety disorder
Phase 1
9/11/2025 - Dose Update PureTech Health plc announced that the first participant has been dosed in the Phase 1 study of Gl…
Full Summary
Protagonist Therapeutics, Inc. stock logo
PTGX
Protagonist Therapeutics
$60.01
+2.4%
+6.8%
The price history of PTGX in the last 30 days
IL-23 in Plaque Psoriasis EMA 9/11/2025 - Application Submitted Protagonist Therapeutics, Inc. announced the submission of an application to the European Medicines…
Full Summary
Avidity Biosciences, Inc. stock logo
RNA
Avidity Biosciences
$40.81
-1.5%
-8.3%
The price history of RNA in the last 30 days
del-zota for people living with Duchenne Muscular Dystrophy amenable to exon 44 skipping (DMD44). 9/10/2025 - Positive Data Avidity Biosciences, Inc. announced positive new data from participants treated continuously with de…
Full Summary
Karyopharm Therapeutics Inc. stock logo
KPTI
Karyopharm Therapeutics
$6.18
-1.4%
+10.5%
The price history of KPTI in the last 30 days
Selinexor Myelofibrosis
Phase 3
9/10/2025 - Enrollment Update Karyopharm Therapeutics Inc. announced that it has completed enrollment in the Phase 3 SENTRY trial…
Full Summary
Immuneering Corporation stock logo
IMRX
Immuneering
$8.13
-2.2%
+132.3%
The price history of IMRX in the last 30 days
Atebimetinib + mGnP in First-Line Pancreatic Cancer Patients Target date: September 25, 2025 9/10/2025 - Survival data Immuneering plans to announce updated overall survival data in first-line pancreatic cancer patients…
Full Summary
Greenwich LifeSciences, Inc. stock logo
GLSI
Greenwich LifeSciences
$11.25
-0.2%
-6.4%
The price history of GLSI in the last 30 days
GLSI-100 Breast cancer recurrences
Fast Track
9/10/2025 - Designation Grant Greenwich LifeSciences, Inc announced that FDA has granted Fast Track designation for GLSI-100 in t…
Full Summary
Treace Medical Concepts, Inc. stock logo
TMCI
Treace Medical Concepts
$7.16
+1.3%
+1.7%
The price history of TMCI in the last 30 days
ALIGN3D Surgical treatment of Hallux Valgus 9/10/2025 - Highlights Treace Medical Concepts, Inc announced it will highlight new product innovations and present new in…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$2.93
-2.0%
-48.3%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY) Schizophrenia and bipolar disorders
Phase 3
9/10/2025 - Efficacy Data BioXcel Therapeutics, announced positive topline exploratory efficacy data from the SERENITY At-Home…
Full Summary
Revolution Medicines, Inc. stock logo
RVMD
Revolution Medicines
$44.59
-0.3%
+22.3%
The price history of RVMD in the last 30 days
daraxonrasib For previously treated metastatic PDAC in patients with KRAS G12 mutations. 9/10/2025 - Provided Update Revolution Medicines, Inc announced key clinical updates from its daraxonrasib Phase 1 clinical tri…
Full Summary
Avidity Biosciences, Inc. stock logo
RNA
Avidity Biosciences
$40.81
-1.5%
-8.3%
The price history of RNA in the last 30 days
EXPLORE44 in People Living with DMD44 9/10/2025 - Positive Data Avidity Biosciences, Inc. announced positive new data from participants treated continuously with d…
Full Summary
Corcept Therapeutics Incorporated stock logo
CORT
Corcept Therapeutics
$74.69
+4.7%
+4.1%
The price history of CORT in the last 30 days
Relacorilant Recurrent Platinum-Resistant Ovarian Cancer
NDA
9/10/2025 - FDA Accepted Corcept Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) has a…
Full Summary
Arrowhead Pharmaceuticals, Inc. stock logo
ARWR
Arrowhead Pharmaceuticals
$30.05
+2.2%
+50.9%
The price history of ARWR in the last 30 days
ARO-MAPT Treatment of Alzheimer's Disease and Other Tauopathies Phase 1/2a 9/10/2025 - Provided Update Arrowhead Pharmaceuticals, Inc announced that it has filed a request for regulatory clearance to in…
Full Summary
Hoth Therapeutics, Inc. stock logo
HOTH
Hoth Therapeutics
$1.77
-3.4%
+37.0%
The price history of HOTH in the last 30 days
HT-001 Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR EMA 9/10/2025 - Clinical trial application Hoth Therapeutics, Inc announced it has submitted its Clinical Trial Application (CTA) to the Europ…
Full Summary
PMV Pharmaceuticals, Inc. stock logo
PMVP
PMV Pharmaceuticals
$1.33
+10.4%
-14.8%
The price history of PMVP in the last 30 days
rezatapopt in patients with advanced solid tumors
Phase 2
9/10/2025 - Interim Data PMV Pharmaceuticals, announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinic…
Full Summary
TG Therapeutics, Inc. stock logo
TGTX
TG Therapeutics
$32.34
+1.1%
+16.6%
The price history of TGTX in the last 30 days
BRIUMVI® (ublituximab-xiiy) For treat relapsing forms of multiple sclerosis (MS). 9/10/2025 - Presentation TG Therapeutics, Inc. announced the upcoming schedule of presentations highlighting BRIUMVI® (ublitu…
Full Summary
Instil Bio, Inc. stock logo
TIL
Instil Bio
$21.59
-6.3%
-25.2%
The price history of TIL in the last 30 days
AXN-2510 In Relapsed/Refractory Solid Tumors
Phase 1
9/10/2025 - Efficacy Data Instil Bio, Inc. announced that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. presented preliminary…
Full Summary
Assertio Holdings, Inc. stock logo
ASRT
Assertio
$0.94
+12.4%
+16.5%
The price history of ASRT in the last 30 days
SYMPAZAN treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age or older 9/10/2025 - Data Presentation Assertio Holdings, Inc. announced that the company will present new data for SYMPAZAN (clobazam) Ora…
Full Summary
Travere Therapeutics, Inc. stock logo
TVTX
Travere Therapeutics
$23.44
+2.9%
+24.9%
The price history of TVTX in the last 30 days
FILSPARI Endothelin and angiotensin II receptor antagonist indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a UPCR ≥1.5 g/g. supplemental New Drug Application (sNDA) 9/10/2025 - review Travere Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has informed t…
Full Summary
Incyte Corporation stock logo
INCY
Incyte
$85.62
+2.0%
+0.8%
The price history of INCY in the last 30 days
povorcitinib AK1 inhibitor 9/10/2025 - Data Presentation Incyte announced that it will present new data from its dermatology portfolio at the European Associ…
Full Summary
Waldencast PLC stock logo
WALD
Waldencast
$1.96
+10.1%
+8.8%
The price history of WALD in the last 30 days
MagIQ™ 9/10/2025 - FDA approved Waldencast plc announced that the U.S. Food and Drug Administration ("FDA") has approved Obagi® sayp…
Full Summary
Sight Sciences, Inc. stock logo
SGHT
Sight Sciences
$3.49
0.0%
-16.7%
The price history of SGHT in the last 30 days
OMNI Device Canal Viscodilation in Combination with Cataract Surgery in Adults with Primary Open-Angle Glaucoma (POAG) 9/9/2025 - Provided Update Sight Sciences, Inc. announced that UnitedHealthcare (UHC) has updated its Glaucoma Surgical Treatm…
Full Summary
Cullinan Therapeutics, Inc. stock logo
CGEM
Cullinan Therapeutics
$6.06
-3.7%
-23.8%
The price history of CGEM in the last 30 days
zipalertinib For patients with heavily pre-treated EGFR ex20ins mutation NSCLC 9/9/2025 - New Data Taiho Oncology, Inc., and Cullinan Therapeutics, Inc announced new data from the REZILIENT1 and RE…
Full Summary
Xilio Therapeutics, Inc. stock logo
XLO
Xilio Therapeutics
$0.76
-1.3%
+6.9%
The price history of XLO in the last 30 days
XTX301 Solid tumors
Phase 2
9/9/2025 - Dose Update Xilio Therapeutics, Inc. announced the initiation of patient dosing in Phase 2 of an ongoing Phase…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$61.64
+0.5%
+41.9%
The price history of IONS in the last 30 days
ION582 Angelman syndrome
Breakthrough Therapy
9/9/2025 - Designation Grant Ionis Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has granted B…
Full Summary
Aclaris Therapeutics, Inc. stock logo
ACRS
Aclaris Therapeutics
$1.85
+0.3%
-0.3%
The price history of ACRS in the last 30 days
ATI-2138 For the Treatment of Moderate to Severe Atopic Dermatitis
Phase 2a
9/9/2025 - Abstract Aclaris Therapeutics, Inc. announced that a late-breaking abstract on its open-label Phase 2a trial…
Full Summary
Emergent Biosolutions Inc. stock logo
EBS
Emergent Biosolutions
$7.84
+0.1%
-13.5%
The price history of EBS in the last 30 days
ACAM2000® For Mpox Indication 9/9/2025 - Provided Update Emergent BioSolutions Inc. announced that a contract modification has been executed in the amount …
Full Summary
Capricor Therapeutics, Inc. stock logo
CAPR
Capricor Therapeutics
$6.15
-1.2%
-20.2%
The price history of CAPR in the last 30 days
deramiocel For the treatment of Duchenne muscular dystrophy (DMD) BLA 9/9/2025 - Provided Update Capricor Therapeutics today issued a statement regarding the U.S. Food and Drug Administration's (F…
Full Summary
Moleculin Biotech, Inc. stock logo
MBRX
Moleculin Biotech
$0.39
+4.9%
-35.6%
The price history of MBRX in the last 30 days
Annamycin Soft tissue sarcoma (STS) lung metastases Phase 2b/3 9/9/2025 - Provided Update Moleculin Biotech, Inc announced updates to its active site status and recruitment for its pivotal …
Full Summary
Agenus Inc. stock logo
AGEN
Agenus
$4.54
+1.6%
+0.3%
The price history of AGEN in the last 30 days
BOT/BAL In Metastatic MSS Colorectal Cancer 9/9/2025 - Provided Update Agenus Inc announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now …
Full Summary
Nektar Therapeutics stock logo
NKTR
Nektar Therapeutics
$50.77
+1.8%
+85.1%
The price history of NKTR in the last 30 days
Rezpegaldesleukin For the treatment of atopic dermatitis.
Phase 2b
9/9/2025 - Presentation Nektar Therapeutics announced today that it will present results from the ongoing REZOLVE-AD Phase 2…
Full Summary
Chimerix, Inc. stock logo
CMRX
Chimerix
$8.54
dordaviprone treatment for recurrent H3 K27M-mutant diffuse glioma 9/9/2025 - Provided Update Jazz Pharmaceuticals plc announced that Modeyso™ (dordaviprone) is recommended by the National Comp…
Full Summary
Microbot Medical Inc. stock logo
MBOT
Microbot Medical
$3.32
-0.5%
+7.9%
The price history of MBOT in the last 30 days
LIBERTY® Robotic Surgical System Device 9/9/2025 - Provided Update Microbot Medical Inc. announced that Harel Gadot, CEO, President & Chairman, will highlight the rece…
Full Summary
Jazz Pharmaceuticals PLC stock logo
JAZZ
Jazz Pharmaceuticals
$129.55
+2.4%
+10.1%
The price history of JAZZ in the last 30 days
dordaviprone treatment for recurrent H3 K27M-mutant diffuse glioma 9/9/2025 - Provided Update Jazz Pharmaceuticals plc announced that Modeyso™ (dordaviprone) is recommended by the National Comp…
Full Summary
CRISPR Therapeutics AG stock logo
CRSP
CRISPR Therapeutics
$59.52
-2.7%
+3.3%
The price history of CRSP in the last 30 days
CTX310 Treatments for Cardiovascular Diseases 9/9/2025 - Late Breaking Presentation CRISPR Therapeutics announced that a late-breaking oral presentation highlighting the Company's Pha…
Full Summary
Alkermes plc stock logo
ALKS
Alkermes
$27.93
+2.0%
-0.6%
The price history of ALKS in the last 30 days
ALKS 2680 For the treatment of narcolepsy
Phase 2
9/8/2025 - Positive Results Alkermes plc announced detailed positive results from the Vibrance-1 phase 2 study evaluating alixor…
Full Summary
Takeda Pharmaceutical Co. stock logo
TAK
Takeda Pharmaceutical
$15.14
+0.1%
-0.3%
The price history of TAK in the last 30 days
TAK-861 In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Phase 3
9/8/2025 - Data Presentation Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of ovepore…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$763.36
-0.2%
+9.2%
The price history of LLY in the last 30 days
Pirtobrutinib A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Phase 3
9/8/2025 - Top-line results Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-313 clinical tr…
Full Summary
Pfizer Inc. stock logo
PFE
Pfizer
$24.08
+0.8%
-3.9%
The price history of PFE in the last 30 days
COMIRNATY® LP.8.1 For active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
Phase 3
9/8/2025 - Top-line results Pfizer Inc. and BioNTech SE announced positive topline results from an ongoing Phase 3 clinical tri…
Full Summary
TG Therapeutics, Inc. stock logo
TGTX
TG Therapeutics
$32.34
+1.1%
+16.6%
The price history of TGTX in the last 30 days
BRIUMVI® (ublituximab-xiiy) For treat relapsing forms of multiple sclerosis (MS).
Phase 3
9/8/2025 - Enrollment Update TG Therapeutics, Inc. announced today that enrollment has commenced in a Phase 3 trial evaluating su…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$583.69
+1.5%
+1.7%
The price history of REGN in the last 30 days
REGN1908 Antibody-Blockers of Cat and Birch Allergies
Phase 3
9/8/2025 - Results Regeneron Pharmaceuticals, Inc announced results evaluating its first-in-class investigational all…
Full Summary
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$28.01
+3.3%
-30.1%
The price history of TNXP in the last 30 days
Tonmya For the management of fibromyalgia. 9/8/2025 - Poster Presentation Tonix Pharmaceuticals presented four posters at the PAINWEEK conference 2025, held September 2-5, 20…
Full Summary
Pulse Biosciences, Inc stock logo
PLSE
Pulse Biosciences
$16.29
-2.1%
+3.9%
The price history of PLSE in the last 30 days
nsPFA Treatment of Atrial Fibrillation 9/8/2025 - FDA approved Pulse Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted approv…
Full Summary
IDEAYA Biosciences, Inc. stock logo
IDYA
IDEAYA Biosciences
$24.72
0.0%
-0.1%
The price history of IDYA in the last 30 days
Darovasertib Non-metastatic uveal melanoma (UM) 9/8/2025 - Data Presentation IDEAYA Biosciences, Inc. will present positive interim data at their 10-Year Anniversary R&D Day fro…
Full Summary
Keros Therapeutics, Inc. stock logo
KROS
Keros Therapeutics
$15.81
+0.0%
+8.8%
The price history of KROS in the last 30 days
KER-065 To treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins
Phase 1
9/8/2025 - Additional data Keros Therapeutics, announced that it presented additional clinical data from its Phase 1 clinical t…
Full Summary
Medicus Pharma Ltd stock logo
MDCX
Medicus Pharma
$2.40
-8.0%
+20.0%
The price history of MDCX in the last 30 days
SKNJCT-004 To Non-Invasively Treat Basal Cell Carcinoma of the Skin (BCC)
Phase 2
9/8/2025 - Clinical Study Medicus Pharma Ltd is pleased to announce that the SKNJCT-004 phase 2 clinical study, to non-invasi…
Full Summary

Frequently Asked Questions

This calendar tracks PDUFA target dates, NDA/BLA submissions and reviews, regulatory meeting outcomes, early-phase trial results, and special designations such as RMAT, Breakthrough Therapy, or orphan status.

The PDUFA date (Prescription Drug User Fee Act) is the FDA’s target deadline to approve or reject a New Drug Application (NDA) or Biologics License Application (BLA). These are major catalysts for biotech stocks, as a decision often triggers significant price movement.

What does the Status column indicate?

This column shows the current stage or outcome of the FDA-related event listed, such as PDUFA Target Date Set, CRL Issued, Approved, or Designation Granted. It gives you a quick snapshot of where the drug is in the regulatory process and what action has occurred (or is expected).

Phase 1: Focuses on safety and dosage in a small group of healthy volunteers.

Phase 2: Explores effectiveness and side effects in a larger patient group.

Phase 3: Confirms effectiveness, monitors side effects, and compares with standard treatments in large populations. This is usually the last step before FDA submission.

Submission means the company has filed an NDA or BLA with the FDA. Review is the FDA’s evaluation period leading up to the PDUFA date. Approval indicates the FDA has given the green light to market the drug.

A grant refers to an award of a designation (i.e., RMAT), while a target date usually refers to a PDUFA date (the FDA’s deadline to act on an NDA or BLA).

Special FDA designations are programs designed to expedite the development and review of promising therapies. Breakthrough Therapy designation is granted to drugs that may offer substantial improvement over existing treatments for serious conditions. Orphan Drug designation is awarded to treatments targeting rare diseases affecting fewer than 200,000 people in the U.S. Other fast-track designations include RMAT (Regenerative Medicine Advanced Therapy), Fast Track, and Accelerated Approval.

Yes, you can export the data to Excel for further sorting, filtering, or integration into personal analytics tools.

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process