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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
Tiziana Life Sciences Ltd stock logo
TLSA
Tiziana Life Sciences
$2.07
+5.1%
+8.9%
The price history of TLSA in the last 30 days
ECTRIMS Pathogenesis of neuroinflammatory diseases 9/25/2025 - Presentation Immunic, Inc announced the presentation of key data in an oral and four poster presentations, includ…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$77.70
-2.5%
-8.7%
The price history of MRK in the last 30 days
EV-303 For Certain Patients with Muscle-Invasive Bladder Cancer 9/25/2025 - Highlights Pfizer Inc will highlight data across its extensive Oncology portfolio at the European Society for M…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$43.45
-1.6%
-8.0%
The price history of BMY in the last 30 days
Deucravacitinib Moderate to severe plaque psoriasis 9/25/2025 - Expansion Bristol Myers Squibb announced an expansion of its direct-to-patient offerings, providing eligible …
Full Summary
AC Immune stock logo
ACIU
AC Immune
$2.91
+6.6%
+38.6%
The price history of ACIU in the last 30 days
ACI-35.030 Alzheimer’s Disease (AD) 9/25/2025 - Publication AC Immune SA announced the peer-reviewed publication in eBioMedicine of results from the completed P…
Full Summary
Leap Therapeutics, Inc. stock logo
LPTX
Leap Therapeutics
$0.35
+12.6%
+16.8%
The price history of LPTX in the last 30 days
DKN-01 Advanced gynecological malignancies 9/25/2025 - Results Leap Therapeutics, Inc announced it will present the final clinical results from Part B of the DeF…
Full Summary
Capricor Therapeutics, Inc. stock logo
CAPR
Capricor Therapeutics
$6.52
+5.3%
+0.8%
The price history of CAPR in the last 30 days
deramiocel For the treatment of Duchenne muscular dystrophy (DMD) BLA 9/25/2025 - Provided Update Capricor Therapeutics announced a regulatory update for its Biologics License Application (BLA) for …
Full Summary
MediWound Ltd. stock logo
MDWD
MediWound
$17.70
-1.8%
+5.1%
The price history of MDWD in the last 30 days
NexoBrid Enzymatically removes nonviable burn tissue Australian TGA Approval 9/25/2025 - Marketing authorization MediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketi…
Full Summary
Vericel Corporation stock logo
VCEL
Vericel
$29.84
-1.4%
-18.1%
The price history of VCEL in the last 30 days
NexoBrid Enzymatically removes nonviable burn tissue Australian TGA Approval 9/25/2025 - Marketing authorization MediWound Ltd. announced that Australia's Therapeutic Goods Administration (TGA) has granted marketi…
Full Summary
Anebulo Pharmaceuticals, Inc. stock logo
ANEB
Anebulo Pharmaceuticals
$2.44
-0.4%
-12.4%
The price history of ANEB in the last 30 days
Selonabant for Acute Cannabis-Induced Toxicity
Phase 1
9/25/2025 - Dose Update Anebulo Pharmaceuticals, Inc announces the first subjects dosed in its Phase 1 single ascending dos…
Full Summary
Vertex Pharmaceuticals Incorporated stock logo
VRTX
Vertex Pharmaceuticals
$381.87
+1.4%
-1.4%
The price history of VRTX in the last 30 days
inaxaplin APOL1-mediated kidney disease 9/25/2025 - Provided Update Vertex Pharmaceuticals Incorporated announced several important advancements across its programs i…
Full Summary
Vanda Pharmaceuticals Inc. stock logo
VNDA
Vanda Pharmaceuticals
$4.83
-1.4%
+3.4%
The price history of VNDA in the last 30 days
HETLIOZ For treat jet lag disorder 9/25/2025 - Publication Vanda Pharmaceuticals Inc. announced the publication of an article titled "Melatonin agonist tasime…
Full Summary
Tiziana Life Sciences Ltd stock logo
TLSA
Tiziana Life Sciences
$2.07
+5.1%
+8.9%
The price history of TLSA in the last 30 days
TZLS-501 A Fully Human anti-IL-6 receptor Monoclonal Antibody 9/25/2025 - Provided Update Tiziana Life Sciences, Ltd announces it will advance its second asset, a fully human anti-IL-6 recep…
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$16.61
-6.5%
+46.2%
The price history of NTLA in the last 30 days
nex-z For Transthyretin (ATTR) Amyloidosis with Polyneuropathy 9/25/2025 - Data Intellia Therapeutics, announced longer-term follow-up data from the ongoing Phase 1 study of invest…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$73.53
-2.4%
-8.1%
The price history of AZN in the last 30 days
ENHERTU® (fam-trastuzumab deruxtecan-nxki) For the treatment of adult patients with unresectable or metastatic HER2 positive sBLA Priority Review 9/24/2025 - FDA Accepted AstraZeneca and Daiichi Sankyo announced that supplemental Biologics License Application (sBLA) fo…
Full Summary
Burning Rock Biotech Limited Sponsored ADR stock logo
BNR
Burning Rock Biotech
$9.11
+2.2%
The price history of BNR in the last 30 days
Capivasertib in Breast Cancer MHLW Approval 9/24/2025 - Approved Riken Genesis Co., Ltd. and Burning Rock Biotech Limited announced that the OncoGuide™ OncoScreen™ P…
Full Summary
Cidara Therapeutics, Inc. stock logo
CDTX
Cidara Therapeutics
$84.76
-4.3%
+26.6%
The price history of CDTX in the last 30 days
CD388 Universal Prevention and Treatment of Influenza
Phase 3
9/24/2025 - Provided Update Cidara Therapeutics, Inc. announced updates to its planned Phase 3 registrational trial of CD388 fo…
Full Summary
FibroGen, Inc stock logo
FGEN
FibroGen
$12.24
-1.1%
+18.3%
The price history of FGEN in the last 30 days
FG-3246 In Patients with Metastatic Castration-Resistant Prostate Cancer
Phase 2
9/24/2025 - Initiation FibroGen, announced the initiation of the Phase 2 monotherapy, dose-optimization trial of FG-3246, a…
Full Summary
ACADIA Pharmaceuticals Inc. stock logo
ACAD
ACADIA Pharmaceuticals
$21.21
-0.2%
-17.5%
The price history of ACAD in the last 30 days
ACP-101 For the treatment of hyperphagia in Prader-Willi syndrome (PWS).
Phase 3
9/24/2025 - Top-line results Acadia Pharmaceuticals Inc. announced top-line results from the Phase 3 COMPASS PWS trial evaluati…
Full Summary
Summit Therapeutics PLC stock logo
SMMT
Summit Therapeutics
$20.26
-1.2%
-24.9%
The price history of SMMT in the last 30 days
Ivonescimab For Lung cancer
Phase 3
9/24/2025 - Data Summit Therapeutics Inc announced that data from the Phase III HARMONi-6 trial, conducted in China…
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$135.67
-1.5%
-0.8%
The price history of BIIB in the last 30 days
Lecanemab (BAN2401) Anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease (AD) Australian TGA Approval 9/24/2025 - Approved Eisai Co. and Biogen Inc. announced that the Therapeutic Goods Administration (TGA) of Australia has…
Full Summary
Envoy Medical, Inc. stock logo
COCH
Envoy Medical
$0.85
+2.8%
-27.3%
The price history of COCH in the last 30 days
Acclaim for Breakthrough Hearing Device 9/24/2025 - Provided Update Envoy Medical® Inc announced it is scaling its commercialization planning for the company's breakthr…
Full Summary
NRx Pharmaceuticals, Inc. stock logo
NRXP
NRx Pharmaceuticals
$2.91
-2.7%
+10.6%
The price history of NRXP in the last 30 days
KETAFREE™ preservative-free ketamine product 9/24/2025 - Provided Update NRx Pharmaceuticals, announced that it was notified yesterday by the United States Food and Drug Ad…
Full Summary
Harmony Biosciences Holdings, Inc. stock logo
HRMY
Harmony Biosciences
$27.04
+1.0%
-27.3%
The price history of HRMY in the last 30 days
ZYN002 In Fragile X Syndrome
Phase 3
9/24/2025 - Top-line results Harmony Biosciences Holdings, Inc announced topline results from its Phase 3 registrational clinica…
Full Summary
Cellectar Biosciences, Inc. stock logo
CLRB
Cellectar Biosciences
$5.75
-0.5%
+20.8%
The price history of CLRB in the last 30 days
CLR 125 For the treatment of relapsed TNBC.
Phase 1b
9/24/2025 - Provided Update Cellectar Biosciences, Inc. have entered into an agreement whereby Evestia will provide Cellectar w…
Full Summary
Akari Therapeutics PLC stock logo
AKTX
Akari Therapeutics
$1.12
+0.9%
+30.2%
The price history of AKTX in the last 30 days
AR-V7 for the treatment of tumors fueled by alternative splicing-drivers, such as the Androgen Receptor splice variant 7 (AR-V7) in prostate cancer. 9/24/2025 - Preclinical Data Akari Therapeutics announced key preclinical data demonstrating the potential of its novel antibody…
Full Summary
Sanofi stock logo
SNY
Sanofi
$45.07
-2.9%
-10.4%
The price history of SNY in the last 30 days
SAR446268 for the treatment of non-congenital myotonic dystrophy type 1
Fast Track
9/23/2025 - Designation Grant Sanofi announced that The US Food and Drug Administration (FDA) has granted fast track designation …
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$218.23
-0.8%
+4.7%
The price history of ABBV in the last 30 days
SKINVIVE Advancing Global Skin Quality 9/23/2025 - Roll Out Allergan Aesthetics, an AbbVie company announced the roll-out of SKINVIVE by JUVÉDERM® in 35 additi…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$43.45
-1.6%
-8.0%
The price history of BMY in the last 30 days
iberdomide Relapsed or Refractory Multiple Myeloma
Phase 3
9/23/2025 - evaluation Bristol Myers Squibb announced that the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an inve…
Full Summary
Elanco Animal Health Incorporated stock logo
ELAN
Elanco Animal Health
$18.93
+1.0%
+5.7%
The price history of ELAN in the last 30 days
Zenrelia Treatment for canine allergic itch and inflammation 9/23/2025 - Provided Update Elanco Animal Health nnounced important updates to the U.S. Zenrelia label, following the Food and …
Full Summary
Seres Therapeutics, Inc. stock logo
MCRB
Seres Therapeutics
$18.90
-2.5%
-2.3%
The price history of MCRB in the last 30 days
SER-155 Prevention of Antibiotic-Resistant Bacterial Infections and Graft-versus-Host Disease (GvHD)
Phase 2
9/23/2025 - Feedback Seres Therapeutics, announced receipt of additional constructive feedback from the U.S. Food and Dr…
Full Summary
atai Life Sciences N.V. stock logo
ATAI
atai Life Sciences
$5.17
-5.8%
+7.0%
The price history of ATAI in the last 30 days
BPL-003 In Patients With Treatment Resistant Depression 9/23/2025 - Positive Data atai Life Sciences announced positive data from a proof-of-concept study investigating a two-dose in…
Full Summary
Scholar Rock Holding Corporation stock logo
SRRK
Scholar Rock
$34.49
+2.3%
+2.1%
The price history of SRRK in the last 30 days
Apitegromab Type 2 and Type 3 Spinal Muscular Atrophy (SMA) 9/23/2025 - Complete Response Letter Scholar Rock announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Respo…
Full Summary
Moderna, Inc. stock logo
MRNA
Moderna
$24.61
-4.9%
-0.5%
The price history of MRNA in the last 30 days
COVID-19 vaccine Covid-19 9/23/2025 - Positive Data Moderna, Inc. announced positive preliminary immunogenicity data for the 2025-2026 formula of mNEXS…
Full Summary
Sensei Biotherapeutics, Inc. stock logo
SNSE
Sensei Biotherapeutics
$8.77
-2.8%
+8.3%
The price history of SNSE in the last 30 days
Solnerstotug in PD-(L)1 Resistant Tumors 9/23/2025 - Provided Update Sensei Biotherapeutics, Inc. announced that it will host a virtual key opinion leader (KOL) event on…
Full Summary
SeaStar Medical Holding Corporation stock logo
ICU
SeaStar Medical
$0.61
-50.9%
-32.3%
The price history of ICU in the last 30 days
QUELIMMUNE For the treatment of children weighing 10 kilograms or more with acute kidney injury (AKI) and sepsis or septic condition requiring kidney replacement therapy (KRT). 9/23/2025 - Results SeaStar Medical Holding Corporation announced today that preliminary results from the SAVE Surveill…
Full Summary
Tevogen Bio Holdings Inc. stock logo
TVGN
Tevogen Bio
$0.79
+1.5%
-14.8%
The price history of TVGN in the last 30 days
TVGN 489 To treat acute, high-risk Covid-19 patients. 9/23/2025 - Provided Update Tevogen today highlights emerging scientific evidence linking persistent viral reservoirs to Long CO…
Full Summary
Veru Inc. stock logo
VERU
Veru
$3.59
+4.1%
+3.5%
The price history of VERU in the last 30 days
Enobosarm ER+/HER2- breast cancer 9/23/2025 - FDA Meeting Veru Inc announced a successful meeting with FDA providing regulatory clarity for enobosarm, a selec…
Full Summary
Neurocrine Biosciences, Inc. stock logo
NBIX
Neurocrine Biosciences
$140.89
-3.9%
+3.0%
The price history of NBIX in the last 30 days
INGREZZA (Valbenazine) Tardive Dyskinesia 9/23/2025 - New Data Neurocrine Biosciences, announced new data from a post-hoc analysis of the Phase 4 KINECT-PRO™ ope…
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$135.67
-1.5%
-0.8%
The price history of BIIB in the last 30 days
nusinersen In Treatment of spinal muscular atrophy (SMA). 9/23/2025 - Complete Response Letter Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Le…
Full Summary
MBX Biosciences, Inc. stock logo
MBX
MBX Biosciences
$17.33
-13.8%
+12.8%
The price history of MBX in the last 30 days
canvuparatide for Hypoparathyroidism
Phase 2
9/22/2025 - Primary Endpoint MBX Biosciences, Inc. announced once-weekly canvuparatide achieved the primary endpoint with statis…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$62.97
-1.5%
+49.3%
The price history of IONS in the last 30 days
Zilganersen for the treatment of children and adults Alexander disease (AxD). 9/22/2025 - Top-line results Ionis Pharmaceuticals, Inc announced positive topline results from the pivotal study of zilganersen…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$62.97
-1.5%
+49.3%
The price history of IONS in the last 30 days
Zilganersen for the treatment of children and adults Alexander disease (AxD). Target date: Q1 2026 9/22/2025 - NDA Filing Ionis Pharmaceuticals, Inc announced that NDA submission planned in Q1 2026
Full Summary
Exact Sciences Corporation stock logo
EXAS
Exact Sciences
$53.68
+1.1%
+16.4%
The price history of EXAS in the last 30 days
Cologuard test For CRC screening 9/22/2025 - Provided Update Exact Sciences Corp. a leading provider of cancer screening and diagnostic tests, is teaming up wit…
Full Summary
Insmed, Inc. stock logo
INSM
Insmed
$135.59
-3.8%
+2.6%
The price history of INSM in the last 30 days
Treprostinil Palmitil Inhalation Powder (TPIP) Pulmonary arterial hypertension (PAH) 9/22/2025 - Abstract Insmed Incorporated announced that it will present seven abstracts from across its late-stage portf…
Full Summary
BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$49.00
-3.3%
+0.3%
The price history of BBIO in the last 30 days
Acoramidis (ATTRibute-CM) Symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) 9/22/2025 - Late Breaking Presentation BridgeBio Pharma, Inc. announced today that one late breaking clinical trials oral presentation, o…
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$16.61
-6.5%
+46.2%
The price history of NTLA in the last 30 days
nex-z For Transthyretin (ATTR) Amyloidosis with Polyneuropathy
Phase 1
9/22/2025 - Data Intellia Therapeutics, announced that longer-term data from the ongoing Phase 1 trial of investiga…
Full Summary
Gossamer Bio, Inc. stock logo
GOSS
Gossamer Bio
$2.78
-7.0%
+9.9%
The price history of GOSS in the last 30 days
seralutinib Treatment of Pulmonary Arterial Hypertension 9/22/2025 - Presentation Gossamer Bio, Inc announced that five scientific presentations related to seralutinib will be prese…
Full Summary
Jazz Pharmaceuticals PLC stock logo
JAZZ
Jazz Pharmaceuticals
$127.80
-1.4%
+2.2%
The price history of JAZZ in the last 30 days
Xywav Idiopathic hypersomnia Phase 4 9/22/2025 - New Data Jazz Pharmaceuticals plc announced new real-world evidence and Phase 4 data reinforcing the value o…
Full Summary
Acasti Pharma Inc. stock logo
ACST
Acasti Pharma
$3.11
GTX-104 IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)
Phase 3
9/22/2025 - Results Grace Therapeutics, Inc. announced that results from its Pivotal Phase 3 STRIVE-ON Safety Trial of G…
Full Summary
Adverum Biotechnologies, Inc. stock logo
ADVM
Adverum Biotechnologies
$4.31
-0.7%
+36.4%
The price history of ADVM in the last 30 days
Ixo-vec For the Treatment of Wet AMD
Phase 3
9/22/2025 - Provided Update Adverum Biotechnologies, Inc announced it has notified sites that it plans to complete screening i…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.30
-3.7%
-6.5%
The price history of MIRA in the last 30 days
Ketamir-2 To treat depression and treatment-resistant depression (TRD).
Phase 1
9/22/2025 - Top-line results MIRA Pharmaceuticals, Inc announced topline results from the single ascending dose (SAD) portion o…
Full Summary
Allarity Therapeutics, Inc. stock logo
ALLR
Allarity Therapeutics
$1.54
-5.5%
+7.7%
The price history of ALLR in the last 30 days
stenoparib (2X-121) ovarian cancer
Phase 2
9/22/2025 - Provided Update Allarity Therapeutics, Inc. presented new and updated clinical data from the ongoing Phase 2 clinica…
Full Summary
Anixa Biosciences Inc stock logo
ANIX
Anixa Biosciences
$3.38
-1.7%
+13.0%
The price history of ANIX in the last 30 days
alpha-lactalbumin In high risk operable triple negative breast cancer
Phase 1
9/22/2025 - Results Anixa Biosciences, Inc announced that final results from the Phase 1 clinical trial of its breast c…
Full Summary
Prima BioMed Ltd stock logo
IMMP
Prima BioMed
$1.68
-0.6%
-0.6%
The price history of IMMP in the last 30 days
eftilagimod alpha For cancer and autoimmune disease
Phase 2
9/22/2025 - evaluation Immutep Limited announces the initiation of an investigator-initiated Phase II trial evaluating neoa…
Full Summary
Achieve Life Sciences, Inc. stock logo
ACHV
Achieve Life Sciences
$2.97
-3.6%
-4.8%
The price history of ACHV in the last 30 days
cytisinicline For the treatment of nicotine dependence 9/22/2025 - Publication Achieve Life Sciences, Inc. announced the publication of new data in Thorax demonstrating that cyti…
Full Summary
CRISPR Therapeutics AG stock logo
CRSP
CRISPR Therapeutics
$60.32
-1.2%
+9.9%
The price history of CRSP in the last 30 days
SRSD107 for Thromboembolic Disorders
Phase 2
9/22/2025 - Dose Update CRISPR Therapeutics announced that the first patient has been dosed in a Phase 2 clinical trial of …
Full Summary
Actuate Therapeutics, Inc. stock logo
ACTU
Actuate Therapeutics
$6.65
-5.3%
-18.8%
The price history of ACTU in the last 30 days
elraglusib In relapsed/refractory Ewing Sarcoma (r/r EWS). 9/22/2025 - Provided Update Actuate Therapeutics, Inc. announced a corporate update on the regulatory path for elraglusib in pan…
Full Summary
Neurocrine Biosciences, Inc. stock logo
NBIX
Neurocrine Biosciences
$140.89
-3.9%
+3.0%
The price history of NBIX in the last 30 days
NBI-1065845 In Adults with Major Depressive Disorder
Phase 2
9/22/2025 - Presentation Neurocrine Biosciences, announced the presentation of new data from the Phase 2 SAVITRI™ study, whi…
Full Summary
Celcuity, Inc. stock logo
CELC
Celcuity
$51.94
-3.8%
+5.0%
The price history of CELC in the last 30 days
VIKTORIA-1 in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer 9/22/2025 - Abstract Celcuity Inc. announced that a late breaking abstract reporting clinical data from the Phase 3 VIKT…
Full Summary
Sanofi stock logo
SNY
Sanofi
$45.07
-2.9%
-10.4%
The price history of SNY in the last 30 days
Tolebrutinib Bruton’s tyrosine kinase (BTK) inhibitor Target date: December 28, 2025 9/22/2025 - Target action date Sanofi SA announced that the U.S. Food and Drug Administration (FDA) extended the review date for ne…
Full Summary
Corcept Therapeutics Incorporated stock logo
CORT
Corcept Therapeutics
$82.73
-1.3%
+18.9%
The price history of CORT in the last 30 days
Relacorilant Recurrent Platinum-Resistant Ovarian Cancer
Phase 3
9/22/2025 - New Data Corcept Therapeutics Incorporated will present new data from its pivotal Phase 3 ROSELLA trial of re…
Full Summary
Lexicon Pharmaceuticals, Inc. stock logo
LXRX
Lexicon Pharmaceuticals
$1.34
+0.8%
+17.5%
The price history of LXRX in the last 30 days
sotagliflozin INPEFA™ (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). 9/22/2025 - Additional data Lexicon Pharmaceuticals, Inc. announced an update to the previous submission of additional clinical …
Full Summary
Delcath Systems, Inc. stock logo
DCTH
Delcath Systems
$10.86
-1.5%
-2.3%
The price history of DCTH in the last 30 days
CHOPIN for percutaneous hepatic perfusion with melphalan in patients with metastatic uveal melanoma.
Phase 2
9/22/2025 - Oral presentation Delcath Systems, Inc announced the acceptance of an oral presentation on results from the investigat…
Full Summary
C4 Therapeutics, Inc. stock logo
CCCC
C4 Therapeutics
$2.19
-9.5%
-14.8%
The price history of CCCC in the last 30 days
cemsidomide IKZF1/3 Degrader
Phase 1
9/20/2025 - Data Presentation C4 Therapeutics, Inc. today presented data from the Phase 1 clinical trial of cemsidomide, an orally…
Full Summary
Teva Pharmaceutical Industries Ltd. stock logo
TEVA
Teva Pharmaceutical Industries
$18.43
-4.4%
+1.4%
The price history of TEVA in the last 30 days
TEV-749 In adult patients with schizophrenia 9/20/2025 - Presentation Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the presenta…
Full Summary
Teva Pharmaceutical Industries Ltd. stock logo
TEVA
Teva Pharmaceutical Industries
$18.43
-4.4%
+1.4%
The price history of TEVA in the last 30 days
AUSTEDO (deutetrabenazine) Tardive dyskinesia and a review of clinical outcome measures in schizophrenia 9/20/2025 - Presentation Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd announced the presenta…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$77.70
-2.5%
-8.7%
The price history of MRK in the last 30 days
KEYTRUDA®(pembrolizumab) For the treatment of patients with locally advanced or metastatic urothelial carcinoma EMA 9/19/2025 - Positive Opinion Merck announced that announced that the European Medicines Agency's Committee for Medicinal Products…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$77.70
-2.5%
-8.7%
The price history of MRK in the last 30 days
ENFLONSIA™ In Infants Born During or Entering Their First RSV Season EMA 9/19/2025 - Recommended Approval Merck announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European…
Full Summary
Syndax Pharmaceuticals, Inc. stock logo
SNDX
Syndax Pharmaceuticals
$15.03
+0.1%
-5.2%
The price history of SNDX in the last 30 days
Revumenib Relapsed/Refractory KMT2Ar Acute Leukemia 9/19/2025 - Provided Update Syndax Pharmaceuticals announced that the National Comprehensive Cancer Network® (NCCN®) Clinical P…
Full Summary
KalVista Pharmaceuticals, Inc. stock logo
KALV
KalVista Pharmaceuticals
$12.10
-6.4%
-8.1%
The price history of KALV in the last 30 days
sebetralstat Therapy for hereditary angioedema (HAE). EMA 9/19/2025 - Approved KalVista Pharmaceuticals, Inc announced that the European Commission (EC) and Swiss Agency for Ther…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$62.97
-1.5%
+49.3%
The price history of IONS in the last 30 days
Olezarsen (Formerly IONIS-APOCIII-L) Severe hypertriglyceridemia 9/19/2025 - Presentation Ionis Pharmaceuticals, Inc announced that TRYNGOLZA® (olezarsen) has been approved in the European …
Full Summary
SAB Biotherapeutics, Inc. stock logo
SABS
SAB Biotherapeutics
$2.10
-2.8%
-2.8%
The price history of SABS in the last 30 days
SAB-142 Anti-thymocyte hpAB therapeutic 9/19/2025 - Highlights SAB Biotherapeutics, Inc. today highlighted multiple presentations made at the 61st Annual Meeting o…
Full Summary
United Therapeutics Corporation stock logo
UTHR
United Therapeutics
$425.42
-3.0%
+37.6%
The price history of UTHR in the last 30 days
Tyvaso (Treprostinil) Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) 9/19/2025 - Provided Update United Therapeutics Corporation announced today that it will host a webcast to review data from the…
Full Summary
Verrica Pharmaceuticals Inc. stock logo
VRCA
Verrica Pharmaceuticals
$4.09
-1.9%
-31.5%
The price history of VRCA in the last 30 days
YCANTH™ (cantharidin) For molluscum contagiosum, which is primarily a pediatric disease. MHLW Approval 9/19/2025 - Approved Verrica Pharmaceuticals Inc. announced that its development partner, Torii Pharmaceutical Co. Ltd. …
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$177.71
+0.6%
+0.6%
The price history of JNJ in the last 30 days
TECVAYLI For patients with newly diagnosed multiple myeloma 9/19/2025 - Provided Update Johnson & Johnson announced that an investigational immune-based induction regimen with TECVAYLI® (…
Full Summary
GENFIT S.A. Unsponsored ADR stock logo
GNFT
GENFIT
$3.53
-2.8%
-13.9%
The price history of GNFT in the last 30 days
VS-01 in ACLF (Acute-on-Chronic Liver Failure) 9/19/2025 - Discontinue GENFIT announced its decision to discontinue its VS-01 program in ACLF (Acute-on-Chronic Liver Fail…
Full Summary
MBX Biosciences, Inc. stock logo
MBX
MBX Biosciences
$17.33
-13.8%
+12.8%
The price history of MBX in the last 30 days
canvuparatide for Hypoparathyroidism
Phase 2
Target date: September 22, 2025
9/19/2025 - Top-line results MBX Biosciences, Inc. announced that it will provide topline results from its Phase 2 clinical tria…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$177.71
+0.6%
+0.6%
The price history of JNJ in the last 30 days
Guselkumab For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis 9/19/2025 - FDA approved Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved a subcut…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$77.70
-2.5%
-8.7%
The price history of MRK in the last 30 days
KEYTRUDA QLEX™ Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab) 9/19/2025 - FDA approved Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™(pembrol…
Full Summary
Greenwich LifeSciences, Inc. stock logo
GLSI
Greenwich LifeSciences
$10.42
-4.8%
-12.7%
The price history of GLSI in the last 30 days
GLSI-100 Breast cancer recurrences 9/18/2025 - Provided Update Greenwich LifeSciences, In announced the expansion of FLAMINGO-01 clinical trial to Ireland.
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$73.53
-2.4%
-8.1%
The price history of AZN in the last 30 days
AIRSUPRA For asthma
Phase 3b
9/18/2025 - Provided Update Astrazeneca announced that The BATURA Phase IIIb trial, which evaluated severe exacerbation risk red…
Full Summary
Trevi Therapeutics, Inc. stock logo
TRVI
Trevi Therapeutics
$8.46
-0.1%
+14.0%
The price history of TRVI in the last 30 days
Haduvio (nalbuphine ER). IPF Chronic Cough
Phase 2a
9/18/2025 - Data Trevi Therapeutics, announced that data from the Phase 2a RIVER trial of nalbuphine ER for the trea…
Full Summary
Gain Therapeutics, Inc. stock logo
GANX
Gain Therapeutics
$1.73
-0.6%
-9.9%
The price history of GANX in the last 30 days
GT-02287 For Parkinson Disease
Phase 1b
9/18/2025 - Study Expansion Gain Therapeutics, Inc. announced the start of the Phase 1b extension study allowing participants …
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$16.61
-6.5%
+46.2%
The price history of NTLA in the last 30 days
onvo-z hereditary angioedema
Phase 3
9/18/2025 - Enrollment Update Intellia Therapeutics, announced it has completed enrollment in the global Phase 3 HAELO study of l…
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$16.61
-6.5%
+46.2%
The price history of NTLA in the last 30 days
onvo-z hereditary angioedema Target date: H1 2026 9/18/2025 - Top-line data Intellia Therapeutics, announced that Topline data are expected in the first half of 2026.
Full Summary
Phio Pharmaceuticals Corp. stock logo
PHIO
Phio Pharmaceuticals
$2.20
-1.3%
+7.8%
The price history of PHIO in the last 30 days
PH-762 (INTASYL) Murine colorectal cancer 9/18/2025 - Presentation Phio Pharmaceuticals Corp announced that Phio Pharmaceuticals is a presenting company at the Life S…
Full Summary
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$24.00
-2.8%
-29.4%
The price history of TNXP in the last 30 days
TNX-102 SL Fibromyalgia FDA Type B Meeting 9/18/2025 - FDA Meeting Tonix Pharmaceuticals announced the successful completion of a Type B Pre-Investigational New Drug…
Full Summary
Acasti Pharma Inc. stock logo
ACST
Acasti Pharma
$3.11
GTX-104 IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH) 9/18/2025 - Provided Update Grace Therapeutics, Inc announced that the U.S. Patent and Trademark Office has issued a U.S. Paten…
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Vertex Pharmaceuticals Incorporated stock logo
VRTX
Vertex Pharmaceuticals
$381.87
+1.4%
-1.4%
The price history of VRTX in the last 30 days
CASGEVY For the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT) 9/18/2025 - Provided Update Vertex Pharmaceuticals announced today a reimbursement agreement with the Italian Medicines Agency (…
Full Summary
Nektar Therapeutics stock logo
NKTR
Nektar Therapeutics
$55.62
-7.8%
+93.3%
The price history of NKTR in the last 30 days
Rezpegaldesleukin For the treatment of atopic dermatitis.
Phase 2b
9/18/2025 - New Data Nektar Therapeutics announced new data from the ongoing REZOLVE-AD Phase 2b study of rezpegaldesleuk…
Full Summary
PDS Biotechnology Corporation stock logo
PDSB
PDS Biotechnology
$1.03
-2.8%
-20.2%
The price history of PDSB in the last 30 days
VERSATILE-002 Treatment of recurrent or metastatic human papillomavirus (HPV)16-positive head and neck cancer.
Phase 2
9/18/2025 - Provided Update PDS Biotechnology announced details of a sub-analysis of the cohort of patients with low PD-L1 expr…
Full Summary
Incyte Corporation stock logo
INCY
Incyte
$81.66
-3.0%
-2.8%
The price history of INCY in the last 30 days
Opzelura® (Ruxolitinib) treatment of mild to moderate atopic dermatitis 9/18/2025 - FDA approved Incyte y announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura® (ruxoliti…
Full Summary
Oruka Therapeutics, Inc. stock logo
ORKA
Oruka Therapeutics
$15.05
-1.4%
+1.6%
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
Innate Pharma S.A. Sponsored ADR stock logo
IPHA
Innate Pharma
$1.82
-1.1%
-11.7%
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
Incyte Corporation stock logo
INCY
Incyte
$81.66
-3.0%
-2.8%
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
Arcutis Biotherapeutics, Inc. stock logo
ARQT
Arcutis Biotherapeutics
$16.73
-3.3%
+5.7%
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
Celldex Therapeutics, Inc. stock logo
CLDX
Celldex Therapeutics
$25.25
-1.4%
+16.1%
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
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$24.00
-2.8%
-29.4%
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
Roivant Sciences Ltd. stock logo
ROIV
Roivant Sciences
$14.96
+1.8%
+26.4%
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
Kymera Therapeutics, Inc. stock logo
KYMR
Kymera Therapeutics
$53.74
+2.4%
+22.5%
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

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