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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
IMMURON stock logo
IMRN
IMMURON
$2.27
+13.3%
+21.1%
The price history of IMRN in the last 30 days
IMM-529 Oral polyclonal antibody, targeting toxin B in the human gut and neutralises main virulence factors of Clostridium infection
IND
10/8/2025 - IND Submission Immuron Limited announce that it has submitted an Investigational New Drug (IND) application to th…
Full Summary
Aquestive Therapeutics, Inc. stock logo
AQST
Aquestive Therapeutics
$6.20
+3.9%
+23.8%
The price history of AQST in the last 30 days
Anaphylm For epinephrine prodrug candidate product 10/8/2025 - Provided Update Aquestive Therapeutics, Inc announced the United States Patent and Trademark Office (USPTO) has iss…
Full Summary
Medtronic PLC stock logo
MDT
Medtronic
$97.88
-0.5%
+5.4%
The price history of MDT in the last 30 days
Hugo for gynecological procedures 10/8/2025 - Clinical Study Medtronic plc announced the start of the Embrace Gynecology investigational device exemption (IDE) …
Full Summary
Abeona Therapeutics Inc. stock logo
ABEO
Abeona Therapeutics
$5.54
+5.5%
-17.3%
The price history of ABEO in the last 30 days
ZEVASKYN To Treat Wounds in Painful Skin Disorder 10/8/2025 - Provided Update Abeona Therapeutics Inc announced activation of Children's Colorado as the newest Qualified Treatme…
Full Summary
Trevi Therapeutics, Inc. stock logo
TRVI
Trevi Therapeutics
$9.82
+2.8%
+29.2%
The price history of TRVI in the last 30 days
nalbuphine ER chronic cough in patients with idiopathic pulmonary fibrosis (IPF) 10/8/2025 - Abstract Presentation Trevi Therapeutics, announced the acceptance of two abstracts for presentation at the CHEST 2025 An…
Full Summary
Aardvark Therapeutics, Inc. stock logo
AARD
Aardvark Therapeutics
$17.13
-1.6%
+108.9%
The price history of AARD in the last 30 days
ARD-101 for Prader-Willi Syndrome 10/8/2025 - Provided Update Aardvark Therapeutics, Inc announces alignment with the U.S. Food and Drug Administration (FDA) on…
Full Summary
Werewolf Therapeutics, Inc. stock logo
HOWL
Werewolf Therapeutics
$1.88
-2.6%
+41.4%
The price history of HOWL in the last 30 days
WTX-124 Solid Tumors
Fast Track
10/8/2025 - Designation Grant Werewolf Therapeutics, Inc. announced that the Company has received Fast Track Designation for the …
Full Summary
Astria Therapeutics, Inc. stock logo
ATXS
Astria Therapeutics
$8.40
+12.4%
+13.1%
The price history of ATXS in the last 30 days
Navenibart For the Treatment of Hereditary Angioedema
Phase 3
10/8/2025 - Initiation Astria Therapeutics, Inc. announced the initiation of the Phase 3 ORBIT-EXPANSE long-term trial of …
Full Summary
Rigel Pharmaceuticals, Inc. stock logo
RIGL
Rigel Pharmaceuticals
$28.76
-2.5%
-29.6%
The price history of RIGL in the last 30 days
R289 For Lower-Risk MDS
Phase 1b
10/8/2025 - Enrollment Update Rigel Pharmaceuticals, Inc nnounced the first patient has been enrolled in the dose expansion phase…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$85.38
-0.6%
+4.7%
The price history of AZN in the last 30 days
Bax24 Patients with treatment-resistant hypertension (rHTN) 10/7/2025 - Results AstraZeneca announced Positive high-level results from the Bax24 Phase III trial showed baxdrostat …
Full Summary
Adicet Bio, Inc. stock logo
ACET
Adicet Bio
$0.93
+8.9%
+21.7%
The price history of ACET in the last 30 days
ADI-001 B cell non-Hodgkin's lymphoma (NHL) 10/7/2025 - Efficacy and Safety Data Adicet Bio, Inc announced initial safety and efficacy data from the first seven patients dosed with …
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$845.55
+0.2%
+14.5%
The price history of LLY in the last 30 days
mirikizumab-mrkz For Crohn's disease 10/7/2025 - New Data New data from Eli Lilly and Company showed Omvoh (mirikizumab-mrkz) is the first and only interleuki…
Full Summary
Akero Therapeutics, Inc. stock logo
AKRO
Akero Therapeutics
$46.49
+1.1%
+4.3%
The price history of AKRO in the last 30 days
Efruxifermin Non-alcoholic steatohepatitis (NASH) 10/7/2025 - Upcoming presentations Akero Therapeutics, Inc. announced two upcoming oral presentations and a poster presentation at th…
Full Summary
Enanta Pharmaceuticals, Inc. stock logo
ENTA
Enanta Pharmaceuticals
$11.30
+2.0%
+26.8%
The price history of ENTA in the last 30 days
EDP-323 Eduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B 10/7/2025 - Data Enanta Pharmaceuticals, Inc announced that data for EDP-323, it's oral, once-daily L-protein inhibi…
Full Summary
Enanta Pharmaceuticals, Inc. stock logo
ENTA
Enanta Pharmaceuticals
$11.30
+2.0%
+26.8%
The price history of ENTA in the last 30 days
zelicapavir For respiratory syncytial virus 10/7/2025 - Data Enanta Pharmaceuticals, Inc announced that data for zelicapavir, its oral, once-daily, N-protein i…
Full Summary
Pulse Biosciences, Inc stock logo
PLSE
Pulse Biosciences
$19.94
+0.4%
+32.6%
The price history of PLSE in the last 30 days
nPulse™ Cardiac Surgical System treatment of atrial fibrillation (AF) 10/7/2025 - Upcoming presentations Pulse Biosciences, Inc. announced the upcoming presentation of early clinical data on the treatment…
Full Summary
Novavax, Inc. stock logo
NVAX
Novavax
$8.90
-3.5%
+15.1%
The price history of NVAX in the last 30 days
Nuvaxovid Covid-19 10/7/2025 - Provided Update Novavax, Inc. announced that it has completed the transfer of the marketing authorization for its CO…
Full Summary
Arrowhead Pharmaceuticals, Inc. stock logo
ARWR
Arrowhead Pharmaceuticals
$36.94
+1.1%
+36.0%
The price history of ARWR in the last 30 days
ARO-DIMER-PA for the Treatment of Mixed Hyperlipidemia 10/7/2025 - Provided Update Arrowhead Pharmaceuticals, Inc. announced that it has filed a request for regulatory clearance to i…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$189.75
+0.5%
+6.4%
The price history of JNJ in the last 30 days
apalutamide For the treatment of prostate cancer (nmCRPC) 10/7/2025 - Presentation Kairos Pharma, Ltd. announced that it has been selected to present at the European Society for Medic…
Full Summary
Atea Pharmaceuticals, Inc. stock logo
AVIR
Atea Pharmaceuticals
$3.10
+4.4%
-4.6%
The price history of AVIR in the last 30 days
Bemnifosbuvir COVID-19 10/7/2025 - New Data Atea Pharmaceuticals, Inc. announced that new data will be presented supporting the combination reg…
Full Summary
Arbutus Biopharma Corporation stock logo
ABUS
Arbutus Biopharma
$4.18
-2.6%
+2.2%
The price history of ABUS in the last 30 days
AB-101 Oral PD-L1 inhibitor 10/7/2025 - Abstract Arbutus Biopharma announced that three abstracts featuring imdusiran data and one abstract featurin…
Full Summary
Galectin Therapeutics Inc. stock logo
GALT
Galectin Therapeutics
$4.74
-0.6%
+1.5%
The price history of GALT in the last 30 days
Belapectin (Formerly GR-MD-02) Non-alcoholic steatohepatitis (NASH) with cirrhosis 10/7/2025 - Provided Update Galectin Therapeutics announced participation in the AASLD Liver Meeting 2025.
Full Summary
Innoviva, Inc. stock logo
INVA
Innoviva
$17.37
+1.0%
-15.1%
The price history of INVA in the last 30 days
Zoliflodacin For the Treatment of Uncomplicated Gonorrhea 10/7/2025 - Data Innoviva, Inc. announced that it will deliver data from six presentations at IDWeek 2025, including …
Full Summary
Envoy Medical, Inc. stock logo
COCH
Envoy Medical
$0.93
-41.5%
-29.0%
The price history of COCH in the last 30 days
Acclaim for Breakthrough Hearing Device 10/7/2025 - FDA approved Envoy Medical, announced that it received approval from the U.S. Food and Drug Administration (FDA) …
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$189.75
+0.5%
+6.4%
The price history of JNJ in the last 30 days
ACUVUE OASYS MAX 1-Day for Astigmatism 10/7/2025 - New Data Johnson & Johnson announced new data on the ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lenses wh…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$189.75
+0.5%
+6.4%
The price history of JNJ in the last 30 days
Icotrokinra For adults and adolescents with plaque psoriasis
Phase 2b
10/7/2025 - Results Johnson & Johnson announced additional Week 12 results from the Phase 2b ANTHEM-UC study of icotroki…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$189.75
+0.5%
+6.4%
The price history of JNJ in the last 30 days
Guselkumab For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Phase 3
10/7/2025 - New Data Johnson & Johnson announced new 48-week data from the Phase 3 ASTRO study evaluating TREMFYA® (guse…
Full Summary
Citius Pharmaceuticals, Inc. stock logo
CTXR
Citius Pharmaceuticals
$1.29
-8.2%
+5.3%
The price history of CTXR in the last 30 days
LYMPHIR For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma 10/7/2025 - Provided Update Citius Oncology, Inc. announced it is actively engaging with regional distribution partners to make…
Full Summary
Verrica Pharmaceuticals Inc. stock logo
VRCA
Verrica Pharmaceuticals
$4.42
-4.1%
-12.6%
The price history of VRCA in the last 30 days
VP-315 For the Treatment of Basal Cell Carcinoma 10/7/2025 - Presentation Verrica Pharmaceuticals announced that it will be presenting both an oral presentation and a poster…
Full Summary
Immix Biopharma, Inc. stock logo
IMMX
Immix Biopharma
$2.54
+1.2%
+17.1%
The price history of IMMX in the last 30 days
NXC-201 NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. 10/7/2025 - Presentation Immix Biopharma, Inc announced that it will present a NXC-201 abstract at the upcoming American Soc…
Full Summary
ClearPoint Neuro, Inc. stock logo
CLPT
ClearPoint Neuro
$29.60
+12.2%
+170.8%
The price history of CLPT in the last 30 days
ClearPoint Prism Neuro Laser Therapy System Brain Tumor Laser Therapy Phase 1/2 10/7/2025 - Results ClearPoint Neuro, Inc announced results from a Phase I-II clinical study at Skåne University Hospit…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$85.38
-0.6%
+4.7%
The price history of AZN in the last 30 days
Datopotamab deruxtecan (Dato-DXd) Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer 10/6/2025 - Positive Results AstraZeneca and Daiichi Sankyo announced Positive high-level results from the TROPION-Breast02 Phase…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$86.39
-1.4%
+2.7%
The price history of MRK in the last 30 days
MK-7240 In Inflammatory Bowel Disease
Phase 2b
10/6/2025 - Study Initiation Merck announced it has initiated three Phase 2b trials evaluating the safety and efficacy of tuliso…
Full Summary
Lyra Therapeutics, Inc. stock logo
LYRA
Lyra Therapeutics
$7.72
+1.7%
+17.0%
The price history of LYRA in the last 30 days
LYR-210 Chronic Rhinosinusitis
Phase 3
10/6/2025 - Upcoming presentations Lyra Therapeutics, Inc. announced the Company's clinical plan and upcoming oral presentation of res…
Full Summary
Cellectar Biosciences, Inc. stock logo
CLRB
Cellectar Biosciences
$4.78
-6.8%
-5.0%
The price history of CLRB in the last 30 days
Iopofosine I-131 Pediatric Brain and Solid Tumors European Commission Conditional Marketing Authorization 10/6/2025 - Marketing authorization Cellectar Biosciences announced that after a scientific advice procedure, the Scientific Advice Wor…
Full Summary
Tango Therapeutics, Inc. stock logo
TNGX
Tango Therapeutics
$6.91
-5.2%
+1.5%
The price history of TNGX in the last 30 days
TNG260 Immunotherapy of Cancer 10/6/2025 - Poster Presentation Tango Therapeutics, Inc. announced that the company will have three poster presentations at the Soci…
Full Summary
Exicure, Inc. stock logo
XCUR
Exicure
$5.32
+23.4%
+23.7%
The price history of XCUR in the last 30 days
burixafor In Multiple Myeloma 10/6/2025 - Provided Update Exicure's ongoing Phase 2 study (NCT05561751) is a randomized, open-label, multicenter trial evaluat…
Full Summary
CareDx, Inc. stock logo
CDNA
CareDx
$14.79
+0.8%
+10.9%
The price history of CDNA in the last 30 days
AlloSeq HCT Chimerism testing kit for Hematopoietic Cell Transplantation 10/6/2025 - Provided Update CareDx, Inc. announced new innovations and products that will be featured at The American Society …
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$12.22
+16.3%
+28.9%
The price history of RGNX in the last 30 days
surabgene lomparvovec for Wet AMD 10/6/2025 - Enrollment Update REGENXBIO Inc. nnounced the completion of enrollment in the ATMOSPHERE® and ASCENT® pivotal studies …
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$12.22
+16.3%
+28.9%
The price history of RGNX in the last 30 days
surabgene lomparvovec for Wet AMD Target date: Q4 2026 10/6/2025 - Top-line data REGENXBIO Inc. announced that Topline pivotal data expected in Q4 2026
Full Summary
Context Therapeutics Inc. stock logo
CNTX
Context Therapeutics
$1.14
+0.9%
+38.8%
The price history of CNTX in the last 30 days
CT-95 For mesothelin-expressing cancers. 10/6/2025 - Poster Presentation Context Therapeutics Inc. announced two posters will be presented at the Society for Immunotherapy o…
Full Summary
Arcutis Biotherapeutics, Inc. stock logo
ARQT
Arcutis Biotherapeutics
$21.24
+3.3%
+22.6%
The price history of ARQT in the last 30 days
ZORYVE™ (roflumilast) Inhibitor of phosphodiesterase-4 (PDE4) supplemental New Drug Application (sNDA) 10/6/2025 - FDA approved Arcutis Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approv…
Full Summary
Humacyte, Inc. stock logo
HUMA
Humacyte
$1.69
+2.4%
+19.9%
The price history of HUMA in the last 30 days
Human Acellular Vessel Coronary Artery Bypass Grafting 10/6/2025 - Publication Humacyte, Inc. announced the publication in Oxford Academic's Military Medicine of positive long-ter…
Full Summary
Spruce Biosciences, Inc. stock logo
SPRB
Spruce Biosciences
$160.08
-12.3%
+1678.7%
The price history of SPRB in the last 30 days
TA-ERT for the treatment of Sanfilippo Syndrome Type B (MPS IIIB).
Breakthrough Therapy
10/6/2025 - Designation Grant Spruce Biosciences, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Brea…
Full Summary
Atossa Genetics Inc. stock logo
ATOS
Atossa Genetics
$1.11
+9.9%
+37.5%
The price history of ATOS in the last 30 days
Z-endoxifen Breast cancer in the neoadjuvant (prior to surgery) setting
Phase 2
10/6/2025 - Provided Update Atossa Therapeutics, Inc. (announces an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen i…
Full Summary
Gain Therapeutics, Inc. stock logo
GANX
Gain Therapeutics
$2.07
+2.5%
+18.3%
The price history of GANX in the last 30 days
GT-02287 GBA1 Parkinson's disease 10/6/2025 - Poster Presentation Gain Therapeutics, Inc. today presented a poster at the International Congress of Parkinson's Diseas…
Full Summary
Neurocrine Biosciences, Inc. stock logo
NBIX
Neurocrine Biosciences
$139.08
+1.5%
-3.3%
The price history of NBIX in the last 30 days
INGREZZA (Valbenazine) Tardive Dyskinesia 10/6/2025 - Data Neurocrine Biosciences, Inc. today presented new data from the open-label KINECT®-HD2 study demonst…
Full Summary
Editas Medicine, Inc. stock logo
EDIT
Editas Medicine
$4.15
+5.6%
+48.7%
The price history of EDIT in the last 30 days
EDIT-401 Gene and Cell Therapy 10/6/2025 - Oral presentation Editas Medicine, Inc. announced an oral presentation at the upcoming European Society of Gene and C…
Full Summary
Avidity Biosciences, Inc. stock logo
RNA
Avidity Biosciences
$48.26
+2.8%
+0.4%
The price history of RNA in the last 30 days
EXPLORE44 in People Living with DMD44 10/6/2025 - Oral presentation Avidity Biosciences, Inc. announced that it will deliver late-breaking oral and poster presentation…
Full Summary
Arcus Biosciences, Inc. stock logo
RCUS
Arcus Biosciences
$15.05
+7.3%
+31.7%
The price history of RCUS in the last 30 days
ARC-20 In patients that had received both prior TKI and anti-PD-1 therapy. 10/6/2025 - Data Arcus Biosciences, Inc announced new monotherapy data for casdatifan, a HIF-2a inhibitor with best…
Full Summary
NeuroSense Therapeutics Ltd. stock logo
NRSN
NeuroSense Therapeutics
$1.22
+6.1%
+5.2%
The price history of NRSN in the last 30 days
PrimeC Amyotrophic lateral sclerosis 10/6/2025 - Findings Update NeuroSense Therapeutics Ltd. announced new positive findings based on plasma samples from its Phase…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$231.26
-0.7%
+10.1%
The price history of ABBV in the last 30 days
BOTOX (onabotulinumtoxinA) Upper Limb Spasticity
Phase 2
10/6/2025 - Top-line results AbbVie announced positive topline results from the Phase 2 ELATE trial evaluating the safety and eff…
Full Summary
KalVista Pharmaceuticals, Inc. stock logo
KALV
KalVista Pharmaceuticals
$11.49
+5.2%
-28.0%
The price history of KALV in the last 30 days
sebetralstat Therapy for hereditary angioedema (HAE). 10/6/2025 - New Data KalVista Pharmaceuticals, Inc announced new data from its KONFIDENT and KONFIDENT-S studies of EKTE…
Full Summary
Biomea Fusion, Inc. stock logo
BMEA
Biomea Fusion
$1.68
-9.2%
-7.2%
The price history of BMEA in the last 30 days
icovamenib For 2 diabetes 10/6/2025 - Results Biomea Fusion, Inc. announced positive 52-week results from its Phase II COVALENT-111 study evaluat…
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$150.97
-0.8%
+6.8%
The price history of BIIB in the last 30 days
LEQEMBI® (lecanemab-irmb) Treatment of Alzheimer's Disease 10/6/2025 - Provided Update Eisai Co., Ltd. and Biogen Inc. announced that lecanemab-irmb subcutaneous injection (U.S. brand na…
Full Summary
Dyne Therapeutics, Inc. stock logo
DYN
Dyne Therapeutics
$14.56
+4.4%
+9.5%
The price history of DYN in the last 30 days
DYNE-101 Designed to enable targeted muscle tissue delivery with the goal of reducing toxic DMPK RNA in the nucleus Phase 1/2 10/6/2025 - Additional data Dyne Therapeutics, Inc. announced additional one-year data from its ongoing Phase 1/2 ACHIEVE clinic…
Full Summary
Arvinas, Inc. stock logo
ARVN
Arvinas
$9.75
+4.8%
+22.8%
The price history of ARVN in the last 30 days
ARV-102 PROTAC® degrader designed to target the LRRK2 protein
Phase 1
10/5/2025 - Positive Data Arvinas, Inc. announced positive pharmacokinetic, pharmacodynamic, and biomarker data from two Phase…
Full Summary
Ovid Therapeutics stock logo
OVID
Ovid Therapeutics
$1.58
-5.4%
+27.4%
The price history of OVID in the last 30 days
OV329 In Treatment-Resistant Seizures
Phase 1
10/3/2025 - Top-line results Ovid Therapeutics Inc. announced positive topline results from its Phase 1 healthy volunteer study …
Full Summary
Esperion Therapeutics, Inc. stock logo
ESPR
Esperion Therapeutics
$2.57
-16.8%
+2.4%
The price history of ESPR in the last 30 days
NEXLETOL treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease 10/3/2025 - Provided Update Esperion announced that it has entered into a settlement agreement with Dr. Reddy's Laboratories, I…
Full Summary
Sarepta Therapeutics, Inc. stock logo
SRPT
Sarepta Therapeutics
$23.38
+1.1%
+32.8%
The price history of SRPT in the last 30 days
ELEVIDYS (delandistrogene moxeparvovec-rokl) Designed to address the underlying cause of Duchenne muscular dystrophy through the targeted production of ELEVIDYS micro-dystrophin in skeletal muscle. 10/3/2025 - Presentation Sarepta Therapeutics, Inc will present at the 30th Annual Congress of the World Muscle Society (WMS…
Full Summary
Xilio Therapeutics, Inc. stock logo
XLO
Xilio Therapeutics
$0.84
+2.3%
+20.9%
The price history of XLO in the last 30 days
XTX301 Solid tumors 10/3/2025 - Poster Presentation Xilio Therapeutics, Inc. announced multiple upcoming poster presentations at the Society for Immun…
Full Summary
BioAtla, Inc. stock logo
BCAB
BioAtla
$0.91
+14.9%
+49.5%
The price history of BCAB in the last 30 days
BA3011 (Mecbotamab Vedotin) Solid Tumors 10/3/2025 - Clinical Data BioAtla, Inc. announced that clinical data for its investigational AXL-targeting antibody-drug conju…
Full Summary
Werewolf Therapeutics, Inc. stock logo
HOWL
Werewolf Therapeutics
$1.88
-2.6%
+41.4%
The price history of HOWL in the last 30 days
WTX-124 Solid Tumors 10/3/2025 - Poster Presentation Werewolf Therapeutics, Inc announced that three posters will be presented at the upcoming Society f…
Full Summary
ALX Oncology Holdings Inc. stock logo
ALXO
ALX Oncology
$1.97
+7.7%
+77.5%
The price history of ALXO in the last 30 days
ASPEN-06 In Patients With HER2-Positive Gastric Cancer 10/3/2025 - Updated data ALX Oncology Holdings Inc nnounced updated data from its Phase 2 ASPEN-06 (NCT05002127) trial will b…
Full Summary
Coherus Oncology, Inc. stock logo
CHRS
Coherus Oncology
$1.76
+2.9%
+28.5%
The price history of CHRS in the last 30 days
CHS-114 In patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) 10/3/2025 - Upcoming presentations Coherus Oncology announced an upcoming poster presentation at the 40th Annual Meeting of the Socie…
Full Summary
Candel Therapeutics, Inc. stock logo
CADL
Candel Therapeutics
$6.30
+11.9%
+23.5%
The price history of CADL in the last 30 days
CAN-2409 Prostate cancer 10/3/2025 - Presentation Candel Therapeutics, Inc. announced the Company will present insights from its enLIGHTEN™ Discovery…
Full Summary
Ovid Therapeutics stock logo
OVID
Ovid Therapeutics
$1.58
-5.4%
+27.4%
The price history of OVID in the last 30 days
OV329 In Treatment-Resistant Seizures
Phase 1
10/3/2025 - Top-line results Ovid Therapeutics Inc. announced positive topline results from its Phase 1 healthy volunteer study …
Full Summary
IMMURON stock logo
IMRN
IMMURON
$2.27
+13.3%
+21.1%
The price history of IMRN in the last 30 days
Travelan To prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC). 10/2/2025 - Provided Update Immuron Limited is pleased to provide shareholders with a brief update on progress with a number of…
Full Summary
Anavex Life Sciences Corp. stock logo
AVXL
Anavex Life Sciences
$9.85
+0.7%
+5.3%
The price history of AVXL in the last 30 days
ANAVEX®3-71 For the treatment of neurodegenerative and neurodevelopmental disorders
Phase 2
10/2/2025 - Top-line results Anavex Life Sciences Corp. announced positive topline results from its placebo-controlled Phase 2 c…
Full Summary
Alterity Therapeutics Limited - Sponsored ADR stock logo
ATHE
Alterity Therapeutics
$4.31
+0.7%
-16.6%
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. 10/2/2025 - Data Alterity Therapeutics announced that data from the ATH434-201 randomized, double-blind Phase 2 cli…
Full Summary
Astria Therapeutics, Inc. stock logo
ATXS
Astria Therapeutics
$8.40
+12.4%
+13.1%
The price history of ATXS in the last 30 days
Navenibart For the Treatment of Hereditary Angioedema
Phase 3
10/2/2025 - Clinical Trial Astria Therapeutics, Inc announced that it has begun opening clinical trial sites in the European Un…
Full Summary
Taysha Gene Therapies, Inc. stock logo
TSHA
Taysha Gene Therapies
$5.06
+7.2%
+56.2%
The price history of TSHA in the last 30 days
TSHA-102 Rett Syndrome
Breakthrough Therapy
10/2/2025 - Designation Grant Taysha Gene Therapies, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Break…
Full Summary
Urogen Pharma stock logo
URGN
Urogen Pharma
$17.33
+2.9%
-19.1%
The price history of URGN in the last 30 days
ZUSDURI for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 10/2/2025 - Publication UroGen Pharma Ltd. announced the publication of a comprehensive review of the clinical development …
Full Summary
Hologic, Inc. stock logo
HOLX
Hologic
$68.34
+0.9%
+2.7%
The price history of HOLX in the last 30 days
Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. Detect Common Causes of Infectious Gastroenteritis 10/2/2025 - FDA Clearance Hologic, Inc announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearanc…
Full Summary
Sanofi stock logo
SNY
Sanofi
$48.80
-0.8%
+4.3%
The price history of SNY in the last 30 days
T1D 4-plex diabetic ketoacidosis (DKA) 10/2/2025 - Provided Update Revvity, Inc. announced a program for expansion of its type 1 diabetes (T1D) offering to include a …
Full Summary
Revvity Inc. stock logo
RVTY
Revvity
$91.90
+0.8%
+6.5%
The price history of RVTY in the last 30 days
T1D 4-plex diabetic ketoacidosis (DKA) 10/2/2025 - Provided Update Revvity, Inc. announced a program for expansion of its type 1 diabetes (T1D) offering to include a …
Full Summary
Edgewise Therapeutics, Inc. stock logo
EWTX
Edgewise Therapeutics
$15.35
+1.4%
+3.2%
The price history of EWTX in the last 30 days
sevasemten For Becker muscular dystrophy 10/2/2025 - Provided Update Edgewise Therapeutics, Inc., announced its participation at the 30th International Annual Congress …
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SS Innovations International, Inc. stock logo
SSII
SS Innovations International
$6.73
-0.7%
+9.6%
The price history of SSII in the last 30 days
SSi Mantra surgical robotic system robotic surgery 10/2/2025 - Provided Update SS Innovations International announced that the Company successfully completed a human factors vali…
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SS Innovations International, Inc. stock logo
SSII
SS Innovations International
$6.73
-0.7%
+9.6%
The price history of SSII in the last 30 days
SSi Mantra surgical robotic system robotic surgery Target date: Q4 2025 10/2/2025 - Pre-Marketing Filing SS Innovations International anticipates submitting a 510(k) premarket notification to the United …
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Amgen Inc. stock logo
AMGN
Amgen
$294.62
-0.3%
+5.2%
The price history of AMGN in the last 30 days
Repatha (Evolocumab) HIV who have high cholesterol, as well as new data from FOURIER evaluating biomarkers of major cardiovascular (CV) events
Phase 3
10/2/2025 - Endpoint Met Amgen announced the Phase 3 VESALIUS-CV clinical trial met its dual primary endpoints demonstrating …
Full Summary
ACADIA Pharmaceuticals Inc. stock logo
ACAD
ACADIA Pharmaceuticals
$21.31
-1.1%
-16.1%
The price history of ACAD in the last 30 days
ACP-711 GABRA3 modulators 10/2/2025 - Late Breaking Presentation Acadia Pharmaceuticals Inc announced one late-breaker oral platform presentation and two poster pr…
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Jazz Pharmaceuticals PLC stock logo
JAZZ
Jazz Pharmaceuticals
$137.78
+0.3%
+6.1%
The price history of JAZZ in the last 30 days
Zepzelca (lurbinectedin) Relapsed Small Cell Lung Cancer (SCLC) 10/2/2025 - FDA approved Jazz Pharmaceuticals announced that the Food and Drug Administration approved lurbinectedin
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Savara Inc. stock logo
SVRA
Savara
$3.47
+1.2%
-9.9%
The price history of SVRA in the last 30 days
Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP) 10/2/2025 - Poster Presentation Savara Inc. announced the acceptance of two abstracts for poster presentation and one abstract as an…
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Mesoblast Limited stock logo
MESO
Mesoblast
$19.75
+9.2%
+35.7%
The price history of MESO in the last 30 days
RYONCIL For the treatment of severe and life-threatening inflammatory conditions. 10/2/2025 - Provided Update Mesoblast Limited announced that a specific Healthcare Common Procedure Coding System (HCPCS) J-Code…
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Cidara Therapeutics, Inc. stock logo
CDTX
Cidara Therapeutics
$98.51
-3.6%
+58.5%
The price history of CDTX in the last 30 days
CD388 Universal Prevention and Treatment of Influenza 10/2/2025 - Provided Update Cidara Therapeutics, Inc. announced it has received an award valued up to $339M from the Biomedical…
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Pharming Group N.V. Sponsored ADR stock logo
PHAR
Pharming Group
$14.77
+0.6%
-0.2%
The price history of PHAR in the last 30 days
Leniolisib Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) supplemental New Drug Application (sNDA) 10/1/2025 - FDA Accepted Pharming Group N.V. announced that the U.S. Food and Drug Administration (FDA) has accepted its sup…
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Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$44.55
-0.2%
-4.6%
The price history of BMY in the last 30 days
BMS-986446 Treatment of Alzheimer's Disease
Fast Track
10/1/2025 - Designation Grant Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Fast Tr…
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Arvinas, Inc. stock logo
ARVN
Arvinas
$9.75
+4.8%
+22.8%
The price history of ARVN in the last 30 days
ARV-102 PROTAC® degrader designed to target the LRRK2 protein 10/1/2025 - Presentation Arvinas, Inc. announced that two presentations, including one e-poster session and one oral platform…
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AstraZeneca PLC stock logo
AZN
AstraZeneca
$85.38
-0.6%
+4.7%
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 BLA 10/1/2025 - FDA Accepted Daiichi Sankyo and AstraZeneca announced that the supplemental Biologics License Application (sBL…
Full Summary
Kura Oncology, Inc. stock logo
KURA
Kura Oncology
$10.08
+6.9%
+23.8%
The price history of KURA in the last 30 days
KOMET-007 Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) 10/1/2025 - Dose Update Kura Oncology, Inc and Kyowa Kirin Co., Ltd. announced dosing of the first patient in a cohort of …
Full Summary
Alnylam Pharmaceuticals, Inc. stock logo
ALNY
Alnylam Pharmaceuticals
$450.68
-1.9%
-1.0%
The price history of ALNY in the last 30 days
Zilebesiran (ALN-AGT) Mild-to-Moderate Hypertension
Phase 3
10/1/2025 - Dosing Update Alnylam Pharmaceuticals, Inc announced that the first patient has been dosed in ZENITH (ZilebEsiraN…
Full Summary
Radiopharm Theranostics Limited - Sponsored ADR stock logo
RADX
Radiopharm Theranostics
$7.54
+7.1%
+30.0%
The price history of RADX in the last 30 days
RAD202 to treat HER2-positive advanced and metastatic cancers 10/1/2025 - Recommendation Radiopharm Theranostics announced that it has received a positive recommendation from the Data Safe…
Full Summary
Adagio Medical Holdings, Inc. stock logo
ADGM
Adagio Medical
$2.25
-4.7%
+61.9%
The price history of ADGM in the last 30 days
FULCRUM-VT for Ventricular Tachycardia 10/1/2025 - Enrollment Update Adagio Medical Holdings, Inc announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. …
Full Summary
MoonLake Immunotherapeutics stock logo
MLTX
MoonLake Immunotherapeutics
$9.10
-1.9%
-85.1%
The price history of MLTX in the last 30 days
Sonelokimab Moderate-to-severe hidradenitis suppurativa 10/1/2025 - Provided Update MoonLake Immunotherapeutics nnounced disastrous VELA-2 trial results for sonelokimab, its highly an…
Full Summary
Fortress Biotech, Inc. stock logo
FBIO
Fortress Biotech
$2.91
-4.6%
-19.2%
The price history of FBIO in the last 30 days
CUTX-101 Menkes disease 10/1/2025 - Complete Response Letter Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration ("FDA") has issued a Co…
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CAMP4 Therapeutics Corporation stock logo
CAMP
CAMP4 Therapeutics
$3.47
-7.1%
+110.5%
The price history of CAMP in the last 30 days
CMP-SYNGAP-01 Treatment rescued multiple SYNGAP1-dependent behavioral phenotypes 10/1/2025 - Study Initiation CAMP4 Therapeutics announced the initiation of toxicology studies conducted under Good Laboratory P…
Full Summary
Solid Biosciences Inc. stock logo
SLDB
Solid Biosciences
$6.31
+14.3%
+23.0%
The price history of SLDB in the last 30 days
SGT-003 For Duchenne Muscular Dystrophy Gene Therapy 10/1/2025 - Presentation Solid Biosciences Inc. will present data from its neuromuscular and cardiac programs at the World M…
Full Summary
CRISPR Therapeutics AG stock logo
CRSP
CRISPR Therapeutics
$76.78
+8.7%
+41.9%
The price history of CRSP in the last 30 days
SyNTase Gene Editing Technology 10/1/2025 - Presentation CRISPR Therapeutics To Present Preclinical Data On Alpha-1 Antitrypsin Deficiency Utilizing Novel Sy…
Full Summary
Aspire Biopharma Holdings, Inc. stock logo
ASBP
Aspire Biopharma
$0.36
+1.4%
-28.8%
The price history of ASBP in the last 30 days
Sublingual Aspirin Diabetes, Weight Management 10/1/2025 - Provided Update Aspire Biopharma Holdings, announced pipeline progress and key milestones expected through the remai…
Full Summary
Avita Medical Inc. stock logo
RCEL
Avita Medical
$5.51
+0.7%
+30.9%
The price history of RCEL in the last 30 days
RECELL System Extensive Burns and Pediatric Patients 10/1/2025 - Provided Update AVITA Medical®, Inc. announced that beginning October 1, 2025, hospitals across the U.S. will be el…
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