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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
Mustang Bio, Inc. stock logo
MBIO
Mustang Bio
$1.53
+1.3%
-19.5%
The price history of MBIO in the last 30 days
MB-106 Relapsed or Refractory B-cell non-Hodgkin lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL)
Phase 1b/2
8/27/2025 - Clinical Trial Moleculin Biotech, Inc., announced the completion of its Phase 1B/2 (MB-106) clinical trial evaluat…
Full Summary
Acasti Pharma Inc. stock logo
ACST
Acasti Pharma
$3.11
GTX-104 IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)
NDA
8/27/2025 - FDA Accepted Grace Therapeutics, Inc. announced that on August 22, 2025 the U.S. Food and Drug Administration (FD…
Full Summary
Fortress Biotech, Inc. stock logo
FBIO
Fortress Biotech
$2.34
-0.4%
+18.2%
The price history of FBIO in the last 30 days
MB-106 Relapsed or Refractory B-cell non-Hodgkin lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL)
Phase 1b/2
8/27/2025 - Clinical Trial Moleculin Biotech, Inc., announced the completion of its Phase 1B/2 (MB-106) clinical trial evaluat…
Full Summary
BeOne Medicines Ltd. - Sponsored ADR stock logo
ONC
BeOne Medicines
$300.14
-2.8%
+1.9%
The price history of ONC in the last 30 days
Tislelizumab Recurrent or Metastatic Nasopharyngeal Cancer EC Approval 8/27/2025 - Approved BeOne Medicines Ltd. announced that the European Commission (EC) has approved TEVIMBRA (tislelizum…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$734.54
-0.2%
-9.1%
The price history of LLY in the last 30 days
Verzenio (abemaciclib) Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Phase 3
8/27/2025 - Top-line results Eli Lilly Announced Topline Results Phase 3 MonarchE Trial.
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$208.24
-0.1%
+10.5%
The price history of ABBV in the last 30 days
RINVOQ (upadacitinib) Moderate to Severe Atopic Dermatitis 8/27/2025 - Provided Update AbbVie today announced that Health Canada has issued a Notice of Compliance for RINVOQ® (upadacitini…
Full Summary
NRx Pharmaceuticals, Inc. stock logo
NRXP
NRx Pharmaceuticals
$2.58
-1.9%
-11.9%
The price history of NRXP in the last 30 days
NRX-100 To treat acute depression and suicidality 8/27/2025 - Provided Update NRx Pharmaceuticals, announced its expanded access policy for NRX-100 (preservative-free ketamine) b…
Full Summary
Tango Therapeutics, Inc. stock logo
TNGX
Tango Therapeutics
$6.90
+3.3%
+3.4%
The price history of TNGX in the last 30 days
Verzenio (abemaciclib) Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Phase 3
8/27/2025 - Top-line results Eli Lilly Announced Topline Results Phase 3 MonarchE Trial.
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$3.96
-24.4%
+132.9%
The price history of BTAI in the last 30 days
IGALMI™ Sublingual film
Phase 3
8/27/2025 - Pivotal trial BioXcel Therapeutics, announced that the SERENITY At-Home Pivotal Phase 3 trial evaluating the safet…
Full Summary
Cellectar Biosciences, Inc. stock logo
CLRB
Cellectar Biosciences
$4.82
+1.3%
-4.2%
The price history of CLRB in the last 30 days
Iopofosine I-131 Pediatric Brain and Solid Tumors 8/27/2025 - Abstract Presentation Cellectar Biosciences, Inc. announced the acceptance of an abstract for oral presentation followed…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$84.16
-1.0%
0.0%
The price history of MRK in the last 30 days
HER3-DXd For the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC)
Phase 3
8/27/2025 - Dose Update Merck announced that The first patient has been dosed in the HERTHENA-Breast04 phase 3 trial evalua…
Full Summary
AbCellera Biologics Inc. stock logo
ABCL
AbCellera Biologics
$4.35
-0.5%
-11.6%
The price history of ABCL in the last 30 days
ABCL575 For the treatment of moderate-to-severe atopic dermatitis (AD)
Phase 1
8/27/2025 - Dose Update AbCellera announced it has dosed the first participants in its Phase 1 clinical trial of ABCL575, a …
Full Summary
Amylyx Pharmaceuticals, Inc. stock logo
AMLX
Amylyx Pharmaceuticals
$9.45
+3.2%
+18.3%
The price history of AMLX in the last 30 days
AMX0035 To treat amyotrophic lateral sclerosis (ALS) 8/27/2025 - Provided Update Amylyx Pharmaceuticals, Inc. announced the decision to discontinue the ORION program of AMX0035 (so…
Full Summary
Moleculin Biotech, Inc. stock logo
MBRX
Moleculin Biotech
$0.61
+11.3%
+10.4%
The price history of MBRX in the last 30 days
MB-106 Relapsed or Refractory B-cell non-Hodgkin lymphomas (NHL) and Chronic Lymphocytic Leukemia (CLL)
Phase 1b/2
8/27/2025 - Clinical Trial Moleculin Biotech, Inc., announced the completion of its Phase 1B/2 (MB-106) clinical trial evaluat…
Full Summary
Alnylam Pharmaceuticals, Inc. stock logo
ALNY
Alnylam Pharmaceuticals
$454.18
+0.7%
+39.8%
The price history of ALNY in the last 30 days
Cemdisiran Immunoglobulin A Nephropathy (IgAN)
Phase 3
8/26/2025 - Endpoint Met Regeneron Pharmaceuticals, announced that the primary and key secondary endpoints were met in the P…
Full Summary
Incannex Healthcare Inc. stock logo
IXHL
Incannex Healthcare
$0.67
-5.6%
-43.7%
The price history of IXHL in the last 30 days
PSX-001 In Patients with Generalised Anxiety Disorder to Proceed
Phase 2
8/26/2025 - Positive Data Incannex Healthcare Inc is pleased to report positive data from its Phase 2 clinical trial of PSX-0…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$734.54
-0.2%
-9.1%
The price history of LLY in the last 30 days
orforglipron Orforglipron for the treatment of obesity and overweight
Phase 3
8/26/2025 - Top-line results Eli Lilly and Company announced positive topline results from the Phase 3 ATTAIN-2 trial, evaluatin…
Full Summary
Gilead Sciences, Inc. stock logo
GILD
Gilead Sciences
$113.92
-0.7%
+0.8%
The price history of GILD in the last 30 days
Lenacapavir For the treatment of HIV infection European Commission Marketing Authorization 8/26/2025 - Marketing authorization Gilead Sciences, Inc announced that the European Commission (EC) has granted marketing authorizatio…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$3.96
-24.4%
+132.9%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY) Schizophrenia and bipolar disorders 8/26/2025 - Provided Update BioXcel Therapeutics, announced that it will host an investor call and live webcast at 8 a.m. ET, Au…
Full Summary
Lipocine Inc. stock logo
LPCN
Lipocine
$3.01
-2.9%
-9.6%
The price history of LPCN in the last 30 days
LPCN 2101 Epilepsy 8/26/2025 - Abstract Lipocine Inc announced that two abstracts related to LPCN 2101 have been accepted for poster presen…
Full Summary
Marker Therapeutics, Inc. stock logo
MRKR
Marker Therapeutics
$0.94
-6.0%
-39.4%
The price history of MRKR in the last 30 days
MT-601 Pancreatic cancer 8/26/2025 - Primary Endpoint Marker Therapeutics, Inc. today provided an update on the progress and clinical observations from …
Full Summary
Genmab A/S Sponsored ADR stock logo
GMAB
Genmab A/S
$24.78
+1.0%
+7.3%
The price history of GMAB in the last 30 days
Rina-S In Heavily Pretreated Patients with Ovarian and Endometrial Cancers
Breakthrough Therapy
8/26/2025 - Designation Grant Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$586.96
-0.1%
+5.1%
The price history of REGN in the last 30 days
Cemdisiran Immunoglobulin A Nephropathy (IgAN)
Phase 3
8/26/2025 - Endpoint Met Regeneron Pharmaceuticals, announced that the primary and key secondary endpoints were met in the P…
Full Summary
Allarity Therapeutics, Inc. stock logo
ALLR
Allarity Therapeutics
$1.59
+11.2%
+42.0%
The price history of ALLR in the last 30 days
Stenoparib For ovarian cancer (AOC)
Fast Track
8/26/2025 - Designation Grant Allarity Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) has granted F…
Full Summary
MediciNova, Inc. stock logo
MNOV
MediciNova
$1.34
-1.5%
-7.6%
The price history of MNOV in the last 30 days
MN-166 (ibudilast) Inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines Phase 2b/3 8/26/2025 - Enrollment Update MediciNova announces that it successfully achieved enrollment of the target number of participants …
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$84.16
-1.0%
0.0%
The price history of MRK in the last 30 days
VERQUVO (vericiguat) Chronic Heart Failure and Reduced Ejection Fraction 8/25/2025 - Clinical Trial Merck announced that new clinical trial and outcomes research data will be presented at the European…
Full Summary
Cytokinetics, Incorporated stock logo
CYTK
Cytokinetics
$37.83
-0.9%
+3.3%
The price history of CYTK in the last 30 days
Aficamten Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) 8/25/2025 - Presentation Cytokinetics announced five presentations related to aficamten at the European Society of Cardiology…
Full Summary
Theravance Biopharma, Inc. stock logo
TBPH
Theravance Biopharma
$13.80
+24.8%
The price history of TBPH in the last 30 days
Ampreloxetine Symptomatic neurogenic orthostatic hypotension
Phase 3
8/25/2025 - Enrollment Completion Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivot…
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$136.36
-0.3%
+5.5%
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) 8/25/2025 - Provided Update Eisai Co., and Biogen Inc. announced today that the anti-amyloid beta (Aβ) monoclonal antibody "LEQE…
Full Summary
Protagonist Therapeutics, Inc. stock logo
PTGX
Protagonist Therapeutics
$61.43
+7.8%
+9.2%
The price history of PTGX in the last 30 days
Rusfertide (PTG-300) Polycythemia vera (PV)
Breakthrough Therapy
8/25/2025 - Designation Grant Protagonist Therapeutic announced today that rusfertide, a potential first-in-class hepcidin-mimetic…
Full Summary
PDS Biotechnology Corporation stock logo
PDSB
PDS Biotechnology
$1.28
-0.8%
+8.5%
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
8/25/2025 - Survival data PDS Biotechnology announced final topline survival data from its VERSATILE-002 Phase 2 clinical tri…
Full Summary
Strongbridge Biopharma plc stock logo
SBBP
Strongbridge Biopharma
$2.00
RECORLEV (levoketoconazole) endogenous Cushing's syndrome 8/25/2025 - Provided Update Xeris Biopharma Holdings, Inc announced the U.S Patent and Trademark Office has issued patent numbe…
Full Summary
Amarin Corporation PLC stock logo
AMRN
Amarin
$15.47
-0.5%
+3.2%
The price history of AMRN in the last 30 days
VASCEPA/VAZKEPA (icosapent ethyl) Prior Peripheral Artery Disease (PAD) 8/25/2025 - Presentation Amarin Corporation plc announced upcoming presentations at the European Society of Cardiology (ESC) …
Full Summary
Evolus, Inc. stock logo
EOLS
Evolus
$7.58
-0.9%
-18.3%
The price history of EOLS in the last 30 days
Evolysse™ Evolus dermal filler, 8/25/2025 - Top-line results Evolus, Inc announced positive topline results from a U.S. pivotal study of Evolysse™ Sculpt, an inj…
Full Summary
argenex SE stock logo
ARGX
argenex
$707.96
0.0%
+18.9%
The price history of ARGX in the last 30 days
VYVGART (efgartigimod alfa) For Adults with Primary Immune Thrombocytopenia 8/25/2025 - Top-line data argenx SE announced positive topline data from the pivotal ADAPT SERON study of VYVGART® (IV: efgart…
Full Summary
BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$49.59
+1.5%
+7.3%
The price history of BBIO in the last 30 days
Acoramidis (ATTRibute-CM) Symptomatic transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM) 8/25/2025 - Oral presentation BridgeBio Pharma, Inc. announced today that one rapid-fire oral presentation on additional open-lab…
Full Summary
Amgen Inc. stock logo
AMGN
Amgen
$287.97
-0.6%
-4.4%
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 8/25/2025 - FDA Approval Amgen announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of R…
Full Summary
Castle Biosciences, Inc. stock logo
CSTL
Castle Biosciences
$22.28
+4.4%
+36.4%
The price history of CSTL in the last 30 days
DecisionDx-SCC High-risk cutaneous squamous cell carcinoma (SCC) 8/25/2025 - Publication Castle Biosciences, announced the publication of two new studies related to its DecisionDx-SCC test…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$47.60
+0.8%
+0.2%
The price history of BMY in the last 30 days
CAMZYOS® (mavacamten) For the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy 8/25/2025 - Presentation Bristol Myers Squibb announced the presentation of new clinical and real-world data from its cardiov…
Full Summary
Catalyst Pharmaceuticals, Inc. stock logo
CPRX
Catalyst Pharmaceuticals
$20.19
+1.3%
-2.9%
The price history of CPRX in the last 30 days
FIRDAPSE® For the treatment of LEMS 8/25/2025 - Provided Update Catalyst Pharmaceuticals, Inc. announced that the Company and its licensor SERB S.A. ("SERB") have …
Full Summary
Xeris Biopharma Holdings, Inc. stock logo
XERS
Xeris Biopharma
$7.99
+0.5%
+57.6%
The price history of XERS in the last 30 days
RECORLEV (levoketoconazole) endogenous Cushing's syndrome 8/25/2025 - Provided Update Xeris Biopharma Holdings, Inc announced the U.S Patent and Trademark Office has issued patent numbe…
Full Summary
Natera, Inc. stock logo
NTRA
Natera
$163.04
-1.6%
+18.1%
The price history of NTRA in the last 30 days
Signatera MRD Test for cancer therapies 8/25/2025 - New Data Natera, Inc announced that it will present new data at the 2025 International Association for the S…
Full Summary
Biofrontera AG stock logo
BFRA
Biofrontera
$2.60
Ameluz For treatment of actinic keratosis
Phase 2b
8/25/2025 - evaluation Biofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz® …
Full Summary
Sionna Therapeutics, Inc. stock logo
SION
Sionna Therapeutics
$25.13
-0.4%
+26.6%
The price history of SION in the last 30 days
SION-451 cystic fibrosis transmembrane conductance regulator (CFTR) protein
Phase 1
8/25/2025 - Dose Update Sionna Therapeutics, announced that the first subjects have been dosed in a Phase 1 trial evaluatin…
Full Summary
Alkermes plc stock logo
ALKS
Alkermes
$29.25
+0.9%
+11.9%
The price history of ALKS in the last 30 days
ALKS 2680 For the treatment of narcolepsy 8/25/2025 - presented results Alkermes plc announced plans to present detailed results from its Vibrance-1 phase 2 study evaluatin…
Full Summary
Citius Pharmaceuticals, Inc. stock logo
CTXR
Citius Pharmaceuticals
$1.37
+3.8%
-11.0%
The price history of CTXR in the last 30 days
LYMPHIR For the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma 8/22/2025 - Provided Update Citius Oncology, Inc the oncology-focused subsidiary of Citius Pharmaceuticals, Inc announced that …
Full Summary
Moderna, Inc. stock logo
MRNA
Moderna
$25.10
+1.5%
-26.0%
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 Health Canada 8/22/2025 - Authorization Moderna announced today that Health Canada has authorized its updated COVID-19 mRNA vaccine, Spikev…
Full Summary
PureTech Health PLC Sponsored ADR stock logo
PRTC
PureTech Health
$18.01
-8.3%
-5.6%
The price history of PRTC in the last 30 days
LYT-100 Idiopathic Pulmonary Fibrosis 8/21/2025 - Provided Update PureTech Health plc demonstrated its growing leadership in idiopathic pulmonary fibrosis (IPF) at t…
Full Summary
Septerna, Inc. stock logo
SEPN
Septerna
$12.63
-0.6%
-8.7%
The price history of SEPN in the last 30 days
SEP-631 For Mast Cell Diseases
Phase 1
8/21/2025 - Dosing Update Septerna, announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$208.24
-0.1%
+10.5%
The price history of ABBV in the last 30 days
RINVOQ (upadacitinib) Moderate to Severe Atopic Dermatitis 8/21/2025 - Top-line results AbbVie announced positive topline results from the second of two pivotal studies of the Phase 3 UP-A…
Full Summary
Dynavax Technologies Corporation stock logo
DVAX
Dynavax Technologies
$10.26
-1.7%
-9.1%
The price history of DVAX in the last 30 days
Z-1018 Shingles Vaccine Profile Phase 1/2 8/21/2025 - Top-line results Dynavax Technologies announced positive topline results from Part 1 of its randomized, observer-bli…
Full Summary
Crinetics Pharmaceuticals, Inc. stock logo
CRNX
Crinetics Pharmaceuticals
$30.40
-1.7%
+0.3%
The price history of CRNX in the last 30 days
Atumelnant In Congenital Adrenal Hyperplasia (CAH) Orphan Drug 8/21/2025 - Designation Grant Crinetics Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted …
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$586.96
-0.1%
+5.1%
The price history of REGN in the last 30 days
EYLEA (aflibercept) Wet age-related macular degeneration (wet AMD) EC Approval 8/21/2025 - Approved Alvotech announced that the European Commission has approved Mynzepli® as a biosimilar to Eylea® (af…
Full Summary
Shattuck Labs, Inc. stock logo
STTK
Shattuck Labs
$1.00
-2.0%
+21.8%
The price history of STTK in the last 30 days
SL-325 In inflammatory bowel disease
Phase 1
Target date: Q3 2025
8/21/2025 - Dose Update Shattuck Labs, Inc announced that The Company is on track to dose the first participant in its Phas…
Full Summary
Shattuck Labs, Inc. stock logo
STTK
Shattuck Labs
$1.00
-2.0%
+21.8%
The price history of STTK in the last 30 days
SL-325 In inflammatory bowel disease
IND
8/21/2025 - Provided Update Shattuck Labs, Inc announced that the Company's Investigational New Drug (IND) application submitte…
Full Summary
Cytosorbents Corporation stock logo
CTSO
Cytosorbents
$0.93
-1.3%
The price history of CTSO in the last 30 days
DrugSorb-ATR Antithrombotic Removal System 8/20/2025 - Regulatory Update CytoSorbents Corporation updates the regulatory status of its appeal with the U.S. Food and Drug Ad…
Full Summary
Pfizer Inc. stock logo
PFE
Pfizer
$25.08
+0.6%
+3.1%
The price history of PFE in the last 30 days
PAXLOVID Covid-19 8/20/2025 - Provided Update Enanta Pharmaceuticals, Inc announced today that it has filed suit in the Unified Patent Court (UP…
Full Summary
NovoCure Limited stock logo
NVCR
NovoCure
$11.91
+0.7%
+2.3%
The price history of NVCR in the last 30 days
Tumor Treating Fields - PANOVA-3 Locally advanced pancreatic cancer 8/20/2025 - Application Submitted Novocure announced it submitted a premarket approval (PMA) application to the U.S. Food and Drug Adm…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$47.60
+0.8%
+0.2%
The price history of BMY in the last 30 days
Opdivo (nivolumab) Resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting 8/20/2025 - FDA Approval Agilent Technologies Inc. announced that its MMR IHC Panel pharmDx (Dako Omnis) has received FDA app…
Full Summary
Savara Inc. stock logo
SVRA
Savara
$3.29
-0.6%
+23.7%
The price history of SVRA in the last 30 days
Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Phase 2
8/20/2025 - Results Savara Inc. announced that the results from the Phase 3 IMPALA-2 clinical trial will be published on…
Full Summary
Evolus, Inc. stock logo
EOLS
Evolus
$7.58
-0.9%
-18.3%
The price history of EOLS in the last 30 days
Evolysse™ Evolus dermal filler, 8/20/2025 - Application Submitted Evolus, Inc. announced that it has submitted the final module of its Premarket Approval (PMA) applic…
Full Summary
Rocket Pharmaceuticals, Inc. stock logo
RCKT
Rocket Pharmaceuticals
$3.32
-2.1%
+6.8%
The price history of RCKT in the last 30 days
RP-A501 Danon Disease 8/20/2025 - Lifted Clinical Hold Rocket Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted t…
Full Summary
Rhythm Pharmaceuticals, Inc. stock logo
RYTM
Rhythm Pharmaceuticals
$102.30
+1.1%
+19.4%
The price history of RYTM in the last 30 days
Setmelanotide (HO) Hypothalamic Obesity supplemental New Drug Application (sNDA) 8/20/2025 - FDA Accepted Rhythm Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has accepted…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.37
-1.4%
-20.3%
The price history of MIRA in the last 30 days
Ketamir-2 To treat depression and treatment-resistant depression (TRD).
Phase 1
8/19/2025 - Dose Update MIRA Pharmaceuticals, Inc. announced the successful completion of the Single Ascending Dose (SAD) p…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$3.96
-24.4%
+132.9%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY) Schizophrenia and bipolar disorders
Phase 3
8/19/2025 - Provided Update BioXcel Therapeutics announced completion of the database lock for its SERENITY At-Home pivotal Pha…
Full Summary
Viking Therapeutics, Inc. stock logo
VKTX
Viking Therapeutics
$26.62
+2.2%
-19.8%
The price history of VKTX in the last 30 days
VK2735 Metabolic disorders
Phase 2
8/19/2025 - Top-line results Viking Therapeutics, Inc. announced positive top-line results from the company's Phase 2 clinical t…
Full Summary
ALX Oncology Holdings Inc. stock logo
ALXO
ALX Oncology
$1.20
+9.1%
+91.7%
The price history of ALXO in the last 30 days
ALX2004 For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors 8/19/2025 - Dose Update ALX Oncology Holdings Inc announced that the first patient has been dosed in the Company's Phase 1 …
Full Summary
Altimmune, Inc. stock logo
ALT
Altimmune
$3.67
+6.7%
-8.9%
The price history of ALT in the last 30 days
pemvidutide for the treatment of obesity and MASH
Fast Track
8/19/2025 - Decision Deferred Altimmune, Inc announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track des…
Full Summary
Aileron Therapeutics, Inc. stock logo
ALRN
Aileron Therapeutics
LTI-03 In Idiopathic Pulmonary Fibrosis
Phase 2
8/19/2025 - Clinical Trial Rein Therapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) h…
Full Summary
Aldeyra Therapeutics, Inc. stock logo
ALDX
Aldeyra Therapeutics
$5.85
-0.7%
+10.0%
The price history of ALDX in the last 30 days
ADX-2191 Primary vitreoretinal lymphoma (PVRL)
Fast Track
8/19/2025 - Designation Grant Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted f…
Full Summary
Delcath Systems, Inc. stock logo
DCTH
Delcath Systems
$10.94
-1.6%
-4.1%
The price history of DCTH in the last 30 days
HEPZATO KIT For the treatment of metastatic uveal melanoma (mUM).
Phase 2
8/19/2025 - Dose Update Delcath Systems, Inc. announced that the first patient has been dosed at the City of Hope National …
Full Summary
Mereo BioPharma Group plc - Sponsored ADR stock logo
MREO
Mereo BioPharma Group
$1.76
Vantictumab for Autosomal Dominant Osteopetrosis Type 2 8/19/2025 - Provided Update āshibio, a privately held, clinical-stage biotechnology company developing novel therapeutics for th…
Full Summary
Madrigal Pharmaceuticals, Inc. stock logo
MDGL
Madrigal Pharmaceuticals
$425.06
+0.0%
+44.5%
The price history of MDGL in the last 30 days
Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. European Commission Conditional Marketing Authorization 8/19/2025 - Marketing authorization Madrigal Pharmaceuticals, Inc announced that the European Commission (EC) has granted conditional m…
Full Summary
HUTCHMED (China) Limited Sponsored ADR stock logo
HCM
HUTCHMED
$14.96
-4.3%
-16.8%
The price history of HCM in the last 30 days
SANOVO for Certain Lung Cancer Patients
Phase 3
8/19/2025 - Enrollment Completion HUTCHMED (China) Limited announces the completion of patient enrollment of SANOVO, a China Phase II…
Full Summary
Celldex Therapeutics, Inc. stock logo
CLDX
Celldex Therapeutics
$22.60
+3.9%
+2.7%
The price history of CLDX in the last 30 days
Barzolvolimab For Prurigo Nodularis
Phase 2
8/19/2025 - Top-line results Celldex Therapeutics, Inc today reported topline results from the Company's ongoing Phase 2 study o…
Full Summary
NeuroOne Medical Technologies Corporation stock logo
NMTC
NeuroOne Medical Technologies
$0.75
-2.7%
-12.0%
The price history of NMTC in the last 30 days
OneRF Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures. 8/18/2025 - FDA Clearance NeuroOne Medical Technologies Corporation announced that it has received U.S. Food and Drug Adminis…
Full Summary
Soligenix Inc. stock logo
SNGX
Soligenix
$3.00
-4.5%
+134.4%
The price history of SNGX in the last 30 days
SGX945 In the Treatment of Aphthous Ulcers in Behçet's Disease Orphan Drug 8/18/2025 - Designation Grant Soligenix, Inc. announced that the Office of Orphan Products Development of the United States (U.S.…
Full Summary
Natera, Inc. stock logo
NTRA
Natera
$163.04
-1.6%
+18.1%
The price history of NTRA in the last 30 days
IMvigor011 in Muscle-Invasive Bladder Cancer
Phase 3
8/18/2025 - Positive Results Natera, Inc. announced positive topline results from the randomized, phase III IMvigor011 clinical t…
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$8.82
-3.3%
+0.3%
The price history of RGNX in the last 30 days
RGX-121 MPS II (Hunter Syndrome) BLA 8/18/2025 - Provided Update REGENXBIO Inc. announced that the U.S. Food and Drug Administration (FDA) extended its review timeli…
Full Summary
Enlivex Therapeutics Ltd. stock logo
ENLV
Enlivex Therapeutics
$1.09
+0.9%
-13.5%
The price history of ENLV in the last 30 days
Allocetra Sepsis 8/18/2025 - Top-line results Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$3.96
-24.4%
+132.9%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY) Schizophrenia and bipolar disorders supplemental New Drug Application (sNDA)
Target date: Q1 2026
8/18/2025 - sNDA Filing BioXcel Therapeutics, announced that sNDA submission on track for Q1 2026
Full Summary
Capricor Therapeutics, Inc. stock logo
CAPR
Capricor Therapeutics
$6.25
-3.4%
-8.0%
The price history of CAPR in the last 30 days
StealthX exosome-based vaccine.
Phase 1
8/18/2025 - Dose Update Capricor Therapeutics announced that the first subjects have been dosed in a Phase 1 clinical trial…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$47.60
+0.8%
+0.2%
The price history of BMY in the last 30 days
iza-bren For Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
Breakthrough Therapy
8/18/2025 - Designation Grant SystImmune Inc. and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA)…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$84.16
-1.0%
0.0%
The price history of MRK in the last 30 days
I-DXd In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Breakthrough Therapy
8/18/2025 - Designation Grant Daiichi Sankyo and Merck announced that Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough…
Full Summary
Labcorp Holdings Inc. stock logo
LH
Labcorp
$279.55
+0.4%
+7.0%
The price history of LH in the last 30 days
Lumipulse® Blood Test for Alzheimer's Disease 8/18/2025 - Provided Update Labcorp announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first…
Full Summary
Opus Genetics, Inc. stock logo
IRD
Opus Genetics
$1.20
-0.4%
OPGx-BEST1 For the treatment of bestrophin-1 (BEST1)-related IRD.
IND
8/18/2025 - FDA Accepted Opus Genetics announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigat…
Full Summary
Dr. Reddy's Laboratories Ltd stock logo
RDY
Dr. Reddy's Laboratories
$14.24
+0.2%
-3.2%
The price history of RDY in the last 30 days
Carac For the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp. 8/18/2025 - Launch Extrovis AG, a global pharmaceutical company focused on research-driven innovation, and Dr. Reddy's …
Full Summary
Savara Inc. stock logo
SVRA
Savara
$3.29
-0.6%
+23.7%
The price history of SVRA in the last 30 days
Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP) 8/18/2025 - FDA Accepted Savara Inc announced the acceptance of three abstracts for poster presentation at the European Resp…
Full Summary
Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$30.08
+1.8%
+8.9%
The price history of RARE in the last 30 days
DTX401 AAV For the Treatment of Glycogen Storage Disease Type Ia (GSDIa) BLA 8/18/2025 - rolling submission Ultragenyx Pharmaceutical announced the initiation of a rolling submission of a Biologics License A…
Full Summary
Plus Therapeutics, Inc. stock logo
PSTV
Plus Therapeutics
$0.49
-3.0%
-15.5%
The price history of PSTV in the last 30 days
REYOBIQ™ For Patients with Leptomeningeal Metastases
Phase 1
8/18/2025 - Positive Data Plus Therapeutics, Inc. announces positive data from the ReSPECT-LM Phase 1 single dose escalation …
Full Summary
Pfizer Inc. stock logo
PFE
Pfizer
$25.08
+0.6%
+3.1%
The price history of PFE in the last 30 days
PAXLOVID Covid-19
Phase 2
8/18/2025 - evaluation Traws Pharma, Inc. announced receipt from the Human Research Ethics Committee (HREC) of approval to…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$3.96
-24.4%
+132.9%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY) Schizophrenia and bipolar disorders supplemental New Drug Application (sNDA) 8/18/2025 - Positive Opinion BioXcel Therapeutics, announced that it has received positive pre-sNDA meeting responses from the U…
Full Summary
Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$30.08
+1.8%
+8.9%
The price history of RARE in the last 30 days
DTX401 AAV For the Treatment of Glycogen Storage Disease Type Ia (GSDIa) BLA
Target date: Q4 2025
8/18/2025 - BLA Filing Ultragenyx Pharmaceutical announced that company has submitted the non-clinical and clinical modules…
Full Summary
Iovance Biotherapeutics, Inc. stock logo
IOVA
Iovance Biotherapeutics
$2.42
-1.2%
-18.0%
The price history of IOVA in the last 30 days
Lifileucel For the Treatment of Advanced Melanoma 8/18/2025 - Notice of Compliance Iovance Biotherapeutics, announced Health Canada has issued a Notice of Compliance with Conditions …
Full Summary
Merit Medical Systems, Inc. stock logo
MMSI
Merit Medical Systems
$90.79
+1.9%
+7.5%
The price history of MMSI in the last 30 days
WRAPSODY Cell-Impermeable Endoprosthesis (CIE). 8/18/2025 - Enrollment Update Merit Medical Systems announced today the successful enrollment of the first patient in the WRAP Nor…
Full Summary
Vanda Pharmaceuticals Inc. stock logo
VNDA
Vanda Pharmaceuticals
$4.62
-1.1%
-1.7%
The price history of VNDA in the last 30 days
HETLIOZ For treat jet lag disorder 8/18/2025 - Regulatory Update Vanda Pharmaceuticals Inc. announced that it secured a landmark victory over the U.S. Food and Drug…
Full Summary
Ascentage Pharma Group International - Unsponsored ADR stock logo
AAPG
Ascentage Pharma Group International
$41.40
-3.1%
+5.4%
The price history of AAPG in the last 30 days
lisaftoclax In Venetoclax-Refractory Patients 8/17/2025 - FDA Clearance Ascentage Pharma announced that it has received clearance by the U.S. Food and Drug Administration …
Full Summary
Veru Inc. stock logo
VERU
Veru
$3.29
-5.2%
-37.3%
The price history of VERU in the last 30 days
Wegovy For cardiovascular risk reduction in adults with known heart disease and overweight or obesity 8/15/2025 - FDA approved Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved a new indication …
Full Summary
Global Blood Therapeutics, Inc. stock logo
GBT
Global Blood Therapeutics
$68.49
Inclacumab + GBT601 Sickle Cell Disease
Phase 3
8/15/2025 - Results Pfizer Inc announced results from the Phase 3 THRIVE-131 study evaluating inclacumab, an investigati…
Full Summary
BioAge Labs, Inc. stock logo
BIOA
BioAge Labs
$4.74
+2.8%
+4.6%
The price history of BIOA in the last 30 days
BGE-102 For the treatment of obesity.
Phase 1
8/15/2025 - Dose Update BioAge Labs, Inc. announced that the first participant has been dosed in a Phase 1 clinical trial ev…
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