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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
Lantheus Holdings, Inc. stock logo
LNTH
Lantheus
$51.87
-28.6%
-37.1%
The price history of LNTH in the last 30 days
Piflufolastat F 18 (formerly 8F-DCFPyL) Biochemically Recurrent Prostate Cancer (CONDOR)
NDA
Target date: March 06, 2026
8/6/2025 - PDUFA Date Lantheus Holdings, announced that The FDA has set an action date goal of March 6, 2026 under the Pr…
Full Summary
Jazz Pharmaceuticals PLC stock logo
JAZZ
Jazz Pharmaceuticals
$105.93
-6.4%
-2.9%
The price history of JAZZ in the last 30 days
dordaviprone treatment for recurrent H3 K27M-mutant diffuse glioma 8/6/2025 - FDA GRANT Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted acc…
Full Summary
Teva Pharmaceutical Industries Ltd. stock logo
TEVA
Teva Pharmaceutical Industries
$16.05
+2.1%
-3.6%
The price history of TEVA in the last 30 days
AJOVY (Fremanezumab-vfrm) Comorbid depression, anxiety or hypertension, as well as migraine 8/6/2025 - FDA approved Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the U.S…
Full Summary
Keros Therapeutics, Inc. stock logo
KROS
Keros Therapeutics
$14.41
+0.1%
+3.6%
The price history of KROS in the last 30 days
KER-065 To treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins 8/6/2025 - Provided Update Keros Therapeutics, Inc. announced a strategic realignment designed to reallocate resources towards…
Full Summary
Lantheus Holdings, Inc. stock logo
LNTH
Lantheus
$51.87
-28.6%
-37.1%
The price history of LNTH in the last 30 days
Piflufolastat F 18 (formerly 8F-DCFPyL) Biochemically Recurrent Prostate Cancer (CONDOR)
NDA
8/6/2025 - FDA Accepted Lantheus Holdings, announced that the Food and Drug Administration (FDA) has accepted a New Drug App…
Full Summary
Moleculin Biotech, Inc. stock logo
MBRX
Moleculin Biotech
$0.66
-4.2%
+25.8%
The price history of MBRX in the last 30 days
Annamycin Soft tissue sarcoma (STS) lung metastases 8/6/2025 - Presentation Moleculin Biotech, Inc., announced the presentation of encouraging preclinical data for its lead dr…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$3.32
+11.8%
+65.2%
The price history of BTAI in the last 30 days
BXCL501 (dexmedetomidine) For dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist 8/6/2025 - Publication BioXcel Therapeutics announced a publication in the peer-reviewed journal Frontiers in Pharmacology…
Full Summary
Cingulate Inc. stock logo
CING
Cingulate
$4.52
-16.6%
+0.2%
The price history of CING in the last 30 days
CTx-1301 Attention Deficit/Hyperactivity Disorder (ADHD) 8/6/2025 - NDA Filing Cingulate announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug …
Full Summary
Lantern Pharma Inc. stock logo
LTRN
Lantern Pharma
$5.14
-1.2%
+45.2%
The price history of LTRN in the last 30 days
LP-184 Prostate cancer
IND
8/6/2025 - FDA Clearance Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma Inc. announced that the U.S. Fo…
Full Summary
Actuate Therapeutics, Inc. stock logo
ACTU
Actuate Therapeutics
$8.17
+11.8%
+30.9%
The price history of ACTU in the last 30 days
elraglusib In relapsed/refractory Ewing Sarcoma (r/r EWS).
Phase 1b
8/6/2025 - Trial Initiation Actuate Therapeutics, Inc. announced the initiation of the Phase 1b trial of elraglusib in combinati…
Full Summary
Chimerix, Inc. stock logo
CMRX
Chimerix
$8.54
dordaviprone treatment for recurrent H3 K27M-mutant diffuse glioma 8/6/2025 - FDA GRANT Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted acc…
Full Summary
RenovoRx, Inc. stock logo
RNXT
RenovoRx
$1.20
-1.6%
-7.7%
The price history of RNXT in the last 30 days
RenovoCath Solid Tumors 8/6/2025 - Provided Update RenovoRx, Inc. announced strong progress in its commercialization efforts, including its growing cus…
Full Summary
Precision BioSciences, Inc. stock logo
DTIL
Precision BioSciences
$4.81
-1.0%
+6.4%
The price history of DTIL in the last 30 days
PBGENE-HBV For chronic hepatitis B virus (HBV) 8/6/2025 - Results Precision BioSciences, Inc announced ELIMINATE-B results as of the data cutoff of July 28, 2025.
Full Summary
Mattel, Inc. stock logo
MAT
Mattel
$17.30
+1.8%
-13.9%
The price history of MAT in the last 30 days
Barbie type 1 diabetes (T1D) 8/6/2025 - Provided Update Mattel, Inc announced a partnership between its iconic Barbie™ brand and Quo Beauty®, the beloved an…
Full Summary
Immix Biopharma, Inc. stock logo
IMMX
Immix Biopharma
$2.60
-8.8%
-2.3%
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. 8/6/2025 - Provided Update Immix Biopharma, Inc. announced important updates about its plan to address other serious diseases…
Full Summary
Urogen Pharma stock logo
URGN
Urogen Pharma
$20.01
-3.4%
+46.0%
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). 8/5/2025 - Provided Update UroGen Pharma announced the 24-month DOR of 72.2% (95% CI 64.1%, 78.8%) by Kaplan-Meier estimate in…
Full Summary
Prima BioMed Ltd stock logo
IMMP
Prima BioMed
$1.75
-1.7%
+2.9%
The price history of IMMP in the last 30 days
eftilagimod alpha For cancer and autoimmune disease 8/5/2025 - Positive Feedback Immutep Limited announces it has received positive and constructive feedback from the US Food and D…
Full Summary
Nuvation Bio Inc. stock logo
NUVB
Nuvation Bio
$2.35
-1.0%
+14.5%
The price history of NUVB in the last 30 days
IBTROZI In Advanced ROS1-Positive Non-Small Cell Lung Cancer 8/5/2025 - Data Presentation Nuvation Bio Inc announced that new data will be presented at the IASLC 2025 World Conference on Lun…
Full Summary
Cassava Sciences, Inc. stock logo
SAVA
Cassava Sciences
$2.34
-4.1%
+12.5%
The price history of SAVA in the last 30 days
Simufilam Alzheimer's Disease 8/4/2025 - Positive Results Cassava Sciences, Inc. today reported positive preclinical results of a study evaluating simufilam i…
Full Summary
Dyne Therapeutics, Inc. stock logo
DYN
Dyne Therapeutics
$11.59
+10.7%
+38.1%
The price history of DYN in the last 30 days
DYNE-251 Duchenne Muscular Dystrophy BLA 8/4/2025 - BLA Filing Dyne Therapeutics, Inc announced that potential BLA submission for U.S. accelerated approval anticip…
Full Summary
Dyne Therapeutics, Inc. stock logo
DYN
Dyne Therapeutics
$11.59
+10.7%
+38.1%
The price history of DYN in the last 30 days
DYNE-251 Duchenne Muscular Dystrophy
Breakthrough Therapy
8/4/2025 - Designation Grant Dyne Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthr…
Full Summary
INmune Bio, Inc. stock logo
INMB
INmune Bio
$2.76
+2.6%
+20.0%
The price history of INMB in the last 30 days
INKmune High-Risk Myelodysplastic Syndrome (MDS) Phase 1/2 8/4/2025 - Provided Update INmune Bio Inc. is pleased to report that its Phase I/II trial (the "CaRe PC" trial) of INKmune™ fo…
Full Summary
TransMedics Group, Inc. stock logo
TMDX
TransMedics Group
$118.80
-5.5%
-4.8%
The price history of TMDX in the last 30 days
OCS™ Heart System For patients with end-stage lung, heart, and liver failure Investigational Device Exemption 8/4/2025 - Conditional approval TransMedics Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted cond…
Full Summary
Dyne Therapeutics, Inc. stock logo
DYN
Dyne Therapeutics
$11.59
+10.7%
+38.1%
The price history of DYN in the last 30 days
DYNE-251 Duchenne Muscular Dystrophy Target date: LATE 2025 8/4/2025 - Data Presentation Dyne Therapeutics, Inc. announced that Data from the DELIVER registrational expansion cohort is exp…
Full Summary
CASI Pharmaceuticals Inc. stock logo
CASI
CASI Pharmaceuticals
$1.68
-13.4%
+19.6%
The price history of CASI in the last 30 days
CID-103 Relapsed Or Refractory Multiple Myeloma 8/4/2025 - FDA Clearance CASI Pharmaceuticals, Inc. announced FDA clearance of an IND application for CID-103, an anti-CD38…
Full Summary
Vertex Pharmaceuticals Incorporated stock logo
VRTX
Vertex Pharmaceuticals
$385.65
+2.8%
-17.3%
The price history of VRTX in the last 30 days
VX-993 For the Treatment of Acute Pain
Phase 2
8/4/2025 - Top-line results Vertex Pharmaceuticals Incorporated announced topline results from its recently completed Phase 2,…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$44.82
-2.2%
-4.8%
The price history of BMY in the last 30 days
Breyanzi (lisocabtagene maraleucel) Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) sBLA 8/4/2025 - Application Accepted Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted the sup…
Full Summary
Cassava Sciences, Inc. stock logo
SAVA
Cassava Sciences
$2.34
-4.1%
+12.5%
The price history of SAVA in the last 30 days
Simufilam Alzheimer's Disease Target date: H1 2026 8/4/2025 - Clinical Study Cassava Sciences, Inc. announced that First clinical study for simufilam in TSC-related epilepsy ex…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$44.82
-2.2%
-4.8%
The price history of BMY in the last 30 days
Breyanzi (lisocabtagene maraleucel) Second-line treatment in adults with relapsed or refractory large B-cell lymphoma (LBCL) sBLA
Target date: December 05, 2025
8/4/2025 - PDUFA Date Bristol Myers Squibb announced that The FDA has granted the application Priority Review and assign…
Full Summary
Exicure, Inc. stock logo
XCUR
Exicure
$7.69
+3.9%
+10.6%
The price history of XCUR in the last 30 days
burixafor In Multiple Myeloma Target date: Q4 2025 8/1/2025 - Top-line results Exicure, Inc. announced that the Topline results from the study are expected in the fourth quarter …
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$3.32
+11.8%
+65.2%
The price history of BTAI in the last 30 days
IGALMI™ Sublingual film
Phase 3
8/1/2025 - Pivotal Study BioXcel Therapeutics, announced completion of the last patient last visit (LPLV) in the pivotal Phas…
Full Summary
Viatris Inc. stock logo
VTRS
Viatris
$8.75
-2.6%
-5.5%
The price history of VTRS in the last 30 days
meloxicam For the Treatment of Moderate-to-Severe Acute Pain
Phase 3
8/1/2025 - Abstract Viatris announced that five abstracts from its Phase 3 program evaluating novel fast-acting formula…
Full Summary
Exicure, Inc. stock logo
XCUR
Exicure
$7.69
+3.9%
+10.6%
The price history of XCUR in the last 30 days
burixafor In Multiple Myeloma
Phase 2
8/1/2025 - Provided Update Exicure, Inc announced it has completed the last patient, last visit in its ongoing Phase 2 clinical…
Full Summary
Allogene Therapeutics, Inc. stock logo
ALLO
Allogene Therapeutics
$1.06
-5.4%
-11.7%
The price history of ALLO in the last 30 days
Cemacabtagene Ansegedleucel For Patients with Large B-Cell Lymphoma (LBCL) Likely to Relapse 8/1/2025 - Provided Update Allogene Therapeutics, Inc announced that it has selected standard fludarabine and cyclophosphamide…
Full Summary
Anavex Life Sciences Corp. stock logo
AVXL
Anavex Life Sciences
$10.97
+0.7%
+7.7%
The price history of AVXL in the last 30 days
ANAVEX®2-73-AD-EP-004 for the potential treatment of early Alzheimer's disease. 7/31/2025 - Findings Update Anavex Life Sciences Corp announced the latest findings for blarcamesine, an oral small molecule fo…
Full Summary
Lantern Pharma Inc. stock logo
LTRN
Lantern Pharma
$5.14
-1.2%
+45.2%
The price history of LTRN in the last 30 days
RADR AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs).
Phase 2
7/31/2025 - Enrollment Completion Lantern Pharma Inc. ( announced the successful completion of targeted enrollment for its Phase 2 HAR…
Full Summary
Nuvectis Pharma, Inc. stock logo
NVCT
Nuvectis Pharma
$6.46
-6.4%
-14.8%
The price history of NVCT in the last 30 days
NXP800 To treat platinum resistant, ARID1a-mutated ovarian carcinoma.
Phase 1b
7/31/2025 - Clinical Update Nuvectis Pharma, Inc. today provided the final clinical data update from the Phase 1b study of NXP8…
Full Summary
Evolus, Inc. stock logo
EOLS
Evolus
$6.37
-28.5%
-31.2%
The price history of EOLS in the last 30 days
Jeuveau Aesthetics 7/31/2025 - Publication Evolus, Inc. announced the publication of a landmark independent study in JAMA Dermatology directly…
Full Summary
4D Molecular Therapeutics, Inc. stock logo
FDMT
4D Molecular Therapeutics
$5.73
-5.3%
+35.8%
The price history of FDMT in the last 30 days
4D-150 Intravitreal vector, R100, and a transgene payload that expresses both aflibercept and a VEGF-C inhibitory RNAi. 7/31/2025 - Positive Results 4D Molecular Therapeutics announced positive results from the SPECTRA clinical trial evaluating 4D-1…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$746.17
-2.6%
-4.1%
The price history of LLY in the last 30 days
tirzepatide For obesity or overweight with weight-related comorbidities, excluding type 2 diabetes.
Phase 3
7/31/2025 - Top-line results Eli Lilly Announced Topline Results From SURPASS-CVOT Head-to-head Phase 3 Trial Comparing Mounjaro …
Full Summary
Instil Bio, Inc. stock logo
TIL
Instil Bio
$26.31
-2.5%
+12.3%
The price history of TIL in the last 30 days
IMM2510/AXN-2510 For front-line patients with advanced non-small cell lung cancer (NSCLC)
Phase 2
7/31/2025 - Efficacy and Safety Data Instil Bio, Inc. announced preliminary safety and efficacy data from the Phase 2 open-label, multic…
Full Summary
Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$28.05
-3.0%
-28.8%
The price history of RARE in the last 30 days
GTX-102 (PP) Pediatric patients with Angelman syndrome in Canada
Phase 3
7/31/2025 - Enrollment Update Ultragenyx Pharmaceutical announced that the Phase 3 Aspire study evaluating GTX-102 (apazunersen) …
Full Summary
BeiGene, Ltd. stock logo
BGNE
BeiGene
BGB-16673 For adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) PRIority MEdicines (PRIME) designation 7/31/2025 - Designation Grant BeOne Medicines announced that the European Medicines Agency (EMA) has granted PRIority MEdicines (…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.43
-6.5%
+26.5%
The price history of MIRA in the last 30 days
Ketamir-2 To treat depression and treatment-resistant depression (TRD). 7/30/2025 - Preclinical Data MIRA Pharmaceuticals, announced new preclinical data showing that its topical Ketamir-2 cream delive…
Full Summary
Sanofi stock logo
SNY
Sanofi
$46.18
-3.5%
-4.2%
The price history of SNY in the last 30 days
Libtayo (cemiplimab) Advanced Cervical Cancer Phase 1/2 7/30/2025 - Clinical Data Sensei Biotherapeutics, Inc that clinical data from the dose expansion cohort of the Phase 1/2 trial…
Full Summary
BVS
Bioventus
$7.29
+18.7%
TalisMann For chronic pain management. 7/30/2025 - Provided Update Bioventus Inc announced today a significant milestone with the U.S. Food and Drug Administration (FD…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$555.13
-2.6%
+1.3%
The price history of REGN in the last 30 days
Libtayo (cemiplimab) Advanced Cervical Cancer Phase 1/2 7/30/2025 - Clinical Data Sensei Biotherapeutics, Inc that clinical data from the dose expansion cohort of the Phase 1/2 trial…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$196.37
-1.1%
+3.6%
The price history of ABBV in the last 30 days
RINVOQ (upadacitinib) Moderate to Severe Atopic Dermatitis 7/30/2025 - Top-line results AbbVie announced positive topline results from the first of two pivotal studies of the Phase 3 UP-AA…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$746.17
-2.6%
-4.1%
The price history of LLY in the last 30 days
donanemab-azbt In early symptomatic Alzheimer's disease
Phase 3
7/30/2025 - Results Eli Lilly and Company announced results from the long-term extension (LTE) of the Phase 3 TRAILBLAZ…
Full Summary
Anika Therapeutics Inc. stock logo
ANIK
Anika Therapeutics
$8.25
-1.2%
-24.9%
The price history of ANIK in the last 30 days
Hyalofast Intended as support for the entrapment of mesenchymal stem cells obtained from autologous bone marrow aspirate concentrate (BMAC) for the repair of chondral and osteochondral lesions. 7/30/2025 - Top-line results Anika Therapeutics, Inc. announced topline results from its U.S. pivotal clinical trial of Hyalofas…
Full Summary
Corbus Pharmaceuticals Holdings, Inc. stock logo
CRBP
Corbus Pharmaceuticals
$9.11
+2.4%
+20.8%
The price history of CRBP in the last 30 days
CRB-701 Targets the expression of Nectin-4 on cancer cells 7/30/2025 - Abstract Corbus Pharmaceuticals announced that an abstract on updated clinical data from its Phase 1/2 clini…
Full Summary
Becton, Dickinson and Company stock logo
BDX
Becton, Dickinson and Company
$172.50
-2.5%
-1.2%
The price history of BDX in the last 30 days
BD Veritor™ System For SARS-CoV-2 7/30/2025 - FDA Clearance BD (Becton, Dickinson and Company) announced that it has received U.S. Food and Drug Administration …
Full Summary
Incannex Healthcare Inc. stock logo
IXHL
Incannex Healthcare
$0.35
-15.2%
+57.1%
The price history of IXHL in the last 30 days
IHL-42X Obstructive Sleep Apnoea (OSA) 7/30/2025 - Top-line results Incannex Healthcare Inc is excited to share positive topline results from its RePOSA Phase 2 clinic…
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$129.34
-2.7%
-3.8%
The price history of BIIB in the last 30 days
LEQEMBI® (lecanemab-irmb) Treatment of Alzheimer's Disease 7/30/2025 - Results Eisai Co., Ltd. and Biogen Inc announced that results on investigational maintenance therapy with…
Full Summary
Tenaya Therapeutics, Inc. stock logo
TNYA
Tenaya Therapeutics
$0.67
-3.0%
+6.6%
The price history of TNYA in the last 30 days
TN-201 Fully functional MYBPC3 gene 7/30/2025 - Provided Update Tenaya Therapeutics, Inc announced positive endorsements from each trial's independent Data Safety a…
Full Summary
NewAmsterdam Pharma Company N.V. stock logo
NAMS
NewAmsterdam Pharma
$23.62
+8.7%
+18.0%
The price history of NAMS in the last 30 days
LDL-C For Alzheimer's Disease 7/30/2025 - Data NewAmsterdam Pharma Company N.V announced full data from the prespecified Alzheimer's disease ("AD")…
Full Summary
Sight Sciences, Inc. stock logo
SGHT
Sight Sciences
$3.68
+5.4%
+3.7%
The price history of SGHT in the last 30 days
TearCare System Meibomian Gland Dysfunction (MGD) 7/29/2025 - Results Sight Sciences, Inc. announced that the manuscript detailing 24-month results from Stage 3 of the SA…
Full Summary
Fulcrum Therapeutics, Inc. stock logo
FULC
Fulcrum Therapeutics
$6.94
+0.9%
-11.6%
The price history of FULC in the last 30 days
pociredir In sickle cell disease 7/29/2025 - Positive Results Fulcrum Therapeutics, today reported positive results from the 12 mg dose cohort of the Phase 1b PIO…
Full Summary
Cognition Therapeutics, Inc. stock logo
CGTX
Cognition Therapeutics
$0.71
-0.7%
+20.8%
The price history of CGTX in the last 30 days
CT1812 Designed to penetrate the blood-retinal barrier and bind selectively and saturably to the σ-2 receptor complex.
Phase 2
7/29/2025 - Results Cognition Therapeutics, presented results from the Phase 2 COG1201 SHIMMER study (NCT05225415) of z…
Full Summary
Cingulate Inc. stock logo
CING
Cingulate
$4.52
-16.6%
+0.2%
The price history of CING in the last 30 days
CTx-1301 Attention Deficit/Hyperactivity Disorder (ADHD)
NDA
7/29/2025 - Provided Update Cingulate Inc. announced that it has received a fiscal year 2025 PDUFA (Prescription Drug User Fee A…
Full Summary
Atossa Genetics Inc. stock logo
ATOS
Atossa Genetics
$0.79
-2.1%
-7.0%
The price history of ATOS in the last 30 days
endoxifen-Z for Breast Cancer 7/29/2025 - Feedback Atossa Therapeutics, Inc. announced positive written feedback from the U.S. Food and Drug Administr…
Full Summary
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$0.93
-2.1%
-25.6%
The price history of ONCY in the last 30 days
Pelareorep In Breast Cancer 7/29/2025 - Provided Update Oncolytics Biotech® Inc. Assuming discussions with the FDA go as expected, the Company expects to c…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$170.72
0.0%
+9.6%
The price history of JNJ in the last 30 days
Guselkumab For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis sBLA 7/29/2025 - sBLA Filing Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) t…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.43
-6.5%
+26.5%
The price history of MIRA in the last 30 days
Ketamir-2 To treat depression and treatment-resistant depression (TRD).
IND
7/29/2025 - FDA Clearance MIRA Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has cleared its Inv…
Full Summary
Aclaris Therapeutics, Inc. stock logo
ACRS
Aclaris Therapeutics
$1.55
+6.9%
The price history of ACRS in the last 30 days
ATI-2138 For the Treatment of Moderate to Severe Atopic Dermatitis
Phase 2a
7/29/2025 - Top-line results Aclaris Therapeutics, Inc. announced positive top-line results from its open-label, single-arm Phas…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$196.37
-1.1%
+3.6%
The price history of ABBV in the last 30 days
venetoclax For Newly Diagnosed Higher-Risk Myelodysplastic Syndromes supplemental New Drug Application (sNDA) 7/29/2025 - sNDA Filing AbbVie announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and …
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$746.17
-2.6%
-4.1%
The price history of LLY in the last 30 days
Pirtobrutinib A non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult
Phase 3
7/29/2025 - Top-line results Eli Lilly and Company announced positive topline results from the Phase 3 BRUIN CLL-314 clinical tr…
Full Summary
Dare Bioscience, Inc. stock logo
DARE
Dare Bioscience
$2.26
-5.8%
-5.8%
The price history of DARE in the last 30 days
Sildenafil Cream Women with Female Sexual Arousal Disorder
Phase 1
7/29/2025 - Provided Update Daré Bioscience, Inc. announced the launch of the first phase of a consumer awareness campaign to s…
Full Summary
Eyepoint Pharmaceuticals, Inc. stock logo
EYPT
Eyepoint Pharmaceuticals
$10.58
-2.8%
+6.3%
The price history of EYPT in the last 30 days
DURAVYU In patients with non-proliferative diabetic retinopathy (NPDR).
Phase 3
7/29/2025 - Enrollment Update EyePoint Pharmaceuticals, Inc. announced it has completed enrollment of its Phase 3 pivotal program…
Full Summary
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$0.93
-2.1%
-25.6%
The price history of ONCY in the last 30 days
Pelareorep In Breast Cancer 7/29/2025 - Regulatory Update Oncolytics Biotech® Inc announced it has initiated regulatory discussions with the U.S. Food and Dru…
Full Summary
Hoth Therapeutics, Inc. stock logo
HOTH
Hoth Therapeutics
$1.32
-4.3%
+1.5%
The price history of HOTH in the last 30 days
HT-001 Cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR
Phase 2
7/29/2025 - Clinical Trial Hoth Therapeutics, Inc announced its engagement with ICON Clinical Research Limited ("ICON") to expa…
Full Summary
Nektar Therapeutics stock logo
NKTR
Nektar Therapeutics
$22.45
-0.5%
-1.2%
The price history of NKTR in the last 30 days
Rezpegaldesleukin For the treatment of atopic dermatitis.
Fast Track
7/29/2025 - Designation Grant Nektar Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted Fast T…
Full Summary
Cardiff Oncology, Inc. stock logo
CRDF
Cardiff Oncology
$2.44
-5.1%
-38.1%
The price history of CRDF in the last 30 days
CRDF-004 RAS-mutated mCRC.
Phase 2
7/29/2025 - Positive Data Cardiff Oncology, Inc. announced positive data from the ongoing CRDF-004, a randomized, Phase 2 clin…
Full Summary
Alterity Therapeutics Limited - Sponsored ADR stock logo
ATHE
Alterity Therapeutics
$5.15
-4.6%
+25.3%
The price history of ATHE in the last 30 days
ATH434 To inhibit the aggregation of pathological proteins implicated in neurodegeneration
Phase 2
7/28/2025 - Top-line data Alterity Therapeutics announced positive topline data from the ATH434-202 open-label Phase 2 clinica…
Full Summary
Moderna, Inc. stock logo
MRNA
Moderna
$26.71
-2.8%
-17.9%
The price history of MRNA in the last 30 days
mRNA-4359 Inhibitor-Resistant/Refractory (CPI-R/R) Melanoma 7/28/2025 - Abstract Moderna, Inc. announced that three abstracts on its investigational mRNA therapeutics have been acc…
Full Summary
Urogen Pharma stock logo
URGN
Urogen Pharma
$20.01
-3.4%
+46.0%
The price history of URGN in the last 30 days
UGN-102 Low-grade, intermediate-risk, Non-muscle invasive bladder cancer (NMIBC)
Phase 3b
7/28/2025 - Publication UroGen Pharma Ltd. announced the publication in Reviews in Urology of results from a Phase 3b study…
Full Summary
Entera Bio Ltd. stock logo
ENTX
Entera Bio
$1.98
-2.0%
+11.2%
The price history of ENTX in the last 30 days
EB613 Parathyroid hormone (1-34), or PTH for osteoporosis Type A Meeting 7/28/2025 - Provided Update Entera Bio Ltd. announced that in a written response to a Type A meeting request, the U.S. Food an…
Full Summary
Acumen Pharmaceuticals, Inc. stock logo
ABOS
Acumen Pharmaceuticals
$1.40
+2.9%
+15.7%
The price history of ABOS in the last 30 days
Sabirnetug for Early Alzheimer's Disease 7/28/2025 - Results Acumen Pharmaceuticals, announced results showing that implementing a blood-based pTau217 screening…
Full Summary
Zymeworks Inc. stock logo
ZYME
Zymeworks
$12.41
-1.0%
-4.2%
The price history of ZYME in the last 30 days
ZW251 In hepatocellular carcinoma models
NDA
7/28/2025 - FDA Clearance Zymeworks announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new…
Full Summary
Ascendis Pharma A/S stock logo
ASND
Ascendis Pharma A/S
$182.60
-2.1%
+8.6%
The price history of ASND in the last 30 days
SKYTROFA® For the Once-Weekly Treatment of Children and Adolescents with Growth Hormone Deficiency 7/28/2025 - FDA approved Ascendis Pharma announced that the U.S. Food & Drug Administration (FDA) has approved SKYTROFA® (lo…
Full Summary
Enlivex Therapeutics Ltd. stock logo
ENLV
Enlivex Therapeutics
$1.35
-2.9%
+14.4%
The price history of ENLV in the last 30 days
Allocetra Sepsis
Phase 2
7/28/2025 - Provided Update Enlivex Therapeutics Ltd announced that all 134 patients in its Phase II stage of its randomized, co…
Full Summary
Radiopharm Theranostics Limited - Sponsored ADR stock logo
RADX
Radiopharm Theranostics
$5.05
-3.8%
+24.7%
The price history of RADX in the last 30 days
RV-01 For the 4Ig isoform
IND
7/28/2025 - FDA Clearance Radiopharm Theranostics announced that the U.S. Food and Drug Administration (FDA) has provided cle…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$73.60
-1.2%
+5.1%
The price history of AZN in the last 30 days
Durvalumab Treatment Of Locally Advanced Or Metastatic Biliary Tract Cancer In Combination With Chemotherapy sBLA Priority Review 7/28/2025 - FDA GRANT AstraZeneca announced that supplemental Biologics License Application (sBLA) for Imfinzi (durvaluma…
Full Summary
Prima BioMed Ltd stock logo
IMMP
Prima BioMed
$1.75
-1.7%
+2.9%
The price history of IMMP in the last 30 days
eftilagimod alpha For cancer and autoimmune disease 7/28/2025 - Abstract Immutep Limited announces three abstracts for clinical trials evaluating its first-in-class MHC Cla…
Full Summary
BeiGene, Ltd. stock logo
BGNE
BeiGene
TEVIMBRA For the first-line treatment of patients with locally advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) EMA 7/28/2025 - Positive Opinion BeOne Medicines Ltd announced that the Committee for Medicinal Products for Human Use (CHMP) of the…
Full Summary
Fulcrum Therapeutics, Inc. stock logo
FULC
Fulcrum Therapeutics
$6.94
+0.9%
-11.6%
The price history of FULC in the last 30 days
pociredir In sickle cell disease 7/28/2025 - Top-line results Fulcrum Therapeutics to present topline results from the 12 mg dose cohort of the Phase 1b PIONEER …
Full Summary
Alterity Therapeutics Limited - Sponsored ADR stock logo
ATHE
Alterity Therapeutics
$5.15
-4.6%
+25.3%
The price history of ATHE in the last 30 days
ATH434-202 In Multiple System Atrophy 7/28/2025 - Top-line data Alterity Therapeutics announced positive topline data from the ATH434-202 open-label Phase 2 clinic…
Full Summary
ProQR Therapeutics N.V. stock logo
PRQR
ProQR Therapeutics
$2.06
-2.8%
-6.4%
The price history of PRQR in the last 30 days
Axiomer Editing Technology Adenosine Deaminase Acting on RNA) 7/28/2025 - Provided Update ProQR Therapeutics NV announced that it will participate in the RNA Editing Summit taking place Jul…
Full Summary
Avidity Biosciences, Inc. stock logo
RNA
Avidity Biosciences
$48.26
+26.1%
+65.0%
The price history of RNA in the last 30 days
del-desiran for Treatment of Myotonic Dystrophy Type 1 Target date: Q4 2025 7/28/2025 - Efficacy and Safety Data Avidity Biosciences, Inc. announced that On track to share updates from ongoing MARINA-OLE™ trial of…
Full Summary
RenovoRx, Inc. stock logo
RNXT
RenovoRx
$1.20
-1.6%
-7.7%
The price history of RNXT in the last 30 days
RenovoCath Solid Tumors 7/28/2025 - Provided Update RenovoRx, Inc. announced the launch of the PanTheR Post-Marketing Registry Study (NCT06805461).
Full Summary
Sarepta Therapeutics, Inc. stock logo
SRPT
Sarepta Therapeutics
$16.26
-2.9%
-14.6%
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. 7/28/2025 - FDA Notification Sarepta Therapeutics, Inc announced that the U.S. Food and Drug Administration (FDA) notified Sarep…
Full Summary
Avidity Biosciences, Inc. stock logo
RNA
Avidity Biosciences
$48.26
+26.1%
+65.0%
The price history of RNA in the last 30 days
del-desiran for Treatment of Myotonic Dystrophy Type 1
Phase 3
7/28/2025 - Enrollment Completion Avidity Biosciences, Inc. announced the completion of enrollment in the ongoing global Phase 3 HARB…
Full Summary
Avidity Biosciences, Inc. stock logo
RNA
Avidity Biosciences
$48.26
+26.1%
+65.0%
The price history of RNA in the last 30 days
del-desiran for Treatment of Myotonic Dystrophy Type 1
Phase 3
Target date: Q2 2026
7/28/2025 - Top-line data Avidity Biosciences, Inc. announced that Topline data from HARBOR, the first global Phase 3 clinical…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.43
-6.5%
+26.5%
The price history of MIRA in the last 30 days
Ketamir-2 To treat depression and treatment-resistant depression (TRD).
IND
7/28/2025 - FDA Clearance MIRA Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has cleared it…
Full Summary
Compugen Ltd. stock logo
CGEN
Compugen
$1.46
-14.1%
The price history of CGEN in the last 30 days
COM701 Solid tumors
Phase 1
7/28/2025 - Data Presentation Compugen Ltd. announced that it will present a pooled analysis of data from three Phase 1 trials eva…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$555.13
-2.6%
+1.3%
The price history of REGN in the last 30 days
Semaglutide (GLP-1 receptor agonist) induced Weight Loss by Preserving Lean Mass
Phase 1b
7/28/2025 - Positive Results Lexaria Bioscience Corp. provides the following partial 8-week positive interim results update on t…
Full Summary
Celcuity, Inc. stock logo
CELC
Celcuity
$44.19
+3.2%
+229.8%
The price history of CELC in the last 30 days
Gedatolisib HR+ / HER2- Metastatic Breast Cancer 7/28/2025 - Top-line results Celcuity Inc announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIK…
Full Summary
Celcuity, Inc. stock logo
CELC
Celcuity
$44.19
+3.2%
+229.8%
The price history of CELC in the last 30 days
Gedatolisib HR+ / HER2- Metastatic Breast Cancer
Phase 1b
7/28/2025 - Top-line results Celcuity Inc reported topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 tri…
Full Summary
Apellis Pharmaceuticals, Inc. stock logo
APLS
Apellis Pharmaceuticals
$23.73
-1.9%
+32.6%
The price history of APLS in the last 30 days
pegcetacoplan Paroxysmal nocturnal hemoglobinuria (PNH)
FDA Approved
7/28/2025 - FDA approved Apellis Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has approved EM…
Full Summary
Assembly Biosciences, Inc. stock logo
ASMB
Assembly Biosciences
$19.43
+3.0%
+7.4%
The price history of ASMB in the last 30 days
ABI-5366 For recurrent genital herpes.
Phase 1a
7/26/2025 - Poster Presentation Assembly Biosciences, Inc announced Phase 1a clinical and preclinical data for its herpes simplex vi…
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