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FDA Drug Approval Calendar

Stay informed on the latest biotech catalysts and regulatory activity with MarketBeat’s FDA Drug Approval Calendar. This resource tracks key milestones including Prescription Drug User Fee Act (PDUFA) dates, New Drug Applications (NDAs), Biologics License Applications (BLAs), Complete Response Letters (CRLs), and other FDA-related announcements. Whether you're monitoring upcoming approvals or reviewing recent FDA decisions, this calendar provides a clear view of the drug development landscape.

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Main CompanyCurrent Price30-Day Price ChangeDrugStatusEvent
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$786.45
+1.1%
+1.7%
The price history of LLY in the last 30 days
Kisunla
For the Treatment of Early Symptomatic Alzheimer's Disease
7/9/2025 - FDA approved
Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a la…
Full Summary
Exact Sciences Corporation stock logo
EXAS
Exact Sciences
$54.99
+2.7%
+0.7%
The price history of EXAS in the last 30 days
Oncodetect™
Molecular Residual Disease Test
7/9/2025 - Provided Update
Exact Sciences Corp announced that its Oncodetect™ molecular residual disease (MRD) test has recei…
Full Summary
Krystal Biotech, Inc. stock logo
KRYS
Krystal Biotech
$148.91
+3.9%
+9.4%
The price history of KRYS in the last 30 days
KB801
For the Treatment of Neurotrophic Keratitis
Phase 1/27/9/2025 - Dose Update
Krystal Biotech, Inc announced that the first patient has been dosed in its Phase 1/2 clinical trial…
Full Summary
Rezolute, Inc. stock logo
RZLT
Rezolute
$5.35
+7.5%
+24.0%
The price history of RZLT in the last 30 days
Ersodetug
For Hypoglycemia Due to Congenital Hyperinsulinism
Phase 3
7/9/2025 - Abstract
Rezolute, Inc announced that the abstract titled "Preliminary Patient Demographics And Baseline Char…
Full Summary
Briacell Therap stock logo
BCTX
Briacell Therap
$2.14
-26.6%
-38.6%
The price history of BCTX in the last 30 days
Bria-OTS
In metastatic breast cancer
7/9/2025 - Provided Update
BriaCell Therapeutics Corp announced the sustained complete resolution of lung metastasis in a patie…
Full Summary
Altimmune, Inc. stock logo
ALT
Altimmune
$4.78
+4.3%
-19.7%
The price history of ALT in the last 30 days
pemvidutide
for the treatment of obesity and MASH
Phase 2
7/9/2025 - Enrollment Update
Altimmune, Inc. announced that it has enrolled the first patient in the RESTORE Phase 2 trial evalua…
Full Summary
Artelo Biosciences, Inc. stock logo
ARTL
Artelo Biosciences
$18.88
+18.8%
+183.5%
The price history of ARTL in the last 30 days
ART26.12
For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
7/9/2025 - Data Presentation
Artelo Biosciences, announced the presentation of preclinical data in an osteaoarthritis (OA) pain …
Full Summary
BioVie Inc. stock logo
BIVI
BioVie
$8.16
-3.7%
-27.2%
The price history of BIVI in the last 30 days
Bezisterim
For Parkinson's Disease Patients
7/9/2025 - Provided Update
BioVie Inc. presented "Bezisterim Epigenetic Effects on Aging and Neurodegeneration" at the 7th Worl…
Full Summary
Evolus, Inc. stock logo
EOLS
Evolus
$9.81
+5.9%
+1.7%
The price history of EOLS in the last 30 days
Nuceiva®
For the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients2.
7/9/2025 - Provided Update
Evolus, Inc announced it has partnered with Symatese to commence distribution of Nuceiva® (botulinu…
Full Summary
Bausch Health Cos Inc. stock logo
BHC
Bausch Health Cos
$6.66
-0.7%
+36.4%
The price history of BHC in the last 30 days
CABTREO
For the Treatment of Acne Vulgaris
7/9/2025 - Provided Update
Bausch Health, Canada Inc announced that PrCABTREOTM (clindamycin phosphate, adapalene and benzoyl …
Full Summary
KALA BIO, Inc. stock logo
KALA
KALA BIO
$5.71
+10.7%
+38.9%
The price history of KALA in the last 30 days
KPI-012
Clinical diagnosis of PCED
7/9/2025 - Enrollment Completion
KALA BIO, Inc. announced the completion of patient enrollment in the CHASE (Corneal Healing After SE…
Full Summary
KALA BIO, Inc. stock logo
KALA
KALA BIO
$5.71
+10.7%
+38.9%
The price history of KALA in the last 30 days
KPI-012
Clinical diagnosis of PCED
Target date: 2025-Q37/9/2025 - Top-line results
KALA BIO, Inc. announced that Topline results from the CHASE trial expected by end of Q3 2025 --
Full Summary
Rhythm Pharmaceuticals, Inc. stock logo
RYTM
Rhythm Pharmaceuticals
$88.37
+35.7%
+32.4%
The price history of RYTM in the last 30 days
bivamelagon
In patients with acquired hypothalamic obesity.
Phase 2
7/9/2025 - Top-line results
Rhythm Pharmaceuticals, Inc. announced positive topline results from its Phase 2 trial evaluating bi…
Full Summary
Bausch Health Cos Inc. stock logo
BHC
Bausch Health Cos
$6.66
-0.7%
+36.4%
The price history of BHC in the last 30 days
PrCABTREOTM
For Treatment Of Acne Vulgaris
7/9/2025 - Provided Update
Bausch Health, Canada Inc., part of Bausch Health Companies Inc. announced that PrCABTREOTM (clinda…
Full Summary
Benitec Biopharma Limited stock logo
BNTC
Benitec Biopharma
$13.14
+4.1%
-18.8%
The price history of BNTC in the last 30 days
BB-301
Oculopharyngeal Muscular Dystrophy (OPMD)
Phase 1b/2a7/9/2025 - Enrollment Update
Benitec Biopharma Inc. announced the recommendation of the independent Data Safety Monitoring Board…
Full Summary
Evoke Pharma, Inc. stock logo
EVOK
Evoke Pharma
$7.18
+169.8%
+142.9%
The price history of EVOK in the last 30 days
GIMOTI (metoclopramide) nasal spray
Acute and recurrent diabetic gastroparesis
7/9/2025 - Notice of Allowance
Evoke Pharma, Inc. announced that it has received a Notice of Allowance from the United States Pat…
Full Summary
Elanco Animal Health Incorporated stock logo
ELAN
Elanco Animal Health
$14.84
+0.6%
+6.4%
The price history of ELAN in the last 30 days
TruCan™ Ultra
Canine Influenza Vaccine
7/9/2025 - Approved
Elanco Animal Health announced the U.S. Department of Agriculture (USDA) has approved TruCan Ultra …
Full Summary
ASBP
Aspire Biopharma
$0.34
+7.6%
-14.7%
The price history of ASBP in the last 30 days
BUZZ BOMB
New Sublingual Pre-Workout Supplement
7/9/2025 - Positive Feedback
Aspire Biopharma Holdings, Inc. announced positive initial consumer feedback from the Company's samp…
Full Summary
MetaVia Inc. stock logo
MTVA
MetaVia
$0.69
+8.5%
-3.7%
The price history of MTVA in the last 30 days
DA-1726
For The Treatment Of Obesity
Phase 1
7/9/2025 - Dosing Update
MetaVia Inc. announced dosing of the first patient in the 48 mg, multiple ascending dose (MAD) coho…
Full Summary
MetaVia Inc. stock logo
MTVA
MetaVia
$0.69
+8.5%
-3.7%
The price history of MTVA in the last 30 days
DA-1726
For The Treatment Of Obesity
Target date: 2025-Q47/9/2025 - Top-line data
MetaVia Inc. announced that Top-Line Data Expected in the Fourth Quarter of 2025
Full Summary
Connect Biopharma Holdings Limited Sponsored ADR stock logo
CNTB
Connect Biopharma
$1.10
-3.2%
+40.7%
The price history of CNTB in the last 30 days
Rademikibart
For Moderate-To-Severe Atopic Dermatitis
NDA
7/9/2025 - NDA Filing
Connect Biopharma Holdings Limited announced that the Company's collaborator and exclusive licensee…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$83.96
+3.2%
+5.9%
The price history of MRK in the last 30 days
MK-8527
novel nucleoside reverse transcriptase translocation inhibitor
7/8/2025 - New Data
Merck announced that new data from its research pipeline for HIV prevention and treatment will be p…
Full Summary
Eton Pharmaceuticals, Inc. stock logo
ETON
Eton Pharmaceuticals
$15.97
+1.1%
+0.8%
The price history of ETON in the last 30 days
ET-600
For the treatment of an endocrinology
NDA
7/8/2025 - FDA review
Eton Pharmaceuticals, Inc announced the Company's New Drug Application (NDA) for ET-600, a propriet…
Full Summary
Eton Pharmaceuticals, Inc. stock logo
ETON
Eton Pharmaceuticals
$15.97
+1.1%
+0.8%
The price history of ETON in the last 30 days
ET-600
For the treatment of an endocrinology
NDA
Target date: 2026-02-25
7/8/2025 - PDUFA Date
Eton Pharmaceuticals, Inc announced that NDA has been assigned a Prescription Drug User Fee Act (…
Full Summary
Larimar Therapeutics, Inc. stock logo
LRMR
Larimar Therapeutics
$3.49
+5.0%
+31.0%
The price history of LRMR in the last 30 days
nomlabofusp
For Friedreich's Ataxia
7/8/2025 - Publication
Larimar Therapeutics, announced the publication of two peer-reviewed articles highlighting nonclin…
Full Summary
Eupraxia Pharmaceuticals Inc. stock logo
EPRX
Eupraxia Pharmaceuticals
$5.54
-1.0%
+39.4%
The price history of EPRX in the last 30 days
EP-104GI
For Treatment of Eosinophilic Esophagitis
Phase 2b
7/8/2025 - Dose Update
Eupraxia Pharmaceuticals Inc. announced the first patient dosed in the Phase 2b randomized, placebo-…
Full Summary
Upstream Bio, Inc. stock logo
UPB
Upstream Bio
$11.48
+5.4%
+1.7%
The price history of UPB in the last 30 days
Verekitug
In Chronic Obstructive Pulmonary Disease (COPD)
Phase 2
7/8/2025 - Dose Update
Upstream Bio, Inc. announced that the first patient has been dosed in the Company's Phase 2 clinica…
Full Summary
Plus Therapeutics, Inc. stock logo
PSTV
Plus Therapeutics
$0.36
+7.4%
+2.8%
The price history of PSTV in the last 30 days
REYOBIQ™
For Patients with Leptomeningeal Metastases
7/8/2025 - Provided Update
Plus Therapeutics, Inc. announced the treatment of its initial patients in the Company's ReSPECT-LM…
Full Summary
Arrowhead Pharmaceuticals, Inc. stock logo
ARWR
Arrowhead Pharmaceuticals
$18.81
+7.2%
+13.5%
The price history of ARWR in the last 30 days
Zodasiran
For the Treatment of Homozygous Familial Hypercholesterolemia
Phase 3
7/8/2025 - Dose Update
Arrowhead Pharmaceuticals, Inc. announced that it has dosed the first subject in the YOSEMITE Phase …
Full Summary
Brainstorm Cell Therapeutics Inc. stock logo
BCLI
Brainstorm Cell Therapeutics
$1.28
-2.7%
+2.8%
The price history of BCLI in the last 30 days
NurOwn
Progressive Multiple Sclerosis (MS)
7/8/2025 - Provided Update
BrainStorm Cell Therapeutics Inc today acknowledged that the U.S. Food and Drug Administration's (F…
Full Summary
Intra-Cellular Therapies, Inc. stock logo
ITCI
Intra-Cellular Therapies
$131.87
CAPLYTA (Lumateperone)
Depressive Episodes associated with Bipolar
supplemental New Drug Application (sNDA)7/8/2025 - sNDA Filing
Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S.…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$155.65
-0.1%
+0.3%
The price history of JNJ in the last 30 days
CAPLYTA (Lumateperone)
Depressive Episodes associated with Bipolar
supplemental New Drug Application (sNDA)7/8/2025 - sNDA Filing
Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S.…
Full Summary
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$1.21
-3.5%
+171.1%
The price history of ONCY in the last 30 days
Pelareorep
In Breast Cancer
7/8/2025 - Clinical Data
Oncolytics Biotech® Inc announced a strategic update highlighting its compelling clinical data from…
Full Summary
Mattel, Inc. stock logo
MAT
Mattel
$20.14
+0.2%
+5.6%
The price history of MAT in the last 30 days
Barbie
type 1 diabetes (T1D)
7/8/2025 - Provided Update
Mattel, Inc announced that Barbie® is debuting the first Barbie doll with type 1 diabetes (T1D).
Full Summary
Rhythm Pharmaceuticals, Inc. stock logo
RYTM
Rhythm Pharmaceuticals
$88.37
+35.7%
+32.4%
The price history of RYTM in the last 30 days
bivamelagon
In patients with acquired hypothalamic obesity.
Phase 2
7/8/2025 - Provided Update
Rhythm Pharmaceuticals, Inc announced the Company will hold a conference call and webcast on Wednes…
Full Summary
Solid Biosciences Inc. stock logo
SLDB
Solid Biosciences
$5.69
+8.5%
+23.1%
The price history of SLDB in the last 30 days
SGT-501
For the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT)
IND
7/8/2025 - FDA Approval
Solid Biosciences Inc. announced approval of its Investigational New Drug (IND) application by the …
Full Summary
Solid Biosciences Inc. stock logo
SLDB
Solid Biosciences
$5.69
+8.5%
+23.1%
The price history of SLDB in the last 30 days
SGT-501
For the treatment of catecholaminergic polymorphic ventricular tachycardia (CPVT)
Phase 1b
7/8/2025 - Clinical Trial
Solid expects to initiate Phase 1b clinical trial of SGT-501 in the fourth quarter of 2025 -
Full Summary
KalVista Pharmaceuticals, Inc. stock logo
KALV
KalVista Pharmaceuticals
$15.85
+6.0%
+7.4%
The price history of KALV in the last 30 days
sebetralstat
Therapy for hereditary angioedema (HAE).
7/7/2025 - FDA Approval
KalVista Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approv…
Full Summary
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$37.81
+6.3%
-3.6%
The price history of TNXP in the last 30 days
TNX-801
Potential Vaccine to Prevent Mpox and Smallpox
7/7/2025 - Data Presentation
Tonix Pharmaceuticals announced that Sina Bavari, PhD, Executive Vice President of Infectious Diseas…
Full Summary
Natera, Inc. stock logo
NTRA
Natera
$163.15
+2.9%
-0.6%
The price history of NTRA in the last 30 days
Latitude™
For Colorectal Cancer
7/7/2025 - Data
Natera, Inc announced data from a colorectal cancer (CRC) study of its tissue-free Latitude™ MRD as…
Full Summary
Boston Scientific Corporation stock logo
BSX
Boston Scientific
$102.83
+0.4%
+2.8%
The price history of BSX in the last 30 days
FARAPULSE™
A nonthermal treatment in which electric fields selectively ablate heart tissue in patients with atrial fibrillation (AF).
7/7/2025 - FDA Approval
Boston Scientific Corporation announced that it has received U.S. Food and Drug Administration (FDA…
Full Summary
BeyondSpring Inc. stock logo
BYSI
BeyondSpring
$2.29
+3.4%
+3.4%
The price history of BYSI in the last 30 days
plinabulin
Patients with non-small cell lung cancer
7/7/2025 - Publication
BeyondSpring Inc. announced publication of a human clinical study in Med (Cell Press) demonstrating…
Full Summary
Cogent Biosciences, Inc. stock logo
COGT
Cogent Biosciences
$10.61
+8.4%
+53.7%
The price history of COGT in the last 30 days
bezuclastinib
In patients with non-advanced systemic mastocytosis
7/7/2025 - Top-line results
Cogent Biosciences, Inc. announced positive top-line results from the registration-directed Part 2 …
Full Summary
Organon & Co. stock logo
OGN
Organon & Co.
$10.03
+0.8%
+2.7%
The price history of OGN in the last 30 days
VTAMA (tapinarof) cream
Plaque psoriasis
7/7/2025 - Recommendation
Organon announced that VTAMA® (tapinarof) cream, 1%,was granted a strong recommendation by the Ameri…
Full Summary
Jasper Therapeutics, Inc. stock logo
JSPR
Jasper Therapeutics
$3.74
+23.8%
-37.1%
The price history of JSPR in the last 30 days
Briquilimab
To address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU)
Phase 1b/2a7/7/2025 - Updated data
Jasper Therapeutics is reporting updated data from Company's BEACON Phase 1b/2a study of subcutaneo…
Full Summary
Artelo Biosciences, Inc. stock logo
ARTL
Artelo Biosciences
$18.88
+18.8%
+183.5%
The price history of ARTL in the last 30 days
ART12.11
For overcoming problematic drug properties which allows for precise control over purity, potency, and consistency.
7/7/2025 - Data Presentation
Artelo Biosciences announced the presentation of compelling new preclinical data on its Cannabidiol…
Full Summary
Urogen Pharma stock logo
URGN
Urogen Pharma
$13.83
+0.9%
+97.0%
The price history of URGN in the last 30 days
UGN-103
For Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
Phase 3
7/7/2025 - Enrollment Completion
UroGen Pharma Ltd. announced that it has completed patient enrollment in its Phase 3 UTOPIA clinica…
Full Summary
Denali Therapeutics Inc. stock logo
DNLI
Denali Therapeutics
$15.14
+5.7%
+3.4%
The price history of DNLI in the last 30 days
tividenofusp
For the treatment of Hunter syndrome (MPS II)
BLA7/7/2025 - FDA review
Denali Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for…
Full Summary
Denali Therapeutics Inc. stock logo
DNLI
Denali Therapeutics
$15.14
+5.7%
+3.4%
The price history of DNLI in the last 30 days
tividenofusp
For the treatment of Hunter syndrome (MPS II)
BLA
Target date: 2026-01-05
7/7/2025 - PDUFA Date
Denali Therapeutics Inc. announced that The FDA granted the BLA Priority Review with a Prescription…
Full Summary
KALA BIO, Inc. stock logo
KALA
KALA BIO
$5.71
+10.7%
+38.9%
The price history of KALA in the last 30 days
KPI-012
Clinical diagnosis of PCED
7/7/2025 - Provided Update
KALA BIO, Inc. announced that the Company will host a webcast event with Key Opinion Leaders (KOLs…
Full Summary
Agenus Inc. stock logo
AGEN
Agenus
$5.28
+8.5%
-5.0%
The price history of AGEN in the last 30 days
BOT/BAL
In Metastatic MSS Colorectal Cancer
Phase 3
7/7/2025 - Provided Update
Agenus also confirmed that it has reached agreement with the U.S. Food and Drug Administration (FDA)…
Full Summary
Mustang Bio, Inc. stock logo
MBIO
Mustang Bio
$3.17
+19.0%
+145.3%
The price history of MBIO in the last 30 days
MB-101
Leptomeningeal brain tumors
Orphan Drug7/7/2025 - Designation Grant
Mustang Bio, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted Orphan Dr…
Full Summary
Fortress Biotech, Inc. stock logo
FBIO
Fortress Biotech
$1.99
+2.8%
-6.8%
The price history of FBIO in the last 30 days
MB-101
Leptomeningeal brain tumors
Orphan Drug7/7/2025 - Designation Grant
Mustang Bio, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted Orphan Dr…
Full Summary
Inspira Technologies OXY B.H.N. Ltd. stock logo
IINN
Inspira Technologies OXY B.H.N.
$1.45
-3.0%
+97.9%
The price history of IINN in the last 30 days
ART100
Cardio-Pulmonary Bypass Device
7/7/2025 - Provided Update
Inspira™ Technologies OXY B.H.N. Ltd. announced that it is engaged in high-level talks with a gover…
Full Summary
Immix Biopharma, Inc. stock logo
IMMX
Immix Biopharma
$2.72
+2.3%
+16.2%
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.
7/7/2025 - Provided Update
Immix Biopharma, Inc. announced accelerated U.S. NEXICART-2 clinical trial progress in relapsed/ref…
Full Summary
Ascendis Pharma A/S stock logo
ASND
Ascendis Pharma A/S
$179.30
+6.6%
+3.5%
The price history of ASND in the last 30 days
TransCon PTH
Adult Hypoparathyroidism
7/7/2025 - Oral presentation
Ascendis Pharma A/S announced two oral presentations at ENDO 2025, the annual meeting of the Endoc…
Full Summary
Apogee Therapeutics Inc. stock logo
APGE
Apogee Therapeutics
$37.97
+4.3%
-5.4%
The price history of APGE in the last 30 days
APG777
For the Treatment for Atopic Dermatitis and Other Inflammatory Diseases
Phase 2
7/6/2025 - Data
Apogee Therapeutics, Inc announced it will report Part A 16-week data from the Phase 2 APEX trial o…
Full Summary
Novartis AG stock logo
NVS
Novartis
$122.83
+0.9%
+4.1%
The price history of NVS in the last 30 days
secukinumab
In adults with newly diagnosed or relapsing giant cell arteritis (GCA).
Phase 3
7/3/2025 - Top-line results
Novartis announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinu…
Full Summary
BioAtla, Inc. stock logo
BCAB
BioAtla
$0.41
+4.4%
-20.2%
The price history of BCAB in the last 30 days
BA3182
In Patients with Treatment Refractory Metastatic Adenocarcinoma
7/3/2025 - Data Presentation
BioAtla, Inc today presented first-in-human data in a poster titled "Preliminary Results from a Fir…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.14
+0.9%
-11.6%
The price history of MIRA in the last 30 days
MIRA-55
Potential treatment for anxiety and cognitive decline.
7/3/2025 - Preclinical Data
MIRA Pharmaceuticals, Inc. announced positive preclinical data demonstrating that Mira-55, the Com…
Full Summary
Vertex Pharmaceuticals Incorporated stock logo
VRTX
Vertex Pharmaceuticals
$475.56
+2.0%
+6.6%
The price history of VRTX in the last 30 days
exagamglogene autotemcel
For severe sickle cell disease
7/3/2025 - Positive Data
Vertex Pharmaceuticals announced positive longer-term data for PrCASGEVY® (exagamglogene autotemcel…
Full Summary
Belite Bio, Inc. Sponsored ADR stock logo
BLTE
Belite Bio
$63.44
+5.5%
+3.3%
The price history of BLTE in the last 30 days
Tinlarebant
In Stargardt Disease
Phase 3
7/2/2025 - Enrollment Update
Belite Bio, Inc announced the completion of enrollment in the PHOENIX trial, a global, 24-month Phas…
Full Summary
Instil Bio, Inc. stock logo
TIL
Instil Bio
$25.79
+10.1%
-26.5%
The price history of TIL in the last 30 days
AXN-2510
In Relapsed/Refractory Solid Tumors
IND
7/2/2025 - FDA Clearance
Instil Bio, Inc. announced the clearance of an Investigational New Drug (IND) application for AXN-25…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$83.96
+3.2%
+5.9%
The price history of MRK in the last 30 days
sotatercept-csrk
In adults with pulmonary arterial hypertension
BLA Priority Review7/2/2025 - FDA GRANT
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority r…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$83.96
+3.2%
+5.9%
The price history of MRK in the last 30 days
sotatercept-csrk
In adults with pulmonary arterial hypertension
BLA Priority Review
Target date: 2025-10-25
7/2/2025 - PDUFA Date
Merck announced that The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date…
Full Summary
Cytosorbents Corporation stock logo
CTSO
Cytosorbents
$1.08
+2.9%
DrugSorb-ATR
Antithrombotic Removal System
7/2/2025 - Regulatory Update
CytoSorbents Corporation today provided a regulatory update on its marketing applications for DrugS…
Full Summary
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$37.81
+6.3%
-3.6%
The price history of TNXP in the last 30 days
TNX-1700
Recombinant human TFF2-human serum albumin or HSA) for the treatment of colon and gastric cancers.
7/2/2025 - Publication
Tonix Pharmaceuticals Holding Corp announced the publication of a paper entitled, "A CXCR4 Partial…
Full Summary
Organon & Co. stock logo
OGN
Organon & Co.
$10.03
+0.8%
+2.7%
The price history of OGN in the last 30 days
OG-6219
In Patients with Endometriosis-Related Pain
Phase 2
7/2/2025 - Endpoint Missed
Organon announced that the Phase 2 ELENA proof-of-concept study evaluating the investigational cand…
Full Summary
VYNE Therapeutics Inc. stock logo
VYNE
VYNE Therapeutics
$1.45
+4.7%
+50.7%
The price history of VYNE in the last 30 days
VYN202
A Novel BD2-Selective BET Inhibitor
Phase 1b
7/2/2025 - Provided Update
VYNE Therapeutics Inc today provided a program update for VYN202 following the clinical hold issue…
Full Summary
Cerus Corporation stock logo
CERS
Cerus
$1.48
+1.0%
+0.3%
The price history of CERS in the last 30 days
INTERCEPT Blood System
for platelets, plasma, IFC, and red blood cells
7/2/2025 - Regulatory Update
Cerus Corporation announced a European regulatory update on the INTERCEPT RBC program.
Full Summary
Inspira Technologies OXY B.H.N. Ltd. stock logo
IINN
Inspira Technologies OXY B.H.N.
$1.45
-3.0%
+97.9%
The price history of IINN in the last 30 days
ART100
Cardio-Pulmonary Bypass Device
7/2/2025 - Provided Update
Inspira™ Technologies OXY B.H.N. Ltd. announced it has secured a binding $22.5 million purchase or…
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$547.06
-0.1%
+5.7%
The price history of REGN in the last 30 days
linvoseltamab-gcpt
For Treatment of Relapsed or Refractory Multiple Myeloma
7/2/2025 - FDA GRANT
Regeneron Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has grant…
Full Summary
I-Mab Sponsored ADR stock logo
IMAB
I-Mab
$2.31
+5.0%
-17.5%
The price history of IMAB in the last 30 days
Givastomig
In patients with advanced cancers
Phase 1b
7/2/2025 - Positive Data
I-Mab announced the presentation of positive Phase 1b combination data for givastomig, in combinati…
Full Summary
Inventiva S.A. Sponsored ADR stock logo
IVA
Inventiva
$3.40
-1.8%
-6.3%
The price history of IVA in the last 30 days
Lanifibranor
Nonalcoholic steatohepatitis (NASH)
Phase 2b
7/2/2025 - Publication
Inventiva announces the publication in Journal of Hepatology Reports, a peer-reviewed, scientific jo…
Full Summary
4D Molecular Therapeutics, Inc. stock logo
FDMT
4D Molecular Therapeutics
$4.46
+5.7%
-6.9%
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.
Phase 3
7/2/2025 - Provided Update
4D Molecular Therapeutics announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet ag…
Full Summary
atai Life Sciences N.V. stock logo
ATAI
atai Life Sciences
$2.71
+2.9%
+18.6%
The price history of ATAI in the last 30 days
BPL-003
In Patients With Treatment Resistant Depression
Phase 2b
7/1/2025 - Top-line results
atai Life Sciences and Beckley Psytech Limited jointly announced positive topline results from the…
Full Summary
NovoCure Limited stock logo
NVCR
NovoCure
$18.10
+3.4%
+7.1%
The price history of NVCR in the last 30 days
Tumor Treating Fields - PANOVA-3
Locally advanced pancreatic cancer
Phase 3
7/1/2025 - Results
Novocure announced that it will present the final secondary endpoint results from the Phase 3 PANOV…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$2.00
-0.7%
+1.8%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY)
Schizophrenia and bipolar disorders
7/1/2025 - Recommendation
BioXcel Therapeutics announced the second positive recommendation by an independent Data Safety Moni…
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$2.00
-0.7%
+1.8%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY)
Schizophrenia and bipolar disorders
Target date: 2025-Q37/1/2025 - Top-line data
BioXcel Therapeutics, Inc announced that Topline data expected in Q3 2025.
Full Summary
Adaptive Biotechnologies Corporation stock logo
ADPT
Adaptive Biotechnologies
$12.00
+2.2%
+14.8%
The price history of ADPT in the last 30 days
clonoSEQ
Treatments for patients with lymphoid malignancies.
7/1/2025 - Provided Update
Adaptive Biotechnologies announced the integration of Adaptive's clonoSEQ® test for measurable resi…
Full Summary
Soleno Therapeutics, Inc. stock logo
SLNO
Soleno Therapeutics
$88.72
+4.1%
+14.1%
The price history of SLNO in the last 30 days
VYKAT XR
To Treat Hyperphagia in Prader-Willi Syndrome
7/1/2025 - Abstract Presentation
Soleno Therapeutics, announced that two abstracts featuring data on VYKAT™ XR (diazoxide choline) ex…
Full Summary
Jazz Pharmaceuticals PLC stock logo
JAZZ
Jazz Pharmaceuticals
$110.73
+1.5%
-1.0%
The price history of JAZZ in the last 30 days
Ziihera
For the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
European Commission Conditional Marketing Authorization7/1/2025 - Marketing authorization
Jazz Pharmaceuticals plc announced that the European Commission (EC) has granted conditional market…
Full Summary
Mustang Bio, Inc. stock logo
MBIO
Mustang Bio
$3.17
+19.0%
+145.3%
The price history of MBIO in the last 30 days
MB-101
Leptomeningeal brain tumors
Orphan Drug7/1/2025 - Designation Grant
Mustang Bio Receives FDA Orphan Drug Designation For MB-101 Treatment Of Malignant Glioma
Full Summary
Fortress Biotech, Inc. stock logo
FBIO
Fortress Biotech
$1.99
+2.8%
-6.8%
The price history of FBIO in the last 30 days
MB-101
Leptomeningeal brain tumors
Orphan Drug7/1/2025 - Designation Grant
Mustang Bio Receives FDA Orphan Drug Designation For MB-101 Treatment Of Malignant Glioma
Full Summary
BioXcel Therapeutics, Inc. stock logo
BTAI
BioXcel Therapeutics
$2.00
-0.7%
+1.8%
The price history of BTAI in the last 30 days
BXCL501 (SERENITY)
Schizophrenia and bipolar disorders
7/1/2025 - Recommendation
BioXcel Therapeutics, Inc. announced the second positive recommendation by an independent Data Safe…
Full Summary
Cue Biopharma, Inc. stock logo
CUE
Cue Biopharma
$0.79
+7.5%
+23.7%
The price history of CUE in the last 30 days
CUE-101
HPV+ recurrent/metastatic head and neck cancer
7/1/2025 - Provided Update
Cue Biopharma, provided an update on its most advanced clinical stage asset, CUE-101, representative…
Full Summary
argenex SE stock logo
ARGX
argenex
$554.95
+3.0%
-4.9%
The price history of ARGX in the last 30 days
ARGX-119
In Congenital Myasthenic Syndromes
Phase 1b
6/30/2025 - Provided Update
argenx SE announced its plan to advance the clinical development of ARGX-119, a first-in-class agon…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$70.60
+0.8%
-3.3%
The price history of AZN in the last 30 days
TAGRISSO® (osimertinib)
Third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system metastases.
NDA
6/30/2025 - Approved
HUTCHMED (China) Limited announces that the New Drug Application ("NDA") for the combination of ORP…
Full Summary
Rocket Pharmaceuticals, Inc. stock logo
RCKT
Rocket Pharmaceuticals
$3.19
+7.6%
+5.5%
The price history of RCKT in the last 30 days
RP-A701
For the Treatment of BAG3-associated Dilated Cardiomyopathy
IND
6/30/2025 - FDA Clearance
Rocket Pharmaceuticals, Inc. announced that it has received clearance from the U.S. Food and Drug Ad…
Full Summary
Cassava Sciences, Inc. stock logo
SAVA
Cassava Sciences
$2.22
+6.5%
+3.0%
The price history of SAVA in the last 30 days
Simufilam
Alzheimer's Disease
6/30/2025 - Poster Presentation
Cassava Sciences, Inc. announced that the Company presented a poster at the TSC International Resea…
Full Summary
Avadel Pharmaceuticals PLC. stock logo
AVDL
Avadel Pharmaceuticals
$9.77
+8.0%
-3.0%
The price history of AVDL in the last 30 days
LUMRYZ (sodium oxybate)
Extended-release sodium oxybate medication
6/30/2025 - Regulatory Update
Avadel Pharmaceuticals plc announced that, on Friday, June 27, 2025, the U.S. Court of Appeals for t…
Full Summary
Moderna, Inc. stock logo
MRNA
Moderna
$32.64
+0.3%
+16.0%
The price history of MRNA in the last 30 days
mRNA-1010
Quadrivalent Seasonal Flu
Phase 3
6/30/2025 - Positive Results
Moderna, Inc. announced positive results from a Phase 3 efficacy study (P304) evaluating the relativ…
Full Summary
Celcuity, Inc. stock logo
CELC
Celcuity
$13.88
+3.6%
+7.5%
The price history of CELC in the last 30 days
Gedatolisib
HR+ / HER2- Metastatic Breast Cancer
6/30/2025 - Clinical Data
Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials…
Full Summary
Plus Therapeutics, Inc. stock logo
PSTV
Plus Therapeutics
$0.36
+7.4%
+2.8%
The price history of PSTV in the last 30 days
REYOBIQ™
For Patients with Leptomeningeal Metastases
6/30/2025 - Trial Initiation
Plus Therapeutics, Inc announces the initiation of the ReSPECT-LM dose optimization trial for REYOBI…
Full Summary
INmune Bio, Inc. stock logo
INMB
INmune Bio
$2.48
+7.6%
-67.6%
The price history of INMB in the last 30 days
XPro
For treatment of Alzheimer's Disease
6/30/2025 - Findings Update
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$133.66
-0.6%
-0.4%
The price history of BIIB in the last 30 days
Felzartamab
For the Treatment of Antibody-Mediated Rejection in Kidney Transplant Recipients
6/30/2025 - Dosing Update
Biogen Inc. announced the initiation of dosing in the global clinical study, PROMINENT.
Full Summary
Artelo Biosciences, Inc. stock logo
ARTL
Artelo Biosciences
$18.88
+18.8%
+183.5%
The price history of ARTL in the last 30 days
ART26.12
For the prevention of chemotherapy-induced peripheral neuropathy, a debilitating and often treatment-altering side effect of cancer therapy.
6/30/2025 - Results
Artelo Biosciences, announced favorable results from its first-in-human study evaluating ART26.12, …
Full Summary
Assembly Biosciences, Inc. stock logo
ASMB
Assembly Biosciences
$18.46
+2.0%
+14.8%
The price history of ASMB in the last 30 days
ABI-1179
For Recurrent Genital Herpes
Phase 1
6/30/2025 - Dosing Update
Assembly Biosciences, Inc. announced that the first participant has been dosed in the Phase 1b porti…
Full Summary
Chemomab Therapeutics Ltd. Sponsored ADR stock logo
CMMB
Chemomab Therapeutics
$1.19
+2.6%
-9.8%
The price history of CMMB in the last 30 days
nebokitug
In Sclerosing Cholangitis
Phase 2
6/30/2025 - Data Presentation
Chemomab Therapeutics, Ltd announced that data from the company's Phase 2 SPRING trial of nebokitug…
Full Summary
Tempest Therapeutics, Inc. stock logo
TPST
Tempest Therapeutics
$7.52
+1.1%
-16.0%
The price history of TPST in the last 30 days
TPST-1120
First-Line Regimen for Hepatocellular Carcinoma
6/30/2025 - Received Approval
Tempest Therapeutics, Inc. announced that the company received approval from the National Medical P…
Full Summary

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