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Recent FDA Drug Approval Process Events

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 Company Current Price 30-Day Price Change Drug Status Event
Precision BioSciences, Inc. stock logo
DTIL
Precision BioSciences
$4.52
+1.6%
-7.8%
The price history of DTIL in the last 30 days
ARCUS Eliminate DNA of living cells and organisms. 7/16/2025 - Additional data Precision BioSciences, Inc announced updated additional preclinical data further validating the sci…
Full Summary
Cue Biopharma, Inc. stock logo
CUE
Cue Biopharma
$0.86
+22.3%
+47.6%
The price history of CUE in the last 30 days
CUE-101 HPV+ recurrent/metastatic head and neck cancer 7/16/2025 - Clinical Update Cue Biopharma, Inc. today provided a clinical update on its most advanced asset, CUE-101, represent…
Full Summary
Voyager Therapeutics, Inc. stock logo
VYGR
Voyager Therapeutics
$3.27
+6.2%
+4.8%
The price history of VYGR in the last 30 days
VY7523 In Alzheimer's Disease 7/16/2025 - Provided Update Voyager Therapeutics, today continued the expansion of its Alzheimer's disease (AD) franchise with …
Full Summary
BioCardia, Inc. stock logo
BCDA
BioCardia
$2.26
-0.9%
+7.1%
The price history of BCDA in the last 30 days
CardiAMP Designed to be a comprehensive biotherapeutic heart failure solution 7/16/2025 - Enrollment Update BioCardia, announced that Henry Ford Health in Detroit, Michigan is now enrolling patients with isc…
Full Summary
Cognition Therapeutics, Inc. stock logo
CGTX
Cognition Therapeutics
$0.62
+8.6%
+120.2%
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
7/16/2025 - Results Cognition Therapeutics, Inc., announced that James E. Galvin, MD, MPH will present results from th…
Full Summary
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$1.25
+10.6%
+87.1%
The price history of ONCY in the last 30 days
Pelareorep In Breast Cancer 7/16/2025 - Provided Update Oncolytics Biotech® Inc summarized its biomarker and translational data for pelareorep, the Company'…
Full Summary
Quince Therapeutics, Inc. stock logo
QNCX
Quince Therapeutics
$1.68
-2.9%
+23.5%
The price history of QNCX in the last 30 days
eDSP For Treatment Of Rare Neurodegenerative Disease Ataxia-Telangiectasia
Phase 3
7/16/2025 - Enrollment Update Quince Therapeutics, Inc. announced that the company has completed enrollment in its pivotal Phase…
Full Summary
Adagene Inc. Sponsored ADR stock logo
ADAG
Adagene
$1.97
+3.7%
+2.6%
The price history of ADAG in the last 30 days
ADG126 Advanced Solid Tumors
Phase 2
Target date: H2 2025
7/15/2025 - Enrollment Update Adagene Inc. announced that Company expects to begin enrolling patients in Phase 2 in 2H 2025
Full Summary
MiNK Therapeutics, Inc. stock logo
INKT
MiNK Therapeutics
$23.11
-17.5%
+208.5%
The price history of INKT in the last 30 days
AgenT-797 Multiple myeloma 7/15/2025 - Publication MiNK Therapeutics, Inc. announced the publication of a peer-reviewed article titled "CAR-iNKT Cells:…
Full Summary
Abeona Therapeutics Inc. stock logo
ABEO
Abeona Therapeutics
$6.26
+5.2%
+4.3%
The price history of ABEO in the last 30 days
ZEVASKYN To Treat Wounds in Painful Skin Disorder 7/15/2025 - Provided Update Abeona Therapeutics Inc. announced activation of the newest Qualified Treatment Center (QTC) for FD…
Full Summary
Intelligent Bio Solutions Inc. stock logo
INBS
Intelligent Bio Solutions
$2.13
+12.1%
+10.4%
The price history of INBS in the last 30 days
SMARTOX in drug and alcohol screening services 7/15/2025 - Provided Update Intelligent Bio Solutions Inc announced a new global distribution agreement with SMARTOX®, a Texas-…
Full Summary
Lantern Pharma Inc. stock logo
LTRN
Lantern Pharma
$3.99
+6.1%
+26.7%
The price history of LTRN in the last 30 days
RADR AI platform to accelerate and optimize the development of antibody-drug conjugates (ADCs). 7/15/2025 - Provided Update Lantern Pharma Inc announced the launch of an innovative AI-powered module within its proprietary R…
Full Summary
Apellis Pharmaceuticals, Inc. stock logo
APLS
Apellis Pharmaceuticals
$19.75
+2.1%
+11.2%
The price history of APLS in the last 30 days
pegcetacoplan Paroxysmal nocturnal hemoglobinuria (PNH) 7/15/2025 - Abstract Presentation Apellis Pharmaceuticals, announced that five abstracts were accepted for oral presentation at the A…
Full Summary
Plus Therapeutics, Inc. stock logo
PSTV
Plus Therapeutics
$0.32
+2.2%
+5.0%
The price history of PSTV in the last 30 days
REYOBIQ™ For Patients with Leptomeningeal Metastases 7/15/2025 - Oral presentation Plus Therapeutics, Inc. announces the oral presentation of its ReSPECT-LM clinical trial results and…
Full Summary
Neurocrine Biosciences, Inc. stock logo
NBIX
Neurocrine Biosciences
$133.48
+1.7%
+6.9%
The price history of NBIX in the last 30 days
CAHtalog Patients With Classic Congenital Adrenal Hyperplasia In US 7/15/2025 - Results Neurocrine Biosciences, Inc. announced results from a new analysis using real-world data from CAHt…
Full Summary
Adagene Inc. Sponsored ADR stock logo
ADAG
Adagene
$1.97
+3.7%
+2.6%
The price history of ADAG in the last 30 days
ADG126 Advanced Solid Tumors FDA Type B Meeting 7/15/2025 - FDA Meeting Adagene Inc. announced outcomes from its Type B meeting with the United States Food and Drug Adminis…
Full Summary
AtriCure, Inc. stock logo
ATRC
AtriCure
$30.38
-0.5%
-6.8%
The price history of ATRC in the last 30 days
LeAAPS For Stroke Prevention 7/15/2025 - Enrollment Completion AtriCure, Inc announced the completion of enrollment in the left atrial appendage exclusion for prop…
Full Summary
SELLAS Life Sciences Group, Inc. stock logo
SLS
SELLAS Life Sciences Group
$1.92
+1.1%
+23.1%
The price history of SLS in the last 30 days
SLS009 For Treatment of Acute Myeloid Leukemia
Phase 2
7/15/2025 - Endpoint Met SELLAS Life Sciences Group, Inc announced that is has met all primary endpoints in its Phase 2 tria…
Full Summary
Kezar Life Sciences, Inc. stock logo
KZR
Kezar Life Sciences
$4.50
-2.6%
+10.0%
The price history of KZR in the last 30 days
zetomipzomib In Patients with Autoimmune Hepatitis
Phase 2a
7/15/2025 - Lifted Clinical Hold Kezar Life Sciences, Inc. announced that the Division of Hepatology and Nutrition of the U.S. Food…
Full Summary
Agenus Inc. stock logo
AGEN
Agenus
$6.36
+2.3%
+33.1%
The price history of AGEN in the last 30 days
AgenT-797 Multiple myeloma 7/15/2025 - Publication MiNK Therapeutics, Inc. announced the publication of a peer-reviewed article titled "CAR-iNKT Cells:…
Full Summary
Dare Bioscience, Inc. stock logo
DARE
Dare Bioscience
$2.62
-7.7%
-9.8%
The price history of DARE in the last 30 days
Ovaprene Intravaginal Contraceptive
Phase 3
7/14/2025 - Efficacy and Safety results Daré Bioscience, Inc. announced positive interim safety and efficacy results from its ongoing Phase …
Full Summary
Abeona Therapeutics Inc. stock logo
ABEO
Abeona Therapeutics
$6.26
+5.2%
+4.3%
The price history of ABEO in the last 30 days
ZEVASKYN To Treat Wounds in Painful Skin Disorder 7/14/2025 - Provided Update Bio-Techne Corporation announced that its Simple Western™ Technology played a key role in supportin…
Full Summary
Vertex Pharmaceuticals Incorporated stock logo
VRTX
Vertex Pharmaceuticals
$469.55
+1.2%
+6.2%
The price history of VRTX in the last 30 days
suzetrigine For the Treatment of Moderate-to-Severe Acute Pain 7/14/2025 - Provided Update Vertex Pharmaceuticals Incorporated announced that it has been named a 2025 Breakthroughs Innovatio…
Full Summary
AstraZeneca PLC stock logo
AZN
AstraZeneca
$70.08
-0.3%
-1.3%
The price history of AZN in the last 30 days
BaxHTN In patients with uncontrolled or treatment resistant hypertension
Phase 3
7/14/2025 - Positive Results AstraZeneca announced Positive high-level results from the BaxHTN Phase III trial showed baxdrostat …
Full Summary
Takeda Pharmaceutical Co. stock logo
TAK
Takeda Pharmaceutical
$14.72
-0.2%
-1.2%
The price history of TAK in the last 30 days
TAK-861 In patients with moderate to severe obstructive sleep apnea undergoing general anesthesia.
Phase 3
7/14/2025 - Endpoint Met Takeda announced that all primary and secondary endpoints were met in two Phase 3 randomized, double…
Full Summary
Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$27.31
+0.4%
-25.5%
The price history of RARE in the last 30 days
evinacumab With Homozygous Familial Hypercholesterolemia (HoFH) 7/14/2025 - Provided Update Ultragenyx Pharmaceutical Inc. announced that Health Canada has extended the approval of Evkeeza® (…
Full Summary
Rani Therapeutics Holdings, Inc. stock logo
RANI
Rani Therapeutics
$0.41
-3.9%
-20.2%
The price history of RANI in the last 30 days
RaniPill For the treatment of obesity 7/14/2025 - Data Presentation Rani Therapeutics Holdings, Inc announced that it will present preclinical data on the RaniPill® ca…
Full Summary
Neurocrine Biosciences, Inc. stock logo
NBIX
Neurocrine Biosciences
$133.48
+1.7%
+6.9%
The price history of NBIX in the last 30 days
crinecerfont For the Treatment of Congenital Adrenal Hyperplasia (CAH) 7/14/2025 - Presentation Neurocrine Biosciences, announced the presentation of new one-year data from the CAHtalyst™ Adult s…
Full Summary
Neurocrine Biosciences, Inc. stock logo
NBIX
Neurocrine Biosciences
$133.48
+1.7%
+6.9%
The price history of NBIX in the last 30 days
CAHtalyst™ For the Treatment of Congenital Adrenal Hyperplasia 7/14/2025 - Data Presentation Neurocrine Biosciences, Inc. announced the presentation of new data from the Phase 3 CAHtalyst™ Adu…
Full Summary
Corcept Therapeutics Incorporated stock logo
CORT
Corcept Therapeutics
$72.85
+2.0%
+1.4%
The price history of CORT in the last 30 days
Relacorilant Recurrent Platinum-Resistant Ovarian Cancer
NDA
7/14/2025 - NDA Filing Corcept Therapeutics Incorporated announced that it has submitted a new drug application (NDA) to t…
Full Summary
Ascendis Pharma A/S stock logo
ASND
Ascendis Pharma A/S
$175.40
+0.4%
+1.4%
The price history of ASND in the last 30 days
TransCon PTH Adult Hypoparathyroidism
Phase 3
7/14/2025 - New Data Ascendis Pharma announced new data from Week 156 of its Phase 3 PaTHway Trial confirming that long…
Full Summary
Gilead Sciences, Inc. stock logo
GILD
Gilead Sciences
$109.85
+0.7%
+1.7%
The price history of GILD in the last 30 days
Yeztugo For HIV Prevention 7/14/2025 - Data Presentation Gilead Sciences, Inc announced that Gilead researchers and collaborators will present new Phase 3 P…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$82.45
+1.1%
+5.2%
The price history of MRK in the last 30 days
MK-8527 novel nucleoside reverse transcriptase translocation inhibitor
Phase 3
7/14/2025 - Clinical Trial Merck announced the initiation of the EXPrESSIVE Phase 3 clinical trials, evaluating the safety and …
Full Summary
Crinetics Pharmaceuticals, Inc. stock logo
CRNX
Crinetics Pharmaceuticals
$31.90
+0.2%
+3.4%
The price history of CRNX in the last 30 days
Paltusotine Acromegaly 7/13/2025 - New Data Crinetics Pharmaceuticals, Inc. announced new data from its clinical development program evaluating …
Full Summary
Rhythm Pharmaceuticals, Inc. stock logo
RYTM
Rhythm Pharmaceuticals
$91.44
+2.3%
+47.6%
The price history of RYTM in the last 30 days
Setmelanotide (HO) Hypothalamic Obesity 7/12/2025 - Data Rhythm Pharmaceuticals, Inc. announced data from three new presentations on the Company's clinical …
Full Summary
MiNK Therapeutics, Inc. stock logo
INKT
MiNK Therapeutics
$23.11
-17.5%
+208.5%
The price history of INKT in the last 30 days
AgenT-797 Multiple myeloma 7/11/2025 - Publication MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene des…
Full Summary
Capricor Therapeutics, Inc. stock logo
CAPR
Capricor Therapeutics
$7.24
+0.8%
-40.6%
The price history of CAPR in the last 30 days
deramiocel For the treatment of Duchenne muscular dystrophy (DMD) BLA 7/11/2025 - Complete Response Letter Capricor Therapeutics announced that it has received a Complete Response Letter (CRL) from the U.S.…
Full Summary
MIRA Pharmaceuticals, Inc. stock logo
MIRA
MIRA Pharmaceuticals
$1.87
+12.7%
+46.1%
The price history of MIRA in the last 30 days
SKNY-1 For Obesity 7/11/2025 - Results MIRA Pharmaceuticals, Inc. announced new preclinical results from SKNY-1, an oral drug candidate fo…
Full Summary
Verastem, Inc. stock logo
VSTM
Verastem
$5.25
+7.4%
-1.1%
The price history of VSTM in the last 30 days
RAMP 201 Vutometinib (VS-6766) alone and in combination with defactinib among patients with recurrent low-grade serous ovarian cancer (LGSOC).
Phase 2
7/11/2025 - Analysis Verastem Oncology announced that the primary analysis of the Phase 2 RAMP 201 clinical trial was p…
Full Summary
Milestone Pharmaceuticals Inc. stock logo
MIST
Milestone Pharmaceuticals
$1.67
+12.8%
-3.5%
The price history of MIST in the last 30 days
Etripamil For Treatment in Paroxysmal Supraventricular Tachycardia 7/11/2025 - FDA review Milestone® Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has acce…
Full Summary
Agenus Inc. stock logo
AGEN
Agenus
$6.36
+2.3%
+33.1%
The price history of AGEN in the last 30 days
AgenT-797 Multiple myeloma 7/11/2025 - Publication MiNK Therapeutics, Inc. announced the publication of another landmark case in Nature's Oncogene des…
Full Summary
Milestone Pharmaceuticals Inc. stock logo
MIST
Milestone Pharmaceuticals
$1.67
+12.8%
-3.5%
The price history of MIST in the last 30 days
Etripamil For Treatment in Paroxysmal Supraventricular Tachycardia Target date: December 13, 2025 7/11/2025 - PDUFA Date Milestone® Pharmaceuticals Inc announced that The FDA has assigned a new Prescription Drug User Fee…
Full Summary
Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$27.31
+0.4%
-25.5%
The price history of RARE in the last 30 days
UX111 For Sanfilippo syndrome type A (MPS IIIA) BLA 7/11/2025 - Complete Response Letter Ultragenyx Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) has issued a Co…
Full Summary
Acumen Pharmaceuticals, Inc. stock logo
ABOS
Acumen Pharmaceuticals
$1.38
+5.3%
+13.1%
The price history of ABOS in the last 30 days
Sabirnetug for Early Alzheimer's Disease 7/10/2025 - Presentation Acumen Pharmaceuticals, will present new findings at the upcoming Alzheimer's Association Internati…
Full Summary
BeOne Medicines Ltd. - Sponsored ADR stock logo
ONC
BeOne Medicines
$279.16
+3.5%
+9.9%
The price history of ONC in the last 30 days
Tislelizumab Recurrent or Metastatic Nasopharyngeal Cancer EC Approval 7/10/2025 - Approved BeOne Medicines Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab), i…
Full Summary
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$45.06
+1.9%
+29.0%
The price history of TNXP in the last 30 days
TNX-801 Potential Vaccine to Prevent Mpox and Smallpox 7/10/2025 - Presentation Tonix Pharmaceuticals announced the presentation of new findings on TNX-801 (recombinant horsepox,…
Full Summary
Ligand Pharmaceuticals Incorporated stock logo
LGND
Ligand Pharmaceuticals
$129.63
+4.3%
+15.2%
The price history of LGND in the last 30 days
ZELSUVMI For the Treatment of Molluscum Contagiosum 7/10/2025 - Provided Update Pelthos Therapeutics Inc. announced the launch of ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the…
Full Summary
Pfizer Inc. stock logo
PFE
Pfizer
$24.59
-0.1%
+2.4%
The price history of PFE in the last 30 days
XTANDI (Enzalutamide) Metastatic Hormone-Sensitive Prostate Cancer
Phase 3
7/10/2025 - Top-line results Pfizer Inc. and Astellas Pharma Inc announced positive topline results from the overall survival (O…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$82.45
+1.1%
+5.2%
The price history of MRK in the last 30 days
Doravirine/Islatravir In adults with HIV-1 infection
NDA
7/10/2025 - FDA review Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Dru…
Full Summary
Stoke Therapeutics, Inc. stock logo
STOK
Stoke Therapeutics
$11.90
+1.3%
+2.1%
The price history of STOK in the last 30 days
zorevunersen For the treatment of Dravet syndrome with a confirmed mutation,
Phase 3
7/10/2025 - Presentation Stoke Therapeutics, Inc and Biogen Inc announced the presentation of data from an analysis that inf…
Full Summary
Cocrystal Pharma, Inc. stock logo
COCP
Cocrystal Pharma
$1.67
-2.0%
+5.0%
The price history of COCP in the last 30 days
CDI-988 For Pandemic Norovirus and Coronavirus 7/10/2025 - Oral presentation Cocrystal Pharma, Inc announces that its first-in-class pan-viral protease inhibitor CDI-988 has be…
Full Summary
REGENXBIO Inc. stock logo
RGNX
REGENXBIO
$8.50
+3.2%
-1.8%
The price history of RGNX in the last 30 days
RGX-202 Duchenne Muscular Dystrophy 7/10/2025 - Publication REGENXBIO Inc. announced the publication of preclinical results comparing a microdystrophin gene the…
Full Summary
PDS Biotechnology Corporation stock logo
PDSB
PDS Biotechnology
$1.21
+3.4%
-25.3%
The price history of PDSB in the last 30 days
PDS01ADC For the treatment of recurrent prostate cancer 7/10/2025 - Provided Update PDS Biotechnology announced patient recruitment has been completed in Stage 1 of a clinical trial o…
Full Summary
Ascentage Pharma Group International - Unsponsored ADR stock logo
AAPG
Ascentage Pharma Group International
$38.62
+5.1%
+22.1%
The price history of AAPG in the last 30 days
lisaftoclax In Venetoclax-Refractory Patients NMPA Approval 7/10/2025 - Approved Ascentage Pharma announced that its proprietary novel Bcl-2 selective inhibitor lisaftoclax (APG-25…
Full Summary
Arcus Biosciences, Inc. stock logo
RCUS
Arcus Biosciences
$9.26
+2.6%
+6.1%
The price history of RCUS in the last 30 days
quemliclustat For Pancreatic Cancer Orphan Drug 7/10/2025 - Designation Grant Arcus Biosciences, Inc announced that quemliclustat, an investigational small molecule CD73 inhibito…
Full Summary
Cognition Therapeutics, Inc. stock logo
CGTX
Cognition Therapeutics
$0.62
+8.6%
+120.2%
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
7/10/2025 - FDA Meeting Cognition Therapeutics, Inc., announced that it conducted an end-of-Phase 2 meeting with the U.S. F…
Full Summary
Krystal Biotech, Inc. stock logo
KRYS
Krystal Biotech
$150.08
+1.6%
+15.4%
The price history of KRYS in the last 30 days
KB801 For the Treatment of Neurotrophic Keratitis Phase 1/2 7/9/2025 - 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
+4.7%
+29.5%
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
Exact Sciences Corporation stock logo
EXAS
Exact Sciences
$53.67
+1.3%
+2.2%
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
BioVie Inc. stock logo
BIVI
BioVie
$7.31
+4.6%
-29.0%
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
Novogen Limited stock logo
KZIA
Novogen
$10.19
-5.6%
+9.2%
The price history of KZIA in the last 30 days
Paxalisib Atypical rhabdoid / teratoid tumors (AT/RT), a rare and highly-aggressive childhood brain cancer
Phase 1b
7/9/2025 - Preliminary Results Kazia Therapeutics announce preliminary results from the first patient in its Phase 1b trial evalua…
Full Summary
Benitec Biopharma Limited stock logo
BNTC
Benitec Biopharma
$11.75
-5.5%
-23.9%
The price history of BNTC in the last 30 days
BB-301 Oculopharyngeal Muscular Dystrophy (OPMD) Phase 1b/2a 7/9/2025 - Enrollment Update Benitec Biopharma Inc. announced the recommendation of the independent Data Safety Monitoring Board…
Full Summary
Evolus, Inc. stock logo
EOLS
Evolus
$9.20
-0.8%
-0.5%
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
KALA BIO, Inc. stock logo
KALA
KALA BIO
$5.96
+9.0%
+42.6%
The price history of KALA in the last 30 days
KPI-012 Clinical diagnosis of PCED Target date: Q3 2025 7/9/2025 - Top-line results KALA BIO, Inc. announced that Topline results from the CHASE trial expected by end of Q3 2025 --
Full Summary
MetaVia Inc. stock logo
MTVA
MetaVia
$0.67
+0.9%
-2.6%
The price history of MTVA in the last 30 days
DA-1726 For The Treatment Of Obesity Target date: Q4 2025 7/9/2025 - Top-line data MetaVia Inc. announced that Top-Line Data Expected in the Fourth Quarter of 2025
Full Summary
Rhythm Pharmaceuticals, Inc. stock logo
RYTM
Rhythm Pharmaceuticals
$91.44
+2.3%
+47.6%
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
Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$27.31
+0.4%
-25.5%
The price history of RARE in the last 30 days
UX143 (setrusumab) Osteogenesis Imperfecta (OI)
Phase 3
7/9/2025 - evaluation Ultragenyx Pharmaceutical announced that the randomized, placebo-controlled Phase 3 portion of the O…
Full Summary
Connect Biopharma Holdings Limited Sponsored ADR stock logo
CNTB
Connect Biopharma
$1.62
+11.0%
+50.0%
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
MetaVia Inc. stock logo
MTVA
MetaVia
$0.67
+0.9%
-2.6%
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
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$788.91
+2.2%
-0.3%
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
KALA BIO, Inc. stock logo
KALA
KALA BIO
$5.96
+9.0%
+42.6%
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
Bausch Health Cos Inc. stock logo
BHC
Bausch Health Cos
$6.44
+0.3%
+12.4%
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 …
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Altimmune, Inc. stock logo
ALT
Altimmune
$4.18
-39.3%
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
Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$45.06
+1.9%
+29.0%
The price history of TNXP in the last 30 days
TNX-102 SL Fibromyalgia
Phase 3
7/9/2025 - Results Tonix Pharmaceuticals announced that full results from its confirmatory Phase 3 RESILIENT trial of …
Full Summary
Elanco Animal Health Incorporated stock logo
ELAN
Elanco Animal Health
$14.51
-0.7%
+6.6%
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
Bausch Health Cos Inc. stock logo
BHC
Bausch Health Cos
$6.44
+0.3%
+12.4%
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…
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Aspire Biopharma Holdings, Inc. stock logo
ASBP
Aspire Biopharma
$0.35
+10.1%
+8.6%
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…
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Eton Pharmaceuticals, Inc. stock logo
ETON
Eton Pharmaceuticals
$13.89
-3.7%
+2.1%
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…
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Upstream Bio, Inc. stock logo
UPB
Upstream Bio
$10.92
-2.0%
+5.9%
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
Solid Biosciences Inc. stock logo
SLDB
Solid Biosciences
$5.58
+3.5%
+21.0%
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 …
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Eton Pharmaceuticals, Inc. stock logo
ETON
Eton Pharmaceuticals
$13.89
-3.7%
+2.1%
The price history of ETON in the last 30 days
ET-600 For the treatment of an endocrinology
NDA
Target date: February 25, 2026
7/8/2025 - PDUFA Date Eton Pharmaceuticals, Inc announced that NDA has been assigned a Prescription Drug User Fee Act (…
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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.…
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Larimar Therapeutics, Inc. stock logo
LRMR
Larimar Therapeutics
$3.20
+1.3%
+19.0%
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…
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Solid Biosciences Inc. stock logo
SLDB
Solid Biosciences
$5.58
+3.5%
+21.0%
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 -
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Eupraxia Pharmaceuticals Inc. stock logo
EPRX
Eupraxia Pharmaceuticals
$5.35
-0.6%
+25.3%
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-…
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Plus Therapeutics, Inc. stock logo
PSTV
Plus Therapeutics
$0.32
+2.2%
+5.0%
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…
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Brainstorm Cell Therapeutics Inc. stock logo
BCLI
Brainstorm Cell Therapeutics
$1.20
+0.8%
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…
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Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$82.45
+1.1%
+5.2%
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…
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Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$164.78
+6.2%
+8.1%
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
Arrowhead Pharmaceuticals, Inc. stock logo
ARWR
Arrowhead Pharmaceuticals
$18.30
+3.8%
+18.1%
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
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$1.25
+10.6%
+87.1%
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…
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Rhythm Pharmaceuticals, Inc. stock logo
RYTM
Rhythm Pharmaceuticals
$91.44
+2.3%
+47.6%
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…
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Mattel, Inc. stock logo
MAT
Mattel
$19.60
+0.6%
+4.0%
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).
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Organon & Co. stock logo
OGN
Organon & Co.
$9.64
+0.8%
-2.3%
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…
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Tonix Pharmaceuticals Holding Corp. stock logo
TNXP
Tonix Pharmaceuticals
$45.06
+1.9%
+29.0%
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…
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Jasper Therapeutics, Inc. stock logo
JSPR
Jasper Therapeutics
$3.35
+1.2%
-38.1%
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/2a 7/7/2025 - Updated data Jasper Therapeutics is reporting updated data from Company's BEACON Phase 1b/2a study of subcutaneo…
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Mustang Bio, Inc. stock logo
MBIO
Mustang Bio
$2.21
-7.5%
+116.7%
The price history of MBIO in the last 30 days
MB-101 Leptomeningeal brain tumors Orphan Drug 7/7/2025 - Designation Grant Mustang Bio, Inc announced that the U.S. Food and Drug Administration ("FDA") has granted Orphan Dr…
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KalVista Pharmaceuticals, Inc. stock logo
KALV
KalVista Pharmaceuticals
$15.79
+4.1%
+30.0%
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…
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Cogent Biosciences, Inc. stock logo
COGT
Cogent Biosciences
$11.86
+3.1%
+55.6%
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
Urogen Pharma stock logo
URGN
Urogen Pharma
$14.34
+2.1%
+8.3%
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

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