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FDA Drug Approval Calendar

MarketBeat's FDA Calendar tracks confirmed drug approvals, clinical trial results, regulatory decisions, and biotech catalysts — updated daily with real-time stock data. Review recent FDA actions including New Drug Application (NDA) approvals, Biologics License Application (BLA) decisions, Complete Response Letters (CRLs), Phase 1–3 trial results, and special designations like Breakthrough Therapy or Orphan Drug status.

Each entry includes the company ticker, current stock price, and 30-day price trend so you can quickly see how the market is responding to FDA news.

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Main Company Current Price 30-Day Price Change Drug Status Event
Compass Pathways PLC Sponsored ADR stock logo
CMPS
Compass Pathways
$14.22
-6.3%
COMP360 psilocybin Therapy for treatment-resistant depression (TRD) 9/10/2026 - Provided Update Compass Pathways plc announced the U.S. grant program recipients to create training programs for he…
Full Summary
Prelude Therapeutics Incorporated stock logo
PRLD
Prelude Therapeutics
$4.67
-8.3%
-18.5%
The price history of PRLD in the last 30 days
PRT13722 Oral KAT6A Selective Degrader 9/10/2026 - FDA Clearance Prelude Therapeutics announced that the U.S. Food and Drug Administration (FDA) cleared the Company…
Full Summary
Prelude Therapeutics Incorporated stock logo
PRLD
Prelude Therapeutics
$4.67
-8.3%
-18.5%
The price history of PRLD in the last 30 days
PRT13722 Oral KAT6A Selective Degrader Target date: Q4 2026 9/10/2026 - Enrollment Update Prelude Therapeutics Incorporated announced that the Company expects to begin enrolling patients in…
Full Summary
BioLineRx Ltd. stock logo
BLRX
BioLineRx
$2.57
+0.8%
-4.5%
The price history of BLRX in the last 30 days
GLIX1 treatment of recurrent and progressive glioblastoma 9/10/2026 - Abstract BioLineRx Ltd. announced that two abstracts featuring GLIX1 have been accepted for presentation, in…
Full Summary
Medicus Pharma Ltd stock logo
MDCX
Medicus Pharma
$0.16
-5.3%
-51.3%
The price history of MDCX in the last 30 days
SKNJCT-003 For the Treatment of Nodular Basal Cell Carcinoma 9/10/2026 - Provided Update Medicus Pharma Ltd. y announced that an abridged Clinical Study Report (CSR) for SKNJCT-003 (NCT0660…
Full Summary
Agenus Inc. stock logo
AGEN
Agenus
$6.89
+0.4%
-0.1%
The price history of AGEN in the last 30 days
BOT/BAL In Metastatic MSS Colorectal Cancer 9/10/2026 - Presentation Agenus Inc announced that a poster evaluating botensilimab (BOT), an Fc-enhanced multifunctional ant…
Full Summary
CAMP4 Therapeutics Corporation stock logo
CAMP
CAMP4 Therapeutics
$4.34
+0.2%
-4.2%
The price history of CAMP in the last 30 days
CMP-002 treat a broad range of genetic diseases Phase 1/2 9/10/2026 - Authorization CAMP4 Therapeutics Corporation announced the company has received authorization from the United Kin…
Full Summary
CAMP4 Therapeutics Corporation stock logo
CAMP
CAMP4 Therapeutics
$4.34
+0.2%
-4.2%
The price history of CAMP in the last 30 days
CMP-002 treat a broad range of genetic diseases Target date: Q4 2026 9/10/2026 - Clinical Trial CAMP4 Therapeutics Corporation announced that the Company anticipates initiation of the clinical tr…
Full Summary
Legend Biotech Corporation Sponsored ADR stock logo
LEGN
Legend Biotech
$19.19
-3.6%
-7.1%
The price history of LEGN in the last 30 days
Ciltacabtagene Autoleucel (cilta-cel) Relapsed and/or Refractory Multiple Myeloma 9/10/2026 - Data Presentation Legend Biotech Corporation announced that data from CARTITUDE-2 and real-world evidence will be pres…
Full Summary
Compass Pathways PLC Sponsored ADR stock logo
CMPS
Compass Pathways
$14.22
-6.3%
COMP360 for treatment resistant depression (TRD). 9/10/2026 - Provided Update Fluence Selected by Compass Pathways as a recipient of its U.S. healthcare provider training grant p…
Full Summary
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$0.77
-2.9%
-6.3%
The price history of ONCY in the last 30 days
Pelareorep In Breast Cancer 9/10/2026 - Positive Results Oncolytics Biotech® Inc. announced positive preclinical results evaluating pelareorep in combinatio…
Full Summary
OPTH
Optimi Health
$4.50
+3.4%
-5.3%
The price history of OPTH in the last 30 days
psilocybin-assisted therapy for Major Depressive Disorder
Phase 2
9/10/2026 - Trial Initiation Optimi Health Corp announces plans to initiate a multisite Phase 2 clinical trial evaluating psilocy…
Full Summary
OPTH
Optimi Health
$4.50
+3.4%
-5.3%
The price history of OPTH in the last 30 days
psilocybin-assisted therapy for Major Depressive Disorder Target date: H1 2027 9/10/2026 - Trial Initiation Optimi Health Corp announced that the trial is planned to be initiated in the first half of 2027
Full Summary
OPTH
Optimi Health
$4.50
+3.4%
-5.3%
The price history of OPTH in the last 30 days
psilocybin-assisted therapy for Major Depressive Disorder Target date: LATE 2027 9/10/2026 - Dose Update Optimi Health Corp. announced that the dosing expected to be complete by the end of 2027.
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$255.00
+1.6%
+2.4%
The price history of ABBV in the last 30 days
Atogepant Episodic Migraine 9/10/2026 - Top-line results AbbVie announced positive topline results from the Phase 3 LUNA study, which evaluated atogepant, a …
Full Summary
Oncobiologics, Inc. stock logo
OTLK
Oncobiologics
$0.66
+2.7%
-39.9%
The price history of OTLK in the last 30 days
LYTENAVA For the Treatment of Wet AMD 9/10/2026 - Provided Update Outlook Therapeutics, Inc. announced that Bob Jahr, Chief Executive Officer, recently participated …
Full Summary
Verrica Pharmaceuticals Inc. stock logo
VRCA
Verrica Pharmaceuticals
$4.95
-2.2%
-2.8%
The price history of VRCA in the last 30 days
VP-315 For the Treatment of Basal Cell Carcinoma 9/10/2026 - Poster Presentation Verrica Pharmaceuticals Inc. announced that it will present posters on YCANTH® (VP-102), a therapy…
Full Summary
Lyell Immunopharma, Inc. stock logo
LYEL
Lyell Immunopharma
$12.20
-5.3%
-13.9%
The price history of LYEL in the last 30 days
LYL273 Metastatic Colorectal Cancer 9/10/2026 - Provided Update Lyell Immunopharma, Inc announced successful completion of the planned technology transfer for LYL2…
Full Summary
IDEAYA Biosciences, Inc. stock logo
IDYA
IDEAYA Biosciences
$37.45
-2.3%
+1.3%
The price history of IDYA in the last 30 days
Darovasertib Non-metastatic uveal melanoma (UM) 9/9/2026 - Dose Update IDEAYA Biosciences, Inc announced that the first patient has been dosed in OptimUM-11, a global Phas…
Full Summary
Compass Pathways PLC Sponsored ADR stock logo
CMPS
Compass Pathways
$14.22
-6.3%
COMP005 for treatment resistant depression (TRD).
Phase 3
9/9/2026 - Top-line results Compass Pathways plc announced the topline 52-week results (Part C) from its Phase 3 COMP005 trial …
Full Summary
Opus Genetics, Inc. stock logo
IRD
Opus Genetics
$6.07
+5.9%
+61.4%
The price history of IRD in the last 30 days
OPGx-BEST1 For the treatment of bestrophin-1 (BEST1)-related IRD. Phase 1/2 9/9/2026 - Positive Results Opus Genetics, Inc announced positive 3- and 6-month results from the low-dose Cohort 1 of BIRD-1, i…
Full Summary
Fate Therapeutics, Inc. stock logo
FATE
Fate Therapeutics
$2.33
-4.5%
-14.3%
The price history of FATE in the last 30 days
FT819 Advanced B-cell Leukemias and Lymphomas 9/9/2026 - Clinical Data Fate Therapeutics, Inc. announced clinical data from its off-the-shelf anti-CD19 CAR T-cell product…
Full Summary
Rezolute, Inc. stock logo
RZLT
Rezolute
$4.17
+2.7%
-11.3%
The price history of RZLT in the last 30 days
Ersodetug For Hypoglycemia Due to Congenital Hyperinsulinism 9/9/2026 - Provided Update Rezolute, Inc. today provided an update on the status of the ongoing U.S. Food and Drug Administrat…
Full Summary
Pyxis Oncology, Inc. stock logo
PYXS
Pyxis Oncology
$3.27
-3.3%
+2.8%
The price history of PYXS in the last 30 days
MICVO Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma 9/9/2026 - Positive Data Pyxis Oncology, Inc. announced positive updated data as of the August 18, 2026 data cutoff date fro…
Full Summary
Incyte Corporation stock logo
INCY
Incyte
$123.28
-2.2%
+2.1%
The price history of INCY in the last 30 days
Elraglusib (9-ING-41) + Retifanlimab + gemcitabine/nab-paclitaxel First Line Therapy for Patients With Advanced Pancreatic Cancer 9/9/2026 - New preclinical data Actuate Therapeutics, Inc. announced new preclinical data evaluating elraglusib in combination with …
Full Summary
Radiopharm Theranostics Limited - Sponsored ADR stock logo
RADX
Radiopharm Theranostics
$2.06
-1.0%
-25.9%
The price history of RADX in the last 30 days
RAD301 Pancreatic Ductal Adenocarcinoma (PDAC).
Phase 1
9/9/2026 - Positive Data Radiopharm Theranostics announced positive data from the Phase 1 imaging trial designed to evaluate…
Full Summary
Autolus Therapeutics PLC Sponsored ADR stock logo
AUTL
Autolus Therapeutics
$1.96
-3.4%
-7.5%
The price history of AUTL in the last 30 days
obe-cel adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL). RMAT Designation 9/9/2026 - Designation Grant Autolus Therapeutics plc announced that the U.S. Food and Drug Administration (FDA) has granted reg…
Full Summary
PureTech Health PLC Sponsored ADR stock logo
PRTC
PureTech Health
$17.42
SPT-300 For the treatment of mood and anxiety disorders, including anxious depression 9/9/2026 - Top-line results Seaport Therapeutics, Inc announced positive topline results from the Phase 1 Driving Simulation T…
Full Summary
Cocrystal Pharma, Inc. stock logo
COCP
Cocrystal Pharma
$1.23
-0.8%
+9.8%
The price history of COCP in the last 30 days
CDI-988 For Pandemic Norovirus and Coronavirus 9/9/2026 - Provided Update Cocrystal Pharma, Inc. announced that the last subject has been dosed in its Phase 1b norovirus cha…
Full Summary
Cocrystal Pharma, Inc. stock logo
COCP
Cocrystal Pharma
$1.23
-0.8%
+9.8%
The price history of COCP in the last 30 days
CDI-988 For Pandemic Norovirus and Coronavirus Target date: LATE 2026 9/9/2026 - Results Cocrystal Pharma, Inc announced that the Preliminary efficacy results expected in late 2026 or ea…
Full Summary
Novogen Limited stock logo
KZIA
Novogen
$11.01
-7.3%
-13.9%
The price history of KZIA in the last 30 days
PNOC035 for Recurrent Pediatric AT/RT Brain Cancer
Phase 2
9/9/2026 - Dose Update Kazia Therapeutics Limited announced that the first patient has been dosed in Arm A of PNOC035, a Ph…
Full Summary
ProQR Therapeutics N.V. stock logo
PRQR
ProQR Therapeutics
$1.94
-2.5%
+4.3%
The price history of PRQR in the last 30 days
AX-0811 for cholestatic liver diseases, including biliary atresia.
Phase 1
9/9/2026 - Dose Update ProQR Therapeutics N.V announced that the first participant has been dosed in the Phase 1 clinical …
Full Summary
BioMarin Pharmaceutical Inc. stock logo
BMRN
BioMarin Pharmaceutical
$65.51
+1.7%
-6.7%
The price history of BMRN in the last 30 days
vosoritide Children with achondroplasia
Phase 3
9/9/2026 - New Data BioMarin Pharmaceutical Inc. announced new data from the Phase 3 CANOPY-HCH-3 study evaluating VOX…
Full Summary
Ascendis Pharma A/S stock logo
ASND
Ascendis Pharma A/S
$261.23
+0.2%
+2.3%
The price history of ASND in the last 30 days
TransCon CNP In Children with Achondroplasia 9/9/2026 - Data Ascendis Pharma A/S announced Week 52 data from the open-label sentinel cohort portion of the reAC…
Full Summary
Upstream Bio, Inc. stock logo
UPB
Upstream Bio
$5.75
-3.5%
-16.8%
The price history of UPB in the last 30 days
Verekitug In Chronic Obstructive Pulmonary Disease (COPD)
Phase 2
9/8/2026 - Results Upstream Bio, Inc. today presented results from the Phase 2 VALIANT clinical trial evaluating the sa…
Full Summary
Beam Therapeutics Inc. stock logo
BEAM
Beam Therapeutics
$24.37
-3.2%
-8.8%
The price history of BEAM in the last 30 days
BEAM-302 In Alpha-1 Antitrypsin Deficiency (AATD) Phase 1/2 9/8/2026 - Clinical Data Beam Therapeutics Inc. announced updated clinical data from the Phase 1/2 trial evaluating BEAM-302…
Full Summary
Roivant Sciences Ltd. stock logo
ROIV
Roivant Sciences
$40.94
-2.1%
+13.2%
The price history of ROIV in the last 30 days
Mosliciguat In PH patients.
Phase 2
9/8/2026 - Positive Results Roivant announced positive results from its Phase 2 PHocus clinical trial evaluating mosliciguat f…
Full Summary
Belite Bio, Inc. Sponsored ADR stock logo
BLTE
Belite Bio
$175.07
-4.4%
-2.2%
The price history of BLTE in the last 30 days
Tinlarebant In Stargardt Disease 9/8/2026 - New Drug Submissions Belite Bio, Inc announced the submission of a New Drug Application (NDA) to the Ministry of Health,…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$63.76
-1.0%
0.0%
The price history of BMY in the last 30 days
arlocabtagene RRMM Patients
Phase 2
9/8/2026 - Positive Results Bristol Myers Squibb announced positive Phase 2 results from the registrational QUINTESSENTIAL tria…
Full Summary
Vor Biopharma Inc. stock logo
VOR
Vor Biopharma
$22.34
-3.9%
telitacicept Sjögren's Disease
Phase 3
9/8/2026 - Enrollment Completion Vor Bio announced the completion of enrollment in UPSTREAM MG, its global Phase 3 registrational tri…
Full Summary
Vor Biopharma Inc. stock logo
VOR
Vor Biopharma
$22.34
-3.9%
telitacicept Sjögren's Disease Target date: H1 2027 9/8/2026 - Top-line results Vor Bio announced Topline results from the 24-week primary endpoint remain expected in the first ha…
Full Summary
Monte Rosa Therapeutics, Inc. stock logo
GLUE
Monte Rosa Therapeutics
$14.32
+0.4%
-10.2%
The price history of GLUE in the last 30 days
MRT-6160 To treat multiple T-cell and/or Th17 mediated autoimmune and inflammatory diseases, including ulcerative colitis (UC).
Phase 2
9/8/2026 - Provided Update Monte Rosa Therapeutics, Inc. announced that its collaborator Novartis has initiated a Phase 2 cli…
Full Summary
Definium Therapeutics, Inc. stock logo
DFTX
Definium Therapeutics
$37.73
-0.7%
-11.8%
The price history of DFTX in the last 30 days
DT120 ODT For Major Depressive Disorder
Breakthrough Therapy
9/8/2026 - Designation Grant Definium Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted B…
Full Summary
Nkarta, Inc. stock logo
NKTX
Nkarta
$2.81
-3.4%
+17.6%
The price history of NKTX in the last 30 days
NKX019 Relapsed/refractory B cell malignancies 9/8/2026 - Provided Update Nkarta, Inc. announced its selection for three scientific presentations at ACR Convergence 2026 bei…
Full Summary
X4 Pharmaceuticals, Inc. stock logo
XFOR
X4 Pharmaceuticals
$3.40
-5.6%
-20.7%
The price history of XFOR in the last 30 days
Mavorixafor In people diagnosed with idiopathic, cyclic, or congenital neutropenia.
Phase 3
9/8/2026 - positive Outcome X4 Pharmaceuticals announced the positive outcome of its Type C Meeting with the U.S. Food and Drug …
Full Summary
Artiva Biotherapeutics, Inc. stock logo
ARTV
Artiva Biotherapeutics
$10.42
-3.4%
-9.6%
The price history of ARTV in the last 30 days
AlloNK in refractory rheumatoid arthritis 9/8/2026 - Provided Update Artiva Biotherapeutics, Inc. today provided an update on anticipated data disclosures and developmen…
Full Summary
BioVie Inc. stock logo
BIVI
BioVie
$1.91
-3.0%
+22.4%
The price history of BIVI in the last 30 days
Bezisterim For Parkinson's Disease Patients
Phase 3
9/8/2026 - Provided Update BioVie Inc. announced next stage of engagement with the Food and Drug Administration (FDA) to advanc…
Full Summary
Briacell Therap stock logo
BCTX
Briacell Therap
$3.60
-0.8%
+5.6%
The price history of BCTX in the last 30 days
Bria-IMT Metastatic breast cancer (breast cancer that has spread beyond the breast) 9/8/2026 - Provided Update BriaCell Therapeutics Corp announced that Memorial Sloan Kettering Cancer Center (MSK) has joined B…
Full Summary
Dyne Therapeutics, Inc. stock logo
DYN
Dyne Therapeutics
$18.42
-4.0%
-29.6%
The price history of DYN in the last 30 days
DYNE-101 Designed to enable targeted muscle tissue delivery with the goal of reducing toxic DMPK RNA in the nucleus 9/8/2026 - Additional data Dyne Therapeutics, Inc. announced that it will present additional one-year clinical data from the P…
Full Summary
Dyne Therapeutics, Inc. stock logo
DYN
Dyne Therapeutics
$18.42
-4.0%
-29.6%
The price history of DYN in the last 30 days
DYNE-101 Designed to enable targeted muscle tissue delivery with the goal of reducing toxic DMPK RNA in the nucleus Target date: Q1 2027 9/8/2026 - Top-line data Dyne Therapeutics, Inc. announced that the Topline data from the ACHIEVE REC are on track for Q1 20…
Full Summary
Avalyn Pharma Inc. stock logo
AVLN
Avalyn Pharma
$34.67
-3.4%
-7.2%
The price history of AVLN in the last 30 days
AP01 Patients with Progressive Pulmonary Fibrosis 9/8/2026 - New Data Avalyn Pharma Inc. announced new data demonstrating predicted aerosol distribution of AP01 and surv…
Full Summary
BioAge Labs, Inc. stock logo
BIOA
BioAge Labs
$8.65
-5.7%
-17.5%
The price history of BIOA in the last 30 days
BGE-102 For the treatment of obesity. 9/8/2026 - Dose Update BioAge Labs, Inc. announced that the first participant has been dosed in QUELL-DME, a randomized, co…
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$11.93
-2.3%
-1.3%
The price history of NTLA in the last 30 days
onvo-z hereditary angioedema BLA 9/8/2026 - FDA Accepted Intellia Therapeutics, today announced the U.S. Food and Drug Administration (FDA) has accepted the…
Full Summary
Intellia Therapeutics, Inc. stock logo
NTLA
Intellia Therapeutics
$11.93
-2.3%
-1.3%
The price history of NTLA in the last 30 days
onvo-z hereditary angioedema BLA
Target date: March 10, 2027
9/8/2026 - PDUFA Date Intellia Therapeutics, announced that the PDUFA target action date of March 10, 2027
Full Summary
Quoin Pharmaceuticals, Ltd. Sponsored ADR stock logo
QNRX
Quoin Pharmaceuticals
$6.90
-1.0%
+17.1%
The price history of QNRX in the last 30 days
QRX003 Nethertons Syndrome RPD Designation 9/8/2026 - Designation Grant Quoin Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted R…
Full Summary
BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$72.50
-4.7%
-13.5%
The price history of BBIO in the last 30 days
BBO-8520 Inhibitor of KRASG12C (ON) state. 9/8/2026 - Clinical Data BridgeBio Oncology Therapeutics, Inc announced new clinical data for KRASG12C inhibitor BBO-8520 an…
Full Summary
Ascendis Pharma A/S stock logo
ASND
Ascendis Pharma A/S
$261.23
+0.2%
+2.3%
The price history of ASND in the last 30 days
TransCon CNP In Children with Achondroplasia 9/7/2026 - Data Ascendis Pharma A/S announced it will share the latest data from its Endocrinology Rare Disease prog…
Full Summary
Nyxoah SA stock logo
NYXH
Nyxoah
$1.50
-1.3%
-5.1%
The price history of NYXH in the last 30 days
Genio For the Treatment of Obstructive Sleep Apnea 9/7/2026 - Provided Update Nyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-a…
Full Summary
Roivant Sciences Ltd. stock logo
ROIV
Roivant Sciences
$40.94
-2.1%
+13.2%
The price history of ROIV in the last 30 days
Mosliciguat In PH patients.
Phase 2
9/6/2026 - Presentation Pulmovant announced that results from the Phase 2 PHocus study of mosliciguat in patients with pulmo…
Full Summary
Rein Therapeutics Inc. stock logo
RNTX
Rein Therapeutics
$0.78
-5.6%
-3.0%
The price history of RNTX in the last 30 days
LTI-03 In Idiopathic Pulmonary Fibrosis 9/4/2026 - Late Breaking Presentation Rein Therapeutics announced that it will present a late-breaking poster at the European Respiratory…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$55.65
-0.7%
-1.6%
The price history of IONS in the last 30 days
Pelacarsen Cardiovascular disease and elevated levels of Lp(a)
Phase 3
9/4/2026 - updated results Royalty Pharma plc announced an update on Novartis’ Phase 3 results from the HORIZON outcomes trial …
Full Summary
Guardant Health, Inc. stock logo
GH
Guardant Health
$159.03
-2.3%
-3.7%
The price history of GH in the last 30 days
Guardant360 Advanced solid tumors. 9/4/2026 - FDA approved Guardant Health, Inc announced that the U.S. Food and Drug Administration (FDA) has approved Guarda…
Full Summary
Inhibrx Biosciences, Inc. stock logo
INBX
Inhibrx Biosciences
$111.42
-1.3%
+13.3%
The price history of INBX in the last 30 days
INBRX-106 refractory or relapsed non-small cell lung cancer (NSCLC) in combination with Keytruda. 9/4/2026 - Presentation Inhibrx Biosciences, Inc. announced that it will host a live webcast presentation on Tuesday, Septe…
Full Summary
Biogen Inc. stock logo
BIIB
Biogen
$215.43
+2.2%
+3.1%
The price history of BIIB in the last 30 days
LEQEMBI® (lecanemab-irmb) Treatment of Alzheimer's Disease National Medical Products Administration 9/3/2026 - Approved Eisai Co., Ltd. and Biogen Inc. announced today that the National Medical Products Administration (N…
Full Summary
Insmed, Inc. stock logo
INSM
Insmed
$127.28
-1.2%
-3.8%
The price history of INSM in the last 30 days
ARIKAYCE® IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC 9/3/2026 - Abstract Presentation nsmed Incorporated announced that five abstracts highlighting data from its respiratory portfolio h…
Full Summary
C4 Therapeutics, Inc. stock logo
CCCC
C4 Therapeutics
$3.40
-1.2%
-12.8%
The price history of CCCC in the last 30 days
cemsidomide IKZF1/3 Degrader 9/3/2026 - New Data C4 Therapeutics, Inc. announced that new biomarker data on the immunomodulatory effects of cemsido…
Full Summary
Climb Bio, Inc. stock logo
CLYM
Climb Bio
$14.95
-0.7%
+3.9%
The price history of CLYM in the last 30 days
CLYM116 for IgAN 9/3/2026 - Positive Data Climb Bio, Inc. announced positive initial data from the ongoing Phase 1 trial evaluating CLYM116, …
Full Summary
Dyne Therapeutics, Inc. stock logo
DYN
Dyne Therapeutics
$18.42
-4.0%
-29.6%
The price history of DYN in the last 30 days
DYNE-253 for Duchenne Muscular Dystrophy 9/3/2026 - Data Presentation Dyne Therapeutics, Inc. announced that it will present preclinical data supporting the ongoing deve…
Full Summary
Harmony Biosciences Holdings, Inc. stock logo
HRMY
Harmony Biosciences
$41.10
-1.2%
+3.3%
The price history of HRMY in the last 30 days
EPX-100 treatment of Dravet syndrome 9/3/2026 - Data Presentation Harmony Biosciences Holdings, Inc announced that it will present encore data from the company’s inv…
Full Summary
Liquidia Corporation stock logo
LQDA
Liquidia
$67.85
-1.8%
-13.9%
The price history of LQDA in the last 30 days
YUTREPIA Inhalation Powder
Fast Track
9/3/2026 - Designation Grant Liquidia Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Tr…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$255.00
+1.6%
+2.4%
The price history of ABBV in the last 30 days
etentamig in patients with triple-class exposed (proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody) relapsed/refractory multiple myeloma (RRMM).
Phase 3
9/3/2026 - Top-line results AbbVie announced positive topline results from the Phase 3 CERVINO study1 evaluating etentamig, an i…
Full Summary
Milestone Pharmaceuticals Inc. stock logo
MIST
Milestone Pharmaceuticals
$1.05
-1.9%
-6.7%
The price history of MIST in the last 30 days
Etripamil For Treatment in Paroxysmal Supraventricular Tachycardia 9/3/2026 - Approved Milestone® Pharmaceuticals Inc announced that China’s National Medical Products Administration (NMP…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$55.65
-0.7%
-1.6%
The price history of IONS in the last 30 days
Zilganersen for the treatment of children and adults Alexander disease (AxD). 9/3/2026 - FDA approved Ionis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approve…
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Stoke Therapeutics, Inc. stock logo
STOK
Stoke Therapeutics
$29.34
-1.9%
-11.0%
The price history of STOK in the last 30 days
zorevunersen For the treatment of Dravet syndrome with a confirmed mutation, 9/3/2026 - Presentation Stoke Therapeutics, Inc. and Biogen Inc announced presentations of data at the 16th European Epilep…
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United Therapeutics Corporation stock logo
UTHR
United Therapeutics
$503.86
-0.6%
-1.5%
The price history of UTHR in the last 30 days
Tyvaso (Treprostinil) Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD) supplemental New Drug Application (sNDA) 9/2/2026 - FDA Accepted United Therapeutics Corporation announced that the FDA has accepted the supplemental New Drug App…
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Opus Genetics, Inc. stock logo
IRD
Opus Genetics
$6.07
+5.9%
+61.4%
The price history of IRD in the last 30 days
OPGx-BEST1 For the treatment of bestrophin-1 (BEST1)-related IRD. Phase 1/2 9/2/2026 - Top-line data Opus Genetics, Inc announced plans to present topline clinical data from Cohort 1 of its Phase 1/2 …
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uniQure N.V. stock logo
QURE
uniQure
$44.47
-3.3%
-1.5%
The price history of QURE in the last 30 days
AMT-130 Huntington's Disease BLA 9/2/2026 - BLA Filing uniQure N.V announced the submission of a Biologics License Application (BLA) to the United States (…
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Teva Pharmaceutical Industries Ltd. stock logo
TEVA
Teva Pharmaceutical Industries
$36.34
-1.4%
-1.4%
The price history of TEVA in the last 30 days
TEV ‘408 anti-IL-15 monoclonal antibody 9/2/2026 - Top-line results Teva Pharmaceutical announced positive topline results from an ongoing Phase 2a study of TEV ‘408, …
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TScan Therapeutics, Inc. stock logo
TCRX
TScan Therapeutics
$0.32
-3.7%
-58.9%
The price history of TCRX in the last 30 days
TSC-101 Solid Tumors 9/2/2026 - Provided Update TScan Therapeutics, Inc. announced it is strategically reorganizing to prioritize its in vivo solid …
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BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$72.50
-4.7%
-13.5%
The price history of BBIO in the last 30 days
Infigratinib PROPEL3 Infigratinib in Children with Achondroplasia 9/2/2026 - Orphan Drug Filing BridgeBio Pharma, Inc. announced today that one late-breaking oral presentation on the impact of ora…
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Scholar Rock Holding Corporation stock logo
SRRK
Scholar Rock
$55.67
+1.9%
+3.4%
The price history of SRRK in the last 30 days
Apitegromab Type 2 and Type 3 Spinal Muscular Atrophy (SMA)
Fast Track
9/2/2026 - Designation Grant Scholar Rock announced that the FDA has granted Fast Track and Orphan Drug designations to apitegro…
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Scholar Rock Holding Corporation stock logo
SRRK
Scholar Rock
$55.67
+1.9%
+3.4%
The price history of SRRK in the last 30 days
Apitegromab Type 2 and Type 3 Spinal Muscular Atrophy (SMA) Orphan Drug 9/2/2026 - Designation Grant Scholar Rock announced that the FDA has granted Fast Track and Orphan Drug designations to apitegro…
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SELLAS Life Sciences Group, Inc. stock logo
SLS
SELLAS Life Sciences Group
$13.49
-3.3%
+14.6%
The price history of SLS in the last 30 days
SLS009 For Treatment of Acute Myeloid Leukemia 9/2/2026 - Abstract SELLAS Life Sciences Group, announced that three abstracts evaluating SLS009 (tambiciclib), a poten…
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Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$14.40
+0.6%
-46.4%
The price history of RARE in the last 30 days
GTX-102 Angelman Syndrome
Phase 3
9/2/2026 - Results Ultragenyx Pharmaceutical announced results from the Phase 3 Aspire study for apazunersen (GTX-102…
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Ocugen, Inc. stock logo
OCGN
Ocugen
$1.03
-3.8%
-26.8%
The price history of OCGN in the last 30 days
OCU410 Dry Age-related Macular Degeneration (Dry AMD)
Phase 3
9/1/2026 - Dose Update Ocugen, Inc announced that the first patient was dosed in the global Phase 3 registrational trial o…
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Adicet Bio, Inc. stock logo
ACET
Adicet Bio
$9.53
-0.1%
+15.4%
The price history of ACET in the last 30 days
ADI-001 B cell non-Hodgkin's lymphoma (NHL)
Phase 1
9/1/2026 - Provided Update Adicet Bio, Inc announced completion of the last patient visit for the planned Phase 1 safety and ef…
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BlossomHill Therapeutics, Inc. stock logo
BLSM
BlossomHill Therapeutics
$21.51
-2.2%
+32.5%
The price history of BLSM in the last 30 days
BH-30643 Treatment of Advanced EGFR C797S-positive NSCLC Phase 1/2 9/1/2026 - Updated data BlossomHill Therapeutics, Inc. announced that updated data from the ongoing Phase 1/2 SOLARA trial …
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Upstream Bio, Inc. stock logo
UPB
Upstream Bio
$5.75
-3.5%
-16.8%
The price history of UPB in the last 30 days
Verekitug In Chronic Obstructive Pulmonary Disease (COPD)
Phase 3
9/1/2026 - Provided Update Upstream Bio, Inc. announced its pivotal Phase 3 development plans for verekitug in severe asthma an…
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Kymera Therapeutics, Inc. stock logo
KYMR
Kymera Therapeutics
$117.00
+1.4%
+2.6%
The price history of KYMR in the last 30 days
KT-621 A potential oral treatment for asthma and other TH2 respiratory diseases. 9/1/2026 - Poster Presentation Kymera Therapeutics, announced that the Company will present two posters featuring previously repor…
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Natera, Inc. stock logo
NTRA
Natera
$326.14
-1.3%
+3.2%
The price history of NTRA in the last 30 days
Signatera MRD Test for cancer therapies 9/1/2026 - Publication Natera, Inc. announced the publication of new data in Blood Neoplasia, validating the prognostic and…
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Novogen Limited stock logo
KZIA
Novogen
$11.01
-7.3%
-13.9%
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 9/1/2026 - New Data Kazia Therapeutics Limited announced new preclinical and translational data showing that its lead a…
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Alumis Inc. stock logo
ALMS
Alumis
$9.90
+1.0%
-61.3%
The price history of ALMS in the last 30 days
envudeucitinib in Moderate-to-Severe Plaque Psoriasis
Phase 2b
9/1/2026 - Endpoint Missed Alumis Inc. announced that its Phase 2b LUMUS trial of envudeucitinib for the treatment of moderate-…
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Stoke Therapeutics, Inc. stock logo
STOK
Stoke Therapeutics
$29.34
-1.9%
-11.0%
The price history of STOK in the last 30 days
zorevunersen For the treatment of Dravet syndrome with a confirmed mutation, 9/1/2026 - Presentation Stoke Therapeutics, Inc and Biogen Inc announced presentations of data at the 16th European Epilep…
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LIFE
Ethos Technologies Inc. Class A Common Stock
$38.85
-2.2%
+15.7%
The price history of LIFE in the last 30 days
Efzofitimod Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) 9/1/2026 - Provided Update aTyr Pharma, Inc. today provided an update on the expected timing of a response from the U.S. Food a…
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Ultragenyx Pharmaceutical Inc. stock logo
RARE
Ultragenyx Pharmaceutical
$14.40
+0.6%
-46.4%
The price history of RARE in the last 30 days
DTX401 Glycogen Storage Disease Type Ia (GSDIa)
Phase 3
9/1/2026 - Publication Ultragenyx Pharmaceutical announced the publication of 96-week data from its Phase 3 study of GENGL…
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IDEAYA Biosciences, Inc. stock logo
IDYA
IDEAYA Biosciences
$37.45
-2.3%
+1.3%
The price history of IDYA in the last 30 days
IDE849 In Solid Tumors FDA Type C Meeting 8/31/2026 - FDA Meeting IDEAYA Biosciences, Inc announced a successful FDA Type C meeting to determine the Phase 3 registr…
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Jazz Pharmaceuticals PLC stock logo
JAZZ
Jazz Pharmaceuticals
$240.48
-0.3%
-3.4%
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)
Phase 3
8/31/2026 - Top-line results BeOne Medicines Ltd. announced positive topline results from the second interim analysis (IA2) of …
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Karyopharm Therapeutics Inc. stock logo
KPTI
Karyopharm Therapeutics
$1.62
-4.1%
-20.2%
The price history of KPTI in the last 30 days
XPOVIO (selinexor) + Jakafi (ruxolitinib) Naïve Myelofibrosis supplemental New Drug Application (sNDA) 8/31/2026 - sNDA Submission Karyopharm Therapeutics Inc. announced that it has submitted a supplemental New Drug Application (s…
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Axsome Therapeutics, Inc. stock logo
AXSM
Axsome Therapeutics
$211.12
+0.2%
-1.6%
The price history of AXSM in the last 30 days
AXS-05 Major Depressive Disorder
Phase 3
8/31/2026 - Dose Update Axsome Therapeutics, Inc announced that the first patient has been dosed in the SUMMIT Phase 3 tria…
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Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$1,122.74
-0.1%
-7.9%
The price history of LLY in the last 30 days
Taltz adults with psoriasis and obesity or overweight
Phase 3b
8/31/2026 - Results Eli Lilly and Company announced 52-week results from TOGETHER-PsO and TOGETHER-PsA, two novel open…
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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.

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.

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.

  • 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