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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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0 Results
Main Company Current Price 30-Day Price Change Drug Status Event
Tiziana Life Sciences Ltd stock logo
TLSA
Tiziana Life Sciences
$1.05
+15.9%
The price history of TLSA in the last 30 days
intranasal foralumab Antibody Attenuates Long COVID Neuroinflammation and Improves Cognitive Function
Phase 2
10/16/2026 - Dose Update Tiziana Life Sciences, Ltd. announced that the last patient has begun dosing in its Phase 2 randomiz…
Full Summary
Tiziana Life Sciences Ltd stock logo
TLSA
Tiziana Life Sciences
$1.05
+15.9%
The price history of TLSA in the last 30 days
intranasal foralumab Antibody Attenuates Long COVID Neuroinflammation and Improves Cognitive Function Target date: Q1 2027 10/16/2026 - Top-line data Tiziana Life Sciences, Ltd. announced that Topline data are anticipated to be announced in Q1 2027.
Full Summary
Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$790.74
-0.7%
+0.8%
The price history of REGN in the last 30 days
Libtayo (cemiplimab) Advanced Cervical Cancer 10/16/2026 - Positive Opinion Regeneron Pharmaceuticals, Inc announced that the European Medicines Agency’s (EMA) Committee for M…
Full Summary
Sanofi stock logo
SNY
Sanofi
$40.61
+0.8%
-4.4%
The price history of SNY in the last 30 days
Libtayo (cemiplimab) Advanced Cervical Cancer 10/16/2026 - Positive Opinion Regeneron Pharmaceuticals, Inc announced that the European Medicines Agency’s (EMA) Committee for M…
Full Summary
Tango Therapeutics, Inc. stock logo
TNGX
Tango Therapeutics
$22.04
-2.9%
+1.3%
The price history of TNGX in the last 30 days
vopimetostat patients with MTAP-deleted and RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). Phase 1/2 10/16/2026 - Updated data Tango Therapeutics, Inc. announced that the Company will present updated data from a Phase 1/2 stu…
Full Summary
Organon & Co. stock logo
OGN
Organon & Co.
$13.76
0.0%
+0.5%
The price history of OGN in the last 30 days
MIUDELLA Hormone-Free Intrauterine Device
Phase 3
10/16/2026 - presented results Organon announced that Sebela Women’s Health will present interim results from an ongoing Phase 3 st…
Full Summary
Ionis Pharmaceuticals, Inc. stock logo
IONS
Ionis Pharmaceuticals
$42.94
-2.7%
-3.4%
The price history of IONS in the last 30 days
Olezarsen (Formerly IONIS-APOCIII-L) Severe hypertriglyceridemia 10/16/2026 - Positive Opinion Ionis Pharmaceuticals, Inc announced that the Committee for Medicinal Products for Human Use (CHMP…
Full Summary
Omeros Corporation stock logo
OMER
Omeros
$16.20
-13.8%
-9.3%
The price history of OMER in the last 30 days
Narsoplimab Hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) 10/16/2026 - Negative opinion Omeros Corporation announced that the European Medicines Agency’s CHMP issued a negative opinion on…
Full Summary
Ascendis Pharma A/S stock logo
ASND
Ascendis Pharma A/S
$225.25
-0.6%
-4.8%
The price history of ASND in the last 30 days
TransCon CNP In Children with Achondroplasia 10/16/2026 - Positive Opinion Ascendis Pharma A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of th…
Full Summary
Insmed, Inc. stock logo
INSM
Insmed
$96.27
-3.0%
-19.8%
The price history of INSM in the last 30 days
Treprostinil Palmitil Inhalation Powder (TPIP) Pulmonary arterial hypertension (PAH) 10/15/2026 - Provided Update Insmed Incorporated a people-first global biopharmaceutical company striving to deliver first- and …
Full Summary
Aquestive Therapeutics, Inc. stock logo
AQST
Aquestive Therapeutics
$3.78
-6.9%
-18.0%
The price history of AQST in the last 30 days
Anaphylm For epinephrine prodrug candidate product
NDA
10/15/2026 - NDA Resubmission Aquestive Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has acknowle…
Full Summary
Aquestive Therapeutics, Inc. stock logo
AQST
Aquestive Therapeutics
$3.78
-6.9%
-18.0%
The price history of AQST in the last 30 days
Anaphylm For epinephrine prodrug candidate product
NDA
Target date: March 16, 2027
10/15/2026 - PDUFA Date Aquestive Therapeutics, Inc. announced that the Prescription Drug User Fee Act (PDUFA) goal action…
Full Summary
Aquestive Therapeutics, Inc. stock logo
AQST
Aquestive Therapeutics
$3.78
-6.9%
-18.0%
The price history of AQST in the last 30 days
Anaphylm For epinephrine prodrug candidate product Target date: Q4 2026 10/15/2026 - Provided Update Aquestive Therapeutics, Inc. announced that the Ex-U.S. strategy remains on track with Canadian N…
Full Summary
Seres Therapeutics, Inc. stock logo
MCRB
Seres Therapeutics
$2.46
-2.8%
-38.5%
The price history of MCRB in the last 30 days
SER-428 to Reduce Risk of Bloodstream Infections in Critically Ill Patients 10/15/2026 - Preclinical Data Seres Therapeutics, Inc. announced that preclinical data supporting the development of SER-428, an i…
Full Summary
Cellectar Biosciences, Inc. stock logo
CLRB
Cellectar Biosciences
$1.14
-4.2%
-52.1%
The price history of CLRB in the last 30 days
Iopofosine I-131 Pediatric Brain and Solid Tumors 10/15/2026 - Results Cellectar Biosciences, announced that efficacy results from a subset of patients treated with iopof…
Full Summary
Immunocore Holdings PLC Sponsored ADR stock logo
IMCR
Immunocore
$29.40
-0.3%
-8.1%
The price history of IMCR in the last 30 days
IMC-S118AI patient with type 1 diabetes
Phase 1
10/15/2026 - Dose Update Immunocore Holdings plc announced that the first patient with type 1 diabetes (T1D) has been dosed …
Full Summary
Legend Biotech Corporation Sponsored ADR stock logo
LEGN
Legend Biotech
$18.48
-6.7%
+4.9%
The price history of LEGN in the last 30 days
LB2501 for the treatment of relapsed or refractory B-cell malignancies, including B-cell non-Hodgkin lymphoma.
IND
10/15/2026 - FDA Clearance Legend Biotech Corporation announced that the U.S. Food and Drug Administration (FDA) has cleared t…
Full Summary
Protara Therapeutics, Inc. stock logo
TARA
Protara Therapeutics
$2.32
-3.3%
-34.6%
The price history of TARA in the last 30 days
THRIVE-3 in Patients on Parenteral Support
Phase 2b
10/15/2026 - Enrollment Update Protara Therapeutics, Inc. announced that it has completed enrollment of the Phase 2b, open-label do…
Full Summary
Jasper Therapeutics, Inc. stock logo
JSPR
Jasper Therapeutics
$0.48
-9.8%
-22.3%
The price history of JSPR in the last 30 days
vensobafusp alfa IgA Nephropathy
Phase 2
10/15/2026 - Enrollment Update - Jasper Therapeutics, announced that it has completed enrollment of the IgA nephropathy (IgAN) coho…
Full Summary
Jasper Therapeutics, Inc. stock logo
JSPR
Jasper Therapeutics
$0.48
-9.8%
-22.3%
The price history of JSPR in the last 30 days
vensobafusp alfa IgA Nephropathy Target date: Q1 2027 10/15/2026 - Expansion Jasper Therapeutics, announces expansion cohort in patients with FSGS, with first patients anticipat…
Full Summary
Eupraxia Pharmaceuticals Inc. stock logo
EPRX
Eupraxia Pharmaceuticals
$6.62
-2.2%
-22.8%
The price history of EPRX in the last 30 days
EP-104GI For Treatment of Eosinophilic Esophagitis 10/15/2026 - Provided Update Eupraxia Pharmaceuticals Inc announced that the ongoing RESOLVE study evaluating the safety and eff…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$1,258.04
+0.5%
+9.1%
The price history of LLY in the last 30 days
mirikizumab-mrkz For Crohn's disease 10/15/2026 - New Data New data analyses from Eli Lilly show patients with moderately to severely active ulcerative coliti…
Full Summary
Edesa Biotech, Inc. stock logo
EDSA
Edesa Biotech
$2.57
-3.7%
-37.9%
The price history of EDSA in the last 30 days
EB06 Moderate-To-Severe Nonsegmental Vitiligo 10/15/2026 - FDA Clearance Edesa Biotech, Inc. reported that the U.S. Food and Drug Administration (FDA) has cleared the compa…
Full Summary
Edesa Biotech, Inc. stock logo
EDSA
Edesa Biotech
$2.57
-3.7%
-37.9%
The price history of EDSA in the last 30 days
EB06 Moderate-To-Severe Nonsegmental Vitiligo Target date: Q4 2027 10/15/2026 - Top-line data Edesa anticipates that topline data will be available fourth quarter 2027.
Full Summary
Revolution Medicines, Inc. stock logo
RVMD
Revolution Medicines
$177.96
-6.0%
-6.8%
The price history of RVMD in the last 30 days
daraxonrasib For previously treated metastatic PDAC in patients with KRAS G12 mutations. 10/15/2026 - Positive Opinion Revolution Medicines, announced that the European Medicines Agency’s (EMA) Committee for Medicinal …
Full Summary
Vogenx Inc stock logo
VOGX
Vogenx
$14.53
-9.5%
-55.3%
The price history of VOGX in the last 30 days
VGX-001-013 for Post-Bariatric Hypoglycemia 10/15/2026 - Initiation Vogenx, Inc. announced the initiation of EMERGE (VGX-001-013), its Phase 2b clinical trial evaluatin…
Full Summary
Crescent Biopharma, Inc. stock logo
CBIO
Crescent Biopharma
$11.84
-5.1%
-29.9%
The price history of CBIO in the last 30 days
CR-001 Treatment of Advanced Solid Tumors 10/15/2026 - Enrollment Update Crescent Biopharma, Inc. announced clinical pipeline momentum, including enrolling patients in coh…
Full Summary
MacroGenics, Inc. stock logo
MGNX
MacroGenics
$3.25
-3.6%
-21.5%
The price history of MGNX in the last 30 days
MGC030 In Patients With Advanced Solid Tumors
Phase 1
10/15/2026 - Dose Update MacroGenics, Inc announced that the first patient has been dosed in the Phase 1 study of MGC030, a …
Full Summary
Opus Genetics, Inc. stock logo
IRD
Opus Genetics
$3.84
-5.2%
-25.9%
The price history of IRD in the last 30 days
OPGx-BEST1 For the treatment of bestrophin-1 (BEST1)-related IRD. 10/15/2026 - Provided Update Opus Genetics, Inc. presented clinical findings from its OPGx-BEST1 and OPGx-LCA5 gene therapy prog…
Full Summary
Pharming Group N.V. Sponsored ADR stock logo
PHAR
Pharming Group
$9.37
-2.8%
-11.2%
The price history of PHAR in the last 30 days
Leniolisib Activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS)
Phase 2
10/14/2026 - Data Presentation Pharming presented positive topline data from its Phase II trial of leniolisib in genetically ident…
Full Summary
Quoin Pharmaceuticals, Ltd. Sponsored ADR stock logo
QNRX
Quoin Pharmaceuticals
$3.90
-3.2%
-44.8%
The price history of QNRX in the last 30 days
QRX003 Nethertons Syndrome Orphan Drug 10/14/2026 - Designation Grant Quoin Pharmaceuticals Ltd. announces that its lead product candidate QRX003 has been granted Orphan…
Full Summary
Ocugen, Inc. stock logo
OCGN
Ocugen
$0.78
-4.1%
-26.4%
The price history of OCGN in the last 30 days
OCU400 (AAV5-hNR2E3) Retinitis pigmentosa (RP) and Leber Congenital amaurosis (LCA). 10/14/2026 - Provided Update Ocugen, Inc. announced the execution of a licensing agreement with Roots Pharmaceutical, and its str…
Full Summary
Parabilis Medicines, Inc. stock logo
PBLS
Parabilis Medicines
$22.75
-9.7%
-45.5%
The price history of PBLS in the last 30 days
Zolucatetide key driver of a range of cancers and tumor types. Phase 1/2 10/14/2026 - Provided Update Parabilis Medicines announced the initiation of a dose-ranging clinical cohort evaluating zolucate…
Full Summary
Entrada Therapeutics, Inc. stock logo
TRDA
Entrada Therapeutics
$4.37
-8.6%
-35.3%
The price history of TRDA in the last 30 days
ELEVATE-44-201 For Duchenne Muscular Dystrophy 10/14/2026 - Provided Update Entrada Therapeutics, Inc. announced that an independent Data Monitoring Committee (DMC), per study…
Full Summary
Entrada Therapeutics, Inc. stock logo
TRDA
Entrada Therapeutics
$4.37
-8.6%
-35.3%
The price history of TRDA in the last 30 days
ELEVATE-44-201 For Duchenne Muscular Dystrophy Target date: Q1 2027 10/14/2026 - Enrollment Update Entrada Therapeutics, Inc. announced that the Cohort 2 enrollment complete with data expected in Q1…
Full Summary
Entrada Therapeutics, Inc. stock logo
TRDA
Entrada Therapeutics
$4.37
-8.6%
-35.3%
The price history of TRDA in the last 30 days
ELEVATE-44-201 For Duchenne Muscular Dystrophy Target date: LATE 2026 10/14/2026 - Data Entrada Therapeutics, Inc. announced that the Company to receive ELEVATE-44-201 data from Cohort 1 …
Full Summary
Zai Lab Limited Unsponsored ADR stock logo
ZLAB
Zai Lab
$23.19
-1.4%
-9.8%
The price history of ZLAB in the last 30 days
ZL-1503 For the Treatment of Atopic Dermatitis 10/14/2026 - Data Zai Lab Limited announced that data from the first clinical trial evaluating ZL-1503, the company’s…
Full Summary
Arrowhead Pharmaceuticals, Inc. stock logo
ARWR
Arrowhead Pharmaceuticals
$55.90
-4.4%
-15.9%
The price history of ARWR in the last 30 days
ARO-MAPT Treatment of Alzheimer's Disease and Other Tauopathies Phase 1/2a 10/14/2026 - Interim Results Arrowhead Pharmaceuticals, Inc. announced interim results from an ongoing Phase 1/2a study of ARO-MA…
Full Summary
BioVie Inc. stock logo
BIVI
BioVie
$1.20
+6.2%
-25.5%
The price history of BIVI in the last 30 days
Bezisterim For Parkinson's Disease Patients 10/14/2026 - Abstract BioVie Inc. announced that two abstracts detailing results from the Company’s ADDRESS-LC Phase 2 tri…
Full Summary
Atara Biotherapeutics, Inc. stock logo
ATRA
Atara Biotherapeutics
$9.18
-4.9%
-5.3%
The price history of ATRA in the last 30 days
Tabelecleucel (tab-cel) Post-Transplant Lymphoproliferative Disease (PTLD) BLA 10/14/2026 - FDA Accepted Atara Biotherapeutics, Inc. announced that its partner, Pierre Fabre Pharmaceuticals, Inc. (PFP), h…
Full Summary
Sarepta Therapeutics, Inc. stock logo
SRPT
Sarepta Therapeutics
$17.10
-3.9%
-15.0%
The price history of SRPT in the last 30 days
SRP-1003 treatment of myotonic dystrophy type 1 (DM1) 10/14/2026 - Preclinical Data Sarepta Therapeutics, Inc today presented new preclinical data at the 22nd Annual Meeting of the O…
Full Summary
Oncolytics Biotech Inc. stock logo
ONCY
Oncolytics Biotech
$0.50
-9.0%
-35.3%
The price history of ONCY in the last 30 days
atezolizumab (Tecentriq) Early-stage breast cancer Phase 1/2 10/14/2026 - Provided Update Oncolytics Biotech® Inc announced an update regarding the status of its GOBLET Phase 1/2 study, inc…
Full Summary
Belite Bio, Inc. Sponsored ADR stock logo
BLTE
Belite Bio
$142.78
-6.4%
-16.5%
The price history of BLTE in the last 30 days
Tinlarebant In Stargardt Disease 10/14/2026 - Authorization Belite Bio, Inc announced Marketing Authorization Application (MAA) submissions to the regulatory a…
Full Summary
Rezolute, Inc. stock logo
RZLT
Rezolute
$3.58
-8.2%
-6.8%
The price history of RZLT in the last 30 days
Ersodetug For Hypoglycemia Due to Congenital Hyperinsulinism
Phase 3
10/14/2026 - open-label Rezolute, Inc. announced that the open-label Phase 3 study of ersodetug in tumor HI (upLIFT) is now …
Full Summary
Rezolute, Inc. stock logo
RZLT
Rezolute
$3.58
-8.2%
-6.8%
The price history of RZLT in the last 30 days
Ersodetug For Hypoglycemia Due to Congenital Hyperinsulinism Target date: H1 2026 10/14/2026 - Top-line results Rezolute, Inc. announced that the Topline results expected mid-December 2026
Full Summary
Estrella Immunopharma, Inc. stock logo
ESLA
Estrella Immunopharma
$0.43
-19.7%
-18.7%
The price history of ESLA in the last 30 days
EB103 ARTEMIS® T-Cell Therapy 10/14/2026 - Provided Update Estrella Immunopharma, Inc announced the activation of a fifth clinical site for its ongoing STARLI…
Full Summary
Vanda Pharmaceuticals Inc. stock logo
VNDA
Vanda Pharmaceuticals
$4.03
-5.0%
-21.4%
The price history of VNDA in the last 30 days
VQW-765 treatment of acute anxiety in adults with social anxiety disorder 10/14/2026 - Provided Update Vanda Pharmaceuticals Inc provided an update on its clinical development program for VQW-765, a nove…
Full Summary
Biomea Fusion, Inc. stock logo
BMEA
Biomea Fusion
$0.87
+3.9%
-52.5%
The price history of BMEA in the last 30 days
BMF-650 GLP-1 receptor agonist 10/13/2026 - Results Biomea Fusion, Inc. announced that it will report results from its Phase I GLP-131 clinical study …
Full Summary
BioNTech SE Sponsored ADR stock logo
BNTX
BioNTech
$87.71
-2.8%
-8.7%
The price history of BNTX in the last 30 days
BNT113 HPV-positive tumors
Phase 2/3
10/13/2026 - Top-line results BioNTech SE announced the first topline results from the AHEAD-MERIT Phase 2/3 clinical trial (NCT04…
Full Summary
Moderna, Inc. stock logo
MRNA
Moderna
$218.01
-7.8%
+41.5%
The price history of MRNA in the last 30 days
mRNA-4157/V940 (KEYTRUDA) Provide an additive benefit and enhance T cell-mediated destruction of tumor cells. 10/13/2026 - Results Merck announced that first-time results from three pivotal clinical trials will be presented during…
Full Summary
Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$146.01
+0.6%
-0.4%
The price history of MRK in the last 30 days
mRNA-4157/V940 (KEYTRUDA) Provide an additive benefit and enhance T cell-mediated destruction of tumor cells. 10/13/2026 - Results Merck announced that first-time results from three pivotal clinical trials will be presented during…
Full Summary
Enanta Pharmaceuticals, Inc. stock logo
ENTA
Enanta Pharmaceuticals
$11.10
-3.2%
-9.0%
The price history of ENTA in the last 30 days
zelicapavir For respiratory syncytial virus 10/13/2026 - Data Enanta Pharmaceuticals, Inc announced that data for zelicapavir, its oral, once-daily, N-protein in…
Full Summary
United Therapeutics Corporation stock logo
UTHR
United Therapeutics
$533.12
-1.5%
+7.8%
The price history of UTHR in the last 30 days
ralinepag For the Treatment of Pulmonary Arterial Hypertension 10/13/2026 - Oral presentation United Therapeutics Corporation announced that two oral and five poster presentations will be presen…
Full Summary
Alkermes plc stock logo
ALKS
Alkermes
$41.22
+2.8%
-5.0%
The price history of ALKS in the last 30 days
LUMRYZ® (sodium oxybate) treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). 10/13/2026 - Oral presentation Alkermes plc announced plans to present two oral presentations and six posters from its industry-le…
Full Summary
Entera Bio Ltd. stock logo
ENTX
Entera Bio
$2.68
-3.2%
-9.5%
The price history of ENTX in the last 30 days
EB613 Parathyroid hormone (1-34), or PTH for osteoporosis 10/13/2026 - Poster Presentation Entera Bio Ltd. announced data from a Plenary Poster Presentation (abstract #7062) and a Late-break…
Full Summary
Beam Therapeutics Inc. stock logo
BEAM
Beam Therapeutics
$23.47
-5.1%
-5.9%
The price history of BEAM in the last 30 days
BEAM-301 To Correct a Glycogen Storage Disease Type I Deficiency Disease Phase 1/2 10/13/2026 - Initial Data Beam Therapeutics Inc. announced that the company will present initial data from the ongoing Phase…
Full Summary
Phio Pharmaceuticals Corp. stock logo
PHIO
Phio Pharmaceuticals
$0.87
-5.9%
-15.4%
The price history of PHIO in the last 30 days
PH-762 (INTASYL) Murine colorectal cancer 10/13/2026 - Provided Update Phio Pharmaceuticals Corp. announced the successful release of its first commercial-scale cGMP batch…
Full Summary
Phio Pharmaceuticals Corp. stock logo
PHIO
Phio Pharmaceuticals
$0.87
-5.9%
-15.4%
The price history of PHIO in the last 30 days
PH-762 (INTASYL) Murine colorectal cancer
Phase 2b
Target date: Q1 2027
10/13/2026 - Initiation Phio Pharmaceuticals Corp announced the Planned Phase 2b Clinical Trial Initiation in First Quarter …
Full Summary
Prelude Therapeutics Incorporated stock logo
PRLD
Prelude Therapeutics
$3.26
-1.8%
-33.1%
The price history of PRLD in the last 30 days
PRT13722 Oral KAT6A Selective Degrader 10/13/2026 - Provided Update Prelude Therapeutics Incorporated announced a clinical trial collaboration and supply agreement wit…
Full Summary
Prelude Therapeutics Incorporated stock logo
PRLD
Prelude Therapeutics
$3.26
-1.8%
-33.1%
The price history of PRLD in the last 30 days
PRT13722 Oral KAT6A Selective Degrader Target date: Q4 2026 10/13/2026 - Enrollment Update Prelude Therapeutics Incorporated announced that its on track to initiate enrollment in the fourth…
Full Summary
Kura Oncology, Inc. stock logo
KURA
Kura Oncology
$9.08
-6.4%
-22.6%
The price history of KURA in the last 30 days
KO-7246 For Diabetes 10/13/2026 - Provided Update Caspian Therapeutics, Inc plan to outline the development strategy for KO-7246, Caspian’s selective,…
Full Summary
Trevi Therapeutics, Inc. stock logo
TRVI
Trevi Therapeutics
$11.88
-1.9%
-20.5%
The price history of TRVI in the last 30 days
nalbuphine ER chronic cough in patients with idiopathic pulmonary fibrosis (IPF)
Phase 2b
10/13/2026 - Provided Update Trevi Therapeutics, announced that results from the Phase 2b CORAL trial were accepted as an oral …
Full Summary
Shattuck Labs, Inc. stock logo
STTK
Shattuck Labs
$5.42
-2.0%
-9.8%
The price history of STTK in the last 30 days
SL-846 treatment of patients with inflammatory and immune-mediated diseases 10/13/2026 - Poster Presentation Shattuck Labs, Inc announced two upcoming poster presentations at United European Gastroenterology …
Full Summary
LIFE
Ethos Technologies Inc. Class A Common Stock
$37.52
-3.2%
+4.2%
The price history of LIFE in the last 30 days
ATYR0101 For the treatment of interstitial lung disease 10/13/2026 - Publication aTyr Pharma, Inc. announced a publication demonstrating the anti-fibrotic effects of ATYR0101 in th…
Full Summary
SAB Biotherapeutics, Inc. stock logo
SABS
SAB Biotherapeutics
$2.53
-2.3%
-27.9%
The price history of SABS in the last 30 days
SAB-142 Anti-thymocyte hpAB therapeutic
Fast Track
10/13/2026 - Designation Grant SAB Biotherapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fas…
Full Summary
Rhythm Pharmaceuticals, Inc. stock logo
RYTM
Rhythm Pharmaceuticals
$86.17
-2.0%
-11.8%
The price history of RYTM in the last 30 days
IMCIVREE (setmelanotide) Obesity and Control of Hunger Associated with POMC, PCSK1 and LEPR Deficiency 10/13/2026 - Provided Update Rhythm Pharmaceuticals, Inc. announced the commercial launch of IMCIVREE® (setmelanotide) in Japan…
Full Summary
AgomAb Therapeutics NV stock logo
AGMB
AgomAb Therapeutics
$8.28
-0.6%
-32.0%
The price history of AGMB in the last 30 days
Ontunisertib Fibrostenosing Crohn’s Disease
Phase 2b
10/13/2026 - Dose Update Agomab Therapeutics NV announced that the first patient has been dosed in NOV-ERA, the Company's gl…
Full Summary
AbbVie Inc. stock logo
ABBV
AbbVie
$285.32
+0.7%
+8.1%
The price history of ABBV in the last 30 days
Risankizumab-rzaa (SKYRIZI) Moderate to Severe Crohn's Disease
Phase 3
10/13/2026 - Findings Update AbbVie announced new findings from the Phase 3 AFFIRM study evaluating a new option for induction tr…
Full Summary
Teleflex Incorporated stock logo
TFX
Teleflex
$130.41
+1.7%
+4.8%
The price history of TFX in the last 30 days
BIOMAG™-LL for the treatment of de novo coronary lesions up to 38 mm 10/12/2026 - Enrollment Update Teleflex Incorporated announced the successful completion of patient enrollment in the BIOMAG™-LL C…
Full Summary
Bristol Myers Squibb Company stock logo
BMY
Bristol Myers Squibb
$59.69
-1.4%
-5.1%
The price history of BMY in the last 30 days
admilparant in adults with idiopathic pulmonary fibrosis (IPF).
Phase 3
10/12/2026 - Top-line results Bristol Myers Squibb announced topline results from the pivotal Phase 3 ALOFT-IPF trial evaluating…
Full Summary
ANI Pharmaceuticals, Inc. stock logo
ANIP
ANI Pharmaceuticals
$72.29
+0.0%
-5.1%
The price history of ANIP in the last 30 days
SYNCHRONICITY in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS). 10/12/2026 - Data ANI Pharmaceuticals, Inc. announced that both 6-month and 24-month data from SYNCHRONICITY, its Ph…
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Zenas BioPharma, Inc. stock logo
ZBIO
Zenas BioPharma
$24.84
-2.2%
-21.1%
The price history of ZBIO in the last 30 days
Obexelimab Immunoglobulin G4-Related Disease (IgG4-RD) 10/12/2026 - Data Zenas BioPharma, Inc. announced new obexelimab data in immunoglobulin G4-related disease (IgG4-RD) p…
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TRAX
First Tracks Biotherapeutics
$34.46
-4.4%
-10.7%
The price history of TRAX in the last 30 days
ANB033 in Celiac Disease
Phase 1b
10/12/2026 - Top-line results First Tracks Biotherapeutics, Inc. announced positive top-line results from Cohort 1 (gluten challe…
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Phathom Pharmaceuticals, Inc. stock logo
PHAT
Phathom Pharmaceuticals
$6.92
-7.7%
-7.5%
The price history of PHAT in the last 30 days
vonoprazan For the Treatment of Heartburn Associated with Non-Erosive GERD 10/12/2026 - Efficacy Data Phathom Pharmaceuticals, Inc. announced new cost-effectiveness data for VOQUEZNA® (vonoprazan), alo…
Full Summary
ODTX
Odyssey Therapeutics
$17.17
-2.3%
-29.6%
The price history of ODTX in the last 30 days
OD-001 in Ulcerative Colitis 10/12/2026 - Provided Update Odyssey Therapeutics, Inc. announced that it will present the design of a randomized, double-blind …
Full Summary
Stoke Therapeutics, Inc. stock logo
STOK
Stoke Therapeutics
$24.17
-1.8%
-15.0%
The price history of STOK in the last 30 days
STK-002 Autosomal Dominant Optic Atrophy (ADOA) 10/12/2026 - Data Presentation Stoke Therapeutics, Inc. announced two presentations of data for STK-002 at the American Academy of…
Full Summary
Mirum Pharmaceuticals, Inc. stock logo
MIRM
Mirum Pharmaceuticals
$80.14
-2.7%
-12.7%
The price history of MIRM in the last 30 days
Maralixibat Alagille Syndrome
Phase 3
10/12/2026 - Top-line results Mirum Pharmaceuticals, Inc announced topline results from the Phase 3 EXPAND study evaluating LIVMA…
Full Summary
Palisade Bio, Inc. stock logo
PALI
Palisade Bio
$1.41
-8.4%
-11.3%
The price history of PALI in the last 30 days
PALI-2108 For patients affected by UC. 10/12/2026 - Findings Update Palisade Bio, Inc announced clinical and translational findings featured in five poster presentation…
Full Summary
Envoy Medical, Inc. stock logo
COCH
Envoy Medical
$0.67
+3.6%
-6.4%
The price history of COCH in the last 30 days
Acclaim for Breakthrough Hearing Device Modular Premarket Approval 10/12/2026 - Application Submitted - Envoy Medical® announced the submission of the second module of its Modular Premarket Approval ("P…
Full Summary
Envoy Medical, Inc. stock logo
COCH
Envoy Medical
$0.67
+3.6%
-6.4%
The price history of COCH in the last 30 days
Acclaim for Breakthrough Hearing Device Target date: Q2 2027 10/12/2026 - Provided Update Envoy Medical® announced that the Advances Toward Targeted Completion of the Final Clinical Module …
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Regeneron Pharmaceuticals, Inc. stock logo
REGN
Regeneron Pharmaceuticals
$790.74
-0.7%
+0.8%
The price history of REGN in the last 30 days
garetosmab-grts in Adults with Fibrodysplasia Ossificans Progressiva (FOP)
Phase 3
10/12/2026 - Results Regeneron Pharmaceuticals, Inc announced positive 84-week results from the Phase 3 OPTIMA trial eva…
Full Summary
Cytokinetics, Incorporated stock logo
CYTK
Cytokinetics
$61.95
-3.1%
-9.9%
The price history of CYTK in the last 30 days
Aficamten Symptomatic obstructive hypertrophic cardiomyopathy (oHCM) 10/12/2026 - Additional data Cytokinetics, Incorporated announced that additional data from ACACIA-HCM (Assessment Comparing Afi…
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Syndax Pharmaceuticals, Inc. stock logo
SNDX
Syndax Pharmaceuticals
$12.90
-5.5%
-26.8%
The price history of SNDX in the last 30 days
Axatilimab Chronic Graft Versus Host Disease (cGVHD)
Phase 2
10/12/2026 - Endpoint Missed Syndax Pharmaceuticals announced that the MAXPIRe Phase 2 trial of axatilimab in idiopathic pulmona…
Full Summary
Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$255.54
+0.9%
-5.3%
The price history of JNJ in the last 30 days
Guselkumab For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis
Phase 3
10/12/2026 - New Data Johnson & Johnson announced new Phase 3 data showing consistent combined fistula remission outcome…
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Savara Inc. stock logo
SVRA
Savara
$4.45
-6.1%
-17.1%
The price history of SVRA in the last 30 days
Molgramostim (IMPALA-2) Autoimmune Pulmonary Alveolar Proteinosis (aPAP) 10/12/2026 - Oral presentation Savara Inc. announced the acceptance of an encore oral presentation on data from the Phase 3 IMPALA…
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Organogenesis stock logo
ORGO
Organogenesis
$1.00
-9.9%
-29.6%
The price history of ORGO in the last 30 days
PuraPly®AM for Hard-to-Heal Diabetic Foot Ulcers 10/12/2026 - Publication Organogenesis Holdings Inc. announced the publication of previously released results from PREPARE1,…
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Mirum Pharmaceuticals, Inc. stock logo
MIRM
Mirum Pharmaceuticals
$80.14
-2.7%
-12.7%
The price history of MIRM in the last 30 days
Maralixibat Alagille Syndrome
Phase 3
10/11/2026 - Provided Update Mirum Pharmaceuticals, Inc. announced that it will host an investor call on Monday, October 12, 202…
Full Summary
TRAX
First Tracks Biotherapeutics
$34.46
-4.4%
-10.7%
The price history of TRAX in the last 30 days
ANB033 in Celiac Disease 10/11/2026 - Provided Update First Tracks Biotherapeutics, Inc. will host an investor call and live webcast to review top-line da…
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AbbVie Inc. stock logo
ABBV
AbbVie
$285.32
+0.7%
+8.1%
The price history of ABBV in the last 30 days
SKYRIZI (risankizumab-rzaa) PsA Active Psoriatic Arthritis 10/11/2026 - Presentation AbbVie announced the presentation of 22 scientific abstracts from its market-leading inflammatory …
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BridgeBio Pharma, Inc. stock logo
BBIO
BridgeBio Pharma
$66.39
-1.1%
-0.3%
The price history of BBIO in the last 30 days
Encaleret Autosomal Dominant Hypocalcemia Type 1 (ADH1) 10/11/2026 - Results BridgeBio Pharma, Inc. today presented bone turnover results and patient-reported outcomes from the …
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Merck & Co., Inc. stock logo
MRK
Merck & Co., Inc.
$146.01
+0.6%
-0.4%
The price history of MRK in the last 30 days
BRUNELLO For Diabetic Macular Edema Phase 2b/3 10/10/2026 - Presentation Merck announced the first presentation of one-year results from the pivotal Phase 2b/3 BRUNELLO tri…
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LB Pharmaceuticals Inc stock logo
LBRX
LB Pharmaceuticals
$36.74
+0.1%
-13.5%
The price history of LBRX in the last 30 days
LB-102 In Patients With Bipolar Depression 10/10/2026 - Presentation LB Pharmaceuticals Inc announced the presentation of four posters at the 39th European College of N…
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Alumis Inc. stock logo
ALMS
Alumis
$6.12
-3.0%
-21.2%
The price history of ALMS in the last 30 days
envudeucitinib in Moderate-to-Severe Plaque Psoriasis
Phase 3
10/9/2026 - New Data Alumis Inc. announced new envudeucitinib data from the ONWARD Phase 3 clinical program—ONWARD1, ONWA…
Full Summary
Eli Lilly and Company stock logo
LLY
Eli Lilly and Company
$1,258.04
+0.5%
+9.1%
The price history of LLY in the last 30 days
Taltz adults with psoriasis and obesity or overweight
Phase 3b
10/9/2026 - Data Eli Lilly and Company announced new exploratory data from the TOGETHER-PsO Phase 3b clinical trial…
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Glaukos Corporation stock logo
GKOS
Glaukos
$164.46
-0.7%
+0.7%
The price history of GKOS in the last 30 days
iDose TR Glaucoma Phase 4 10/9/2026 - Top-line results Glaukos Corporation announced positive topline results from the Phase 4 prospective, randomized, co…
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Teva Pharmaceutical Industries Ltd. stock logo
TEVA
Teva Pharmaceutical Industries
$41.44
+0.8%
+6.0%
The price history of TEVA in the last 30 days
WELTRUZA Adults with Schizophrenia 10/9/2026 - FDA approved Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the U.…
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PureTech Health PLC Sponsored ADR stock logo
PRTC
PureTech Health
$17.42
SPT-320 to treat generalized anxiety disorder 10/9/2026 - Presentation Seaport Therapeutics, Inc announced the presentation of Phase 1 clinical data for GlyphAgo™ (SPT-320…
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Johnson & Johnson stock logo
JNJ
Johnson & Johnson
$255.54
+0.9%
-5.3%
The price history of JNJ in the last 30 days
Icotrokinra For adults and adolescents with plaque psoriasis
Phase 3
10/9/2026 - Results Johnson & Johnson announced new two-year results from the Phase 3 ICONIC-LEADa study evaluating ICO…
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Arcutis Biotherapeutics, Inc. stock logo
ARQT
Arcutis Biotherapeutics
$28.82
-1.0%
+13.7%
The price history of ARQT in the last 30 days
ZORYVE™ (roflumilast) Inhibitor of phosphodiesterase-4 (PDE4) 10/9/2026 - Data Presentation Arcutis Biotherapeutics, Inc announced data presented across its ZORYVE® (roflumilast) portfolio a…
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Milestone Pharmaceuticals Inc. stock logo
MIST
Milestone Pharmaceuticals
$0.71
-11.0%
-22.8%
The price history of MIST in the last 30 days
ReVeRA-301 treatment of atrial fibrillation with rapid ventricular rate 10/9/2026 - Enrollment Update Milestone® Pharmaceuticals Inc announced that the first European patient has been enrolled in ReVe…
Full Summary

Frequently Asked Questions

This calendar tracks PDUFA target dates, NDA/BLA submissions and reviews, regulatory meeting outcomes, early-phase trial results, and special designations such as RMAT, Breakthrough Therapy, or orphan status.

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