FDA

Updated daily, the FDA calendar gives you insight into FDA actions on companies and upcoming actions the FDA is expected to take. Benzinga's FDA calendar shows historical FDA data, upcoming dates that companies will be impacted by the FDA and ranges of dates.

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DISC-0974
For the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
06/12/2026
8:30 AM
Updated data

Disc Medicine, Inc. announces updated data from multiple clinical programs to be presented at the EHA Annual Meeting in Stockholm, Sweden.

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COGT
COGTCogent Biosciences Inc
bezuclastinib
In patients with non-advanced systemic mastocytosis
06/12/2026
8:00 AM
Results

Cogent Biosciences, Inc announced detailed and updated clinical results from the registration-directed APEX clinical trial of bezuclastinib in patients with advanced systemic mastocytosis (AdvSM) demonstrating clinically meaningful results as measured by consensus criteria used to assess patient response.

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JAZZ
JAZZJazz Pharmaceuticals PLC
Zepzelca (lurbinectedin)
Relapsed Small Cell Lung Cancer (SCLC)
Phase 306/12/2026
8:00 AM
Results

Jazz Pharmaceuticals plc announced top-line results from the Phase 3 LAGOON trial, conducted by PharmaMar, evaluating Zepzelca® (lurbinectedin) in patients with relapsed (second-line) metastatic small cell lung cancer (SCLC).

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BCRX
BCRXBioCryst Pharmaceuticals Inc
ORLADEYO (berotralstat)
Hereditary angioedema (HAE)
06/12/2026
7:00 AM
New Data

BioCryst Pharmaceuticals, Inc announced new clinical data and real-world evidence for ORLADEYO® (berotralstat), the first and only targeted oral prophylactic therapy for patients with hereditary angioedema (HAE) aged 2 and older, in addition to new data from the Phase 1b/2 multicenter, dose-ranging, open-label ALPHA-STAR study of navenibart, an investigational, long-acting, monoclonal antibody plasma kallikrein inhibitor for prophylaxis to prevent attacks of HAE.

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KYMR
KYMRKymera Therapeutics Inc
KT-621
A potential oral treatment for asthma and other TH2 respiratory diseases.
Phase 106/12/2026
7:00 AM
Results

Kymera Therapeutics announced that the results from the Phase 1 study of KT-621, its first-in-class, oral STAT6 degrader, in healthy Japanese adults were shared in an oral presentation at the Japanese Dermatological Association (JDA) Annual Meeting being held June 11-14, 2026, in Kyoto, Japan.

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ABBV
ABBVAbbVie Inc
venetoclax
For Newly Diagnosed Higher-Risk Myelodysplastic Syndromes
Phase 306/12/2026
3:00 AM
New Data

AbbVie announced new Phase 3 data on a fixed-duration venetoclax-based combination at the European Hematology Association (EHA) 2026 Congress taking place June 11-14 in Stockholm, Sweden. Final results from the Phase 3 CLL14 trial in previously untreated chronic lymphocytic leukemia (CLL), which was conducted in collaboration with the German CLL Study Group, will be featured in an oral presentation.

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HCM
HCMHUTCHMED (China) Limited
ESLIM-02
for Warm Antibody Autoimmune Hemolytic
Phase 306/11/2026
8:00 PM
Results

HUTCHMED (China) Limited announces results from the Phase III part of the ESLIM-02 study of sovleplenib in patients with warm antibody autoimmune hemolytic anemia ("wAIHA") in China were presented on Thursday, June 11, 2026 during the European Hematology Association ("EHA") Congress in Stockholm, Sweden.

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ASND
ASNDAscendis Pharma A/S
TransCon PTH
Adult Hypoparathyroidism
Phase 206/11/2026
4:02 PM
Data

Ascendis Pharma A/S announced 5-year (Week 266) data from its Phase 2 PaTH Forward Trial showing that long-term treatment with TransCon PTH (palopegteriparatide) demonstrated sustained efficacy and safety in adults with hypoparathyroidism.

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SLN
SLNSilence Therapeutics PLC
divesiran
In patients with polycythemia vera
Phase 106/11/2026
1:20 PM
Follow-up data

Silence Therapeutics plc today presented follow-up and quality-of-life data from the Phase 1 SANRECO study evaluating divesiran, a first-in-class siRNA therapy targeting TMPRSS6, in 21 phlebotomy-dependent patients with polycythemia vera (PV) at the European Hematology Association (EHA) 2026 Annual Congress.

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GMAB
GMABGenmab A/S
epcoritamab
To-Treat Relapsed/Refractory Follicular Lymphoma
06/11/2026
10:45 AM
New Data

Genmab A/S announced new data from a post-hoc subgroup analysis from the pivotal Phase 3 EPCORE® FL-1 trial, evaluating epcoritamab, a subcutaneous T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (epcoritamab + R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL), whichshowed that epcoritamab + R2 deliveredconsistent and sustained efficacy benefits across clinically relevant subgroups, including Follicular Lymphoma International Prognostic Index (FLIPI) score (0–2 vs 3–5), progression of disease less than or equal to two years from the date of initial frontline therapy (POD24) (POD24 vs non-POD24), and patient fitness (non-Hodgkin lymphoma 5 score).

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VCN-01
Retinoblastoma
Phase 106/11/2026
8:00 AM
Provided Update

Theriva™ Biologics, Inc. announced that clinical and translational results from VCN-01's Phase 1 clinical trial in Head & Neck Squamous Cell Carcinoma (HNSCC) were recently published on-line first in the journal Clinical Cancer Research.

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ELVN-001
In Chronic Myeloid Leukemia
06/11/2026
8:00 AM
Positive Data

Enliven Therapeutics, Inc. today presented updated positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML).

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CRBU
CRBUCaribou Biosciences, Inc.
CB-011
Allogeneic anti-BCMA CAR-T cell therapy engineered using Cas12a chRDNA technology.
06/11/2026
8:00 AM
Follow-up data

Caribou Biosciences, Inc. today reported longer follow up data for the ongoing CaMMouflage phase 1 trial of CB-011, the Company's off-the-shelf BCMA-targeted CAR-T cell therapy, being evaluated for relapsed or refractory multiple myeloma (r/r MM).

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KURA
KURAKura Oncology Inc
KOMET-007
Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)
Phase 1/206/11/2026
8:09 AM
Results

Kura Oncology, Inc and Kyowa Kirin Co., Ltd. announced encouraging long-term results from the Phase 1/2 KOMET-007 single-arm trial (NCT05735184) evaluating ziftomenib in combination with intensive chemotherapy, 7+3, in newly diagnosed NPM1-m or KMT2A-r AML. These results will be presented at the European Hematology Association 2026 Congress.

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GH
GHGuardant Health Inc
Guardant360
Advanced solid tumors.
06/11/2026
8:10 AM
FDA approved

Guardant Health, Inc announced that the U.S. Food and Drug Administration (FDA) has approved Guardant360® CDx as a companion diagnostic (CDx) for Boehringer Ingelheim's HERNEXEOS® (zongertinib tablets), the first targeted therapy for adults with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC) as an initial treatment option.

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IGC-AD1
For Agitation in Alzheimer's disease.
Phase 206/11/2026
8:30 AM
evaluation

IGC Pharma, Inc. announced that its Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's dementia has reached the Company's previously disclosed target enrollment of 146 patients, with 146 participants randomized at baseline.

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CYDYCytoDyn Inc
leronlimab
in Alzheimer's Disease
Phase 2a06/11/2026
8:30 AM
Dose Update

CytoDyn Inc. announced that the first patient has been dosed in a Phase 2a clinical study evaluating leronlimab in patients with Alzheimer's disease, in collaboration with Weill Cornell Medicine.

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LQDA
LQDALiquidia Corp
YUTREPIA
Inhalation Powder
06/11/2026
8:30 AM
Poster Presentation

Liquidia Corporation announced today that the company will present four posters at the PHA 2026 International PH Conference and Scientific Sessions taking place June 11-14 in Dallas.

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RNXT
RNXTRenovoRx, Inc.
RenovoCath
Solid Tumors
06/11/2026
8:30 AM
Publication

RenovoRx, Inc. announced the publication of a peer-reviewed case study from researchers at Moffitt Cancer Center was recently published in Radiology Case Reports.

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DRTS
DRTSAlpha Tau Medical Ltd.
Alpha DaRT
Prostate cancer
06/11/2026
8:33 AM
Enrollment Update

Alpha Tau Medical Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company to proceed with enrollment of the final seven patients in its U.S. REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial, following the FDA's review of a pre-specified interim safety report of the first three patients treated in the trial.

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IMNM
IMNMImmunome Inc
IM-1617
Patients with Advanced Solid Tumors
Phase 106/11/2026
7:32 AM
Dose Update

Immunome, Inc announced that the first patient has been dosed in the Phase 1, first-in-human trial of IM-1617, a potential first-in-class ADC directed at an undisclosed solid tumor target and incorporating HC74, Immunome's proprietary TOP1 inhibitor payload.

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MDCX
MDCXMedicus Pharma Ltd
Teverelix
Acute Urinary Retention
New Drug Application (NDA)06/11/2026
7:30 AM
NDA submission

Medicus Pharma Ltd. announced submission of an Investigational New Drug (IND) application to the Department of Health, Abu Dhabi (DOH) for PRECISION-E2, a first-of-its-kind, Phase 2a genomics-enabled clinical trial evaluating Teverelix® in women with symptomatic endometriosis in the United Arab Emirates (UAE).

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IMRX
IMRXImmuneering Corporation
Atebimetinib + mGnP
in First-Line Pancreatic Cancer Patients
Phase 306/11/2026
7:30 AM
Dose Update

Immuneering Corporation nnounced that the first patient has been dosed in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial evaluating atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) in first-line metastatic pancreatic cancer patients.

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SLN
SLNSilence Therapeutics PLC
divesiran
In patients with polycythemia vera
06/11/2026
7:30 AM
Presentation

Silence Therapeutics plc today presented follow-up and quality-of-life data from the Phase 1 SANRECO study evaluating divesiran, a first-in-class siRNA therapy targeting TMPRSS6, in 21 phlebotomy-dependent patients with polycythemia vera (PV) at the European Hematology Association (EHA) 2026 Annual Congress.

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CGEN
CGENCompugen Ltd
COM701
Solid tumors
06/11/2026
7:05 AM
Poster Presentation

Compugen Ltd announced that it will present a trial-in-progress poster on the MAIA-ovarian Phase 1 study of COM701, a potential first-in-class anti-PVRIG antibody, at the ESMO Gynaecological Cancers Congress 2026, taking place from June 17 to June 19, 2026, in Copenhagen, Denmark.

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NRIX
NRIXNurix Therapeutics Inc
NX-5948
Autoimmune Disease
Phase 1a/b06/11/2026
7:00 AM
Clinical Data

Nurix Therapeutics, Inc announced updated clinical data from the Company's ongoing NX-5948-301 Phase 1a/b clinical trial evaluating bexobrutideg (NX-5948), an investigational oral CNS-penetrant BTK degrader, in patients with chronic lymphocytic leukemia (CLL)..

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TAK
TAKTakeda Pharmaceutical Co Ltd
TAK-279
For the Treatment of Active Psoriatic Arthritis
Phase 306/11/2026
7:00 AM
Top-line results

Takeda announced positive topline results for the Phase 3, randomized, multicenter, double-blind study comparing zasocitinib (TAK-279), an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, to deucravacitinib in adults with moderate-to-severe plaque psoriasis (PsO).

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CCCC
CCCCC4 Therapeutics Inc
cemsidomide
IKZF1/3 Degrader
06/11/2026
7:00 AM
Presentation

C4 Therapeutics, Inc. will present further analysis from its fully enrolled Phase 1 trial of cemsidomide, a next-generation oral IKZF1/3 degrader, in combination with dexamethasone for the treatment of relapsed/refractory multiple myeloma (RRMM) in a poster presentation at the European Hematology Association (EHA) 2026 Congress on Friday, June 12, 2026 at 6:45 pm CEST / 12:45 pm ET.

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ACIU
ACIUAC Immune SA
ACI-7104
Parkinson's Disease
06/11/2026
7:00 AM
Provided Update

AC Immune SA announced it will receive a research grant of $4 million from The Vijay and Marie Goradia Charitable Foundation. The grant will support extending Part 1 of the ongoing Phase 2 VacSYn trial of ACI-7104, AC Immune's anti-alpha-synuclein (a-syn) active immunotherapy, in early Parkinson's disease (PD).

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CLYM
CLYMClimb Bio Inc
Budoprutug
Treatment of Primary Membranous Nephropathy
Phase 1b06/11/2026
7:00 AM
Initial Data

Climb Bio, Inc. announced initial data from the ongoing Phase 1b portion of its Phase 1b/2a study evaluating budoprutug, an anti-CD19 monoclonal antibody, in adults with primary immune thrombocytopenia (ITP) demonstrating an encouraging safety and tolerability profile, robust B-cell depletion, and meaningful platelet responses in heavily pretreated patients.

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SNDX
SNDXSyndax Pharmaceuticals Inc
Revumenib
Relapsed/Refractory KMT2Ar Acute Leukemia
06/11/2026
7:00 AM
Data

Syndax Pharmaceuticals announced that data from the Phase 1/2 SAVE trial of an all-oral regimen of Revuforj® (revumenib), decitabine/cedazuridine, and venetoclax in relapsed or refractory (R/R) NPM1 mutated (NPM1m), KMT2A-rearranged (KMT2Ar), or NUP98-rearranged (NUP98r) acute myeloid leukemia (AML) were published in the Journal of Clinical Oncology and simultaneously presented at the European Hematology Association (EHA) 2026 Congress in Stockholm, Sweden.

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PPBT
PPBTPurple Biotech Ltd
CAPTN-3
For Cancer
06/11/2026
7:00 AM
Presentation

Purple Biotech Ltd announced the presentation of new preclinical data from its lead CAPTN-3 program, IM1240, at the European Association for Cancer Research (EACR) 2026 Annual Congress, being held June 8-11, 2026, in Budapest, Hungary.

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CLLS
CLLSCellectis SA
Lasme-cel
in heavily pretreated patients with relapsed or refractory CD22+ B-cell acute lymphoblastic leukemia (r/r B-ALL)
Phase 106/11/2026
2:40 AM
Data

Cellectis presents final Phase 1 data from the BALLI-01 clinical trial evaluating lasme-cel, a CD22 directed allogeneic CAR-T therapy, in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL), and preliminary data from the NATHALI-01 study evaluating eti-cel, a dual CD20 and CD22 directed CAR-T in relapsed/refractory B-cell non Hodgkin lymphoma (r/r B-NHL), at the European Hematology Association (EHA) 2026 Annual Congress.

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VRTX
VRTXVertex Pharmaceuticals Inc
CASGEVY
For the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT)
06/11/2026
2:01 AM
Data

Vertex Pharmaceuticals Incorporated announced data demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT).

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EVX-04
for acute myeloid leukemia
06/11/2026
2:00 AM
Preclinical Data

Evaxion A/S announces new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML). Developed with AI-Immunology™, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome.

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Recent FDA Approvals

What is an FDA Calendar?

Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment strategy is to make informed decisions, being in the know of when to expect these events, how these events will pan out and the potential stock reaction in the run-up to the event and post the event.

Benzinga’s FDA calendar is a meaningfully designed, user friendly, dynamically updated and simplistic investment tool that is a ‘must-have’ for those looking to make money from the volatility that is typic of trading in biotech stocks.

The calendar lists down all key catalysts that can materially impact stocks, including:

  • PDUFA dates, or in other words FDA decision dates
  • Filing schedules for regulatory applications such as new drug application, or NDA, supplemental NDA, Biologic License Application, or BLA, supplemental BLA, Premarket Approval Application, or Premarket Notification 510(k), etc
  • FDA decisions (approvals/complete response letter/delay)
  • According to special statuses for treatment options, including orphan drug designation, rare disease designation, accelerated approval, priority review etc.
  • FDA’s Advisory Committee, or Adcom, meetings
  • Review meetings with FDA (pre-investigational new drug application meetings, end-of-phase meetings, Type A, Type B and Type C meetings)
  • Decisions by overseas regulatory agencies
  • Clinical data readouts
  • Presentation of data at various scientific conferences.

The calendar allows data screening, based on company names or tickers, events, date-wise or based on a date range. They are designed to serve as a ‘one-stop shop’ for data needs of investors, both existing and potential, to capitalize on the opportunities these catalysts throw up or cut the losses from an adverse development. 

What is a Catalyst?

A catalyst is any event/development that has the potential to swing the stock, usually in an appreciable way, in either direction, depending on how it materializes. 

Biotech Stock Movers

Regulatory actions and clinical readouts are stock-moving catalysts. The magnitude of the impact is usually disproportionate. Most clinical-stage biotechs, or companies which are yet to commercialize a product, do not generate revenues. The exceptions are those which may have out-licensed therapies-in-development to another company and as a result generate revenues in the form of licensing revenues. So, it will be years of investment (time money and efforts) into drug development, which usually takes about 10-15 years, on the promise of generating future returns.

A promising outcome in a particular stage of drug development is perceived by the market as an incremental step in bringing the company closer to that distant goal of marketing a potential blockbuster drug that could fetch it billions in revenues. This explains the huge positive move in a stock when a company reports a positive clinical readout.

Similarly, an unfavorable or a partially successful outcome could suggest all the investment the company may have made in the investigational therapy could go down the drain. Quite appropriately, investors punish the stock by selling it in droves.

PDUFA and Adcom events are binary events that have two outcomes, triggering moves in stock depending on which outcome materializes.

Stock Movers

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Frequently Asked Questions

Q

What is an FDA PDUFA date?

A

Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company. The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company.

PDUFA was passed in the U.S. in 1992, which allows the FDA to collect fees from the sponsor company to fund the review process.

A CRL is issued by the FDA when it deems that the regulatory application is not complete in its current form. The deficiencies usually that lead to rejection could be the need for additional clinical studies to establish the efficacy and/or safety of the treatment option, problems with chemistry, manufacturing and controls, etc.

A delay in the review period may stem from the FDA needs additional time to review any additional data/information that may have been tabled subsequent to the submission of the regulatory application or the FDA’s inability to complete site inspections where the drug ingredients are being made etc.

The FDA may mention a specific date or a period (say Q1, Q2, Q3, Q4, first-half, second-half, the name of the month) as the timeline by which a decision will be given. If the FDA does not mention any timeline, the company may roughly calculate a timeline based on the data of filing the regulatory application. If the company doesn’t provide a timeline either, it is left to the investors to do the calculations.

Q

How long does an FDA approval take?

A

A regulatory application (NDA, sNDA, BLA, sBLA, etc.) is usually accepted for standard review or priority review. A standard review will mean the FDA has to hand out its verdict within 10 months of filing the application. The review window for a priority review gets shortened to six months.

Once a company files for a regulatory application, the FDA takes up to 60 days to respond with an ‘accepted for review’ or ‘refuse-to-file’ decision.

Q

How do you find FDA approvals?

A

A Catalysts Calendar is one way of tracking all the decisions in a single place. Usually, the FDA puts out a release and/or communicates to the company, which in turn will issue a press release.