FDA Calendar

CERo Therapeutics Holdings, Inc., announced that The trial is focused on patients with acute myeloid leukemia (AML), and patient enrollment is underway, with expected dosing of the first patient during the first half of 2025.

SpringWorks Therapeutics, Inc. that the Company anticipates the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will adopt an opinion on the marketing authorization application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of adults with desmoid tumors in the second quarter of 2025.

Azitra, Inc announced that it is developing ATR04-484 for the treatment of EGFR inhibitor-associated rash with plans to dose first patient in Phase 1/2 trial in the first half of 2025

Verastem Oncology Expect to initiate a Phase 1/2a trial in the U.S. in advanced KRAS G12D mutant solid tumors in mid-2025

Aclaris Therapeutics, Inc. announced that Initiation of Upcoming Phase 1a/1b Clinical Trial Expected in the Second Quarter of 2025 -

uniQure N.V. announced that Additional regulatory update and guidance on the Biologics License Application submission expected in the second quarter of 2025

Nurix Therapeutics, Inc. Phase 1 trial, which is anticipated to begin in Q2 2025.

Cullinan Therapeutics, announced that Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025

Cardiff Oncology, Inc. announced that Additional clinical data from CRDF-004 trial expected in 1H 2025

OS Therapies announced that it has submitted a request for a formal meeting with the Center for Biologics Evaluation and Research (CBER) of the United States Food & Drug Administration (FDA) to gain alignment on the clinical endpoints required to support Breakthrough Therapy Designation (BTD) and Accelerated Approval via a conditional BLA of investigational off-the-shelf immunotherapy candidate OST-HER2 in the prevention or delay of recurrence of fully resected, lung metastatic osteosarcoma.

CERo Therapeutics Holdings, Inc., announced that Company believes it is on track for dosing the first patient in the first half of 2025.

atai Life Sciences announced that Topline results from the core stage of the Phase 2b clinical trial are expected in mid-2025

Cognition Therapeutics, announced that Full Analysis will be Provided in the Second Quarter of 2025

Trevi Therapeutics, announced that Topline results continue to be expected in the first half of 2025.

Alzamend Neuro, Inc announced its plans to initiate the first of five highly anticipated phase II clinical studies of AL001, with the first study, in healthy human subjects, expected to commence in the second quarter of 2025.

Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second fiscal quarter of 2025.

Opthea Limited announced that The topline results from both trials are anticipated in early Q2 CY25 (COAST) and mid-CY25 (ShORe).

Rallybio Corporation announced that Pharmacokinetic (PK) and safety data from the second trimester are expected in the second quarter of 2025, with PK

Achieve Life Sciences, Inc announced that Achieve Reiterates Planned Cytisinicline NDA Submission in Q2 2025

Cyclo Therapeutics, Inc announced that Company on track for topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ in H1 2025

Allarity Therapeutics, Inc announced that Patient enrollment is expected to begin in the first half of 2025

Sangamo Therapeutics, Inc. announced Data to support Accelerated Approval pathway expected in first half of 2025

Kura is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ziftomenib in the second quarter of 2025.

Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.

Rezolute, Inc. announced that sunRIZE enrollment completion expected in Q2 2025

Apogee Therapeutics, Inc announced that Part A 16-week proof-of-concept data anticipated in mid-2025.

Entrada Therapeutics, Inc. announced that Company on track to initiate ELEVATE-44-201 in Q2 2025 –

United Therapeutics Corporation announced that First xenotransplant is expected to occur around mid-year 2025

Zentalis® Pharmaceuticals, Inc. announced that Company aligned with FDA on seamless study design for DENALI Part 2 in patients with Cyclin E1+ PROC; study expected to begin 1H 2025

Ocugen, Inc. announced that Phase 1 clinical trial is anticipated to start in 2Q 2025

Ventyx Biosciences, Inc. Topline data from ongoing Phase 2 biomarker trial of VTX3232 in participants with early Parkinson's disease expected in H1 2025

Verastem expects to initiate a Phase 1/2a study mid-2025

C4 Therapeutics, Inc. announced that CFT1946 Phase 1 Trial Continues to Progress in BRAF V600X Solid Tumors With Monotherapy Dose Escalation Expected to Complete in 1H 2025

Kymera Therapeutics KT-621 (STAT6) Phase 1 healthy volunteer trial ongoing, with data expected in 2Q25

Kymera Therapeutics announce plans to initiate a KT-621 Phase 1b trial in atopic dermatitis (AD) patients in 2Q25

Kymera Therapeutics announced that KT-295 (TYK2) to advance into Phase 1 testing in 2Q25

Ocular Therapeutix, Inc. announced that Company plans to seek FDA feedback in H1 2025 on clinical trial design for AXPAXLI in NPDR

GH Research PLC announced that Full response to the IND hold planned to be submitted in mid-2025

Monte Rosa Therapeutics, Inc. announced that MRT-8102, a NEK7-directed MGD targeting diseases driven by IL-1β and the NLRP3 inflammasome, on track for IND filing in H1 2025

Rapport Therapeutics, Inc Ongoing Phase 2a trial of RAP-219 in focal epilepsy is on track and topline data is expected in mid-2025

Sensei Biotherapeutics, Inc. announced that Clinical data update expected in Q2 2025

Cingulate Inc announced that Submission of New Drug Application Targeted for Mid 2025

Immuneering Corporation announced that Further IMM-1-104 Phase 2a data expected in 2Q'25

Opthea Limited announced that ShORe in mid-2025

Opthea Limited announced that DME program to be advanced after wet AMD topline data readout anticipated for COAST in early CY Q2 2025

VYNE Therapeutics Inc. Top-line data from the 24-week vehicle-controlled treatment period are expected in mid-2025.

Vir Biotechnology, Inc announced that The designations are supported by compelling positive safety and efficacy data from the Phase 2 SOLSTICE trial, from which the Company recently presented new data at AASLD The Liver Meeting® in San Diego, U.S. Vir Biotechnology's Phase 3 ECLIPSE registrational program evaluating tobevibart and elebsiran in CHD will commence in the first half of 2025.

Trevi Therapeutics, Inc. announced that topline results continue to be expected in the first half of 2025

Company plans to initiate first-in-human studies with RJVA-001 in first half of 2025

Zealand Pharma A/S announced that ompletion of enrollment into ZUPREME-1 is expected in the first half of 2025.

Microbot Medical announced that FDA 510(k) Clearance Anticipated During the Second Quarter of 2025

Cardiff Oncology Announced that Additional clinical data from CRDF-004 trial expected in 1H 2025 -

Outlook Therapeutics, Inc announced that First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025.

Relmada Therapeutics, announced that With positive results, Phase 2a proof-of-concept study expected to begin in H1 2025

Ionis Pharmaceuticals, announced the pivotal Phase 3 study design following successful alignment with the U.S. Food and Drug Administration (FDA) on ION582, an investigational medicine for the treatment of people living with Angelman syndrome (AS).

Aclaris Therapeutics, Inc. announced that Top-line Data Anticipated in First Half of 2025

Scholar Rock Obesity program progressing with Phase 2 EMBRAZE trial on track for readout in Q2 2025

Xencor continues to expect initial data from the ongoing study during the first half of 2025.

Fractyl Health, Inc announced that REMAIN-1 weight maintenance pivotal study on-track to report mid-point data analysis in Q2 2025

Mineralys Therapeutics, Inc announced that Topline data now anticipated in mid first half of 2025 –.

Avidity Biosciences, Inc. announced that on track to initiate del-brax functional cohort in 1H 2025

Avidity Biosciences, announced that Inc. Enrollment in the del-brax biomarker cohort expected to be completed in 1H 2025

Zymeworks announced that investigational new drug application (IND) submissions for ZW220 in 1H

Kymera Therapeutics announced that The Company expects to report Phase 1 data in the first half of 2025.,

Genelux Corporation announced that Interim readout expected mid-2025

Supernus Pharmaceuticals announced that Topline results from Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant depression expected first-half 2025,

Adicet Bio, Inc. announced that Company plans to report initial clinical data from Phase 1 study in multiple autoimmune diseases in the first half of 2025

Lyra Therapeutics, Inc. announced that Topline Results Expected Q2 2025

Kymera Therapeutics, announced that KT-621 is expected to start Phase 1 in October, with Phase 1 data in the first half of 2025

Traws Pharma, Inc announced that Phase 2 study expected to begin in H1 2025

Barinthus Biotherapeutics plc announced that Data update for PCA001 anticipated in H1 2025.

Kymera Therapeutics, announced that with Phase 1 data in the first half of 2025

Tectonic Therapeutic, announced that Phase 1b single dose hemodynamic proof-of-concept clinical trial in Group 2 Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF) escalated to the highest dose of TX45 (3 mg/kg) based on favorable tolerability profile observed at lower doses, with topline trial results expected in the second quarter of 2025

Vera Therapeutics, Inc announced that On track to announce topline results from ORIGIN 3 trial in Q2 2025.

Scholar Rock announced that Topline results expected in 2Q 2025

I-Mab announced that Randomized Phase 2 study of uliledlimab in combination with pembrolizumab plus chemotherapy expected to begin in 1H 2025

Actuate Therapeutics, Inc. announced that Enrollment Ongoing with Topline Data Anticipated in 1H 2025

Zealand Pharma A/S announced that Higher doses up to 26 mg over a 28-week treatment period are being evaluated in the ongoing Part 2 of the trial with topline results expected in the first half of 2025

Relay Therapeutics, Inc. Triplet combination with ribociclib expected to move into dose expansion in 1H 2025

Arcutis Biotherapeutics, Inc announced that Phase 1b results expected first half of 2025

Ocuphire Pharma, Inc. announced that the Top-line data from VEGA-3 Phase 3 trial expected in first half of 2025

Keros announced that it will present topline data in the second quarter of 2025.

IO Biotech announced that The primary endpoint of progression-free survival (PFS) is projected to be reached in the first half of 2025.

Sutro Biopharma, Inc announced that Initial data from this study is expected in the first half of 2025

Tonix Pharmaceuticals announced that Topline results are expected in the first half of 2025

Kura Oncology, Inc. announced that Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 –

Tectonic Therapeutic, announced that Phase 1b hemodynamic trial evaluating single doses of TX45 in subjects with Group 2 PH-HFpEF continues to enroll as planned, with topline study results expected in mid-2025

Processa Pharmaceuticals announced that Initial data expected mid-2025

Lisata Therapeutics, Inc. announced that Top-line data now anticipated mid-2025

Passage Bio, Inc. announced that its has Plan to initiate dosing of FTD-C9orf72 patients in 1H 2025

Artelo Biosciences announced that Phase 1 trial results expected in the first half of 2025,

GT Biopharma, Inc announced that initial clinical data expected in H1 2025

Elevation Oncology, Inc announced to provide additional data in 1H 2025

DiaMedica Therapeutics Inc. announced that Key Proof-of-Concept Results Expected in the First Half of 2025

Savara Inc announced that Company Plans to Complete BLA Submission in 1H 2025

Adicet Bio preliminary clinical data expected in 1H 2025

GSK plc announced that The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in H1 2025.

VYNE Therapeutics Inc. announced that Top-line data from the 24-week double-blind portion of the trial expected in mid-2025

Rhythm Pharmaceuticals, Inc. announced that the Topline data from ongoing pivotal Phase 3 clinical trial in hypothalamic obesity on track for 2Q 2025 -

Syndax Pharmaceuticals announced that could support a supplemental New Drug Application (sNDA) filing for revumenib in R/R mNPM1 AML in the first half of 2025.

Opthea intends to report topline results from these two trials by mid-2025.

Spectral AI, Inc announced that The data obtained in the study will be compared to assessment by physicians and used for regulatory submission to the FDA by the first half of 2025.

Tourmaline Bio, Inc announced that Topline data from the ongoing Phase 2b spiriTED trial are expected in the first half of 2025

Lisata expects the complete data set of all 155 patients from the study by mid-2025.

Cassava Sciences, Inc. announced that Top-line results for on-going, 76-week Phase 3 trial expected approximately mid-year 2025

, Ionis announced that Data from the study are expected as early as the first half of 2025.

Inozyme Pharma announced that topline data expected to be reported in mid-2025

Acasti Pharma Inc announced that New Drug Application (NDA) submission in the first half of calendar 2025

Rezolute announced that the topline results anticipated in the first half of 2025.

Pfizer is expected to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in 2025, based on the outcome of this Phase 3 study.

Topline data from the study are expected in 2025

Final analysis from the trial are expected in 2025