Biotech catalysts, December 2027

86 tracked events across 67 companies

Clinical trial milestones, FDA decision dates, SEC filings and earnings scheduled for December 2027, compiled from ClinicalTrials.gov and SEC EDGAR.

DateTickerEventTypePhase
December 1, 2027 NVO A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function Trial Milestone Phase 1
December 1, 2027 RVMD Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) Trial Milestone Phase 3
December 1, 2027 REPL Study of RP2 in Combination With Second-line Therapy in Patients With Locally Advanced or Metastatic HCC Trial Milestone Phase 2
December 1, 2027 QURE Safety, PK/PD, and Exploratory Efficacy Study of AMT-191 in Classic Fabry Disease Trial Milestone Phase 1/Phase 2
December 1, 2027 ALMS Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of ESK-001 in Plaque Psoriasis Trial Milestone Phase 2
December 2, 2027 PFE Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents Trial Milestone Phase 3
December 2, 2027 PGEN Zopa Retreatment and Vector Shedding in Adults With RRP Trial Milestone Phase 4
December 6, 2027 TAK A Study of TAK-755 in Adults With Acute Ischemic Stroke Trial Milestone Phase 2
December 7, 2027 MRNA A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children Trial Milestone Phase 1
December 14, 2027 ALNY A Study to Evaluate ALN-6222 in Participants With Obesity Trial Milestone Phase 1
December 15, 2027 JNJ A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) Trial Milestone Phase 3
December 15, 2027 JNJ A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia Trial Milestone Phase 2
December 15, 2027 ABBV A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy and Who Are Naïve to Biologic Therapy Trial Milestone Phase 2
December 15, 2027 ABBV Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis Trial Milestone Phase 2
December 15, 2027 ABBV Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma Trial Milestone Phase 3
December 15, 2027 GILD Study With Various Immunotherapy Treatments in Participants With Lung Cancer Trial Milestone Phase 2
December 15, 2027 SVA Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell). Trial Milestone Phase 3
December 15, 2027 BNTX A Clinical Trial Testing the Safety of Pumitamig (an Investigational Drug) and How Well it Works When Combined With Chemotherapy for People Who Have Not Been Treated Yet for Pancreatic Cancer Trial Milestone Phase 2
December 15, 2027 VNDA Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies Trial Milestone Phase 1
December 15, 2027 AAPG APG-2449 in Patients With Advanced Solid Tumors Trial Milestone Phase 1
December 15, 2027 AAPG A Study of HQP1351 in Patients With GIST or Other Solid Tumors Trial Milestone Phase 1
December 15, 2027 BMRN A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia Trial Milestone Phase 2
December 15, 2027 BMRN A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH) Trial Milestone Phase 2
December 15, 2027 BMRN AAV Gene Therapy Study for Subjects with PKU Trial Milestone Phase 1/Phase 2
December 15, 2027 AXSM A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder Trial Milestone Phase 3
December 15, 2027 AXSM An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD Trial Milestone Phase 3
December 15, 2027 AXSM Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT) Trial Milestone Phase 3
December 15, 2027 IBRX Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma Trial Milestone Phase 2
December 15, 2027 ARWR Study of Inhaled ARO-RAGE in Allergen-induced Mild Asthma Trial Milestone Phase 2
December 15, 2027 ASND A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Infants (0 to <2 Years of Age) With Achondroplasia Trial Milestone Phase 2
December 15, 2027 NTLA MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM) Trial Milestone Phase 3
December 15, 2027 IOVA A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Melanoma Trial Milestone Phase 2
December 15, 2027 PCVX A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Trial Milestone Phase 2
December 15, 2027 PCVX A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults Trial Milestone Phase 1
December 15, 2027 IMVT Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis Trial Milestone Phase 3
December 15, 2027 ANVS A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD Trial Milestone Phase 3
December 15, 2027 CANF A Phase 3 Study in Moderate-to-Severe Plaque Psoriasis With Piclidenoson to Study Safety and Efficacy Trial Milestone Phase 3
December 15, 2027 DNLI A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric and Young Adult Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II) Trial Milestone Phase 2/Phase 3
December 15, 2027 RNAC Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders Trial Milestone Phase 1/Phase 2
December 15, 2027 ALXO ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer Trial Milestone Phase 2
December 15, 2027 OCS Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research Trial Milestone Phase 3
December 15, 2027 SNDX A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation Trial Milestone Phase 1/Phase 2
December 15, 2027 CRBP A Study to Evaluate CRB-701 Compared to Investigator's Choice Therapy in Previously Treated Oropharyngeal Squamous Cell Carcinoma Trial Milestone Phase 3
December 15, 2027 EWTX A Study of EDG-15400 in Adults With Heart Failure With Preserved Ejection Fraction (EQUINOX-HFpEF) Trial Milestone Phase 2
December 15, 2027 EWTX A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM) Trial Milestone Phase 2
December 15, 2027 CRVS Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa Trial Milestone Phase 1
December 15, 2027 KURA A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST) Trial Milestone Phase 1
December 15, 2027 INTS A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3) Trial Milestone Phase 3
December 15, 2027 BCTX Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. Trial Milestone Phase 3
December 15, 2027 MPLT A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis Trial Milestone Phase 2
December 15, 2027 NERV Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications Trial Milestone Phase 3
December 15, 2027 RADX 177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors Trial Milestone EARLY_Phase 1
December 15, 2027 RADX HEAT Trial (HER2 Antibody Therapy With Lutetium-177) Trial Milestone EARLY_Phase 1
December 15, 2027 RADX 177Lu-BetaBart in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors Trial Milestone Phase 1/Phase 2
December 15, 2027 KYMR A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma Trial Milestone Phase 2
December 15, 2027 WVE A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity Trial Milestone Phase 1/Phase 2
December 15, 2027 OTLK A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders Trial Milestone Phase 3
December 15, 2027 TMCI A Study Comparing the MAGICTouch™ Sirolimus-coated Balloon With a Paclitaxel-coated Balloon for Treating Severe Narrowing or Blockage in the Femoropopliteal Arteries. Trial Milestone Phase 2/Phase 3
December 15, 2027 MAZE A Study of MZE782 in Adults With PKU Trial Milestone Phase 2
December 15, 2027 XNCR Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis Trial Milestone Phase 1/Phase 2
December 15, 2027 XNCR Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors Trial Milestone Phase 1
December 15, 2027 ALLO Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL Trial Milestone Phase 2
December 15, 2027 GNPX Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients Trial Milestone Phase 1/Phase 2
December 18, 2027 MRK A Clinical Study of V503 in Chinese Females Who Have Previously Received a Bivalent Human Papillomavirus (HPV) Vaccine (V503-108) Trial Milestone Phase 3
December 23, 2027 JAZZ A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH Trial Milestone Phase 3
December 26, 2027 AMGN Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION) Trial Milestone Phase 3
December 27, 2027 ALNY TRITON-PN: A Study to Evaluate the Efficacy and Safety of Nucresiran in Patients With Hereditary Transthyretin Amyloidosis With Polyneuropathy Trial Milestone Phase 3
December 30, 2027 AMGN A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) Trial Milestone Phase 2
December 30, 2027 BEAM A Phase 1/2, Dose-Exploration Study to Evaluate the Safety and Efficacy of BEAM-301 in Patients With Glycogen Storage Disease Type Ia (GSDIa) Trial Milestone Phase 1/Phase 2
December 30, 2027 RLAY A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors Trial Milestone Phase 1
December 30, 2027 PBYI A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer Trial Milestone Phase 2
December 30, 2027 MNKD Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis Trial Milestone Phase 2
December 30, 2027 CGEM A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Rheumatoid Arthritis Trial Milestone Phase 1
December 31, 2027 ONC A Study of BG-C477 in Participants With Advanced Solid Tumors Trial Milestone Phase 1
December 31, 2027 AAPG A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918. Trial Milestone Phase 1
December 31, 2027 AAPG A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1) Trial Milestone Phase 3
December 31, 2027 INBS A Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders Trial Milestone Phase 2
December 31, 2027 GRFS A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Trial Milestone Phase 3
December 31, 2027 ADRX Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients Trial Milestone Phase 1/Phase 2
December 31, 2027 SRPT A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD) - Non-Ambulatory Cohort Trial Milestone Phase 1
December 31, 2027 SUPN Safety and Tolerability Study of SPN-817 in Adult Patients With Treatment Resistant Epilepsy Trial Milestone Phase 2
December 31, 2027 SUPN SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures Trial Milestone Phase 2
December 31, 2027 OLMA Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer Trial Milestone Phase 1
December 31, 2027 KNSA Phase 2/3 Study of Participants With Recurrent Pericarditis Evaluating the Efficacy and Safety of KPL-387 Trial Milestone Phase 2/Phase 3
December 31, 2027 KNSA Transition to KPL-387 Monotherapy Dosing & Administration Study Trial Milestone Phase 2
December 31, 2027 CATX MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma Trial Milestone Phase 1/Phase 2

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Companies on this page

NVO · RVMD · REPL · QURE · ALMS · PFE · PGEN · TAK · MRNA · ALNY · JNJ · ABBV · GILD · SVA · BNTX · VNDA · AAPG · BMRN · AXSM · IBRX · ARWR · ASND · NTLA · IOVA · PCVX · IMVT · ANVS · CANF · DNLI · RNAC · ALXO · OCS · SNDX · CRBP · EWTX · CRVS · KURA · INTS · BCTX · MPLT · NERV · RADX · KYMR · WVE · OTLK · TMCI · MAZE · XNCR · ALLO · GNPX · MRK · JAZZ · AMGN · BEAM · RLAY · PBYI · MNKD · CGEM · ONC · INBS · GRFS · ADRX · SRPT · SUPN · OLMA · KNSA · CATX