Biotech catalysts, January 2028

35 tracked events across 28 companies

Clinical trial milestones, FDA decision dates, SEC filings and earnings scheduled for January 2028, compiled from ClinicalTrials.gov and SEC EDGAR.

DateTickerEventTypePhase
January 1, 2028 JNJ Nipocalimab in Moderate to Severe Sjogren's Disease Trial Milestone Phase 3
January 1, 2028 JAZZ A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer Trial Milestone Phase 2
January 5, 2028 PFE A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors Trial Milestone Phase 1
January 5, 2028 ALNY A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT) Trial Milestone Phase 1/Phase 2
January 7, 2028 REGN Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Trial Milestone Phase 3
January 8, 2028 MRK A Study of Adjuvant Intismeran Autogene (V940) and Pembrolizumab in Renal Cell Carcinoma (V940-004). Trial Milestone Phase 2
January 15, 2028 ABBV A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies Trial Milestone Phase 2
January 15, 2028 GILD Study of Oral Weekly Lepetegravir (Formerly GS-1720) and Lenacapavir Pacfosacil (Formerly GS-4182) Versus Biktarvy in People With HIV-1 Who Are Virologically Suppressed Trial Milestone Phase 2/Phase 3
January 15, 2028 ARGX A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome Trial Milestone Phase 2
January 15, 2028 BNTX A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma Trial Milestone Phase 2
January 15, 2028 IBRX N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer Trial Milestone Phase 1
January 15, 2028 XENE A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3) Trial Milestone Phase 3
January 15, 2028 KPTI A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM. Trial Milestone Phase 2
January 15, 2028 ACAD ACP-204 in Adults With Alzheimer's Disease Psychosis Trial Milestone Phase 2/Phase 3
January 15, 2028 MDGL A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis Trial Milestone Phase 3
January 15, 2028 SUPN Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD Trial Milestone Phase 4
January 15, 2028 NRIX A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201) Trial Milestone Phase 2
January 15, 2028 MBX A Study to Investigate Canvuparatide Compared With Placebo in Adult Patients With Hypoparathyroidism Trial Milestone Phase 3
January 15, 2028 IMTX SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma Trial Milestone Phase 3
January 15, 2028 TYRA Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors With Activating FGF/FGFR Pathway Aberrations Trial Milestone Phase 1
January 15, 2028 CRMD Comparing The Safety And Efficacy Of DEFENCATH® In Reducing Central-Line Bloodstream Infections (CLABSIs) In Adults And Adolescent Participants Receiving Total Parenteral Nutrition Through A Central Venous Catheter (CVC) Trial Milestone Phase 3
January 15, 2028 FATE FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors Trial Milestone Phase 1
January 17, 2028 AGIO A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria Trial Milestone Phase 1
January 19, 2028 JNJ A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring Trial Milestone Phase 1
January 19, 2028 NVO A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and Metabolism After Meals in People With Obesity Trial Milestone Phase 1
January 21, 2028 REGN Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes Trial Milestone Phase 2
January 25, 2028 MRK Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007) Trial Milestone Phase 3
January 26, 2028 REGN A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) Trial Milestone Phase 2
January 28, 2028 REGN A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea Trial Milestone Phase 2
January 28, 2028 JAZZ Study of Lurbinectedin Monotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Ewing Sarcoma Trial Milestone Phase 1/Phase 2
January 29, 2028 AMGN An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease Trial Milestone Phase 2
January 30, 2028 VRTX Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN) Trial Milestone Phase 3
January 31, 2028 BIIB A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old Trial Milestone Phase 2
January 31, 2028 JAZZ A Study of Lurbinectedin in Combination With Durvalumab for the Treatment of Participants With ES-SCLC Trial Milestone Phase 2
January 31, 2028 CATX Lead-212 PSV359 Therapy for Patients With Solid Tumors Trial Milestone Phase 1/Phase 2

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JNJ · JAZZ · PFE · ALNY · REGN · MRK · ABBV · GILD · ARGX · BNTX · IBRX · XENE · KPTI · ACAD · MDGL · SUPN · NRIX · MBX · IMTX · TYRA · CRMD · FATE · AGIO · NVO · AMGN · VRTX · BIIB · CATX