Biotech catalysts, September 2027

56 tracked events across 43 companies

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

DateTickerEventTypePhase
September 1, 2027 NVO REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels Trial Milestone Phase 3
September 2, 2027 IBRX IBRX-042 In Participants With HPV-Associated Tumors Trial Milestone Phase 1
September 3, 2027 NVO A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes Trial Milestone Phase 2
September 9, 2027 NVS A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation Trial Milestone Phase 2
September 12, 2027 NVO A Study to See How Safe a New Medicine (NNC0642-1895) is in Healthy People Trial Milestone Phase 1
September 13, 2027 TAK A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD) Trial Milestone Phase 3
September 15, 2027 LLY A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight Trial Milestone Phase 2
September 15, 2027 LLY A Master Protocol Study of Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight (ATTAIN-Hypertension) GZL1 Trial Milestone Phase 3
September 15, 2027 LLY A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants Trial Milestone Phase 1
September 15, 2027 ABBV Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 Trial Milestone Phase 1
September 15, 2027 ARGX A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis Trial Milestone Phase 2/Phase 3
September 15, 2027 ARGX A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP Trial Milestone Phase 3
September 15, 2027 SVA Phase Ⅲ Clinical Trial of an Inactivated Hepatitis A Vaccine Trial Milestone Phase 3
September 15, 2027 IONS A Study to Assess the Safety, Tolerability and Efficacy of ION775 Trial Milestone Phase 2
September 15, 2027 IONS Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ION464 Administered to Adults With Multiple System Atrophy (HORIZON) Trial Milestone Phase 1
September 15, 2027 IONS ATTUNE: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION440 in Participants With Methyl CpG Binding Protein 2 (MECP2) Duplication Syndrome (MDS) Trial Milestone Phase 1/Phase 2
September 15, 2027 RARE Clinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) Deficiency Trial Milestone Phase 3
September 15, 2027 ALKS Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Trial Milestone Phase 3
September 15, 2027 DFTX A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend) Trial Milestone Phase 3
September 15, 2027 ASND A Clinical Trial to Evaluate Efficacy and Safety of Navepegritide in Adolescents (12 - 18 Years of Age) With Achondroplasia. Trial Milestone Phase 2
September 15, 2027 CYTK Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction Trial Milestone Phase 3
September 15, 2027 IOVA A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer Trial Milestone Phase 1/Phase 2
September 15, 2027 TEVA A Trial to Test if TEV-56286 is Effective for Treatment of Participants With Multiple System Atrophy Trial Milestone Phase 2
September 15, 2027 KARD A Study of the Efficacy and Safety of Danicamtiv in Participants With Symptomatic Genetic and Familial Dilated Cardiomyopathy Trial Milestone Phase 2/Phase 3
September 15, 2027 IMVT A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis Trial Milestone Phase 2
September 15, 2027 CORT Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma Trial Milestone Phase 2
September 15, 2027 RCUS Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers Trial Milestone Phase 1
September 15, 2027 GKOS Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus Trial Milestone Phase 4
September 15, 2027 TRVI The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC) Trial Milestone Phase 2
September 15, 2027 KYTX KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis Trial Milestone Phase 2/Phase 3
September 15, 2027 ANRO ALTO-100 in Bipolar Disorder With Depression (BD-D) Trial Milestone Phase 2
September 15, 2027 CLYM A Phase 1b/2a Study of Budoprutug in Systemic Lupus Erythematosus (SLE) Trial Milestone Phase 1/Phase 2
September 15, 2027 XFOR A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections Trial Milestone Phase 3
September 15, 2027 AGEN A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer Trial Milestone Phase 2
September 17, 2027 ARWR A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus Trial Milestone Phase 1/Phase 2
September 23, 2027 INCY Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders Trial Milestone Phase 2
September 24, 2027 TAK Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis Trial Milestone Phase 3
September 24, 2027 BIIB A Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND) Trial Milestone Phase 3
September 28, 2027 REGN A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Trial Milestone Phase 2/Phase 3
September 28, 2027 INCY A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease Trial Milestone Phase 3
September 28, 2027 ONC Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors Trial Milestone Phase 1
September 29, 2027 JNJ A Long-term Extension Study of Ustekinumab in Pediatric Participants Trial Milestone Phase 3
September 30, 2027 REGN Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies Trial Milestone Phase 1
September 30, 2027 INCY An Open-Label Study to Enable Continued Treatment Access for Subjects Previously Enrolled in Studies of Ruxolitinib Trial Milestone Phase 2
September 30, 2027 ONC An Investigational Study of BGB-58067 As a Single Agent and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors Trial Milestone Phase 1
September 30, 2027 BIIB A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK) Trial Milestone Phase 1
September 30, 2027 VNDA Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness Trial Milestone Phase 3
September 30, 2027 BMRN Immune Modulation During Palynziq® Treatment in Adults (IMPALA) Trial Milestone Phase 4
September 30, 2027 ALNY A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma Trial Milestone Phase 1
September 30, 2027 MRNA A Study to Investigate the Safety, Reactogenicity, and Immunogenicity of mRNA-1469 Vaccine to Prevent Ebola-Bundibugyo Virus Disease in Healthy Adult Participants Trial Milestone Phase 1
September 30, 2027 GRFS A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD) Trial Milestone Phase 3
September 30, 2027 IMCR Study of IMC-P115C in Advanced PRAME-Positive Cancers Trial Milestone Phase 1
September 30, 2027 ALT RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) Trial Milestone Phase 2
September 30, 2027 MAIA THIO Sequenced With Cemiplimab in Advanced NSCLC Trial Milestone Phase 2
September 30, 2027 FATE A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease Trial Milestone Phase 1
September 30, 2027 CGEM A Phase 1b Study of CLN-049 in Combination With Azacitidine and Venetoclax in AML Patients Trial Milestone Phase 1

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NVO · IBRX · NVS · TAK · LLY · ABBV · ARGX · SVA · IONS · RARE · ALKS · DFTX · ASND · CYTK · IOVA · TEVA · KARD · IMVT · CORT · RCUS · GKOS · TRVI · KYTX · ANRO · CLYM · XFOR · AGEN · ARWR · INCY · BIIB · REGN · ONC · JNJ · VNDA · BMRN · ALNY · MRNA · GRFS · IMCR · ALT · MAIA · FATE · CGEM