Clinical Trials (Phase II)
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Patients treated with Longboard Pharmaceuticals’ bexicaserin saw a 32.5% drop in the frequency of countable motor seizures relative to placebo in a Phase 1b/IIa study. The company’s shares soared 316% Tuesday on the news.
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Anavex Life Sciences' stock dropped by more than a third in value on Tuesday after results for a Phase II/III Rett syndrome study failed to impress investors.
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Tango Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of TNG348 in Patients with BRCA1/2-Mutant and Other HRD+ Cancers
1/3/2024
Tango Therapeutics, Inc. announced that the first patient has been dosed in the phase 1/2 trial evaluating TNG348 as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant or other HRD+ cancers.
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Chemomab Announces Completion of Patient Enrollment in CM-101 Phase 2 Primary Sclerosing Cholangitis Trial and Moves Up Expected Topline Readout to Midyear 2024
1/3/2024
Chemomab Therapeutics Ltd. announced early completion of patient enrollment in its Phase 2 clinical trial assessing CM-101 as a treatment for primary sclerosing cholangitis.
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Upstream Bio Announces Dosing of First Patients in a Phase 2 Clinical Trial of Verekitug (UPB-101) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
1/3/2024
Upstream Bio today announced the dosing of the first patients in a Phase 2 clinical trial of verekitug in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
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ENYO Pharma Announces a €39 Million Series C Financing and FDA Clearance to Advance Vonafexor in a Phase 2 Clinical Trial for Patients With Alport Syndrome
1/3/2024
ENYO Pharma (“ENYO”) announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical study of Vonafexor, a highly selective FXR agonist, for the treatment of Alport Syndrome.
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Ultragenyx Announces Completion of Enrollment in Global Phase 1/2 Trial of GTX-102 in Pediatric Patients with Angelman Syndrome
1/3/2024
Ultragenyx Pharmaceutical Inc. today announced the completion of patient enrollment in its Phase 1/2 clinical trial of GTX-102 for the treatment of pediatric patients with Angelman syndrome (AS).
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Athira Pharma Completes Enrollment of Phase 2/3 LIFT-AD Clinical Trial of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease
1/3/2024
Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced completion of enrollment in the Phase 2/3 LIFT-AD clinical trial of fosgonimeton as a potential treatment for mild-to-moderate Alzheimer’s disease.
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Arch Biopartners Receives Approval from the Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury
1/3/2024
Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it has received approval in Turkey from the Ministry of Health to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
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OcuTerra Therapeutics Announces Last Patient Completes Final Visit in Nesvategrast (OTT166) Eye Drop Phase 2 DR:EAM Clinical Trial in Diabetic Retinopathy
1/3/2024
OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases for which the current standard of care of “watch-and-wait” does not prevent or control the progression of disease, today announced the completion of the last patient’s final visit in the Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial of nesvategrast (OTT166).
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Investigator-initiated Phase 1/2 Clinical Trial Using Salarius Pharmaceuticals’ Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment
1/3/2024
Salarius Pharmaceuticals, Inc. announces that the hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center is now listed as active and recruiting on clinical trials.gov – trial NCT04734990.
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AC Immune Progress Update on Phase 2 Active Immunotherapy Clinical Pipeline for Alzheimer's and Parkinson diseases
1/3/2024
AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today provided an update on positive progress in its active immunotherapy programs, with three Phase 2 trials progressing to key clinical milestones in 2024.
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OBI Pharma Announces U.S. FDA Clearance of IND Application for a Phase 1/2 Study of OBI-992
1/3/2024
OBI Pharma, a clinical stage oncology company, announced that the U.S. Food and Drug Administration has cleared an investigational new drug application for OBI-992, to conduct a Phase 1/2 study of its novel antibody - drug conjugate cancer therapy targeting TROP2.
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IRLAB is Granted an End-of-Phase 2 Meeting with the FDA for the Phase III-Ready Mesdopetam Program
1/3/2024
IRLAB Therapeutics AB announced that the US FDA has granted IRLAB an end-of-Phase 2 meeting for the mesdopetam program on February 20, 2024.
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Longboard Pharmaceuticals Announces Positive Topline Data from the PACIFIC Study, a Phase 1b/2a Clinical Trial, for Bexicaserin (LP352) in Participants with Developmental and Epileptic Encephalopathies (DEEs)
1/2/2024
Longboard Pharmaceuticals today announced positive topline data from the PACIFIC Study evaluating bexicaserin (LP352), a potentially best-in-class and highly selective, oral, novel 5-HT2C receptor superagonist for seizures associated with a broad range of Developmental and Epileptic Encephalopathies (DEEs).
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Avenue Therapeutics Announces Completion of Enrollment in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)
1/2/2024
Avenue Therapeutics, Inc. today announced that all patients have been enrolled in the Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy.
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INmune Bio Announces First Patient Dosed in a Phase 1/2 Study of INKmune™ in Patients with Metastatic Castration-Resistant Prostate Cancer
1/2/2024
INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, dosed the first patient in the Phase I/II trial in men with metastatic castration-resistant prostate cancer (mCRPC) on December 27, 2023.
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Inventprise Completes Vaccination of Participants in a Phase 2 Dose Ranging Study of its 25 Valent Pneumococcal Vaccine Candidate
1/2/2024
Biotechnology company Inventprise Inc.n announced the completion of vaccination in their Phase 2 dose ranging study of its 25-valent pneumococcal conjugate vaccine in young adults.
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Gannex Announces Positive Interim Results from 52-Week Phase II Clinical Trial of Once-Daily ASC41 Tablet in Patients with Biopsy-Confirmed Non-alcoholic Steatohepatitis
1/2/2024
Gannex Pharma Co., Ltd. ("Gannex"), a wholly-owned company of Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces today positive interim results from the 52-week Phase II clinical trial of thyroid hormone receptor β (THRβ) agonist ASC41 tablet for treatment of patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH).
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NKGen Biotech, Inc. Announces Dosing of First Patient in its Phase 1/2a Trial with Autologous NK Cell Product, SNK01, for the Treatment of Moderate Alzheimer’s Disease
12/28/2023
NKGen Biotech, Inc. announced the dosing of the first patient in its Phase 1/2a trial evaluating SNK01, a cryopreserved autologous, non-genetically modified NK cell therapy product with enhanced cytotoxicity and activating receptor expression.