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Latest Phase 1/2 Clinical Trials Stock News

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ALX Oncology Announces New Data Demonstrating Evorpacept in Combination with Zanidatamab Generates Promising Antitumor Activity in Advanced Breast Cancer

December 10
Last Trade: 1.61 -0.11 -6.34

Data from Phase 1b/2 clinical trial to be presented at 2024 San Antonio Breast Cancer Symposium (SABCS) show encouraging clinical activity in patients with heavily pretreated HER2-positive breast cancer who had received multiple HER2-targeted agents, including fam-trastuzumab deruxtecan-nxki (ENHERTU®) Combination therapy was well tolerated with a manageable safety profile consistent with prior experience with each investigational...Read more


Lisata Therapeutics Announces Completion of Enrollment in the CENDIFOX Trial

December 10
Last Trade: 2.65 0.005 0.19

BASKING RIDGE, N.J., Dec. 10, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced the successful completion of patient enrollment in all three cohorts of the Phase 1b/2a CENDIFOX trial. This investigator-initiated trial, led by Dr. Anup Kasi at The...Read more


Curis Announces Additional Data from TakeAim Leukemia Study

December 10
Last Trade: 4.04 -0.10 -2.44

LEXINGTON, Mass., Dec. 10, 2024 /PRNewswire/ -- Curis, Inc. ("Curis") (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, yesterday presented data from the TakeAim Leukemia study (CA-4948-102) in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) at the 66th ASH annual meeting. The additional data presented include data for 21 patients with...Read more


AC Immune Reports Interim Safety Data from Phase 1b/2 ABATE Trial of ACI-24.060 in Down syndrome

December 10
Last Trade: 3.13 -0.02 -0.48

ACI-24.060 was generally safe and well tolerated in individuals with Down syndrome with no serious adverse events related to the study drug No cases of amyloid-related imaging abnormalities observed in this study population Based upon these findings, AC Immune plans to open the high-dose cohort in ABATE in individuals with Down syndrome Lausanne, Switzerland, December 10, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage...Read more


Lyell Immunopharma Presents Positive Initial Clinical Data from the Phase 1-2 Clinical Trial of IMPT-314 for the Treatment of B-cell Lymphoma at the 2024 ASH Annual Meeting

December 9
Last Trade: 0.94 0.04 3.89

Objective response rate (ORR) of 94% and a complete response (CR) rate of 71% demonstrated after IMPT-314 treatment in CAR T-naïve patients with large B-cell lymphoma who had received at least 2 prior lines of therapy Manageable safety profile with no high-grade cytokine release syndrome (CRS) and low rates of Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS); adverse events were resolved with standard treatment...Read more


BeiGene Advances Leadership in CLL at ASH 2024 with New Data From Its Hematology Franchise Including BRUKINSA® and Novel Pipeline Assets

December 9
Last Trade: 187.91 -19.71 -9.49

5-year follow-up from SEQUOIA study demonstrated treatment with BRUKINSA reduced the risk of progression or death by 71% compared to bendamustine-rituximab in patients with treatment-naïve CLL, further solidifying its position as the leader in new patient starts in both frontline and relapsed/refractory (R/R) CLL with the broadest label of any BTK inhibitor At a median follow-up of 1.5 years, promising data from the 320 mg expansion...Read more


CRISPR Therapeutics Presents Data at the 2024 American Society of Hematology (ASH) Annual Meeting

December 9
Last Trade: 48.62 -1.22 -2.45

Preliminary data demonstrate that CTX112™ has the potential to provide meaningful clinical benefit with a well-tolerated safety profile using a standard lymphodepletion protocol Company announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX112 for the treatment of certain relapsed or refractory (R/R) CD19-positive B-cell malignancies CTX112 is also in a Phase...Read more


Vor Bio Provides Clinical Update Further Validating Approach of Using Shielded Transplants to Deliver Targeted Therapies; Receives Supportive Feedback from FDA Regarding Registrational Trial Design

December 9
Last Trade: 1.00 -0.04 -3.85

Preliminary data suggests improved relapse-free survival compared to published groups of acute myeloid leukemia (AML) patients at high risk of relapse post-transplant Trem-cel + Mylotarg continue to demonstrate engraftment, shielding, and broadened therapeutic window Company has received supportive feedback from the FDA regarding a registrational clinical trial design CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Vor Bio...Read more


Genmab: Two Data Analyses from Clinical Trials Show Epcoritamab (DuoBody® CD3xCD20) Induces Durable, Complete Responses as Monotherapy and Combination Treatment in Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

December 9
Last Trade: 21.92 -0.19 -0.86

Results from Arm 1 of the EPCORE® NHL-2 trial show treatment with epcoritamab combination led to an overall response rate (ORR) of 100 percent and a complete response (CR) rate of 87 percent in high-risk patients with previously untreated diffuse large B-cell lymphoma (DLBCL) Extended follow-up data from EPCORE® NHL-1 trial demonstrates durability of responses and long-term safety of epcoritamab monotherapy for patients with...Read more


AbbVie: Two Data Analyses From Clinical Trials Show Epcoritamab (DuoBody® CD3xCD20) Induces Durable Complete Reponses As Monotherapy and Combination Treatment in Patients With Diffuse Large B-Cell Lymphoma

December 9
Last Trade: 175.58 -7.35 -4.02

Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) NORTH CHICAGO, Ill., Dec. 9, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new results from two ongoing clinical trials evaluating epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma (DLBCL) at the 66th Annual Meeting and Exposition of...Read more


Molecular Partners Presents Clinical Data Supporting its Ongoing MP0533 Study and Preclinical Data on Next-Gen Conditioning Agent MP0621 at ASH 2024

December 8
Last Trade: 5.77 0.16 2.85

MP0533 phase 1/2a dose escalation study continues with overall acceptable safety profile to date as well as initial antileukemic and pharmacodynamic activity Clinical protocol amendment in process with optimized dosing scheme to overcome target-mediated drug disposition and test the full potential of MP0533 Switch-DARPin MP0621 demonstrates intended mechanism in vivo, achieving killing of cKit+ cells while reducing off-target effects...Read more


Genmab: Investigational Epcoritamab (DuoBody® CD3xCD20) Monotherapy Achieves High Overall and Complete Response Rates in Clinical Trial of Patients With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) in Preliminary Analysis

December 8
Last Trade: 21.92 -0.19 -0.86

COPENHAGEN, Denmark / Dec 08, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB): Preliminary analyses from the EPCORE® CLL-1 trial demonstrates overall response rate (ORR) of 61 percent and complete response (CR) rate of 39 percent in heavily pretreated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) who received epcoritamab monotherapy In the study, 75 percent of evaluable responders achieved undetectable...Read more


AbbVie: Investigational Epcoritamab (DuoBody® CD3xCD20) Combination Therapy Shows High Response Rates in Clinical Trial of Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

December 7
Last Trade: 175.58 -7.35 -4.02

Data presented at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH) NORTH CHICAGO, Ill., Dec. 7, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced updated results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration investigational epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with...Read more


Genmab: Investigational Epcoritamab (DuoBody® CD3xCD20) Combination Therapy Demonstrates High Response Rates in Clinical Trial of Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

December 7
Last Trade: 21.92 -0.19 -0.86

COPENHAGEN, Denmark / Dec 07, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB): Results show 96 percent overall response rate (ORR), 87 percent complete response (CR), and 80 percent 21-month progression-free survival (PFS) in patients with relapsed or refractory (R/R) follicular lymphoma (FL) following treatment with epcoritamab plus lenalidomide + rituximab (R2) Long-term follow-up results demonstrated strong and durable efficacy,...Read more


Beam Therapeutics Announces New Data from BEACON Phase 1/2 Clinical Trial of BEAM-101 in Sickle Cell Disease at American Society of Hematology (ASH) Annual Meeting

December 7
Last Trade: 28.94 1.42 5.16

All Seven Patients Treated with BEAM-101 Achieved Hemoglobin F (HbF) Induction of >60%, Hemoglobin S (HbS) Reduction to <40%, and Resolution of Anemia Post-BEAM-101 Treatment Initial Safety Profile Consistent with Busulfan Conditioning and Autologous Hematopoietic Stem Cell Transplantation All Seven Patients Dosed Achieved Target Cell Dose with One or Two Mobilization Cycles and Experienced Rapid Neutrophil and Platelet...Read more


Merus’ Petosemtamab Monotherapy Interim Data Continues to Demonstrate Clinically Meaningful Activity in 2L+ r/m HNSCC

December 7
Last Trade: 42.91 -0.84 -1.92

Petosemtamab in combination with pembrolizumab in 1L r/m PD-L1 expressing HNSCC ongoing with clinical data update planned for 2025 Petosemtamab in mCRC evaluation expanded to include 1L and 3L+; initial clinical data planned for 2025 – Conference Call on Saturday, December 7th at 9:00 a.m. ET UTRECHT, The Netherlands and CAMBRIDGE, Mass., Dec. 07, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our),...Read more


Stoke Therapeutics Presents New Open-Label Extension (OLE) Study Data That Further Support the Potential for Zorevunersen as a Disease-Modifying Medicine for the Treatment of Dravet Syndrome

December 6
Last Trade: 13.50 -0.26 -1.89

Substantial and durable reductions in convulsive seizure frequency observed in patients treated with 2 or 3 doses of 70mg followed by 45mg maintenance dosing on top of the best available anti-seizure medicines Patients experienced continuous improvements in multiple measures of cognition and behavior with ongoing treatment through 2 years Data support proposed Phase 3 registrational study regimen; Update anticipated before...Read more


Medicenna Therapeutics Provides Clinical Update and Announces First Complete Responder in MDNA11 and KEYTRUDA® (pembrolizumab) Combination Dose Escalation Arm of the ABILITY-1 Study

December 5
Last Trade: 1.85 -0.03 -1.60

70-year-old patient with advanced chemo-refractory anal cancer achieves complete response (CR) in 8 weeks when treated with MDNA11 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) Complete regression of all tumors in two CPI-resistant patients in monotherapy arms continue to show durability with a patient with melanoma remaining tumor free at week 63 while a patient...Read more


Monte Rosa Therapeutics Provides Development Progress Update for Ongoing MRT-2359 Phase 1/2 Study in Patients with MYC-driven Solid Tumors

December 5
Last Trade: 9.89 -0.31 -3.04

Results from dose escalation arms of Phase 1/2 study of MRT-2359 demonstrated a favorable safety profile and targeted levels of GSPT1 degradation using a 21 days on, 7 days off drug dosing schedule in heavily pretreated solid tumor patients Recommended Phase 2 dose determined as 0.5 mg daily at a 21 days on, 7 days off drug dosing schedule Additional MRT-2359 Phase 1/2 study clinical results, including biomarker and activity data,...Read more


Recursion announces first patient dosed in Phase 1/2 clinical study of REC-1245, a potential first-in-class, RBM39 degrader for Biomarker-Enriched Solid Tumors and Lymphoma

December 3
Last Trade: 7.72 -0.55 -6.65

First program to result from end-to-end use of OS to identify a novel target and new chemical matter, which moved from target ID to IND enabling studies in under 18 months with ~200 compounds synthesized REC-1245 is a potent and selective RBM39 degrader with a potential first-in-class profile in Solid tumors and Lymphoma >100,000 patients in the US and EU5 initially addressable SALT LAKE CITY, Dec. 03, 2024 (GLOBE NEWSWIRE) --...Read more


Oncolytics Biotech Reports Completion of Initial Safety Phase Enrollment for GOBLET Trial's New Pancreatic Cancer Cohort

December 3
Last Trade: 0.86 -0.02 -2.27

Early safety and tolerability results from six randomized patients support continued enrollment of pelareorep combined with modified FOLFIRINOX, with or without atezolizumab The study will begin with 30 patients, with an option to expand to an additional 34 participants SAN DIEGO and CALGARY, AB, Dec. 3, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in...Read more


Jasper Therapeutics Announces First Patient Dosed in Phase 1b/2a ETESIAN Clinical Study of Briquilimab in Asthma

December 2
Last Trade: 22.29 -0.11 -0.49

REDWOOD CITY, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, today announced that the first patient has been dosed in Jasper’s Phase 1b/2a...Read more


BriaCell Therapeutics Announces First Patient Dosed with Bria-OTS™ in Metastatic Breast Cancer Study

November 21
Last Trade: 1.01 -0.19 -15.55

Phase 1/2 dose escalation study to evaluate BriaCell’s personalized next generation immunotherapy treatment in metastatic breast cancer Bria-OTS™ to be studied as monotherapy and in combination with BeiGene’s anti-PD-1 antibody PHILADELPHIA and VANCOUVER, British Columbia, Nov. 21, 2024 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that develops novel...Read more


Perspective Therapeutics to Pursue Dose Escalation of [212Pb]VMT-α-NET in its Ongoing Phase 1/2a Clinical Trial Based on Data Presented at the 2024 North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium

November 21
Last Trade: 3.58 -0.19 -5.04

[212Pb]VMT-α-NET continued to have a favorable safety profile, with no dose-limiting toxicities observed at the two doses tested (2.5 and 5.0 mCi) Eight of nine patients had durable control of disease. Six of nine patients had a measurable reduction of tumor volume, one of whom had a confirmed response as defined by RECIST v1.1. Signal of anti-tumor activity was generally more pronounced in patients with lower body weight Perspective...Read more


uniQure Announces Dosing of First Patient in GenTLE Phase I/IIa Clinical Trial of AMT-260 for the Treatment of Refractory Mesial Temporal Lobe Epilepsy

November 21
Last Trade: 16.26 8.96 122.74

LEXINGTON, Mass. and AMSTERDAM, Nov. 21, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the first patient has been dosed in the GenTLE Phase I/IIa clinical trial of AMT-260 for the treatment of refractory mesial temporal lobe epilepsy (MTLE). “The dosing of the first patient in our Phase I/II trial in...Read more


First Patient Dosed in Aptevo Therapeutics' Ongoing RAINIER Trial Achieves 90% Reduction in Leukemic Blasts Within the First 30 Days of Treatment, Continues Overall Efficacy Trend Seen in Prior Mipletamig AML Studies

November 20
Last Trade: 8.50 -0.23 -2.63

Potential to redefine frontline AML treatment being evaluated in clinic: Mipletamig, CD3 x CD123 bispecific, in combination with standard of care, offers a multi-mechanism strategy for potential improved patient outcomes Favorable early safety, efficacy, tolerability and durability of remission data informed Aptevo's ongoing RAINIER Phase 1b/2 trial SEATTLE, WA / ACCESSWIRE / November 20, 2024 / Aptevo Therapeutics ("Aptevo")...Read more


Aptose Biosciences Initiates TUSCANY Phase 1/2 Study for Newly Diagnosed AML Patients to Receive Tuspetinib-based Triplet Therapy

November 20
Last Trade: 0.19 -0.01 -5.68

TUSCANY study is open to enroll patients to receive TUS+VEN+AZA triplet at select US sites Favorable safety and broad clinical activity make tuspetinib an ideal agent to combine with venetoclax and azacitidine to potentially address larger AML populations Study execution update is expected during ASH 2024 SAN DIEGO and TORONTO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose” or the “Company”) (NASDAQ: APTO, TSX:...Read more


Ocugen Announces Compelling Preliminary Data for OCU410—a Single Dose Novel Modifier Gene Therapy to Treat Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

November 19
Last Trade: 0.88 -0.01 -1.26

MALVERN, Pa., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry...Read more


Intensity Therapeutics Presents INT230-6 Phase 1/2 Data in Sarcoma and an Overview of its Ongoing Global Randomized Phase 3 Sarcoma Trial ("INVINCIBLE-3 Study") in a Late-Breaking Session at the 2024 Annual Connective Tissue Oncology Society Meeting

November 18
Last Trade: 2.34 -0.32 -12.19

Phase 1/2 data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone INVINCIBLE-3 Study is recruiting and expected to enroll 333 patients with leiomyosarcoma, liposarcoma and undeferential pleomorphic sarcoma; authorizations for the INVINCIBLE-3 Study have been received in the U.S., Canada,...Read more


Neurogene Provides Update on NGN-401 Gene Therapy Clinical Trial for Rett Syndrome

November 18
Last Trade: 24.42 1.11 4.76

NEW YORK / Nov 18, 2024 / Business Wire / Neurogene Inc. (Nasdaq: NGNE), a clinical-stage company founded to bring life-changing genetic medicines to patients and families affected by rare neurological diseases, today announced an update on its ongoing Phase 1/2 open-label clinical trial evaluating NGN-401 gene therapy for the treatment of Rett syndrome. As previously disclosed, on November 11, 2024, Neurogene became aware of an emerging...Read more


Eupraxia Pharmaceuticals Announces Positive Data from Fifth Cohort of RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis

November 12
Last Trade: 4.62 -0.04 -0.86

One of three patients in Cohort 5 achieved complete histological remission at 12 weeks. Consistent improvement in patient-reported outcomes with six of six evaluable patients in the fourth and fifth cohorts experiencing a reduction in symptom (SDI1) scores at 12 weeks. At 24 weeks, the fourth cohort experienced the largest average reduction in SDI scores of all cohorts to date. The fifth cohort continued to show improved patient...Read more


Armata Pharmaceuticals Announces the Completion of Enrollment of its Phase 1b/2a diSArm Study Evaluating Intravenous AP-SA02 as a Potential Treatment for Staphylococcus aureus Bacteremia

November 12
Last Trade: 2.14 -0.08 -3.60

Topline data anticipated in Q1 2025 to support potential initiation of a pivotal bacteremia efficacy trial in 2025 LOS ANGELES, Nov. 12, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that it has...Read more


Neurogene Reports Positive Interim Efficacy Data from First Four Low-Dose Pediatric Participants in NGN-401 Gene Therapy Clinical Trial for Rett Syndrome

November 11
Last Trade: 24.42 1.11 4.76

All participants experienced a 2-point improvement in the clinician-rated Clinical Global Impression-Improvement (CGI-I) scale from baseline All participants improved in the caregiver-completed Rett Syndrome Behavior Questionnaire (RSBQ), ranging from 28 to 52 percent improvement from baseline All participants with disruptions in sleep, constipation, and dysphagia at baseline demonstrated objective improvements Gains in skill and...Read more


NuCana Announces Encouraging Initial Data from Phase 1b/2 Modular Study of NUC-3373 in Combination with Pembrolizumab or Docetaxel

November 11
Last Trade: 1.28 -0.04 -3.03

Patients with Advanced Solid Tumors who had Exhausted All Other Treatment Options and were PD-(L)1 Experienced Achieved Significant Tumor Volume Reductions and Prolonged Progression Free Survival Following Treatment with NUC-3373 plus Pembrolizumab One Patient Achieved a 100% Reduction in their Target Lesion Patients with Lung Cancer who had Exhausted All Other Treatment Options Achieved Prolonged Progression Free Survival Following...Read more


Medicenna Therapeutics Announces Positive Single-Agent Activity of MDNA11 from Dose Expansion Cohort and Encouraging Safety Profile in Combination with KEYTRUDA® (pembrolizumab) at the 39th Annual Meeting of SITC

November 11
Last Trade: 1.85 -0.03 -1.60

Single-agent MDNA11 shows a 30% objective response rate (3 of 10) in the monotherapy dose expansion cohort among patients with advanced and/or metastatic solid tumors who had disease progression with immune checkpoint inhibitor (ICI) therapy Among ICI-resistant, high-dose MDNA11, phase 2-eligible patients in the monotherapy escalation and expansion cohorts (N=20), the response rate is 25% (5/20) including 1 complete response (CR) and 4...Read more


Ultragenyx Pharmaceutical Presents Positive Update on GTX-102 Angelman Syndrome Program at FAST’s 17th Annual Global Science Summit

November 9
Last Trade: 49.55 0.23 0.47

Phase 1/2 data show improvements across all domains and confirm that Phase 3 Aspire study is amply powered to establish efficacy of GTX-102 Phase 3 program on track to begin enrollment by end-of-year NOVATO, Calif., Nov. 09, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced Phase 1/2 data in support of the Phase 3 Aspire study for GTX-102, its investigational antisense oligonucleotide for...Read more


Kineta Updates KVA12123 Clinical Results from Ongoing Phase 1/2 VISTA101 Study at Society for Immunotherapy of Cancer (2024)

November 8
Last Trade: 0.63 -0.03 -4.55

Updated clinical data from VISTA101 presented at SITC 2024. Monotherapy arm fully enrolled and combination arm expected to be fully enrolled by year-end. Encouraging clinical responses observed in monotherapy (KVA12123 alone) and combination (KVA12123 plus Merck’s anti-PD-1 therapy, KEYTRUDA® [pembrolizumab]) cohorts. Favorable tolerability and toxicity profile in both arms, no dose limiting toxicities and a very clean safety profile...Read more


Tango Therapeutics Reports Positive TNG462 Clinical Data and Provides Update on PRMT5 Development Program

November 6
Last Trade: 3.27 0.06 1.87

TNG462 demonstrated durable clinical activity across multiple tumor types, including non-small cell lung cancer (NSCLC) and pancreatic cancer, in ongoing phase 1/2 clinical trial, moving into full development  Multiple TNG462 combination studies planned in 1H 2025  Clinical collaboration established with Revolution Medicines to evaluate TNG462 in combination with RAS(ON) multi- and G12D-selective inhibitors  TNG456, a...Read more


Xencor Doses First Subject in Phase 1/2 Study of XmAb®942 in Development for Patients with Inflammatory Bowel Disease

November 4
Last Trade: 25.32 0.12 0.48

PASADENA, Calif. / Nov 04, 2024 / Business Wire / Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today announced that it has initiated dosing of healthy volunteers in the first-in-human study of XmAb®942, an investigational high-potency extended half-life anti-TL1A antibody. Xencor continues to expect initial data from the...Read more


Vaccinex Reports New Findings for SIGNAL-AD Phase 1b/2 Trial of Pepinemab at Clinical Trials on Alzheimer’s Disease (CTAD) Conference in Madrid, Spain

October 31
Last Trade: 3.92 0.13 3.43

ROCHESTER, N.Y., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Vaccinex (Nasdaq: VCNX) today provided an update on new clinical findings from its SIGNAL-AD Phase 1b/2 trial of pepinemab antibody in Alzheimer’s disease. Vaccinex recently announced positive results of the phase 1b/2 study of its lead product, pepinemab, in early stages of Alzheimer’s disease (AD). The purpose of this report is to share additional data demonstrating stage-specific...Read more


Avidity Biosciences Pursues Potential Accelerated Approval Path with Initiation of Biomarker Cohort in FORTITUDE™ Trial for Delpacibart Braxlosiran (del-brax/AOC 1020) in People Living with Facioscapulohumeral Muscular Dystrophy

October 30
Last Trade: 36.79 -0.06 -0.16

Biomarker cohort for delpacibart braxlosiran (del-brax), the first potential therapy to target DUX4, is measuring changes in DUX4 regulated biomarkers; del-brax 2 mg/kg will be administered every six weeks Enrollment in the del-brax biomarker cohort expected to be completed in 1H 2025; on track to initiate del-brax functional cohort in 1H 2025 In previously reported initial data, del-brax 2 mg/kg every six weeks showed unprecedented...Read more


Lexeo Therapeutics Announces Positive Interim Data for LX1001, First-Ever Gene Therapy to Impact the Underlying Genetic Cause of APOE4-Associated Alzheimer’s Disease, at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference

October 30
Last Trade: 8.27 -0.02 -0.24

Dose-dependent increase in neuroprotective APOE2 expression in all participants with ongoing durability at 12 months Consistent reductions across CSF tau biomarkers and tau PET in majority of participants LX1001 well tolerated across all dose cohorts with no reports of amyloid-related imaging abnormalities (ARIA) Company to host webcast today at 7:00 AM ET NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc....Read more


NKGen Biotech Presents Phase 1/2a Troculeucel Data in Alzheimer’s Disease at the 17th Annual Clinical Trials on Alzheimer’s Disease (CTAD) Conference

October 29
Last Trade: 0.50 -0.02 -3.75

Newly analyzed biomarker data from the initial dose-escalation Phase 1 AD trial found that troculeucel reduces GFAP, NfL, p-tau181, GDF-15, and LTBP2 levels, which are detectable up to 10 years before dementia symptoms appear according to recent reports. This suggests a potential role for the use of troculeucel in delaying or preventing dementia onset in asymptomatic individuals with detectable biomarkers. Preliminary analysis from the...Read more


Tyra Biosciences Reports Interim Clinical Proof-of-Concept Data for TYRA-300, an Investigational Oral FGFR3-Selective Inhibitor, in Phase 1/2 SURF301 Study in Patients with Metastatic Urothelial Cancer (mUC)

October 24
Last Trade: 15.91 -0.09 -0.56

Encouraging preliminary anti-tumor activity observed in heavily pre-treated population At ≥ 90 mg QD, 6 out of 11 (54.5%) patients with FGFR3+ mUC achieved a confirmed partial response (PR), with 100% disease control rate and sustained duration of activity Positive safety results across all QD doses, with infrequent FGFR2/FGFR1-associated toxicities Conference call scheduled for October 25th, 2024, at 8AM EDT CARLSBAD, Calif.,...Read more


NAYA Biosciences Announces Initiation of Phase 1/2a Clinical Trial for its GPC3-targeted NK Engager Bispecific Antibody in Patients with Hepatocellular Carcinoma

October 24
Last Trade: 0.85 0.00 0.00

SARASOTA, Fla. and MIAMI, Oct. 24, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences (“NAYA”) (NASDAQ: NAYA), a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and fertility, today announced an update regarding its clinic trial plans. The Company received regulatory approval from the Israeli Ministry of Health in July 2024 and subsequent institutional review board...Read more


Vaccinex to Report Promising New Efficacy Data for SIGNAL-AD Phase 1b/2 trial of Pepinemab at Clinical Trials on Alzheimer’s Disease (CTAD) Conference on October 31, 2024

October 24
Last Trade: 3.92 0.13 3.43

ROCHESTER, N.Y., Oct. 24, 2024 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) and cancer through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present promising new efficacy and safety data for its randomized, double-blind, phase 1b/2 SIGNAL-AD study of pepinemab treatment for Alzheimer’s disease at...Read more


Intellia Therapeutics Presents Positive Results from the Phase 2 Study of NTLA-2002, an Investigational In Vivo CRISPR Gene Editing Treatment for Hereditary Angioedema (HAE)

October 24
Last Trade: 14.43 -0.19 -1.30

Deep attack rate reductions achieved in both dose levels tested; a single 50 mg dose resulted in a mean monthly attack rate reduction of 77% and 81% compared to placebo during weeks 1-16 and 5-16, respectively Eight of 11 patients in the 50 mg arm were completely attack free following a one-time infusion through the latest follow-up; data support NTLA-2002’s potential to be a functional cure for hereditary angioedema (HAE) NTLA-2002...Read more


BridgeBio Pharma Shares Positive Data from High Dose Cohort of Phase 1/2 CANaspire Study of Gene Therapy BBP-812 for Canavan Disease at ESGCT 2024

October 24
Last Trade: 29.22 -0.28 -0.95

Continued, progressive improvement in motor function and achievement of motor milestones at 12-months post-treatment represents an important and statistically significant change, in contrast to the disease course observed in BridgeBio’s ongoing CANinform natural history comparator study Significant and sustained reductions in N-acetylaspartate (NAA) levels in urine, cerebrospinal fluid (CSF), and brain in all participants who received...Read more


PMV Pharmaceuticals Provides a Progress Update on PYNNACLE Clinical Trial

October 23
Last Trade: 1.65 0.06 3.77

Enrollment on track in registrational Phase 2 portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors; more than 75% of sites activated across the U.S., Europe, and Asia-Pacific; interim analysis expected by mid-2025 Dose-limiting toxicities observed in rezatapopt and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) combination arm of Phase 1b...Read more


Oncternal Therapeutics Announces Updated Safety and Efficacy Data for Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer

October 22
Last Trade: 0.53 0.00 0.00

SAN DIEGO, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT) (the “Company”) today announced updated data from its Phase 1/2 Study of ONCT-534 for the treatment of patients with relapsed or refractory metastatic Castration-Resistant Prostate Cancer (mCRPC). Based on initial pharmacokinetic results, two additional dosing cohorts with twice daily (BID) oral dosing of ONCT-534 had been incorporated in the Phase...Read more


Lexeo Therapeutics to Present New Interim Data from Phase 1/2 Trial of LX1001 at the Clinical Trials on Alzheimer’s Disease (CTAD) 2024 Conference

October 22
Last Trade: 8.27 -0.02 -0.24

NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that interim data from the ongoing Phase 1/2 trial (NCT03634007) of LX1001 have been selected as a late-breaking oral presentation at the Clinical Trials on Alzheimer’s...Read more


INOVIO Announces New Data at Scientific Conferences for Lead Candidate, INO-3107, as a Potential Treatment for RRP

October 21
Last Trade: 4.13 -0.01 -0.24

American Association for Cancer Research (AACR) Special Conference: Tumor Immunology and Immunotherapy: New immunology data showed ability of INO-3107 to induce an antigen-specific T cell response against HPV-6 and HPV-11 and drive recruitment of T cells into airway tissues and papilloma International Society of Vaccines Conference: Full safety and efficacy data from Phase 1/2 clinical study in patients with Recurrent Respiratory...Read more


Tenaya Therapeutics Announces Updates on TN-201 Gene Therapy Program for MYBPC3-associated HCM

October 17
Last Trade: 3.62 -0.16 -4.23

Independent Data Safety and Monitoring Board Endorsed Dose Escalation and Broadening of Eligibility Criteria; Cohort 2 Now Enrolling Initial Data from Cohort 1 to be Reported in December 2024 Highlights Recently Presented Insights on Pediatric MYBPC3-associated HCM Disease Burden SOUTH SAN FRANCISCO, Calif., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with...Read more


uniQure Announces Dosing of First Patient in Phase I/II Clinical Trial of AMT-162 for the Treatment SOD1-ALS

October 15
Last Trade: 16.26 8.96 122.74

LEXINGTON, Mass. and AMSTERDAM, Oct. 15, 2024 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that the first patient has been dosed in the Phase I/II clinical trial of AMT-162 for the treatment of amyotrophic lateral sclerosis (ALS) caused by mutations in superoxide dismutase 1 (SOD1), a rare, inherited and...Read more


Jasper Therapeutics Reports Positive Data from SPOTLIGHT Study of Briquilimab in Chronic Inducible Urticaria

October 14
Last Trade: 22.29 -0.11 -0.49

14 of 15 participants enrolled achieved a clinical response 10 of 12 participants in the 120mg cohort achieved a complete response No serious adverse events; no grade 3 or higher adverse events reported Initial data from BEACON study expected week of January 6th, 2025, including 180mg Q8W cohort Company to host conference call and webinar today at 8:00 a.m. EDT REDWOOD CITY, Calif., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Jasper...Read more


Benitec Biopharma Reports Positive Data from Two Subjects Treated with Low-Dose BB-301 in Phase 1b/2a Study Presented at 29th Annual Congress of the World Muscle Society

October 12
Last Trade: 11.97 -0.21 -1.72

Subject 1 and Subject 2 experienced durable, clinically meaningful improvements in swallowing at 9-months and 6-months post-BB-301 treatment, respectively, with Subject 2 achieving a Sydney Swallow Questionnaire Score Representative of Clinically Normal Swallowing Management plans to host a conference call on October 14 at 8:30 am EDT to discuss the interim results, details below HAYWARD, Calif., Oct. 12, 2024 (GLOBE NEWSWIRE) --...Read more


Perspective Therapeutics to Advance Investigation of Potential First-In-Class Radiopharmaceutical Therapy [212Pb]VMT01 Based on Data Presented at the 21st International Congress of the Society for Melanoma Research

October 11
Last Trade: 3.58 -0.19 -5.04

[212Pb]VMT01 was observed to be safe, and no dose-limiting toxicities were observed at the two doses tested (3.0 and 5.0 mCi) Prolonged progression-free survival and tumor response were observed in heavily pretreated patients who received the low (3.0 mCi) dose of [212Pb]VMT01, consistent with preclinical findings Trial is progressing with testing [212Pb]VMT01 at a lower (1.5mCi) dose to further elucidate the optimal dose for...Read more


Theriva Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

October 3
Last Trade: 1.32 0.02 1.46

ROCKVILLE, Md., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics, Inc. (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced a positive outcome from the Data and Safety Monitoring Committee (DSMC) review of results from the second Cohort of its Phase 1b/2a randomized, double-blinded,...Read more


Immix Biopharma Advances CAR-T NXC-201 to Expansion Cohort Dose Level in U.S. AL Amyloidosis Trial NEXICART-2

October 2
Last Trade: 2.26 -0.28 -11.02

Now dosing at dose expansion level of 450 million NXC-201 CAR+T cells. First cohort at 150 million CAR+T cells already successfully completed Each of these two doses have produced complete responses in prior clinical studies Lead site Memorial Sloan Kettering Cancer Center (MSKCC); 4 disclosed clinical sites so far NXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S....Read more


Plus Therapeutics Reports ReSPECT-GBM Clinical Trial Update at the 2024 Congress of Neurological Surgeons Annual Meeting

October 1
Last Trade: 1.34 -0.008 -0.59

Rhenium (186Re) Obisbemeda delivered by convection enhanced delivery (CED) continues to show safety, response, and potential efficacy Mean Phase 2 absorbed dose was 300 Gy and 89% of patients exceeded the minimal dose threshold of 100 Gy ReSPECT-GBM Phase 1/2 trial has expanded to two new sites at leading U.S. academic medical centers in New York and Upper Midwest AUSTIN, Texas, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics,...Read more


EDAP TMS Announces First Patients Treated in Phase I/II Study Evaluating Focal One Robotic HIFU for the Treatment of Benign Prostatic Hyperplasia (BPH)

October 1
Last Trade: 2.23 -0.04 -1.76

LYON, France, October 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patients have been treated in a Phase I/II study evaluating the Company’s proprietary Focal One® robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH). “We’ve been offering targeted HIFU ablation to prostate cancer patients for more...Read more


NervGen Pharma Provides Update on Phase 1b/2a Clinical Trial of NVG-291 in Spinal Cord Injury

September 30
Last Trade: 2.65 0.09 3.32

Target enrollment in the chronic cohort close to completion Vancouver, British Columbia--(Newsfile Corp. - September 30, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced that target enrollment of the chronic cohort in its Phase 1b/2a proof-of-concept, double-blind, randomized...Read more


Estrella Immunopharma Achieves Complete Response in First Patient Treated with CD19- Redirected ARTEMIS® T-cells

September 27
Last Trade: 1.44 0.0031 0.22

EMERYVILLE, Calif. / Sep 27, 2024 / Business Wire / Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial has achieved a complete response (CR) one month after receiving an...Read more


INmune Bio: INKmune™ Demonstrates Excellent Safety and Increased NK-Cell Activity in First Dosing Cohort

September 26
Last Trade: 5.61 0.29 5.45

BOCA RATON, Fla., Sept. 26, 2024 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial (the “CaRe PC” trial) for men with metastatic Castration-Resistant Prostate Cancer (mCRPC). The Company is pleased to announce initial results from the first patient cohort in the...Read more


AIM ImmunoTech Reports Positive Preliminary Data in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer

September 19
Last Trade: 0.22 -0.0004 -0.18

Preliminary finding of stable disease in two out of three patients at 6 months in the first subject cohort Combination of Ampligen and Imfinzi continues to be generally well-tolerated with no severe adverse events or dose-limiting toxicities OCALA, Fla., Sept. 19, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”) today announced positive preliminary data from the Phase 1b/2 study (“DURIPANC”) evaluating...Read more


4D Molecular Therapeutics Highlights Robust and Durable Clinical Activity for 4D-150 and Design of 4FRONT Phase 3 Program at 4D-150 Wet AMD Development Day

September 18
Last Trade: 7.21 0.03 0.42

4D-150 demonstrated robust and durable clinical activity across all wet age-related macular degeneration (wet AMD) patient populations based on longest available follow-up data In broad population (Phase 2b), 70% injection-free through 52 weeks In severe population (Phase 1/2a), 83% overall reduction in annualized injections through 52 weeks 4D-150 continues to be safe and well tolerated with intraocular inflammation (IOI)...Read more


BiomX to Provide Latest Update on Positive Phase 1b/2a Clinical Trial Data for BX004 at the North American Cystic Fibrosis Conference

September 18
Last Trade: 0.65 0.02 2.54

GAITHERSBURG, Md., Sept. 18, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, announces the Company will present further data from BiomX’s Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary...Read more


Adagene Presents Results at ESMO Congress that Show Best-in-Class Therapeutic Potential for Anti-CTLA-4 SAFEbody® ADG126 (Muzastotug) in Combination with KEYTRUDA® (Pembrolizumab) in Advanced/Metastatic Microsatellite-stable (MSS) Colorectal Cancer (CRC)...

September 16
Last Trade: 2.20 0.18 8.91

Confirmed partial responses (PRs) doubled to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases for overall response rate (ORR) of 24% (4/17) with ADG126 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab  Median progression-free survival of 8.5 months observed in patients without liver and peritoneal metastases at the ADG126 10 mg/kg Q3W dose  At the 10 mg/kg dose level, 12-month...Read more


Genmab: Investigational Rinatabart Sesutecan (Rina-S) Shows Promising Anti-Tumor Activity as Single Agent in Heavily Pretreated Patients with Ovarian and Endometrial Cancers in Phase 1/2 Clinical Trial

September 15
Last Trade: 21.92 -0.19 -0.86

Treatment with rinatabart sesutecan (Rina-S) showed encouraging response rate in heavily pretreated patients with ovarian cancer in dose expansion cohort Responses with Rina-S were observed across FRα expression levels Phase 3 trial will further evaluate the safety and efficacy of Rina-S at 120 mg/m2 in patients with advanced ovarian cancer COPENHAGEN, Denmark / Sep 15, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today...Read more


Johnson & Johnson: RYBREVANT® (amivantamab-vmjw) plus chemotherapy show 49 percent overall response rate in metastatic colorectal cancer

September 14
Last Trade: 148.82 -0.78 -0.52

Median duration of response reaches 7.4 months with combination treatment in patients with aggressive form of disease New results show potential of RYBREVANT® beyond lung cancer BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new data from the Phase 1b/2 OrigAMI-1 study, which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy (mFOLFOX6 [FOLFOX] or FOLFIRI)...Read more


Bicycle Therapeutics Presents Updated Clinical Results Across Oncology Pipeline at ESMO Congress 2024

September 14
Last Trade: 20.77 -0.28 -1.33

Updated monotherapy data for Nectin-4 targeting zelenectide pevedotin in metastatic urothelial cancer (mUC) showed a promising 45% overall response rate (ORR), 11.1 months median duration of response and a generally well-tolerated safety profile EphA2-targeting BT5528 demonstrated an emerging differentiated safety profile and antitumor activity in patients with advanced solid tumors, including a 45% ORR in mUC 6.5 mg/m2 every two weeks...Read more


ESSA Pharma Presents Updated Phase 1/2 Masofaniten (EPI-7386) Clinical Data at the 2024 ESMO Congress

September 13
Last Trade: 1.72 0.02 1.18

Combination of masofaniten plus enzalutamide continues to be well tolerated with durable reductions in PSA in patients with mCRPC Phase 2 dose expansion currently underway at the RP2CDs of masofaniten 600 mg BID in combination with enzalutamide 160 mg QD Across all dosing cohorts, 88% of patients achieved PSA90, 69% of patients achieved PSA90 in less than 90 days, and 63% of patients achieved PSA <0.2ng/mL. After 15.2 months of...Read more


Ascendis Pharma to Present First Results from Platinum-Resistant Ovarian Cancer (PROC) Cohort of the Phase 1/2 IL-Believe Trial at ESMO 2024

September 13
Last Trade: 130.56 -1.86 -1.40

Anti-tumor clinical responses were observed in 29% (4/14) of efficacy-evaluable patients with PROC treated with TransCon IL-2 β/γ in combination with chemotherapy Initial data suggest clinical activity in heavily pre-treated PROC patients and that TransCon IL-2 β/γ in combination with chemotherapy was generally well-tolerated COPENHAGEN, Denmark, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today...Read more


NKGen Biotech’s Positive Phase 1 Clinical Data in Moderate Alzheimer’s Disease Advances Troculeucel into Phase 2 with First Patient Dosed in Phase 1/2a Trial

September 12
Last Trade: 0.50 -0.02 -3.75

Two of the first three patients in the Phase 1 cohort of the Phase 1/2a clinical trial, treated at the highest dose of 6 billion cells per treatment, were found to have improved CDR-SB cognitive scores, resulting in a clinical upgrade from moderate AD to mild AD after only three months on therapy. First patient dosed in the Phase 2 cohort of the trial, continuing at the highest dose of 6 billion cells per treatment. With the...Read more


Sernova Announces New Positive Data from Phase I/II Trial Regarding Islet Survival and Function

September 12
Last Trade: 0.25 0.00 0.00

Abundant, richly vascularized and functioning islets observed throughout all chambers of Sernova’s Cell Pouch more than 5 years after islet transplantation Histological data confirmation of healthy beta, alpha and delta cells secreting insulin, glucagon, and somatostatin in all Cell Pouch Chambers Sernova’s Cell Pouch safely contains its therapeutic cells and provides full retrievability using conventional instruments and...Read more


Eupraxia Pharmaceuticals Announces Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis

September 11
Last Trade: 4.62 -0.04 -0.86

Consistent improvement in patient reported outcomes with 10 of 11 evaluable patients in the first four cohorts experiencing a reduction in symptom (SDI1) scores at 12 weeks The fourth cohort showed the greatest percentage change in histology (EoEHSS2) scores of any cohort to date The RESOLVE Phase 1b/2a trial is progressing as anticipated with no serious adverse events reported in all four fully-dosed cohorts VICTORIA, BC,...Read more


BridgeBio Pharma Reports Topline Results from Phase 1/2 Trial of Investigational Gene Therapy for Congenital Adrenal Hyperplasia (CAH)

September 10
Last Trade: 29.22 -0.28 -0.95

Increase in endogenous cortisol production achieved in all patients in higher dose cohorts of BBP-631, a result seen for the first time ever in CAH patients The gene therapy was well tolerated with no treatment-related serious adverse events (SAEs) reported Despite novel scientific advancements achieved with this program, the data do not warrant additional capital investment at this time and the gene therapy budget is being...Read more


Scholar Rock Completes Enrollment in Phase 2 EMBRAZE Proof-of-Concept Trial of Apitegromab in Obesity

September 10
Last Trade: 45.31 -0.17 -0.37

Topline results expected in 2Q 2025 CAMBRIDGE, Mass. / Sep 10, 2024 / Business Wire / Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced it has completed enrollment in the Phase 2 EMBRAZE trial designed to show...Read more


Acelyrin Announces Positive Proof-of-Concept Data From Phase 1/2 Clinical Trial of Lonigutamab as a Subcutaneous Treatment for Thyroid Eye Disease to be Presented at 42nd Annual Meeting of European Society of Ophthalmic Plastic and Reconstructive Su

September 10
Last Trade: 4.19 -0.10 -2.33

Rapid-fire Oral Presentation to Highlight Efficacy, Safety, and Quality of Life Outcomes LOS ANGELES, Sept. 10, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive data from its Phase 1/2 clinical trial of lonigutamab (an anti-insulin-like growth factor 1 receptor,...Read more


Stoke Therapeutics Presents Zorevunersen Data Showing Substantial Reductions in Seizures and Improvements in Multiple Measures of Cognition and Behavior That Support the Potential for Disease Modification in Dravet Syndrome

September 10
Last Trade: 13.50 -0.26 -1.89

New data showed improvements in cognition and behavior during the first year of treatment with additional increases demonstrated as treatment continued  Clinical effects observed across the Phase 1/2a and open-label extension studies (OLEs) of zorevunersen are a first in the treatment of Dravet syndrome and support plans for the Company’s Phase 3 registrational study  Zorevunersen generally well-tolerated across the...Read more


Actuate Therapeutics Obtains Complete Responses and Provides Update on Clinical Trial of Elraglusib for the Treatment of Relapsed/Refractory Ewing Sarcoma

September 9
Last Trade: 8.68 0.00 0.00

Elraglusib Demonstrated Anti-Tumor Activity with Two Ongoing Durable Complete Responses and ~62% Disease Control Rate in First 8 Patients with Relapsed/Refractory Ewing and Ewing-related Sarcomas Enrollment Ongoing with Topline Data Anticipated in 1H 2025 CHICAGO and FORT WORTH, Texas, Sept. 09, 2024 (GLOBE NEWSWIRE)  – Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage...Read more


Updated Data for Nuvalent's ALK-Selective Inhibitor, NVL-655, and ROS1-Selective Inhibitor, Zidesamtinib, Continue to Support Potential Best-in-Class Profiles

September 9
Last Trade: 93.88 -0.03 -0.03

Updated Phase 1 data from ALKOVE-1 and ARROS-1 clinical trials to be presented at the ESMO Congress 2024 Durable activity of NVL-655 and zidesamtinib in heavily pre-treated patient populations supports ongoing Phase 2 investigation in earlier lines of treatment Company plans to host a conference call on September 14, 2024 at 8:30 a.m. ET/2:30 p.m. CEST following oral presentations at ESMO CAMBRIDGE, Mass., Sept. 9, 2024...Read more


Longboard Pharmaceuticals Announces Positive Interim Analysis Results from the Open-Label Extension (OLE) of the Phase 1b/2a PACIFIC Study Evaluating Bexicaserin in Participants with Developmental and Epileptic Encephalopathies (DEEs)

September 8
Last Trade: 60.00 0.00 0.00

Bexicaserin achieved an overall median seizure reduction of 57.7% in countable motor seizures over an approximate 9-month treatment period Favorable safety and tolerability results continue to be observed Data to be presented at the 15th European Epilepsy Congress in Rome, Italy Full 12-month OLE dataset expected early next year LA JOLLA, Calif. / Sep 08, 2024 / Business Wire / Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a...Read more


New Clinical Data Validates Vor Bio’s Approach of Using Shielded Transplants to Deliver Targeted Therapies

September 5
Last Trade: 1.00 -0.04 -3.85

Trem-cel + Mylotarg demonstrated engraftment, shielding, broadened therapeutic window, and patient benefit VCAR33ALLO demonstrates encouraging biomarker data at lowest dose New asset VADC45 with significant potential opportunities across oncology, gene therapy, and autoimmune disorders CAMBRIDGE, Mass., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, today announced...Read more


Rigel Pharmaceuticals Announces First Patient Enrolled in Phase 1b/2 Triplet Therapy Trial of REZLIDHIA® (olutasidenib) in mIDH1 AML

September 5
Last Trade: 20.82 -2.34 -10.10

First trial in Rigel's multi-year strategic development alliance with MD Anderson Phase 1b/2 trial of decitabine and venetoclax in combination with Rigel's targeted mIDH1 inhibitor REZLIDHIA for patients with mIDH1 AML SOUTH SAN FRANCISCO, Calif., Sept. 5, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced the first...Read more


ALX Oncology Announces First Patients Dosed with Evorpacept and Sarclisa As Part of Randomized Phase 1/2 UMBRELLA Study with Sanofi

September 4
Last Trade: 1.61 -0.11 -6.34

SOUTH SAN FRANCISCO, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq: ALXO), an immuno-oncology company developing therapies that block the CD47 immune checkpoint pathway, announced the first patients have been dosed in an arm of the randomized UMBRELLA phase 1/2 clinical study partnered with Sanofi that is evaluating evorpacept in combination with SARCLISA®...Read more


Dyne Therapeutics Announces New Clinical Data from Phase 1/2 DELIVER Trial of DYNE-251 in Duchenne Muscular Dystrophy Demonstrating Unprecedented Dystrophin Expression and Functional Improvement in Multiple Cohorts

September 3
Last Trade: 28.35 -0.33 -1.15

Initiating Registrational Cohorts with Update on Path to Registration by Year-End 2024 Virtual Investor Event Today at 8:00 a.m. ET  WALTHAM, Mass., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced new clinical data from its ongoing...Read more


Immix Biopharma Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2

August 28
Last Trade: 2.26 -0.28 -11.02

New Sites Expand Opportunities for Patient Access and Enrollment Clinical Trial Sites Added Include Cleveland Clinic, UC Davis, and Sutter Health Lead site Memorial Sloan Kettering Cancer Center (MSKCC) Data from ex-U.S. clinical trial reported at ASGCT 2024 showed a 92% overall response rate LOS ANGELES, CA, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a...Read more


Ocugen Announces Completion of Dosing in Subjects with Stargardt Disease in High Dose Cohort of Phase 1/2 GARDian Clinical Trial of OCU410ST—A Modifier Gene Therapy

August 28
Last Trade: 0.88 -0.01 -1.26

MALVERN, Pa., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease. Stargardt...Read more


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