Latest Phase 1 Clinical Trials Stock News

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Biodexa Pharmaceuticals Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D Update

February 23
Last Trade: 1.49 -0.05 -3.25

Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) Biodexa Announces Positive Top Line Phase I Clinical Trial Results for Diffuse Midline Glioma and Provides R&D Update Median Overall Survival of 16.5 Months vs 10.0 months in Comparable Cohort CARDIFF, United Kingdom, February 23, 2024 (GLOBE NEWSWIRE) – Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of...Read more

Elevation Oncology Expands Ongoing Phase 1 Clinical Trial of EO-3021 Globally, Dosing First Patient in Japan

February 22
Last Trade: 2.56 -0.14 -5.19

On track to provide update from ongoing Phase 1 clinical trial in mid-2024; additional data expected in 1H 2025  BOSTON, Feb. 22, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that it has expanded its ongoing...Read more

Acumen Pharmaceuticals to Present Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting

February 21
Last Trade: 3.56 0.22 6.59

Oral presentation to explore drug effect of sabirnetug (ACU193) on key cerebrospinal fluid biomarkers in early AD Poster presentation to showcase method used to develop a first-of-its-kind assay to measure target engagement of an AβO-selective antibody On track to initiate a Phase 2 trial evaluating sabirnetug in the first half of 2024 Sabirnetug is the nonproprietary name for ACU193 now accepted by the United States Adopted Name...Read more

Kazia Therapeutics Reports Early Conclusion of Clinical Trial After Reaching Primary Endpoint

February 21
Last Trade: 0.31 0.0085 2.84

Paxalisib plus Radiotherapy Data Shows Promise for Treating Patients with PI3K Pathway Mutation Brain Metastases SYDNEY, Feb. 21, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specializing in oncology, today announced the early conclusion based on positive safety and promising clinical response findings observed to date of an important two-part Phase I trial. This investigator-initiated trial...Read more

Teva Pharmaceuticals Presents New Data Supporting Safety, Tolerability and Target Engagement of Anti-TL1A (TEV-‘574) Antibody at the 2024 ECCO Annual Meeting

February 20
Last Trade: 12.89 -0.16 -1.23

Results demonstrate rapid and sustained suppression of free TL1A, confirming target engagement of anti-TL1A (TEV-’574)1 Anti-TL1A (TEV-’574) was shown to be safe and well-tolerated, with a low incidence of antidrug antibodies2 Data support the ongoing Phase 2b clinical investigation of anti-TL1A (TEV-’574) in inflammatory bowel disease3 TEL AVIV, Israel & PARSIPPANY, N.J. / Feb 20, 2024 / Business Wire / Teva Pharmaceuticals, a...Read more

Tharimmune Announces Positive Results in Phase 1 Clinical Trial of TH104, its Lead Clinical Therapeutic Candidate

February 20
Last Trade: 0.37 -0.007 -1.85

Positive safety/tolerability profile achieved with TH104 showing self-resolving, mild side effect profile aligned with previous studies Phase 1 clinical trial compared oral transmucosal delivery of TH104 to injectable reference approved drug completed Company fully funded into 2025 with Phase 2 moderate-to-severe chronic pruritus in primary biliary cholangitis (PBC) study on-track and expected to initiate in 2024 BRIDGEWATER, NJ /...Read more

Monopar Therapeutics Receives Clearance to Proceed with First-in-Human Phase 1 Trial of Novel Radiopharmaceutical MNPR-101-Zr in Advanced Cancers

February 20
Last Trade: 1.30 0.18 16.07

WILMETTE, Ill., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 dosimetry trial of its novel radiopharmaceutical MNPR-101-Zr. The MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll...Read more

Arvinas Announces First-in-Human Dosing of ARV-102, an Investigational PROTAC® Protein Degrader for Neurodegenerative Disease

February 20
Last Trade: 47.00 0.49 1.05

ARV-102 is a novel oral PROTAC® protein degrader designed to cross the blood-brain barrier and target leucine-rich repeat kinase 2 (LRRK2)  The Phase 1 trial of ARV-102 will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers  NEW HAVEN, Conn., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on...Read more

Medicus Pharma Publishes Phase 1 Clinical Study Report Demonstrating Safety & Tolerability in All Participants with Basal Cell Carcinoma

February 15
Last Trade: 2.59 0.00 0.00

The Clinical Study Report Also Describes Efficacy in 6 Participants Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Medicus Pharma Ltd. (TSXV: MDCX) (FSE: N46) ("Medicus" or the "Company") is pleased to announce that it has published the abbreviated clinical study report (CSR) from the SKNJCT-001 Phase 1 safety and tolerability study. SKNJCT-001 is an open-label, dose-escalation, placebo-controlled trial to evaluate dose...Read more

Theratechnologies Completes Enrollment of First Six Patients in Updated Phase 1 Clinical Trial of Sudocetaxel Zendusortide in Advanced Ovarian Cancer

February 15
Last Trade: 1.64 0.03 1.55

Study milestone further extends momentum for Company’s lead PDC candidate and oncology clinical development program MONTREAL, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced completion of enrollment of the first six participants in Part 3 of its...Read more

Repare Therapeutics Doses First Patient in Phase 1 Clinical Trial of RP-1664

February 15
Last Trade: 6.34 0.08 1.28

RP-1664 is a Potential First-in-Class, Selective, PLK4 Inhibitor CAMBRIDGE, Mass. & MONTREAL / Feb 15, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, today announced the first patient has been dosed in the Company’s Phase 1 LIONS (PLK4 Inhibitor in Advanced Solid Tumors) clinical trial evaluating RP-1664, a potential first-in-class,...Read more

Results from First Patient in Kiromic BioPharma’s Deltacel-01 Clinical Trial Indicate Tumor Reduction at Two Months

February 14
Last Trade: 3.46 0.11 3.28

Second Patient Completed Treatment and Third Patient Dosed in Phase 1 Study Evaluating Deltacel™ for the Treatment of Non-Small Cell Lung Cancer HOUSTON / Feb 14, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces continued encouraging clinical findings from the most recent follow-up visit of the first patient enrolled in Deltacel-01, the Company’s Phase 1 clinical trial evaluating...Read more

TScan Therapeutics to Host Virtual KOL Event to Discuss Updated Results from Phase 1 Heme Malignancies Study Presented at the 2024 Tandem Meetings of ASTCT and CIBMTR

February 14
Last Trade: 6.76 -0.06 -0.88

TScan’s abstract selected by the Tandem Meetings to receive a Best Abstracts Award Company to discuss the potential implications of initial data from a large prospective clinical trial assessing the relationship between donor chimerism and risk of relapse WALTHAM, Mass., Feb. 14, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor...Read more

Pasithea Therapeutics Announces Opening of Enrollment in the U.S. for its Phase 1 Trial of PAS-004

February 13
Last Trade: 7.42 0.22 3.06

Activation of four U.S. sites for Phase 1 clinical trial of PAS-004 to evaluate safety, dose, key biomarker data and preliminary efficacy  Plans to open three additional sites in Eastern Europe in the coming months  Preliminary interim data expected in 2H 2024  SOUTH SAN FRANCISCO, Calif. and MIAMI, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a...Read more

Anixa Biosciences Initiates Dosing in Second Cohort of Ovarian Cancer CAR-T Clinical Trial

February 12
Last Trade: 3.59 0.03 0.84

Dose escalation for fourth patient follows successful completion of first cohort SAN JOSE, Calif., Feb. 12, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that treatment has commenced for the fourth patient in the ongoing Phase 1 clinical trial of its novel chimeric...Read more

Biodexa Pharmaceuticals Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients

February 8
Last Trade: 1.49 -0.05 -3.25

Biodexa Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients CARDIFF, United Kingdom, February 8, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes and rare/orphan brain...Read more

Cogent Biosciences to Present SUMMIT Part 1b Data with Bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) at the 2024 AAAAI Annual Meeting

February 5
Last Trade: 7.44 -1.51 -16.87

WALTHAM, Mass. and BOULDER, Colo., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced its upcoming posters for bezuclastinib at the 2024 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) being held in Washington, D.C. from February 23-26, 2024. The company will host a...Read more

Tharimmune Announces Dosing of First Patient in Phase 1 Clinical Trial of TH104, its Lead Candidate for Pruritus in Primary Biliary Cholangitis

February 5
Last Trade: 0.37 -0.007 -1.85

Phase 1 clinical trial dosing of first patient complete; primary objective to assess safety/tolerability and absolute bioavailability of TH104 Phase 1 study expected to be completed in 1Q24 with topline readout in 2Q24 Company fully funded into 2025 with full readouts of Phase 1 and 2 in moderate-to-severe chronic pruritus in PBC expected in 4Q24/1Q25 BRIDGEWATER, NJ / ACCESSWIRE / February 5, 2024 / Tharimmune, Inc. (NASDAQ:THAR)...Read more

Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111)

February 5
Last Trade: 3.31 0.05 1.53

RT-111 achieved high bioavailability in humans  RT-111 was well-tolerated, with no serious adverse events  Celltrion has right of first negotiation to acquire worldwide rights to RT-111 following a Phase 1 clinical trial that meets its primary endpoints  Rani has now successfully completed three Phase 1 trials using RaniPill® technology  Company to host conference call today at 8:30 a.m. ET / 5:30 a.m....Read more

NeuroBo Pharmaceuticals Announces FDA Clearance of IND for a Phase 1 Clinical Trial of DA-1726 for the Treatment of Obesity

February 1
Last Trade: 5.30 -0.43 -7.50

Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024 CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic...Read more

Intellia Therapeutics Announces Publication of Positive Interim Phase 1 Data for NTLA-2002 in Patients with Hereditary Angioedema in the New England Journal of Medicine

January 31
Last Trade: 26.10 -1.08 -3.97

Data reinforce the potential of NTLA-2002 to eliminate angioedema attacks in people living with hereditary angioedema (HAE) after a single dose A single dose of NTLA-2002 led to 95% mean reduction in monthly HAE attack rate with 9 of 10 patients remaining completely attack free following the 16-week primary observation period through the latest follow-up reported NTLA-2002 was well-tolerated at all dose levels Second NEJM...Read more

Kura Oncology Reports Positive Preliminary Ziftomenib Combination Data in Acute Myeloid Leukemia

January 30
Last Trade: 20.25 0.66 3.37

No differentiation syndrome events reported  100% CR rate with 7+3 in newly diagnosed NPM1-m and KMT2A-r AML  56% CR/CRh with ven/aza in menin inhibitor naïve patients with R/R AML  80% of patients remain on trial as of data cutoff, including all NPM1-m patients  200 mg dose of ziftomenib cleared in ven/aza cohorts, enrollment at 400 mg dose ongoing  Management to host virtual investor event today at 8:00...Read more

Cellectar Biosciences Announces Enrollment of the First Patient in Pediatric High-Grade Gliomas Phase 1b Clinical Study

January 30
Last Trade: 3.34 -0.01 -0.30

FLORHAM PARK, N.J., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the first patient has been enrolled in its Phase 1b clinical trial evaluating iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, in pediatric patients with relapsed...Read more

Kodiak Sciences Announces Upcoming Presentation of First Time Results of KSI-501ABC Phase 1 Study at the Angiogenesis, Exudation, and Degeneration 2024 Virtual Meeting

January 30
Last Trade: 5.30 0.03 0.57

PALO ALTO, Calif., Jan. 30, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, announced today that first time results of the KSI-501ABC Phase 1 Study will be presented at the Angiogenesis, Exudation, and Degeneration 2024 virtual meeting. KSI-501ABC is the second product...Read more

Tharimmune Announces Initiation of Phase 1 Clinical Trial of TH104 and Provides Business Update

January 29
Last Trade: 0.37 -0.007 -1.85

Phase 1 trial initiated to assess safety/tolerability and absolute bioavailability of TH104 with topline data expected in 2Q24 Planning well underway for Phase 2 of TH104 in primary biliary cholangitis (PBC) patients suffering from moderate-to-severe chronic pruritus Company outlines near-clinical pipeline of novel antibody technology for multiple immuno-oncology targets and plans an R&D day in 2024 Company fully funded into 2025...Read more

Kiromic BioPharma Reports Favorable Early Efficacy Results from First Patient in Deltacel-01 Phase 1 Clinical Trial in Non-Small Cell Lung Cancer

January 29
Last Trade: 3.46 0.11 3.28

Stabilization of Disease Observed at Six Weeks, Therapy Continues to Be Well Tolerated HOUSTON / Jan 29, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable early efficacy results from the first patient enrolled in the Phase 1 Deltacel-01 clinical trial with Deltacel™ for treating stage 4 metastatic non-small cell lung cancer (NSCLC). Favorable preliminary evidence demonstrates...Read more

Gracell Biotechnologies Announces FDA Clearance of IND Application for Phase 1 Clinical Trial of FasTCAR-T GC012F as Early-Line Treatment of Multiple Myeloma

January 29

SAN DIEGO and SUZHOU, China and SHANGHAI, China, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) has cleared Gracell’s Investigational New Drug...Read more

Safety in Multiple-Ascending-Dose Healthy Subjects Clinical Trial Part Successfully Established for the NanoViricides Ultra-Broad-Spectrum Antiviral Drug NV-CoV-2 with No Adverse Events Found

January 29
Last Trade: 1.33 0.06 4.72

SHELTON, CT / ACCESSWIRE / January 29, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the healthy subjects part of the Phase 1a/1b Clinical Trial of NV-CoV-2 was completed successfully. No adverse events were reported in any of the multiple ascending dose cohorts, confirming the excellent...Read more

Alvotech Announces Positive Top-Line Results from a Pharmacokinetic Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva®

January 29
Last Trade: 16.03 0.46 2.95

The study, which assessed the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult subjects, met its primary endpoints Prolia® and Xgeva® (denosumab) are indicated for the treatment of bone disease REYKJAVIK, Iceland, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide,...Read more

Processa Pharmaceuticals Announces Successful Completion of Phase 1b Safety Evaluation of NGC-Cap in Patients with Advanced Cancer Resulting in Recommended Phase 2 Doses

January 25
Last Trade: 2.20 -0.06 -2.65

Next Generation Capecitabine (NGC-Cap) provides patients with 2-10 times greater exposure to its 5-FU cancer treatment metabolite than capecitabine administration NGC-Cap was better tolerated with positive preliminary efficacy results than FDA-approved capecitabine HANOVER, MD, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company...Read more

Corbus Pharmaceuticals: Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU

January 23
Last Trade: 25.75 0.30 1.18

NORWOOD, Mass., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), announced today that the abstract for the first-in-human Phase 1 dose escalation study of SYS6002 (CRB-701) has been released, and the corresponding up-to-date data will be presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The data referred to in the...Read more

Panbela Therapeutics Announces Publication of Clinical Data Titled: Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: A New Approaches to Neuroblastoma Therapy Trial

January 18
Last Trade: 1.12 0.01 0.90

MINNEAPOLIS, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs announces the publication of clinical data from studies of CPP-1X (also known as α-Difluoromethylornithine (DFMO) or Eflornithine) in neuroblastoma. According to Hogarty et al, children with relapsed refractory...Read more

Cardiff Oncology Announces Publication of Data from Phase 1b study in second-line KRAS-mutated mCRC in Clinical Cancer Research

January 17
Last Trade: 1.67 -0.02 -1.18

Findings from the Phase 1b portion of company's Phase 1b/2 study in second-line KRAS-mutated mCRC highlight the safety and promising efficacy of onvansertib in combination with standard-of-care These peer-reviewed published data are part of the Phase 1b/2 data Cardiff Oncology announced in August 2023 and informed the shift to investigation in first-line in RAS-mutated mCRC (CRDF-004) SAN DIEGO, Jan. 17, 2024 /PRNewswire/ --...Read more

Arcus Biosciences: Data from a Phase 1b Study of Quemliclustat-Based Regimens Showed Promising Overall Survival in Treatment-Naïve Metastatic Pancreatic Cancer

January 16
Last Trade: 19.53 -0.14 -0.71

Median Overall Survival was 15.7 months for all patients treated with 100 mg quemliclustat-based regimens in the ARC-8 study, which exceeds the historical benchmark data for chemotherapy alone A 37% reduction in risk of death and a 5.9-month improvement in median overall survival was observed for patients treated with quemliclustat-based regimens when compared to a Synthetic Control Arm® (SCA®) of patients treated with chemotherapy...Read more

VYNE Therapeutics Announces Positive Biomarker Data from Successful Phase 1b Trial of VYN201 for the Treatment of Vitiligo

January 10
Last Trade: 2.26 0.09 4.15

VYN201 demonstrated positive effect on key biomarkers relevant to vitiligo Data supports VYN201’s rapid onset of action and previously announced positive clinical results Program is on track for Phase 2b initiation in Q2 BRIDGEWATER, N.J., Jan. 10, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and...Read more

Bio-Path Holdings Announces Completion of First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients

January 10
Last Trade: 5.85 5.49 1,516.02

HOUSTON, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle...Read more

NGM Bio Announces New Clinical Data from Ongoing Trial of NGM707 in Advanced Solid Tumors and Outlines Evolved Strategy for Aldafermin and NGM120 to Focus on Rare Conditions with Significant Unmet Need

January 9
Last Trade: 1.91 0.00 0.00

Encouraging findings in heavily pretreated patients in multiple solid tumor indications, including MSS colorectal cancer (CRC), in ongoing Phase 1 Part 1b study evaluating NGM707, a dual ILT2/ILT4 antagonist antibody, in combination with KEYTRUDA® (pembrolizumab) Aldafermin, an engineered FGF19 analog, has been granted Orphan Drug Designation by the FDA for the treatment of primary sclerosing cholangitis (PSC), a rare liver...Read more

Nature Medicine Publishes Updated Preliminary Phase 1 Data From Elicio Therapeutic’s AMPLIFY-201 Phase 1 Solid Tumor Study of ELI-002

January 9
Last Trade: 4.10 0.09 2.24

Data showed ELI-002 administered as a monotherapy induced robust, polyfunctional and durable KRAS specific CD4+ and CD8+ T cell responses Tumor biomarker reduction was observed in 84% of patients correlating with a median relapse-free survival of 16.3 months Phase 2 trial of ELI-002 monotherapy in pancreatic ductal adenocarcinoma (“PDAC”) planned to initiate in early 2024 BOSTON, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Elicio...Read more

Biomea Fusion Announces Dosing of First Type 1 Diabetes Patient in Phase II Study (COVALENT-112) with BMF-219

January 8
Last Trade: 15.98 -0.16 -0.99

The clinical study, COVALENT-112, has initiated enrollment of adults living with type 1 diabetes in the US and Canada. Eligible patients include those who have been diagnosed with type 1 diabetes for up to 15 years. Data from the Phase II study are expected in 2024. REDWOOD CITY, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to...Read more

ORIC Pharmaceuticals Provides Initial Phase 1b Data for ORIC-944, Operational Highlights for 2023, and Anticipated Upcoming Milestones

January 8
Last Trade: 11.02 0.90 8.89

Initial Phase 1b monotherapy data for ORIC-944 in metastatic prostate cancer demonstrates potential best-in-class profile, including half-life >10 hours, robust target engagement and well tolerated safety profile, supporting advancement for combination development Initiation of combination study of ORIC-944 with AR inhibitor(s) in metastatic prostate cancer expected in first half of 2024 and program update expected in mid-2024...Read more

Biora Therapeutics Announces Initiation of Phase 1 Clinical Study of BT-600

January 8
Last Trade: 0.85 0.03 3.63

First-in-human trial of BT-600 drug-device combination, following multiple successful device-only human studies SAD/MAD study to evaluate safety and PK/PD of BT-600, including concentrations in colon tissue SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced initiation of its phase 1, first-in-human clinical study of...Read more

Fate Therapeutics Announces Initiation of Phase 1 Clinical Trial for FT825 / ONO-8250 in Patients with HER2-expressing Advanced Solid Tumors

January 8
Last Trade: 6.96 0.08 1.16

iPSC-derived CAR T-cell Product Candidate Incorporates Seven Synthetic Controls of Cell Function including a Novel HER2-targeted Antigen Binding Domain Phase 1 Study is Being Conducted in Collaboration with Ono Pharmaceutical SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell...Read more

Cybin Announces Positive Topline Data from Phase 1 Studies of Proprietary Deuterated DMT Molecules CYB004 and SPL028

January 8
Last Trade: 0.38 -0.02 -5.71

Intravenous (“IV”) CYB004 demonstrated robust and rapid-onset psychedelic effects at lower doses compared to native DMT, suggesting potential as a short-acting, scalable treatment  Intramuscular (“IM”) dosing of SPL028 produced robust, short-duration psychedelic effects in the majority of participants  Both IV and IM routes were safe and well-tolerated, with potential for IM administration to provide more convenient,...Read more

Xilio Therapeutics Highlights Recent Advances Across Clinical Pipeline and Encouraging Preliminary Phase 1 Safety Data for XTX301, a Tumor-Activated IL-12, Further Validating the Promise of Its Tumor-Activated Immuno-Oncology Therapies

January 8
Last Trade: 0.58 0.03 5.84

Dosing XTX301 at 45 ug/kg once every three weeks (dose level 3) in ongoing Phase 1 trial, nearly 100x the maximum tolerated dose of rhIL-12, with no dose-limiting toxicities observed to date Initiated patient dosing in Phase 1/2 trial for XTX101, a tumor-activated, Fc-enhanced anti-CTLA-4, in combination with atezolizumab Based on recently accelerated enrollment, now plan to report Phase 2 trial data for XTX202, a tumor-activated,...Read more

Tryp Therapeutics Announces Significant Milestone in Its Clinical Trial Program for Trp-8803 (IV-infused Psilocin)

January 8
Last Trade: 0.04 0.00 0.00

KELOWNA BC / ACCESSWIRE / January 8, 2024 / Tryp Therapeutics, Inc. ("Tryp" or the "Company") (CSE:TRYP)(OTCQB:TRYPF), a pioneering clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs,today announced a significant milestone in its clinical trial program for TRP-8803 (IV-infused psilocin). The Company has received approval...Read more

Vincerx Pharma Announces Compelling Clinical Efficacy of Enitociclib in Combination with Venetoclax and Prednisone in Lymphoma

January 7
Last Trade: 3.58 -0.25 -6.53

Investigators from the National Institutes of Health (NIH) report 2 partial responses (PR) in 3 peripheral T-cell lymphoma (PTCL) patients and 1 PR in 2 double-hit diffuse large b-cell lymphoma (DH-DLBCL) patients in ongoing dose-escalation trial of enitociclib in combination with venetoclax and prednisone Vincerx remains on target to report early clinical data from lead VersAptx™ platform compounds, VIP236 (early 2024) and VIP943 (mid...Read more

Kiromic BioPharma Reports Favorable Early Safety and Tolerability Data from First Patient Enrolled in the Phase 1 Deltacel-01 Clinical Trial

January 5
Last Trade: 3.46 0.11 3.28

Company Executives Available to Meet with Investment Professionals January 8-10 in San Francisco HOUSTON / Jan 05, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reports favorable safety and...Read more

Silo Pharma Successfully Completes First Phase of Dose-Ranging Study of SPC-15 an Intranasal Treatment for PTSD

January 4
Last Trade: 1.57 0.04 2.61

Final validation report expected in first quarter 2024 ENGLEWOOD CLIFFS, NJ, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or “the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today provided an update on its previously announced dose-ranging study of SPC-15, a targeted prophylactic treatment for post-traumatic stress...Read more

First Patient Dosed in Trial Evaluating Efti and the Anti-PD-L1 Therapy BAVENCIO® in Metastatic Urothelial Cancer

January 4
Last Trade: 2.24 -0.04 -1.75

SYDNEY, AUSTRALIA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will...Read more

InflaRx Announces Positive Topline Results from the Multiple Ascending Dose (MAD) Phase I Study with C5aR Inhibitor INF904

January 4
Last Trade: 1.51 0.04 2.72

MAD pharmacokinetic and pharmacodynamic data support best-in-class potential of INF904 over tested dose range of 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days: Achieved ≥90% blockade of C5a-induced neutrophil activation over 14-day dosing period Achieved favorable concentration-time profiles with target exposures of therapeutic potential Well tolerated with no safety signals of concern over entire dose...Read more

GlycoMimetics Announces Positive Initial Safety and Pharmacokinetic Results from Phase 1a Healthy Volunteer Study of GMI-1687

January 4
Last Trade: 2.90 -0.03 -1.02

First in human trial evaluating highly potent E-selectin antagonist, GMI-1687, met its primary and secondary endpoints with no dose-limiting toxicities or safety signals Single ascending dose study confirmed that subcutaneous dosing generated linear pharmacokinetics and achieved target plasma concentrations across all dosing levels GMI-1687 is being developed as a potential patient-controlled point-of-care treatment for inflammatory...Read more

Keros Therapeutics to Develop KER-065 for the Treatment of Obesity

January 3
Last Trade: 63.61 2.62 4.30

Keros commenced a randomized, double-blind, placebo-controlled, two-part Phase 1 clinical trial to evaluate single and multiple ascending doses of KER-065 in healthy volunteers Keros expects to report initial data from this Phase 1 clinical trial in the first quarter of 2025 Preclinical data showed potential proof-of-mechanism of KER-065 for the treatment of obesity Keros believes these preclinical data support developing KER-065...Read more

Regulus Therapeutics Announces Completion of Enrollment in Third Cohort of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD)

January 2
Last Trade: 1.46 -0.07 -4.58

SAN DIEGO, Jan. 2, 2024 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced it has completed enrollment in the third cohort of patients in the Phase 1b MAD study of RGLS8429 for the treatment of ADPKD. "The completion of our third and final randomized...Read more

atai Life Sciences Announces Positive Topline Results from Single Ascending Dose Phase 1 Study with EMP-01 (R-MDMA)

January 2
Last Trade: 1.83 0.00 0.00

EMP-01 (R-MDMA) was generally well-tolerated and treatment-related adverse events (AEs) were as expected The PK profile of EMP-01 was dose-proportional, and a range of exploratory pharmacodynamic (PD) measures, including subjective reports and blood-based biomarkers, showed dose-dependent changes EMP-01 administration resulted in a differentiated subjective experience compared to racemic MDMA, a result that is likely to have...Read more

SELLAS Life Sciences Reports Positive Follow-Up Immune Response and Survival Data in Completed Phase 1 Study of Galinpepimut-S Combined with Opdivo® in Advanced Malignant Pleural Mesothelioma

December 27
Last Trade: 0.94 0.05 5.79

Primary Endpoint of Safety and Efficacy Met with Clinical Activity and Increased Survival Observed 70.3 Weeks Median Overall Survival for Patients Treated with Combination Therapy; Median Overall Survival in Relapsed/Refractory Patients Treated with Standard of Care is Approximately 28 Weeks Median Overall Survival of Patients without GPS Immune Response was 9.0 Months vs. 27.8 Months for Patients with GPS-Specific Immune...Read more

Beyond Cancer Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors

December 27
Last Trade: 1.75 -0.11 -5.91

No dose limiting toxicities were reported in the first cohort of ultra-high concentration of nitric oxide administered at 25,000 parts per million (PPM) Phase 1 study continues to recruit eligible patients in the next protocol defined cohort of 50,000 ppm in multiple centers in Israel HAMILTON, Bermuda, Dec. 27, 2023 (GLOBE NEWSWIRE) --  Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) and a clinical...Read more

Tyra Biosciences Doses First Patient with TYRA-200 and Provides Positive Updates on TYRA-300

December 22
Last Trade: 19.27 0.40 2.12

Initiated SURF201 Phase 1 Study; dosed first patient with TYRA-200 Cleared multiple dose cohorts in SURF301 and continues to dose escalate with TYRA-300 Received FDA feedback on TYRA-300 Phase 2 ACH study: IND submission planned for 2H 2024 CARLSBAD, Calif., Dec. 22, 2023 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that...Read more

Vaxart Announces Last Subject Dosed in Phase 1 Trial of Its Norovirus Vaccine Candidate in Lactating Mothers

December 21
Last Trade: 1.27 -0.13 -9.29

On track to report topline data by the end of 2024 SOUTH SAN FRANCISCO, Calif., Dec. 21, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has completed enrollment and dosing in the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate focused on lactating mothers. “This is an important step forward as we drive toward a vaccine candidate that may make it possible for...Read more

BioLineRx Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating Motixafortide for CD34+ Hematopoietic Stem Cell Mobilization for Gene Therapies in Sickle Cell Disease

December 21
Last Trade: 1.18 -0.06 -4.84

Proof-of-concept study is initial step toward goal of identifying more efficient CD34+ HSC mobilization regimen for patients with sickle cell disease choosing gene therapy  TEL AVIV, Israel, Dec. 21, 2023 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that the first patient has been...Read more

Annexon Reports Phase 1 Results for ANX1502, its Oral Small Molecule Inhibitor of the Classical Complement Pathway

December 20
Last Trade: 5.25 0.25 5.00

Target Levels of Active Drug Achieved in Healthy Volunteers with Oral Twice-Daily Dosing; Supportive Impact on Pharmacodynamic Biomarker of Complement Activity ANX1502 Generally Well Tolerated Across Cohorts with No Serious Adverse Events Tablet Formulation of ANX1502 Expected to Advance into Proof-of-Concept Study in Patients with Cold Agglutinin Disease (CAD) in 2024 BRISBANE, Calif., Dec. 20, 2023 (GLOBE NEWSWIRE) --...Read more

Rallybio Announces Preliminary Phase 1 Multiple Ascending Dose Data for RLYB116, an Innovative Subcutaneously Injected Inhibitor of Complement Component 5

December 20
Last Trade: 1.70 -0.13 -7.10

100 mg Results Demonstrated a Mean Reduction of Greater than 93% in Free C5 with Low Volume Once-a-Week Subcutaneous Dosing  Data Supports the Study of RLYB116 as a Differentiated Therapeutic for the Treatment of Generalized Myasthenia Gravis  Company Announces Extension of Runway to 3Q 2025 As Part of Portfolio Prioritization  Conference Call and Webcast Today at 8:30 AM Eastern Time  NEW HAVEN, Conn. / Dec 20,...Read more

Daré Bioscience Announces Positive Topline Pharmacokinetic and Exploratory Efficacy Results from the DARE-PDM1 Phase 1 Clinical Study

December 20
Last Trade: 0.54 0.10 21.64

SAN DIEGO, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1. DARE-PDM1 is an investigational product designed to deliver diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), vaginally via the company’s proprietary hydrogel to...Read more

Processa Pharmaceuticals Provides Interim Analysis from Ongoing Phase 1b Trial of Next Generation Capecitabine Showing Improved Safety Over Capecitabine

December 19
Last Trade: 2.20 -0.06 -2.65

FDA acknowledges that NGC-Cap is a New Chemical Entity given the changes to metabolism and distribution of its major metabolite 5-FU Interim analysis of the NGC-Cap Phase 1b data shows improved safety, even with 5-FU exposure much greater than that from capecitabine Company to conduct Fireside Chat at 4:30PM ET on December 20, 2023 HANOVER, MD, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA)...Read more

Cyclacel Pharmaceuticals Reports Fadraciclib Phase 1 Data Suggesting Efficacy Against Tumors With CDKN2A, CDKN2B and MTAP Deletions

December 18
Last Trade: 2.65 0.02 0.76

Patient Pharmacodynamic Data Show Decrease in CDKN2A, CDKN2B, and PRMT5 Protein Levels  A Squamous Non-Small Cell Lung Cancer Patient with CDKN2B Deletion Achieved Marked Tumor Shrinkage after One Cycle  Retrospective Analysis Identified CDKN2A, CDKN2B and/or MTAP Deletions in Four Patients Previously Dosed with Fadra Achieving Responses or Stable Disease  Forthcoming Phase 2 Study to Further Evaluate Fadra...Read more

PepGen Announces First Patient Dosed in Phase 1 FREEDOM-DM1 Clinical Trial of PGN-EDODM1 for Myotonic Dystrophy Type 1 (DM1)

December 18
Last Trade: 13.88 -0.07 -0.50

Safety, transcript splicing correction and clinical outcome measures data at 5 mg/kg PGN-EDODM1 dose level in patients from FREEDOM-DM1 clinical trial expected in 2024 Clearance of Clinical Trial Application (CTA) by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) extends enrollment in FREEDOM-DM1 Phase 1 clinical trial to third country  BOSTON, Dec. 18, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a...Read more

Viridian Therapeutics Announces Positive Clinical Data in Healthy Volunteer Study and Selects VRDN-003 as Potential Best-in-Class Subcutaneous anti-IGF-1R Program with Extended Half-Life for Pivotal Development in Thyroid Eye Disease

December 18
Last Trade: 18.77 0.78 4.34

VRDN-003 clinical data exceeded expectations with extended half-life of 40-50 days, 4-5x longer than VRDN-001, supporting a potential best-in-class, low-volume, less frequent, self-administered subcutaneous therapy for thyroid eye disease (TED)  Data support VRDN-003 dosing as infrequently as once every eight weeks and is expected to reach exposure levels associated with robust clinical response in earlier trials of VRDN-001 in TED...Read more

Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis

December 18
Last Trade: 1.79 0.04 2.29

LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC is a next-generation lanthanum-based phosphate...Read more

Cullinan Oncology Announces First Patient Dosed in Phase 1 Trial Evaluating CLN-617, a Novel Fusion Protein Uniquely Harnessing Both IL-2 and IL-12 Cytokines

December 14
Last Trade: 18.00 0.46 2.62

CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic, targeted oncology therapies, today announced that the first patient has been dosed with CLN-617 in a Phase 1 clinical trial. This is a first-in-human, multi-center, open label study designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy...Read more

Kiromic BioPharma Announces First Patient Dosed in Phase 1 Study Evaluating Deltacel™ for the Treatment of Non-Small Cell Lung Cancer

December 14
Last Trade: 3.46 0.11 3.28

Initial Tolerability and Safety Data from First Patient Expected by Year-End, with Preliminary Efficacy Results by End of January 2024 HOUSTON / Dec 14, 2023 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”), a clinical-stage, fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on...Read more

Schrödinger Highlights Progress of Clinical Programs and Discloses Three New Programs at First Therapeutics Pipeline Investor Event

December 14
Last Trade: 30.48 0.45 1.50

Reports data showing SGR-1505 is well-tolerated and achieves target engagement in Phase 1 healthy volunteer study Highlights expanding portfolio including newly-disclosed EGFRC797S, PRMT5-MTA and NLRP3 programs Outlines broad discovery and development efforts targeting synthetic lethality and DNA-damage repair mechanisms, including PRMT5-MTA, SGR-3515 and SGR-2921 programs NEW YORK / Dec 14, 2023 / Business Wire / Schrödinger...Read more

Bio-Path Successfully Completes First Dose Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia

December 14
Last Trade: 5.85 5.49 1,516.02

HOUSTON, Dec. 14, 2023 (GLOBE NEWSWIRE) -- Biosystem., (NASDAQ: BPTH) a biotechnology company leveraging its proprietary DNAbilize® antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid...Read more

BioAtla Hosting Virtual R&D Day to Highlight BA3071 CAB-CTLA-4 Phase 1 Data in Multiple Solid Tumor Types

December 13
Last Trade: 2.48 0.12 5.08

Multiple confirmed responses and durable disease control observed Emerging differentiated safety profile enables further exploration at higher doses Ongoing Phase 2 clinical study of monotherapy and in combination with a PD-1 inhibitor SAN DIEGO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody...Read more

Black Diamond Therapeutics Announces Topline Results from Phase 1 Dose Escalation Trial of BDTX-1535 in Patients with Recurrent GBM

December 13
Last Trade: 4.70 0.21 4.68

Initial results show promising clinical activity in heavily pretreated patients 22 patients evaluable for efficacy: 3 patients on therapy longer than 10 months, 1 patient longer than 6 months, and 5 patients longer than 4 months 19 patients with measurable disease by RANO criteria: 1 patient with confirmed partial response and 8 patients with stable disease BDTX-1535 generally well tolerated, consistent with prior disclosures and no...Read more

Shattuck Labs Announces Positive Initial Topline Data from Ongoing Phase 1 A/B Dose Expansion Clinical Trial of SL-172154 with Azacitidine in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML)...

December 13
Last Trade: 9.25 0.33 3.70

Observed 79% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations; initial complete response (CR)/marrow complete response (mCR) rate of 64%  Observed 27% initial CR/complete response with incomplete hematologic recovery (CRi) in frontline TP53m AML patients, and 5/11 evaluable patients achieved stable disease with decreasing blast counts and peripheral blood count improvement, these...Read more

C4 Therapeutics Announces Positive Data from CFT7455 Phase 1 Trial in Relapsed/Refractory Multiple Myeloma

December 12
Last Trade: 8.99 0.19 2.16

Data Support 14 Days On/14 Days Off as Optimal Dosing Schedule; CFT7455 is Well Tolerated with Promising Signs of Anti-Myeloma Activity Completed Monotherapy Dose Escalation Demonstrates Anti-Myeloma Activity and Immunomodulatory Effects to Support CFT7455 in Combination with Novel Multiple Myeloma Agents and as a Monotherapy Maintenance Option CFT7455 in Combination with Dexamethasone Results in IMWG Responses at the First Two Dose...Read more

Bristol-Myers Squibb: Two Early Studies Evaluating Potential First-in-Class CELMoD™ Agent Golcadomide for the Treatment of Non-Hodgkin Lymphomas Presented at ASH 2023

December 11
Last Trade: 51.66 0.33 0.64

Phase 1b DLBCL-001 study reinforces promising activity and combinability of golcadomide with R-CHOP in patients with previously untreated aggressive B-cell lymphoma Phase 1/2 CC-99282-NHL-001 study demonstrates activity and combinability with rituximab in heavily pretreated patients with diffuse large B-cell lymphoma PRINCETON, N.J. / Dec 11, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) announced the results of two early...Read more

Bristol Myers Squibb Announces Data at ASH 2023 from Diverse Multiple Myeloma Pipeline, Underscoring Range of Tailored Treatment Approaches to Address Unique Patient Needs

December 11
Last Trade: 51.66 0.33 0.64

Updated results highlight the range of differentiated research platforms across BMS’ multiple myeloma pipeline, including cell therapy and protein degradation Data will be presented for first-in-class GPRC5D CAR T BMS-986393, novel CELMoD™ agent mezigdomide, and unique 2+1 bispecific T cell engager alnuctamab PRINCETON, N.J. / Dec 11, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced updated results from three...Read more

IN8bio Announces Positive Clinical Update Demonstrating Continued Durable Complete Remission in 100% of Evaluable Patients in Phase 1 Trial of INB-100 in Leukemia

December 11
Last Trade: 0.95 -0.06 -5.64

Durable complete remission (CR) achieved in 100% of treated patients, including high-risk and relapsed acute myeloid leukemia (AML) patients and those who had failed multiple prior lines of therapy, including CAR-T. All trial participants remain alive and relapse free as of last assessment, and six patients have been relapse free for over one year. New data shows long-term in-vivo expansion and persistence of allogeneic gamma-delta T...Read more

Gracell Biotechnologies Presents Updated Clinical Data from FasTCAR-T GC012F Demonstrating Deep and Durable Responses in Newly Diagnosed Multiple Myeloma at ASH 2023

December 11

Minimal residual disease negativity (MRD-) observed in all treated patients in the ongoing study, with 95% (21/22) achieving stringent complete response (sCR) through a median follow-up of 18.8 months GC012F is a FasTCAR-enabled B-cell maturation antigen (BCMA) and CD19 dual-targeting autologous CAR-T therapy being evaluated for hematologic malignancies and autoimmune disease SAN DIEGO and SUZHOU, China and SHANGHAI, China, Dec. 11,...Read more

Harpoon Therapeutics Presents HPN217 Phase 1 Clinical Data in Relapsed/Refractory Multiple Myeloma (RRMM) at ASH 2023 and Announces Selection of Recommended Phase 2 Dose (RP2D)

December 11
Last Trade: 22.93 -0.03 -0.13

HPN217 was well tolerated and demonstrated robust and durable clinical activity at doses ranging from 2.15 to 24 mg in heavily pre-treated patients, including patients with prior exposure to BCMA-targeted therapy At the 12 mg dose, cohorts demonstrated favorable activity and safety profile:- 63% ORR; with 53% VGPR or better- CRS reported in 16% of patients, no Grade 3 events, no ICANS Findings support further clinical...Read more

ORIC Pharmaceuticals: Initial Phase 1 Dose Escalation Data for ORIC-533 in Relapsed/Refractory Multiple Myeloma Demonstrates Clinical Activity and Strong Safety Profile Supporting Potential for Combination Development

December 11
Last Trade: 11.02 0.90 8.89

Preliminary evidence of clinical antimyeloma activity, including reduction in paraprotein, demonstrated in multiple patients Clean safety profile with only Grade 1 and 2 treatment related adverse events and no dose limiting toxicities or dose reductions Clinical activity, safety profile, and dose-dependent increases in immune cell activation support potential for combination studies with other multiple myeloma agents, including BCMA-...Read more

Nurix Therapeutics Presents Positive Clinical Data from Its Novel Bruton’s Tyrosine Kinase (BTK) Degrader Programs, NX-5948 and NX-2127, at the 65th American Society of Hematology (ASH) Annual Meeting

December 11
Last Trade: 10.20 -0.35 -3.32

Positive preliminary efficacy data with a favorable safety profile support plans to develop NX-5948 broadly in chronic lymphocytic leukemia (CLL) Rapid durable complete responses in a heavily pretreated relapsed/refractory patient population support continued development of NX-2127 in non-Hodgkin lymphoma (NHL) Nurix will webcast a Key Opinion Leader (KOL) event at 8:30 p.m. PT today to review data presented at the ASH meeting from...Read more

MEI Pharma Reports Clinical Data on Oral CDK9 Inhibitor Voruciclib at ASH2023

December 11
Last Trade: 4.31 0.10 2.38

Safety Profile Observed to Date as Monotherapy and in Combination with Venetoclax Suggests no Overlapping Toxicity Initial Results from Correlative Studies Demonstrate On-target Reductions in Mcl-1 and RNA Pol II p-S2 SAN DIEGO / Dec 11, 2023 / Business Wire / MEI Pharma, Inc. (Nasdaq: MEIP), a clinical-stage pharmaceutical company evaluating novel drug candidates to address known resistance mechanisms to standard-of-care cancer...Read more

Tharimmune Announces Positive Topline Data with TH104, its Lead Candidate for Moderate-to-Severe Pruritus in Chronic Liver Disease Patients

December 11
Last Trade: 0.37 -0.007 -1.85

Phase 1 ex-US trial in chronic liver disease patients in an open-label study showed a 33.3% decrease in 24-hour mean itching intensity score after a single dose TH104 was well tolerated with no unexpected treatment-emergent adverse events comparable to previous phase 1 studies Company funded into early 2025 and expects bridging PK data in the US and Phase 2a results for chronic pruritus in primary biliary cholangitis (PBC) in...Read more

Syndax Pharmaceuticals Announces Positive Data for Revumenib in Patients with Acute Leukemias from the BEAT AML, SAVE AML and AUGMENT-102 Phase 1 Combination Trials

December 11
Last Trade: 23.13 0.42 1.85

Data collectively highlight revumenib's combination potential with current standard of care agents and support advancement into pivotal combination trials in the frontline setting  100% CRc observed in BEAT AML trial exploring revumenib in combination with venetoclax/azacitidine in newly diagnosed mNPM1 or KMT2Ar AML  78% CRc observed in SAVE AML trial, an all-oral combination of revumenib, venetoclax and...Read more

Marker Therapeutics Announces Sustained Complete Response in First Lymphoma Patient Treated with MT-601 following CAR T Relapse

December 11
Last Trade: 3.94 -0.0099 -0.25

HOUSTON, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today reported a clinical update on the APOLLO study. The Phase 1 APOLLO study is investigating MT-601, a multi-tumor associated antigen (multiTAA)-specific T cell...Read more

Defence Therapeutics Receives FDA Approval for Phase I Clinical Trial Targeting Solid Cancer Tumors with AccuTOX(R)

December 11
Last Trade: 1.90 -0.07 -3.55

Vancouver, British Columbia--(Newsfile Corp. - December 11, 2023) - Defence Therapeutics Inc. (CSE: DTC) (OTC Pink: DTCFF) (FSE: DTC) ("Defence" or the "Company"), one of the leading Canadian biotechnology companies working in the field of immune-oncology is pleased to announce that the U.S. FDA has cleared today "Study May Proceed" its Investigational New Drug (IND) application for a Phase I clinical trial of ACCUM-002TM Dimer CDCA-SV40...Read more

Poseida Therapeutics Presents Positive Early Results from its Phase 1 Trial of Allogeneic CAR-T P-BCMA-ALLO1 in Relapsed-Refractory Multiple Myeloma at the 65th American Society of Hematology (ASH) Annual Meeting

December 10
Last Trade: 3.25 0.03 0.93

82% ORR and deep clinical responses from off-the-shelf, allogeneic BCMA-targeted CAR-T in heavily pretreated patients receiving adequate lymphodepletion 100% ORR in these patients who were not previously treated with a BCMA-targeted bispecific T cell-engaging antibody Favorable emerging safety and reliability profile, with all (100%) intent-to-treat (ITT) patients receiving therapy, no GvHD or dose-limiting toxicities and low...Read more

Jasper Therapeutics Presents Positive Final Results from Phase 1 Study of Briquilimab in Patients with AML or MDS Undergoing Hematopoietic Cell Transplant in Oral Presentation at ASH 2023

December 10
Last Trade: 20.24 0.84 4.33

REDWOOD CITY, Calif., Dec. 10, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on the development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell...Read more

Corvus Pharmaceuticals Presents New Interim Soquelitinib Data from its Phase 1/1b T Cell Lymphoma Trial

December 9
Last Trade: 2.35 0.04 1.73

Anti-tumor activity and durability of responses data support advancement of soquelitinib (formerly known as CPI-818) into Phase 3 registrational clinical trial and its potential to address the need for new treatments for peripheral T cell lymphoma (PTCL) Results confirmed patient eligibility requirements and endpoints planned for soquelitinib Phase 3 clinical trial in PTCL BURLINGAME, Calif., Dec. 09, 2023 (GLOBE NEWSWIRE) --...Read more

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Immix Biopharma

Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...