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Latest Phase 1 Clinical Trials Stock News

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Kiromic BioPharma Provides Updates on its Deltacel-01 Clinical Trial

June 20
Last Trade: 2.51 -0.09 -3.46

Follow-up Findings Show Stable Disease FDA and IRB Approve IND for a Single-Use, Single-Patient Treatment with Deltacel Fast Track Designation Request Submitted to FDA Complete Enrollment in Trial’s Second Cohort Expected in July HOUSTON / Jun 20, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports follow-up results from the second, third and fourth patients enrolled in its Deltacel-01...Read more


Oncolytics Biotech Doses First Patient in Study of Pelareorep/FOLFIRINOX Combination Therapy in Pancreatic Cancer

June 20
Last Trade: 1.00 0.0045 0.45

Demonstrating pelareorep's synergy with modified FOLFIRINOX +/- atezolizumab in pancreatic cancer could expand the number of patients it may benefit Funding for the study comes from the US$5 million Therapeutic Accelerator Award from PanCAN SAN DIEGO, and CALGARY, AB, June 20, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapeutics for oncology,...Read more


Neumora Therapeutics Announces Initiation of Phase 1b Study of NMRA-511 for Treatment of Alzheimer’s Disease Agitation

June 20
Last Trade: 9.04 0.19 2.15

NMRA-511 is a highly potent and selective, best-in-class, antagonist of the vasopressin 1a receptor, which is known to play a role in regulation of aggression, stress and anxiety response NMRA-511 was generally well-tolerated at all dose levels in Phase 1 single ascending dose / multiple ascending dose study, with no serious adverse events reported to date Alzheimer’s disease agitation is associated with increased morbidity and...Read more


Assembly Biosciences Doses First Participant in Phase 1b Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 for the Treatment of Chronic Hepatitis B Virus Infection

June 18
Last Trade: 15.51 0.21 1.37

SOUTH SAN FRANCISCO, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV) infection. Chronic...Read more


Spyre Therapeutics Announces First Participants Dosed in Phase 1 Trial of SPY001, its Novel Half-life Extended anti-α4β7 Antibody, for the Treatment of Inflammatory Bowel Disease

June 18
Last Trade: 25.10 -0.54 -2.11

Preclinical data for SPY001 demonstrate the potential for improved dosing over standard of care, including the potential for dosing every eight or twelve weeks compared to dosing every two weeks for subcutaneous vedolizumab Interim subcutaneous pharmacokinetic and safety data from healthy volunteers anticipated by year-end 2024 SPY002, an extended half-life anti-TL1A antibody designed for enhanced potency to both TL1A monomers and...Read more


Aprea Therapeutics Announces First Patient Dosed in ACESOT-1051 Phase 1 Trial Evaluating Oral WEE1 Inhibitor APR-1051

June 17
Last Trade: 4.03 -0.04 -0.98

APR-1051 is a highly selective and potentially best-in-class oral WEE1 inhibitor Phase 1 ACESOT-1051 clinical trial is evaluating APR-1051 as monotherapy treatment in patients with significant unmet medical need Dosing of the first patient in the ACESOT-1051 study represents a key advancement in Aprea’s clinical pipeline DOYLESTOWN, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”,...Read more


Cytokinetics Announces Initiation of Phase 1 Study of Aficamten in Healthy Japanese Participants

June 17
Last Trade: 52.90 1.08 2.08

SOUTH SAN FRANCISCO, Calif., June 17, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 study evaluating the pharmacokinetics, safety and tolerability of aficamten in healthy Japanese and Caucasian participants. “We are conducting this Phase 1 bridging study to characterize the pharmacokinetics of aficamten in healthy Japanese adults and to...Read more


Kymera Therapeutics Presents New Clinical Data from the Ongoing Phase 1 Trial of STAT3 Degrader KT-333 at EHA Annual Meeting

June 14
Last Trade: 31.91 0.64 2.05

KT-333 demonstrated initial clinical proof of concept across multiple hematological malignancies, including complete responses in two patients with Hodgkin’s lymphoma Robust STAT3 knockdown and positive immunomodulatory effect achieved in blood and tumor KT-333 was well-tolerated with Phase 1 dose escalation ongoing and additional data expected in the second half of 2024 WATERTOWN, Mass., June 14, 2024 (GLOBE NEWSWIRE) -- Kymera...Read more


Shattuck Labs Announces Updated Positive Interim Data from Phase 1B Dose Expansion Clinical Trial of SL-172154 in Combination with Azacitidine (AZA) in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia...

June 14
Last Trade: 4.42 0.26 6.12

Observed 67% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations; initial complete remission (CR)/marrow complete remission (mCR) rate of 58% and median overall survival had not yet been reached Observed 43% ORR in frontline TP53m AML patients, 33% CR/complete remission with incomplete hematologic recovery (CRi) and median overall survival had not yet been reached SL-172154 demonstrated a...Read more


Revelation Biosciences Has Completed Dosing of its First in Human Phase 1 Clinical Study of Gemini

June 13
Last Trade: 2.26 0.11 5.12

Top-line data forthcoming SAN DIEGO / Jun 13, 2024 / Business Wire / Revelation Biosciences, Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on harnessing the power of trained immunity for the prevention and treatment of disease, announced today that it has completed enrollment and dosing of its first in human Phase 1 clinical study (RVL-HV02). The study, which was conducted...Read more


VYNE Therapeutics Announces Dosing of First Participants in Phase 1a Trial of Novel BD2-Selective BET Inhibitor VYN202

June 13
Last Trade: 1.78 0.04 2.29

VYN202 has been designed to achieve class-leading potency and BD2-selectivity Trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of VYN202 in healthy volunteers; top-line data expected in 2H’24 BRIDGEWATER, N.J., June 13, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and...Read more


Pasithea Therapeutics Announces Completion of Enrollment and Initial Dosing of Cohort 2 following Positive Safety Review Committee (SRC) Recommendation for PAS-004 in Ongoing Phase 1 Clinical Trial

June 13
Last Trade: 4.88 -0.02 -0.41

MIAMI, June 13, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other indications, announced today that an independent Safety Review Committee (SRC) has completed its safety review of data from the first dose cohort (2mg) treated...Read more


Processa Pharmaceuticals Announces Positive Efficacy Results from Preliminary Evaluation of Phase 1b Dose-escalating Trial with NGC-Cap in Gastrointestinal Cancer

June 11
Last Trade: 1.83 0.01 0.75

Eight of 12 evaluable patients (66.7%) had progression-free survival (PFS) ranging from 5 to 11 months At the highest NGC-Cap dose, all three evaluable patients had PFS with two partial responses (PR) and one stable disease (SD) For all NGC-Cap doses, 5-Fluorouracil (5-FU) exposure was greater and fluoro-beta-alanine (FBAL) exposure was lower with a better or similar side-effect profile than monotherapy capecitabine HANOVER,...Read more


Athira Pharma Completes First Cohort in Phase 1 Clinical Trial of ATH-1105, an Oral, Small Molecule Drug Candidate for Amyotrophic Lateral Sclerosis (ALS)

June 11
Last Trade: 2.20 -0.09 -3.93

BOTHELL, Wash., June 11, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that it has completed the first cohort of healthy volunteers in its ongoing, first-in-human, dose escalation Phase 1 clinical study evaluating ATH-1105, an oral, small molecule positive modulator of...Read more


Assembly Biosciences Doses First Participant in Phase 1a/b Clinical Trial of Herpes Simplex Virus Helicase-Primase Inhibitor Candidate ABI-5366

June 10
Last Trade: 15.51 0.21 1.37

Phase 1a study portion of single ascending dosing in healthy participants will inform the development of ABI-5366 with interim data expected in Q3 2024  Phase 1b study portion of multiple ascending weekly doses in participants with recurrent genital herpes on track to initiate by end of year with interim data expected in 1H 2025  SOUTH SAN FRANCISCO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc....Read more


Arcturus Therapeutics Presents New Clinical Data at 47th Annual European Cystic Fibrosis Conference

June 7
Last Trade: 27.06 0.47 1.77

ARCT-032 is safe and well tolerated with no serious adverse events (SAEs) in 36 study participants, including 4 adults with cystic fibrosis (CF) Phase 1b interim data includes a CF participant with Class 1 mutations and three participants with F508del mutations being treated with Trikafta® Early trend of improved lung function with an average absolute response of +4.0% (ranging up to +9%) and relative change of +5.8% FEV1 on Day 8,...Read more


HUTCHMED Initiates Phase I Trial of Menin Inhibitor HMPL-506 in Patients with Hematological Malignancies in China

June 6
Last Trade: 17.86 0.60 3.48

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated Phase I clinical trial of its menin inhibitor HMPL-506 in patients with hematological malignancies in China. The first patient received their first dose on May 31, 2024. This is a Phase I, multicenter, open-label clinical study to evaluate the safety,...Read more


Kiromic BioPharma Reports Six-Month Results from First Patient Enrolled in Deltacel-01 Clinical Trial

June 6
Last Trade: 2.51 -0.09 -3.46

Favorable Follow-up Findings Include Stable Disease and a 13% Decrease in Tumor Size HOUSTON / Jun 06, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable six-month follow-up results from the first patient enrolled in the Deltacel-01 Phase 1 clinical trial. This trial is evaluating Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in...Read more


Replimune Announces Positive Topline Primary Analysis Data by Independent Central Review from IGNYTE Clinical Trial of RP1 plus Nivolumab in Anti-PD1 Failed Melanoma

June 6
Last Trade: 8.63 0.76 9.66

Primary endpoint data shows 12-month overall response rate (ORR) of 33.6% Biologics license application (BLA) submission intended for 2H 2024; first patient expected to be enrolled in IGNYTE-3 confirmatory trial in Q3 2024 Company to host conference call and webcast today at 8:00 a.m. ET WOBURN, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the...Read more


First Participants Vaccinated in IMUNON’s IMNN-101 Phase 1 Clinical Trial

June 5
Last Trade: 1.08 0.02 1.77

DNA vaccine proof-of-concept study expected to demonstrate an “mRNA better” platform LAWRENCEVILLE, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, announces that the first participants have been treated in the IMNN-101 Phase 1 clinical trial....Read more


Surrozen Initiates Dosing of First Patient in Phase 1b Clinical Trial of SZN-043 for Severe Alcohol-Associated Hepatitis

June 4
Last Trade: 9.91 -0.13 -1.29

SZN-043 is a novel hepatocyte-specific R-spondin mimetic bispecific fusion protein targeting ASGR1 Anticipate potential proof-of-concept data available in the first half of 2025 SOUTH SAN FRANSCISO, Calif., June 04, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt pathway for tissue repair and regeneration, today...Read more


TuHURA Biosciences and Kintara Therapeutics Announce Positive Results from Phase 1b Trial of IFx-2.0, a Novel Personalized Cancer Vaccine, in Checkpoint Inhibitor Resistant Advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC)...

June 3
Last Trade: 0.27 -0.0008 -0.29

TuHURA's lead candidate, IFx-2.0, was safe and well tolerated at once weekly dosing for 3 weeks Eighty percent (80%) of ICI naïve patients with advanced MCC who failed to respond to pembrolizumab or avelumab therapy achieved a durable Complete Response (CR), pathologic CR or Partial Response (PR) following IFx-2.0 therapy and rechallenge with an anti-PD(L)-1 checkpoint inhibitor Data presented at the 2024 American Society of Clinical...Read more


Indaptus Therapeutics Announces New Positive Data from Ongoing Phase 1 Trial of Decoy20

June 3
Last Trade: 2.24 -0.08 -3.45

Latest data from first and second cohorts support Company’s 'pulse-prime' approach, demonstrating rapid clearance, broad immune activation, and encouraging safety profile Poster Presented at American Society of Clinical Oncology Annual Meeting NEW YORK, June 03, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection...Read more


ALX Oncology Presents First Evorpacept Combination Data with an Antibody-Drug Conjugate from Phase 1 ASPEN-07 Clinical Trial in Patients with Advanced Bladder Cancer

June 2
Last Trade: 6.72 -0.16 -2.33

Evorpacept in combination with PADCEV®, an approved antibody-drug conjugate (“ADC”), demonstrated promising activity and was generally well tolerated Company to host conference call and webcast with Samuel A. Funt, M.D., of Memorial Sloan Kettering Cancer Center on Friday, June 7, 2024, at 1:00 PM ET SOUTH SAN FRANCISCO, Calif., June 02, 2024 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., (“ALX Oncology” or “the Company”) (Nasdaq:...Read more


Intellia Therapeutics Announces Positive Long-Term Data from Ongoing Phase 1 Study of NTLA-2002, an Investigational In Vivo CRISPR Gene Editing Treatment for Hereditary Angioedema (HAE)

June 2
Last Trade: 23.71 -0.44 -1.82

Extended follow-up data reaching over two years in the earliest patients dosed reinforce the potential of NTLA-2002 to be a functional cure for people living with hereditary angioedema (HAE) Eight of 10 patients remain completely attack-free following the 16-week primary observation period through the latest follow-up, including patients with the most severe disease Single dose of NTLA-2002 led to a 98% mean reduction in monthly HAE...Read more


Kymera Therapeutics Presents New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

June 1
Last Trade: 31.91 0.64 2.05

KT-253 demonstrates initial clinical proof of concept in patients with tumor types shown to be sensitive in preclinical models, including responses in MCC and AML Evidence of target engagement and potent upregulation of p53 pathway biomarkers even at the lowest dose levels in solid tumor and AML patients KT-253 was generally well tolerated without hematologic adverse events seen with traditional MDM2 small molecule inhibitors KT-253...Read more


Molecular Partners Presents Positive Data From Completed Phase 1 Trial Of MP0317 (FAP X CD40 DARPin) Monotherapy In Patients With Advanced Solid Tumors At ASCO 2024

June 1
Last Trade: 10.14 -0.87 -7.90

Mechanism of action supported by observed MP0317 localization and immune cell activation in the tumor microenvironment Favorable and manageable safety profile observed at all tested dose levels Weekly and three-weekly dosing schedules established, supported by pharmacokinetics and pharmacodynamics Data support further clinical evaluation of MP0317 in combination settings ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., June 01,...Read more


Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024

May 31
Last Trade: 35.40 0.28 0.80

Monotherapy brenetafusp (IMC-F106C) in late-line cutaneous melanoma demonstrated promising disease control (partial response and stable disease), progression free survival (PFS), and ctDNA molecular response Clinical activity was enriched in PRAME positive patients with 58% disease control rate and 4.2 months median PFS Peripheral blood T cell fitness was associated with increased brenetafusp clinical activity and was higher in...Read more


Kiromic BioPharma Reports Favorable Results at Six Weeks from Fourth Patient in Deltacel-01 Clinical Trial

May 29
Last Trade: 2.51 -0.09 -3.46

Scans of this first patient in the second cohort show 8.5% reduction in tumor size HOUSTON / May 29, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports favorable safety and tolerability, and early efficacy in the fourth patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel™ (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta...Read more


Allakos Announces First Patient Dosed in Phase 1 Trial of AK006 in Chronic Spontaneous Urticaria

May 28
Last Trade: 1.11 0.08 7.28

Top-line Phase 1 CSU results expected at year end 2024  SAN CARLOS, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (Nasdaq: ALLK), a biotechnology company developing AK006 for the treatment of mast cell-driven diseases, today announced that the first patient with chronic spontaneous urticaria (CSU) has been dosed in a randomized, double-blind, placebo-controlled Phase 1 trial of AK006. The Phase 1 trial is designed to...Read more


Protagenic Therapeutics' Stress-Regulating Peptide Demonstrates Exceptional Safety in Single Dose Portion of Phase I Trial, Paving the Way for Next Steps Toward Potential Breakthrough Treatments in Stress Related Neuropsychiatric Disorders

May 22
Last Trade: 0.91 -0.05 -4.92

No Clinically-Relevant Adverse Events Reported in Single Dose Portion, Multiple Dose Portion to Commence Investor Call Scheduled for today, Wednesday, May 22, at 10:00 am ET to Discuss Potential Impact on PTSD, Depression, Anxiety, Addiction, and Obesity NEW YORK, NY / ACCESSWIRE / May 22, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, today announced the complete safety data set from...Read more


Indaptus Therapeutics Announces Completion of First Patient to Receive Multiple Doses of Decoy20, the Company’s Broad-Based, “Pulse-Prime” Immuno-Oncology Therapy for Advanced Solid Tumors

May 22
Last Trade: 2.24 -0.08 -3.45

First-in-human trial confirms “Pulse-Prime” hypothesis targeting stimulation of innate and adaptive immune systems Investigational package of broad immune agonists derived from Gram-negative bacteria which induces dozens of cytokines/chemokines that are quickly cleared from the body Identification of tolerable single dose in Phase 1a, recommended for multi-dosing, will be presented at ASCO NEW YORK, May 22, 2024 (GLOBE NEWSWIRE) --...Read more


Anixa Biosciences Commences Treatment of Fifth Patient in Ovarian Cancer CAR-T Clinical Trial

May 21
Last Trade: 2.49 0.02 0.81

 Novel and proprietary CAR-T approach holds potential to be first effective CAR-T therapy for solid tumors SAN JOSE, Calif., May 21, 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 fifth patient in its ongoing Phase 1 clinical...Read more


Sonnet BioTherapeutics Announces Updated Clinical Data for SON-1010 as Monotherapy or Combined with an anti-PD-L1, along with an Increase in the Dose-Escalation Target

May 20
Last Trade: 0.92 -0.12 -11.54

The SON-1010 studies have together enrolled 61 subjects, to date, as dose escalation continues in SB101 and SB221 at higher levels Patients have received up to 25 cycles of SON-1010 as monotherapy and 10 cycles of SON-1010 with atezolizumab (Tecentriq®) without dose-limiting toxicity at any dose level Cytokine data reveals about 10-fold extended half-life for SON-1010 compared with rhIL-12 that induces prolonged and controlled IFNγ...Read more


Carisma Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial of CT-0525, a Novel HER2-Targeting CAR-Monocyte

May 16
Last Trade: 1.04 0.03 2.48

CT-0525 is the first CAR-Monocyte to be evaluated in humans in the solid tumor setting Initial data expected by year-end 2024 PHILADELPHIA, May 16, 2024 /PRNewswire/ -- Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, today announced that the first patient was dosed in its Phase 1 clinical...Read more


Voyager Therapeutics Announces First Participants Dosed in Single Ascending Dose Trial of VY-TAU01 for the Treatment of Alzheimer’s Disease

May 16
Last Trade: 8.02 0.23 2.95

LEXINGTON, Mass., May 16, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that the first participants were dosed in a Phase 1a single ascending dose (SAD) trial of VY-TAU01, an investigational anti-tau antibody developed to inhibit the spread of pathological tau in Alzheimer’s disease. The objective of the randomized, double-blind,...Read more


Arvinas and Pfizer Announce Updated Clinical Data from Phase 1b Trial of Vepdegestrant in Combination with Palbociclib (IBRANCE®)

May 16
Last Trade: 25.27 -0.04 -0.16

After six months of additional follow-up, clinical benefit rate (63%), overall response rate (41.9%), median progression-free survival (11.2 months), and safety profile of vepdegestrant in combination with palbociclib were consistent with data previously reported at SABCS in December 2023  At the recommended Phase 3 dose of 200 mg vepdegestrant in combination with palbociclib, patients achieved a median progression-free survival...Read more


Genentech Reports Positive Phase Ib Results for Its Dual GLP-1/GIP Receptor Agonist CT-388 in People With Obesity

May 16
Last Trade: 35.50 0.27 0.77

Over 24 weeks, a once-weekly subcutaneous injection of CT-388 achieved a clinically meaningful and statistically significant mean placebo-adjusted weight loss of 18.8% (p < 0.001)  At week 24, 100% of CT-388 treated participants achieved >5% weight loss, 70% achieved >15% and 45% achieved >20% weight loss  In a subgroup with pre-diabetes at baseline, CT-388 treatment normalized glycemia in all patients, indicating...Read more


Phio Pharmaceuticals Announces Completion of Dosing in First Patient Cohort in PH-762 Phase 1b Dose-Escalation Study

May 15
Last Trade: 0.70 -0.01 -1.81

PH-762 is Phio’s lead product candidate Screening on the next cohort is on-going MARLBOROUGH, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL™ siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, today announced progress on its Phase 1b clinical study for their lead compound...Read more


Genprex Doses First Patient in Acclaim-3 Clinical Study of Reqorsa® Immunogene Therapy in Combination with Tecentriq® to Treat Small Cell Lung Cancer

May 14
Last Trade: 2.07 0.02 1.00

Expects to Initiate the Phase 2 Expansion Study in the Second Half of 2024 Acclaim-3 Study Supported by FDA Orphan Drug and Fast Track Designations AUSTIN, Texas, May 14, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the first patient has been enrolled and...Read more


IMUNON Announces Site Activation for IMNN-101 Phase 1 Vaccine Study

May 13
Last Trade: 1.08 0.02 1.77

Proof-of-concept study for Imunon’s first vaccine utilizing its proprietary PlaCCine platform is now open for enrollment Topline results expected this year LAWRENCEVILLE, N.J., May 13, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, today announced that DM Clinical Research in Philadelphia is the...Read more


Senti Biosciences Announces First Patient Dosed in Phase 1 Clinical Trial of SENTI-202 for the Treatment of Relapsed or Refractory Hematologic Malignancies Including Acute Myeloid Leukemia

May 13
Last Trade: 0.25 0.0067 2.73

SENTI-202 is a potential first-in-class Logic Gated off-the-shelf CAR-NK cell therapy  Initial clinical efficacy data expected by year-end 2024 and durability data expected in 2025  SOUTH SAN FRANCISCO, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today...Read more


Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1076986 in Healthy Adults

May 9
Last Trade: 134.93 0.86 0.64

SAN DIEGO, May 9, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1076986 in healthy adult participants. NBI-1076986 is an investigational, oral, M4 subtype-selective muscarinic acetylcholine receptor antagonist for the potential treatment...Read more


Fate Therapeutics Announces First Lupus Patient Treated in Phase 1 Autoimmunity Study of Off-the-shelf FT819 CAR T-cell Program

May 9
Last Trade: 3.75 0.16 4.46

Pre-treatment Sample of Patient’s Blood Showed Rapid and Potent Depletion of CD19+ B Cells in Ex Vivo Cytotoxicity Assay with FT819 Translational Data from FT819 Phase 1 B Cell Malignancies Study Support Key Therapeutic Mechanisms of Activity for B Cell-mediated Autoimmune Diseases Initial Clinical Observations of FT522 CAR NK Cell Program in Phase 1 B Cell Lymphoma Study Show Rapid, Deep, and Sustained B Cell Depletion and Enhanced...Read more


TScan Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating TCR-T Therapy for the Treatment of Solid Tumors

May 9
Last Trade: 6.81 -0.43 -5.95

Patient dosed with TSC-203-A0201 targeting cancer-associated antigen PRAME On-track to report initial data from the solid tumor clinical trial in 2024 WALTHAM, Mass., May 09, 2024 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced that...Read more


CytomX Therapeutics Announces Positive Initial Phase 1a Dose Escalation Data for Monotherapy CX-904 (EGFRxCD3 PROBODY® T-Cell Engager)

May 8
Last Trade: 1.30 0.02 1.56

CX-904 demonstrated a favorable safety profile with no cytokine release syndrome (CRS) of any grade observed in step-dosing cohorts and no grade >1 CRS observed overall  Encouraging initial signs of efficacy observed for CX-904 in advanced pancreatic cancer, including 2 of 6 patients (33%) with a confirmed partial response and all 6 patients (100%) with disease control  Preliminary pharmacokinetic and pharmacodynamic...Read more


Neurocrine Biosciences Announces Initiation of Phase 1 Clinical Study Evaluating Effects of NBI-1117567 in Healthy Adults

May 8
Last Trade: 134.93 0.86 0.64

SAN DIEGO, May 8, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced the initiation of its Phase 1 first-in-human clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational compound NBI-1117567 in healthy adult participants. NBI-1117567 is an investigational, oral, M1/M4 (M1 preferring) selective muscarinic agonist for the potential treatment of...Read more


Cytokinetics Announces Topline Data From Phase 1 Clinical Study of CK-4021586

May 8
Last Trade: 52.90 1.08 2.08

Data Support Advancement to Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024 Full Data from the Phase 1 Study to be Presented at a Medical Congress in 2H 2024 SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced topline data from the Phase 1 study of CK-4021586 (CK-586). The study met its primary...Read more


Verve Therapeutics Announces Dosing of First Patient in Heart-2 Phase 1b Clinical Trial Evaluating VERVE-102

May 7
Last Trade: 5.25 0.12 2.34

VERVE-102 is an investigational in vivo base editing medicine designed to permanently inactivate the PCSK9 gene in the liver to durably reduce blood low-density lipoprotein cholesterol Heart-2 enrolling patients with heterozygous familial hypercholesterolemia or premature coronary artery disease BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care...Read more


Regulus Therapeutics Advances to Cohort 4 of Phase 1b Multiple-Ascending Dose (MAD) Clinical Trial of RGLS8429 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

May 6
Last Trade: 2.44 -0.09 -3.37

SAN DIEGO, May 6, 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, after review of all available safety data, the Company initiated screening in the of the fourth cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. Patients in the...Read more


Kazia Therapeutics Reports Successful Stage 1 Completion Of The EVT801 Phase 1 Clinical Trial In Advanced Cancer Patients

May 1
Last Trade: 0.26 -0.0099 -3.67

SYDNEY, May 1, 2024 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA), a biotechnology company specialising in oncology, is pleased to announce that the Safety Review Team (SRT) of the EVT801 Phase 1 clinical trial has concluded that the primary and secondary objectives of stage 1 of the trial have successfully been met. Consisting of the trial's lead investigators, independent medical monitor, and key members from Kazia...Read more


Aileron Therapeutics Announces Positive Data from Cohort 1 of the Phase 1b Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis (IPF)

May 1
Last Trade: 2.84 -0.21 -6.74

Low-dose LTI-03 (2.5 mg BID), a Caveolin-1 related peptide, reduced expression of multiple profibrotic proteins in both pathological basal-like cells and fibroblasts and increased the expression of a biomarker indicative of epithelial health, suggesting potential therapeutic effect Positive trend was observed in seven of eight IPF biomarkers evaluated Low-dose LTI-03 was well-tolerated, with no safety signal observed Data from Cohort...Read more


Vaxart Announces Positive Results for Its Bivalent Norovirus Vaccine Candidate in Lactating Mothers

April 30
Last Trade: 0.71 -0.01 -1.66

Antibody rise observed in lactating mothers and in their breast milk Long-term goal is to provide protection to infants through passive antibody transfer SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has completed the topline analysis for the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate. The trial was focused on...Read more


INmune Bio Provides Update on Two Patients from the Phase 1b Alzheimer’s Disease Trial who Continue to Receive XPro™ Under Compassionate Use for Over Three Years

April 30
Last Trade: 7.40 -0.30 -3.90

Boca Raton, Florida, April 30, 2024 (GLOBE NEWSWIRE) --  INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, is pleased to share an update on two patients from the Phase 1b trial completed in 2021 who have continued to receive XPro™ for treatment of Alzheimer’s Disease (AD) for more than three...Read more


Biora Therapeutics Announces Completion of Multiple-Ascending Dose (MAD) Cohorts for Clinical Trial of BT-600

April 30
Last Trade: 0.70 0.0079 1.14

Dosing of all patients in the trial has been successfully completed Final results are expected to be available in late Q2 2024 SAN DIEGO, April 30, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced completion of dosing for the multiple-ascending dose cohorts for its clinical study of BT-600, a drug-device combination consisting of the...Read more


Sutro Biopharma Announces Initiation of Randomized Portion (Part 2) of REFRαME-O1 Trial

April 30
Last Trade: 3.19 -0.09 -2.60

Part 2 of REFRαME-O1, the registration-directed study of luvelta for patients with platinum-resistant ovarian cancer (PROC), is open for enrollment  Planned 50 patients in Dose-Optimization (Part 1) of REFRαME-O1 have been enrolled and are in follow up  SOUTH SAN FRANCISCO, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering...Read more


Repare Therapeutics & Debiopharm Announce First Patient Dosed in Phase 1/1b MYTHIC Trial Evaluating the Synthetic Lethal Combination of PKMYT1 and WEE1 Inhibition

April 30
Last Trade: 3.52 0.00 0.00

MONTREAL & LAUSANNE, Switzerland / Apr 30, 2024 / Business Wire / Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, and Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, today announced that the first patient has been dosed in Module 4 of...Read more


Debiopharm & Repare Therapeutics Announce First Patient Dosed in Phase 1/1b Mythic Trial Evaluating the Synthetic Lethal Combination of WEE1 AND PKMYT1 Inhibition

April 30
Last Trade: 3.52 0.00 0.00

LAUSANNE, Switzerland & MONTREAL / Apr 30, 2024 / Business Wire / Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, and Repare Therapeutics Inc. (“Repare”) (Nasdaq: RPTX), a leading clinical-stage precision oncology company, announced that the first patient has been dosed in Module 4 of the ongoing Phase 1/1b...Read more


NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon

April 30
Last Trade: 1.84 -0.19 -9.48

SHELTON, CT / ACCESSWIRE / April 30, 2024 / NanoViricides, Inc. (NYSE Amer:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, reports that the Phase I Clinical Trial of NV-387 is completed successfully and data lock is expected soon. The Phase 1 clinical trial, protocol number KM-NVCoV2-001, which received approval from the regulatory agency in India for healthy as well as COVID-19 participants, was closed...Read more


MannKind to Proceed With Phase 1 Nintedanib Dpi (Mnkd-201) Study for Pulmonary Fibrotic Diseases

April 30
Last Trade: 5.08 0.22 4.42

First-in-human study to evaluate safety, tolerability and pharmacokinetics (PK) in healthy volunteers Enrollment of first study participant anticipated in June 2024 DANBURY, Conn. and WESTLAKE VILLAGE, Calif., April 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan...Read more


Terns Pharmaceuticals Announces Data from Ongoing Phase 1 Pharmacokinetic Study of Allosteric BCR-ABL Inhibitor TERN-701 in Adult Healthy Volunteers and Highlights Potential for Competitive Differentiation

April 29
Last Trade: 7.06 0.08 1.15

Ability to dose TERN-701 without regard to food represents a key potential differentiator within the allosteric BCR-ABL inhibitor class Pharmacokinetic data show no clinically significant difference in exposure between fed and fasted dosing Phase 1 CARDINAL trial evaluating TERN-701 in 2L+ CML patients remains ongoing, with interim data from initial cohorts anticipated in second half of 2024 FOSTER CITY, Calif., April 29, 2024...Read more


Gain Therapeutics Announces Positive Results from the Single Ascending Dose (SAD) Part of the Phase 1 Clinical Trial of GT-02287, a Novel GCase-Targeting Small Molecule Therapy for GBA1 Parkinson’s Disease

April 24
Last Trade: 1.25 -0.05 -3.85

BETHESDA, Md., April 24, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, announces positive results from the single ascending dose (SAD) part of its Phase 1 study. GT-02287 was generally well tolerated up to and including the highest planned dose level, and...Read more


Kiromic BioPharma Reports Consistent Favorable Safety, Tolerability, and Efficacy in Deltacel-01 Clinical Trial First Three Patients

April 24
Last Trade: 2.51 -0.09 -3.46

Follow-up Scans Show Continued Stable Disease in First Patient Cohort Company to Apply for FDA Fast Track Designation HOUSTON / Apr 24, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces consistent favorable safety, tolerability, and efficacy from follow-up visits of the first cohort of three patients enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is...Read more


Pasithea Therapeutics Announces the First Cohort has Completed the Initial Dosing in its Phase 1 Trial Evaluating PAS-004 in RAS, NF1 and RAF Mutated Cancers

April 24
Last Trade: 4.88 -0.02 -0.41

SOUTH SAN FRANCISCO, Calif. and MIAMI, Fla., April 24, 2024 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the treatment of neurofibromatosis type 1 (NF1) and other indications, today announced the first cohort of 3 patients have commenced dosing. PAS-004 is being evaluated in a Phase 1...Read more


Alto Neuroscience Announces Positive Phase 1 Results for ALTO-101, a Novel PDE4 Inhibitor in Development for Schizophrenia

April 23
Last Trade: 11.04 0.00 0.00

ALTO-101 demonstrated a favorable pharmacokinetic and tolerability profile; novel transdermal formulation delivered significantly greater drug exposure and fewer adverse events typically associated with PDE4 inhibitors  First-in-human achievement of target exposure with proprietary transdermal patch formulation developed in partnership with MEDRx  Proof-of-concept study in cognitive impairment associated with schizophrenia...Read more


Theriva Biologics Announces Positive Topline Data from Investigator Sponsored Phase 1 Trial of Intravitreal VCN-01 in Pediatric Patients with Refractory Retinoblastoma

April 23
Last Trade: 0.25 0.0088 3.59

Phase 1 trial in collaboration with Sant Joan de Déu-Barcelona Children’s Hospital (SJD) determined to have a positive outcome by the study Monitoring Committee Safety and clinical outcomes support the therapeutic potential of VCN-01 in retinoblastoma and emphasize VCN-01’s potential for use in diverse cancer indications ROCKVILLE, Md., April 23, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), a diversified...Read more


Krystal Biotech Announces First Patient Dosed in Phase 1 Clinical Trial of Inhaled KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors of the Lung

April 22
Last Trade: 170.49 -0.72 -0.42

Received Fast Track Designations for both inhaled and intratumoral KB707 PITTSBURGH, April 22, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, announced today that the first patient was dosed in its Phase 1 clinical trial (KYANITE-1) evaluating inhaled KB707, a modified HSV-1 vector designed to deliver genes encoding both human interleukin-12 (IL-12) and...Read more


Ocular Therapeutix Announces Positive Topline Phase 1 Data for AXPAXLI™ in Diabetic Retinopathy

April 18
Last Trade: 6.10 0.02 0.33

46.2% of patients demonstrated a 1- or 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 40 weeks in the AXPAXLI arm, compared to 0% in the control arm No patients in the AXPAXLI group experienced worsening in DRSS compared to 12.5% in the control arm at 40 weeks AXPAXLI was generally well tolerated with no inflammation observed Ocular intends to present the Phase 1 HELIOS study at an upcoming...Read more


Bio-Path Holdings Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients

April 18
Last Trade: 2.22 -0.08 -3.51

HOUSTON, April 18, 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 second 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...Read more


NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity

April 17
Last Trade: 4.15 0.05 1.32

Phase 1 Clinical Trial Timelines Significantly Accelerated Top-Line Data Readout from Single Ascending Dose Part 1 Now Expected in the Third Quarter of 2024 First Patient Dosed in the Multiple Ascending Dose Part 2 Expected in the Third Quarter of 2024 CAMBRIDGE, Mass., April 17, 2024 /PRNewswire/ -- NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on transforming cardiometabolic...Read more


Compass Therapeutics Announces First Patient Dosed in the Phase 1 Study of CTX-8371 in Patients with Solid Tumors

April 16
Last Trade: 1.10 -0.01 -0.90

The first patient was dosed in the Phase 1 dose escalation trial of CTX-8371.This study is conducted in patients with advanced solid tumors who progressed on at least one prior regimen containing a checkpoint blocker.   CTX-8371 is a novel dual checkpoint blocker that simultaneously targets the programmed death receptor PD-1 and its ligand PD-L1. Compass advanced CTX-8371 to the clinic following pre-clinical observations of...Read more


ORIC Pharmaceuticals Announces First Patients Dosed Across Three Expansion Cohorts in Phase 1b Trial of ORIC-114 in Patients with Mutated NSCLC

April 15
Last Trade: 7.24 0.23 3.28

Initiated multiple Phase 1b expansion cohorts to determine the RP2D of ORIC-114 in NSCLC patients with EGFR exon 20, HER2 exon 20, or EGFR atypical mutations Additionally, the company initiated an extension cohort to evaluate ORIC-114 for the treatment of patients with first-line, treatment-naïve EGFR exon 20 NSCLC Expect to report updated Phase 1b data in the first half of 2025 SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, April 15,...Read more


Edgewise Therapeutics Announces Positive Two-Year Topline Results from the ARCH Open Label Trial of Sevasemten (EDG-5506) in Adults with Becker Muscular Dystrophy (Becker)

April 15
Last Trade: 17.47 0.66 3.93

The North Star Ambulatory Assessment (NSAA) remained stable relative to declines reported in Becker natural history studies  Significant decreases were observed in circulating levels of creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2), biomarkers associated with skeletal muscle damage  Sevasemten was well-tolerated  Edgewise leadership to discuss ARCH findings on Tuesday, April 16 at 8:30 a.m. Eastern...Read more


Viracta Therapeutics Announces Positive Topline Nana-val Results from Stage 1 of the NAVAL-1 Trial in Patients with Relapsed or Refractory Epstein-Barr Virus-Positive (EBV+) Peripheral T-Cell Lymphoma

April 15
Last Trade: 0.61 0.04 7.21

Patients in the Nana-val (nanatinostat in combination with valganciclovir) treatment arm achieved clinically meaningful anti-tumor responses with an overall response rate of 50% and a complete response rate of 20% in the intent-to-treat population (71% and 29% in the efficacy-evaluable population) with a generally manageable safety profile  Nana-val demonstrated substantially greater efficacy than nanatinostat monotherapy, further...Read more


Neumora Therapeutics Announces Clinical Hold of Phase 1 NMRA-266 Study

April 15
Last Trade: 9.04 0.19 2.15

WATERTOWN, Mass., April 15, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, today announced that the Phase 1 trial of NMRA-266 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). NMRA-266 is a positive allosteric modulator (PAM) of the M4 muscarinic...Read more


Agenus Announces Updated Phase 1 Data and Progress on BOT/BAL Development in Metastatic MSS Colorectal Cancer

April 12
Last Trade: 14.19 0.62 4.57

Updated Phase 1 data demonstrate a 12-month overall survival (OS) of 71% and 18-month OS of 62% Company plans to discuss encouraging Phase 2 interim results with the FDA Company plans to submit Phase 2 data to a major medical conference in the second half of 2024 LEXINGTON, Mass. / Apr 12, 2024 / Business Wire / Agenus Inc. (NASDAQ: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers,...Read more


Citius Pharmaceuticals Announces Addition of City of Hope to UMN's Phase 1 Trial of LYMPHIR in Combination with CAR-T for the Treatment of B-Cell Lymphoma

April 11
Last Trade: 0.63 -0.008 -1.25

National Cancer Institute (NCI)-designated research and treatment center City of Hope, in Duarte, CA, to participate in the University of Minnesota (UMN) Masonic Cancer Center's ongoing Phase 1 trial to determine the maximum tolerated dose of LYMPHIR plus CAR-T therapy CRANFORD, N.J., April 11, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company...Read more


MEI Pharma Reports Initial Data from Clinical Study Evaluating ME-344 in Combination with Bevacizumab (Avastin®) in Relapsed Metastatic Colorectal Cancer Patients

April 11
Last Trade: 2.86 0.02 0.70

Cohort 1 Exceeds Predetermined Non-Progression Threshold in the Ongoing Phase 1b Study  ME-344 in Combination with Bevacizumab was Generally Well-tolerated with no Evidence of Overlapping Toxicity  MEI to Continue Advancing ME-344 via Development of a New Formulation with the Potential to Increase Biological Activity, Patient Convenience and Commercial Opportunity  SAN DIEGO / Apr 11, 2024 / Business Wire / MEI Pharma,...Read more


Enliven Therapeutics Announces Positive Proof of Concept Data from Phase 1 Clinical Trial of ELVN-001 in Chronic Myeloid Leukemia

April 11
Last Trade: 21.00 -0.04 -0.19

Achieved initial cumulative MMR rate of 44% (7/16) by 12 weeks in response-evaluable patients, which compares favorably to precedent Phase 1 trials of approved BCR::ABL1 TKIs Achieved initial cumulative MMR rate of 44% (4/9) by 12 weeks in response-evaluable patients who were previously treated with asciminib ELVN-001 was well tolerated with no ≥ Grade 3 treatment-related non-hematologic toxicities reported  Company to...Read more


Monopar Therapeutics Initiates Radiopharma Phase 1 Clinical Trial for MNPR-101-Zr in Advanced Cancer Patients

April 10
Last Trade: 0.70 0.03 3.98

WILMETTE, Ill., April 10, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, today announced that its Phase 1 dosimetry clinical trial for its novel radiopharmaceutical imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) is now active and recruiting patients with advanced cancers. The antibody...Read more


Corvus Pharmaceuticals Announces Initiation of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis

April 9
Last Trade: 1.87 -0.04 -2.09

Atopic dermatitis is the first immune disease indication being studied in the clinic for soquelitinib, the Company’s selective ITK inhibitor Corvus anticipates releasing initial clinical data from trial before year-end 2024 BURLINGAME, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced the initiation of the Company’s randomized,...Read more


Seres Therapeutics Announces Completion of Patient Enrollment for SER-155 Phase 1B Cohort 2 Clinical Trial in Allogenic HSCT

April 9
Last Trade: 0.80 0.05 6.07

Clinical data readout expected end of Q3 2024 SER-155 and other Seres microbiome therapeutic candidates have potential to expand microbiome therapeutic franchise into additional medically vulnerable patient populations CAMBRIDGE, Mass. / Apr 09, 2024 / Business Wire / Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, announced today that enrollment is complete in the placebo-controlled Cohort 2 of its...Read more


Alkermes Announces Positive Topline Results From Phase 1b Study of ALKS 2680 Demonstrating Improved Wakefulness in Patients With Narcolepsy Type 2 and Idiopathic Hypersomnia

April 9
Last Trade: 25.15 0.09 0.36

Orexin 2 Receptor Agonist ALKS 2680 Demonstrated Clinically Meaningful and Statistically Significant Improvements from Baseline in Mean Sleep Latency Compared to Placebo at All Doses Tested in Both Narcolepsy Type 2 and Idiopathic Hypersomnia  ALKS 2680 Was Generally Well Tolerated at All Doses Tested  Dose-Dependent Effects and Pharmacodynamic Profile Support Advancement Into Planned Phase 2 Study  DUBLIN,...Read more


Poseida Therapeutics Presents New Phase 1 Data at AACR 2024 Supporting Potential of P-BCMA-ALLO1 Allogeneic CAR-T Therapy to Benefit Broad Range of Patients with Multiple Myeloma

April 8
Last Trade: 2.86 0.21 8.11

Promising early data suggest patients with relapsed/refractory multiple myeloma who progressed after prior BCMA-targeted therapy achieved clinical responses with P-BCMA-ALLO1, which was well tolerated Following efforts to optimize allogeneic CAR-T therapy, Poseida is presenting a new data analysis underscoring the need for higher lymphodepletion chemotherapy doses when treating solid tumors vs. multiple myeloma SAN DIEGO, April...Read more


CytomX Therapeutics Announces First Patient Dosed with CX-2051, a Conditionally Activated EpCAM-Directed ADC, in a Phase 1 Study in Patients with Advanced Solid Tumors

April 8
Last Trade: 1.30 0.02 1.56

SOUTH SAN FRANCISCO, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, today announced the first patient has been dosed in a Phase 1 dose escalation study (NCT06265688) of CX-2051 in patients with advanced solid tumors. CX-2051 is a masked PROBODY® antibody drug conjugate (ADC) directed toward epithelial cell adhesion molecule...Read more


Biora Therapeutics Achieves Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap™ Platform Development

April 4
Last Trade: 0.70 0.0079 1.14

All pharmacokinetic endpoints were achieved, with a PK profile consistent with drug delivery and absorption in the colon All NaviCap™ devices performed as intended and were well tolerated, with no safety signals observed Multiple-ascending dose (MAD) portion of the trial is underway and progressing well SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining...Read more


ADC Therapeutics Announces Updates on LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Glofitamab or Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

April 4
Last Trade: 2.71 0.02 0.74

Dose escalation in Phase 1b trial completed with no dose-limiting toxicities, no or low-grade cytokine release syndrome and no immune effector cell-associated neurotoxicity syndrome across all patients and early signs of anti-tumor activity Enrollment in Part 2 dose expansion has been initiated LAUSANNE, Switzerland, April 04, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced the completion of dose escalation...Read more


FibroGen Announces Topline Results from Phase 1 Monotherapy Study of FG-3246 in Patients with Metastatic Castration-Resistant Prostate Cancer

April 2
Last Trade: 1.17 0.07 6.36

FG-3246 demonstrated efficacy in adenocarcinoma selected cohorts receiving biologically active doses of FG-3246 at ≥ 1.2 mg/kg in heavily pre-treated, biomarker unselected patients: Median radiographic progression free survival of 8.7 months PSA50 response in 36% of patients Confirmed radiographic objective response rate of 20%, with a median duration of response of 7.5 months FG-3246 demonstrated an acceptable safety profile;...Read more


Kiromic BioPharma Reports Favorable Safety, Tolerability, and Early Efficacy from Third Patient in Deltacel-01 Clinical Trial

April 2
Last Trade: 2.51 -0.09 -3.46

Trial’s Safety Monitoring Committee Recommends Maintaining Initial Cell Dose Level for Next Cohort of Patients HOUSTON / Apr 02, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) reports early efficacy results showing tumor stabilization in the third patient enrolled in the Company’s Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel™ (KB-GDT-01), Kiromic’s allogeneic,...Read more


Corbus Pharmaceuticals Announces Dosing of First Patient in U.S. Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC

April 2
Last Trade: 43.06 0.39 0.91

Study enrolling patients with metastatic urothelial cancer (mUC) and other Nectin-4 enriched tumors Emerging clinical profile from CSPC’s Phase 1 China study indicates differentiation from PADCEV NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S....Read more


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