Astria Therapeutics

Latest Phase 1/2 Clinical Trials Stock News

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BioNTech and OncoC4 Present Positive Phase 1/2 Data for Antibody Candidate BNT316/ONC-392 in Hard-to-Treat NSCLC at ASCO

June 2
Last Trade: 108.13 4.01 3.85

BNT316/ONC-392 is a next-generation anti-CTLA-4 monoclonal antibody candidate jointly developed by BioNTech and OncoC4 as monotherapy or combination therapy in a range of solid tumor indications, including non-small cell lung cancer (NSCLC) Interim data of BNT316/ONC-392 from the ongoing Phase 1/2 trial to be presented at this year’s ASCO Annual Meeting demonstrate encouraging signs of clinical anti-tumor activity and a manageable...Read more


Sensei Biotherapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial of SNS-101, a Conditionally Active VISTA-blocking Antibody, for the Treatment of Advanced Solid Tumors

June 1
Last Trade: 1.41 -0.05 -3.42

Topline Phase 1 monotherapy and initial combination data expected in 2024  BOSTON, June 01, 2023 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical-stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, today announced that the first patient has been dosed in its Phase 1/2 clinical trial evaluating SNS-101 for the treatment of advanced...Read more


Travere Therapeutics Announces Positive Topline Results from Cohort 6 in the Phase 1/2 COMPOSE Study of Pegtibatinase in Classical Homocystinuria

May 31
Last Trade: 19.05 0.85 4.67

Data from the four patients treated with the highest dose of pegtibatinase showed a clinically meaningful 67.1% mean relative reduction in total homocysteine from baseline Pegtibatinase has been generally well-tolerated to date The Company is engaging with regulators and expects to initiate a pivotal Phase 3 Study by year-end 2023 Company to host conference call and webcast today at 8.30 a.m. ET SAN DIEGO, May 31, 2023 (GLOBE...Read more


Innate Pharma Highlights Phase 1/2 Dose Escalation Safety and Preliminary Efficacy of Sanofi Developed First NK Cell Engager SAR’579 / IPH6101 in R/R AML

May 26
Last Trade: 2.93 0.10 3.53

SAR’579/IPH6101, ANKET® platform lead asset, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi, now under development by partner Sanofi Preliminary data published show SAR’579 was well tolerated and induced 3 complete responses in the 8 patients at 1 mg/kg as highest dose Phase 1/2 data will be presented as an oral presentation at the ASCO 2023 Annual...Read more


Theseus Pharmaceuticals Reports Initial Dose Escalation Data from Ongoing Phase 1/2 Trial of THE-630 in Patients with Advanced GIST

May 25
Last Trade: 8.78 0.17 1.97

THE-630 demonstrates encouraging safety profile through Cohort 6 (18 mg), supportive of continued dose escalation  Dose-dependent reductions observed in ctDNA KIT-mutant allele fractions for both major classes of KIT resistance mutations at exposures consistent with preclinical predictions observed in Predictive Resistance Assay™  Evidence of clinical activity observed in heavily pre-treated patient population at exposures...Read more


Wave Life Sciences Announces Topline Results from Phase 1b/2a FOCUS-C9 Study of WVE-004 for C9orf72-associated Amyotrophic Lateral Sclerosis and Frontotemporal Dementia

May 23
Last Trade: 4.55 0.39 9.38

Potent and durable target engagement observed across cohorts, including with 10 mg doses administered every 12 weeks which were also generally safe and well-tolerated WVE-004 did not show clinical benefit compared with placebo; additionally, poly(GP) reductions did not correlate with clinical outcomes -- Wave to discontinue development of WVE-004 Wave to host investor conference call at 8:30 a.m. ET today CAMBRIDGE, Mass., May 23,...Read more


Panbela Therapeutics Announces Clinical Trial with Moffitt Cancer Center for Phase I/II Program in STK11 Mutant Non-Small Cell Lung Cancer

May 22
Last Trade: 6.58 0.22 3.46

MINNEAPOLIS, May 22, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC). The initial goal of the Phase I trial will be to ascertain the...Read more


Clearmind Medicine Announces First US Site for its Phase I/IIa Clinical Trial Evaluating CMND-100 in Patients with Alcohol Use Disorder

May 22
Last Trade: 0.56 -0.001 -0.18

Tel Aviv, Israel / Vancouver, Canada, May 22, 2023 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced the selection of its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100...Read more


Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial

May 21
Last Trade: 2.04 0.05 2.51

8 AL Amyloidosis patients relapsed/refractory to DARZALEX®-based regimens were treated with CAR-T NXC-201 100% (8/8) overall response rate and 63% (5/8) complete response (MRD 10-5) was demonstrated by NXC-201 with zero ICANs, zero grade 4 CRS 62% (5/8) had NYHA classification III or IV heart failure prior to treatment with NXC-201 Best responder duration of response was 16.5 months with response ongoing as of the data cutoff date of...Read more


Phase 1/2 Interim Data on Moderna's mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia (PA), Presented at the 2023 ASGCT Annual Meeting

May 19
Last Trade: 130.51 1.99 1.55

First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement To date, mRNA-3927 has been generally well-tolerated at the doses administered, with encouraging early signs of dose-dependent pharmacology and potential clinical benefits No occurrence of dose-limiting toxicities or study discontinuations due to drug-related treatment-emergent adverse events (TEAEs) More than 280 doses of mRNA-3927...Read more


Ultragenyx Pharmaceutical Receives FDA Agreement to Expand Ongoing Global Phase 1/2 Trial Evaluating GTX-102 in Patients with Angelman Syndrome in the U.S.

May 17
Last Trade: 50.85 1.24 2.50

NOVATO, Calif., May 17, 2023 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the U.S. Food and Drug Administration (FDA) has reviewed and agreed to a protocol amendment to the Phase 1/2 study of GTX-102 in pediatric patients with Angelman syndrome that enables the company to harmonize dose ranges in the U.S. with those being used in ex-U.S. cohorts of the study. Outside of the U.S., the Phase 1/2...Read more


Olema Oncology Announces OP-1250 Continues to Demonstrate Attractive Combinability with CDK4/6 Inhibitor Palbociclib in Phase 1b/2 Study

May 11
Last Trade: 5.67 -0.08 -1.39

OP-1250 in combination with palbociclib was well-tolerated in patients with ER+/HER2- metastatic breast cancer, with no dose-limiting toxicities, and no observed drug-drug interaction Overall tolerability profile of the combination is consistent with the FDA-approved label of palbociclib plus an endocrine agent Tumor responses have been observed in patients previously treated with CDK4/6 inhibitors SAN FRANCISCO, May 11, 2023...Read more


Onconova Therapeutics Doses First Patient in Phase 1/2a Trial of Narazaciclib Combined with Letrozole in Endometrial Cancer

May 11
Last Trade: 1.20 0.02 1.69

Prior data provide clinical proof-of-concept for narazaciclib’s mechanism of action in endometrial cancer Preliminary data from trial’s Phase 1 portion expected in 4Q 2023 NEWTOWN, Pa., May 11, 2023 (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the first...Read more


FDA Removes Partial Clinical Hold on Salarius Pharmaceuticals’ Phase 1/2 Clinical Trial with Seclidemstat in Patients with Ewing Sarcoma

May 9
Last Trade: 1.61 0.13 8.78

Decision Follows Review of Comprehensive Safety Data Package Submitted by the Company Salarius Plans to Meet with FDA to Discuss Future Development and Potential Registration Pathways HOUSTON, May 09, 2023 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (NASDAQ: SLRX), a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment...Read more


CureVac Announces Dosing of First Participant in Combined Phase 1/2 Study of Multivalent, Modified Influenza Vaccine Candidates Developed in Collaboration with GSK

May 8
Last Trade: 9.36 0.25 2.74

Initial Phase 1 part started with multivalent modified mRNA influenza vaccine candidates Candidates developed in collaboration with GSK within broad infectious disease vaccine program encode for antigens covering four WHO-recommended flu strains TÜBINGEN, GERMANY and BOSTON, MA / ACCESSWIRE / May 8, 2023 / CureVac N.V. (NASDAQ:CVAC) ("CureVac"), a global biopharmaceutical company developing a new class of transformative medicines...Read more


Moderna Announces Phase 1/2 Data on mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia (PA) to be Presented at the 2023 ASGCT Annual Meeting

May 3
Last Trade: 130.51 1.99 1.55

After completing enrollment in 5 dose cohorts, and with no dose-limiting safety signals observed to date by the independent DSMB, the Phase 1/2 trial of mRNA-3927 advances to the dose-expansion phase to determine a recommended dose CAMBRIDGE, MA / ACCESSWIRE / May 3, 2023 / Moderna,Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that an abstract reporting on...Read more


Immix Biopharma Announces Early Positive IMX-110 Interim Clinical Trial Data Demonstrating 100% Tumor Shrinkage in Advanced Metastatic Colorectal Cancer at the Lowest Dose of IMX-110 + BeiGene / Novartis Anti-PD-1 Antibody Tislelizumab

May 3
Last Trade: 2.04 0.05 2.51

100% Tumor Shrinkage at 2-months in advanced metastatic colorectal cancer was demonstrated by IMX-110 + BeiGene / Novartis anti-PD-1 Antibody Tislelizumab combination in the first, lowest dose cohort (two out of two first evaluable patients) in its ongoing phase 1b/2a dose escalation clinical trial IMMINENT-01 We believe results bolster scientific basis for IMX-110 in unlocking the immune system’s ability to fight cancer LOS...Read more


Moleculin Biotech Successfully Completes First Cohort in Phase 1b/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)

May 2
Last Trade: 0.61 0.04 6.48

Preliminary results demonstrate a durable complete response at starting dose level in elderly subject Positive results from first cohort allows Company to progress to second cohort in Phase 1b portion of the Phase 1b/2 trial with 230 mg/m2 dose of Annamycin HOUSTON, May 2, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a growing pipeline,...Read more


Tempest Therapeutics Announces Positive Early Results from Global Randomized Phase 1b/2 Combination Study of TPST-1120 in First-Line Hepatocellular Carcinoma

April 28
Last Trade: 1.45 0.01 0.69

Positive randomized data with TPST-1120 combined with atezolizumab + bevacizumab compared head-to-head with atezolizumab + bevacizumab The addition of TPST-1120 resulted in a clinically-meaningful improvement in both confirmed and unconfirmed RECIST responses The number of patients on treatment and on study markedly favors the TPST-1120 arm Company to host webcast conference call today at 8:30 a.m. ET BRISBANE, Calif., April 28,...Read more


Avidity Biosciences Announces Positive Topline Data from AOC 1001 Phase 1/2 MARINA™ Trial Demonstrating Functional Improvement, Disease Modification and Favorable Safety and Tolerability Profile in People Living with Myotonic Dystrophy Type 1

April 27
Last Trade: 11.15 0.28 2.58

Topline data presented at AAN annual meeting showed AOC 1001 achieved directional improvements in multiple functional endpoint assessments - myotonia (vHOT), measures of strength (total QMT) and mobility (10mWRT, Timed Up and Go) AOC 1001 data demonstrate favorable safety/tolerability profile with most adverse events mild or moderate Topline AOC 1001 data identify dose range for pivotal study; Avidity continues to work to resolve...Read more


ContraFect Announces First Patient Dosed in the Phase 1b/2 Study of Exebacase in Patients with Chronic Prosthetic Joint Infections of the Knee

April 26
Last Trade: 1.39 0.04 2.96

YONKERS, N.Y., April 26, 2023 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, today announces the first patient has been dosed in the Phase 1b/2 of exebacase in the setting of an...Read more


Lineage Cell Therapeutics: RG6501 (OpRegen®) Phase 1/2a Clinical Results Support the Potential for OpRegen to Slow, Stop or Reverse Disease Progression in Geographic Atrophy Secondary to Age-Related Macular Degeneration

April 26
Last Trade: 1.32 0.04 3.12

Preliminary Evidence of Durable Anatomical and Functional Improvements Following Administration of OpRegen Cells Extensive OpRegen Surgical Bleb Coverage of Areas of GA May Be Critical for Optimizing Patient Outcomes OCT Imaging With Segmentation Analysis is Advantageous in Assessment of Retinal Integrity Post-Treatment CARLSBAD, Calif. / Apr 26, 2023 / Business Wire / Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a...Read more


Arrowhead Pharmaceuticals’ Proprietary Pulmonary TRiM™ Platform Achieves High Levels of Target Gene Knockdown and Long Duration of Effect

April 25
Last Trade: 36.05 1.38 3.98

Interim Results from Ongoing ARO-RAGE Phase 1/2 Study Demonstrate up to 90% Serum sRAGE Reduction with Mean Maximum Reduction of 80% after Two Doses Further Data to be Presented at Upcoming R&D Day PASADENA, Calif. / Apr 25, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced interim results from an ongoing Phase 1/2 clinical study of ARO-RAGE, the company’s investigational RNA interference (RNAi)...Read more


Vaccinex Completes Enrollment in Phase 1b/2 SIGNAL-AD (Alzheimer’s Disease) Study of Pepinemab

April 25
Last Trade: 0.42 0.01 3.56

Topline data anticipated in mid-2024 SIGNAL-AD builds on promising data from the Phase 2 SIGNAL Study in Huntington’s Disease ROCHESTER, N.Y., April 25, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, today announced that it has completed enrollment goal in the...Read more


LIXTE Biotechnology Reports First Spanish Site Activated to Begin Accrual of Patients for a Phase 1b/2 Clinical Trial of LIXTE's Lead Anti-Cancer Compound, LB-100, Added to Doxorubicin as First-Line Treatment of Advanced Soft Tissue Sarcoma

April 24
Last Trade: 0.67 0.0075 1.13

First clinical trial seeking to determine if the potentiation of cytotoxic chemotherapy by LB-100 occurs in cancer patients as has been shown in multiple animal studies across a spectrum of cancers PASADENA, CA, April 24, 2023 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”) a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, announced that the...Read more


Plus Therapeutics Completes Enrollment of the Original Three Patients Required for Cohort 8 of ReSPECT-GBM Phase 1/2a Trial

April 19
Last Trade: 3.93 0.02 0.51

AUSTIN, Texas, April 19, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the completion of enrollment of the original three patients required in Cohort 8 of the ReSPECT-GBM Phase 1/2a dose escalation clinical trial of rhenium (186Re)...Read more


MiNK Therapeutics Announces Clinical Data of Allogeneic iNKT Cells (agenT-797) in Solid Tumor Cancers at the AACR Annual Meeting

April 18
Last Trade: 1.83 0.03 1.67

Allogeneic iNKTs, agenT-797, administered alone or in combination with anti-PD-1 therapy, shows activity in patients with refractory solid tumor cancers. In a patient with metastatic gastric cancer who had no response to treatment with pembrolizumab and nivolumab/FOLFOX, agenT-797 induced a partial response with 42% tumor shrinkage, which continues beyond 9 months. AgenT-797 was administered without toxic lymphodepletion, persists for...Read more


Repare Therapeutics Presents Initial Clinical Data from the Phase 1/2 TRESR and ATTACC Trials Evaluating Camonsertib in Combination with Three PARP Inhibitors at the 2023 AACR Annual Meeting

April 18
Last Trade: 11.42 0.79 7.43

Camonsertib PARPi combinations demonstrated 48% CBR in patients with unmet medical needs, across tumor types, and regardless of PARPi partner or platinum resistance, with a favorable safety and tolerability profile Combination results showed most benefit in late-line ovarian cancer demonstrating 32% overall response, 58% CBR and mPFS of approximately 7 months Early ctDNA molecular responses in 66% of evaluable patients confirms...Read more


Lisata Therapeutics and WARPNINE Announce First Patient Treated in the iLSTA Trial of LSTA1, a Novel Tumor-Targeting and Penetrating Peptide, in Patients with Locally Advanced Non-Resectable Pancreatic Ductal Adenocarcinoma

April 18
Last Trade: 4.21 -0.04 -0.84

The iLSTA Trial is the first study combining LSTA1 with standard-of-care chemotherapy and immunotherapy WARPNINE to provide funding and local trial management BASKING RIDGE, N.J. and SUBIACO, Australia, April 18, 2023 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other...Read more


Evaxion Biotech announces promising clinical data for DNA-based personalized cancer immunotherapy EVX-02: Phase 1/2a trial met both primary and secondary endpoints

April 18
Last Trade: 1.48 -0.01 -0.67

All 10 patients with late stage melanoma who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses and were relapse-free at their last assessment Results further validate predictive potential of proprietary AI technology and pave the way for advancement of EVX-03, a next-generation DNA-based personalized cancer immunotherapy, into the clinic in Q4 COPENHAGEN, Denmark, April 18, 2023 (GLOBE NEWSWIRE)...Read more


Merus’ Petosemtamab Interim Data Demonstrates Clinically Meaningful Activity in Previously Treated Head and Neck Squamous Cell Carcinoma (HNSCC)

April 17
Last Trade: 21.95 -0.54 -2.40

37% overall response rate (ORR) observed in 43 evaluable patients 6 months median duration of response as of Feb. 1, 2023 data cutoff date End-of-phase meeting with U.S. Food & Drug Administration provides clarity to potential registration path in HNSCC Investor call on April 17, 2023 at 6:30 p.m. ET UTRECHT, The Netherlands and CAMBRIDGE, Mass., April 17, 2023 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the...Read more


Vaccitech Presents Interim Data from Phase 1b/2 Study of VTP-200 at 35th Annual International Papillomavirus Conference (IPVC) Highlighting Favorable Tolerability and Immunogenicity Profile

April 17
Last Trade: 2.41 -0.02 -0.81

VTP-200 was generally well-tolerated and was administered with no product-related grade 3 unsolicited adverse events and no product-related serious adverse events (SAEs) in women with low grade human papillomavirus-related cervical lesions Interim data showed encouraging initial immunogenicity results, particularly in relation to the E1, E2 and E6 antigens OXFORD, United Kingdom, April 17, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc...Read more


23andMe Announces Phase 1 Results from the First-in-Human Phase 1/2a Study of 23ME-00610, an Investigational Antibody Targeting CD200R1

April 14
Last Trade: 2.05 0.07 3.54

First clinical results to be presented at the AACR Annual Meeting 2023 showed 23ME-00610 demonstrated an acceptable safety and tolerability profile, with favorable pharmacokinetics and peripheral CD200R1 saturation in patients with advanced solid malignancies Recommended dose selected for evaluation of anti-tumor activity in the ongoing Phase 2a portion of the Phase 1/2a study ORLANDO, Fla., April 14, 2023 (GLOBE NEWSWIRE) --...Read more


Ocugen Announces Positive Preliminary Safety and Efficacy Results from the Phase 1/2 Trial of OCU400, a Modifier Gene Therapy Product Candidate, for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis

April 14
Last Trade: 0.47 0.02 4.58

Favorable safety and tolerability profile related to OCU400 investigational product candidate Initial clinical data from low and medium dose cohorts indicates positive trend in Multi-luminance mobility testing and Best-Corrected Visual Acuity scores for OCU400 treated eyes 71.4% (5/7) of OCU400 treated eyes in low and medium dose cohorts experienced at least 1 Lux luminance level improvement in mobility test from baseline 66.7% (2/3)...Read more


Aeglea BioTherapeutics Announces Interim Results from Ongoing Phase 1/2 Clinical Trial of Pegtarviliase for the Treatment of Classical Homocystinuria and Begins Process to Explore Strategic Alternatives

April 12
Last Trade: 0.13 -0.0024 -1.84

Results from Cohorts 1 and 2 Showed a Dose-Dependent Reduction in Total Homocysteine Levels Results from Cohort 3 Indicated Additional Dose Exploration and Data from Longer Treatment Duration May be Needed AUSTIN, Texas, April 12, 2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing human enzyme therapeutics to benefit people with rare metabolic diseases, today...Read more


Kineta Announces First Patient Dosed in Phase 1/2 Clinical Study of KVA12123 for Advanced Solid Tumors

April 12
Last Trade: 3.00 0.00 0.00

VISTA blocking immunotherapy engineered to address immunosuppression in the tumor microenvironment (TME) Phase 1 initial data readout anticipated by end of 2023 SEATTLE, April 12, 2023 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, announced today the first patient has been dosed in a Phase...Read more


Cellectis Announces Dosing of First Patient in Europe with its In-house Manufactured Product Candidate UCART22

April 11
Last Trade: 1.99 0.02 1.02

UCART22 is currently the most advanced allogeneic CAR T-cell product in development for relapsed or refractory B-cell acute lymphoblastic leukemia The BALLI-01 study (evaluating UCART22) is actively enrolling patients with relapsed or refractory B-cell ALL after FCA lymphodepletion NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Cellectis (the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company...Read more


Ault Alliance Announces Alzamend Neuro Has Initiated Its Phase I/IIA Trial for Its Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type

April 4
Last Trade: 0.73 -0.04 -5.56

Ault Alliance Congratulates Alzamend Neuro on This Important and Historic Milestone in Clinical Drug Discovery and Development LAS VEGAS / Apr 04, 2023 / Business Wire / Ault Alliance, Inc. (NYSE American: AULT), a diversified holding company (“Ault Alliance” or the “Company”), is proud to announce that Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”) has initiated its Phase I/IIA clinical trial for its immunotherapeutic vaccine...Read more


Alzamend Neuro Announces the Initiation of a Phase I/IIA Trial for Its Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type

April 3
Last Trade: 0.73 -0.04 -5.56

ATLANTA / Apr 03, 2023 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced the initiation of a phase I/IIA clinical trial for its immunotherapy vaccine (ALZN002) to treat...Read more


Alzamend Neuro Receives FDA “Study May Proceed” Letter for Phase I/IIA Trial Under Its Investigational New Drug Application for an Immunotherapy Vaccine (ALZN002) to Treat Mild to Moderate Dementia of the Alzheimer’s Type

April 3
Last Trade: 0.73 -0.04 -5.56

ATLANTA / Apr 03, 2023 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder, major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced receipt of a “Study May Proceed” letter from the U.S. Food and Drug Administration (“FDA”) for...Read more


ContraFect Announces Initiation of a Phase 1b/2 Study of Exebacase in Patients with Chronic Prosthetic Joint Infections of the Knee

April 3
Last Trade: 1.39 0.04 2.96

YONKERS, New York, April 03, 2023 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq: CFRX), a clinical-stage biotechnology company focused on the discovery and development of direct lytic agents (DLAs), including lysins and amurin peptides, as new medical modalities for the treatment of life-threatening, antibiotic-resistant infections, announced the initiation of a Phase 1b/2 of exebacase in the setting of an arthroscopic debridement,...Read more


Medicenna Therapeutics Provides Clinical Update from Monotherapy Dose Escalation Portion of Phase 1/2 ABILITY Study

March 30
Last Trade: 0.60 -0.01 -2.02

Additional evidence of durable anti-cancer activity with MDNA11 monotherapy seen in latest radiographic scans from first four dose escalation cohorts Continued tumor reduction and complete regression of one of three metastatic lesions in fourth-line pancreatic cancer patient with confirmed partial response Stable disease maintained for more than 70 weeks in patient with metastatic melanoma MDNA11 continues to selectively and...Read more


Plus Therapeutics Successfully Treats First Patient in Cohort 8 of ReSPECT-GBM Phase 1/2a Trial

March 28
Last Trade: 3.93 0.02 0.51

Company also enrolling ReSPECT-GBM Phase 2 trial Presentation of data from Phase 1/2a and Phase 2 trials planned in 2023 AUSTIN, Texas, March 28, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced the first patient in Cohort eight of...Read more


Vaccitech Announces Positive Topline Final Data for HBV002 Study in People with Chronic Hepatitis B

March 28
Last Trade: 2.41 -0.02 -0.81

Completed Phase 1b/2a trial of VTP-300 met its primary and secondary endpoints VTP-300 is the first antigen-specific immunotherapy shown to induce sustained reductions in Hepatitis B surface antigen (HBsAg) Results will be presented at the upcoming European Association for the Study of the Liver (EASL) Congress in June OXFORD, United Kingdom, March 28, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC), a clinical-stage...Read more


Revive Therapeutics Provides Update on Psilocybin Clinical Study for Methamphetamine Use Disorder

March 28
Last Trade: 0.05 0.00 0.00

TORONTO, March 28, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s Phase I/II clinical study (the “Study”) (NCT05322954) evaluating the safety and feasibility of oral psilocybin as a potential...Read more


Ocugen Announces FDA Approval for Enrollment of Pediatric Patients in Ongoing OCU400 Phase 1/2 Clinical Trial for the Treatment of Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA)

March 27
Last Trade: 0.47 0.02 4.58

U.S. Food & Drug Administration (FDA) approves enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial who have: 1) RP associated with NR2E3 and RHO mutations and 2) LCA associated with CEP290 gene mutations Ocugen has completed enrollment of adult RP patients with NR2E3 and RHO mutations in the Phase 1/2 trial and expanded enrollment in LCA patients with CEP290 mutations MALVERN, Pa., March 27, 2023 (GLOBE NEWSWIRE)...Read more


Nexcella, an Immix Biopharma Subsidiary, Announces New Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in AL Amyloidosis Patients + Additional Positive Multiple Myeloma Safety Data Demonstrating NXC-201 Outpatient CAR-T Treatment...

March 23
Last Trade: 2.04 0.05 2.51

LOS ANGELES, March 23, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) today announced that NXC-201 treatment continues to demonstrate 100% complete hematologic responses and 100% organ response rate – cardiac, renal, liver response – in a total of 8 AL amyloidosis patients (an additional 2 patients maintaining 100% complete response). Additionally,...Read more


Plus Therapeutics Initiates Cohort 3 in Phase 1/Part A of the ReSPECT-LM Trial for Leptomeningeal Metastases

March 22
Last Trade: 3.93 0.02 0.51

AUSTIN, Texas, March 22, 2023 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system cancers, today announced treatment of the first patient in Cohort 3 of the ReSPECT-LM Phase 1/2a dose escalation clinical trial of rhenium (186Re) obisbemeda for the treatment of...Read more


Vaccinex Announces Initiation of Single-Arm Open Label, Phase Ib/2 Study to Evaluate Pepinemab in Combination with Avelumab as Second Line Combination Immunotherapy for Patients with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

March 21
Last Trade: 0.42 0.01 3.56

The study is intended to assess whether pepinemab can reverse the suppressive tumor microenvironment found in PDAC, thereby facilitating the anti-tumor activity of immune checkpoint blockade This Vaccinex-sponsored study will be conducted at the University of Rochester Primary funding support is provided by Gateway Discovery Award, administered by ASCO’s “Conquer Cancer Foundation” ROCHESTER, N.Y., March 21, 2023 (GLOBE NEWSWIRE)...Read more


Vaccitech’s VTP-200 Ph 1b/2 Study Demonstrates Favorable Tolerability and Immunogenicity Profile at Interim Analysis in Women with Low-Grade Human Papillomavirus (HPV)-related Cervical Lesions

March 20
Last Trade: 2.41 -0.02 -0.81

VTP-200 was generally well-tolerated with no product-related serious adverse events (SAEs) Interim data showed encouraging initial immunogenicity results, particularly in relation to the E1, E2 and E6 antigens used in VTP-200 HPV001 clinical trial will continue as planned to the 12-month primary endpoint OXFORD, United Kingdom, March 20, 2023 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical...Read more


Enlivex Therapeutics Receives Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra combined with chemotherapy in patients with peritoneal metastases arising from solid cancers

March 20
Last Trade: 2.65 0.11 4.13

Nes-Ziona, Israel, March 20, 2023 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that an independent Data and Safety Monitoring Board (DSMB) has completed an interim data review for the first cohort of patients in the Company’s ongoing Phase I/II clinical trial of Allocetra™ in patients with advanced-stage peritoneal metastasis...Read more


Stoke Therapeutics Announces That FDA Will Allow the Administration of a Higher Single Dose of STK-001 (70mg) in the Ongoing Phase 1/2a MONARCH Study of Children and Adolescents with Dravet Syndrome

March 15
Last Trade: 12.17 0.88 7.79

BEDFORD, Mass. / Mar 15, 2023 / Business Wire / Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to addressing the underlying cause of severe diseases by upregulating protein expression with RNA-based medicines, today announced that the FDA will allow the administration of a higher single dose of STK-001 (70mg) in its ongoing Phase 1/2a MONARCH study of children and adolescents with Dravet syndrome. This new 70mg...Read more


Bellicum Pharmaceuticals Discontinues Phase 1/2 Trials and Initiates Evaluation of Strategic Alternatives

March 14
Last Trade: 0.30 -0.32 -51.77

HOUSTON, March 14, 2023 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), today announced its decision to discontinue its ongoing Phase 1/2 clinical trials evaluating the safety and preliminary efficacy of its GoCAR-T cell product candidates in combination with rimiducid in heavily pre-treated cancer patients. The trials for BPX-601 and BPX-603 are being discontinued following the Company’s assessment of the risk/benefit...Read more


Vaccinex Reports that KEYNOTE B-84 has Reached Targeted Enrollment for Pre-planned Interim Analysis

March 9
Last Trade: 0.42 0.01 3.56

Interim analysis will be performed when the last of these patients has completed a tumor assessment scan approximately 9 weeks after initiating treatment The open-label Phase 1b/2 KEYNOTE B-84 study is evaluating the use of pepinemab in combination with Merck’s KEYTRUDA (pembrolizumab) in R/M HNSCC ROCHESTER, N.Y., March 09, 2023 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a...Read more


Sernova Announces Initial Islet Transplantation in First Two Patients Enrolled in Second Cohort of its U.S. Phase 1/2 Clinical Trial for Treatment of Type 1 Diabetes

March 8
Last Trade: 0.82 0.00 0.00

Third patient now implanted with higher capacity, 10-chamber Cell Pouch Company anticipates first interim data from second cohort in Q4 2023   LONDON, Ontario, March 08, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, announced today that the first two patients in the second cohort of its active U.S. Phase 1/2 clinical trial for the...Read more


Armata Pharmaceuticals Announces Positive Topline Data from Phase 1b/2a SWARM-P.a. Clinical Trial of Inhaled AP-PA02 in Patients with Cystic Fibrosis

March 6
Last Trade: 1.61 0.11 7.33

AP-PA02 is well-tolerated and data supports progression to Phase 2b Also announces first subject dosed in Phase 2 'Tailwind' clinical trial of inhaled AP-PA02 in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) NCFB represents Armata's third active clinical program MARINA DEL REY, Calif., March 6, 2023 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company...Read more


Immuneering Presents Preclinical Data with Lead Program IMM-1-104 Supporting Universal-RAS Activity

March 5
Last Trade: 8.75 -0.67 -7.11

Broad response demonstrated through deep cyclic inhibition of MAPK pathway, independent of specific RAS mutation Phase 1/2a clinical trial with IMM-1-104 underway in patients with advanced solid tumors harboring RAS mutations CAMBRIDGE, Mass., March 05, 2023 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company developing medicines for broad populations of cancer patients with an initial aim...Read more


Moleculin Biotech Announces Dosing of First Subject in Italy for Phase 1/2 Trial Evaluating Annamycin in Combination with Cytarabine (Ara-C) for the Treatment of Acute Myeloid Leukemia (AML)

March 1
Last Trade: 0.61 0.04 6.48

HOUSTON, March 1, 2023 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced the first subject has been treated in Italy in the Company's Phase 1/2 trial evaluating Annamycin in combination with Cytarabine (Ara-C) for the treatment of subjects with AML who are...Read more


Cybin Announces Positive Data from its CYB003 Phase 1/2a Trial and Provides Update on its CYB004 Development Program

February 28
Last Trade: 0.27 0.0007 0.26

TORONTO / Feb 28, 2023 / Business Wire / Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (“Cybin” or the “Company”), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics® today announced significant progress updates for its two lead clinical development programs: CYB003, its proprietary deuterated psilocybin analog for the potential treatment of Major Depressive Disorder and CYB004, its proprietary deuterated...Read more


23andMe Announces First Patient Dosed for the Phase 2a Portion of its Phase 1/2a Study of 23ME-00610, an Investigational Antibody Targeting CD200R1 in Patients with Advanced Solid Malignancies

February 28
Last Trade: 2.05 0.07 3.54

SOUTH SAN FRANCISCO, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME) (23andMe), a leading human genetics and biopharmaceutical company, with a mission to help people access, understand and benefit from the human genome, dosed the first patient in the Phase 2a portion of its Phase 1/2a (Phase 2a) study evaluating 23ME-00610, an investigational antibody targeting CD200R1, in patients with advanced solid...Read more


Nexcella Announces 50 Patients Already Treated with CAR-T NXC-201; Estimates 100-Patient Total Enrollment for U.S. Food and Drug Administration Approval BLA Submission

February 27
Last Trade: 2.04 0.05 2.51

Robust enrollment of up to 5 patients per month continues in ongoing Phase 1b/2a next-generation CAR-T NXC-201 clinical trial in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis Nexcella on track to present 50-patient cohort multiple myeloma data later this year at a premier scientific forum Los Angeles, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”), a biopharmaceutical company...Read more


IMUNON and Break Through Cancer Commence Enrollment in a Phase 1/2 Clinical Study of IMNN-001 in Combination with Avastin in Advanced Ovarian Cancer

February 27
Last Trade: 1.25 0.08 6.84

The study will be partially funded by Break Through Cancer through the Ovarian Minimal Residual Disease Team Lab LAWRENCEVILLE, NJ and CAMBRIDGE, MA, Feb. 27, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage biotechnology company, and Break Through Cancer, a public foundation dedicated to empowering outstanding researchers and clinicians to both intercept and find cures for some of the most difficult-to-treat...Read more


RegenXBio: Additional Positive Interim Data from Phase I/II Trial of REGENXBIO'S RGX-111 for the Treatment of Severe MPS I Presented at WORLDSymposium™

February 24
Last Trade: 19.72 1.16 6.25

RGX-111 is an investigational AAV Therapeutic for the treatment of severe MPS I that is part of REGENXBIO's clinical-stage pipeline of neurodegenerative disease programs RGX-111, a potential one-time gene therapy for MPS I, continues to be well-tolerated across two dose levels, with no drug-related serious adverse events New biomarker and neurodevelopmental data continue to indicate encouraging CNS profile in patients dosed with...Read more


Passage Bio Presents Additional Interim Data from Imagine-1 Study for GM1 Gangliosidosis at 19th Annual WORLDSymposium™ 2023

February 24
Last Trade: 0.97 -0.009 -0.92

Additional interim biomarker and efficacy data from first six patients continue to demonstrate both the high and low dose of PBGM01 led to a biological effect in patients PBGM01 administration resulted in stabilization of MRI severity scores in all treated patients through 6 to twelve months of follow-up PHILADELPHIA, Feb. 24, 2023 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company...Read more


Enlivex Therapeutics Receives Clearance From Spanish Agency of Medicines and Medical Devices For Treatment of Patients with Advanced Solid Malignancies in the Ongoing Allocetra Phase I/II Clinical Trial

February 23
Last Trade: 2.65 0.11 4.13

Nes-Ziona, Israel, Feb. 23, 2023 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has authorized the expansion of the Company’s Phase I/II of AllocetraTM in patients with advanced solid malignancies. The clearance of the Phase I/II by the AEMPS follows recent...Read more


Denali Therapeutics Announces New Interim Data from DNL310 Phase 1/2 Study for MPS II and DNL126 Preclinical Data for MPS IIIA at WORLDSymposium™

February 22
Last Trade: 31.52 0.60 1.94

Over 49 weeks of DNL310 (ETV:IDS) treatment in the Phase 1/2 study, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive capabilities) scores and global impression scales were observed Interim Phase 1/2 data also suggest that DNL310 improves hearing, as assessed by auditory brainstem response testing Additional biomarker data out to 49 weeks continue to...Read more


4D Molecular Therapeutics Presents Interim Data from 4D-310 INGLAXA Phase 1/2 Clinical Trials & Development Plans for Fabry Disease Cardiomyopathy at WORLDSymposium™

February 22
Last Trade: 18.36 0.28 1.55

All three patients with 12 months of follow-up demonstrated improvement in multiple FDA-recommended cardiac endpoints at relatively low dose of 1E13 vg/kg Cardiac biopsy demonstrated selective and widespread transgene expression within ~50% of cardiomyocytes Engaging with FDA to lift clinical hold and resume enrollment with updated exclusion criteria and highly effective rituximab/sirolimus immunosuppressive regimen to reduce risk of...Read more


Sangamo Therapeutics Announces Evidence of Clinical Benefit in Phase 1/2 STAAR Study in Fabry Disease

February 22
Last Trade: 1.15 0.04 3.60

BRISBANE, Calif. / Feb 22, 2023 / Business Wire / Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced updated preliminary data as of the October 20, 2022 cutoff date from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease. These data, which present new biomarker data and results from the first...Read more


BiomX Announces Positive Results from Part 1 of the Phase 1b/2a Study Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

February 22
Last Trade: 0.38 -0.04 -10.21

BX004 therapy safe and well-tolerated across all patients and dose levels Preliminary signals of efficacy also observed, with notable reductions in bacterial burden Dosing in patients in Part 2 initiated, results expected in Q3 23 Company to host webcast/cc to discuss Part 1 data today at 9:00 am ET CAMBRIDGE, Mass. and NESS ZIONA, Israel, Feb. 22, 2023 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the...Read more


Clearside Biomedical Announces Positive Data Presentations on CLS-AX OASIS Clinical Trial and Use of SCS Microinjector® Presented at the Angiogenesis and Macula Society Annual Meetings

February 21
Last Trade: 1.15 0.03 2.68

CLS-AX OASIS Results Show Favorable Safety Data, Durability and Biologic Effect Over 6 Months in Treatment-Experienced Anti-VEGF Sub-Responders  SCS Microinjector® Featured in Favorable Data Presentations Related to Multiple Therapies in Clinical Development  ALPHARETTA, Ga., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of...Read more


Jasper Therapeutics Announces Positive Follow-up Clinical Data from Investigator-Sponsored Study of Briquilimab Conditioning in Fanconi Anemia Patients at the 2023 Transplantation & Cellular Therapy Meetings of the ASTCT and CIBMTR

February 17
Last Trade: 1.62 -0.03 -1.82

Both Fanconi Anemia patients treated with briquilimab successfully engrafted with neutrophil engraftment within 11 days 100% total donor chimerism was achieved through six months for the first patient and through three months for the second patient Both patients are doing well post-transplant with briquilimab-based conditioning REDWOOD CITY, Calif., Feb. 17, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR)...Read more


Theriva Biologics Announces Presentation of Safety and Pharmacokinetic Data from Cohort 1 of the Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients

February 16
Last Trade: 0.64 0.0009 0.14

Data presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Analysis of patients receiving meropenem suggest that SYN-004 is well-tolerated with HCT and was not observed in blood samples from the majority of the evaluable patients ROCKVILLE, Md., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage...Read more


First AML Patient Transplanted with Vor Bio’s Trem-cel Demonstrated Durable Engraftment through Multiple Mylotarg™ Cycles at Initial Dose Level

February 16
Last Trade: 4.85 0.11 2.32

Trem-cel exhibited robust engraftment five months post-transplant through three cycles of Mylotarg Mylotarg treatment enriched CD33-negative donor hematopoiesis Second patient successfully received trem-cel transplant and achieved neutrophil engraftment and platelet recovery CAMBRIDGE, Mass., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, presented clinical data from...Read more


Inozyme Pharma Reports Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701

February 16
Last Trade: 6.43 0.06 0.94

Rapid, significant, and sustained increase in plasma pyrophosphate (PPi) observed and encouraging patient reported outcome data in all dose cohorts in ENPP1 Deficiency trial  Rapid and significant increase in PPi observed in all dose cohorts with sustained increase observed in highest dose cohort in ABCC6 Deficiency (PXE) trial  INZ-701 was generally well-tolerated and exhibited a favorable safety profile in both...Read more


INOVIO Announces Positive Preliminary Results from Second Cohort of Phase 1/2 Trial with INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis

February 16
Last Trade: 0.58 0.0069 1.21

10 of 11 patients (91%) had a reduction in number of surgical interventions, measured from Day 0 to one year following initial treatment; 4 of the 10 patients did not need any surgery Treatment with INO-3107 achieved statistical significance based on clinical endpoint of reduction in overall number of surgical interventions compared with previous year INO-3107 was well-tolerated and immunogenic, with efficacy and safety results for...Read more


LAVA Therapeutics Announces Initial Data from the Ongoing Phase 1/2a Clinical Trial of LAVA-1207 in Therapy Refractory mCRPC at the 2023 ASCO GU Symposium

February 16
Last Trade: 2.60 0.70 36.84

Favorable safety profile to date, with no occurrence of high-grade (>2) cytokine release syndrome or dose-limiting toxicities Preliminary signs of anti-tumor activity were observed, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients at week 8 and PSA levels stabilizing or decreasing in heavily pre-treated patients Dose escalation is ongoing UTRECHT, The Netherlands and PHILADELPHIA, Feb. 16, 2023 (GLOBE...Read more


Jasper Therapeutics Announces Positive Follow-up Clinical Data from Investigator-Sponsored Study of Briquilimab Conditioning in Sickle Cell Disease Patients

February 16
Last Trade: 1.62 -0.03 -1.82

First two sickle cell disease participants have achieved 100% donor myeloid chimerism through 100 days follow-up Third sickle cell disease participant has now achieved 100% donor myeloid chimerism through 30 days follow-up All three participants have increased their hemoglobin at last follow-up relative to baseline REDWOOD CITY, Calif., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a...Read more


Immix Biopharma Subsidiary Nexcella Enters into U.S. GMP Manufacturing Agreement to Expand Ongoing NXC-201 Phase 1b/2 Clinical Trial to the U.S.

February 15
Last Trade: 2.04 0.05 2.51

Nexcella, Inc. initiates process of bringing NXC-201 to the United States by entering into an agreement with a well-known GMP cell therapy manufacturer that will supply Phase 1b/2 NXC-201 clinical trial material NXC-201 is in development for the treatment of patients with relapsed or refractory multiple myeloma and light chain (AL) amyloidosis Nexcella believes recently reported Phase 1b data from the ongoing Phase 1b/2 clinical trial...Read more


Bicycle Therapeutics Announces Phase I Dose Escalation Results from Ongoing Phase I/II Study of BT8009

February 14
Last Trade: 25.26 0.96 3.95

CAMBRIDGE, England & BOSTON / Feb 14, 2023 / Business Wire / Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced monotherapy Phase I dose escalation results of the ongoing Phase I/II trial of BT8009, a novel BTC™ targeting Nectin-4. The results will be presented at the 2023 American...Read more


Blueprint Medicines Announces Partial Clinical Hold for Phase 1/2 VELA Trial of BLU-222

February 10
Last Trade: 58.22 1.43 2.52

CAMBRIDGE, Mass., Feb. 10, 2023 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) today announced that the U.S. Food and Drug Administration (FDA) verbally informed the company on February 8, 2023 that it has placed a partial clinical hold on the Phase 1/2 VELA trial of BLU-222 due to visual adverse events (AEs) observed in a limited number of patients. Patients currently enrolled in the trial are continuing on study drug at...Read more


Gilead: Kite’s Tecartus® CAR T-Cell Therapy Demonstrates Overall Survival Benefit in Three-Year Follow-up of Pivotal ZUMA-3 Trial in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

February 9
Last Trade: 77.89 1.68 2.20

SANTA MONICA, Calif. / Feb 09, 2023 / Business Wire / Kite, a Gilead Company (Nasdaq: GILD), today announced the three-year follow-up results from the pivotal ZUMA-3 study of the CAR T-cell therapy Tecartus® (brexucabtagene autoleucel). Results from the analysis showed a median overall survival (OS) of 26 months and demonstrated that responses remained durable in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R...Read more


Astria Therapeutics Initiates ALPHA-STAR Phase 1b/2 Clinical Trial of STAR-0215 in People with HAE

February 8
Last Trade: 11.35 -0.10 -0.87

BOSTON / Feb 08, 2023 / Business Wire / Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today announced the initiation of the ALPHA-STAR Phase 1b/2 clinical trial of STAR-0215 in people living with HAE. Initial proof-of-concept results in HAE patients from...Read more


Creative Medical Technology Holdings Announces IRB Approval for FDA Cleared Phase 1/2 Clinical Trial of Novel Cell Therapy for the Treatment of Type 1 Diabetes

February 8
Last Trade: 0.58 -0.0001 -0.02

Company reaches next clinical trial milestone for treatment of Type 1 Diabetes with the first novel allogenic cellular therapy in the dorsal artery of the pancreas in the United States PHOENIX, Feb. 8, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced...Read more


Immix Biopharma Announces Dosing of First 2 Patients in its IMX-110 + BeiGene/Novartis anti-PD-1 Tislelizumab Phase 1b/2a Combination Clinical Trial in Patients with Advanced Cancer

February 7
Last Trade: 2.04 0.05 2.51

IMX-110 + Beigene/Novartis anti-PD-1 Tislelizumab combination designed to enhance response to solid tumors by turning immunologically “cold” tumors “hot” Initial data anticipated in 1H 2023 LOS ANGELES, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and...Read more


GeoVax Labs Expands Gedeptin® Clinical Research for Advanced Head and Neck Cancers

February 7
Last Trade: 0.62 -0.0057 -0.91

Phase 1/2 Trial Now Active at Stanford, Emory, and Thomas Jefferson Universities ATLANTA, GA, Feb. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced today its clinical trial of Gedeptin® for patients with recurrent head and neck cancers is now actively enrolling patients at three major...Read more


NeoGenomics: RaDaR(R) Assay Demonstrates Clinical Potential for Helping Oncologists Determine Whether or Not Muscle-Invasive Bladder Cancer Patients Undergo Radical Surgery

February 6
Last Trade: 17.98 0.33 1.87

Newly-published data shows a strong link between tumor DNA circulating in blood and patient responses to investigational neoadjuvant treatment with immune therapies FT. MYERS, FL / ACCESSWIRE / February 6, 2023 / NeoGenomics, Inc. (NASDAQ:NEO), a leading provider of oncology testing and global contract research services, today announced results of a new study of the RaDaR® assay in patients with muscle-invasive bladder cancer...Read more


Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-MMP7 for Treatment of Idiopathic Pulmonary Fibrosis

February 2
Last Trade: 36.05 1.38 3.98

PASADENA, Calif. / Feb 02, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) announced today that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-MMP7, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce the expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF). “MMP7 is thought to play multiple roles in IPF...Read more


Clearside Biomedical Announces Positive 6-Month Results from OASIS Extension Study with Suprachoroidal CLS-AX (axitinib injectable suspension) in Wet AMD

February 2
Last Trade: 1.15 0.03 2.68

 Suprachoroidal CLS-AX Resulted in Favorable Safety Data, Durability and Biologic Effect Over 6 Months in Treatment-Experienced Anti-VEGF Sub-Responders   67% of Extension Study Participants Went at Least 6 Months Without Needing Additional Treatment  Extension Participants Experienced a 77 - 85% Reduction in Treatment Burden Over 6 Months  Webcast and Conference Call Today at 8:30 A.M. ET Hosted by...Read more


C4 Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating CFT1946, an Orally Bioavailable BiDAC™ Degrader, in BRAF V600 Mutant Solid Tumors

January 30
Last Trade: 3.39 0.03 0.89

WATERTOWN, Mass., Jan. 30, 2023 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the first patient has been dosed in its Phase 1/2 clinical trial of CFT1946, an orally bioavailable mutant-selective BiDAC™...Read more


Aptose Biosciences Initiates Dosing of Tuspetinib in APTIVATE Expansion Trial in Patients with Acute Myeloid Leukemia

January 30
Last Trade: 0.43 0.00 0.00

•  AML Patients Receive Tuspetinib Monotherapy to Kick Off APTIVATE Phase 1/2 Trial•  New Response Emerges with 40 mg Tuspetinib in FLT3 Wildtype AML Patient•  Aptose Elucidates Rationale for Tuspetinib’s Superior Safety Profile SAN DIEGO and TORONTO, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. (“Aptose”) (NASDAQ: APTO, TSX: APS) today announced the 120 mg monotherapy dosing of patients in the...Read more


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C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...

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