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FibroGen Announces Presentation of Positive Interim Data from the Phase 1b Study of FG-3246 (FOR46) in Combination with Enzalutamide in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) at the 2024 American Society of Clinical Oncology...

May 23
Last Trade: 1.30 0.02 1.56

FG-3246 and enzalutamide combination therapy led to a median radiographic progression free survival (rPFS) of 10.2 months in biomarker unselected patients FG-3246 demonstrated an acceptable safety profile; adverse events consistent with those observed in other antibody drug conjugate therapies with a MMAE payload Recommended Phase 2 dose of FG-3246 was established at 2.1 mg/kg every 3 weeks in combination with enzalutamide given at...Read more


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

May 23
Last Trade: 3.90 0.04 1.04

Eight of nine patients responding to the treatment, plus the encouraging safety data observed in the RESOLVE Phase 1b/2a trial of EP-104GI, provided the catalyst for the trial expansion Early low-dose cohorts showing meaningful improvement in patient symptoms and biological evidence of disease Trial expansion allows more patients to be treated at higher doses and followed for up to 52 weeks, up from 24 weeks VICTORIA, BC, May 23,...Read more


Verastem Oncology Announces Positive Initial Interim Safety and Efficacy Results from RAMP 205 Trial Evaluating Avutometinib Plus Defactinib in Combination with Gemcitabine and Nab-paclitaxel in First-Line Metastatic Pancreatic Cancer​

May 23
Last Trade: 4.12 -8.06 -66.17

83% (5/6) of patients achieved a confirmed partial response in cohort 1, the most mature dose level; one dose-limiting toxicity was observed, however, the dose level was subsequently cleared after additional patients were enrolled Follow up of patients in the additional dose and schedule cohorts is ongoing to determine the recommended Phase 2 dose​ for study expansion Poster presentation on Saturday, June 1, 2024 at the ASCO Annual...Read more


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

May 21
Last Trade: 3.90 0.04 1.04

Trial's first and second cohorts maintaining signs of potential efficacy out to 24 weeks Data from  the second cohort showed improvements in eosinophil counts and histological scores out to 12 weeks suggesting a dose response over the first cohort Data from the trial's third cohort suggest improvements in patient-reported symptoms and histological outcomes at 12 weeks EP-104GI showed an encouraging safety profile in all three...Read more


Dyne Therapeutics Announces New Clinical Data from ACHIEVE Trial of DYNE-101 in DM1 and DELIVER Trial of DYNE-251 in DMD Demonstrating Compelling Impact on Key Disease Biomarkers and Improvement in Multiple Functional Endpoints

May 20
Last Trade: 31.22 -0.03 -0.10

In Phase 1/2 ACHIEVE Trial, DYNE-101 Demonstrated Dose Dependent 27% Mean Splicing Correction Across All Patients in the 5.4 mg/kg Cohort at 3 Months  DYNE-101 Showed Improvement in Myotonia, Muscle Strength, and Timed Function Tests and in DM1-ACTIVc and MDHI Patient Reported Outcomes  In Phase 1/2 DELIVER Trial, DYNE-251 Showed 3.2% Mean Unadjusted (7.6% Mean Muscle Adjusted) Dystrophin Expression at 6 Months in 10 mg/kg...Read more


Avenue Therapeutics Announces Last Patient Last Visit in Phase 1b/2a Clinical Trial of AJ201 for the Treatment of Spinal and Bulbar Muscular Atrophy (Kennedy's Disease)

May 16
Last Trade: 3.62 0.00 0.00

MIAMI, May 16, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the completion of the last patient’s final visit in the Company’s Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also...Read more


Ionis Pharmaceuticals and Biogen Announce Topline Phase 1/2 Study Results of Investigational Drug in Amyotrophic Lateral Sclerosis

May 16
Last Trade: 37.28 -0.72 -1.89

Development of BIIB105, an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), will be discontinued based on data from the Phase 1/2 ALSpire study Biogen and Ionis continue their long-standing commitment to developing therapies for ALS given the devastating impact of this progressive, fatal neurodegenerative condition CARLSBAD, Calif. and CAMBRIDGE, Mass., May 16, 2024 /PRNewswire/ -- Ionis...Read more


Biogen and Ionis Pharmaceuticals Announce Topline Phase 1/2 Study Results of Investigational Drug in Amyotrophic Lateral Sclerosis

May 16
Last Trade: 217.81 -0.25 -0.11

Development of BIIB105, an investigational antisense oligonucleotide for amyotrophic lateral sclerosis (ALS), will be discontinued based on data from the Phase 1/2 ALSpire study Biogen and Ionis continue their long-standing commitment to developing therapies for ALS given the devastating impact of this progressive, fatal neurodegenerative condition CAMBRIDGE, Mass. and CARLSBAD, Calif., May 16, 2024 (GLOBE NEWSWIRE) -- Biogen Inc....Read more


Ionis Pharmaceuticals announces positive topline results from Phase 1/2a trial of ION582 for Angelman syndrome

May 16
Last Trade: 37.28 -0.72 -1.89

ION582 demonstrated consistent improvements across multiple functional domains in Angelman syndrome patients ION582 was safe and well tolerated at all dose levels Ionis plans to move ION582 into pivotal trial Detailed ION582 data to be presented at upcoming medical meeting CARLSBAD, Calif., May 16, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline data from the HALOS Phase 1/2a...Read more


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

May 15
Last Trade: 1.75 -0.03 -1.69

MALVERN, Pa., May 15, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease as a...Read more


Immix Biopharma Announces Positive NXC-201 Relapsed/Refractory AL Amyloidosis Clinical Data in ASGCT 2024 Late Breaking Oral Presentation

May 10
Last Trade: 2.25 0.13 6.13

92% (12/13) overall response rate (ORR) for relapsed/refractory AL Amyloidosis patients enrolled in NEXICART-1: 12 out of 12 patients not exposed to prior BCMA-targeted bispecific responded to NXC-201 (100% ORR), of which 9 out of 12 were complete responders (75% CRs) 1 patient with prior exposure to BCMA-targeted bispecific treatment did not respond Best responder duration of response was 28.0 months with response ongoing as...Read more


Regeneron Pharmaceuticals Latest DB-OTO Results Show Dramatically Improved Hearing to Normal Levels in a Child with Profound Genetic Deafness within 24 Weeks and Initial Hearing Improvements in a Second Child at 6 Weeks

May 8
Last Trade: 985.02 4.45 0.45

Preliminary data detailed in an ASGCT oral presentation include results for one of the youngest children in the world to receive a gene therapy for genetic deafness Ongoing Phase 1/2 CHORD trial is currently enrolling infants and children in the U.S., UK and Spain TARRYTOWN, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the investigational gene therapy DB-OTO improved...Read more


Kiora Pharmaceuticals Reports Additional Clinical Data for KIO-301 Showing a Statistically Significant Increase in Brain Activity in the Visual Cortex in Patients with Retinitis Pigmentosa

May 6
Last Trade: 0.55 0.01 2.46

Previously released ABACUS-1 clinical trial results reported KIO-301, a small molecule photoswitch, is safe, tolerable, and improved vision in patients with late-stage retinitis pigmentosa. Additional analysis of functional MRI data demonstrated a statistically significant increase in neural activity over baseline within the brain's visual processing center. The increase in observed brain activity was time-dependent and...Read more


Wave Life Sciences Announces Approval of First Clinical Trial Application for RestorAATion-2 Trial of WVE-006 in Individuals with Alpha-1 Antitrypsin Deficiency (AATD)

April 30
Last Trade: 6.22 0.13 2.13

CAMBRIDGE, Mass., April 30, 2024 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced the approval of its first clinical trial application (CTA) for its RestorAATion-2 clinical trial of WVE-006, the company’s first-in-class RNA editing oligonucleotide, which is being developed for the treatment...Read more


AIM ImmunoTech Announces First Dose Level is Generally Well-Tolerated in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic Cancer

April 29
Last Trade: 0.39 -0.01 -2.97

OCALA, Fla., April 29, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that it has taken an essential step forward in testing the combination of AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (the “DURIPANC” study). See: ClinicalTrials.gov...Read more


INmune Bio Completes First Cohort and Initiates Second Cohort of Phase 1/2 Study of INKmune™ Natural Killer Cell Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer

April 29
Last Trade: 10.11 -0.01 -0.10

Boca Raton, Florida, April 29, 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, continues to advance its Natural Killer (NK) cell therapy, INKmune™, in a Phase I/II trial for men with metastatic castration-resistant prostate cancer (mCRPC). The Company is pleased to...Read more


Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-CFB for Treatment of Complement Mediated Kidney Disease

April 24
Last Trade: 24.88 0.21 0.85

PASADENA, Calif. / Apr 24, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced today that it has dosed the first subjects in a Phase 1/2a clinical trial (NCT06209177) of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic, in up to 66 healthy volunteers and patients with complement mediated kidney disease. James Hamilton, M.D., MBA, Chief of Discovery and Translational Medicine at...Read more


CureVac Announces Start of Combined Phase 1/2 Study in Avian Influenza (H5N1); Development in Collaboration with GSK

April 24
Last Trade: 3.69 -0.28 -7.05

Phase 1 part of combined Phase 1/2 study initiated as part of pandemic preparedness against highly pathogenic avian influenza (H5N1) virus, considered to be potential future pandemic threat Study will assess monovalent vaccine candidate, encoding an influenza A H5-antigen using proprietary second-generation mRNA backbone Avian influenza is latest program progressing to clinical trials under broad infectious disease collaboration...Read more


Enlivex Therapeutics Announces Dosing of First Two Patients in its Randomized, Controlled Phase I/II Trial Evaluating Allocetra™ in Patients with Knee Osteoarthritis

April 22
Last Trade: 1.40 0.03 2.21

Nes-Ziona, Israel, April 22, 2024 (GLOBE NEWSWIRE) --  Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first two patients have been dosed in the Company’s multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis. The Phase I/II multi-center trial is...Read more


Ocugen Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 2 of Phase 1/2 ArMaDa Clinical Trial of OCU410—A Modifier Gene Therapy

April 19
Last Trade: 1.75 -0.03 -1.69

MALVERN, Pa., April 19, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an...Read more


Barinthus Biotherapeutics Announces Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus (HPV) Infections

April 18
Last Trade: 2.21 -0.05 -2.21

Primary safety endpoint met; VTP-200 was generally well-tolerated, with no treatment-related grade 3 or higher adverse events (AEs) or serious AEs (SAEs). Positive trends in clearance rate for both high-risk (hr)HPV (60%, Group 2) and cervical lesions (67%,Groups 2 and 5), were observed in the groups receiving the highest ChAdOx dose. Pooled data from the five different active dose groups demonstrated no statistically significant...Read more


Oncternal Therapeutics Announces First Patient Dosed in Fourth Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer

April 18
Last Trade: 9.21 0.11 1.21

SAN DIEGO, April 18, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors...Read more


Benitec Biopharma Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study

April 18
Last Trade: 9.26 -0.15 -1.59

First efficacy signals demonstrated for a gene therapy under development for Oculopharyngeal Muscular Dystrophy (OPMD) which affects ~15,000 patients worldwide BB-301 facilitated improvements across multiple measures of swallowing function in the first Phase 1b/2a clinical study subject as compared to pretreatment assessments conducted during the observational natural history portion of the study Virtual R&D Day being held today...Read more


Ultragenyx Pharmaceutical Announces Positive Interim Phase 1/2 Data in Patients with Angelman Syndrome After Treatment with GTX-102

April 15
Last Trade: 40.34 0.44 1.10

Expansion Cohorts showed rapid, clinically meaningful improvement across multiple domains; improvements consistent or exceeding Dose-escalation Cohorts data at Day 170 Additional long-term data in Dose-escalation Cohorts showed increasing and sustained clinical benefit through Day 758 Company will host investor call at 8:00 a.m. ET NOVATO, Calif., April 15, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)...Read more


Boundless Bio Announces First Patient Dosed in First-in-Human Phase 1/2 Clinical Trial of BBI-825 in Cancer Patients with Resistance Gene Amplifications

April 11
Last Trade: 11.31 0.79 7.51

STARMAP (Study Treating Acquired Resistance: MAPK Amplifications) is a first-in-human, 3-part, Phase 1/2 study of BBI-825 as a single agent and in combination with select targeted cancer therapies BBI-825 is a novel, oral, selective ribonucleotide reductase (RNR) inhibitor and Boundless Bio’s second extrachromosomal DNA (ecDNA)-directed therapy (ecDTx) to enter clinical development Preclinically, BBI-825 has demonstrated tumor growth...Read more


Alpine Immune Sciences Shares Updated Clinical Data from Povetacicept in IgA Nephropathy

April 10
Last Trade: 64.97 0.00 0.00

Povetacicept administered subcutaneously once every four weeks continues to be well tolerated in IgA nephropathy, with UPCR reductions of greater than 60% observed at 36 weeks, associated with remission, resolution of hematuria, and stable renal function (eGFR)  Company reports successful end of phase 2 meeting with FDA, supporting advancement to a registrational, placebo-controlled phase 3 study of povetacicept in IgA nephropathy,...Read more


ALX Oncology Reports Encouraging Clinical Data of Evorpacept in Combination with Standard-of-Care in an Ongoing Phase 1/2 Clinical Trial in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (“R/R B-NHL”)

April 9
Last Trade: 13.17 -1.52 -10.35

Twenty patients with indolent (n=18) and aggressive (n=2) R/R B-NHL received evorpacept plus standard rituximab and lenalidomide (“R2”) Evorpacept plus R2 was well tolerated with a safety profile similar to historical R2 The combination achieved promising initial activity with a best overall response rate (“ORR”) of 94% and a complete response rate (“CRR”) of 83% in patients with indolent R/R B-NHL (R2 historical CRR benchmark is...Read more


Bristol-Myers Squibb: KRAZATI (adagrasib) in Combination with Cetuximab Demonstrates Clinically Meaningful Activity as a Targeted Treatment Option for Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer...

April 8
Last Trade: 41.24 -0.30 -0.72

Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program PRINCETON, N.J. / Apr 08, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced data from the cohorts of the Phase 1/ 2 KRYSTAL-1 study evaluating KRAZATI® (adagrasib) in combination with cetuximab for the...Read more


Inozyme Pharma Announces Positive Topline Data from Ongoing Phase 1/2 Trials of INZ-701 in Adults with ABCC6 Deficiency (PXE) and ENPP1 Deficiency

April 8
Last Trade: 4.57 0.01 0.22

Favorable safety and immunogenicity profile in ABCC6 Deficiency, with clinical improvements in vascular pathology, visual function and patient reported outcomes (PROs)  Natural history study highlights stroke as common feature among patients with early-onset ABCC6 Deficiency  Favorable safety, immunogenicity and clinical outcome data were maintained through 48 weeks in Cohorts 1-3 in ENPP1 Deficiency; Data from Cohort 4...Read more


Replimune: Interim Results from the ARTACUS Clinical Trial of RP1 Monotherapy in Solid Organ and Hematopoietic Cell Transplant Recipients with Skin Cancers Presented During Oral Presentation at the American Association of Cancer Research (AACR) 2024 Annua...

April 7
Last Trade: 5.22 -0.44 -7.77

SAN DIEGO, April 07, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of oncolytic immunotherapies, today announced the presentation of interim results from ARTACUS, a Phase 1/2 clinical trial evaluating RP1 monotherapy for the treatment of skin cancers in patients who have had solid organ or hematopoietic cell transplants, by Michael R....Read more


Ocugen Announces Positive Data and Safety Monitoring Board Review and Initiation of Enrollment in Medium Dose for OCU410—a Modifier Gene Therapy—in Phase 1/2 ArMaDa Study for Geographic Atrophy

April 5
Last Trade: 1.75 -0.03 -1.69

Established Low Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial DSMB Approval to Proceed with Medium Dose Cohort Dosing Malvern, Pa., April 05, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the...Read more


Achilles Therapeutics Provides Interim Phase I/IIa Update on Clonal Neoantigen Reactive T Cells in Advanced NSCLC and Melanoma Including First Patients Dosed with Enhanced Host Conditioning

April 4
Last Trade: 0.91 0.01 1.53

Improved VELOS™ manufacturing process delivering higher cNeT doses  Protocols updated to evaluate the benefit of enhanced host conditioning, with further data expected in 2H 2024  First three patients dosed in CHIRON and THETIS with enhanced host chemo-conditioning, along with IL-2 aligned to standard TIL therapy, show improved cNeT persistence and engraftment  LONDON, April 04, 2024 (GLOBE NEWSWIRE) -- Achilles...Read more


4D Molecular Therapeutics Announces Update on Regulatory Interactions and Development Path for 4D-710 for Treatment of Cystic Fibrosis

March 28
Last Trade: 25.15 0.00 0.00

Conducted initial pivotal study interactions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA); Company has clear registration path for 4D-710 for treatment of cystic fibrosis (CF) lung disease in people with CF (pwCF) who are ineligible for or cannot tolerate approved CF modulator therapies AEROW clinical trial Phase 2 Expansion Cohort dose selection and initiation expected in Q2 2024, with...Read more


Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

March 27
Last Trade: 1.39 -0.03 -2.11

Deep Cyclic Inhibitor of the MAPK pathway demonstrated strong tumor growth inhibition in preclinical studies of RAF or RAS mutant tumors, both as monotherapy and in combination  Phase 1 portion of the Phase 1/2a trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of IMM-6-415 and establish a candidate recommended Phase 2 dose (RP2D)  Initial PK, PD and safety data expected in...Read more


Stoke Therapeutics Announces Landmark New Data That Support the Potential for STK-001 to be the First Disease-Modifying Medicine for the Treatment of Patients with Dravet Syndrome

March 25
Last Trade: 14.41 -0.30 -2.04

Phase 1/2a End of Study Data: 70mg doses demonstrated substantial and sustained reductions in convulsive seizure frequency on top of the best available anti-seizure medicines; Median reductions of 85% (n=10) at 3 months and 74% (n=9) at 6 months after last dose  Open Label Extension Studies: Durable reductions in seizures and clinically meaningful improvements in multiple measures of cognition and behavior were maintained over 12...Read more


Astria Therapeutics Announces Positive Initial Proof-of-Concept Results from the ALPHA-STAR Phase 1b/2 Trial of STAR-0215 for HAE

March 25
Last Trade: 9.02 0.00 0.00

STAR-0215 Dosed Once or Twice Over 6 Months Reduced Monthly Attack Rates by 90-96%, Supporting Chronic Dosing 2 or 4 Times Per Year  92-100% Decrease in Moderate or Severe Attacks and 91-95% Reduction in Attacks Requiring Rescue Medications with STAR-0215  Very Well-Tolerated with No Serious Adverse Events and No Discontinuations  Phase 3 Initiation on Track for Q1 2025, with Top-Line Results Expected by Year End...Read more


Moleculin Biotech Announces Positive Interim Data in Annamycin MB-106 Phase 1B/2 AML Trial

March 25
Last Trade: 4.93 -0.22 -4.27

Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 60% (50% CR) in 2nd line AML subjects AnnAraC has potential to fill significant unmet need and expected to increase 2nd line AML CRs more than double over existing 2nd line therapies All 82 Annamycin subjects (in multiple studies) continue to show no signs of cardiotoxicity during study; Lower toxicity profile than traditional intensive therapy Annamycin is...Read more


Acelyrin Announces Positive Phase 1/2 Proof-of-Concept Data for Lonigutamab, First Subcutaneous Anti-IGF-1R to Demonstrate Clinical Responses in Thyroid Eye Disease

March 20
Last Trade: 4.13 -0.09 -2.13

Rapid improvements demonstrated for proptosis, clinical activity scores, and diplopia versus placebo with a favorable safety profile Phase 2b/3 trial to be initiated in the second half of 2024 Conference call to review these data to be held at 8:30 a.m. ET today LOS ANGELES, March 20, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery...Read more


Jasper Therapeutics Announces First Patient Dosed in Phase 1b/2a SPOTLIGHT Clinical Study of Briquilimab in Chronic Inducible Urticaria

March 19
Last Trade: 23.92 0.10 0.42

REDWOOD CITY, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) in mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), today announced that the first patient has been dosed in Jasper’s Phase 1b/2a (SPOTLIGHT) clinical study of...Read more


Nuvation Bio Doses First Patient in Phase 1/2 Study of NUV-1511 for the Treatment of Advanced Solid Tumors

March 14
Last Trade: 3.08 0.00 0.00

NUV-1511 is the Company’s first drug-drug conjugate (DDC) to enter the clinic NEW YORK / Mar 14, 2024 / Business Wire / Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic. “Dosing...Read more


Immuneering Announces Positive Topline Results from Phase 1 Portion of its Phase 1/2a Clinical Trial of IMM-1-104 in RAS-Mutant Solid Tumors

March 14
Last Trade: 1.39 -0.03 -2.11

IMM-1-104 has been well-tolerated, demonstrating the potential for a differentiated safety profile  100% suppression of acquired RAS alterations was observed in evaluable patients profiled for ctDNA and treated with IMM-1-104, supporting goal of Universal-RAS activity  Target lesion regression observed in over half of patients treated with IMM-1-104 at 320mg or 240mg QD, with best individual lesion regression of -35.7% and...Read more


Clearmind Medicine Obtains Clearance for its Psychedelic- Based Alcoholism Clinical Trial

March 13
Last Trade: 1.15 0.03 2.22

Vancouver, Canada, March 13, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a clinical- stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, announced that it has received approval from the Israeli Ministry of Health to commence its phase I/IIa clinical trial for alcohol use...Read more


Ocugen Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410

March 13
Last Trade: 1.75 -0.03 -1.69

MALVERN, Pa., March 13, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an...Read more


Kineta: KVA12123 Clears Additional Cohorts in Monotherapy and in Combination Therapy Arms in the Phase 1/2 VISTA-101 Clinical Trial; Initial Clinical Response Data Reported

March 12
Last Trade: 0.46 -0.0067 -1.43

Partial response and stable disease reported in combination cohort, and durable stable disease observed in monotherapy cohorts No dose limiting toxicities observed at any dose level Cleared fifth of six monotherapy cohorts and second of four combination cohorts Kineta is actively exploring strategic alternatives to maximize value for all stakeholders SEATTLE, March 12, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a...Read more


Sonnet BioTherapeutics Announces Early Safety Data from the Company’s Phase 1b/2a Clinical Trial of SON-080 in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Met the Study’s Initial Pre-Specified Objective

March 11
Last Trade: 1.65 0.15 10.00

Safety in the Phase 1b part of Sonnet's double-blind, randomized, controlled trial of SON‑080 was reviewed by the study's Data Safety Monitoring Board (DSMB) The adverse event profile and tolerability of SON-080 was consistent with data from previous IL-6 candidates, meeting the Phase 1b safety objective Sonnet will leverage this safety data to support initiation of a Phase 2 clinical trial in Diabetic Peripheral Neuropathy (DPN), a...Read more


Arrowhead Pharmaceuticals Initiates Phase 1/2a Study of ARO-DM1 for Treatment of Type 1 Myotonic Dystrophy

March 8
Last Trade: 24.88 0.21 0.85

- Preclinical data show ARO-DM1 reduces muscular DMPK expression and corrects spliceopathies, which could lead to improved muscle strength and function PASADENA, Calif. / Mar 08, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced today that it has dosed the first subjects in a Phase 1/2a double-blinded, placebo-controlled, dose-escalating study (NCT06138743) to evaluate single and multiple ascending doses...Read more


Precision BioSciences Announces MHRA Approval for Partner iECURE to Expand Phase 1/2 Clinical Trial of ARCUS Gene Editing Program in OTC Deficiency

March 6
Last Trade: 12.74 -0.26 -2.00

Insertion of a functional OTC gene through ARCUS in vivo gene editing may provide lasting clinical benefit for children with OTC deficiency who are in dire need for effective treatments CTA approval for ECUR-506 in the United Kingdom provides further regulatory support for Precision BioSciences’ ARCUS in vivo gene editing platform DURHAM, N.C. / Mar 06, 2024 / Business Wire / Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced...Read more


Innate Pharma: First Patient dosed in Phase 1/2 study of IPH6501 in relapsed /refractory B-Cell non-Hodgkin’s Lymphoma

March 6
Last Trade: 2.90 -0.06 -1.98

Phase 1/2 study is evaluating IPH6501, a first-in-class CD20-targeting tetraspecific natural killer cell engager, from ANKET® platform, for the treatment of CD20-expressing B-cell Non-Hodgkin's Lymphomas. MARSEILLE, France / Mar 06, 2024 / Business Wire / Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced the first patient was dosed in its Phase 1/2 multicenter trial...Read more


RegenXBio Announces New Positive Initial Efficacy Data From Affinity Duchenne® Trial

March 5
Last Trade: 14.92 -0.04 -0.27

New three-month assessment in first patient at dose level 2 demonstrates robust microdystrophin expression Patient aged 12 years at dosing had expression level at 75.7% of control Early evidence of strength and motor function improvement observed On track to initiate pivotal trial in second half of 2024 Webcast this morning, Tuesday, March 5, 8:30 a.m. ET, with principal investigator ROCKVILLE, Md., March 5, 2024...Read more


Oncolytics Biotech Files Amendment to Initiate New Pancreatic Cancer GOBLET Cohort Supported by PanCAN

March 5
Last Trade: 1.09 0.03 2.83

US$5M grant supports study of pelareorep in combination with modified FOLFIRINOX +/- atezolizumab Testing with the most common therapies could facilitate broad use of pelareorep in pancreatic cancer patients SAN DIEGO and CALGARY, AB, March 5, 2024 /CNW/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, today announced it has submitted an amendment to...Read more


Neurogene Announces Expansion and Plans for More Rapid Patient Enrollment of Rett Syndrome Gene Therapy Clinical Trial

March 4
Last Trade: 32.11 0.62 1.97

Ongoing Phase 1/2 clinical trial for NGN-401 to include additional patients in Cohort 1 and a dose-escalation cohort Both previously planned updates are expected to provide a more robust dataset to inform future registrational trial design Removal of staggered dosing in Cohort 1 expected to enable the anticipated completion of Cohort 1 dosing in the second half of 2024 Third patient dosed in Cohort 1 NEW YORK / Mar 04, 2024 /...Read more


Avidity Biosciences Announces Positive AOC 1001 Long-term Data Showing Reversal of Disease Progression in People Living with Myotonic Dystrophy Type 1 Across Multiple Endpoints; Same Key Endpoints Agreed for Phase 3 HARBOR™ Trial

March 4
Last Trade: 27.45 -0.02 -0.07

Avidity accelerates global Phase 3 HARBOR™ study initiation to Q2 2024 following regulatory agreement on study design; primary endpoint is video hand opening time (vHOT) and secondary endpoints include muscle strength and activities of daily living Delpacibart etedesiran (AOC 1001) demonstrated consistent and durable improvements in myotonia, muscle strength and activities of daily living in people with DM1 in long-term data from...Read more


Taysha Gene Therapies Announces Updates to TSHA-102 Clinical Program in Rett Syndrome

February 29
Last Trade: 3.24 0.28 9.46

REVEAL adolescent and adult trial will proceed to high dose cohort following Independent Data Monitoring Committee approval of Company’s request to initiate dose escalation; dosing of first patient in cohort two (high dose, n=3) expected in Q2 2024 REVEAL adolescent and adult trial will now expand into the U.S. following submission to FDA (age 12+ protocol) Dosing of second patient in cohort one (low dose) of REVEAL pediatric trial...Read more


Memorial Sloan Kettering Cancer Center Now Enrolling Patients in Phase 1/2 Clinical Trial of IMUNON’s IMNN-001 in Combination with Bevacizumab in Advanced Ovarian Cancer

February 27
Last Trade: 1.51 0.06 4.14

Trial will evaluate the effect of this combination therapy on minimal residual disease LAWRENCEVILLE, N.J., Feb. 27, 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, announces that Memorial Sloan Kettering Cancer Center has joined MD Anderson Cancer Center in enrolling patients in a Phase 1/2...Read more


Purple Biotech Presents Data of its Phase 1 Head & Neck Cancer of NT219 in combination with Cetuximab at ESMO TAT Congress 2024

February 27
Last Trade: 0.75 -0.06 -6.88

NT219 was well tolerated Anti-tumor activity at relevant higher dose levels observed with 29% Objective Response Rate (ORR) and 71% Disease Control Rate (DCR) REHOVOT, Israel, Feb. 27, 2024 (GLOBE NEWSWIRE) --  Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune...Read more


Clearmind Medicine Receives Approval to Commence its Phase I/IIa Clinical Trial of CMND-100 for Alcohol Use Disorder

February 23
Last Trade: 1.15 0.03 2.22

For the first time, patients with alcohol use disorder will receive the company's unique and proprietary psychedelic - MEAI Vancouver, Canada, Feb. 23, 2024 (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, is pleased to announce it...Read more


Ocugen Announces Dosing Completion of Subjects with Stargardt in Cohort 1 of Phase 1/2 Clinical Trial Evaluating the Safety and Efficacy of OCU410ST

February 22
Last Trade: 1.75 -0.03 -1.69

MALVERN, Pa., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the first cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease. Stargardt...Read more


Celcuity Announces First Patient Dosed in Phase 1b/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer

February 22
Last Trade: 15.64 -0.22 -1.39

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer...Read more


Avidity Biosciences to Present New AOC 1001 Long-term Efficacy and Safety Data from MARINA-OLE™ Trial in People Living with Myotonic Dystrophy Type 1 (DM1) at 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference

February 15
Last Trade: 27.45 -0.02 -0.07

John W. Day, MD, PhD, Professor of Neurology and Pediatrics, and Director, Division of Neuromuscular Medicine, Stanford University School of Medicine and a principal investigator in END-DM1, ongoing natural history study will join Avidity management to present data from MARINA-OLE™ Avidity to host Volume 8 of investor and analyst event series via webcast March 4, 2024, at 8:00 a.m. ET SAN DIEGO, Feb. 15, 2024 /PRNewswire/...Read more


NervGen Pharma on Track to Complete Enrollment, Deliver Data Readout in Phase 1b/2a Clinical Trial for NVG-291 in Spinal Cord Injury

February 15
Last Trade: 2.06 -0.03 -1.44

On track to complete enrollment of the chronic cohort in Q2 2024 Data readout from chronic cohort expected in Q3 2024 Planning underway to make NVG-291 available to placebo-treated subjects following cohort completion Vancouver, British Columbia--(Newsfile Corp. - February 15, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of...Read more


Dyne Therapeutics Announces Upcoming Presentations on Initial Clinical Data From its ACHIEVE Trial in DM1 Patients and DELIVER Trial in DMD Patients at the 2024 Muscular Dystrophy Association Clinical & Scientific Conference

February 14
Last Trade: 31.22 -0.03 -0.10

Presentations will Highlight Initial Data Announced in January 2024 Demonstrating Proof-of-Concept in its DM1 and DMD Programs, Validating the Promise of the FORCE™ Platform and Targeted Delivery to Muscle  Additional Data from ACHIEVE and DELIVER Trials Expected in the Second Half of 2024  WALTHAM, Mass., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (Nasdaq: DYN), a clinical-stage muscle disease company...Read more


AIM ImmunoTech Announces First Subject Dosed in the Netherlands for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi (durvalumab) for the Treatment of Pancreatic Cancer

February 14
Last Trade: 0.39 -0.01 -2.97

OCALA, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the first subject has been dosed at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC Study”). The...Read more


Carrick Therapeutics Announces First Patient Dosed in Phase 1b/2 Clinical Trial of Samuraciclib in Combination with Vepdegestrant in Patients with Advanced Breast Cancer

February 14
Last Trade: 35.23 0.00 0.00

BOSTON, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the first patient has been dosed in its Phase 1b/2 clinical trial evaluating the combination of samuraciclib (CT7001), an investigational oral and first-in-class inhibitor of CDK7, and vepdegestrant (ARV-471), an investigational oral PROTAC®...Read more


Medicenna Therapeutics Announces First Patient Dosed in ABILITY-1 Study of MDNA11 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Advanced Solid Tumors

February 13
Last Trade: 2.36 0.02 0.85

The ABILITY-1 Study is evaluating MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumors MDNA11 continues to demonstrate encouraging single-agent activity from the monotherapy dose escalation portion of the ABILITY-1 Study Company expects to report results from both the monotherapy expansion and combination escalation and expansion arms...Read more


4D Molecular Therapeutics Presents Interim Data from 4D-310 INGLAXA Phase 1/2 Clinical Trials for Fabry Disease Cardiomyopathy at WORLDSymposium™ 2024

February 12
Last Trade: 25.15 0.00 0.00

4D-310 demonstrated clinically meaningful cardiac endpoint improvements through 12-24 months in contractility (echocardiography), peak VO2 (cardiopulmonary exercise testing) and/or cardiac quality of life (KCCQ) in all five evaluable patients Cardiac biopsies were obtained from a patient at week 6 and 24 and showed robust and durable delivery, transgene expression and clearance of Gb3 substrate in cardiomyocytes No new...Read more


Nuvalent Initiates the Phase 2 Portion of ALKOVE-1 Clinical Trial for Patients with ALK-Positive NSCLC and other Solid Tumors

February 12
Last Trade: 67.95 1.27 1.90

Alignment with US Food and Drug Administration on a Recommended Phase 2 Dose for NVL-655 of 150 mg once daily Phase 2 Designed with Registrational Intent for TKI Pre-Treated Patients with ALK-Positive NSCLC and Enables Preliminary Evaluation in the TKI-naïve Setting CAMBRIDGE, Mass., Feb. 12, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted...Read more


Genenta Science Demonstrated Reprogramming of the Tumor Microenvironment in GBM Patients, Paving the Way for Innovative Treatments of Solid Tumors

February 8
Last Trade: 3.30 0.00 0.00

MILAN, Italy and NEW YORK, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Genenta Science (NASDAQ: GNTA), a clinical-stage immuno-oncology (I/O) company developing a cell-based platform harnessing the power of hematopoietic stem cells to provide durable and safe treatments for solid tumors, today announced that: We have successfully dosed the first of three patients in Cohort 8 (Temferon™ at 4x10^6/kg), the last cohort of the Phase 1 dose-ranging...Read more


REGENXBIO Announces Completion of Enrollment in Cohort 2 and Additional Positive Interim Data in AFFINITY DUCHENNE® Trial

February 7
Last Trade: 14.92 -0.04 -0.27

Completed enrollment in cohort 2 of the Phase I/II AFFINITY DUCHENNE® trial of RGX-202, a potential one-time AAV Therapeutic for the treatment of Duchenne that includes an optimized transgene for a novel microdystrophin New three-month assessment in third patient at dose level 1 demonstrates largest increase in microdystrophin expression Patient aged 6.6 years old had expression level at 83.4% of control On track to initiate...Read more


MiNK Therapeutics' AgenT-797 Shows Promising Results in the Treatment of Severe Acute Respiratory Distress, Published in Nature Communications

February 6
Last Trade: 0.96 -0.03 -2.54

NEW YORK, Feb. 06, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced the publication of results in Nature Communications from a phase 1/2 study of agenT-797 in patients with...Read more


Sangamo Therapeutics Announces Updated Phase 1/2 STAAR Study Data in Fabry Disease Showing Sustained Benefit and Differentiated Safety Profile

February 5
Last Trade: 0.60 -0.02 -3.67

Sustained elevated expression of alpha-galactosidase A (α-Gal A) activity maintained for up to three years for the longest-treated patient as of the data cutoff date. All 12 patients withdrawn from enzyme replacement therapy (ERT) remain off ERT, with sustained elevated α-Gal A activity observed for up to 19 months as of the data cutoff date. Total antibody (Ab) or neutralizing antibody (Nab) titers against α-Gal A decreased markedly in...Read more


Eupraxia Pharmaceuticals Announces Updated Positive Clinical Data in EP-104GI RESOLVE Trial for the Treatment of Eosinophilic Esophagitis

February 5
Last Trade: 3.90 0.04 1.04

No serious or treatment related adverse events in either the first or second cohort Second cohort demonstrated an average 60% reduction in Dysphasia Likert score and an average 80% reduction in Odynophagia Likert score First cohort maintaining signs of efficacy to six months Third cohort now fully dosed at five times the first cohort dose and two-and-a-half times the second cohort dose Results from third cohort are expected in the...Read more


Vaxcyte Completes Enrollment of Phase 1/2 Study Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease (IPD) in Adults Aged 50 and Older

January 29
Last Trade: 68.76 -0.51 -0.74

Topline Safety, Tolerability and Immunogenicity Data from VAX-31 Phase 1/2 Study (n=1,015) Expected in Third Quarter of 2024  VAX-31 is Designed to Provide Coverage for Approximately 95% of IPD Circulating in the U.S. Adult Population  Company’s Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise, VAX-24 and VAX-31, Intended to Deliver the Broadest-Spectrum of Coverage Against IPD  SAN CARLOS,...Read more


LIXTE Biotechnology: First Patient Dosed with LIXTE’s LB-100 and GSK’s Immunotherapy Dostarlimab-gxly in Ovarian Clear Cell Carcinoma Trial

January 29
Last Trade: 2.43 0.04 1.63

PASADENA, CA, Jan. 29, 2024 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT and LIXTW) (“LIXTE” or the “Company”), today announced the dosing of the first patient in a Phase 1b/2 clinical trial to assess whether adding LIXTE’s LB-100 to GSK’s programmed death receptor-1 (PD-1)-blocking monoclonal antibody, dostarlimab-gxly, may enhance the effectiveness of immunotherapy in the treatment of ovarian clear cell carcinoma...Read more


Moleculin Biotech Announces 2023 Year-End Annamycin Clinical Trials Preliminary Data and 2024 Expectations for Multiple Data Readouts and Transition to Pivotal Phase 2B/3

January 24
Last Trade: 4.93 -0.22 -4.27

MB-106 AML Phase 1B/2 trial (MB-106) preliminary data readout: Reached 67% recruitment MB-106 preliminary results: Intent to Treat CR rate of 40% plus a CR/ CRi rate of 47% (N=15); Dosed Per Protocol CR rate of 46% plus a CR/CRi rate of 54% (N=13) First 1st line AML subject treated and resulted in a CR in MB-106 No CR/CRi's in MB-106 have relapsed to date MB-107 STS Lung Mets Phase 1B/2 trial preliminary data readout: Phase 1B...Read more


AIM ImmunoTech Announces First Subject is Enrolled in Phase 1b/2 Study Evaluating Ampligen® in Combination with AstraZeneca’s Imfinzi® for the Treatment of Late-Stage Pancreatic Cancer

January 22
Last Trade: 0.39 -0.01 -2.97

OCALA, Fla., Jan. 22, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the first subject has been enrolled at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen® (rintatolimod) with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer (the “DURIPANC...Read more


Vor Bio Doses First AML Patient with VCAR33 (ALLO) and Provides Corporate Update

January 17
Last Trade: 1.56 -0.06 -3.42

First patient dosed in company’s second clinical program with initial data expected in second half of 2024 Cash runway extended into second half of 2025 with clinical trials on track CAMBRIDGE, Mass., Jan. 17, 2024 (GLOBE NEWSWIRE) -- Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, announced today it has dosed the first patient in VBP301, its Phase 1/2, multicenter, open-label, first-in-human study of...Read more


Kineta Provides Update on its Ongoing Phase 1/2 VISTA-101 Clinical Trial of KVA12123 in Patients with Advanced Solid Tumors

January 17
Last Trade: 0.46 -0.0067 -1.43

Cleared First Four Monotherapy Doses and Initial Combination Cohort with No Dose Limiting Toxicities at any Dose Level KVA12123 Monotherapy Demonstrated Dose Proportional Induction of Pro-inflammatory Biomarkers Required for Strong Anti-tumor Activity Additional Monotherapy Clinical Efficacy Data and Initial Combination Clinical Data Anticipated in Q2 2024 SEATTLE, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Kineta, Inc. (Nasdaq: KA), a...Read more


Elicio Therapeutics to Present ELI-002 7P (AMPLIFY-7P) Trial in Progress Poster on Phase 1/2 Study of Lymph Node-Targeted Vaccine at ASCO GI Symposium

January 17
Last Trade: 8.41 -0.44 -4.97

AMPLIFY-7P study builds on preliminary positive findings from the 2-peptide formulation of ELI-002 published in Nature Medicine demonstrating tumor biomarker reduction, with strong T cell responses that correlated with reduced risk of relapse and death ELI-002 7P is a 7-peptide formulation of the therapeutic cancer vaccine designed to stimulate an immune response against the seven KRAS mutations that drive 25% of all solid tumors,...Read more


Perspective Therapeutics Commences Recruitment for Second Dose Escalation Cohorts in Clinical Studies of Two Lead Programs: [(212)Pb]VMT-α-NET and [(212)Pb]VMT01

January 17
Last Trade: 1.49 -0.02 -1.32

SEATTLE, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (NYSE AMERICAN: CATX), today announced that it began patient recruitment for the second dosing cohorts (Cohort 2) in clinical studies for both of its lead product candidates, [212Pb]VMT-α-NET and [212Pb]VMT01, after the safety monitoring committees for each study unanimously recommended moving forward. In addition, the first patient in cohort 2 of the [212Pb]VMT01...Read more


Enlivex Therapeutics Receives IMOH Regulatory Authorization for the Initiation of a Multi-Country, Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Up To 160 Patients with Moderate to Severe Knee Osteoarthritis

January 17
Last Trade: 1.40 0.03 2.21

Second study of Allocetra in knee osteoarthritis, following the on-going Phase I/II trial in pre-surgery, end-stage osteoarthritis, that is continuing to enroll patients Nes-Ziona, Israel, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Israeli Ministry of Health (IMOH) authorized the initiation of a...Read more


AIM ImmunoTech Announces Open Enrollment for Phase 1b/2 Study Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi® (durvalumab) for the Treatment of Pancreatic Cancer

January 10
Last Trade: 0.39 -0.01 -2.97

First enrollment and first subject dosing expected soon at Erasmus Medical Center in Rotterdam, Netherlands Management discusses the announcement and what this means here: video OCALA, Fla., Jan. 10, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that enrollment is open at Erasmus Medical Center (“Erasmus MC”) in a Phase 1b/2 clinical trial combining AIM’s Ampligen®...Read more


Taysha Gene Therapies Announces First Pediatric Patient Dosed with TSHA-102 in REVEAL Phase 1/2 Pediatric Trial in Rett Syndrome

January 10
Last Trade: 3.24 0.28 9.46

Initiation of REVEAL pediatric trial in the U.S. broadens the clinical evaluation of TSHA-102 to female patients 5-8 years old with stage three Rett syndrome MHRA authorized the CTA for TSHA-102 in pediatric patients with Rett syndrome, enabling expansion of ongoing U.S. REVEAL pediatric trial into the U.K. TSHA-102 clinical program now includes broad evaluation across pediatric, adolescent and adult patients in three countries...Read more


Medicenna Therapeutics Commences Enrollment in the ABILITY-1 Study Combining MDNA11 with Pembrolizumab

January 9
Last Trade: 2.36 0.02 0.85

The ABILITY-1 Study will evaluate MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumors MDNA11 continues to demonstrate encouraging single-agent activity from the dose escalation portion of the ABILITY-1 Study MDNA11 is generally well tolerated with no dose-limiting toxicities or vascular leak syndrome reported in any of the dose...Read more


Affimed Provides Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer

January 8
Last Trade: 4.19 -0.52 -11.04

Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohort Follow-up shows three of the initially reported responses have now been confirmed (1 CR, 2 PR) and one still awaiting a confirmatory scan Study to be expanded to a total of 40 EGFRwt NSCLC patients Enrollment in the EGFR-mutant (mut) NSCLC cohort is...Read more


Oncternal Therapeutics Enrolls Patients into the Third Dosing Cohort of its Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer

January 8
Last Trade: 9.21 0.11 1.21

SAN DIEGO, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the fourth patient has now been enrolled into its Phase 1/2 study of ONCT-534, its dual-action androgen receptor inhibitor, for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved...Read more


Vaxcyte Provides Clinical and Regulatory Progress Update on Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV) Franchise

January 4
Last Trade: 68.76 -0.51 -0.74

Company Doses First Participants in Phase 2 Portion of Ongoing VAX-31 Phase 1/2 Study in Adults Following Independent Review of Phase 1 Safety and Tolerability Data; Topline Safety, Tolerability and Immunogenicity Data Expected in Third Quarter of 2024  Following Successful End-of-Phase 2 Meeting with FDA, Company Planning for Initiation of VAX-24 Adult Phase 3 Pivotal, Non-Inferiority Study in Second Half of 2024; Topline...Read more


GeoVax Labs Announces Gedeptin® Patient Enrollment Closure for Phase 1/2 Clinical Trial Among Advanced Head and Neck Cancer Patients

January 4
Last Trade: 1.74 0.05 2.96

Therapy Demonstrated Safety, Stabilization/Shrinkage of Treated Tumors Expanded Development for Monotherapy and Combination Therapy Anticipated ATLANTA, GA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the closure of patient enrollment for the Phase 1/2 clinical study...Read more


Medivir´s licensee, Tango Therapeutics, has dosed the first patient with TNG348, a novel USP1 inhibitor, in a phase 1/2 clinical study

January 4
Last Trade: 6.91 -0.18 -2.54

STOCKHOLM, Jan. 4, 2024 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that Medivir's licensee, Tango Therapeutics (NASDAQ: TNGX; Tango), has dosed the first patient with TNG348, a novel USP1 inhibitor. Tango received U.S. Food and Drug Administration clearance on its Investigational New Drug...Read more


Investigator-Initiated Phase 1/2 Clinical Trial Using Salarius Pharmaceuticals’ Seclidemstat in Combination with Azacitidine to Treat Hematologic Cancers Resumes Patient Enrollment

January 3
Last Trade: 0.48 0.0098 2.07

HOUSTON, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Salarius Pharmaceuticals, Inc. (Nasdaq: SLRX) announces that the hematologic cancer Phase 1/2 clinical trial being conducted at the University of Texas MD Anderson Cancer Center (MDACC or MD Anderson) is now listed as active and recruiting on clinical trials.gov – trial NCT04734990. Salarius also announces that an additional Ewing sarcoma patient treated with seclidemstat, topotecan and...Read more


Ultragenyx Pharmaceutical Announces Completion of Enrollment in Global Phase 1/2 Trial of GTX-102 in Pediatric Patients with Angelman Syndrome

January 3
Last Trade: 40.34 0.44 1.10

NOVATO, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, today announced the completion of patient enrollment in its Phase 1/2 clinical trial of GTX-102 for the treatment of pediatric patients with Angelman syndrome (AS). The dose-expansion cohorts (Cohorts...Read more


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