Latest Clinical Trials Stock News

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Apellis Pharmaceuticals: Positive One-Year Data from Phase 2 Study of Pegcetacoplan in Post-Transplant Recurrence of C3G and IC-MPGN Presented as Late-Breaker at ERA Congress

May 24
Last Trade: 40.61 0.93 2.34

Rapid reduction in disease activity seen at 12 weeks was sustained at one year 55% of patients showed zero C3c staining intensity, indicating that C3c deposits were cleared Highlighted as late-breaking oral presentation at the European Renal Association (ERA) Congress WALTHAM, Mass. and STOCKHOLM, Sweden, May 24, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today announced...Read more

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

Supernus Pharmaceuticals Announces Promising Interim Data from Ongoing Open-Label Phase 2a Study of SPN-817 in Epilepsy

May 23
Last Trade: 27.51 -0.26 -0.94

 SPN-817 is a novel, first-in-class highly selective acetylcholinesterase (AChE) inhibitor for epilepsy Company to host webcast today at 4:30 p.m. ET to discuss the interim data ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced...Read more

Kymera Therapeutics Presents New Preclinical Data for KT-621, a First-In-Class, Oral STAT6 Degrader at the ATS Annual Meeting

May 22
Last Trade: 34.05 -0.19 -0.55

KT-621, a potent, selective, oral STAT6 degrader, demonstrated comparable or superior activity to dupilumab in preclinical studies including an asthma model shared at the ATS Annual Meeting Additional KT-621 preclinical data was also featured in a poster presentation at Digestive Disease Week KT-621 expected to start Phase 1 in the second half of 2024, with Phase 1 data in the first half of 2025 WATERTOWN, Mass., May 22, 2024...Read more

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

May 22
Last Trade: 1.56 -0.11 -6.59

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

NanoVibronix Announces Commencement of UroShield Clinical Study at the University of Michigan

May 22
Last Trade: 0.78 0.03 4.16

ELMSFORD, N.Y. / May 22, 2024 / Business Wire / NanoVibronix, Inc. (Nasdaq: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that the University of Michigan will begin the pilot phase of its clinical trial of UroShield this week. The “pilot” phase of the study is the first component of the broader study. As...Read more

Adlai Nortye Announces First Patient Dosed in Randomized Phase II Clinical Trial of Palupiprant (AN0025) for the Treatment of Locally Advanced Rectal Cancer with Radiation Therapy

May 22
Last Trade: 10.50 -1.53 -12.72

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, May 22, 2024 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, recently announced that the first patient was dosed in the Phase II clinical trial known as ARTEMIS (Augmenting RadioTherapy in REctal Cancer to Minimise Invasive Surgery). This clinical...Read more

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

May 22
Last Trade: 2.34 -0.02 -0.85

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

Zai Lab Initiates Global Phase 2 Clinical Trial Evaluating ZL-1102 As a Topical Treatment for Chronic Plaque Psoriasis

May 22
Last Trade: 17.92 -1.14 -5.98

This is the first compound in Zai’s portfolio of internally developed drugs to advance into Phase 2, demonstrating Zai’s global capabilities Based on a proof-of-concept study, ZL-1102 is the first topical biologic to show penetration of psoriatic skin resulting in a clinical response SHANGHAI & CAMBRIDGE, Mass. / May 22, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the first patient has...Read more

Scholar Rock Announces Initiation of Phase 2 EMBRAZE Trial of Apitegromab in Obesity and New Preclinical Data Supporting SRK-439 in Obesity

May 22
Last Trade: 10.67 -0.12 -1.11

Phase 2 EMBRAZE proof-of-concept trial designed to assess apitegromab's ability to safely preserve lean muscle mass in individuals on GLP-1 receptor agonist therapy for obesity New preclinical head-to-head comparison shows that SRK-439 is more potent than an anti-ActRII antibody in maintaining lean mass in diet-induced obesity (DIO) mice; lean mass loss with SRK-439, 1mg/kg dose was equivalent to anti-ActRII antibody, 20mg/kg...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

Rezolute Reports Positive Topline Results from Phase 2 Proof of Concept Study of RZ402 in Patients with Diabetic Macular Edema (DME)

May 21
Last Trade: 3.56 0.50 16.34

Met primary study endpoints: good safety profile and reduction in central subfield thickness (CST) First oral therapy to demonstrate reduction in macular edema; supports potential for early disease intervention Virtual investor event to be held today at 5:30pm ET REDWOOD CITY, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a clinical-stage biopharmaceutical company...Read more

More than one-half of patients with Crohn's disease treated with Eli Lilly's mirikizumab achieved clinical remission at one year, including patients with previous biologic failure

May 21
Last Trade: 807.43 -1.02 -0.13

Nearly one-half of patients on mirikizumab achieved endoscopic response at 52 weeks; most of these patients were also in clinical remission INDIANAPOLIS, May 21, 2024 /PRNewswire/ -- In Eli Lilly and Company's (NYSE: LLY) pivotal Phase 3 VIVID-1 study, patients with moderately to severely active Crohn's disease, with or without previous biologic failure, achieved statistically significant and clinically meaningful...Read more

Aligos Therapeutics Announces the Completion of Enrollment in the ALG-055009 Phase 2a HERALD Study for the Treatment of MASH

May 21
Last Trade: 0.58 -0.02 -3.33

Topline data now projected in early Q4 2024 Rohit Loomba, MD, MHSc to serve as Principal Investigator SOUTH SAN FRANCISCO, Calif., May 21, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has completed enrollment in the ALG-055009 Phase 2a...Read more

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

May 21
Last Trade: 2.42 -0.25 -9.21

 Novel and proprietary CAR-T approach holds potential to be first effective CAR-T therapy for solid tumors SAN JOSE, Calif., May 21, 2024 /PRNewswire/ -- Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that treatment has commenced for the fifth patient in its ongoing Phase 1 clinical...Read more

PureTech Health Founded Entity Vedanta Biosciences Enrolls First Patient in Pivotal Phase 3 RESTORATiVE303 Study of VE303 for the Prevention of Recurrent C. difficile Infection

May 21
Last Trade: 29.25 0.00 0.00

VE303 is an orally administered, potential first-in-class live biotherapeutic product candidate being developed to prevent recurrence of Clostridioides difficile infection (CDI) BOSTON / May 21, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Vedanta Biosciences, a clinical-stage company that is developing...Read more

Citius Pharmaceuticals Achieves Primary and Secondary Endpoints in Phase 3 Trial of Mino-Lok Antibiotic Lock Solution

May 21
Last Trade: 0.66 -0.02 -3.54

Trial achieves statistically significant primary endpoint (p=0.0006) Secondary endpoint demonstrates statistically significant overall success of Mino-Lok therapy with a greater percentage of patients retaining their catheters (p=0.0025) CRANFORD, N.J., May 21, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and...Read more

Larimar Therapeutics Announces FDA has Removed Partial Clinical Hold for Nomlabofusp Program in Friedreich’s Ataxia

May 20
Last Trade: 7.08 -0.39 -5.22

Food and Drug Administration (FDA) removed partial clinical hold following review of Phase 2 dose exploration study data Ongoing open label extension (OLE) study initially evaluating 25 mg; Larimar plans to dose escalate to 50 mg following further characterization of frataxin pharmacodynamics (PD) at the 25 mg dose Interim data from OLE study remains on track for Q4 2024 Biologics License Application (BLA) submission targeted for 2H...Read more

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

May 20
Last Trade: 1.65 0.15 10.00

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

Mira Pharmaceuticals Advances Preclinical Trials Towards an IND Submission This Year for Ketamir-2, a Differentiated Oral Ketamine Analog

May 20
Last Trade: 0.89 0.005 0.57

Investigative studies are underway testing Ketamir-2 as the potential first at home ketamine analog treatment for PTSD, depression, and neuropathic pain, including cancer pain  MIAMI, May 20, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, announced that it has advanced...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

Esperion: Bempedoic Acid Met Primary Endpoint of Phase 3 Trial in Japan for the Treatment for Hypercholesterolemia

May 20
Last Trade: 2.13 -0.12 -5.33

ANN ARBOR, Mich., May 20, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) and Otsuka Pharmaceutical Co., Ltd (Otsuka) announced today that the primary endpoint was achieved in the Phase 3 trial in Japan for bempedoic acid as a potential treatment for patients with hypercholesterolemia. The trial demonstrated statistically significant outcomes on the primary endpoint for bempedoic acid and highlighted its potential future value to...Read more

Marinus Pharmaceuticals Announces Key Business Updates for Tuberous Sclerosis Complex Program

May 17
Last Trade: 1.38 0.08 6.15

Enrollment complete in Phase 3 TrustTSC trial with topline data anticipated in the first half of Q4 2024 USPTO grants additional method of use patent for ganaxolone in TSC RADNOR, Pa. / May 17, 2024 / Business Wire / Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced completion of enrollment in the global Phase 3...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

MoonLake Immunotherapeutics starts Phase 3 VELA program of the Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa

May 16
Last Trade: 40.85 0.89 2.23

VELA is the first Phase 3 program in hidradenitis suppurativa to use the higher clinical response level of HiSCR75 as the primary endpoint The topline primary endpoint readout at week 16, together with data on other endpoints, is expected as of mid-2025 Program will evaluate sonelokimab for a total of 52 weeks, across VELA-1 and VELA-2, at sites in the United States and Europe, using a design informed by the landmark Phase 2 MIRA...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

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

May 16
Last Trade: 1.35 0.09 7.14

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

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

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

May 16
Last Trade: 8.23 0.13 1.60

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

Tourmaline Bio Initiates Clinical Development of TOUR006 for Cardiovascular Diseases with First Patient Dosed in Phase 2 TRANQUILITY Trial

May 16
Last Trade: 13.45 -0.21 -1.54

First patient dosed in trial to evaluate the safety, pharmacokinetics and pharmacodynamics of TOUR006 in patients with inflammatory risk and chronic kidney disease  Topline data anticipated in the first half of 2025 with potential to advance TOUR006 toward Phase 3 readiness for atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases  TRANQUILITY trial intended to provide evidence of TOUR006’s...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

Eli Lilly: With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin

May 16
Last Trade: 807.43 -1.02 -0.13

Efsitora met the primary endpoint in both QWINT-2 and QWINT-4 with once-a-week dosing regimen for people living with type 2 diabetes Efsitora was equally safe and effective among adults naïve to insulin therapy currently using and not using GLP-1 receptor agonists INDIANAPOLIS, May 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline results from the QWINT-2 and QWINT-4 phase 3 clinical trials...Read more

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

May 16
Last Trade: 35.23 0.00 0.00

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

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

May 16
Last Trade: 31.60 -0.19 -0.60

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

Apogee Therapeutics Announces Dosing of First Patient in Phase 2 Atopic Dermatitis Trial of APG777, a Novel Subcutaneous Half-life Extended Anti-IL-13 Antibody for the Treatment of Atopic Dermatitis and Other Inflammatory Diseases

May 15
Last Trade: 48.03 1.99 4.32

Interim clinical data from APG777 Phase 1 healthy volunteers study exceeded all trial objectives and achieved a half-life of approximately 75 days with a potentially best-in-class profile 16-week proof-of-concept data from Part A of the Phase 2 trial expected in 2H 2025 Pipeline-in-a-product potential with a Phase 2 in asthma expected to initiate in 2025 and plans for additional indication expansion SAN FRANCISCO and WALTHAM,...Read more

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

May 15
Last Trade: 0.77 -0.0028 -0.36

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

Moleculin Biotech Announces Commencement of NIH-Funded Phase 2 Clinical Trial of STAT3 Inhibitor for the Treatment of Glioblastoma (NU 21C06)

May 15
Last Trade: 4.93 -0.22 -4.27

Investigator-Initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune "memory" in glioblastoma animal models HOUSTON, May 15, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a clinical-stage pharmaceutical company with a broad...Read more

Veru Announces Steven B. Heymsfield M.D. as the Principal Investigator for its Enobosarm Phase 2b Clinical Trial for High Quality Weight Loss

May 15
Last Trade: 1.23 -0.04 -3.15

MIAMI, FL, May 15, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced Steven B. Heymsfield, M.D., a Professor and the Director of the Body Composition-Metabolism Laboratory at the Pennington Biomedical Research Center...Read more

Atossa Therapeutics Announces Last Patient, Last Dose in its Phase 2 Karisma-Endoxifen Clinical Trial

May 15
Last Trade: 1.46 0.00 0.00

SEATTLE, May 15, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced that the last patient in the Company’s Karisma-Endoxifen clinical trial received their final dose of study medication. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer. The Karisma-Endoxifen...Read more

Celldex Therapeutics Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Prurigo Nodularis

May 15
Last Trade: 36.92 0.60 1.65

HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the function and survival...Read more

Reviva Pharmaceuticals Announces Enrollment Update for Open Label Extension Study Evaluating Brilaroxazine in Schizophrenia

May 15
Last Trade: 1.53 0.08 5.52

358 enrolled and 223 patients currently on treatment across sites in the USA, Europe and Asia  Brilaroxazine is generally well tolerated to date in patients with acute and stable schizophrenia  Topline data from 1-year open-label extension (OLE) trial expected in Q4 2024  CUPERTINO, Calif., May 15, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a late-stage...Read more

TFF Pharmaceuticals Provides Update on Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the Prevention of Lung Transplant Rejection

May 15
Last Trade: 2.21 0.17 8.33

Patient Enrollment Has Accelerated with Now 10 Patients Enrolled in Phase 2 Trial 6 out of 6 Patients Who Completed the 12-Week Treatment Have Chosen to Remain on TFF TAC by Proceeding to the Safety Extension Phase; 1 patient has been treated for over a year and 3 additional patients have been treated for more than 6 months Variability in Systemic Exposure to Tacrolimus Was Reduced with TFF TAC Which Could Lower Risk of Acute...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

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

May 14
Last Trade: 2.20 -0.01 -0.45

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

Fortress Biotech Announces First Patient Dosed in Multi-Center Phase 2 Study of Triplex for Control of CMV in Patients Undergoing Liver Transplantation

May 14
Last Trade: 1.87 0.03 1.63

Helocyte, a majority-owned subsidiary of Fortress Biotech, is developing Triplex for the prevention and treatment of cytomegalovirus in multiple transplant indications, as well as HIV Clinical trial funded by a NIAID grant to a multi-center university consortium Study is evaluating whether Triplex is safe and effective in improving the outcomes of liver transplant recipients MIAMI, May 14, 2024 (GLOBE NEWSWIRE) -- Fortress...Read more

Equillium Announces Interim Enrollment Achieved in Phase 3 EQUATOR Study of Itolizumab in Acute Graft-Versus-Host Disease

May 14
Last Trade: 1.40 0.00 0.00

More than 100 patients enrolled from over 100 clinical trial sites active in 12 countries Delivery of the interim data review to Ono Pharmaceutical Co. Ltd. (Ono) expected during Q3 will trigger Ono’s option exercise period LA JOLLA, Calif. / May 14, 2024 / Business Wire / Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders,...Read more

89bio Initiates Phase 3 ENLIGHTEN-Cirrhosis Trial of Pegozafermin in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Compensated Cirrhosis

May 14
Last Trade: 8.14 -0.04 -0.49

With the initiation of ENLIGHTEN-Cirrhosis, pegozafermin is the first FGF21 analog to enter a Phase 3 trial in MASH patients with compensated cirrhosis (F4) Regression of fibrosis by histology at month 24 will serve as the basis for potential accelerated approval with clinical outcomes to support the potential for confirmatory or full approval SAN FRANCISCO, May 14, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a...Read more

aTyr Pharma Announces Second Positive DSMB Review for Efzofitimod in Phase 3 EFZO-FIT™ Study in Pulmonary Sarcoidosis

May 14
Last Trade: 1.80 0.00 0.00

Independent data and safety monitoring board (DSMB) recommends continuation of study without any modifications. Findings further support favorable safety profile of efzofitimod. SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform,...Read more

Kura Oncology Completes Enrollment in Registration-Directed Trial of Ziftomenib in NPM1-Mutant AML

May 14
Last Trade: 21.17 -0.26 -1.21

Company enrolls 85 patients with R/R NPM1-mutant AML in fewer than 16 months  Topline data expected in early 2025  Breakthrough Therapy Designation to enable expedited review by FDA  SAN DIEGO, May 14, 2024 (GLOBE NEWSWIRE) --  Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced that...Read more

Pliant Therapeutics Announces Positive Topline Data from a Phase 2a Collagen PET Imaging Clinical Trial of Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis

May 14
Last Trade: 12.73 -0.67 -5.00

12-week treatment with Bexotegrast 160 mg resulted in reduction of total lung collagen as measured by PET imaging, compared to an increase on placebo Improvement in FVC and​ reduction in cough severity reported in bexotegrast-treated patients at all timepoints compared to placebo Bexotegrast 160 mg was well tolerated over 12 weeks of treatment with no serious adverse events and no discontinuations SOUTH SAN...Read more

Neumora Therapeutics Announces Initiation of Phase 2 Study of Navacaprant in Bipolar Depression

May 14
Last Trade: 9.17 -0.14 -1.50

Potential to alleviate unmet need associated with depressed mood and anhedonia in bipolar depression; navacaprant has demonstrated the ability to improve these symptoms in MDD in a Phase 2 study Navacaprant is also currently in Phase 3 development for the treatment of MDD with data from KOASTAL-1 anticipated in the fourth quarter of 2024 WATERTOWN, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a...Read more

HUTCHMED Initiates Phase II/III Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma in Collaboration with Hengrui

May 13
Last Trade: 18.73 0.01 0.05

Almost half a million people diagnosed each year across the globe Collaboration based on synergistic potential of inhibiting angiogenesis and tumor-associated macrophages with HUTCHMED’s surufatinib and anti-PD-1 activity with Hengrui’s camrelizumab, promoting the immune response against tumor cells HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”)...Read more

HUTCHMED Initiates the RAPHAEL Registrational Phase III Trial of HMPL-306 for Patients with IDH1- and/or IDH2-Mutated Relapsed/Refractory Acute Myeloid Leukemia in China

May 13
Last Trade: 18.73 0.01 0.05

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 14, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a registrational Phase III clinical trial of HMPL-306 in patients with mutated isocitrate dehydrogenase (“IDH”) 1 or 2 relapsed / refractory acute myeloid leukemia (“AML”) in China. The first patient received their first dose on May 11,...Read more

Kodiak Sciences Announces Treatment of First Patients in Phase 3 GLOW2 Study of Tarcocimab Tedromer in Diabetic Retinopathy

May 13
Last Trade: 3.07 -0.04 -1.29

PALO ALTO, Calif., May 13, 2024 /PRNewswire/ -- Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat a broad spectrum of retinal diseases, announced today that the first patients with diabetic retinopathy (DR) have been treated in the randomized double masked Phase 3 GLOW2 study of tarcocimab tedromer. GLOW2 is the second Phase 3...Read more

Novo Nordisk: Once-weekly and once-monthly Mim8 demonstrate superior reduction of treated bleeding episodes compared to on-demand and prior prophylaxis treatment in people with haemophilia A in the Frontier 2 trial

May 13
Last Trade: 136.04 0.47 0.35

Bagsværd, Denmark, 13 May 2024 – Novo Nordisk (NYSE: NVO) today announced the headline results from the FRONTIER 2 trial, a pivotal phase 3a, 26-week open-label, randomised, controlled, multi-arm trial in 254 people. The trial investigated the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment in people aged 12 years or older with...Read more

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

May 13
Last Trade: 1.51 0.06 4.14

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

Ascendis Pharma: Significant and Sustained Improvements in Renal Function Reported for Adults with Chronic Hypoparathyroidism Treated with TransCon™ PTH (Palopegteriparatide): 2-year Results from Phase 3 PaTHway Trial

May 13
Last Trade: 130.41 0.97 0.75

COPENHAGEN, Denmark, May 13, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced 2-year results from a post-hoc analysis of the Company’s Phase 3 PaTHway Trial demonstrating significant and sustained improvements in renal function in adults with chronic hypoparathyroidism treated with TransCon PTH (palopegteriparatide). The data were shared in an oral presentation on May 12 by Peter Schwarz, M.D., Professor of...Read more

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

May 13
Last Trade: 0.34 -0.01 -3.11

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

Merck Provides Update on Phase 3 KeyVibe-010 Trial Evaluating an Investigational Coformulation of Vibostolimab and Pembrolizumab as Adjuvant Treatment for Patients With Resected High-Risk Melanoma

May 13
Last Trade: 129.49 -1.60 -1.22

RAHWAY, N.J. / May 13, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial. The trial is evaluating the investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to KEYTRUDA alone, as adjuvant...Read more

Bristol Myers Squibb Provides Update on Phase 3 CheckMate -73L Trial

May 10
Last Trade: 41.24 -0.30 -0.72

PRINCETON, N.J. / May 10, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -73L trial did not meet its primary endpoint of progression-free survival (PFS) in unresectable, locally advanced stage III non-small cell lung cancer (NSCLC). CheckMate -73L evaluated Opdivo® (nivolumab) with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy® (ipilimumab) versus CCRT followed by...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

PDS Biotechnology VERSATILE-002 Phase 2 Clinical Trial Meets Primary Study Endpoints in First Line Recurrent/Metastatic HPV16-Positive Head and Neck Cancer

May 9
Last Trade: 3.08 -0.04 -1.28

30 month median overall survival (OS); median OS independent of patient CPS score ORR 34% (CPS≥1); 48% (CPS≥20) Phase 3 registrational trial planned to initiate in 2024 PRINCETON, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of...Read more

Fusion Pharmaceuticals Announces First Patient Dosed in the Phase 2 Portion of the AlphaBreak Trial Evaluating FPI-2265 in Metastatic Castration-Resistant Prostate Cancer

May 9
Last Trade: 21.48 -0.02 -0.09

AlphaBreak is a Phase 2/3 registrational program for FPI-2265 in patients with metastatic castration-resistant prostate cancer HAMILTON, ON and BOSTON, May 9, 2024 /CNW/ -- Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines, today announced that the first patient has been dosed in the Phase 2 portion of the AlphaBreak...Read more

Actym Therapeutics Announces Positive Top-Line GEMINI-2 Phase 3 Clinical Trial Results of Imsidolimab (IL-36R) in Generalized Pustular Psoriasis (GPP)

May 9
Last Trade: 23.91 -1.05 -4.21

All eight patients from GEMINI-1 who responded to a single intravenous (IV) imsidolimab dose and were subsequently re-randomized to monthly subcutaneous (SC) maintenance dosing of imsidolimab in GEMINI-2 through at least 24 weeks maintained clear to almost clear skin and none experienced a flare Of the remaining eight responding patients from GEMINI-1 re-randomized to placebo in GEMINI-2, 25% maintained clear to almost clear skin and...Read more

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

May 9
Last Trade: 139.40 -1.11 -0.79

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

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

May 9
Last Trade: 3.52 0.09 2.62

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

Movano Health Submits Exemplary Sp02 Clinical Trial Results in Key Step Towards FDA 510(k) Clearance Decision

May 9
Last Trade: 0.45 -0.66 -59.51

Unlocking business-to-business opportunities with Evie Med, Movano Health's ring pulse oximeter, remains a key priority for the Company. PLEASANTON, Calif., May 9, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced that it successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability on April 22, 2024 to the U.S. Food and Drug Administration (FDA) as part of its...Read more

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

May 9
Last Trade: 8.41 -0.29 -3.33

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

Merck Provides Update on Phase 3 KEYNOTE-B21 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Chemotherapy, With or Without Radiotherapy, for Patients With Newly Diagnosed, High-Risk Endometrial Cancer After Surgery With Curative Intent

May 9
Last Trade: 129.49 -1.60 -1.22

RAHWAY, N.J. / May 09, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-B21 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival (DFS) for the treatment of patients with newly diagnosed, high-risk endometrial...Read more

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

May 8
Last Trade: 1.75 -0.08 -4.37

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

Oculis Announces Completion of Enrollment in Phase 2 Randomized Controlled ACUITY Trial with OCS-05 for Acute Optic Neuritis

May 8
Last Trade: 11.85 -0.05 -0.42

Topline results anticipated in Q4 2024 for Phase 2 trial evaluating the safety and tolerability of OCS-05 in patients with Acute Optic Neuritis (AON) Oculis also aims to complete an IND submission for OCS-05 in the U.S. in 2024 OCS-05 has been granted orphan drug designation in the United States and Europe for AON, an indication for which there are no approved therapies ZUG, Switzerland, May 08, 2024 (GLOBE NEWSWIRE) -- Oculis...Read more

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

May 8
Last Trade: 139.40 -1.11 -0.79

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

ProQR Therapeutics Announces Preclinical Proof of Concept Data for AX-0810 Axiomer™ RNA Editing Program Targeting NTCP for Cholestatic Diseases

May 8
Last Trade: 1.88 -0.01 -0.53

ProQR scientists report for the first time in the ADAR RNA editing field in vivo proof of target engagement (RNA editing) leading to meaningful changes in biomarkers in NHPs using Axiomer™ RNA Editing Oligonucleotides Preclinical proof of concept for the Company’s AX-0810 program targeting NTCP for cholestatic diseases presented at ASGCT Annual Meeting Management webinar May 9, 2024 at 8:00 am EDT LEIDEN, Netherlands &...Read more

Acumen Pharmaceuticals Announces First Patient Dosed in ALTITUDE-AD, a Phase 2 Clinical Trial of Sabirnetug (ACU193) in Early Alzheimer’s Disease

May 8
Last Trade: 3.40 0.00 0.00

CHARLOTTESVILLE, Va., May 08, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that the first patient has been dosed with sabirnetug (ACU193) in the ALTITUDE-AD Phase 2 clinical trial designed to evaluate the clinical...Read more

Cytokinetics Announces Start of CEDAR-HCM, a Clinical Trial of Aficamten in a Pediatric Population With Symptomatic Obstructive Hypertrophic Cardiomyopathy

May 8
Last Trade: 48.30 -0.68 -1.39

SOUTH SAN FRANCISCO, Calif., May 08, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (HCM), is open to enrollment. Aficamten is a next-in-class cardiac myosin inhibitor in...Read more

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

May 8
Last Trade: 48.30 -0.68 -1.39

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

Alterity Therapeutics Phase 2 Data Monitoring Committee Recommends Continuing Clinical Trial as Planned After Third Review

May 8
Last Trade: 1.99 0.05 2.59

 ATH434-201 Trial on Track to Complete in November 2024  Top-Line Data Expected in January 2025  MELBOURNE, Australia and SAN FRANCISCO, May 08, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the Company”), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced that an independent Data Monitoring Committee...Read more

Aldeyra Therapeutics Enrolls First Patient in Phase 3 Clinical Trial Designed to Enable Potential Resubmission of New Drug Application of Reproxalap in Dry Eye Disease

May 8
Last Trade: 3.91 0.12 3.17

Clinical Results and Potential New Drug Application Submission Expected in the Second Half of 2024 LEXINGTON, Mass. / May 08, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced enrollment of the first patient in a Phase 3 dry eye chamber clinical trial...Read more

Teva Pharmaceutical and Medincell Announce Positive Phase 3 Efficacy Results from SOLARIS Trial Evaluating TEV-‘749 (olanzapine) as a Once-Monthly Subcutaneous Long-Acting Injectable in Adults with Schizophrenia

May 8
Last Trade: 16.60 -0.16 -0.95

The study met its primary endpoint achieving clinically meaningful and statistically significant reductions across all TEV-‘749 dose groups versus placebo in the Positive and Negative Syndrome Scale (PANSS) total score, a widely used assessment tool for schizophrenia symptom severity TEV-‘749 was well tolerated, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date: additional safety data is being...Read more

Compass Pathways announces durable improvement in symptoms through 12 weeks in open-label phase 2 study of COMP360 psilocybin in post-traumatic stress disorder

May 8
Last Trade: 7.48 0.02 0.27

Study met primary safety endpoint; administration was well tolerated, with no serious adverse events observed Early and clinically meaningful improvement from baseline in mean CAPS-5 total score (29.5 point reduction at week 12), with change from baseline in mean SDS total score (14.4 point reduction at week 12) 81.8% response (reduction of ≥ 15 points in CAPS-5 score), 63.6% remission (total CAPS-5 ≤ 20) rates at week 4 with 77.3%...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

NeuroSense Therapeutics Announces New Positive Data Analysis from PARADIGM Clinical Trial Demonstrating Statistically Significant Slowing of Disease Progression in High-Risk ALS Patients

May 7
Last Trade: 1.17 0.007 0.60

PrimeC slowed disease progression by 43% (p=0.02) in pre-specified high-risk ALS patients Consistent data across subgroups underscore the potential of PrimeC to redefine the ALS treatment paradigm CAMBRIDGE, Mass., May 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, announces new analyses from its Phase 2b PARADIGM...Read more

Eledon Pharmaceuticals Announces Clinical Progress with Tegoprubart in the Prevention of Transplant Rejection

May 7
Last Trade: 2.82 -0.07 -2.42

First participant dosed in clinical trial at University of Chicago Medicine assessing the use of tegoprubart to prevent islet cell transplant rejection in patients with type 1 diabetes Company reports updated data from ongoing Phase 1b trial evaluating tegoprubart for prevention of rejection in kidney transplantation IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today...Read more

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

May 7
Last Trade: 5.28 -0.05 -0.94

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

Achieve Life Sciences Announces Publication of Cytisinicline Vaping Cessation Trial Results in JAMA Internal Medicine

May 6
Last Trade: 5.41 0.00 0.00

Phase 2 ORCA-V1 trial showed treatment with cytisinicline more than doubled odds of quitting e-cigarettes compared with placebo   Cytisinicline treatment well tolerated with no serious adverse events reported and excellent compliance to study treatment Achieve expects to conduct an End-of-Phase 2 Meeting with the FDA later this year to discuss Phase 3 trial plans SEATTLE and VANCOUVER, British Columbia, May 06, 2024...Read more

NRx Pharmaceuticals Announces Final Clinical Trial Results: Superior Safety Combined with Similar Efficacy in the Trial of NRX-101 Compared to Lurasidone in Suicidal Bipolar Depression

May 6
Last Trade: 3.95 0.33 9.12

Both drugs demonstrated > 50% response for treating depression. NRX-101 demonstrated a mean 76% reduction in symptoms of akathisia compared to lurasidone that was sustained over 42 days (Effect Size .37; P=0.025), using prespecified analytic methodology memorialized in FDA Special Protocol Agreement. Levels of akathisia with NRX-101 were essentially zero at day 42 This safety advantage was previously reported in the Company's...Read more

Edgewise Therapeutics Doses First Patient in Phase 2 CIRRUS-HCM Trial of EDG-7500 in Obstructive Hypertrophic Cardiomyopathy (HCM)

May 6
Last Trade: 17.11 -0.20 -1.16

BOULDER, Colo. / May 06, 2024 / Business Wire / Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today announced the dosing of the first patient in the Phase 2 CIRRUS-HCM trial of EDG-7500. EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM and other diseases of...Read more

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

May 6
Last Trade: 2.02 0.10 5.21

SAN DIEGO, May 6, 2024 /PRNewswire/ -- Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced, after review of all available safety data, the Company initiated screening in the of the fourth cohort of patients in the Phase 1b MAD study of RGSL8429 for the treatment of ADPKD. Patients in the...Read more

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C4 Therapeutics

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...