STOCKHOLM, July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STOCKHOLM: CALTX) ("Calliditas") today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver...Read more
First-in-Class CCL24 Neutralizing Antibody CM-101 Demonstrated a Favorable Safety Profile and Was Generally Well-Tolerated Demonstrated Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis (PSC), Establishing Clinical Proof-of-Concept for the Disease-Modifying Potential of CM-101 Treatment with CM-101 Led to Statistically Significant Improvements in Liver...Read more
Enrollment acceleration drives earlier-than-anticipated data availability for this potentially best-in-class IBD treatment Topline results for both UC and CD now anticipated in Q4 2024 Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug (anti-TL1A) for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) patients PARSIPPANY, N.J. & PARIS / Jul 25, 2024 / Business Wire / Teva...Read more
SAGE-324 (BIIB124) did not demonstrate a statistically significant dose-response relationship on the primary endpoint in participants with essential tremor No statistically significant differences were demonstrated between any dose of SAGE-324 and placebo in the change from baseline for the primary endpoint CAMBRIDGE, Mass. / Jul 24, 2024 / Business Wire / Sage Therapeutics, Inc. (NASDAQ: Sage) and Biogen Inc. (NASDAQ: BIIB) announced...Read more
Virios projects releasing top line results from this groundbreaking Proof of Concept study in October 2024 Published data indicates increased Epstein-Barr herpes virus in Long-COVID patients, highlighting potential for antiviral therapy to treat fatigue and other Long-COVID symptoms ATLANTA, July 23, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology...Read more
LB54640 has shown targeted effect on MC4R without hyperpigmentation BOSTON, July 23, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that the first patients have been dosed in the Company’s Phase 2 clinical trial evaluating LB54640, an...Read more
56.4% major response rate exceeded 20% primary endpoint 98.2% disease control rate achieved in heavily pretreated patients Responses shown in difficult-to-treat, high-needs patient populations with approximately 27% of patients refractory to all available therapies and 40% dual-class refractory (BTKi and rituximab) FLORHAM PARK, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage...Read more
THIO followed by cemiplimab shown to be well tolerated throughout trial, with far lower toxicity compared to standard of care treatments 6 patients on trial regimen for more than 12 months have completed up to 21 cycles, with treatment ongoing CHICAGO / Jul 23, 2024 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies...Read more
SEATTLE, July 22, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (“Atossa” or the “Company”) today announced that the 12-patient 80mg pharmacokinetic (PK) run-in cohort of the Phase 2 EVANGELINE (Endoxifen Versus exemestANe GosEreLIn) study has fully enrolled. EVANGELINE is a randomized non-inferiority trial of Atossa’s patented Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, and exemestane plus goserelin...Read more
5 patients treated in "safety cohort" showed no drug related Serious Adverse Events Restart of trial after amendment approved by MHRA to increase dose level EDINBURGH, Scotland, July 22, 2024 /PRNewswire/ -- TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today...Read more
Progression free survival (PFS) extended to 9.1 months in ADC resistant patient - quadruple the PFS of patients in similar studies 1, 2, 3 Significant reduction of “Eye-Bulging” metastatic breast cancer tumor was previously reported Heavily pre-treated patient had failed 8 prior regimens including antibody-drug conjugate (ADC) therapy and continues to receive BriaCell treatment PHILADELPHIA and VANCOUVER, British...Read more
43% of Participants Showed Improvement on the UMSARS Activities of Daily Living Scale 29% of Participants had Stable or Improved Neurological Symptoms Objective Biomarkers Demonstrated Improvement Consistent with Clinical Findings ATH434 was Well-Tolerated with No Safety Signals Detected MELBOURNE, Australia and SAN FRANCISCO, July 17, 2024 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE)...Read more
Robust reduction in anti-VEGF injection treatment burden through Week 24 achieved in 30 patients at planned Phase 3 dose (3E10 vg/eye) with 89% reduction in annualized injection rate; 93% of patients received 0 or 1 injection and 77% were injection-free Improvement in mean best corrected visual acuity (BCVA) from baseline through Week 24 achieved at 3E10 vg/eye dose (+4.2 letters); dose response in favor of 3E10 vg/eye dose...Read more
6E10 combined with local prophylaxis selected for Phase 3 pivotal trials, with a favorable safety profile and potential best-in-class product profile at 26 weeks Efficacy: 76% of 6E10 patients were injection free, with maintained visual acuity and fluid control Safety: 100% of 6E10 difluprednate-alone patients had no or minimal inflammation, and none received corticosteroids for treatment of inflammation beyond the scheduled...Read more
Three New Sites Join HT-001 Trial, GW University Hospital, UC Irvine and Northwell Health NEW YORK, July 16, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that it has received written approval from the GW University Hospital, UC Irvine and Northwell Health to proceed with its First-in-Human (FIH) Phase 2a clinical trial of HT-001 for the...Read more
Complete enrollment achieved nearly six months ahead of plan Top-line data now anticipated mid-2025 Addition of second-line cholangiocarcinoma arm to BOLSTER trial BASKING RIDGE, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases,...Read more
300 patients enrolled in the study, including patients with and without the cognitive biomarker On track to report topline data in October 2024 Alto to host investor day focused on ALTO-100 on September 9, 2024 MOUNTAIN VIEW, Calif. / Jul 16, 2024 / Business Wire / Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for...Read more
Bexotegrast at 320 mg was well tolerated up to 40 weeks of treatment with no treatment-related severe or serious adverse events 320 mg cohort demonstrated improvement in liver stiffness by transient elastography at Week 24 compared to placebo Statistically significant improvement in alkaline phosphatase (ALP) levels over 24 weeks compared to placebo Continued improvement in hepatocyte function and bile flow by...Read more
Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) Results consistent with those shown in earlier human volunteer studies and Phase 2a studies Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to...Read more
Media Release Efti in combination with KEYTRUDA® (pembrolizumab) achieved a 35.5% response rate in evaluable patients (N=31), according to RECIST 1.1, among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1 High complete response rate of 9.7% with three patients showing a disappearance of cancer lesions post treatment Durability of responses tracks well and over 50% of patients...Read more
CARDIFF, UK / ACCESSWIRE / July 11, 2024 / Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), an acquisition-focused clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is making good progress with eRapa™, its drug to treat Familial Adenomatous Polyposis (FAP). FAP is a mostly inherited condition that puts people at a much greater risk of developing...Read more
Tailwind is evaluating inhaled AP-PA02 in non-cystic fibrosis bronchiectasis (NCFB), its second patient population, following successful evaluation in patients with cystic fibrosis (SWARM-P.a.) in 2023 Phase 2 Topline data anticipated in 2H 2024 followed by potential initiation of a pivotal bronchiectasis trial in 2025 LOS ANGELES, July 11, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the...Read more
Encouraging 68% improvement in responder rate results from patients who achieved both the conjunctival staining “sign” and ocular pain “symptom” endpoints from the 240 patient Phase 2 Dry Eye Disease (DED) trial Conjunctival staining and ocular pain represent potential co-primary endpoints to be explored in future trials LONDON and NEW YORK, July 10, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage...Read more
NeuroSense to submit the 12-month data to FDA to discuss path forward CAMBRIDGE, Mass., July 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announces additional positive results from its 12-month PARADIGM Phase 2b study of PrimeC in ALS patients. In the study, complication-free...Read more
Development of Auxora in AKI is supported by both clinical and pre-clinical evidence Topline data expected in 2025 LA JOLLA, Calif., July 9, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses,...Read more
Exceeded enrollment target due to patient demand; trial size increased to 121 patients Bempikibart topline results remain on track to be released in Q4'24 WALTHAM, Mass., July 9, 2024 /PRNewswire/ -- Q32 Bio Inc. (NASDAQ: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced that it has completed enrollment in the SIGNAL-AD...Read more
WATERTOWN, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that following a review of preliminary KT-474 safety and efficacy data by an Independent Data Review Committee, Sanofi has informed Kymera that it intends to expand the ongoing Hidradenitis...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 08, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 2 trial evaluating petosemtamab in combination with standard chemotherapy in second line (2L)...Read more
The NEST-IN1 clinical study did not meet its primary or secondary efficacy endpoints, and the company will discontinue further development of HIL-214 in infants The company is exploring the potential for continued development of HIL-214 and HIL-216 in adults BOSTON, July 08, 2024 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines,...Read more
~39% Overall Response Rate (ORR): 1 CR and 6 PRs (2 awaiting confirmation) by RECIST 1.1 out of 18 evaluable MTAP-deletion urothelial and NSCLC patients ~94% Disease Control Rate (DCR): 1 CR and 6 PRs and 10 SD by RECIST 1.1 ~78% of Patients with Tumor Shrinkage: 14 patients observed tumor shrinkage ~81% ctDNA Molecular Response Rate (MRR): 13 of 16 patients with > 50% ctDNA reduction AE Profile: ~5.6% drug-related grade >3...Read more
MONTREAL, July 03, 2024 (GLOBE NEWSWIRE) -- IntelGenx Corp. (the “Company” or “IntelGenx” a subsidiary of IntelGenx Technologies Corp.) (OTCQB: IGXT; TSX: IGX), has successfully completed the BUENA Alzheimer’s disease (AD) study. The BUENA study was designed as a Phase 2a proof of concept study to investigate the extent to which different doses of Montelukast (MTK) could improve cognition in adults with AD as well as to provide...Read more
GAITHERSBURG, Md., July 02, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the first patient has been dosed in its Phase 2 open-label clinical trial evaluating Descartes-08 in patients with systematic lupus erythematosus (SLE). Descartes-08, Cartesian’s lead mRNA cell therapy candidate...Read more
Trial met primary endpoint with statistical significance, with 71% of myasthenia gravis patients treated with Descartes-08 observed to have a clinically meaningful improvement in MGC score at Month 3 compared to 25% for placebo Deep and durable responses up to at least six months observed in patients treated with Descartes-08 Safety profile continues to support outpatient administration Company expects to hold End-of-Phase 2 meeting...Read more
Patient Screening is Underway at Rocky Mountain Cancer Centers, Part of the US Oncology Network and Sarah Cannon Research Institute; Astera Cancer Care, Part of the OneOncology Network; and Norton Cancer Institute ALPHA3 Will be the First Pivotal Trial to Offer CAR T as Part of First Line (1L) Treatment at Community Cancer Centers, Where 80% of Patients Receive Care ALPHA3 Expected to Complete Enrollment in 1H 2026; Potential BLA...Read more
Disease progression was slowed by 36% (p=0.009) in participants who received PrimeC for 12 months compared to those who initially received a placebo Consistent data across multiple endpoints underscore the potential of PrimeC to redefine the ALS treatment paradigm NeuroSense planning for Phase 3 clinical study in the U.S. and Europe CAMBRIDGE, Mass., July 1, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN)...Read more
Primary objective of the trial met with statistically significant dose response with up to 43.6% relative reduction (2.1 day improvement) in median time to solid food tolerance versus placebo in hyper-inflamed patients Statistically significant dose response with up to 61.7% reduction in severe organ failure in all patients versus placebo Up to 100% reduction in hospital stays longer than 21 days Planning End-of-Phase 2...Read more
New data suggests that baseline serum myeloperoxidase (MPO) levels below the threshold may predict overall survival (OS) improvement when comparing the CM24+nivolumab+Nal-IRI/5FU/LV vs. Nal-IRI/5FU/LV arms Data reported at the 2024 ASCO annual meeting demonstrated reduced risk of death and cancer progression, prolongation of OS and progression free survival (PFS) as well as higher objective response rate (ORR) and disease control rate...Read more
100% of evaluable participants at Month 6 achieved target absolute neutrophil count (ANC) increase with once-daily, oral mavorixafor +/- stable-dose G-CSF as of the interim analysis data cut-off date Durable mean ANC levels above the lower limit of normal for CN were achieved for participants on mavorixafor monotherapy at Months 3 and 6 Company webinar today at 8:00 am ET will detail the interim clinical results and feature clinical...Read more
NEW YORK, June 26, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease. Expanded access...Read more
Multiple patients have now exceeded 30 weeks on treatment Boston (June 25, 2024)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced that multiple patients in its Phase 2 clinical trial of stenoparib for advanced recurrent ovarian cancer have been on treatment for more than 30 weeks. The...Read more
To date Sernova reports 7 patients in its Phase I/II type 1 diabetes clinical trial achieved freedom from insulin injections and demonstrate blood sugar control in the non-diabetic range (HbA1c 6.5%); 6 patients have reached between 5.5 and 50 months of sustained insulin independence and freedom from severe hypoglycemic episodes; Completion of enrollment in Cohort 2 LONDON, Ontario; BOSTON, Massachusetts...Read more
NR improved the six-minute walking distance and treadmill walking time for those with PAD LOS ANGELES / Jun 24, 2024 / Business Wire / ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research, shares results from a milestone phase II clinical study showcasing the promising effects of nicotinamide riboside (NR) supplementation for people with peripheral artery disease (PAD). This study was...Read more
Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP) Overall 75% Non-progression Rate at 12 Months Median Decrease in Overall Polyp Burden at 12 Months of 17% Cohort 2 Non-progression Rate at 12 months of 81% and Median Decrease in Poly Burden of 29% Informs Phase 3 Dosage Regimen Data Reported in Oral Presentation at 2024 Bi-Annual InSIGHT Meeting JUNE 24 --...Read more
SRK-439, a myostatin inhibitor, is part of Scholar Rock’s industry-leading anti-myostatin portfolio Obesity program continues to progress, with first participants dosed in Phase 2 EMBRAZE trial of apitegromab in obesity CAMBRIDGE, Mass. / Jun 24, 2024 / Business Wire / Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic...Read more
Targeting IDE397 Phase 2 monotherapy expansion dose clinical data update in over ~15 evaluable MTAP lung and bladder cancer patients in H2 2024, including RECIST 1.1 clinical efficacy waterfall, swim-lane plot, ctDNA molecular response analysis, AE profile, PK and pharmacodynamics Initiating IDE397 Phase 2 monotherapy expansion in MTAP bladder cancer, in addition to the earlier reported Phase 2 expansion in MTAP squamous lung...Read more
GAITHERSBURG, Md., June 23, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented data from the 48-week Phase 2 MOMENTUM clinical trial of pemvidutide, its GLP-1/glucagon dual receptor agonist candidate, in obesity, including the results of a recently completed body composition analysis, at the American Diabetes Association’s (ADA) 84th Scientific Sessions. “We’re pleased...Read more
Mezagitamab-Treated Patients Showed Rapid and Sustained Increases in Platelet Counts That Persisted 8 Weeks After the Last Dose Through to Week 161 Mezagitamab Had a Favorable Safety Profile, with No New Safety Signals1 Takeda Plans to Initiate Global Phase 3 Trial of Mezagitamab in ITP in the Second Half of FY2024 OSAKA, Japan & CAMBRIDGE, Mass. / Jun 22, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today presented positive...Read more
ALPHA3 Trial Has the Potential to Position Cema-cel as Part of First Line (1L) Treatment for LBCL to Improve Cure Rates First Prospective Trial to Incorporate the Foresight Diagnostics’s Investigational CLARITY™ Test to Identify Patients with LBCL Who Have Minimal Residual Disease (MRD) and are Likely to Relapse Following Standard 1L Treatment Unique Profile of Investigational AlloCAR T™ Products May Expand Access to CAR T within...Read more
ALTO-101 has been shown to positively impact cognition and key cognition-related EEG markers in humans when delivered orally Novel transdermal formulation of ALTO-101 exhibited favorable pharmacokinetics and tolerability, greater drug exposure, and fewer PDE4 associated adverse events compared to ALTO-101 administered orally LOS ALTOS, Calif. / Jun 20, 2024 / Business Wire / Alto Neuroscience, Inc. (“Alto”) (NYSE: ANRO)...Read more
DUBLIN, June 20, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced top-line results from the Phase 2b clinical trial (NCT05122650) evaluating the efficacy and safety of suvecaltamide (JZP385), an investigational, highly selective and state-dependent modulator of T-type calcium channels, in adult patients with essential tremor (ET). Suvecaltamide did not achieve statistical significance at 30mg versus...Read more
In ED patients that do not respond to PDE5i monotherapy ~30-40% of ED patients do not respond to PDE5i treatment Data from this Phase 2 clinical study is expected by end of calendar year 2024 Published clinical data and mechanisms of action support clinical study of bremelanotide in combination with a PDE5i Phase 3 clinical study with new co-formulated bremelanotide plus a PDE5i in ED patients that do not respond to PDE5i...Read more
FDA lifts PTC518 partial clinical hold based on PIVOT-HD data Conference call and webcast to be held June 20th at 8:00 am EDT WARREN, N.J., June 20, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today shared interim results from the Phase 2 PIVOT-HD study of PTC518 in Huntington's disease (HD) patients. At Month 12, PTC518 treatment resulted in dose-dependent lowering of mutant huntingtin (mHTT) protein in...Read more
Rapid, robust, and clinically significant reduction in depression symptoms Trials of MB22001 show substantial improvements in mood, energy, creativity, wellbeing, depression and sleep, including REM sleep. One month post cessation of treatment, the antidepressant response is sustained with a 65% overall reduction in depressive symptoms. VANCOUVER, BC / ACCESSWIRE / June 20, 2024 / MindBio Therapeutics Corp. (CSE:MBIO)...Read more
TORONTO, June 18, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the University of Calgary’s Conjoint Health Research Ethics Board (CHREB) has approved the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical team at the University of Calgary Cumming School of...Read more
WALTHAM, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE) today announced topline results from the Phase 2b portion of the Inhaled iMatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT), a Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multi-national trial of AV-101, a novel dry powder inhaled formulation of imatinib, in adults with pulmonary arterial hypertension (PAH). The...Read more
- VANTAGE PBC interim analysis shows 3.8 point reduction from baseline and 2.3 point placebo-adjusted (p=0.0026) reduction in primary endpoint of pruritus - VISTAS PSC interim analysis exceeds efficacy threshold for study continuation - Mirum to host conference call to discuss analyses, today, June 17 at 8:30 a.m. ET/5:30 a.m. PT FOSTER CITY, Calif. / Jun 17, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today...Read more
BOSTON and ATLANTA, June 17, 2024 (GLOBE NEWSWIRE) -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (“Inhibikase” or “Company”), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson's disease, Parkinson's-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced the company has completed enrollment in the Phase 2 ‘201’ trial evaluating the...Read more
Patients who received nipocalimab 15 mg/kg demonstrated a greater than 70 percent relative average improvement on the primary endpoint compared to patients who received placebo Sjögren's disease is a chronic, debilitating, and prevalent autoantibody disease with no approved advanced treatments VIENNA, June 15, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announces patients treated with nipocalimab demonstrated...Read more
Patients in MagnetisMM-3 demonstrated a median overall survival (OS) of 24.6 months, with median progression-free survival (PFS) of 17.2 months NEW YORK / Jun 14, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM). The study demonstrated...Read more
HOUSTON, June 14, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, presented interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in a...Read more
Long term follow-up from REVIVE Phase 2 study up to 3 years shows durable hematocrit (Hct) control (< 45%), decreased phlebotomy use, long-term tolerability, and no new safety signals in patients with polycythemia vera Patients receiving rusfertide in the open-label extension of the REVIVE study are eligible to roll over to the THRIVE study for an additional 2 years of treatment NEWARK, CA / ACCESSWIRE / June 14, 2024 /...Read more
Administration of CardiolRx™ led to a marked reduction in the primary efficacy endpoint of pericarditis pain CardiolRx™ also shown to reduce inflammation in patients with elevated CRP 89% of patients have continued into the extension phase of the study Toronto, Ontario--(Newsfile Corp. - June 13, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused...Read more
Majority of patients continue to be followed for survival with multiple patients approaching 3 years Median Overall Survival (mOS) remains at 30 months based on the most recent data cut with approximately six months of additional follow-up PRINCETON, N.J., June 12, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the...Read more
Co-Administration Phase 2 study of bremelanotide with tirzepatide (GLP-1) to provide key information for melanocortin treatments of obesity Topline data expected by end of calendar year 2024 Additional studies under assessment for multiple metabolic conditions CRANBURY, N.J., June 12, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on...Read more
VANCOUVER, BC / ACCESSWIRE / June 12, 2024 / MindBio Therapeutics Corp. (CSE:MBIO)(Frankfurt:WF6), (the "Company" or "MindBio"), a leading biopharmaceutical company in psychiatric medicine development using microdoses of psychedelic medicines, is delighted to report positive secondary data from its world-first take-home microdosing depression trial using MB22001 completed earlier this year. Data from MindBio's Phase 2A Depression trial...Read more
Topline data expected in December 2024 Phase 2b design optimized for success; clear path to market in this high value indication expected with positive result BOSTON, June 11, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced that it has completed enrollment in RewinD-LB, a Phase 2b trial evaluating...Read more
The SURVEYOR Study met its primary endpoint demonstrating a statistically significant difference as measured by the HD-Cognitive Assessment Battery (HD-CAB) composite score at baseline between healthy participants and participants with Huntington’s Disease (HD) prior to any treatment with dalzanemdor (SAGE-718) or placebo; further underscoring the cognitive impact of HD For participants with HD that received dalzanemdor or placebo,...Read more
30 Patients Relapsed or Refractory to Venetoclax-Based Regimens Enrolled Ahead of Schedule Overall Response Rate (ORR) of 33% and 50% Achieved to Date in 60 mg QW and 30 mg BIW Cohorts, Respectively 45 mg (Safety Dose) Once a Week of SLS009 Showed a Median Overall Survival (OS) of 5.4 Months vs. 2.5 Months with Standard of Care; 60 mg Once a Week and 30 mg Twice a Week Median OS Have Not Been Reached Yet 100%...Read more
Interim results of REGEN-007 Phase 2 trial show stabilization of kidney function for 18 months Safety profile consistent with prior studies and comparable to kidney biopsy Resumed manufacturing and both PROACT 1 and PROACT 2 Phase 3 trials Management to host live webcast today at 8:00 a.m. ET WINSTON-SALEM, N.C., June 10, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage...Read more
Improvements in multiple sign efficacy endpoints were observed in full population and with predictive and more pronounced effects in the TNFR1 genetic biomarker population as identified in prior successful Phase 2 symptoms trial Rapid treatment effect on corneal inflammation was observed in TNFR1 genetic biomarker patients as early as Day 15 and was statistically significant at final efficacy visit on Day 43 Licaminlimab was well...Read more
Injection-free subgroup results demonstrated that a single intravitreal dose of 4D-150 without any supplemental anti-VEGF injections resulted in stable mean visual acuity that was equal to or higher than in the standard bimonthly aflibercept control group at all six timepoints through Week 24 Single intravitreal 3E10 vg/eye dose resulted in sustained reduction and stabilization of mean central subfield thickness (CST) compared to...Read more
SYNERGY-NASH results were presented at the European Association for the Study of the Liver Congress 2024 and simultaneously published in The New England Journal of Medicine INDIANAPOLIS, June 8, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced detailed results from SYNERGY-NASH, a phase 2 study of 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with...Read more
Data highlighted in oral presentation at the European Association for the Study of the Liver (EASL) Congress WARMISTER, Pa., June 06, 2024 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus” or the “Company”), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, announced new preliminary...Read more
In the HBV003 trial, 67% of participants had HBsAg <10 IU/mL and 19% of participants had undetectable HBsAg when assessed for NUC discontinuation (end of treatment) or later, and 76% of participants were eligible for nucleos(t)ide analogue (NUC) therapy discontinuation. In the IM-PROVE II trial, conducted in partnership with Arbutus Biopharma, a statistically significant difference was observed in HBsAg levels between the VTP-300...Read more
PICCOLO trial met its primary endpoint of objective response rate (ORR) Data from the study will be presented at a future medical meeting NORTH CHICAGO, Ill., June 6, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today positive topline results from the Phase 2 PICCOLO trial evaluating investigational mirvetuximab soravtansine (ELAHERE®) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive,...Read more
Trial will evaluate once-daily VYN201 gel in subjects with either active or stable nonsegmental vitiligo Top-line data from the 24-week double-blind portion of the trial expected in mid-2025 BRIDGEWATER, N.J., June 05, 2024 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company developing proprietary, innovative and differentiated therapies for the treatment...Read more
Preliminary Phase 2 SOLSTICE trial data reinforce the potential of both regimens to be transformative treatments in an area of high unmet medical need Conference call scheduled for June 5, 2024, at 6:00 a.m. ET / 12:00 p.m. CEST SAN FRANCISCO / Jun 05, 2024 / Business Wire / Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new preliminary data from its Phase 2 SOLSTICE hepatitis delta clinical trial evaluating...Read more
At the end of treatment, 33.3% of patients receiving imdusiran for 48 weeks, interferon (IFN) for 24 weeks and ongoing nucleoside analogue (NA) therapy achieved undetectable levels of HBsAg that were maintained in 100% of these patients 24 weeks after completing imdusiran and IFN treatment Of the patients who have stopped all therapy, six still have undetectable levels of HBsAg and HBV DNA, with two of these patients reaching 12 weeks...Read more
Encouraging clinical activity with observed deepening of responses in 35 evaluable first line head and neck patients treated with HB-200 plus pembrolizumab In a subset of 17 evaluable patients with PD-L1 combined positive score (CPS) of 20 or higher, the Company’s selected registrational pivotal trial population, data showed confirmed ORR of 53%, CR rate of 18%, and DCR of 82% Preliminary progression-free survival (PFS) was 16.3...Read more
Results in Performance of the Upper Limb (PUL 2.0) Continue to Show Benefits in Skeletal Muscle Function After 3 Years of CAP-1002 Treatment (p< 0.001) Stabilization in Left Ventricular Ejection Fraction (LVEF) Suggests Preservation of Cardiac Function Results Recently Shared with FDA at Type-B Meeting Held in May 2024 SAN DIEGO, June 04, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company...Read more
THIO’s favorable disease control and overall response rates exceed reported standard-of-care data in third line treatment CHICAGO / Jun 04, 2024 / Business Wire / MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced new efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the...Read more
20% of all subjects that completed the 24-week treatment period achieved SALT ≤ 20 29% of completed subjects with moderate to severe disease (baseline SALT 35 to <95) achieved SALT ≤ 20 EQ101 was well tolerated in subjects with alopecia areata with no serious adverse events reported Data supports advancing EQ101 development in alopecia areata to include dose and delivery optimization Data provides further support for opportunistic...Read more
In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015) At Month 18, there was a statistically significant improvement in body proportionality (p-value of 0.001). The mean upper to lower body segment ratio was 1.88 at...Read more
Up to 75% of Patients Treated with VK2809 Achieved NASH Resolution with No Worsening of Fibrosis as Compared to 29% for Placebo (p=0.0001) Up to 57% of VK2809-Treated Patients Achieved ≥1-Stage Improvement in Fibrosis with No Worsening of NASH as Compared to 34% for Placebo (p<0.05) Up to 48% of VK2809-Treated Patients Achieved Both Resolution of NASH and a ≥1-Stage Improvement in Fibrosis as Compared to 20% for Placebo...Read more
100% of Participants (n=6) With CAH Maintained Androstenedione (A4) Below the Upper Limit of Normal at all Time Points on Atumelnant (80 mg) CAH Participants Achieved More Than a 90% Reduction of A4 and 97% Reduction of 17-OHP on Atumelnant (80 mg), Beginning at Two Weeks and Sustained Through 12 Weeks In the ADCS Trial, Atumelnant (80 mg) Normalized 24-hr Urinary Free Cortisol Levels for 100% of Participants (n=5) During Treatment...Read more
KP1077 was well tolerated and showed meaningful clinical improvements in patient-reported assessments of daytime sleepiness, sleep inertia, and brain fog Additional data presented on pharmacokinetics of morning and nighttime doses of KP1077 European Commission has granted Orphan Drug Designation for KP1077 for the treatment of idiopathic hypersomnia CELEBRATION, Fla., June 03, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc....Read more
Results from innovaTV207 evaluating tisotumab vedotin, showing 32.5% confirmed objective response rate in patients with recurrent or metastatic HNSCC, presented in a rapid oral session at 2024 ASCO® Annual Meeting HNSCC is the sixth most common cancer worldwide, with incidence rates expected to increase 30% by 2030i COPENHAGEN, Denmark / Jun 03, 2024 / Business Wire / Genmab A/S (Nasdaq: GMAB) announced today that data from the Phase...Read more
Updated analysis from Memorial Sloan Kettering Cancer Center presented at ASCO 2024 has expanded to 42 patients with clinical complete response New treatment options are needed for patients facing negative impacts to quality-of-life with current standard of care Additional registrational studies of dostarlimab-gxly in dMMR/microsatellite instability-high rectal (MSI-H) and colorectal cancer are recruiting PHILADELPHIA / Jun 03, 2024...Read more
GSBR-1290 achieved a clinically meaningful and statistically significant placebo-adjusted mean weight loss of 6.2% (p<0.0001) in the Phase 2a obesity study and up to 6.9% (p<0.0001) in the capsule to tablet PK study, in both cases at 12 weeks GSBR-1290 demonstrated generally favorable safety and tolerability results with low AE-related study discontinuations Pharmacokinetic data support dose proportional exposure and once-daily...Read more
75% eye preservation rate (9 of 12 enucleation patients) ~67% (8 of 12 enucleation patients) observed greater than 30% tumor shrinkage and median tumor shrinkage of 47% by volume change after 6 months Company-sponsored Phase 2 Neoadjuvant UM: Over 40 patients enrolled, and for the 8 patients with ≥4-months of darovasertib observed median tumor shrinkage of 72% by volume change and eye preserved for the majority of...Read more
Cue Biopharma is developing the first-ever class of therapeutics for the treatment of cancer that mimic the natural signals, or “Cues”, of the immune system. This novel class of injectable biologics selectively engages and modulates tumor-specific T cells directly within the patient’s body to transform...
CLICK TO LEARN MORE