Phase III KATHERINE results reinforce Kadcyla as the standard of care for this population, with more than 82,000 people treated to date Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study These data will be presented as an oral presentation at the 2023 San Antonio Breast Cancer Symposium and included in the official press program SOUTH SAN FRANCISCO,...Read more
First presentation of progression-free survival (PFS) primary endpoint data show zanidatamab plus palbociclib and fulvestrant demonstrated a PFS of 67% at 6 months and a median PFS of 12 months in patients with heavily pre-treated HER2+/HR+ metastatic breast cancer (mBC) Efficacy and safety results support further investigation of this targeted combination therapy as a potential chemotherapy-free option for patients with HER2+/HR+ mBC...Read more
FREMONT, CA, Dec. 07, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced an update on the Company's eight-week long ADHD Phase II part II clinical study taking place at the University of California San Francisco (UCSF) Medical Center and five Taiwanese...Read more
PLYMOUTH MEETING, Pa., Dec. 7, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (Nasdaq: HRMY) today announced positive topline results from its Phase 2 signal detection study evaluating the safety and efficacy of pitolisant in adult patients with myotonic dystrophy type 1 (DM1). A clinically meaningful improvement was demonstrated on the primary efficacy endpoint, the change from baseline to the end...Read more
Atopic Dermatitis (AD) trial is the second KT-474 Phase 2 clinical trial to begin enrolling patients this quarter following trial in Hidradenitis Suppurativa (HS) Topline Phase 2 data from both the AD and HS trials expected in the first half of 2025 WATERTOWN, Mass., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule...Read more
Licaminlimab is a novel anti-TNFα biologic eye drop with an established dual mechanism of action, anti-inflammatory and anti-apoptotic, and a potential transformative impact on the treatment of inflammatory eye diseases RELIEF Phase 2b trial will evaluate the efficacy and safety of licaminlimab in moderate-to-severe Dry Eye Disease, and further explore the potential of a genetic biomarker Trial was initiated as planned with topline...Read more
First Presentation of KeyVibe-002 Results at ESMO I-O 2023 Annual Meeting RAHWAY, N.J. / Dec 07, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced full results from the non-registrational Phase 2 KeyVibe-002 trial evaluating vibostolimab/pembrolizumab, an investigational coformulation of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1...Read more
BOTHELL, Wash., Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the achievement of first-patient-in for the Phase 2a human challenge clinical trial with CC-42344, an investigational new oral antiviral inhibitor for the treatment of pandemic and seasonal influenza A. This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, viral and...Read more
100% CR/CRi Rate in Patients Treated with Tamibarotene, Venetoclax and Azacitidine Compared to 70% in Patients Randomized to Treatment with Venetoclax and Azacitidine Alone Triplet Regimen Continues to Demonstrate Favorable Tolerability Additional Data Expected in 2024 Management to Host Conference Call at 8:30 a.m. ET Today CAMBRIDGE, Mass. / Dec 06, 2023 / Business Wire / Syros Pharmaceuticals (NASDAQ:...Read more
Primary endpoint met; 40 mg/day orally administered deucrictibant significantly reduced mean monthly attack rate by 84.5% (p=0.0008) compared to placebo 92.3% reduction in occurrence of moderate and severe attacks 92.6% fewer attacks treated with on-demand medication by participants Deucrictibant well-tolerated Pharvaris to host a conference call today at 8:00 a.m. EST ZUG, Switzerland, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Pharvaris...Read more
Top-Line Results from 6-month double-blind Phase 2b PARADIGM trial with NeuroSense's lead drug candidate for ALS, PrimeC, include: PrimeC achieved primary safety and tolerability endpoints with a safety and tolerability profile comparable to placebo Meaningful slowing of disease progression: 29% difference (P=0.12) in favor of ALSFRS-R outcome for patients treated with PrimeC vs placebo Slow Vital Capacity: observed a positive...Read more
Expect to enroll approximately 160 subjects and study 3 doses of Haduvio against placebo Primary efficacy endpoint is the relative change in 24-hour cough frequency of Haduvio versus placebo NEW HAVEN, Conn., Dec. 5, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for patients with chronic cough in...Read more
All evaluable participants, with prior PARP inhibitor therapy and chemotherapy, showed significant tumor shrinkage including one complete response Early data follows Phase 2 dose optimization change from once-daily to twice-daily Boston (December 5, 2023) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (Nasdaq: ALLR), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with...Read more
BDC-1001 is a Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) in Phase 2 development for HER2-positive breast, colorectal, endometrial, and gastroesophageal cancers Poster detailing trial design and rationale to be presented at the 2023 San Antonio Breast Cancer Symposium on Wednesday, December 6 REDWOOD CITY, Calif., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage...Read more
Study will aim to enroll about 20 patients to establish safety and clinical activity PETACH TIKVA, Israel / Dec 04, 2023 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that it completed the design of a Phase IIa study protocol for the treatment of patients...Read more
Both EYP-1901 cohorts demonstrated a statistically non-inferior change in BCVA versus aflibercept control with a numerical difference of only -0.3 and -0.4 letters, respectively for the 2 mg and 3 mg dose at blended six-month endpoint Positive safety profile continues with no EYP-1901-related ocular or systemic SAEs Key secondary endpoints were achieved with both EYP-1901 doses. These include an over 80% reduction in...Read more
LONDON and NEW YORK, Dec. 04, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and for neuropathic corneal pain, a severe ocular condition without an FDA approved therapy, is pleased to announce the last patient of a planned 240-patient double-blind...Read more
Highlights: First participants enrolled in the US Naval Medical Research Command Clinical Trial Clinical Study initiated to evaluate the efficacy of a new Immuron clinical product to protecting volunteers against moderate to severe campylobacteriosis New CampETEC product is a prophylactic therapeutic designed to protect against Campylobacter and Enterotoxigenic Escherichia coli (ETEC) infections, two of the major causes of...Read more
Danuglipron demonstrated mean placebo-adjusted weight reductions ranging from -8% to -13% at 32 weeks and -5% to -9.5% at 26 weeks While most common adverse events were mild and gastrointestinal in nature consistent with the mechanism, high rates were observed; no new safety signals were observed High discontinuation rates, greater than 50%, were seen across all doses compared to approximately 40% with placebo Ongoing pharmacokinetic...Read more
Achieved mean weight loss of 15.6% on 2.4 mg dose of pemvidutide at Week 48, with weight loss continuing at the end of treatment Over 30% of subjects achieved 20% or more weight loss on 2.4 mg dose at 48 weeks Robust reductions in BMI and serum lipids and improvements in blood pressure without imbalances in cardiac events, arrhythmias or clinically meaningful increases in heart rate Altimmune to host conference call tomorrow at 8:30...Read more
Rapid, robust, and clinically significant reduction of depression symptoms observed after a single dose of CYB003, with a clear incremental benefit of a second dose Primary efficacy endpoint achieved with an impressive mean -14 point difference in Montgomery-Asberg Depression Rating Scale (“MADRS”) score reduction from baseline between CYB003 (12mg) vs. placebo (p=0.0005) at 3 weeks At 6 weeks, incremental MADRS score...Read more
The PROGRESS study marks initiation of the late-stage development program for AAK1 inhibitor LX9211, with potential to become the first new, non-opioid drug therapy in high-unmet need neuropathic pain in more than 20 years LX9211 has previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for DPNP THE WOODLANDS, Texas, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)...Read more
NEW YORK, Nov. 30, 2023 (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 company has successfully enrolled and dosed four new patients with non-active secondary progressive multiple sclerosis (na-SPMS) in the Brigham and Women’s Hospital, a founding member of...Read more
After only 3 cycles, patient experienced a remarkable improvement of eye-bulging “proptosis” caused by orbital metastatic breast cancer tumor behind the eye. Significant ocular pain reduction recorded. Heavily treated patient had 7 prior failed regimens. The patient continues to receive treatment. PHILADELPHIA and VANCOUVER, British Columbia, Nov. 30, 2023 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW)...Read more
STOCKHOLM, Nov. 30, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ('Calliditas') today announced the initiation of a Phase 2 clinical study to evaluate setanaxib in Alport syndrome. Calliditas is a company focused on developing and commercializing novel treatments in rare diseases with significant unmet medical needs. This randomized, double-blind, placebo-controlled study will evaluate...Read more
LUMINOSITY trial demonstrated compelling clinical benefits across key endpoints Teliso-V is an investigational first-in-class, c-Met protein directed antibody-drug conjugate (ADC) being studied in patients with previously treated non-small cell lung cancer (NSCLC) with c-Met overexpression Data from the study will be presented at a future medical meeting and we will discuss with global health authorities the potential to support an...Read more
SBI-100 Ophthalmic Emulsion, a CB1 agonist/activator delivered as a topical eye drop, was developed to treat patients with elevated intraocular pressure Phase 2 study evaluating efficacy and safety using two concentrations of SBI-100 OE vs. placebo, dosing twice a day for 14 days Analysis of IOP data from 50% of patients enrolled in Phase 2 study to be performed in Q1 2024 SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Skye...Read more
IRVINE, Calif., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, today announced the first patient enrollment in the PEERLESS II study. This prospective, global, multi-center randomized controlled trial (“RCT”) compares the outcomes of intermediate-risk acute pulmonary embolism (“PE”)...Read more
SAN DIEGO / Nov 27, 2023 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the initiation of a Phase 2 study evaluating the efficacy and safety of ACP-204 for the treatment of hallucinations and delusions associated with Alzheimer's disease psychosis (ADP). Of the more than 6.5 million people in the United States living with Alzheimer’s disease (AD), approximately 30% will experience psychosis, commonly consisting...Read more
Data at week 48 demonstrated that treatment with pegozafermin led to sustained statistically significant improvements across liver fat and non-invasive tests (NITs) of liver injury/inflammation and fibrosis in NASH patients with fibrosis stage F2-F3 Subgroups of patients treated with pegozafermin on background GLP-1-based therapies and patients with compensated cirrhosis (F4) each showed robust benefits at week 48 Pegozafermin...Read more
Oral brepocitinib failed to meet its primary endpoint of Systemic Lupus Erythematosus Responder Index (SRI-4) change of 4 at Week 52 Priovant plans to continue progressing the program in indications outside of Systemic Lupus Erythematosus (SLE) given the drug’s favorable safety and tolerability profile, six other positive phase 2 studies, and active arm performance in this study Priovant expects to announce topline results from the...Read more
VANCOUVER, British Columbia, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today reported topline results from the randomized, double-blind, placebo-controlled, Phase 2 proof-of-concept X-NOVA clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 10 mg and 20 mg of XEN1101 in 168 patients with moderate to severe major...Read more
No severe adverse events reported to date Topline data expected as early as Q1 2024 OCALA, Fla., Nov. 21, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the last subject has completed treatment in the Company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with the Post-COVID condition of fatigue (“AMP-518”). AIM Chief Executive Officer...Read more
Data partially fulfills the safety and efficacy hypotheses of one pilot and two Phase II clinical studies Ainos aims to pursue a pre-IND meeting with the U.S. FDA ahead of a planned Phase III study SAN DIEGO, CA / ACCESSWIRE / November 21, 2023 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon...Read more
PETACH TIKVA, Israel / Nov 21, 2023 / Business Wire / Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that a patient who participated in the Phase II Liver Cancer Study and was treated with namodenoson has a complete response and overall survival of 6.9 years (82.8 months). Liver...Read more
Clinical response (IGA 0/1 and EASI-75) achieved at Week 16 with rademikibart treatment was maintained through Week 52 with both every two weeks (Q2W) and every four weeks (Q4W) dosing regimens Approximately 90% of patients on Q4W dose maintained both IGA 0/1 and EASI-75 through Week 52 Over 36 weeks of treatment in Stage 2 of the study, the percentage of patients achieving IGA 0/1 and EASI-75 continued to increase Rademikibart...Read more
Topline Phase 2b data expected in June 2024 More than 120 sites around the world actively recruiting in the Phase 3 portion of the IMPAHCT trial WALTHAM, Mass., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Aerovate Therapeutics, Inc. (Nasdaq: AVTE), a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease, today announced the Phase 2b portion of...Read more
1.0% Formulation Reached Primary Endpoint with Statistical Significance Full Analysis Identified Additional Efficacy Signals TORONTO, ON / ACCESSWIRE / November 20, 2023 / Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company focused on inflammatory and immune-related diseases, today announced favorable final results from a Phase 2b dose-ranging clinical study of the company's drug candidate, EB01...Read more
SEATTLE, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, today announced that it has reached full enrollment in the Company’s Karisma-Endoxifen clinical trial, the 240-person Phase 2 study investigating (Z)-endoxifen in premenopausal women with...Read more
Alzamend’s recently completed Phase IIA study of AL001 in Alzheimer’s patients and healthy subjects showed a benign safety profile and identified a candidate dose that is unlikely to require therapeutic drug monitoring Safety aspects of AL001 development may qualify for a 505(b)(2) NDA pathway for FDA approval ATLANTA / Nov 20, 2023 / Business Wire / Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical...Read more
40 Percent of Low Transfusion Burden Cohort Achieved Transfusion IndependenceOne Study Patient Achieved Hemoglobin Response Endpoint Safety Profile Consistent with Data Reported in Healthy Volunteers Study Company Expects to Initiate Phase 2b Study in Mid-2024 CAMBRIDGE, Mass., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering...Read more
LA JOLLA, Calif., Nov. 19, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova’s collaborator, Justin Lathia PhD, Co-Director of the Brain Tumor Research and Therapeutic Development Center of Excellence at Cleveland Clinic Lerner Research Institute, and Professor,...Read more
Iluzanebart demonstrated favorable safety and tolerability, including no hematologic adverse events Clear CNS target engagement and downstream pharmacological activity at 20 mg/kg consistent with Phase 1 data; Directionally supportive changes in individual patients at 6 months on MRI and NfL biomarkers Natural History Study continued to provide critical insights on MRI and NfL biomarkers; sCSF1R emerging as key biomarker...Read more
Enrollment Completion Signifies Critical Progress to Phase 3 of PF614 Trial Results Expected in December 2023 SAN DIEGO, CA / ACCESSWIRE / November 16, 2023 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that the PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover...Read more
Confirmed objective response rate of 52% in pediatric patients and 41% in adult patients, as assessed by Blinded Independent Central Review Mirdametinib treatment resulted in deep and durable responses and significant improvements in key secondary patient-reported outcome measures Mirdametinib was generally well tolerated with low rates of Grade 3+ adverse events Additional data expected to be presented at medical...Read more
The Company received a cash refund of approximately $2.8M USD pursuant to an Australian Research and Development Tax Incentive. Boca Raton, Florida, Nov. 15, 2023 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company dedicated to advancing treatments that leverage the patient’s innate immune system to combat disease, has received acceptance of a Clinical Trial Application...Read more
This is the longest Niagen NR clinical trial to date spanning two years and showcases that long-term Niagen NR is safe and well tolerated LOS ANGELES / Nov 15, 2023 / Business Wire / ChromaDex Corp. (NASDAQ:CDXC), one of the global authorities on Nicotinamide Adenine Dinucleotide (NAD+) and healthy aging research, shares results from a phase II clinical study published in the peer-reviewed journal, Movement Disorders, by a team of...Read more
Phase IIa trial outcome indicates the potential for a new way to help Alzheimer’s patients’ agitation Tel-Aviv, Nov. 15, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), unveiled positive topline results from its investigator-initiated Phase IIa trial at the...Read more
SAINT LAURENT, Quebec, Nov. 14, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX) (OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that the Swedish Medical Products Agency (“MPA”), the Swedish Ethical Review Authority, and the Regional Biobank Centre have approved the planned clinical study to investigate the use of IntelGenx’s Montelukast VersaFilm® for the treatment of Parkinson’s Disease (“PD”). PD is the second most...Read more
SUNNYVALE, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the Food and Drug Administration (FDA) approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. BioCardia announces that the Food and Drug...Read more
Orally administered LYT-300 achieved a statistically significant (p=0.0001) reduction in the stress hormone response, as measured by salivary cortisol, compared to placebo This proof-of-concept trial demonstrating a reduction in the physiological stress response supports the further development of LYT-300 as a potential treatment for a range of anxiety disorders Anxiety disorders affect nearly 30 percent of U.S. adults1, yet current...Read more
Late Breaking Poster Presentation Reports New Results Demonstrating Robust Liver Fat Reductions Across Key Subgroups, Including Patients with Type 2 Diabetes and Among Those with F2 or F3 Fibrosis Presentation also Highlights Previously Reported Results Showing Successful Achievement of Study's Primary Endpoint, Statistically Significant Liver Fat Reductions from Baseline to Week 12 Among Patients Receiving VK2809 52-Week Biopsy...Read more
Updated positive interim Phase 2 data demonstrate potential efficacy of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients Focusing Phase 3 development program on patients with Stage 3b and 4 diabetic CKD at highest risk of advancing to kidney failure and need for renal replacement therapy Dr. Bruce Culleton appointed ProKidney CEO following Dr. Tim Bertram’s transition to advisory role Sufficient...Read more
Demonstrated improvements among best reported of fibrosis-reducing compounds Liver stiffness results complemented by positive changes in disease biomarkers and HepQuant Duo liver function test “These findings presented today at AASLD The Liver Meeting® confirm that rencofilstat’s novel mechanism of action represents a fresh approach to the treatment of severe liver disease.” (Patrick Mayo, PhD, Hepion’s Senior VP, Clinical...Read more
Results demonstrate improvements in sarcopenia and other clinically meaningful outcomes Patients converting from placebo to LPCN 1148 in the ongoing open label extension also showed improvement in sarcopenia SALT LAKE CITY, Nov. 13, 2023 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating Central Nervous System (CNS) disorders, today announced that results of its Phase 2 study evaluating...Read more
As previously reported, the ALPINE 4 study met its primary endpoint, with aldafermin 3 mg demonstrating a statistically significant reduction in Enhanced Liver Fibrosis (ELF) score compared to placebo after 48 weeks of treatment ELF, an FDA-approved non-invasive blood test, can be used to predict liver-related events in patients with nonalcoholic steatohepatitis (NASH) and compensated cirrhosis Dose-dependent improvements reported...Read more
Plozasiran achieved mean max reductions of up to 90% in APOC3 and 87% in triglycerides in patients with severe hypertriglyceridemia In patients with mixed dyslipidemia, mean max reduction in APOC3 was up to 89% leading to robust and durable reductions in multiple atherogenic lipoproteins Company will host a virtual analyst and investor event today, November 13, 2023, at 4:30 pm ET PASADENA, Calif. / Nov 13, 2023 / Business Wire /...Read more
Data from two Phase 2 studies in PBC show combination of OCA + bezafibrate achieved biochemical remission (normalization of ALP, total bilirubin, GGT, ALT and AST) in 40-44% of patients in the first 12 weeks OCA 5 or 5-10 mg + bezafibrate 400 mg cohorts in both studies showed a >60% reduction from baseline in serum ALP (primary endpoint) Treatment-emergent adverse events were generally balanced across all cohorts in both...Read more
Study Did Not Meet Primary or Secondary Efficacy Endpoints in Rheumatoid Arthritis Efficacy Results Do Not Support Further Development of Zunsemetinib Company to Host Conference Call and Webcast Today at 8:00 AM ET WAYNE, Pa., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drugs for immuno-inflammatory diseases, today announced...Read more
Children with Autism Spectrum Disorder are at Risk for Low Bone Density Preliminary Data Suggest that the Administration of Oxytocin May Favorably Impact Bone Formation and Strength Recent Meta-Analysis Reported that Plasma Oxytocin Levels Tend to be Lower in Children with Autism Spectrum Disorder than Controls1 CHATHAM, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the...Read more
Continued treatment over two years with donidalorsen demonstrated sustained reduction in hereditary angioedema attacks and improved quality of life Donidalorsen recently received orphan drug designation in the U.S. Topline Phase 3 results expected in H1 2024 CARLSBAD, Calif., Nov. 9, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive results from an ongoing Phase 2 open-label extension (OLE)...Read more
A total of 171 head and neck squamous cell carcinoma (HNSCC) patients enrolled in randomised, multicentre Phase IIb trial evaluating efti in combination with pembrolizumab Efti has FDA Fast Track designation for first-line treatment of HNSCC SYDNEY, AUSTRALIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3...Read more
75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival (OS) in similar patients is 7-11 months 12-month survival rate in ICI resistant patients is 72% Median OS in ICI resistant patients is approximately 20 months; published median OS is 3.4 months PRINCETON, N.J., Nov. 09, 2023 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the...Read more
Primary Endpoint of Confirmed Disability Improvement at 12 Months Not Achieved Company to Further Analyze Data and Evaluate Strategic Options for ATA188 Program with Focusing of Resources and Planned Expense Reductions Expected to Extend Cash Runway Beyond Q3 2025 Allogeneic CAR-T Portfolio Advancing with Several Catalysts Anticipated in the Next 18 Months THOUSAND OAKS, Calif. / Nov 08, 2023 / Business Wire / Atara Biotherapeutics,...Read more
Data presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting Longitudinal comparison of biomarkers in tumor microenvironment showed a gradual, durable response over time in T lymphotactic CXCR3 ligands and cytolytic factors Phase 2 study ongoing; topline interim results expected before year end OCALA, Fla., Nov. 08, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM”), an...Read more
Median overall survival of 15.5 months with BXCL701 + KEYTRUDA® (pembrolizumab), compared to 9.6 months with checkpoint inhibitor monotherapy in late-line refractory patients in separate Phase 2 trial1 59% of studied patients alive at one year following treatment with BXCL701 + KEYTRUDA Median progression-free survival of 4.2 months with BXCL701 + KEYTRUDA compared to 2.1 months with checkpoint inhibitor monotherapy in...Read more
ATH434-201 is a randomized, double-blind, placebo-controlled study in early-stage MSA Lead clinical development program enrolled 77 participants globally MELBOURNE, Australia and SAN FRANCISCO, Nov. 08, 2023 (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...Read more
OraGrowtH210 Results Show LUM-201 Dose of 1.6 mg/kg Achieves Annualized Height Velocities (AHV) of 8.2 cm/yr at 6 Months and 8.0 cm/yr at 12 Months, Comparable to Growth Rates for Moderate PGHD Population Delta at 6 and 12-month AHV Between Optimal LUM-201 Dose of 1.6 mg/kg and rhGH Comparator Arm is Within the Non-inferiority Margin (< 2 cm/yr) Suggested by FDA for Recent Approvals Initial 24-month LUM-201 Data from Combined...Read more
The Study Met Its Primary Endpoint with 53.3% and 54.2% of Patients Treated With TAK-279 (15 mg and 30 mg Respectively) Achieving At Least an ACR 20 Response Compared to 29.2% in the Placebo Group at Week 12 (p = 0.002)1 TAK-279 Demonstrated Improvements in Key Secondary Endpoints and a Safety Profile Consistent with the Phase 2b Psoriasis Study1 Takeda Will Initiate Phase 3 Studies in Plaque Psoriasis in FY23 and Psoriatic Arthritis in...Read more
Top-line results expected mid 2024 Strong physician interest drove SHINE study completion PURCHASE, N.Y., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), (the “Company” or “Cognition”), today announced that the last participant was randomized in the Phase 2 SHINE study (NCT03507790) of CT1812, the company’s lead candidate for the treatment of age-related neurodegenerative diseases of the...Read more
Compelling efficacy signal in favor of larsucosterol in the key secondary endpoint of mortality at 90 days. Clinically relevant reduction in 90-day mortality of 41% for 30 mg dose and 35% for 90 mg dose compared with standard of care (SOC) Numerical improvement in primary endpoint of mortality or transplant at 90 days did not achieve statistical significance More pronounced effect in the U.S. trial population of 232 patients,...Read more
Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study showed promising ORR and six-month PFS results, irrespective of PD-L1 expression Domvanalimab is the only Fc-silent anti-TIGIT antibody in Phase 3 for upper GI adenocarcinomas and has the potential to be first to market for these cancers Detailed results will be presented on November 7 at 12pm PT / 3pm ET during the ASCO Monthly Plenary Series FOSTER...Read more
VTX958 225 mg BID and 300 mg BID doses achieved statistical significance on the primary endpoint (PASI 75) and all key secondary endpoints at Week 16 Efficacy results did not meet the internal target to support further development of VTX958 in psoriasis; Ventyx to terminate Phase 2 trials of VTX958 in plaque psoriasis and psoriatic arthritis The ongoing Phase 2 trial of VTX958 in Crohn’s disease will continue to enroll; Ventyx intends...Read more
“Extra-strength” 40U formulation demonstrated a duration of 26 weeks, or 6 months, when measuring the time for a patient to return back to their baseline Glabellar Line score after a single treatment 40U results indicate a similar safety profile to lower dose arms in the study NEWPORT BEACH, Calif. / Nov 06, 2023 / Business Wire / Evolus, Inc. (NASDAQ: EOLS), a performance beauty company with a focus on building an aesthetic portfolio...Read more
Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups Mean change from baseline to week 12 in UAS7 of -23.87 in 300 mg q8w dose group and -23.02 in 150 mg q4w dose group Barzolvolimab was generally well tolerated with a favorable safety profile Treatment will continue to 52 weeks; results support further development of...Read more
Planned Subgroup Analysis of RAMP 201 Data Showed Combination Demonstrated Robust Efficacy in Recurrent LGSOC Regardless of Number and Class of Prior Therapies Including After Poor Response to Prior Therapy Late-Breaking Abstract Featured as an Oral Presentation during a Plenary Session at the Annual Global Meeting of the International Gynecologic Cancer Society BOSTON / Nov 06, 2023 / Business Wire / Verastem Oncology (Nasdaq: VSTM)...Read more
Clinical efficacy results (secondary endpoints) and safety results (primary endpoints) expected December 2023 Biogen collaboration biomarker results expected Q1 2024 Primary biomarker endpoints to be reported H1 2024 CAMBRIDGE, Mass., Nov. 6, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced it has completed...Read more
52.5% reduction with high-dose and 47.7% reduction with low-dose combination compared to baseline, and an acceptable tolerability profile Novel investigational drug leverages SGLT2 inhibition and high selectivity ETA receptor antagonism with potential to deliver step-change efficacy and acceptable fluid retention Plans for Phase III start underway WILMINGTON, Del. / Nov 03, 2023 / Business Wire / Combination of zibotentan with...Read more
Media Release Statistically significant increases of Th1 biomarkers (IFN-gamma, CXCL-10), circulating immune cells (lymphocytes), and RNA levels of immune activating genes were observed and linked to improved clinical outcomes Early increase in absolute lymphocyte count is correlated with the positive Overall Survival results in non-small cell lung cancer patients recently reported at ESMO 2023, and is a potential on-treatment...Read more
Initial positive interim data revealed notable improvements in patients with borderline resectable pancreatic ductal adenorcarcinoma (PDAC) after experimental treatment with CAN-2409 Estimated overall survival rate was 71.4% at 36 months in CAN-2409 treated patients versus 16.7% in the control arm after chemoradiation In patients with progressive disease, there was both a CA19-9 and a survival response to salvage chemotherapy in the...Read more
ABBV-RGX-314 continues to be well tolerated in 50 patients from dose levels 1 and 2 (Cohorts 1-3) with no drug-related serious adverse events Dose level 2 prevented disease progression and reduced vision-threatening events in non-proliferative diabetic retinopathy patients at 1 Year 70.8% of patients achieved Diabetic Retinopathy Severity Scale improvement vs. 25.0 % in control 0% of patients worsened ≥2 steps vs. 37.5...Read more
Confirmed objective response rate (ORR) of 40% in PD-L1 positive (TPS ≥1%) patients with no prior checkpoint inhibitor therapy (CPI) Median progression-free survival (PFS) of 6.3 months in PD-L1 positive patients at time of data cut off Confirmed ORR of 50% in patients with PD-L1 high expression (TPS ≥50%) and 38% in patients with PD-L1 low expression (TPS 1-49%) RAPT to host webcast conference call today at 10:00 am PT SOUTH SAN...Read more
In a total of 26 ibezapolstat-treated patients in Phases 2a and 2b, the Clinical Cure rate is 96% Meets protocol primary objective of assessing the primary efficacy endpoint of the Clinical Cure rate after 10 days of oral treatment Ibezapolstat was well tolerated; no drug-related Serious Adverse Events Further analyses forthcoming regarding secondary and exploratory endpoints, including Sustained Clinical Cure data,...Read more
Expect to enroll 60 subjects across a broad range of cough frequencies RIVER topline data expected in the second half of 2024 NEW HAVEN, Conn., Nov. 2, 2023 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for difficult to treat patients with chronic cough in idiopathic pulmonary fibrosis (IPF), refractory chronic...Read more
Interim readout shows rapid, robust, and clinically significant reduction of depression symptoms three weeks after a single 12mg dose, with an unprecedented mean -14 point Montgomery-Asberg Depression Rating Scale ("MADRS") score reduction from baseline between CYB003 (12mg) vs. placebo (p= 0.0005) For reference, pooled data from 232 industry studies of current standard of care antidepressants, selective serotonin reuptake...Read more
COVID-19 Phase 2 clinical trial fully enrolled Study compares mono- and bivalent vaccine candidates against licensed comparator COVID-19 vaccine First participant dosed in seasonal flu Phase 2 part of combined Phase 1/2 study Study compares a potentially differentiated, multivalent vaccine candidate with broad antigen coverage against licensed comparator vaccine TÜBINGEN, GERMAN and BOSTON, MA / ACCESSWIRE / November...Read more
Successful Completion of Recruitment Driven by Strong Clinical Site Participation and Investigator Support Topline Data Expected in Q3 2024 ALPHARETTA, Ga., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today the completion of recruitment in...Read more
Toronto, Ontario--(Newsfile Corp. - November 1, 2023) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that it has exceeded 50% of the patient enrollment target for its Phase II open-label pilot study...Read more
SYDNEY, Nov. 1, 2023 /PRNewswire/ -- Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, is pleased to provide a preliminary update from the ongoing investigator-initiated Phase 2 clinical trial (NCT04906096) evaluating paxalisib as monotherapy treatment in patients with relapsed/refractory primary central nervous system lymphoma (r/r PCNSL). This is an open-label, Phase 2 clinical trial,...Read more
Additional Analyses of Phase 2b Data Conducted in Population of Study Participants with Female Sexual Interest/Arousal Disorder (FSIAD), With Primary Complaint of Arousal Dysfunction Achieved Statistical Significance and Clinically Meaningful Improvement in Phase 2b Co-Primary Endpoint Assessing Arousal Sensation, and Statistical Significance in Items from Phase 2b Co-Primary Endpoint Scale Evaluating Concern Related to Difficulties...Read more
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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