Treatment with adjuvant TAGRISSO reduced the risk of death by more than half WILMINGTON, Del. / Jun 04, 2023 / Business Wire / Positive results from the ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), compared to placebo in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth...Read more
Patients treated with dual immunotherapy-based combination demonstrate sustained clinical benefits after four years vs. chemotherapy alone, with magnitude of benefit more pronounced amongst patient subgroups with high unmet needs Late-breaking data to be presented during the 2023 American Society of Clinical Oncology Annual Meeting PRINCETON, N.J. / Jun 04, 2023 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced...Read more
Results from MIRASOL Also Show ELAHERE is the First Treatment to Demonstrate an Overall Survival Benefit in a Phase 3 Trial in Platinum-Resistant Ovarian Cancer Compared to Chemotherapy Clinically Meaningful Improvements in Progression Free Survival and Overall Survival Observed with ELAHERE Regardless of Prior Bevacizumab Status Data Further Support Potential of ELAHERE to Become the New Standard of Care for Patients with FRα-Positive...Read more
Data presented at ASCO annual meeting demonstrate 55% Disease Control Rate (DCR) in heavily pre-treated GIST patients, including 100% DCR and 17% overall response rate (ORR) in efficacy evaluable 2nd-line GIST patients; data immature to estimate progression free survival (PFS) Combination of bezuclastinib and sunitinib is well-tolerated and consistent with published sunitinib monotherapy safety profile Cogent to...Read more
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone RAHWAY, N.J. & KINGSTON, Ontario / Jun 03, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial...Read more
WILMINGTON, Del. / Jun 03, 2023 / Business Wire / Positive results from a planned interim analysis of the DUO-O Phase III trial showed that treatment with a combination of LYNPARZA® (olaparib), IMFINZI® (durvalumab), chemotherapy and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with...Read more
Early on-treatment ctDNA reduction in stable disease patients treated with KIMMTRAK was associated with longer overall survival (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md, 3 June 2023) Immunocore Holdings plc (Nasdaq: IMCR), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases,...Read more
First global Phase III trial of immunotherapy and chemotherapy combination to demonstrate clinical benefit in this setting Trial will continue to assess event-free survival WILMINGTON, Del. / Jun 02, 2023 / Business Wire / Positive high-level results from a planned interim analysis of the MATTERHORN Phase III trial showed treatment with AstraZeneca’s IMFINZI® (durvalumab) added to standard-of-care FLOT (fluorouracil, leucovorin,...Read more
NEW YORK, June 02, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the Consortium of Multiple Sclerosis Centers (CMSC) annual meeting. A link to the oral presentation is included below. Michael S. Weiss, Chairman and Chief...Read more
Data support that antibiotic aztreonam-avibactam (ATM-AVI) is effective and well-tolerated in treating infections caused by Gram-negative bacteria, with a similar safety profile to aztreonam alone NEW YORK / Jun 01, 2023 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 program comprising the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies evaluating the efficacy, safety, and...Read more
EDMONTON, Alberta / Jun 01, 2023 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced the results of a post-hoc, pooled analysis of the Phase 2 AURA-LV (NCT02141672) and Phase 3 AURORA 1 (NCT03021499) studies, which found that LUPKYNIS® with mycophenolate mofetil (MMF) and low-dose steroids resulted in earlier and greater reductions in proteinuria in lupus nephritis (LN) patients with high...Read more
Study is Investigating RenovoGem™ as Potential New Option for Pancreatic Cancer Treatment Recent Positive Interim Data Analysis from Study Revealed 60% Survival Benefit and 65% Side Effect Reduction Versus Systemic Chemotherapy LOS ALTOS, Calif. & DALLAS / Jun 01, 2023 / Business Wire / RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies,...Read more
HAT-301 is the Pivotal Efficacy Study to Support Upcoming NDA Filing Top Line Results Planned for Release in July 2023 TARRYTOWN, NY, June 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD), and other serious conditions with intractable...Read more
GAITHERSBURG, Md., June 1, 2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its PIKA Rabies Vaccine (the "Vaccine") was granted Phase 3 clinical trial approval from the Food and Drug...Read more
Hyalofast – a single-stage, off-the-shelf, resorbable, hyaluronic acid scaffold for cartilage repair – is marketed in over 35 countries outside the U.S. where it has been clinically demonstrated to be safe and effective Hyalofast has been designated as a breakthrough device by FDA, allowing prioritized interaction and review; Anika to begin filing modular PMA in 2024 with final module filing expected in 2025 Hyalofast...Read more
Study demonstrates statistically significant and clinically relevant reduction in annualized bleeding rate compared to prophylaxis and on-demand intravenous regimens Marstacimab, if approved, has the potential to become the first once-weekly subcutaneous treatment for people living with hemophilia B and the first treatment administered as a flat dose for people living with hemophilia A or B A novel, investigational anti-tissue factor...Read more
TORONTO, May 30, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) evaluating the safety and efficacy of...Read more
Reports significant uptick in enrollment activities Tigris trial enrollment at 61 patients TORONTO, May 30, 2023 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an enrollment update on Tigris, the Company’s follow-on study designed to build on knowledge gained from the earlier EUPHRATES...Read more
The research conducted at Cedar Clinical Research in Draper is part of the first ever phase 3 program of psilocybin therapy, and the largest of its kind VANCOUVER, BC, May 30, 2023 /CNW/ - Numinus Wellness Inc. (TSX: NUMI) is pleased to announce that Cedar Clinical Research (CCR) has begun studying COMP360 psilocybin therapy, an investigational new therapy for treatment-resistant depression (TRD), as part of the largest-ever...Read more
WASHINGTON, May 25, 2023 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its Phase III study of tradipitant in motion sickness, confirming the previously reported results demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. The Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States...Read more
Clinically meaningful efficacy results observed with half (60mcg) of the approved dose of IGALMI™ Greater than 50% PEC response rate attained; proportionally consistent with dose response when compared to rates seen in SERENITY I and II BXCL501 was well tolerated and demonstrated favorable safety results supporting potential for at-home use SERENITY III Part 2 planned as an adaptive trial design with 60mcg and 80mcg to potentially...Read more
256-patient enrollment target met plus 11% over-enrollment; Primary endpoint based on patient reported outcomes from study expected in October 2023 SAN FRANCISCO, CA / ACCESSWIRE / May 25, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that the Company has successfully over-enrolled its global, pivotal, Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer...Read more
PLYMOUTH MEETING, Pa., May 25, 2023 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today announced that its Phase 3 registrational INTUNE study evaluating the safety and efficacy of pitolisant in adult patients with idiopathic hypersomnia (IH) has completed enrollment nine...Read more
SAN DIEGO, May 24, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ: MRTX), a commercial-stage oncology company, today announced that the SAPPHIRE study did not meet its primary endpoint of overall survival at the final analysis. SAPPHIRE is a Phase 3 study evaluating sitravatinib in combination with nivolumab (OPDIVO®)1 versus docetaxel in patients with second or third line advanced non-squamous non-small cell lung cancer...Read more
Conference call and webcast to be held at 5:00 pm EDT SOUTH PLAINFIELD, N.J., May 23, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today reported topline results from the MOVE-FA trial of vatiquinone in patients with Friedreich ataxia. The study did not meet its primary endpoint of statistically significant change in mFARS score at 72 weeks in the primary analysis population. However, vatiquinone treatment...Read more
ORCA-3 demonstrated statistically significant topline results in primary and secondary smoking cessation endpoints for both 6- and 12-week cytisinicline treatment durations compared to placebo Cytisinicline demonstrated 6x increase in odds of continuous smoking abstinence at 6 months Cytisinicline treatment well tolerated with low rates of adverse events reported Management to host conference call today, May 23 at 8:30AM...Read more
SAN FRANCISCO, May 23, 2023 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced the initiation of ENTRUST, a Phase 3 trial evaluating the efficacy, safety and tolerability of pegozafermin in patients with severe hypertriglyceridemia (SHTG). "We are pleased...Read more
DIAMOND trial in Diabetic Macular Edema (DME) with topical OCS-01 met its stage 1 objective of validating the loading and maintenance dosing regimen designed to optimize OCS-01 efficacy potential with robust statistical significance Primary efficacy endpoint of mean change in Best Corrected Visual Acuity (BCVA) versus baseline at Week 6 showed statistically significant increase in visual acuity in the OCS-01 arm compared to vehicle...Read more
The Phase 3 MANTRA trial did not meet the primary endpoint of progression free survival vs. standard of care The median PFS was 3.6 months for milademetan versus 2.2 months for trabectedin with a hazard ratio of 0.89 Rain to host a conference call at 8:30 a.m. ET NEWARK, Calif., May 22, 2023 (GLOBE NEWSWIRE) -- Rain Oncology Inc. (NasdaqGS: RAIN), (Rain), a late-stage company developing precision oncology...Read more
RedHill has elected to terminate RHB-204's U.S. Phase 3 study for Non-tuberculosis Mycobacteria (NTM) disease due to low accrual rate and plans to shift resources to more rapidly advance RHB-107 late-stage development for outpatient treatment of COVID-19 RedHill's advanced pipeline also includes: Opaganib – in collaboration with the U.S. Government's Radiation and Nuclear Countermeasures Program for development as a potential treatment...Read more
Dupixent is the first and only investigational biologic for COPD that has demonstrated a significant reduction in moderate or severe acute exacerbations by 30% compared to placebo Dupixent is the first and only investigational biologic for COPD that has significantly improved lung function at 12 and 52 weeks, with numerical improvements seen as early as 2 weeks Dupixent significantly improved quality of life, with numerical...Read more
Continued Treatment with Patisiran in Open-Label Extension Period Showed Evidence of Sustained Benefit across Measures of Functional Capacity and Health Status and Quality of Life, as well as Cardiac Stress and Injury, through 18 Months Safety Profile Consistent with that Observed in 12-Month Double-Blind Period, with No New Safety Findings CAMBRIDGE, Mass. / May 20, 2023 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY),...Read more
Statistically Significant Improvement in Chorea Associated with Huntington's Disease Seen as Early as Week 2 Chorea Improvement Supported by Statistically Significant Clinical Global Impression of Change (CGI-C) Response Status and Patient Global Impression of Change (PGI-C) Response Status Scores at Week 12 First Phase 3 Study to Implement Huntington's Disease Health Index (HD-HI), a Patient-Reported Outcome...Read more
Met primary endpoint of noninferiority of roxadustat to erythropoietin alfa Plan to file supplemental New Drug Application in China SAN FRANCISCO and BEIJING, May 18, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) and its subsidiary, FibroGen (China) Medical Technology Development Co., Ltd. today announced positive topline data from Company’s Phase 3 clinical study of roxadustat for treatment of anemia in patients receiving...Read more
TEL AVIV, Israel, May 18, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced positive pharmacokinetic (PK) data in the first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas. During Part I of this...Read more
Results support potential for a new treatment option that builds on the benefit of first-line standard of care TAGRISSO monotherapy WILMINGTON, Del. / May 17, 2023 / Business Wire / Positive high-level results from the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS)...Read more
Highly statistically significant and clinically meaningful results 63% mean blood Phe reduction in primary analysis population (p<0.0001) Conference call and webcast to be held at 8:00 AM EDT SOUTH PLAINFIELD, N.J., May 17, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the primary endpoint was achieved in the APHENITY, Phase 3 registration-directed clinical trial of...Read more
Avidity plans to double the number of participants receiving 4 mg/kg of AOC 1001 in MARINA Open-Label Extension (MARINA-OLE™) study by dose escalating participants currently on 2 mg/kg of AOC 1001 FDA allows new participant enrollment for 2 mg/kg of AOC 1001 First look at data from the MARINA-OLE study planned for the end of 2023 SAN DIEGO, May 17, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical...Read more
ADORING 1 met the primary and all secondary endpoints, consistent with the positive topline results from the Phase 3 ADORING 2 trial reported in March, marking Roivant’s 10th consecutive positive Phase 3 study since 2019 45.4% of subjects receiving VTAMA achieved the primary endpoint of vIGA-AD™ response of clear (0) or almost clear (1) with at least a 2-grade improvement from baseline at Week 8, versus 13.9% on vehicle...Read more
~60% reduction in annualized infection rate seen in the mavorixafor arm vs. placebo (p<0.01) >75% reduction in the percentage of individuals experiencing severe infections (Grade 3 or higher) in the mavorixafor group vs. placebo group >70% reduction in mean total days with infections (2 weeks on mavorixafor treatment vs. 7 weeks on placebo) Company on track to submit NDA for mavorixafor early in 2H 2023 following completion...Read more
Primary Study Completion Anticipated in the Second Quarter of 2024 PASADENA, Calif. / May 16, 2023 / Business Wire / Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has completed enrollment of its global Phase 3 clinical trial (PALISADE) evaluating ARO-APOC3 for the treatment of familial chylomicronemia syndrome. The company anticipates that the primary portion of the study will be complete in the second quarter...Read more
GAITHERSBURG, Md., May 16, 2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced its PIKA Rabies Vaccine has received Phase 3 clinical trial approval from the Drug Regulatory Authority of...Read more
Oramed has completed an analysis of its U.S.-based Phase 3 oral insulin trial with significant lowering of A1C levels seen in patient subgroups NEW YORK, May 15, 2023 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com) announced today that Hefei Tianhui Biotechnology Co. Ltd. (HTIT), a strategic partner of Oramed, has successfully completed its Phase 3 trials of oral insulin in type 2...Read more
TORONTO, May 12, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy of...Read more
Sulbactam-durlobactam is the first pathogen-targeted therapy under investigation for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). WALTHAM, Mass. / May 11, 2023 / Business Wire / Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA) focused on delivering...Read more
The Cognition Maintenance Study (CMS) is a 6-month, Randomized Controlled Trial of Simufilam in Over 125 Patients with Alzheimer’s Disease. Primary Outcome Measures Are Safety and Change in Cognition Scores. Top-line Clinical Results of the CMS Are Expected in Q3 2023. AUSTIN, Texas, May 11, 2023 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced the completion of...Read more
WARREN, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH) (“Bellerophon” or the “Company”), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary diseases, today announced that the last patient has completed blinded treatment in the ongoing Phase 3 REBUILD study of INOpulse®, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic...Read more
Montrouge, France, May 10, 2023 DBV Technologies Announces New England Journal of Medicine Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin™ Peanut in Toddlers The New England Journal of Medicine (NEJM) published results that demonstrated epicutaneous immunotherapy (EPITTM) with Viaskin Peanut was statistically superior to placebo in desensitizing children to peanut by increasing the peanut dose that triggers allergic...Read more
Primary endpoint based on patient reported outcomes from study expected in October 2023 With the completion of the PIPE financing of unregistered shares and 6-month lock up term, Jaguar has agreed, as described below, not to issue additional equity securities before October 22, 2023 - by which point the Company expects to have released top line data for the OnTarget trial SAN FRANCISCO, CA / ACCESSWIRE / May 9, 2023 / Jaguar Health,...Read more
Phase III Study Designed to Establish the Effect of Ivonescimab in Lung Cancer Patients Whose Tumors Progressed after EGFR-TKI Therapy MENLO PARK, Calif. / May 09, 2023 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that the first United States-based patient has been enrolled in the Phase III HARMONi study. HARMONi is a Phase III multiregional, randomized, double-blinded...Read more
Additional data presentations further characterize the efficacy and safety profiles of linaclotide in this patient population Functional constipation affects an estimated 6 million 6-17 year-olds in the U.S.1; there are currently no FDA-approved prescription therapies BOSTON / May 08, 2023 / Business Wire / Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, presented findings during the 2023 Digestive...Read more
Data from Phase 3 open-label single-arm study of VOWST found nearly 95% of individuals with a clinical response at 8 weeks remained free of CDI through Week 24, regardless of number of prior C. difficile infections (CDI) Results from ECOSPOR IV add to data from ECOSPOR III Phase 3 study and together supported the recent VOWST FDA approval CAMBRIDGE, Mass. & HOBOKEN, N.J. / May 08, 2023 / Business Wire / Seres...Read more
Company successfully submits GTX-104 Pivotal Phase 3 protocol IND amendment to the FDA with expectation for first patient dosed in calendar Q4 2023 Strategic realignment prioritizes GTX-104 and expects to extend cash runway through a potential New Drug Application (NDA) filing for GTX-104 LAVAL, Québec, May 8, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company...Read more
SAN FRANCISCO, May 05, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that MATTERHORN, a Phase 3 clinical study of roxadustat for treatment of anemia in patients with transfusion-dependent lower risk myelodysplastic syndromes (MDS) did not meet its primary efficacy endpoint. The proportion of patients who achieved red blood cell transfusion independence in the first 28 weeks was 47.5% for the roxadustat arm...Read more
Results Confirm and Extend Response Results from Phase 3 FLASH Study PRINCETON, N.J., May 4, 2023 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today positive clinical results from a compatibility study evaluating HyBryte™ (synthetic hypericin...Read more
Nearly half (47%) of the participants on donanemab (compared to 29% on placebo) had no clinical progression at 1 year (defined as no decline in CDR-SB) Phase 3 trial met primary endpoint and all secondary endpoints measuring cognitive and functional decline Donanemab treatment slowed clinical decline by 35% compared to placebo, and resulted in 40% less decline on the ability to perform activities of daily living Over half of all...Read more
Results Show Statistically Significant Improvements in PFS, ORR, and OS Compared to Chemotherapy First Medicine to Demonstrate an Overall Survival Advantage in Platinum-Resistant Ovarian Cancer Submission of MAA in Europe and sBLA in US Anticipated in H2 2023 Conference Call to be Held at 8:00 AM ET Today WALTHAM, Mass. / May 03, 2023 / Business Wire / ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug...Read more
ZURICH, SWITZERLAND / ACCESSWIRE / May 2, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed with the Phase 3 program for Quilience®...Read more
A total of 652 children, ages 2 to 5, were enrolled in the study Topline data expected in the third quarter Atopic dermatitis (AD) affects approximately 26 million adults and children in the United States WESTLAKE VILLAGE, Calif., May 02, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage biopharmaceutical company focused on developing meaningful innovations in immune-dermatology,...Read more
The DUPLEX Study did not achieve the primary efficacy eGFR slope endpoint over 108 weeks of treatment Secondary and topline exploratory endpoints trended favorably for sparsentan Treatment with sparsentan resulted in a reduction of proteinuria that was sustained through 108 weeks of treatment Sparsentan was well-tolerated with a consistent safety profile across all clinical trials conducted to date and comparable to...Read more
INDIANAPOLIS, May 1, 2023 /PRNewswire/ -- New secondary analysis from Eli Lilly and Company's (NYSE: LLY) Phase 3 clinical development program showed patients receiving lebrikizumab who were assessed at 16 weeks experienced improved or cleared face or hand dermatitis, which can be particularly burdensome and stigmatizing because these areas are highly visible parts of the body. An additional secondary analysis further demonstrated...Read more
DUBLIN / May 01, 2023 / Business Wire / Horizon Therapeutics plc (Nasdaq: HZNP) today announced that the first patient has been enrolled in a Phase 3 clinical trial in Japan evaluating TEPEZZA for the treatment of adults with chronic Thyroid Eye Disease (TED) and low clinical activity score (CAS), which is a measure of disease activity. The trial includes patients with an initial diagnosis of TED between two to 10 years prior to the study...Read more
TEL AVIV, Israel, May 01, 2023 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced positive safety results in the first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas. PRF-110 was administrated...Read more
Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting Results show the potential for XTANDI to add to the standard of care in prostate cancer, if approved TOKYO and NEW YORK, April 29, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) announced today that XTANDI® (enzalutamide)...Read more
Participants with obesity or overweight and type 2 diabetes taking tirzepatide lost up to 34.4 lb. (15.6 kg) Lilly plans to complete rolling submission to the FDA in the coming weeks INDIANAPOLIS, April 27, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that tirzepatide (10 mg and 15 mg) achieved superior weight loss compared to placebo at 72 weeks of treatment in results from SURMOUNT-2. The study met both...Read more
Mavacamten met the primary endpoint for the treatment of Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy Mavacamten demonstrated a safety profile consistent with previous studies If approved, mavacamten is expected to be the first cardiac myosin inhibitor approved in China for the treatment of oHCM LianBio to host a live virtual analyst and investor event to review EXPLORER-CN topline data and the China...Read more
Post-hoc analyses from four Phase III studies indicate Vabysmo dried retinal fluid faster with fewer injections in wet age-related macular degeneration (AMD) and diabetic macular edema (DME) More Vabysmo patients with wet AMD had absence of retinal fluid at 12 weeks in a post-hoc analysis from the Phase III TENAYA and LUCERNE studies DME patients treated with Vabysmo had less blood vessel leakage in the macula at 16 weeks in a post-hoc...Read more
WATERTOWN, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing innovative therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that it has resumed screening and enrollment in ENLIGHTEN II, its second pivotal Phase 3 clinical trial of LYR-210 in patients with CRS. LYR-210 is a bioresorbable nasal...Read more
Eplontersen halted neuropathy disease progression and improved neuropathy impairment and quality of life WILMINGTON, Del. / Apr 24, 2023 / Business Wire / Detailed results from the NEURO-TTRansform Phase III trial in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) showed AstraZeneca and Ionis’ eplontersen met all co-primary endpoints and secondary endpoints at 66 weeks versus an external placebo...Read more
NEURO-TTRansform study met all co-primary and secondary endpoints Positive results to be presented today at AAN 2023 demonstrate eplontersen efficacy, safety and administration profile may provide an important new treatment option in this fatal disease with significant unmet need Ionis to host webcast on Tuesday, April 25 at 1 p.m. ET CARLSBAD, Calif., April 24, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today...Read more
Enrollment Completed Several Months Ahead of Schedule, Reflecting Significant Unmet Need and Patient Demand for New Options Topline Results Expected in 2H 2024 NAARDEN, the Netherlands and MIAMI, April 24, 2023 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam Pharma” or the “Company”), a clinical-stage company focused on the research and development of transformative oral therapies for major...Read more
GAITHERSBURG, Md. and SHANGHAI, April 24, 2023 /PRNewswire/ -- I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, today announced that the first patient in a Phase 3 registrational trial (ClinicalTrials.gov Identifier: NCT05709093) in China for patients with higher-risk myelodysplastic syndrome (MDS) has been treated with...Read more
CRANFORD, N.J., April 24, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has advanced its clinical trial for Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. Of the...Read more
Govorestat demonstrated consistent long-term clinical outcomes benefit across a range of functional measures in the ACTION-Galactosemia Kids trial, confirming prior biomarker data Govorestat treatment improved activities of daily living, behavior, cognition, fine motor skills, adaptive skills and tremor vs. placebo Company plans to request a pre-NDA meeting with the FDA as soon as possible to discuss a potential NDA submission in...Read more
The Phase 3 ELEVATE study demonstrated atogepant is effective and well-tolerated for the preventive treatment of episodic migraine in people who previously failed two to four classes of conventional oral medications used for prevention The trial met its primary and secondary endpoints with results showcasing a significant reduction in mean monthly migraine days for those with episodic migraine taking atogepant 60 mg once daily compared...Read more
NEWARK, Calif., April 21, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that results from the ENHANCE phase 3 global study evaluating seladelpar for primary biliary cholangitis (PBC) have been published in Hepatology: Seladelpar efficacy and safety at 3...Read more
Superior overall survival for tislelizumab plus chemotherapy versus chemotherapy in first-line treatment setting BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Apr 20, 2023 / Business Wire / BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced the global RATIONALE 305 trial met its primary endpoint of overall survival, with tislelizumab in combination with chemotherapy...Read more
TORONTO, April 18, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today an update on the Company’s U.S. Food & Drug Administration (“FDA”) Phase 3 clinical trial (the “Study”) (NCT04504734) to evaluate the safety and efficacy...Read more
Next IDMC Meeting Scheduled for Q3 2023 REGAL on Track for Interim Analysis by Late 2023/Early 2024 NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced a positive review of the ongoing Phase 3 REGAL clinical trial...Read more
Results presented at AACR 2023 found that four times as many patients treated with Imfinzi plus chemotherapy before surgery achieved pathologic complete response versus those treated with neoadjuvant chemotherapy alone WILMINGTON, Del. / Apr 16, 2023 / Business Wire / Positive results from the AEGEAN Phase III trial showed that treatment with AstraZeneca’s IMFINZI® (durvalumab) in combination with neoadjuvant chemotherapy before...Read more
In the first-ever positive Phase III trial in the adjuvant hepatocellular carcinoma (HCC) setting, Tecentriq plus Avastin reduced the risk of disease recurrence by 28% Up to 80% of people with this type of HCC experience disease recurrence, at which point they are faced with poorer prognosis and shorter survival These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 and included in the...Read more
Results from Phase 3 KEYNOTE-966 to be presented at AACR 2023 Annual Meeting during Clinical Trials Plenary Session, included in official meeting press program and published simultaneously in The Lancet RAHWAY, N.J. / Apr 16, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-966 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in...Read more
Phase 3 Clinical Trial Demonstrated the Safety Profile of Veklury in Patients with Severe Renal Impairment Real-World Evidence Demonstrated Veklury Reduced COVID-19- Associated Mortality and Readmission Rates in Immunocompromised Patients Across All Variants of Concern, Including Omicron Gilead Presents Positive Phase 1 Data for its Investigational Oral COVID-19 Antiviral Treatment, Obeldesivir (GS-5245) FOSTER CITY, Calif. / Apr 16,...Read more
Top-Line Results Expected in the First Half of 2023 LEXINGTON, Mass. / Apr 13, 2023 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced completion of enrollment in the Phase 3 INVIGORATE-2 clinical trial of topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of allergic conjunctivitis. “Today, millions of allergic conjunctivitis patients rely on therapies...Read more
DURHAM, N.C., April 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced it has completed enrollment of a Phase 3 trial in hemodialysis access. The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for...Read more
Enrollment expected to complete in mid-Q2 2023 As of March 24, 2023, as previously announced, the Company's cash position was approximately $15.3 million SAN FRANCISCO, CA / ACCESSWIRE / April 11, 2023 / Jaguar Health, Inc. (Nasdaq:JAGX) ("Jaguar" or the "Company") today announced that patient enrollment has surpassed 90% in the Company's pivotal Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult...Read more
RAHWAY, N.J. & NUTLEY, N.J. / Apr 07, 2023 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today provided updates on two Phase 3 trials, LEAP-003 and LEAP-017 investigating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. LEAP-003: Merck and Eisai are discontinuing the Phase 3 LEAP-003 trial...Read more
LUPKYNIS® treated patients showed histologic activity improvement with stable chronicity scores similar to active control arm of mycophenolate mofetil (MMF) and low dose steroids alone Data further reinforces differentiation of LUPKYNIS from first generation calcineurin inhibitors (CNIs) Conference call to be hosted today at 8:30 a.m. EDT EDMONTON, Alberta / Apr 05, 2023 / Business Wire / Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH)...Read more
Enrollment triggers milestone payment Carlsbad, CA and Shanghai, China, April 05, 2023 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade” or the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, announced today that its development partner Newsoara Biopharma Co. Ltd, has enrolled the first patient in its ongoing Phase 3 clinical trial in...Read more
Trial On Track for 3Q 2023 Results Pivotal Phase 3 Trial in Pediatric/Adolescent Patients Planned to Begin Mid-2023 KANSAS CITY, Kan., April 04, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced it has completed the...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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