Participant baseline characteristics in INFRONT-3 suggest a representative study population that enables testing of the effects of latozinemab in frontotemporal dementia with a progranulin gene mutation (FTD-GRN) Latozinemab, a novel investigational human monoclonal antibody, is the most advanced PGRN-elevating candidate in development for the treatment of FTD-GRN SOUTH SAN FRANCISCO, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) --...Read more
LOS ANGELES, Sept. 19, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive results from the company’s global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients will be shared as a late-breaking oral presentation at the 2024...Read more
Data from the CENTERSTONE study shows single-dose Xofluza reduces transmission of influenza from an infected person to household members This is the first time that any antiviral used in the treatment of a respiratory viral illness has demonstrated a transmission reduction benefit in a global Phase III study Reducing the spread of infection in the household could help limit transmission within communities and societies,...Read more
Infusion related reactions in patients receiving 30-minute BRIUMVI infusions were all mild (Grade 1) and resolved completely Data also demonstrate patients switching from prior anti-CD20 treatment can successfully eliminate initial BRIUMVI infusion NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today presented updated data from the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in...Read more
Trial met primary endpoint, non-inferior immune response for both vaccines when co-administered compared with separate administration Co-administration of the RSV and shingles adjuvanted vaccines was well tolerated, with acceptable reactogenicity and safety profiles These data advance the science of co-administration of recommended adult vaccines PHILADELPHIA / Sep 18, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced...Read more
During year 5 of treatment with BRIUMVI the annualized relapse rate was 0.020, equivalent to one relapse occurring every 50 years of patient treatment Overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment NEW YORK, Sept. 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated data presentations...Read more
Final results from the DAYBREAK long-term extension study showed brain volume loss decreased during Phase 3 studies and was sustained with continuous Zeposia treatment for up to 5 years More than eight years of DAYBREAK data confirm established safety profile of Zeposia, with rates of treatment-emergent adverse events declining or stable over time PRINCETON, N.J. / Sep 18, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today...Read more
Daiichi Sankyo and Merck’s patritumab deruxtecan demonstrates a statistically significant progression-free survival improvement in this EGFR-mutated non-small cell lung cancer population with high unmet need following prior EGFR TKI treatment Discussions with global regulatory authorities to be initiated BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 17, 2024 / Business Wire / The HERTHENA-Lung02 phase 3 trial evaluating patritumab...Read more
Cabozantinib continues to demonstrate a significant improvement in progression-free survival versus placebo in patients with advanced neuroendocrine tumors, including across key subgroups Findings were the basis for the supplemental New Drug Application filed with the U.S. Food and Drug Administration for cabozantinib for advanced neuroendocrine tumors ALAMEDA, Calif. / Sep 16, 2024 / Business Wire / Exelixis, Inc....Read more
QUEENSBURY, N.Y. / Sep 16, 2024 / Business Wire / Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater from University Hospital...Read more
5-year survival rate of 82.6% and 73% reduction in overall risk of death (hazard ratio of 0.27) are the strongest Multikine efficacy results reported to date, reflecting results in patients who met the CEL-SCI confirmatory Registration Study target population criteria and were deemed at low risk for recurrence, therefore not recommended per NCCN guidelines to receive chemotherapy post-surgery Data provide further evidence that the...Read more
Longest survival follow-up ever reported for a Phase III immunotherapy trial in this setting WILMINGTON, Del. / Sep 16, 2024 / Business Wire / Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not...Read more
Late-breaking results selected for presentation during a Presidential Symposium session and an official Press Briefing at the European Society for Medical Oncology Congress 2024 and simultaneous publication in the New England Journal of Medicine KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival as pre-operative (neoadjuvant) treatment...Read more
These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial; data selected for official ESMO press conference At ten years, more than 40% (43%) of patients treated with Opdivo plus Yervoy were alive; a decade ago, this patient population faced a survival rate of around 25% after only one year Data to be presented today as a mini oral and simultaneously published in The New England Journal of...Read more
ALAMEDA, Calif. / Sep 15, 2024 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced detailed final overall survival (OS) results from CONTACT-02, a phase 3 pivotal study evaluating cabozantinib (CABOMETYX®) in combination with atezolizumab (Tecentriq®) compared with a second novel hormonal therapy (NHT) in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable extra-pelvic soft tissue disease who...Read more
At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab RAHWAY, N.J. / Sep 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced long-term overall survival (OS) data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA® (pembrolizumab), Merck’s...Read more
Findings are from ancillary study of phase 3 STAMPEDE trial Data support company’s plan to expand Decipher Prostate test to patients with metastatic disease SOUTH SAN FRANCISCO, Calif. / Sep 15, 2024 / Business Wire / Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that new data from a phase 3 trial of the multi-center, randomized STAMPEDE clinical trial show that its Decipher Prostate Genomic...Read more
Study met its primary endpoint, demonstrating significant improvement in radiographic progression-free survival Overall Response Rate was 38.1% vs. 12.0% for the ARPI switch arm, including 9.3% Complete Responses Patients demonstrated statistically significant improvement in time to reduction of health-related quality of life (HRQoL) as measured by Functional Assessment of Cancer Therapy—Prostate (FACT-P) Interim Overall Survival...Read more
In the Phase 3 LEAP-012 trial, KEYTRUDA plus LENVIMA in combination with TACE reduced the risk of disease progression or death by 34% compared to TACE alone Late-breaking first interim analysis results are being presented during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 RAHWAY, N.J. & NUTLEY, N.J. / Sep 14, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
Phase 3 POD1UM-303/InterAACT2 trial met primary endpoint of progression-free survival and demonstrated improvement across secondary endpoints in patients with squamous cell anal carcinoma (SCAC) taking retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) Late-breaking data presented at the European Society for Medical Oncology (ESMO) Congress 2024 support the planned U.S. filing of a supplemental...Read more
KEYNOTE-A18 is the first Phase 3 study of an immunotherapy in combination with CRT to demonstrate a statistically significant and clinically meaningful improvement in overall survival versus CRT alone in these patients Results were selected for the official press briefing and presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 and published simultaneously in The...Read more
KEYTRUDA is the first anti-PD-1/L1 therapy in combination with trastuzumab and chemotherapy to demonstrate a statistically significant improvement in OS in this patient population Results from the final analysis of KEYNOTE-811 are being presented during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2024 and published simultaneously in the New England Journal of Medicine In the U.S., KEYTRUDA, in...Read more
Post-progression outcomes showed significant and sustained improvement for RYBREVANT® plus standard of care versus chemotherapy alone BARCELONA, Sept. 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the Phase 3 MARIPOSA-2 study which showed RYBREVANT® (amivantamab-vmjw) combined with chemotherapy led to consistent benefit across post-progression outcomes in adult patients with...Read more
BOSTON, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for the treatment of COVID-19. The trial did not meet...Read more
99.9% of Participants Did Not Acquire HIV Infection in the Lenacapavir Group, with 2 Incident Cases Among 2,180 Participants PURPOSE 2 Trial Results for Cisgender Men and Gender-Diverse People Add to the Body of Evidence for the Investigational Use of Lenacapavir for HIV Prevention Gilead Stopped the Blinded Phase of the Trial at Interim Analysis and Will Offer Open-Label Lenacapavir to All Participants FOSTER CITY,...Read more
On track to announce topline results from ORIGIN 3 trial in Q2 2025 Expect to present 96-week data from ORIGIN Phase 2b clinical trial of atacicept in IgAN in Q4 2024 BRISBANE, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today...Read more
Losmapimod failed to show an improvement in relative surface area (RSA), a measure of reachable workspace (RWS), versus placebo at week 48 Fulcrum to suspend future losmapimod development Robust cash position enables Fulcrum to continue its mission to develop therapies addressing diseases of high unmet need including pociredir for the treatment of sickle cell disease (SCD) CAMBRIDGE, Mass., Sept. 12, 2024 (GLOBE...Read more
Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect comparison evaluates disease control of EYLEA HD and faricimab across different pivotal Phase 3 trials in wAMD TARRYTOWN, N.Y., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced new...Read more
RAHWAY, N.J. / Sep 11, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive top-line results from its pivotal Phase 3 trial (V503-064) evaluating the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26 years. The trial met its primary and secondary endpoints demonstrating that...Read more
Confirming the results of Study A, this second pivotal trial in biologic-naïve patients met primary and key secondary endpoints, showing treatment with Dupixent resulted in a nearly 50% reduction in itch and urticaria activity scores compared to placebo More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by antihistamines Data will support regulatory resubmission in the U.S. by year-end; if...Read more
Soquelitinib is a potential first-in-class ITK inhibitor with broad potential in cancer and immune diseases There are currently no fully approved agents for the treatment of relapsed PTCL and soquelitinib has been granted Orphan Drug Designation and Fast Track Designation by the FDA BURLINGAME, Calif., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company,...Read more
Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin TIR measures approach target set by American Diabetes Association Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today...Read more
Statistically Significant and Clinically Meaningful Efficacy Data with Favorable Benefit/Risk ratio from DUBLIN-3 Phase 3 Study of Plinabulin plus Docetaxel vs. Docetaxel in EGFR Wild-Type NSCLC after Progression on Platinum-based Therapy Plinabulin/Docetaxel Combination Significantly Improved Overall Survival (OS), Progression Free Survival (PFS), Objective Response Rate (ORR), 2- and 3-year OS Rates and Significantly Reduced Grade 4...Read more
Veligrotug (VRDN-001) achieved all primary and secondary endpoints in THRIVE, the largest phase 3 trial conducted to date of an anti-IGF-1R antibody in thyroid eye disease (TED), with a week 15 proptosis responder rate (PRR) of 70% and a placebo-adjusted PRR of 64% (p < 0.0001) All secondary endpoints were highly statistically significant (p < 0.0001), with clinically meaningful patient outcomes, including complete resolution...Read more
Late-breaking data at WCLC show Libtayo monotherapy nearly doubled median overall survival and reduced the risks of death and disease progression by 41% and 50%, respectively, compared to chemotherapy WCLC presentation also reviews data on overall survival, progression-free survival and response rate among patients who added chemotherapy to Libtayo following disease progression TARRYTOWN, N.Y., Sept. 09, 2024 (GLOBE NEWSWIRE) --...Read more
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population Presidential Symposium for NeoCOAST-2 demonstrates potential for datopotamab deruxtecan plus IMFINZI® (durvalumab) and chemotherapy in neoadjuvant early-stage non-small cell lung cancer WILMINGTON, Del. / Sep 09, 2024 / Business...Read more
Statistically significant vocal biomarker speech latency data reinforce the strong efficacy of brilaroxazine for negative symptoms and other key symptom domains of schizophrenia Additional vocal biomarker data from ongoing open label extension study evaluating brilaroxazine in schizophrenia expected Q4 2024 CUPERTINO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH)...Read more
Outcomes is the third study in the Phase 3 SYNCHRONY clinical trial program SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today reported the first patient was dosed in the Phase 3 SYNCHRONY Outcomes trial. The study...Read more
New longer-term data from the MARIPOSA study confirm superior outcomes of chemotherapy-free RYBREVANT® plus LAZCLUZE™ regimen compared to osimertinib monotherapy as first-line therapy Results from an interim analysis featured in late-breaker oral presentation at WCLC SAN DIEGO, Sept. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced longer follow-up data from the landmark Phase 3 MARIPOSA study which...Read more
AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan demonstrated meaningfully greater magnitude of progression-free survival benefit in patients with this biomarker AstraZeneca and Roche Tissue Diagnostics are collaborating to co-develop and commercialize the TROP2-QCS biomarker companion diagnostic WILMINGTON, Del. / Sep 08, 2024 / Business Wire / Results from an exploratory analysis of the TROPION-Lung01 Phase III trial showed...Read more
Summit to Initiate HARMONi-7, a Phase III Trial in First-Line PD-L1 High, Advanced NSCLC, in Early 2025 Ivonescimab Is the First Drug to Achieve Clinically Meaningful Benefit over Pembrolizumab in a Randomized Phase III Clinical Trial in NSCLC Median PFS of 11.14 Months vs. 5.82 Months, Respectively, for Patients Receiving Ivonescimab vs. Pembrolizumab; PFS Improvement Was Observed Broadly in Patients Across Subgroups, including PD-L1...Read more
Mean Change From Baseline in Disease Severity Score (DSS) Showed Significant Improvement with Molgramostim Compared with Placebo at Weeks 24 and 48 Responder Analysis Results for Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO%) Showed Significantly Higher Proportions of Molgramostim Responders Compared with Placebo at Weeks 24 and 48 Responder Analysis Results for St. George’s Respiratory Questionnaire...Read more
Two posters presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2024 Pivotal TransportNPC™ study is the most comprehensive ongoing controlled pivotal study regarding patient size, global footprint, duration and clinical outcomes for NPC1 Topline data from the 48-week interim analysis of 104 enrolled patients in TransportNPC™ on track for H1 2025 Trappsol® Cyclo™ demonstrated to be well...Read more
Top-line data from VEGA-3 Phase 3 trial expected in first half of 2025 Top-line data from LYNX-2 Phase 3 trial in patients with decreased visual acuity under low light conditions following keratorefractive surgery expected in first quarter of 2025 FARMINGTON HILLS, Mich., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and...Read more
Estimated 23 million annual agitation episodes in the at-home setting 1-3 No FDA-approved therapies in the at-home setting for acute treatment of agitation associated with bipolar disorders or schizophrenia NEW HAVEN, Conn., Sept. 05, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and...Read more
In the phase 3 study, QWINT-1, efsitora was administered via four fixed doses once weekly in a single-use autoinjector in people with type 2 diabetes using basal insulin for the first time In a second phase 3 study, QWINT-3, efsitora also delivered non-inferior A1C reduction compared to daily insulin in people with type 2 diabetes switching from daily basal injections INDIANAPOLIS, Sept. 5, 2024 /PRNewswire/ -- Eli Lilly and Company...Read more
Topline results from NORSE EIGHT expected in Q4 CY2024 ISELIN, N.J., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the...Read more
Results showed reductions in heart attack, stroke and heart failure events in all patients with even greater benefit for heart failure events among patients with longer diabetes duration New analysis further differentiates INPEFA among SGLT inhibitors THE WOODLANDS, Texas, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a post-hoc analysis of Phase 3 data from the SCORED clinical...Read more
413 patients enrolled in PEAK Phase 3 GIST trial, exceeding enrollment target; top-line results expected by end of 2025 PEAK interim futility analysis completed with no changes to study Registration-directed SUMMIT trial in NonAdvanced Systemic Mastocytosis (NonAdvSM) now on track to complete enrollment in Q1 2025; top-line results expected 2H 2025 WALTHAM, Mass. and BOULDER, Colo., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cogent...Read more
TORONTO, Sept. 03, 2024 (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 update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock. Tigris...Read more
Refined the focus of the Phase 3 program to accelerate path to potential U.S. approval and commercial launch in the Company’s highest priority market Discontinued the ex-U.S.-based PROACT 2 trial and focused Company resources on PROACT 1 to expedite enrollment and accelerate estimated topline data readout to Q3 2027 WINSTON-SALEM, N.C., Sept. 03, 2024 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company”),...Read more
Plozasiran reduced triglycerides by 80% from baseline and reduced the risk of developing acute pancreatitis by 83% Similar responses were observed in patients with genetically confirmed and clinically diagnosed FCS Based on these findings, Arrowhead plans to file a New Drug Application by year-end 2024 PALISADE results simultaneously published in The New England Journal of Medicine Company hosting a virtual analyst and investor event...Read more
Cumulative analysis of data up to 3.5 years from EXPLORER-LTE showed consistent and sustained improvements in echocardiographic measures and symptoms, with no new safety signals observed CAMZYOS is the first and only approved cardiac myosin inhibitor that targets the source of symptomatic obstructive hypertrophic cardiomyopathy PRINCETON, N.J. / Sep 01, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced new...Read more
Based on a per-protocol interim analysis of safety and efficacy data, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue without modifications No new safety signals observed at interim analysis Primary endpoint of progression free survival projected to be reached in the first half of 2025 NEW YORK, Aug. 30, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical...Read more
In the Overall Population, Achieved 28% Reduction in Primary Composite of All-Cause Mortality and Recurrent Cardiovascular Events, and 31% and 36% Reductions in All-Cause Mortality During the 33-36-Month Double-Blind Period and up to Month 42, Respectively In the Monotherapy Population, Reduced Composite Primary Endpoint by 33% and All-Cause Mortality up to Month 42 by 35% Strong Trends of Additive Efficacy on Top of Tafamidis Across...Read more
RAHWAY, N.J. / Aug 29, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-867 and KEYNOTE-630. Merck is discontinuing the Phase 3 KEYNOTE-867 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II (stage IIB N0, M0)...Read more
Long-term safety and tolerability profile consistent with pivotal data in atopic dermatitis (AD), with no new safety signals observed during 56 weeks of treatment Results from open-label extension study highlight that 71.9% of patients who rolled over from the roflumilast cream treatment arm in INTEGUMENT-PED achieved EASI-75 at Week 56 Arcutis intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug...Read more
Oral presentation highlighted results from confirmatory Phase 3 RESILIENT study of TNX-102 SL (sublingual cyclobenzaprine HCl) treatment demonstrating statistically significant improvement in primary endpoint of fibromyalgia nociplastic pain and in all six key secondary endpoints, including sleep quality NDA submission on track for second half 2024; Fast Track designation granted by FDA; FDA decision expected 2025 TNX-102 SL is a...Read more
Top-line data with unexpected results requiring further clarification, did not meet primary endpoint as per protocol Potent growth hormone release following macimorelin stimulation Safety of macimorelin confirmed in the pediatric population TORONTO, ONTARIO, Aug. 27, 2024 (GLOBE NEWSWIRE) -- COSCIENS Biopharma Inc. (NASDAQ: CSCI) (TSX: CSCI) (“COSCIENS” or the “Company”), a specialty biopharmaceutical company developing and...Read more
In all-comer cohort of immunocompetent individuals at risk of contracting symptomatic COVID-19 in their everyday social interactions, participants receiving pemivibart experienced a 1.9% rate of confirmed symptomatic COVID-19 compared to an 11.9% rate for participants receiving placebo, an 84% relative risk reduction (nominal p= 0.000061) In immunocompromised participants, pemivibart demonstrated a rate of 3% of confirmed symptomatic...Read more
The initiation of a second Phase 3 clinical trial for bomedemstat demonstrates company’s commitment to advancing research in myeloproliferative neoplasms (MPNs) RAHWAY, N.J. / Aug 27, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of Shorespan-007, a pivotal Phase 3 clinical trial evaluating bomedemstat, an investigational orally available lysine-specific...Read more
DUBLIN, Aug. 22, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced top-line results from the Phase 3 open-label, single-arm trial in Japan evaluating the safety and efficacy of cannabidiol oral solution (marketed as Epidiolex®/Epidyolex® globally) as an adjunctive treatment for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC). The trial did not...Read more
TEL AVIV, Israel, Aug. 20, 2024 (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 encouraging early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, the Company’s proprietary post-surgical pain formulation. The study, which has now completed full enrollment...Read more
176-week SURMOUNT-1 Phase 3 study in adults with pre-diabetes is the longest completed trial of tirzepatide to date Tirzepatide resulted in sustained weight loss through the treatment period, averaging a 22.9% decrease in body weight with the 15 mg dose at end of treatment Results are consistent with the combined pharmacology of GIP and GLP-1 receptor agonism INDIANAPOLIS, Aug. 20, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more
The safety and effectiveness of nafamostat is being assessed in the NEPHRO CRRT registrational trial in 166 patients at up to 14 clinical sites Primary endpoint in the NEPHRO CRRT study is measured over the first 24 hours, with patients completing the study after 72 hours Dr. Stuart Goldstein, a world-renowned nephrologist, is the first physician to enroll a patient in the NEPHRO CRRT study SAN MATEO, Calif., Aug. 19, 2024...Read more
In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines The companies are evaluating adjustments to the...Read more
Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®) or placebo in combination with lenalidomide and rituximab met its primary endpoint of progression free survival (PFS) in relapsed or refractory follicular lymphoma (FL) Based on these results, Incyte expects to file a supplemental Biologics License Application for tafasitamab in combination with lenalidomide and rituximab in FL by the end of the...Read more
Phase III clinical trial is evaluating RenovoGem™ for the treatment of Locally Advanced Pancreatic Cancer UNMC opened enrollment of TIGeR-PaC in June 2024 and joins esteemed clinical sites throughout United States participating in the study LOS ALTOS, Calif., Aug. 14, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology...Read more
WOBURN, Mass., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced that the first patient has been randomized and dosed in the IGNYTE-3 study – a global Phase 3 clinical trial assessing the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab in patients with advanced...Read more
First assessment from an RSV vaccine study in immunocompromised adults show ABRYSVO was well-tolerated and generated strong neutralizing responses after a single dose in adults ≥ 18 years of age These results add to the growing body of evidence indicating a single dose of ABRYSVO provides strong immune protection against outcomes caused by RSV NEW YORK / Aug 12, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive...Read more
Met the primary endpoint, achieving statistically significant 68% (p<0.0001) reduction in proteinuria compared to placebo in a broad study population Positive results consistent across all subgroups, including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys Demonstrated favorable safety, consistent with established profile Companies plan to submit data for regulatory approval in the US and EU...Read more
New Drug Application Resubmission Anticipated in 2024 LEXINGTON, Mass. / Aug 08, 2024 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated and metabolic diseases, today announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical...Read more
RAHWAY, N.J. / Aug 08, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the discontinuation of the Phase 3 KeyVibe-008 trial based on the recommendation of an independent Data Monitoring Committee (DMC). The trial is evaluating the investigational fixed-dose combination (coformulation) of vibostolimab, an anti-TIGIT antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1...Read more
The Independent Data Monitoring Committee (IDMC) recommended continuation of the clinical trial based on safety assessment and pre-determined futility and efficacy stopping boundaries The results of the IDMC review have been delivered to Ono Pharmaceutical Co., Ltd. triggering the 90-day period to exercise its option to acquire Equillium’s rights to itolizumab for JPY 5 billion plus potential milestone payments LA JOLLA, Calif. / Aug...Read more
Phase 3 ABTECT Trial evaluating obefazimod in moderately to severely active ulcerative colitis (UC) surpassed the 600-patient enrollment milestone confirming ABTECT currently on pace to reach full enrollment in early Q1 2025 To date, baseline participants baseline characteristics and trial trends in line with observations from Phase 2b trial PARIS, France, August 6, 2024, 8:30 a.m. CEST – Abivax SA (Euronext Paris & Nasdaq:...Read more
Patient Dosing Initiated in Phase 3 ARCHER II Trial of C1q Inhibitor ANX007; Topline Data Expected in Second Half 2026 Additional Data from Phase 2 ARCHER Trial Demonstrated Both Significant Vision Protection in Standard and Low Light Conditions, and Significant Structural Protection in Regions of the Eye Important for Visual Acuity BRISBANE, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a...Read more
Tirzepatide reduced the risk of heart failure outcomes – heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death – by 38% compared to placebo Tirzepatide significantly improved heart failure symptoms and physical limitations Tirzepatide led to 15.7% weight loss in a combined population of people with and without type 2 diabetes INDIANAPOLIS, Aug. 1, 2024 /PRNewswire/ -- Eli Lilly...Read more
BASKING RIDGE, N.J. & RAHWAY, N.J. / Aug 01, 2024 / Business Wire / Daiichi Sankyo (TSE: 4568) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the first patient has been dosed in the IDeate-Lung02 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) in patients with relapsed small cell lung cancer (SCLC) versus treatment of physician’s choice...Read more
125 patients enrolled Record July patient enrollment to start the second half of 2024 TORONTO, Aug. 01, 2024 (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 update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in...Read more
ACTIVATE-KidsT is Agios’ First Pediatric Data Readout; Safety Results Consistent with Safety Profile for Mitapivat Previously Observed in Adults with PK Deficiency Who are Regularly Transfused Prespecified Statistical Criterion for the Primary Endpoint in ACTIVATE-KidsT Was Not Met; Results Were Clinically Meaningful, with Observed Response Rates Higher for Mitapivat than Placebo for the Primary Endpoint of Transfusion Reduction...Read more
DUBLIN, July 31, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia (IH). "IH is a debilitating sleep disorder characterized by profound sleep inertia, or difficulty waking up and...Read more
ATEV demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis Detailed results to be presented at upcoming medical conferences DURHAM, N.C., July 31, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial...Read more
Pamrevlumab arm of the Precision PromiseSM study in metastatic pancreatic cancer, sponsored and conducted by the Pancreatic Cancer Action Network (PanCAN), did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis LAPIS study in locally advanced, unresectable pancreatic cancer, sponsored by FibroGen, did not meet the primary endpoint of overall...Read more
Ongoing open-label extension trials of simufilam in Alzheimer’s disease to be extended by up to an additional 36 months. The extension provides participants the opportunity to continue on treatment, if they desire, pending results of the ongoing pivotal Phase 3 trials. Company plans to add cognition and plasma biomarker monitoring to the open-label extension trials to gather additional long-term data on simufilam treatment. AUSTIN,...Read more
SOL-R evaluates repeat AXPAXLI™ dosing for wet age-related macular degeneration (wet AMD) Global non-inferiority study comparing AXPAXLI, dosed every six months, to 2 mg aflibercept every eight weeks BEDFORD, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and...Read more
ALPHARETTA, Ga., July 29, 2024 (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 that its partner, Arctic Vision, reported positive topline results from its Phase 3 clinical trial of ARCATUS® (ARVN001) for the treatment of Uveitic Macular Edema (UME) in China. In addition,...Read more
Achieved primary endpoint of LS mean reduction in LDL-C on top of maximally tolerated lipid modifying therapies at day 84 with statistically significant reduction (p<0.0001), which was sustained at day 365 (p<0.0001) Obicetrapib lowered LDL-C by 36.3% at day 84 and 41.5% at day 365, compared to placebo Observed to be generally well-tolerated with safety results comparable to placebo NewAmsterdam to host...Read more
Co-primary endpoint of PASI 75 and sPGA 0/1 score at 24 weeks to serve as basis for U.S. regulatory submission Pivotal Phase 3 program supported by positive Phase 2 STRIDE clinical data as well as ongoing open-label extension (OLE) study Topline data anticipated in 2026 SOUTH SAN FRANCISCO, Calif., July 29, 2024 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a clinical-stage biopharmaceutical company developing...Read more
THRIVE-2 exceeded its enrollment target due to patient demand; 188 patients enrolled with approximately 40% from US sites THRIVE topline readout in patients with active TED on track for September 2024 THRIVE-2 topline readout on track for year-end 2024 WALTHAM, Mass. / Jul 25, 2024 / Business Wire / Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential...Read more
SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the confirmatory Phase 3 trial of its autologous CardiAMP cell therapy product candidate for patients with ischemic heart failure of reduced ejection fraction (HFrEF) has commenced enrollment in the United...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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