MENLO PARK, Calif., April 22, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic, and neurologic disorders by modulating the effects of the hormone cortisol, today announced positive results from the open-label portion of the pivotal Phase 3 GRACE trial of its proprietary selective...Read more
Results from the Phase 3 SELECT-GCA study showed 46 percent of patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®; 15 mg) with a 26-week steroid taper regimen achieved sustained remission from week 12 through week 52 compared to 29 percent of patients receiving placebo with a 52-week steroid taper regimen1 The safety profile in GCA was generally consistent with that in approved indications, and no new...Read more
Iomab-B led bone marrow transplant produced high rates of complete remission and durable complete remission regardless of TP53 mutation status in patients age 55 and above with high-risk active relapsed or refractory acute myeloid leukemia Median Overall Survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not...Read more
Tavapadon met the primary endpoint in the pivotal Phase 3 TEMPO-3 adjunctive trial, demonstrating a statistically significant increase in total “on” time without troublesome dyskinesia compared with placebo over 27 weeks Results demonstrate tavapadon’s potential to provide the right balance of motor control, safety and tolerability for people living with Parkinson’s disease Additional data from the trial will be presented at a future...Read more
Tirzepatide achieved a mean apnea-hypopnea index reduction of up to 63% (about 30 fewer events per hour), meeting all primary and key secondary endpoints in two phase 3 clinical trials Tirzepatide meaningfully improved sleep apnea symptoms in those with moderate-to-severe OSA and obesity with and without PAP therapy, and based on these results Lilly plans to submit these data for global regulatory reviews INDIANAPOLIS, April 17,...Read more
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeks The twice-yearly, 10-minute SC injection has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations U.S. FDA and EMA accepted filings based on...Read more
Longest survival follow-up ever reported for immunotherapy treatment in this setting WILMINGTON, Del. / Apr 16, 2024 / Business Wire / Updated exploratory results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care chemotherapy demonstrated a clinically meaningful long-term overall survival (OS) benefit at three years for patients with advanced biliary tract cancer...Read more
Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.9 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES)= 0.61) Lumateperone 42 mg also met the key secondary...Read more
APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN1 IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide2; complement activation is a key driver of glomerular inflammation in IgAN3,4 There is a need for effective, targeted therapies for IgAN2,5; up to 30% of patients with...Read more
Trial did not meet pre-defined stopping criteria at the interim analysis; Marinus has completed RAISE enrollment at approximately 100 patients with topline results expected summer 2024 Future development of IV ganaxolone in refractory status epilepticus to be assessed following review of the final RAISE results Enrollment in the TrustTSC trial expected to complete mid-May with topline data on track for the first half of Q4 2024 Cost...Read more
Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma Data from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting SOUTH SAN FRANCISCO, Calif. / Apr 15, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:...Read more
Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine Seventy percent of subjects achieved ≥50% reduction in monthly migraine days at Weeks 13-16 and this was consistent during the 48 weeks of open-label treatment Findings will be showcased in an oral presentation at the American Academy of Neurology (AAN) Annual Meeting...Read more
LYNX-2 Follows SPA Agreement with FDA Development of PS is Funded by Ocuphire’s Partner Viatris FARMINGTON HILLS, Mich., April 11, 2024 (GLOBE NEWSWIRE) -- Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of unmet needs of patients with retinal and refractive eye disorders, today announced the enrollment of the first subject in the LYNX-2 Phase 3...Read more
AJOVY confirms efficacy in new Phase 3 data significantly reducing the number of migraine days per month All critical efficacy endpoints met significance as set out apriori through hierarchical testing AJOVY confirmed a favorable safety profile TEL AVIV, Israel & PARSIPPANY, N.J. / Apr 11, 2024 / Business Wire / Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced...Read more
101 patients enrolled TORONTO, April 10, 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...Read more
GAITHERSBURG, Md., April 9, 2024 /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 positive interim results from the ongoing Phase 3 clinical trial (the "Phase 3 Trial" or the "Trial") of its...Read more
NAARDEN, the Netherlands and MIAMI, April 09, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today...Read more
ABRYSVO met its trial primary endpoints in adults aged 18 to 59 with an increased respiratory syncytial virus (RSV) disease risk. The vaccine was well-tolerated and demonstrated an immune response non-inferior to adults aged 60 years and older Pfizer intends to submit these findings to regulatory agencies to seek approval of ABRYSVO in adults 18 to 59 years of age NEW YORK / Apr 09, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today...Read more
MENLO PARK, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in ROSELLA, a pivotal Phase 3 trial of its proprietary selective cortisol modulator...Read more
SHANGHAI, China & JERSEY CITY, N.J. / Apr 08, 2024 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Prolia® and Xgeva® (denosumab) biosimilar HLX14 met the primary endpoints. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates,...Read more
Olezarsen met the primary endpoint with statistically significant reduction of fasting triglycerides and showed substantial, clinically meaningful reduction in acute pancreatitis events Results demonstrate olezarsen may represent a novel treatment option for this rare, life-threatening disease, for which there are no approved treatments in the U.S. Data presented today at ACC 2024 and published in The New England Journal of...Read more
First and only immunotherapy to demonstrate survival benefit in this setting in a global Phase III trial WILMINGTON, Del. / Apr 05, 2024 / Business Wire / Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients...Read more
RAHWAY, N.J. / Apr 04, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced it has initiated a Phase 3 clinical trial evaluating MK-1084, an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor KRAS G12C mutations and express PD-L1...Read more
Multiple clinical trial sites to be opened under collaboration with large network of community-based oncology practices Acclaim-3 Study Supported by FDA Orphan Drug and Fast Track Designations AUSTIN, Texas, April 3, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on...Read more
PLYMOUTH MEETING, Pa., April 3, 2024 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY) has initiated its global Phase 3 registrational trial, the TEMPO study, to evaluate the safety and efficacy of pitolisant as a treatment for excessive daytime sleepiness (EDS) and behavioral symptoms in patients aged six years and older with Prader-Willi syndrome (PWS). The TEMPO study initiation follows a successful...Read more
Randomized Study with 18 Weeks Continuous Treatment Expected to Replicate and Extend Results from the First, Statistically Significant Phase 3 Study PRINCETON, N.J., April 3, 2024 /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 that it has...Read more
TEL AVIV, Israel, April 02, 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 it has reached the 50% enrollment target for the second part of Phase 3 clinical trial of PRF-110 in bunionectomy. In total, over 200 patients have been enrolled, of up to approximately 400 patients at...Read more
Key study underway in registration-directed PALISADE Phase 3 program for fasedienol in social anxiety disorder Social anxiety disorder affects over 25 million Americans SOUTH SAN FRANCISCO, Calif. / Apr 01, 2024 / Business Wire / Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver groundbreaking therapies for individuals affected by psychiatric and neurological disorders, today...Read more
The SIERRA results demonstrate Iomab-B's ability to overcome the negative impact of a TP53 mutation in patients who otherwise would have limited treatment options and dismal prognosis -Represents the eleventh oral presentation of the Phase 3 SIERRA results demonstrating continued recognition of the high potential for Iomab-B led allogeneic bone marrow transplant by the bone marrow transplant community NEW YORK, April 1,...Read more
MENLO PARK, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in GRADIENT, a Phase 3 trial of its proprietary selective cortisol modulator...Read more
NEW YORK, April 01, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, announced the initiation of the ENGAGE Phase 3 trial of solriamfetol, an investigational treatment for binge eating disorder (BED) in adults. ENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating...Read more
PRINCETON, N.J. / Mar 28, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease. The study did not meet its primary endpoint of clinical remission at Week 12. The safety profile of Zeposia...Read more
The METIS trial demonstrated 21.9 months median time to intracranial progression for patients treated with Tumor Treating Fields and supportive care compared to 11.3 months for patients treated with supportive care alone Novocure to host investor conference call at 8 a.m. EDT ROOT, Switzerland / Mar 27, 2024 / Business Wire / Novocure (NASDAQ: NVCR) today announced the phase 3 METIS clinical trial met its primary endpoint,...Read more
Enrollment Reached Over 2,200 High-Risk Patients in Bemnifosbuvir Monotherapy Cohort Results from SUNRISE-3 Expected in 2H’24 BOSTON, March 27, 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 that the company has completed enrollment of the global...Read more
mRNA-1283 induced a more robust immune response compared to Spikevax® COVID-19 vaccine, mRNA-1273.222 Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the way for combination vaccine against influenza and COVID-19, mRNA-1083 CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1283, the Company's next-generation COVID-19...Read more
On track to achieve 250 patient enrollment target in March 2024 Top-line data for 32-week primary endpoint expected in the first quarter of 2025 NEWARK, CA / ACCESSWIRE / March 26, 2024 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") announced it has randomized 241 patients in the ongoing Phase 3 VERIFY clinical trial evaluating rusfertide in polycythemia vera ("PV") as of today and expects to meet the trial's 250...Read more
An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials. The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification. Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program. AUSTIN, Texas, March 25, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a...Read more
On track to report pivotal complete response data by mid-4Q 2024 CAMBRIDGE, Mass. / Mar 25, 2024 / Business Wire / Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today announced that the enrollment of 190 patients has been completed in the SELECT-MDS-1 Phase 3 clinical trial evaluating tamibarotene in newly...Read more
AXS-12 statistically significantly reduced cataplexy attacks compared to placebo (p=0.018, primary endpoint) AXS-12 achieved statistically significant remission of cataplexy compared to placebo (p=0.008) AXS-12 statistically significantly reduced excessive daytime sleepiness (EDS) severity compared to placebo (p=0.027, CGI-S for EDS) AXS-12 statistically significantly improved concentration and memory compared to placebo (p=0.004,...Read more
Analysis of secondary endpoint of symptomatic COVID-19 events in CANOPY is unrelated to regulatory filing or review, but may be hypothesis generating for future Invivyd discovery and development work Today’s update on Day 67 and Day 90 event rates is the first of two planned public updates on symptomatic COVID-19 events in CANOPY; Invivyd plans to analyze all future events at Day 180 Further defining the relationship between serum...Read more
RAHWAY, N.J. / Mar 21, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic...Read more
Opdivo plus Yervoy demonstrates statistically significant and clinically meaningful improvement in overall survival compared to investigator’s choice of sorafenib or lenvatinib PRINCETON, N.J. / Mar 20, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -9DW trial evaluating Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for patients with advanced hepatocellular...Read more
OASIS 3 study provides additional supporting efficacy data as well as long-term safety data of elinzanetant, complementing positive topline results of OASIS 1 and 2 studies Bayer will submit data from OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause Elinzanetant is the first dual...Read more
Results from multiple Phase 3 trials of V116 and a real-world evidence study of pneumococcal serotypes presented at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults RAHWAY, N.J. / Mar 19, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced...Read more
Trial met the primary efficacy endpoint demonstrating non-inferiority of the incidence of acute kidney injury for INTERCEPT Red Blood Cells compared to conventional red blood cells CONCORD, Calif. / Mar 19, 2024 / Business Wire / Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex...Read more
NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD). PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine...Read more
56% of Participants on Paltusotine Achieved IGF-1 ≤1.0 xULN vs. 5% on Placebo (p<0.0001) Paltusotine was Generally Well-tolerated with No Serious Adverse Events Positive Topline Results Support Planned NDA Submission to the FDA in 2H 2024 Management Will Host a Conference Call Today at 8:30 a.m. Eastern Time SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) a clinical stage...Read more
CAMBRIDGE, Mass., March 18, 2024 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced the first patient dosed in the global pivotal, Phase 3 MAGNITUDE trial of NTLA-2001. NTLA-2001 is an investigational in vivo CRISPR-based therapy designed as a single-dose treatment to inactivate the TTR gene and...Read more
AUSTIN, Texas / Mar 18, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a collaboration with the Fédération Francophone de Cancérologie Digestive and CHU Dijon Bourgogne on the CIRCULATE-PRODIGE-70 study, a randomized, multicenter, prospective phase III clinical trial in France investigating molecular residual disease (MRD)-guided adjuvant treatment in stage II colorectal cancer...Read more
The company announced the initiation of RAPIDe-3, the Phase 3 clinical trial evaluating the efficacy and safety of deucrictibant immediate-release capsule (PHVS416) for the treatment of HAE attacks ZUG, Switzerland, March 18, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks,...Read more
Dostarlimab-gxly plus chemotherapy is the only immuno-oncology combination to show statistically significant and clinically meaningful overall survival (OS) in the overall population 31% reduction in risk of death and 16.4-month improvement in median OS observed with dostarlimab-gxly plus chemotherapy versus chemotherapy in the overall population 37% reduction in risk of disease progression or death and 6-month improvement in median...Read more
KEYTRUDA plus CRT is the first immunotherapy-based regimen to demonstrate a statistically significant improvement in OS in these patients RAHWAY, N.J. / Mar 15, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT)...Read more
Anaphylm meets all predefined primary and secondary pharmacokinetic endpoints Anaphylm time to maximum concentration (Tmax) is consistently faster than autoinjectors Anaphylm exposure levels (AUC) are comparable to autoinjectors for 30 minutes after dosing Anaphylm is well-tolerated with no serious adverse events Company receives positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) regarding the...Read more
With U.S. Food and Drug Administration (“FDA”) alignment on multisite, multinational Phase 3 program design Company expects to commence Phase 3 program around mid-year 2024 15 U.S. clinical trials sites targeted; European sites to be added Robust and sustained improvement in depression symptoms with CYB003 at four months with 75% of patients in remission from depression after two doses (16mg) Breakthrough Therapy...Read more
THARROS is the first-ever prospective trial to investigate the potential of an inhaled triple therapy to reduce cardiopulmonary events, a key driver of mortality, in COPD First patients dosed in ATHLOS Phase III trial assessing impact of BREZTRI on integrated cardiopulmonary parameters associated with health status and survival in patients with COPD WILMINGTON, Del. / Mar 13, 2024 / Business Wire / AstraZeneca today announced the...Read more
THE WOODLANDS, Texas, March 12, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a post hoc analysis of clinical data from its inTandem3 Phase 3 trial demonstrated that treatment with sotagliflozin resulted in improved glycemic control in patients with type 1 diabetes and chronic kidney disease (CKD). In this important patient population, treatment with sotagliflozin successfully lowered A1C, body...Read more
TANDEM is designed to evaluate obicetrapib and ezetimibe fixed-dose combination (“FDC”) as an adjunct to diet and maximally tolerated lipid lowering therapy in patients with HeFH, ASCVD or ASCVD risk equivalents requiring additional lowering of low-density lipoprotein cholesterol (“LDL-C”) Company expects to report topline data in the first quarter of 2025 TANDEM is being conducted in parallel with BROOKLYN, BROADWAY and...Read more
Co-primary endpoints in ENLIGHTEN-Fibrosis assessed at week 52 will potentially support accelerated approval in non-cirrhotic MASH (fibrosis stage F2-F3) patients ENLIGHTEN-Cirrhosis, the second trial in the program, is planned to evaluate patients with compensated cirrhosis (F4) and is expected to initiate in the second quarter of 2024 SAN FRANCISCO, March 12, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage...Read more
SUNNYVALE, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Centers for Medicare & Medicaid Services (CMS) approval for reimbursement coverage of the confirmatory Phase III clinical trial of CardiAMP autologous cell therapy for the treatment of patients with ischemic heart...Read more
ECHELON-3 trial of ADCETRIS in combination with lenalidomide and rituximab showed significant improvement in primary endpoint of overall survival and in secondary endpoints of progression free survival and overall response rate versus lenalidomide and rituximab plus placebo, regardless of CD30 expression Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS NEW YORK / Mar 12, 2024 /...Read more
STAFFORD, Texas, March 12, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the initiation of the first clinical sites in Europe in collaboration with GEICAM in Spain. The Company has partnered with GEICAM,...Read more
Study Did Not Meet Primary Endpoint SAN DIEGO / Mar 11, 2024 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the Phase 3 ADVANCE-2 trial evaluating pimavanserin for the treatment of negative symptoms of schizophrenia. Pimavanserin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, the change from baseline to week 26 on the Negative...Read more
Phase 3 RESILIENT study of Tonmya met its primary endpoint of daily pain reduction (p=0.00005) and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes on sleep, fatigue, FIQ-R symptoms and FIQ-R function ranging from 0.3 to 0.5 Cognitive dysfunction, or “brain fog,” nominally improved on FIQ-R memory item (p=0.001) where the patients rated their level of memory problems NDA...Read more
INDIANAPOLIS, March 10, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced results from a first-of-its-kind study of lebrikizumab specifically designed for people with skin of color and moderate-to-severe atopic dermatitis, commonly called eczema. In this study, treatment with lebrikizumab, an investigational medicine, showed improvement in skin clearance and itch relief. These late-breaking results from a Phase 3...Read more
Investigational roflumilast cream 0.05% met the primary endpoint and all secondary endpoints, showing significant improvement across multiple efficacy endpoints as early as Week 1 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint New data highlight rapid and significant reduction in itch as early as 24 hours following first...Read more
PHOENIX Study Did Not Meet Prespecified Primary or Secondary Endpoints Data From 664-Participant Study Reinforce That AMX0035 is Generally Safe and Well-Tolerated Within the Next Eight Weeks, Amylyx Will Continue to Engage With Regulatory Authorities and the ALS Community to Share Topline Data; Amylyx Will Share Plans for RELYVRIO/ALBRIOZA in ALS Which May Include Voluntarily Withdrawing RELYVRIO/ALBRIOZA From the Market At This Time,...Read more
CardiAMP cell therapy-treated patients had 37% relative risk reduction in heart death equivalent (death, heart transplant, left ventricular assist device implantation) and 9% relative risk reduction in non-fatal major adverse cardiac and cerebrovascular events (MACCE) at mean 20-month follow-up compared to control patients on guideline-directed heart medications alone Large sub-set of treated patients with elevated NTproBNP – a marker...Read more
HIGH POINT, N.C., March 04, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes ("T1D"), today announced the submission of the study protocol to the FDA for the Company’s first Phase 3 trial evaluating the safety and efficacy of its lead candidate,...Read more
ABRYSVO, a bivalent vaccine, maintained consistently high protective efficacy for both RSV A and RSV B disease through two seasons after a single dose. ABRYSVO efficacy was 77.8% against RSV lower respiratory tract disease with three or more symptoms in a second full RSV season in adults 60 years of age or older. NEW YORK / Feb 29, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced top-line ABRYSVO® vaccine efficacy and...Read more
Matching adjusted indirect comparison addresses key questions and limitations associated with previously presented analysis and suggests efficacy advantage of BRUKINSA vs acalabrutinib BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Feb 29, 2024 / Business Wire / BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced a new matching adjusted indirect comparison (MAIC) of the efficacy...Read more
Sustained efficacy was confirmed with an annualized relapse rate of 0.098 and 67% of patients were relapse-free at six years Safety was consistent with prior findings and the established safety profile of Zeposia with nearly 10 years of clinical experience In a separate DAYBREAK analysis, nearly 97% of followed patients were relapse-free at 90 days post Zeposia discontinuation; patients that did relapse showed no evidence of rebound...Read more
Apraglutide met the primary endpoint of relative change from baseline in actual weekly parenteral support (PS) volume at week 24, driven by both stoma and colon-in-continuity populations Apraglutide also showed a clinically meaningful improvement at week 24, with patients achieving at least one day off PS per week Apraglutide was generally well-tolerated, and the safety profile was consistent with previously-reported studies...Read more
On an Intent-to-Treat Analysis, Co-Primary Symptom Endpoint Met, Statistical Significance (P<0.025) Multiple Secondary Symptom Endpoints Met, Statistical Significance (P<0.025) On an Intent-to-Treat Analysis, Co-Primary Sign Endpoint and Secondary Sign Endpoints Not Met PL9643 Demonstrated Superiority Over Vehicle in Multiple Sign Endpoints Excellent Safety and Tolerability Profile Future Discussions Planned with...Read more
93 patients enrolled February represents a second record breaking consecutive month for patient enrollment TORONTO, Feb. 28, 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...Read more
PIVOT-006 Phase 3 open-label trial of adjuvant cretostimogene is CG Oncology’s earliest disease stage clinical trial for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) Primary endpoint of PIVOT-006 Phase 3 clinical trial is overall recurrence-free survival (RFS), with secondary endpoints including RFS at 12 and 24 months and progression-free survival (PFS) IRVINE, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- CG...Read more
As previously announced, planning is underway with FDA to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI) As anticipated, an End of Phase 2 Meeting (EOP2) with FDA is now confirmed to occur in late April 2024 to finalize the Phase 3 development plan Per FDA Guidance, Acurx also announced it has submitted the required pre-meeting Briefing Document to FDA yesterday,...Read more
Planned Phase 3b trial Designed to Confirm Efficacy and Safety of NurOwn in mild-to-moderate ALS patients NEW YORK, Feb. 27, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it will present a poster (#M201) outlining the proposed design for a Phase 3b trial of NurOwn® in amyotrophic lateral...Read more
STAFFORD, Texas, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the expansion of the clinical trial into Europe. The Company's application to expand Flamingo-01 into Europe...Read more
Japanese Product Now Under Review for Nationwide Marketing Approval BOSTON / Feb 27, 2024 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, noted that its Founded Entity Akili, Inc. (Nasdaq: AKLI) announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s...Read more
Japanese Product Now Under Review for Nationwide Marketing Approval BOSTON / Feb 26, 2024 / Business Wire / Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare. SDT-001 is the Japanese, localized version of Akili’s AKL-T01 (marketed as...Read more
Clarified path for HS Phase 3 program with study design, patient population and endpoints agreed One dose of SLK (120mg) to be tested with a similar protocol as in Phase 2 Total Phase 3 population of 800 patients to be complemented by Phase 2 population for registration Phase 3 trial has similar design to validated Phase 2 trial and in line with the Company’s communications and expectations First patient expected to be randomized...Read more
Active relapsed or refractory AML patients 65+ years receiving an Iomab-B led Bone Marrow Transplant (BMT) achieved significant improvement in survival at one and two years compared to control arm patients none of whom survived even one year Unprecedented 100% BMT access and engraftment in evaluable patients receiving a therapeutic dose of Iomab-B despite high leukemia burden and multiple lines of prior...Read more
94% of attacks required only one dose to achieve primary endpoint Further analyses demonstrate efficacy across all levels of attack severity Additional safety data reinforces flexibility of dosing CAMBRIDGE, Mass. & SALISBURY, England / Feb 26, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization...Read more
IMC-F106C is Immunocore’s first-in-class bispecific TCR ImmTAC candidate targeting PRAME HLA-A02; nivolumab is manufactured by Bristol Myers Squibb The clinical trial collaboration relates to Immunocore’s PRISM-MEL-301 registrational Phase 3 clinical trial in first-line advanced cutaneous melanoma, evaluating IMC-F106C in combination with nivolumab versus a control arm of either nivolumab or the fixed-dose combination of nivolumab and...Read more
REHOVOT, Israel and MONMOUTH JUNCTION, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology company, today announced that patient enrollment has been completed in the Phase 3 RINGSIDE study evaluating AL102 in desmoid tumors. A total of 156 patients were enrolled. ”Completion of enrollment in RINGSIDE represents a significant milestone in the development of AL102,” said Kenneth...Read more
ORALTO Phase 3 trial focused on desired initial target indication of early oral step-down treatment of invasive aspergillosis infections in adults who have limited or no treatment options Non-inferiority trial will enroll approximately 216 patients with primary endpoint of all-cause mortality at day 42 Key secondary endpoint includes superiority of oral step-down treatment with MAT2203 vs. AmBisome® (liposomal amphotericin B) for...Read more
First EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting WILMINGTON, Del. / Feb 19, 2024 / Business Wire / Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III...Read more
Results include pharmacokinetic and pharmacodynamic data, and post-hoc subgroup analyses of the Phase 3 GENESIS trial Presentations on Thursday, February 22, 2024 in San Antonio, Texas TEL AVIV, Israel, Feb. 16, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that new post-hoc...Read more
Late-breaking phase 3 data for KONFIDENT trial on Sunday, February 25, 2024 CAMBRIDGE, Mass. & SALISBURY, England / Feb 16, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the acceptance of multiple abstracts at the 2024 American Academy of...Read more
Findings demonstrate significant reduction in pain and opioid consumption through 96 hours versus active comparator Significantly greater proportion of opioid-free patients receiving EXPAREL TAMPA, Fla., Feb. 15, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc., (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the publication of its...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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