The Northwell Health Cancer Institute is the Most Recent Clinical Site to Join the TIGeR-PaC Study, and RenovoRx Aims to Reach Full Patient Enrollment in the First Half of 2025 Phase III Clinical Trial is Evaluating the TAMP™ (Trans-Arterial Micro-Perfusion) Therapy Platform for the Treatment of Locally Advanced Pancreatic Cancer LOS ALTOS, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”)...Read more
TEL AVIV, Israel, Nov. 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 the receipt of partial topline data from its contract research organization (CRO), Lotus Clinical Research ("Lotus"), for the Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management...Read more
MELT-300 Demonstrates Statistically Superior Compared to Both Sublingual Midazolam (P=0.009) and Placebo (P<0.001) for Providing Successful Procedural Sedation Proportion of Patients Requiring Rescue Sedation Was Nearly Two-Fold Higher for Sublingual Midazolam Compared with MELT-300 (P=0.003) MELT-300 Had a Favorable Safety Profile That Was Generally Comparable to Placebo NASHVILLE, Tenn. / Nov 20, 2024 / Business Wire / Melt...Read more
Achieved all co-primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies versus each of placebo, ezetimibe 10 mg, and obicetrapib 10 mg monotherapy at day 84 with statistical significance (p<0.001) Obicetrapib and ezetimibe fixed-dose combination observed to lower LDL-C by approximately 50% at day 84, compared to placebo, with over 70% of patients achieving LDL-C levels below 55...Read more
Dapirolizumab pegol (DZP) met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity A greater response was observed across multiple clinical endpoints among participants treated with DZP including 50% less severe disease flares compared to participants on standard of care alone Systemic Lupus Erythematosus is a...Read more
ICONIC-LEAD achieved its co-primary endpoints of PASI-90 and IGA of 0 or 1 at week 16; 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24 ICONIC-TOTAL achieved its primary endpoint of IGA score of 0 or 1 at week 16 in patients with plaque psoriasis in difficult-to-treat areas Protagonist has earned a $165 million milestone under the terms of recently amended agreement, inclusive of $50 million in accelerated...Read more
Icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, met its co-primary endpoints in patients with moderate to severe plaque psoriasis 74% of patients achieved clear or almost clear skin (IGA 0/1) at week 24 Comprehensive results are being prepared for presentation at upcoming medical congresses SPRING HOUSE, Pa., Nov. 18, 2024 /PRNewswire/ -- Johnson &...Read more
MENLO PARK, Calif., Nov. 18, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study evaluating adjuvant treatment regimens in patients with Stage I adenocarcinoma...Read more
Met primary endpoint with LDL-C mean reduction versus placebo of 36.3% at day 84 and 41.5% at day 365 Lp(a) mean reduction versus placebo of 45.9% at day 84 and 54.3% at day 365 Total LDL-P mean reduction versus placebo of 52.5% at day 180, with small LDL-P reduction of 102.4% Safety results comparable to placebo NAARDEN, the Netherlands and MIAMI, Nov. 18, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or...Read more
Acoramidis demonstrated the earliest known time to separation in cardiovascular outcomes in the ATTRibute-CM study (3 months), with statistically significant risk reduction of 36% on All-Cause Mortality (ACM) alone at Month 36 within the Open Label Extension The continued curve separation of the composite endpoint of ACM and recurrent cardiovascular-related hospitalizations (CVH) emphasizes the importance of early intervention...Read more
Plozasiran induced deep and sustained reductions in triglycerides and impacted a wide spectrum of lipoproteins that may be involved with atherosclerotic cardiovascular disease Similar responses were observed in patients with genetically confirmed and clinically diagnosed FCS Mean reductions in triglycerides of up to -73% in patients from MUIR and -86% in patients from SHASTA-2 with favorable reductions in remnant cholesterol and...Read more
In a first-of-its-kind study, tirzepatide also alleviated heart failure symptoms and physical limitations Patients on tirzepatide experienced improved exercise capacity, greater weight loss and reduced systemic inflammation Lilly has initiated submissions for tirzepatide for the treatment of HFpEF and obesity to global regulatory agencies INDIANAPOLIS, Nov. 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today...Read more
SOUTH SAN FRANCISCO, Calif., Nov. 16, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data from post-hoc analyses of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil were presented at the American Heart Association Scientific Sessions 2024 in Chicago,...Read more
New Findings Demonstrate 81% of Participants Achieve Durable Biochemical Response by Month 30 with Livdelzi Nearly Half of Participants with Primary Biliary Cholangitis (PBC) Achieve Alkaline Phosphatase (ALP) Normalization with Livdelzi Livdelzi Reduced Pruritus Severity in PBC Participants and Led to Near Resolution of Itch in 27% of Participants with Moderate to Severe Itch FOSTER CITY, Calif. / Nov 15, 2024 / Business Wire /...Read more
A review of study data by an independent Data Review Committee found that CHAPERONE is not meeting its primary three-year efficacy endpoint Company to discontinue study, review full data set, and evaluate next steps for the program NEW YORK, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company, today announced that a review of the CHAPERONE data by an independent Data Review...Read more
SURMOUNT-1 results show a 94% reduction in risk of progression to type 2 diabetes across all pooled doses of tirzepatide compared to placebo over three years Results suggest one new case of diabetes could be prevented for every nine patients treated with tirzepatide Participants treated with tirzepatide had an average weight reduction of 22.9% (15 mg dose) INDIANAPOLIS, Nov. 13, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:...Read more
Two trials for active psoriatic arthritis (PsA) with one focusing on biologic-naïve patients and including evaluation of radiographic progression (IZAR-1), and the other focusing on TNF-IR patients while being the first trial to include risankizumab as an active reference arm (IZAR-2) Program will evaluate sonelokimab for a total of 52 weeks, across IZAR-1 and IZAR-2, at sites in the United States, Europe and Latin America, using a...Read more
PARADIGM ™ program comprises two 12-week randomized, placebo-controlled studies (APPROACH and EMBRACE) and a long-term extension study (EXTEND) APPROACH ™: A Phase III, Placebo-Controlled, Randomized, Double-Blind Trial of Oral Doses of CYB003 to Assess Combined Safety and Efficacy in Humans with Major Depressive Disorder has been initiated and will enroll 220 patients at 36 clinical sites across the U.S. and Europe; topline...Read more
Newly Presented Results, to be Published in The New England Journal of Medicine, Include Adherence and Pharmacokinetics Data; Data Underscore High Efficacy and Safety Profile of Lenacapavir Among Broad and Geographically Diverse Range of Individuals FDA Recently Granted Breakthrough Therapy Designation for Lenacapavir for PrEP; Gilead to Begin Regulatory Filings by End of 2024 Gilead Spearheading Lenacapavir Access...Read more
SELECT-MDS-1 Did Not Meet its Primary Endpoint Company to Discontinue Study, Review Full Data Set, and Evaluate Next Steps CAMBRIDGE, Mass. / Nov 12, 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 SELECT-MDS-1 Phase 3 trial evaluating tamibarotene in...Read more
DEEp OCEAN is the first pivotal clinical trial designed to study DEEs broadly Initial sites activated with additional sites expected to be activated in the coming weeks LA JOLLA, Calif. / Nov 12, 2024 / Business Wire / Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that it has initiated its...Read more
CANOPY manuscript preprint includes six-month off-drug follow-up period that highlighted strong protection by pemivibart versus placebo in the immunocompetent Cohort B during KP.3 and KP.3.1.1 dominant wave CANOPY exploratory clinical efficacy data, to date, reconfirm a high level of risk reduction from developing symptomatic COVID-19 in immunocompetent participants Preprint describes Invivyd scientists’ novel method for predicting...Read more
First-of-its-kind study of >1K patients evaluating the impact of adjuvant treatment escalation in patients tested with Signatera™; results to be presented at ASCO GI in Jan. 2025 AUSTIN, Texas / Nov 12, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the completion of a study using Signatera from the CALGB (Alliance)/SWOG 80702 randomized, phase III clinical...Read more
INDIGO is the largest clinical trial conducted in patients living with IgG4-RD Topline INDIGO results expected by the end of 2025 WALTHAM, Mass., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative immunology-based therapies, today announced the...Read more
First patient randomized in SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Received FDA feedback on protocol for TRANQUILITY In-Care trial of BXCL501 for agitation associated with Alzheimer’s dementia (AAD) Estimated 140 million annual acute agitation episodes associated with these conditions 1-3 NEW HAVEN, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- BioXcel...Read more
These results showed reduction in tumor volume, building on the established safety and efficacy profile of KOSELUGO in certain children and has the potential to support expanded use in certain adults RAHWAY, N.J. / Nov 12, 2024 / Business Wire / Alexion, AstraZeneca Rare Disease and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 KOMET trial, which is...Read more
CANTON, Mass., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension...Read more
Oral presentation highlighting IGNYTE primary analysis data shows anti-tumor activity across all subgroups with injected and non-injected lesions responding with similar frequency, depth, duration, and kinetics Initial biomarker data shows increase in tumor CD8+ T cell and PD-L1 expression after dosing along with an increase in gene signatures associated with CD8+ T cells and inflammatory cytokines, highlighting the potential of RP1...Read more
TEZSPIRE demonstrated a statistically significant and clinically meaningful reduction in nasal polyp size and reduced nasal congestion compared to placebo WILMINGTON, Del. / Nov 08, 2024 / Business Wire / Positive high-level results from the Phase III WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) showed that AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab) demonstrated a statistically...Read more
Statistically Significant Reduction in Nasal Polyp Size, Nasal Congestion Compared to Placebo THOUSAND OAKS, Calif., Nov. 7, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]). The trial demonstrated patients treated with TEZSPIRE® (tezepelumab-ekko) had a statistically...Read more
Phase 3 single-arm, baseline-controlled trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs) currently enrolling participants at leading vascular anomaly centers across the U.S. Microcystic LMs is a chronically debilitating and lifelong genetic disease affecting an estimated more than 30,000 diagnosed patients in the U.S. QTORIN™ rapamycin...Read more
Long-term follow-up data highlight further reductions in tumor size, increase in ORR with additional CRs, sustained improvement in desmoid tumor symptoms, and consistent safety profile, now with a median duration of therapy of approximately 3 years STAMFORD, Conn., Nov. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and...Read more
The efficacy and safety of CAPLYTA (lumateperone) as a maintenance treatment in adults with schizophrenia was demonstrated in a randomized withdrawal trial The study demonstrated a statistically significant (p=0.0002) longer time to relapse in schizophrenia patients treated with lumateperone compared to placebo BEDMINSTER, N.J., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical...Read more
Findings Presented at the 2024 Psych Congress Include Data From More Than 300 Patients SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented data from more than 300 patients diagnosed with tardive dyskinesia and treated with INGREZZA® (valbenazine) capsules. These data showed significant improvements in functional, social, emotional and health-related quality of life measures in...Read more
SAN DIEGO, Nov. 4, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) presented data from the long-term KINECT®-4 study demonstrating tardive dyskinesia remission in nearly 60% of participants at Week 48 with once-daily INGREZZA® (valbenazine) capsules treatment. This research, "Remission of Tardive Dyskinesia in Patients Receiving Long-Term Valbenazine Treatment" (Poster #98), was shared at the 2024 Psych Congress in...Read more
135 patients enrolled TORONTO, Nov. 04, 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
Bagsværd, Denmark, 1 November 2024 – Novo Nordisk today announced the headline results from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blinded trial in 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3)1. Part 1 of the ESSENCE trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to...Read more
Teva’s presentation of findings from six schizophrenia studies at Psych Congress 2024 highlights its commitment to finding new innovations in neuroscience Data show TEV-'749 drug delivery technology resulted in no occurrence of Post-Injection Delirium/Sedation Syndrome (PDSS) events to date Real-world analyses of UZEDY (risperidone) subcutaneous long-acting injectable reveal high adherence rates and utilization in adults with...Read more
Long-term treatment with COBENFY was associated with continued improvements in symptoms of schizophrenia, demonstrating maintenance of effect COBENFY was generally well tolerated over 52 weeks with a side effect profile consistent with prior trials of COBENFY in schizophrenia In-trial qualitative interviews found that a majority of participants treated with COBENFY in the long-term EMERGENT-5 trial reported Quality of Life improvements...Read more
First Phase 3 PDT study in patients with sBCC in the United States. Primary and secondary endpoints all highly statistically significant p<0.0001 Correlates to data seen in Europe where sBCC is already incorporated in the Summary of Product Characteristics. BCC is the most common skin cancer in the US, with more than 3 million cases each year1. WOBURN, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI)...Read more
Co-primary Endpoint Changed to Absolute Total Symptom Score (Abs-TSS) from Total Symptom Score Improvement of ≥ 50% (TSS50) Following Alignment with the FDA Spleen Volume Response Rate ≥ 35% (SVR35) Remains a Co-primary Endpoint Promising Improvement in Abs-TSS and SVR35 from Phase 1 Trial of Selinexor in Combination with Ruxolitinib Adds Confidence in Phase 3 SENTRY Trial Proactively Increasing Total Sample Size of the SENTRY...Read more
ICoN-1 study presentation planned November 1 at NTM Symposium Australia Study is cleared by health authorities to proceed in Australia, U.S., Japan and South Korea, with Taiwan anticipated by end of year DANBURY, Conn., Oct. 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine...Read more
Topline data now anticipated in mid first half of 2025 Management to host virtual KOL event today to discuss the unmet need in hypertension, as well as a review of the ongoing pivotal clinical program for lorundrostat in hypertension RADNOR, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension,...Read more
A change in the initiation of donanemab dosing, shifting one vial of donanemab from the first infusion to the third infusion, lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen used in the pivotal Phase 3 clinical trial Reduction of amyloid plaque and P-tau217 on this modified titration was comparable to patients receiving the standard dosing regimen Lilly intends to submit this data to global...Read more
KarXT demonstrated a statistically significant 9.2-point reduction in PANSS Total score from baseline at Week 5 compared to placebo (p=0.0014) Trial also met all secondary endpoints, demonstrating statistically significant reductions in positive and negative symptoms of schizophrenia, as measured by the PANSS positive subscale, PANSS negative subscale and PANSS negative Marder factor score KarXT has a tolerable safety profile with no...Read more
Following strong protection (84% relative risk reduction versus placebo) demonstrated through month 6 with pemivibart, CANOPY clinical trial participants were followed for an additional six-month period (months 7-12), with no additional doses, to assess safety and efficacy as drug concentrations declined over time In the six-month off-drug follow-up period (months 7-12), substantially reduced concentrations of PEMGARDA reduced the risk...Read more
SUNNYVALE, Calif., Oct. 28, 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 the completion of its last protocol specified follow-up visit in CardiAMP HF, a prospective, randomized, double-blinded, placebo procedure controlled, multi-center pivotal clinical trial for the treatment of heart...Read more
A greater number of patients treated with subcutaneous TREMFYA® induction and maintenance achieved clinical and endoscopic remission at 48 weeks in the Phase 3 GRAVITI study versus placebo TREMFYA® could become the first IL-23 treatment to offer both a subcutaneous and intravenous (IV) induction regimen for patients living with Crohn's disease (CD), pending FDA approval PHILADELPHIA, Oct. 28, 2024 /PRNewswire/ -- Johnson &...Read more
New safety and tolerability data show high treatment compliance with apraglutide, low incidence of injection site reactions and adverse events associated with GI tolerability Findings reinforce the clinical profile of once-weekly apraglutide; Ironwood expects to complete U.S. regulatory submission in Q1 2025 One apraglutide poster recognized as presidential poster recipient New linaclotide data shed light on...Read more
ATEV™ demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis access ATEV also showed superior function and patency in female, obese and diabetic patients, subgroups with historically poor outcomes with autogenous fistula procedures DURHAM, N.C., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage...Read more
At three years, over 80% of patients with moderately to severely active UC who were in remission with mirikizumab sustained long-term remission and relief from disruptive symptoms, including bowel urgency Mirikizumab also helped over 50% of patients with moderately to severely active Crohn's disease sustain long-term endoscopic remission for up to five years INDIANAPOLIS, Oct. 28, 2024 /PRNewswire/ -- Eli Lilly and Company...Read more
The INTerpath-009 clinical trial demonstrates continued expansion of the INTerpath clinical program, as the third Phase 3 trial for the investigational individualized neoantigen therapy, V940 (mRNA-4157), focused on earlier stages of cancer RAHWAY, N.J. & CAMBRIDGE, Mass. / Oct 28, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), today announced the...Read more
Phase 3 trial data show that early treatment is correlated with shorter attack duration Rigorous comparison of Phase 3 results for oral sebetralstat and pivotal trial results of IV recombinant C1-inhibitor for on-demand treatment of HAE attacks shows no differences in time to beginning of symptom relief CAMBRIDGE, Mass. & SALISBURY, England / Oct 28, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today...Read more
Primary endpoint was met with 74% of participants dosed with LNZ100 achieving three-lines or greater improvement at 3 hours post treatment，and maintaining their optimal distance visual acuity (i.e., not losing 5 or more letters). The difference in efficacy was statistically significant in the LNZ100 treatment group compared to the vehicle group (p<0.0001) Rapid onset and long duration shown with 69% of participants achieving...Read more
Statistically significant 68% (p<0.0001) proteinuria reduction compared to placebo, with reduction observed as early as Week 4 All secondary endpoints favored treatment with pegcetacoplan, including: Stabilized eGFR, a key measure of kidney function 71% of patients achieved zero C3c staining intensity, demonstrating complete clearance of C3c deposits Results consistent across subgroups including C3G and IC-MPGN,...Read more
In first dedicated study of a selective IL-13 inhibitor in patients previously treated with dupilumab, the majority of patients had a history of inadequate response to dupilumab EBGLYSS also provided meaningful improvements in difficult-to-treat face and hand dermatitis The safety profile of EBGLYSS was consistent with previous Phase 3 studies and of the patients who reported eye-related events, facial dermatitis or...Read more
New patient-reported outcome data from INTEGUMENT-1 and -2 demonstrate that ZORYVE cream 0.15% rapidly decreased the impact of atopic dermatitis (AD), including sleep loss and daily activities, on patients and families ZORYVE cream 0.15% resulted in significant improvements across all efficacy endpoints, including validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Success and rapid itch reduction within 24-hours...Read more
Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status Confirmatory data to support U.S. regulatory resubmission by year-end; if approved, Dupixent would be the first new targeted treatment for people living with chronic spontaneous urticaria in more than 10 years More than 300,000 people in the U.S. suffer from chronic spontaneous urticaria that is inadequately...Read more
Trial did not meet the primary endpoint of percent change in 28-day TSC-associated seizure frequency (p=0.09); results showed numerically higher response rates for ganaxolone than placebo Ganaxolone was generally well-tolerated in TrustTSC with a safety profile consistent with previous clinical trials Cost reduction activities are underway Marinus has engaged Barclays as an advisor to assist with evaluating strategic...Read more
Second Phase 3 LUCIA pivotal trial first patient dosing expected by end of 2024 Topline data anticipated in 2026 WATERTOWN, Mass., Oct. 24, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases, today announced that the first patient has been dosed in the Phase 3...Read more
Topline Data from 52-week Phase 3 Study Expected in Late 2025 CAMBRIDGE, Mass., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that enrollment is complete for the Phase 3 RISE UP study. This global, double-blind, randomized, placebo-controlled trial is evaluating the efficacy and...Read more
SAN DIEGO, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics, Inc. (“Gyre”) (Nasdaq: GYRE), a self-sustainable, commercial-stage biotechnology company with clinical development programs focusing on a variety of chronic organ diseases, today announced that the last patient in Gyre Pharmaceuticals’ pivotal Phase 3 trial in the People’s Republic of China (“PRC”) evaluating F351 (hydronidone) for Chronic Hepatitis B (“CHB”)-associated liver...Read more
Based on a Review of Unblinded Data, an Independent Data Monitoring Committee (IDMC) Confirmed that Predetermined Futility Criteria Have Not Been Met IDMC Also Recommended Continuing Trial without Changes, Including no Need for a Potential Upsizing ENSURE Program Remains on Track to be Completed in 2026 Webcast to be Held Today, October 22, at 8:00 am ET NEW YORK, Oct. 22, 2024 /PRNewswire/ -- Immunic,...Read more
REDWOOD CITY, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the first patient has been dosed in RASolute 302, a Phase 3 registrational study of RMC-6236, a RAS(ON) multi-selective inhibitor, in patients with previously treated, metastatic pancreatic ductal adenocarcinoma...Read more
Positive results from the MAESTRO-NASH OUTCOMES study could make resmetirom the first medication approved for patients with compensated NASH cirrhosis, a population at high risk of progressing to adverse liver-related outcomes Study may also support full approval of RezdiffraTM (resmetirom) in noncirrhotic NASH CONSHOHOCKEN, Pa., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical...Read more
88% of EYLEA HD patients had a last assigned dosing interval of ≥12 weeks at week 156, while sustaining visual and anatomic improvements achieved in the first 96 weeks, in this extension study of the Phase 3 PHOTON trial presented at AAO Patients switched to EYLEA HD experienced substantially slower fluid reaccumulation, as compared to their previous rate of fluid reaccumulation with EYLEA® (aflibercept) Injection 2 mg The consistent...Read more
Phase 3 Confirmatory Trial Met Pre-Specified Primary Efficacy Endpoint and Demonstrated Excellent Tolerability and a Favorable Safety Profile Through 12 Months, Supporting Anticipated New Drug Application (NDA) Submission by End of 2024 Data Suggest Epioxa Has the Potential to Provide the Ophthalmic Community and Patients with the First FDA-Approved, Non-Invasive Drug Therapy Alternative for Keratoconus ALISO VIEJO, Calif. / Oct 16,...Read more
GAITHERSBURG, Md., Oct. 16, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The clinical hold is due to a...Read more
STRIDE-8 results presented at IDWeek build on the proven clinical profile of CAPVAXIVE, marking the latest Phase 3 study evaluating CAPVAXIVE to demonstrate robust immune responses in adults CAPVAXIVE covers the serotypes responsible for approximately 84% of invasive pneumococcal disease cases in adults 50 and older RAHWAY, N.J. / Oct 16, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada,...Read more
MINT Study Results Show Clinically Meaningful and Statistically Significant Efficacy in AChR+ and MuSK+ Patients First and Only Phase 3 Placebo-Controlled gMG Trial for a Biologic That Tapered Corticosteroid Use THOUSAND OAKS, Calif., Oct. 15, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of positive top-line results from the Phase 3 MINT trial evaluating the efficacy and safety of UPLIZNA®...Read more
35 sites active and enrolling in pivotal Phase 3 study of Bria-IMT™ combination with immune check point inhibitor in metastatic breast cancer (MBC) Primary endpoint is overall survival (OS) with Bria-IMT™ regimen plus Check Point Inhibitor (CPI) vs treatment of physician’s choice Interim data analysis planned at 144 events (deaths) could provide full approval and marketing authorization Pivotal Phase 3 study patient enrollment...Read more
Jazz plans to submit supplemental New Drug Application in first half of 2025 for this combination therapy as a first-line maintenance treatment for ES-SCLC DUBLIN, Oct. 15, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced positive top-line results from the Phase 3 clinical trial evaluating Zepzelca® (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq®) compared to atezolizumab...Read more
SOL-1 is now expected to be enrolled and fully randomized by year-end 2024 Topline clinical data from SOL-1 are now expected in Q4 2025 BEDFORD, Mass., Oct. 15, 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 commercialization of innovative therapies for retinal diseases and other eye...Read more
Topline Results Expected Q2 2025 WATERTOWN, Mass., Oct. 15, 2024 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today announced that the pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210 in adult patients with CRS who have not had prior...Read more
Data show more patients treated with mirikizumab achieved histologic response at Week 52 compared to ustekinumab New data are first-of-its-kind analysis of microscopic mucosal resolution that go beyond endoscopy, setting a new potential standard for the evaluation of therapeutic response INDIANAPOLIS, Oct. 14, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced data demonstrating more patients with moderately to...Read more
First and only PARP inhibitor plus ARPI combination to demonstrate statistically significant overall survival (OS) benefit in patients with metastatic castration-resistant prostate cancer (mCRPC) Results to be shared with global health authorities to potentially update the TALZENNA label NEW YORK / Oct 10, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced positive topline results from the final prespecified overall...Read more
TREMFYA® is now U.S. FDA-approved for ulcerative colitis and under review for Crohn's disease TREMFYA® is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of patients with Crohn's disease, inclusive of those who are biologic-naïve and biologic-refractory Ninety percent more biologic-naïve patients and three times more biologic-refractory patients with ulcerative colitis...Read more
Topline Readout Expected in Q4 2024 FDA Agrees to a MELT-300 Phase 3 Special Protocol Assessment NASHVILLE, Tenn. / Oct 10, 2024 / Business Wire / Melt Pharmaceuticals, Inc. (“Melt”), a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced the dosing of the last patient in its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT‑300, a non-IV,...Read more
Data Presented at the CHEST 2024 Annual Meeting BRIDGEWATER, N.J., Oct. 8, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today presented positive late-breaking subgroup data from the Phase 3 ASPEN study, a global, randomized, double-blind, placebo-controlled...Read more
GSK’s RSV vaccine is the only RSV vaccine with efficacy and safety data available through three full seasons, including in people at increased risk Safety and reactogenicity data are consistent with previous results from the phase III program GSK will continue to provide data on longer-term follow-up to help recommending bodies determine future revaccination schedules PHILADELPHIA / Oct 08, 2024 / Business Wire / GSK plc (LSE/NYSE:...Read more
KEYNOTE-689 is the first Phase 3 trial to demonstrate statistically significant and clinically meaningful improvement in EFS in the intent-to-treat population in the neoadjuvant and adjuvant setting for an anti-PD-1 therapy in earlier stages of head and neck squamous cell carcinoma RAHWAY, N.J. / Oct 08, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3...Read more
NTLA-2002 is a single-dose treatment designed to prevent potentially life-threatening swelling attacks in people with hereditary angioedema (HAE) NTLA-2002 is Intellia’s second in vivo candidate to enter late-stage clinical development from its modular gene editing platform CAMBRIDGE, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on...Read more
Independent Data Monitoring Committee recommended trial stop early due to overwhelming efficacy at pre-planned analysis AstraZeneca’s inhaled anti-inflammatory rescue medication AIRSUPRA demonstrated significant benefit compared to albuterol WILMINGTON, Del. / Oct 07, 2024 / Business Wire / Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s AIRSUPRA ® (albuterol/budesonide) met the primary endpoint,...Read more
Apitegromab met primary endpoint with statistically significant and clinically meaningful improvement in motor function as measured by the gold standard Hammersmith Functional Motor Scale Expanded (HFMSE) for patients with SMA receiving apitegromab versus placebo (current standard of care) at week 52 30.4% of patients receiving apitegromab had >3 point improvement in HFMSE versus 12.5% of patients on placebo Patients receiving...Read more
FDA Grants Fast Track Designation for Ivonescimab in 2L+ EGFRm NSCLC HARMONi Completed Enrollment for Summit’s First Sponsored Study Evaluating Ivonescimab Topline data from the HARMONi Trial Is Expected in Mid-2025 MIAMI / Oct 03, 2024 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that we have completed enrollment in our HARMONi clinical trial, a multi-regional Phase III...Read more
132 patients enrolled TORONTO, Oct. 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...Read more
Anticipated advantages of UGN-103 include a shorter manufacturing process and a simpler reconstitution procedure PRINCETON, N.J. / Oct 02, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that the first patient was dosed in the Phase 3 clinical trial of investigational drug UGN-103...Read more
Adult patients with breast cancer are a prespecified subgroup of the recently conducted OnTarget trial evaluating crofelemer for prophylaxis of cancer therapy-related diarrhea OnTarget results in breast cancer patients have been submitted to a relevant oncology conference SAN FRANCISCO, CA / ACCESSWIRE / October 1, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that the recently completed analysis of the...Read more
Unblinded Interim Analysis to be Conducted During the Current Quarter Top-line Results Anticipated in First Quarter of 2025 PETACH TIKVA, Israel, Oct. 01, 2024 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has enrolled the last patient required in order to conduct the planned unblinded interim analysis in its...Read more
Head-to-head data, presented at OPTIONS XII for the Control of Influenza Conference, demonstrates advantage of sa-mRNA over conventional mRNA in duration of immune response; Results highlight CSL and Arcturus Therapeutics' commitment to advancing COVID-19 vaccine innovation to protect public health. WALTHAM, Mass. and SAN DIEGO, Sept. 30, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and self-amplifying...Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
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