The marketing authorization for SKYRIZI® (risankizumab) marks its fourth approved indication in the European Union The approval is supported by data from two pivotal Phase 3 trials: The INSPIRE induction trial1 and COMMAND maintenance trial2 In both trials, SKYRIZI achieved the primary endpoint of clinical remission (per Adapted Mayo Score*) and key secondary endpoints, including mucosal healing** and histologic endoscopic mucosal...Read more
Opinion granted based on positive overall survival and progression-free survival results from the Phase 3 KEYNOTE-A39 trial Positive opinion marks step forward for a potential new first-line standard of care for the treatment of patients with this disease in Europe RAHWAY, N.J. / Jul 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s...Read more
Results Underscore Continued Progress on Commercial Execution, Driving the Growth Portfolio and Pipeline Advancement Second Quarter Revenues were $12.2 Billion, increasing 9% (+11% Adjusting for Foreign Exchange) Growth Portfolio Revenues were $5.6 Billion, increasing 18% (+21% Adjusting for Foreign Exchange) GAAP EPS was $0.83 and Non-GAAP EPS was $2.07; Includes Net Impact of $(0.04) Per Share for GAAP EPS and Non-GAAP EPS Due to...Read more
Diluted EPS of $2.16; Adjusted Diluted EPS of $2.42 Reaffirms 2024 Adjusted Diluted EPS Guidance Floor of Greater Than $6.80 Adjusted diluted EPS of $2.42, up 15% from $2.10 in the second quarter of 2023. Premium and service revenues of $36.0 billion in the second quarter of 2024. Membership increase of 34% in Marketplace, compared to the second quarter of 2023. ST. LOUIS, July 26, 2024 /PRNewswire/ -- Centene...Read more
TOKYO and CAMBRIDGE, Mass., July 26, 2024 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval...Read more
Second Quarter Revenue Increased 23% Year-Over-Year Raising Full Year 2024 Total Omnipod Revenue Outlook ACTON, Mass. / Jul 26, 2024 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced certain preliminary revenue results for the three months ended June 30, 2024. The Company plans to report full second...Read more
Study reports high accuracy of Signatera for surveillance of MCC patients, suggests potential to reduce frequency of surveillance imaging AUSTIN, Texas / Jul 26, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced a new study published in the Journal of Clinical Oncology highlighting the utility of its personalized and tumor-informed molecular residual disease (MRD) test,...Read more
SOMERSET, N.J., July 26, 2024 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced preliminary, unaudited financial results for the six-months ended June 30, 2024. For the six-months ended June 30, 2024, Legend Biotech expects to record an adjusted net loss for the period of approximately $94.7 million to $109.7 million. See “Use of Non-IFRS Financial Measures”...Read more
RYTELO, for both RS+ and RS- patients, has a Category 1 recommendation for second-line treatment and a Category 2A recommendation for first-line treatment of patients who are ESA ineligible (serum EPO >500 mU/mL) FOSTER CITY, Calif. / Jul 26, 2024 / Business Wire / Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that the...Read more
Initiative initially funded by $10 million grant from the Bill & Melinda Gates Foundation NEW YORK / Jul 26, 2024 / Business Wire / Schrödinger, Inc. (Nasdaq: SDGR), whose physics-based computational platform is transforming the way therapeutics and materials are discovered, today announced that it is embarking on an initiative to expand its computational platform to predict toxicology risk early in drug discovery. The goal of the...Read more
STOCKHOLM, July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (STOCKHOLM: CALTX) ("Calliditas") today announced that the Phase 2b TRANSFORM trial met its primary endpoint, showing statistically significant improvement in ALP (Alkaline Phosphatase) for both doses tested versus placebo. The trial evaluated setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver...Read more
Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms, no bias found,...Read more
HIGH POINT, N.C., July 26, 2024 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an...Read more
$30.3 million financing upfront with up to an additional $92.4 million tied to exercise of warrants, with certain of the warrants subject to shareholder approval Fundraise supports development of novel antibody PMN310 for Alzheimer’s Disease patients Proceeds expected to support Company beyond 6 month and 12 month data from the PMN310 Phase Ib study in Alzheimer’s patients TORONTO, Ontario and CAMBRIDGE, Massachusetts, July 26,...Read more
Topline results demonstrated a favorable safety profile and tolerability across four ascending dose levels in healthy volunteers and showed dose dependent levels of PMN310 antibody in Cerebrospinal fluid (CSF) suggestive of its potential for target engagement in Alzheimer’s disease patients CAMBRIDGE, Massachusetts and TORONTO, Ontario, July 26, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (Nasdaq: PMN), a biotechnology...Read more
MINNEAPOLIS, July 26, 2024 (GLOBE NEWSWIRE) -- OneMedNet Corporation (Nasdaq: ONMD) (“OneMedNet” or the “Company”), the leading curator of regulatory-grade Real World Data ("RWD"), inclusive of electronic health records, laboratory results and, uniquely, medical imaging, today announced that it has entered into securities purchase agreements with certain institutional investors, including an affiliate of Off the Chain Capital and an...Read more
Scienture, Inc., a private branded and specialty pharmaceutical company, entered into a business combination with TRxADE Health Inc., in an all-stock transaction valued at $103 million. TAMPA, FL and COMMACK, NY, July 26, 2024 (GLOBE NEWSWIRE) -- TRxADE HEALTH, INC. (“TRxADE”) (Nasdaq: MEDS) and Scienture, Inc. (“Scienture”) today announced the closing of TRxADE’s business combination with Scienture in an all-stock...Read more
Presentation to feature Silo’s novel therapeutics for the underserved SARASOTA, FL, July 26, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that CEO Eric Weisblum will present at the H.C. Wainwright 25th Annual...Read more
VANCOUVER, British Columbia, July 26, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (the “Company”), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, announces that, further to the press releases dated May 23, 2024, June 20, 2024, July 19, 2024, and July 22, 2024, the Company has closed its previously announced over-subscribed non-brokered private...Read more
Southlake, TX, July 26, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced an analysis published by the Innovation Value Institute (IVI) titled “Introduction of AI assisted Digital...Read more
CHARLOTTE, N.C., July 26, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GENE”), a global leader in genomics-based tests in health, wellness and serious disease and the parent company of geneType™, has conducted an operations review and announces that it intends to transition to a capital light operations model – which is anticipated to result in an immediate material reduction in operating...Read more
MINNEAPOLIS, July 26, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming the lives of patients suffering from fluid overload, today announced that the first patient has been treated with the newly launched QUELIMMUNE™ therapy in a commercial setting at Cincinnati Children’s. QUELIMMUNE, manufactured for SeaStar Medical (Nasdaq: ICU) and exclusively licensed and distributed in...Read more
Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart...Read more
Reports Second-Quarter Diluted EPS of $0.77 on a GAAP Basis, a Decrease of 32.5 Percent; Adjusted Diluted EPS of $2.65, a Decrease of 8.9 Percent; These Results Include an Unfavorable Impact of $0.52 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $14.462 Billion, an Increase of 4.3 Percent on a Reported Basis and 5.6 Percent on an Operational Basis Second-Quarter...Read more
Strong underlying growth supports FY 2024 guidance upgrade, with both Total Revenue and Core EPS now expected to increase by a mid teens percentage at CER1 CAMBRIDGE, United Kingdom / Jul 25, 2024 / Business Wire / AstraZeneca: Revenue and EPS summary H1 2024 % Change Q2 2024 % Change $m Actual CER $m Actual CER - Product...Read more
A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9) after up to four years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients. NEW YORK / Jul 25, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) today announced that the European Commission...Read more
SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ:ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, announced today that Intuitive President David J. Rosa has been appointed to the Company’s Board of Directors, effective July 24, 2024. Rosa joins Intuitive CEO Gary S. Guthart, PhD, as one of two Intuitive executives on the Company’s Board. As president, Rosa...Read more
New 5-Year Clinical and Real-World Data Reinforce Biktarvy® as a Long-Term Treatment Option for a Diverse Range of People with HIV, Including Those with Comorbidities Investigational, Once-Daily, Once-Weekly and Twice-Yearly Dosing Frequencies Across Administration Methods Aim to Expand Options, Advance Public Health and Help Address Unmet Needs in HIV Treatment FOSTER CITY, Calif. / Jul 25, 2024 / Business Wire / Gilead...Read more
Collaboration on Flow Cytometry-Based Companion Diagnostics to Advance Personalized Health Care FRANKLIN LAKES, N.J. and SECAUCUS, N.J., July 25, 2024 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, today announced a global collaboration agreement to develop, manufacture and commercialize flow...Read more
New collaboration will allow Humana to further modernize its cloud infrastructure and leverage Google Cloud’s Generative AI capabilities to accelerate innovation in healthcare. LOUISVILLE, Ky. & SUNNYVALE, Calif. / Jul 25, 2024 / Business Wire / Humana Inc. (NYSE: HUM), a leading health and well-being company, today announced a new multi-year agreement with Google Cloud to further modernize Humana’s cloud infrastructure and...Read more
ALHAMBRA, Calif., July 25, 2024 /PRNewswire/ -- Astrana Health, Inc. ("Astrana"), together with its subsidiaries and affiliated entities ("the Company") (NASDAQ: ASTH), a leading provider-centric, technology-powered healthcare company enabling providers to deliver accessible, high-quality, and high-value care to all, today announced it has entered into a definitive agreement to acquire Collaborative Health Systems ("CHS"), a...Read more
GE HealthCare selects AWS as its strategic cloud provider to deliver entirely new, purpose-built foundation models designed to fast-track the development of innovative healthcare applications GE HealthCare plans to train and deploy clinical foundation models on AWS’s machine learning and generative AI technologies to help healthcare providers expedite clinical and operational workflows to improve delivery of care CHICAGO / Jul 25,...Read more
New Veeva Pulse findings show congresses and early-career experts have the strongest influence on patient outcomes PLEASANTON, Calif., July 25, 2024 /PRNewswire/ -- Veeva Systems (NYSE: VEEV) today revealed that targeted pre-launch scientific outreach maximizes medical affairs teams' impact on treatment adoption in the latest Veeva Pulse Field Trends Report. The analysis shows biopharmas investing in pre-launch scientific activities...Read more
$478 million in second quarter global net product sales First CIDP patients treated with VYVGART® Hytrulo following June 21st FDA approval On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024 Management to host conference call today at 2:30 PM CET (8:30 AM ET) Regulated Information – Inside Information July 25, 2024 7:00 AM CET - Amsterdam, the Netherlands – argenx SE...Read more
SAN DIEGO / Jul 25, 2024 / Business Wire / DexCom, Inc. (Nasdaq: DXCM) today reported its financial results as of and for the quarter ended June 30, 2024. Second Quarter 2024 Financial Highlights: Revenue grew 15% year-over-year to $1.004 billion on a reported basis and 16% year-over-year on an organic1 basis. U.S. revenue grew 19% and international revenue grew 7% on a reported basis and 10% on an organic1 basis, all on a...Read more
Conference Call Scheduled for 9 a.m. EDT Today EXTON, Pa., July 25, 2024 /PRNewswire/ -- West Pharmaceutical Services, Inc. (NYSE: WST) today announced its financial results for the second-quarter 2024 and updated full-year 2024 financial guidance. Second-Quarter 2024 Summary (comparisons to prior-year period) Net sales of $702.1 million declined 6.9%; organic net sales declined 5.9%. Reported-diluted EPS of $1.51,...Read more
Enrollment acceleration drives earlier-than-anticipated data availability for this potentially best-in-class IBD treatment Topline results for both UC and CD now anticipated in Q4 2024 Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug (anti-TL1A) for moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) patients PARSIPPANY, N.J. & PARIS / Jul 25, 2024 / Business Wire / Teva...Read more
MARLBOROUGH, Mass. / Jul 25, 2024 / Business Wire / Hologic, Inc. (Nasdaq: HOLX), a global leader in women’s health, has completed its previously announced acquisition of Endomagnetics Ltd (Endomag), a privately held UK-based developer of breast cancer surgery technologies, for approximately $310 million. “We are thrilled to complete the acquisition of Endomag and are looking forward to working with our new colleagues to increase access to...Read more
SAN JUAN CAPISTRANO, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- The Ensign Group, Inc. (Nasdaq: ENSG), the parent company of the Ensign(TM) group of companies, which provide post-acute healthcare services and invest in the long-term healthcare industry, primarily in skilled nursing and senior living facilities, announced operating results for the second quarter of 2024, reporting GAAP diluted earnings per share of $1.22 and adjusted...Read more
Five Year Collaboration Intended to Advance PD-1 / VEGF Bispecific in Several Solid Tumors across Multiple Clinical Trials MIAMI & HOUSTON / Jul 25, 2024 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) and The University of Texas MD Anderson Cancer Center (MD Anderson) today announced a strategic five-year collaboration agreement for the purpose of accelerating the development of...Read more
Ms. Hamill brings extensive experience and proven leadership focused on commercial growth and shareholder value DUBLIN, July 25, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the election of a new independent director, Laura Hamill, to its Board of Directors. Ms. Hamill, a 35-year veteran of the pharmaceutical industry brings broad executive leadership and global commercial...Read more
Continued strong performance with 2Q24 financial results Raising full year 2024 profit outlook PLANO, Texas, July 25, 2024 (GLOBE NEWSWIRE) -- Integer Holdings Corporation (NYSE:ITGR) today announced results for the three months ended June 28, 2024. Second Quarter 2024 Highlights (compared to Second Quarter 2023, except as noted) Sales increased 9% to $436 million, with organic growth of 5%. GAAP net income...Read more
Quarterly net revenues of $150 million, up 19% year-over-year, with 3,963 active patients on therapy as of June 30, 2024 Positive results from Phase 3 METIS trial in brain metastases from non-small cell lung cancer presented at ASCO 2024 ROOT, Switzerland / Jul 25, 2024 / Business Wire / Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended June 30, 2024. Novocure is a global oncology company working to extend...Read more
FOSTER CITY, Calif. / Jul 25, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as the higher...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
BOTHELL, Wash. / Jul 25, 2024 / Business Wire / Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, today provided an update on recent business development activity, including three recently closed transactions that are expected to enhance the company’s antibody-drug conjugate (ADC) capabilities. Immunome acquired worldwide, exclusive rights to: A panel...Read more
In a study conducted by Brigham & Women’s Hospital, Nanox.AI-Based Analysis helps Reveal Coronary Artery Calcium in over 50% of IMID Patients; Lead author Brittany Weber, MD, PhD, declared as ‘Young Investigator Awards’ Winner In a study conducted by Jefferson Einstein Hospital, Nanox.AI Cardiac Solution Flags CAD High-Risk Patients, Drives Significant Revenue Additional data presented by Corewell Health, Massachusetts...Read more
Weekly subcutaneous doses of pemvidutide resulted in up to 68.5% relative reduction in liver fat content (LFC), with up to 55.6% of subjects achieving LFC normalization after 12 weeks of treatment LFC changes were accompanied by significant improvements in body weight and non-invasive markers of liver inflammation Pemvidutide is currently being evaluated in the Phase 2b IMPACT trial in subjects with metabolic dysfunction-associated...Read more
Initiated Phase 2 clinical trial MALVERN, Pa., July 25, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that dosing is complete in the third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a novel modifier gene therapy candidate being...Read more
Treatment of first randomized person with preclinical AD expected this quarter Phase 2b ReTain trial is fully funded and conducted by development partner Lausanne, Switzerland, July 25, 2024 – AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, today announced that its active-immunotherapy candidate, ACI-35.030 (now called JNJ-2056), targeting the...Read more
Treatment with INZ-701 shown to prevent intimal proliferation in both ENPP1-deficient and wild-type mice, supporting its potential therapeutic application beyond traditional ERT BOSTON, July 25, 2024 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“the Company” or “Inozyme”), a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases that affect bone health and blood vessel function,...Read more
Meets primary study endpoints with pharmacokinetics (PK) comparable whether Anaphylm is administered by subjects or by healthcare providers (HCPs) Final supportive study, the Oral Allergy Syndrome (OAS) challenge study, currently enrolling Continues to anticipate requesting a pre-New Drug Application (NDA) meeting before the end of the third quarter WARREN, N.J., July 25, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc....Read more
DENVER / Jul 25, 2024 / Business Wire / Modivcare Inc. (the “Company” or “Modivcare”) (Nasdaq: MODV), a healthcare services company integrating technology into personalized care experiences, focused on improving health outcomes, announces the expansion of its relationship with BayCare Health System. As a leading community-based health system in West Central Florida, BayCare is committed to meeting the wide-ranging health needs in every...Read more
Data reviewed complies with standards that would be used to evaluate an EU Marketing Authorization Application PLYMOUTH MEETING, Pa., July 25, 2024 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Medicines Agency's Committee...Read more
VeroSource, a subsidiary of HEALWELL, built the new Patient Summary feature that launched on the MyHealthNB mobile app in partnership with Canada Health Infoway and the Government of New Brunswick. The Patient Summary feature allows users to create a summary of their medical information including medications, immunizations, lab results and imaging reports, which can then be securely shared with healthcare professionals and care...Read more
Q2 2024 Revenue Increased 11% to $49.9 Million ENGLEWOOD, Colo., July 25, 2024 /PRNewswire/ -- Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today reported its financial and operational results for the second quarter ended June 30, 2024. Key Second Quarter Highlights and...Read more
SALT LAKE CITY, UT / ACCESSWIRE / July 25, 2024 / As previously projected, Utah Medical Products, Inc. (Nasdaq:UTMD) realized second calendar quarter (2Q) and first half (1H) 2024 financial results which reflect a substantial decline in revenues. Currencies in this release are denoted as $ or USD = U.S. Dollars; AUD = Australia Dollars; £ or GBP = UK Pound Sterling; C$ or CAD = Canadian Dollars; and € or EUR = Euros. Currency amounts...Read more
Presentation to highlight positive outcomes of Iomab-B led bone marrow transplant in difficult to treat TP53 patients and the mutation-agnostic mechanism of Actimab-A for patients with relapsed or refractory acute myeloid leukemia Iomab-B and Actimab-A represent the only clinical stage antibody radiation conjugates in development for patients with acute myeloid leukemia NEW YORK, July 25, 2024 /PRNewswire/ -- Actinium...Read more
Sickle cell disease affects approximately 100,000 patients in the U.S. annually and is a debilitating and life-threatening condition with high unmet need Current conditioning with non-targeted chemotherapies provides limited access to potentially curative bone marrow transplant and recently approved gene therapies for sickle cell disease patients Initial trial focused on conditioning for bone marrow transplant intended to...Read more
ALL represents 10% of all leukemia cases in the United States, progresses rapidly, and is typically fatal within weeks or months if left untreated1 There is an urgent need to develop new therapies for ALL for patients who are not candidates for hematopoietic stem cell transplantation (HSCT) or relapse after FDA ODD and RPDD designations for UCART22 marks an important step towards developing allogeneic CAR T products that would be...Read more
BURLINGTON, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Supplemental New Drug Application...Read more
Data demonstrated in vitro and in vivo ITK inhibition with soquelitinib induced switching of proinflammatory Th17 cells into anti-inflammatory Treg cells Publication confirms and extends understanding of ITK inhibition mechanism of action and its potential in inflammatory autoimmune and allergic diseases Data published by leading researchers from Cornell University in peer-reviewed journal Science Signaling BURLINGAME, Calif., July...Read more
SUNNYVALE, Calif., July 25, 2024 (GLOBE NEWSWIRE) -- 23andMe Holding Co. (Nasdaq: ME), a leading genetic health and biopharmaceutical company, in collaboration with 20 lung cancer advocacy organizations, today announced a new study to help advance research in lung cancer. The focus of the Lung Cancer Genetics Study is to better understand the genetics of people with lung cancer in order to improve detection, risk reduction, and care....Read more
Potential best-in-class therapeutic index for lead candidate anti-CTLA-4 SAFEbody® ADG126 (muzastotug) with higher, more frequent and repeat dosing in combination with Merck’s anti-PD-1 therapy KEYTRUDA* (pembrolizumab) to unleash potential efficacy, while maintaining safety comparable to pembrolizumab alone Poster planned at European Society of Medical Oncology (ESMO) Congress 2024 in September for ADG126 in combination...Read more
BELGRADE, MT / ACCESSWIRE / July 25, 2024 / Xtant Medical Holdings, Inc. (NYSE American:XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that Sean Browne, President and Chief Executive Officer, and Scott Neils, Chief Financial Officer, will attend the Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase being held August 13-15, 2024 at...Read more
WALTHAM, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for review Checkpoint’s resubmission of its Biologics License Application (“BLA”) for cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, as a potential new treatment for...Read more
NEW YORK, July 25, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, announced today that an abstract related to IO102-IO103, the company’s lead investigational therapeutic cancer vaccine candidate, has been accepted for poster presentation at the European Society for Medical Oncology (ESMO) Congress...Read more
Clinical benefit observed among non-small cell lung cancer (NSCLC) patients harboring mutant KRAS (mKRAS) variants in the Phase 2 mecbotamab vedotin (CAB-AXL-ADC) study; AXL tumoral expression highly associated with multiple mKRAS variants Evalstotug (CAB-CTLA-4 antibody) as a monotherapy and in combination with PD-1 continues to provide promising anti-tumor activity with a differentiated safety profile associated with a low...Read more
LOS ANGELES, CA, July 25, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”) (Nasdaq: IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and autoimmune disease, today announced that the California Institute for Regenerative Medicine (CIRM) has awarded Immix Biopharma cell therapy division Nexcella an $8 million CLIN2 grant award to support clinical...Read more
MISSISSAUGA, Canada, July 25, 2024 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that it is presenting results of a novel Quality Assessment Product (“QAP™”) for supporting Point-of-Care-Tests (“POCTs”) for infection with the Hepatitis C Virus (“HCV”) at the American Diagnostic and Laboratory Medicine (“ADLM”) conference taking place in...Read more
Latest positive preclinical data provides another step in the path to potential IND submission this year for novel ketamine analog MIAMI, FL / ACCESSWIRE / July 25, 2024 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, today announced new insights garnered from additional, recently received preclinical study data regarding the mechanism of action and toxicology...Read more
Prioritizing autoimmune programs aims to focus upon near-term and intermediate value creation potential, while retaining oncology programs as promising clinical data continues to mature Company anticipates annualized capital and workforce requirements to be reduced by approximately 25 percent BOSTON, July 25, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a...Read more
GAITHERSBURG, Md., July 25, 2024 (GLOBE NEWSWIRE) -- BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a leader in AI-driven drug discovery, announced significant advancements in its ongoing collaboration with the Lieber Institute for Brain Development (LIBD). Building on the progress detailed in our May 16, 2024 release, our research has now pinpointed specific molecular pathways associated with bipolar...Read more
CHICAGO, IL / ACCESSWIRE / July 25, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that it has signed a distribution agreement (the "Agreement") with...Read more
CHICAGO, IL / ACCESSWIRE / July 25, 2024 / Cosmos Health Inc. ("Cosmos Health" or the "Company'') (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that its wholly-owned subsidiary, Decahedron Ltd ("Decahedron"),...Read more
TEL AVIV, Israel, July 25, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB) (“Chemomab” or the “Company”), a clinical stage biotechnology company developing innovative therapeutics for fibro-inflammatory diseases with high unmet need, today announced that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") that is expected to result in gross proceeds of...Read more
First-in-Class CCL24 Neutralizing Antibody CM-101 Demonstrated a Favorable Safety Profile and Was Generally Well-Tolerated Demonstrated Anti-Fibrotic, Anti-Inflammatory and Anti-Cholestatic Activity across Multiple Components of Primary Sclerosing Cholangitis (PSC), Establishing Clinical Proof-of-Concept for the Disease-Modifying Potential of CM-101 Treatment with CM-101 Led to Statistically Significant Improvements in Liver...Read more
NESS ZIONA, Israel, July 25, 2024 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a dermatology company pioneering treatments for patients with severe skin conditions, conducting a Phase 3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, and with two approved large-category dermatology products, TWYNEO® for the treatment of acne vulgaris and EPSOLAY® for the treatment of inflammatory lesions of rosacea,...Read more
$721 PMPM Savings Over 24 Month Period for Graduates $508 PMPM Savings for Non-Graduates MIAMI / Jul 25, 2024 / Business Wire / Ontrak, Inc (NASDAQ: OTRK), a leading AI-powered and technology-enabled behavioral healthcare company, announced the impressive results of a formal evaluation conducted on the Ontrak WholeHealth+ program. The study evaluated the program’s impact on one of its Medicaid health plan customer’s medical costs. The...Read more
AUSTIN, Texas, July 25, 2024 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (“Plus” or the “Company”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, will have multiple opportunities to present data at the 2024 Society for Neuro-Oncology (SNO) / American Society for Clinical Oncology (ASCO) CNS Metastases...Read more
NEW HAVEN, Conn., July 25, 2024 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO), announces that its unaudited non-GAAP Cash Burn/Generated from Operations (CBFO) for Q2-2024 was $0.3M of cash generated for the quarter. It is important to note that a small contributing factor to the cash increase was the incoming cash collections that were expected in Q1, but were delayed and received in Q2 due to the...Read more
BERKELEY, Calif. and MAINZ, Germany, July 25, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in early detection of cancer, today announced significant improvements to its ColoAlert product, currently being commercialized across Europe and in select international markets. These updates aim to enhance customer satisfaction and streamline lab operations. ColoAlert is a highly...Read more
Definitive agreement sells out the 10mL SoloGard production capacity at Sharps’ manufacturing site in the EU and drives expansion to support the project’s growth in the future Sharps’ portfolio of products provides attractive options to the U.S. Pharmaceutical Healthcare Industry as companies look for alternatives to Chinese-manufactured disposable syringes Sharps has exceeded the product sales commitments for the EU-based facility...Read more
Expands AI/ML driven offering to include novel oncology biomarker discovery to predict patient outcomes and drug response in oncology Biomarker discovery market estimated by third party research to be $51.5 billion in 2024 PITTSBURGH, July 25, 2024 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), a leader in AI-driven drug discovery and biologics, today announced that it is expanding its AI/ML driven drug discovery...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
Fast Track is designed to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need Fast Track designation for Tonmya recognizes fibromyalgia as a serious condition impacting more than 10 million U.S. adults NDA submission on track for second half 2024 Tonmya has the potential to be the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., July 25, 2024 (GLOBE...Read more
WARRINGTON, Pa., July 25, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced an update of istaroxime in both clinical and business development. Istaroxime is a novel first-in-class therapy that is designed to improve systolic contraction and diastolic...Read more
Indus Group Consumes Approximately 450 Million Pounds of Cotton Annually for the Manufacture of Apparel, Footwear, and Accessories for Global Brands and Retailers STONY BROOK, NY / ACCESSWIRE / July 25, 2024 / Applied DNA Sciences, Inc. (NASDAQ:APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, today announced the signing of a five-year license and commercialization agreement for its CertainT®...Read more
Confirmation of oral bioavailability and significant brain exposure in rodent models supports expedited development of EB-003, with Investigational New Drug (IND) filing and first patient dosed expected in 2025 CAMBRIDGE, Mass. / Jul 25, 2024 / Business Wire / Enveric Biosciences (NASDAQ: ENVB) (“Enveric”), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders,...Read more
WESTON, Fla., July 25, 2024 (GLOBE NEWSWIRE) -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA, or “ZyVersa”), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, announces that obesity and its related metabolic complications has been selected as the lead indication for Inflammasome ASC Inhibitor IC 100. “Obesity, a well-established risk factor for an array of...Read more
Southlake, TX, July 25, 2024 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that the MyoVista® wavECGTM has been selected by the Innovation Value Institute as a technology which can...Read more
60 Degrees Pharmaceuticals has been awarded a contract with the United States Army Medical Materiel Development Activity to facilitate commercial validation of new bottle and replacement blister packaging of ARAKODA® (tafenoquine), the Company’s FDA-approved product indicated for malaria prevention Anticipating increasing ARAKODA sales volume in 2024, the Company increased the commercial batch size of ARAKODA in Q1 2024 Q1 2024...Read more
HOUSTON, TX / ACCESSWIRE / July 25, 2024 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced that its abstract has been selected for poster presentation at the 2024 SNO/ASCO CNS Cancer Conference being held August 8-10, 2024 in Denver, CO. Details of...Read more
BRANFORD, Conn. / Jul 25, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR) (the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the closing of its previously announced public offering of 16,667,000 shares of common stock, at a public offering price of $0.30 per share. Total gross proceeds from the offering, before deducting underwriting...Read more
Lease agreement for new CenterWell Senior Primary Care and Conviva Care Centers locations will provide convenient primary care services designed especially for seniors. LOUISVILLE, Ky. / Jul 24, 2024 / Business Wire / CenterWell, the health care services business of Humana Inc. (NYSE: HUM), today announced plans to lease clinical space and open senior-focused primary care centers at 23 Walmart Supercenter retail stores in Florida,...Read more
IRVINE, Calif. / Jul 24, 2024 / Business Wire / Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended June 30, 2024. Highlights and Outlook Q2 sales grew 7%; constant currency1 sales grew 8% Q2 TAVR sales grew 5%; constant currency1 sales grew 6% Q2 TMTT sales grew 75%; increasing contribution to Edwards' growth Q2 EPS of $0.61; adjusted1 EPS of $0.70 Significant TAVR and TMTT clinical evidence to be...Read more
IRVINE, Calif. / Jul 24, 2024 / Business Wire / Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic regurgitation (AR), a...Read more
Highlights Net business wins in the quarter of $2,579 million, an increase of 6.6% on quarter two 2023. Reflects a net book to bill in the quarter of 1.22, and a trailing twelve month net book to bill of 1.24. Closing backlog of $23.8 billion, an increase of 2.0% on quarter one 2024 and 9.9% on quarter two 2023. Quarter two revenue of $2,120.2 million representing an increase of 4.9% on prior year revenue and 5.3% on a constant...Read more
Reaffirms Full Year 2024 Earnings Guidance LONG BEACH, Calif. / Jul 24, 2024 / Business Wire / Molina Healthcare, Inc. (NYSE: MOH) (the “Company”) today reported second quarter 2024 GAAP earnings per diluted share of $5.17 and adjusted earnings per diluted share of $5.86. Financial results are summarized below: Three months ended Six months ended June 30, June...Read more
Now Approved for Children of All Ages with CLN2 Batten Disease, Regardless of Whether They Yet Show Symptoms SAN RAFAEL, Calif., July 24, 2024 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application (sBLA) for BRINEURA® (cerliponase alfa) to slow the loss of ambulation in children of all ages with...Read more
Consolidated Results of Operations, As Reported and As Adjusted – Three-month periods ended June 30, 2024 and 2023: KING OF PRUSSIA, Pa., July 24, 2024 /PRNewswire/ -- Universal Health Services, Inc. (NYSE: UHS) announced today that its reported net income attributable to UHS was $289.2 million, or $4.26 per diluted share, during the second quarter of 2024, as compared to $171.3 million, or $2.42 per diluted share, during the...Read more
Agreement establishes Charles River as the preferred partner for Autobahn Labs, leveraging drug discovery and development capabilities to accelerate the translation of academic discoveries into novel therapeutics Under the agreement, Charles River will make an equity investment in Autobahn Labs Justin Bryans, Chief Scientific Officer, Discovery at Charles River, named to Autobahn’s Board of Directors WILMINGTON, Mass. & SAN...Read more
CINCINNATI / Jul 24, 2024 / Business Wire / Chemed Corporation (Chemed) (NYSE: CHE), which operates VITAS Healthcare Corporation (VITAS), one of the nation’s largest providers of end-of-life care, and Roto-Rooter, the nation’s largest commercial and residential plumbing and drain cleaning services provider, reported financial results for its second quarter ended June 30, 2024, versus the comparable prior-year period. Changes to Non-GAAP...Read more
Conference call scheduled for 4:30 p.m. ET today VK2735 to Advance to Phase 3 for Obesity; End-of-Phase 2 Meeting Planned for 2H24 Oral VK2735 Phase 2 Study in Obesity Expected to Begin 4Q24 Positive Biopsy Results From VK2809 Reported in June; End-of-Phase 2 Meeting in NASH/MASH Planned for 4Q24 Enrollment Completed in Phase 1b Study of VK0214 for X-ALD; Data Expected 2H24 In Vivo Data From Novel Amylin Agonist Program Reported at...Read more
Second Quarter Revenues of $399.1 Million Net Sales of Proprietary Products Increased Approximately 16% Year-Over-Year GAAP Net Income from Continuing Operations of $94.7 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.55 Company Reiterates 2024 Financial Expectations DUBLIN, July 24, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the...Read more
NOVATO, Calif., July 24, 2024 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) today announced that the company will share the latest clinical data, regulatory progress and program next steps for GTX-102, its investigational antisense oligonucleotide for Angelman syndrome, on Wednesday, July 24, at the 2024 Angelman Syndrome Foundation (ASF) Family Conference and Research Symposium in Sandusky, Ohio. “Since our positive...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., July 24, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced that the first patient has been dosed in the Company’s phase 3 trial evaluating the efficacy and safety of petosemtamab, a Biclonics® targeting EGFR and LGR5,...Read more
BATON ROUGE, La., July 24, 2024 (GLOBE NEWSWIRE) -- Amedisys, Inc. (NASDAQ: AMED) today reported its financial results for the three and six-month periods ended June 30, 2024. Three-Month Periods Ended June 30, 2024 and 2023 Net service revenue increased $38.2 million to $591.2 million compared to $553.0 million in 2023. Net income attributable to Amedisys, Inc. of $32.3 million, which is inclusive of merger-related...Read more
CORAL GABLES, Fla., July 24, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that it has entered into a License, Supply, and Commercialization Agreement with Kye Pharmaceuticals Inc., ("Kye"...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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Immix Biopharma is a clinical-stage biopharmaceutical company pioneering a novel class of CAR-T cell therapies and Tissue-Specific Therapeutics targeting oncology and immuno-dysregulated diseases with >75 patients treated to-date. Our lead cell therapy asset is NXC-201...
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