Late-breaking abstract featuring IGNYTE clinical trial data, including subgroup and initial biomarker analyses, selected for oral presentation
Data from ARTACUS clinical trial of RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies selected for encore poster presentation WOBURN, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel... Read more
Results from OVATION 2 Study of IMNN-001 to be highlighted in late-breaking acceptance
Company also announces FDA End-of-Phase 2 in-person meeting to discuss Phase 3 trial of IMNN-001
Phase 3 trial is expected to begin in Q1 2025 LAWRENCEVILLE, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in late-stage development with its DNA-mediated immunotherapy, today announced the acceptance of a late-breaking presentation featuring... Read more
Data, including overall survival, from ARC-10, a randomized study evaluating domvanalimab plus zimberelimab in front-line, PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC), will be presented in a late-breaking poster presentation
An oral presentation will highlight data from an Investigator Sponsored Trial for domvanalimab and zimberelimab in anti-PD-1 refractory hepatocellular carcinoma, demonstrating further proof of concept for the Fc-silent... Read more
WALTHAM, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology therapies for people living with cancer, today announced that initial data from its Phase 1C dose escalation of XTX101 (vilastobart) in combination with atezolizumab in patients with advanced solid tumors will be presented in a late-breaker poster session at the Society for Immunotherapy... Read more
NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced positive results demonstrating the anti-inflammatory potential of our anti-CD3 antibody (foralumab) in combination with semaglutide, a GLP-1 agonist marketed... Read more
BRIDGEWATER, NJ / ACCESSWIRE / October 30, 2024 / Tharimmune, Inc. (NASDAQ:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company developing a portfolio of therapeutic candidates in inflammation and immunology, received positive feedback from a Scientific Advice meeting with the European Medicines Agency (EMA) that included guidance on a planned Phase 2 trial to advance TH104, the Company's lead clinical-stage candidate for moderate-to-severe pruritus... Read more
Nes-Ziona, Israel, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the Japanese Patent Office issued a notice of allowance for patent application number 2022-512861 titled “THERAPEUTIC APOPTOTIC CELLS FOR TREATMENT OF OSTEOARTHRITIS”. Once issued, the resulting patent will provide Enlivex with added intellectual property (IP) protection... Read more
CONSHOHOCKEN, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), today announced multiple resmetirom data presentations at the upcoming American Association for the Study of Liver Diseases (AASLD) Liver Meeting, taking place from November 15-19, 2024 in San Diego.
Bill Sibold,... 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, chronic kidney disease (CKD) and... Read more
CAMBRIDGE, Mass. / Oct 30, 2024 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Company will present data from its transthyretin amyloidosis (ATTR) and hypertension programs at the upcoming American Heart Association (AHA) Scientific Sessions 2024, November 16–18, 2024.
Data presentations for the Company’s flagship TTR franchise include new findings from an analysis of the HELIOS-B Phase... Read more
BOSTON / Oct 30, 2024 / Business Wire / Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today announced that it will present interim quality of life results from the ALPHA-STAR trial of navenibart (STAR-0215) at the Canadian Society of Allergy and Clinical Immunology (CSACI) Annual Scientific Meeting in Banff, Alberta, Canada on November 7, 2024.
Adil Adatia, M.D., Assistant... Read more
WILMINGTON, Del. / Oct 30, 2024 / Business Wire / Incyte (Nasdaq: INCY) announced today that it will present at the following investor conferences during the month of November: Guggenheim’s Inaugural Healthcare Innovation Conference on Monday, November 11, 2024 at 2:00 pm (EST)
Jefferies London Healthcare Conference on Tuesday, November 19, 2024 at 9:30 am (GMT) The presentations will be webcast live and can be accessed at Investor.Incyte.com and will be available... Read more
Biomarker cohort for delpacibart braxlosiran (del-brax), the first potential therapy to target DUX4, is measuring changes in DUX4 regulated biomarkers; del-brax 2 mg/kg will be administered every six weeks
Enrollment in the del-brax biomarker cohort expected to be completed in 1H 2025; on track to initiate del-brax functional cohort in 1H 2025
In previously reported initial data, del-brax 2 mg/kg every six weeks showed unprecedented and consistent reductions of DUX4... Read more
Results indicated PMN310 was generally well-tolerated and monthly dosing can provide CSF levels adequate for target engagement
Initiation of Phase 1b clinical trial in Alzheimer’s disease patients planned for year-end 2024 CAMBRIDGE, Massachusetts and TORONTO, Ontario, Oct. 30, 2024 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins... Read more
PRINCETON, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced it will host a virtual key opinion leader (KOL) event on Wednesday, November 20, 2024 at 2:00 PM ET. To register, click here.
The... Read more
After successful SEISMiC A and B studies in Early Cardiogenic Shock, SEISMiC C will treat more severe SCAI Stage C cardiogenic shock to complete the assessment of the intended Phase 3 patient population
Windtree plans to engage with regulatory authorities in 2025 for Transition to Phase 3 clinical trial WARRINGTON, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused... Read more
The clinics are located in favorable locations, are revenue generating and EBITDA positive
Clinics offer a comprehensive range of mental health services
Acquisition is expected to be immediately accretive to revenue and EBITDA for HOPE and NRx MIAMI, Oct. 30, 2024 /PRNewswire/ -- HOPE Therapeutics, Inc., ("HOPE," the "Company"), a medical and technology driven company, and a wholly-owned subsidiary of NRx Pharmaceuticals, Inc. ("NRx") (Nasdaq: NRXP), today announced... Read more
Study done in collaboration with Memorial Sloan Kettering and led by Dr. Winston Wong, Head and Neck Oncologist and Dr. Alan Ho, Chief of the Head and Neck Oncology Service
IIT will evaluate eseba-vec in patients who are HPV16+ after treatment for curative intent
Potential to expand the eseba-vec HNSCC opportunity into adjuvant care
Initial safety and efficacy data from IIT expected in 2026 NEW YORK and VIENNA, Oct. 30, 2024 (GLOBE NEWSWIRE) -- HOOKIPA Pharma Inc.... Read more
Q3 2024 Net Revenue of $11.5 million
Commercializing DefenCath with Four of Top Five US Dialysis Providers
Conference Call Scheduled for Today at 8:30 a.m. Eastern Time BERKELEY HEIGHTS, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the third quarter... Read more
CAPLYTA Q3 2024 net product sales were $175.2 million, compared to $125.8 million for the same period in 2023, representing a 39% increase
CAPLYTA’s strong prescription uptake continues: Q3 2024 CAPLYTA total prescriptions increased 38%, versus the same period in 2023
CAPLYTA 2024 net product sales guidance range raised to $665 to $685 million
Following a successful pre-supplemental NDA (sNDA) meeting with the U.S. Food and Drug Administration (FDA), the... Read more
Ivonescimab Monotherapy Became First Drug to Achieve Clinically Meaningful Benefit over Pembrolizumab Monotherapy in a Phase III Randomized Clinical Trial in NSCLC, HARMONi-2, Reducing Risk of Disease Progression or Death by 49% in First-Line PD-L1 Positive Advanced NSCLC in China
Enrollment Completed in Global Phase III HARMONi Trial in 2L+ EGFRm Advanced NSCLC; Received Fast Track Designation from FDA; Topline Data Expected in Mid-2025
Summit Intends to Expand HARMONi-3... Read more
On track to report topline data from Phase 3 VERITAC-2 trial in 4Q24 or 1Q25
Initial clinical data from Phase 1/2 TACTIVE-U sub-study of abemaciclib in combination with vepdegestrant to be presented at San Antonio Breast Cancer Symposium in December 2024
Recently presented new preclinical data for the PROTAC LRRK2 degrader ARV-102 demonstrating that LRRK2 degradation affects biomarkers in the CSF
$1.1 billion in cash, cash equivalents and marketable... Read more
Achieved $128.2 million in AYVAKIT net product revenues in the third quarter 2024
Raising AYVAKIT net product revenue guidance to $475 million to $480 million for 2024
On track to initiate the registration-enabling HARBOR Part 2 study of elenestinib in ISM by year end CAMBRIDGE, Mass., Oct. 30, 2024 /PRNewswire/ -- Blueprint Medicines Corporation (Nasdaq: BPMC) today reported financial results, provided a business update for the third... Read more
BOSTON / Oct 30, 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, today announced that members of the management team will participate in two upcoming investor conferences. Webcasts of the presentations will be available at https://investors.puretechhealth.com.
UBS Global Healthcare Conference Presenters: Bharatt... Read more
Publication describes the structure of phage Pa193, a top candidate for inclusion into Armata's multi-phage anti-Pseudomonas clinical products LOS ANGELES, Oct. 30, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced... Read more
Statistically significant 100% reduction (p = 0.0027) in new-onset severe respiratory failure and 64.2% reduction (p = 0.0476) in new-onset persistent respiratory failure in combined high and medium dose Auxora patients versus combined low dose Auxora and placebo patients
Statistically significant stratified win ratio of 1.640 (p = 0.0372) for high dose Auxora compared to placebo
Clinically meaningful reduction observed for high dose Auxora patients compared to placebo... Read more
Poster to be presented in a late-breaking abstract session at the Society for Immunotherapy of Cancer (SITC) on Saturday, November 9, 2024 ROCKVILLE, Md., Oct. 30, 2024 /PRNewswire/ -- I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company exclusively focused on the development of highly differentiated immunotherapies for the treatment of cancer, today announced the presentation of a poster highlighting Phase 1 optimized dose estimation... Read more
INGREZZA® (valbenazine) Third Quarter Net Product Sales of $613 Million Representing 26% Year-Over-Year Growth
INGREZZA® (valbenazine) 2024 Net Product Sales Guidance Raised to $2.30 - $2.32 Billion
Board Authorizes $300 Million Share Repurchase Plan SAN DIEGO, Oct. 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the third quarter ended September 30, 2024 and provided an update on its 2024 financial... Read more
BOSTON, Oct. 30, 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 three upcoming poster presentations supporting the combination of bemnifosbuvir and ruzasvir as a potential treatment for Hepatitis C Virus (HCV). The combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor,... Read more
Nomlabofusp program update expected mid-December to include available safety, pharmacokinetic (PK) and frataxin data, as well as available clinical outcomes observations from patients with Friedreich’s ataxia (FA) receiving 25 mg of nomlabofusp daily for 30-180 days in ongoing open label extension (OLE) study
Initiation of PK run-in study in adolescents on track by year-end 2024
Initiation of global confirmatory/registration study planned mid-2025
Biologics License... Read more
LONDON and NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP), a severe ocular condition without an FDA approved therapy, and for inflammatory dry eye disease (DED), a multi-billion-dollar market, is pleased to announce that it will be presenting at the 10th International Tear Film & Ocular Surface Society Conference... Read more
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. / Oct 30, 2024 / Business Wire / United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter ended September 30, 2024. Total revenues in the third quarter of 2024 grew 23 percent year-over-year to $748.9 million, compared to $609.4 million in the third quarter of 2023.
"I’m proud of the close to 1,300 Unitherians who have contributed to yet another... Read more
Vancouver, British Columbia--(Newsfile Corp. - October 30, 2024) - PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE:18H) ("PreveCeutical" or the "Company"), a health sciences company that develops innovative options for preventive and curative therapies utilizing organic and nature-identical products, is pleased to announce that it has signed a definitive agreement on the 29 October, 2024 (the "Agreement") to sell certain intellectual property assets (the "Assets")... Read more
MINNEAPOLIS, Oct. 30, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today reported its financial results for the first quarter ended September 30, 2024.
First Quarter FY2025 Highlights First quarter organic revenue increased by 4% (5% reported) to $289.5 million.
GAAP earnings per share (EPS) was $0.21 versus $0.31 one year ago. Delivered adjusted EPS of $0.42 compared to $0.41 one year ago.
Continued adoption and utilization across the Diagnostics... Read more
Dose-dependent increase in neuroprotective APOE2 expression in all participants with ongoing durability at 12 months
Consistent reductions across CSF tau biomarkers and tau PET in majority of participants
LX1001 well tolerated across all dose cohorts with no reports of amyloid-related imaging abnormalities (ARIA)
Company to host webcast today at 7:00 AM ET NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic... Read more
Scott Koenig, M.D., Ph.D., to step down as President and CEO
Board to initiate search process to identify new CEO ROCKVILLE, MD, Oct. 30, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that Scott Koenig, M.D., Ph.D., intends to step down as President and Chief Executive... Read more
U.S. Food and Drug Administration (FDA) lifted Clinical Hold on COVALENT-111 (Type 2 Diabetes) & COVALENT-112 (Type 1 Diabetes) trials
COVALENT-111 Phase 2b 26-week topline data of the dose expansion cohorts expected in December 2024
COVALENT-112 Phase 2a 26-week topline data of the open label portion expected in December 2024
On track to announce our third clinical candidate, BMF-650, for the treatment of diabetes and obesity – a next-generation, oral small-molecule... Read more
Total Revenues of $539.5 million, Cabozantinib Franchise U.S. Net Product Revenues of $478.1 million
GAAP Diluted EPS of $0.40, Non-GAAP Diluted EPS of $0.47
Increasing Total Revenues and Net Product Revenues Guidance
Favorable Ruling on Cabozantinib Patent Litigation Received from U.S. District Court
Collaboration with Merck Expands Zanzalintinib Development Program
Conference Call and Webcast Today at 5:00 PM Eastern Time ALAMEDA,... Read more
Achieved $11 million in ZURZUVAE® (zuranolone) collaboration revenue during the third quarter of 2024 (50% of the net revenue recorded by Biogen), representing 49% growth from the second quarter
Sage and Biogen will not pursue further development of zuranolone in major depressive disorder (MDD) in the U.S.
Topline data from the DIMENSION Study in Huntington’s Disease (HD) expected late 2024
Cash, cash equivalents and marketable securities of $569 million as of September... Read more
Phase 2a proof-of-concept study of SPR720 for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) did not meet its primary endpoint, based on planned interim analysis of 16 patients
Phase 3 PIVOT-PO trial of tebipenem HBr remains on track for enrollment completion in 2H 2025
Cash runway extended into mid-2026 following a reduction in workforce and restructuring of operations; Unaudited Q3 2024 ending cash balance of $76.3M CAMBRIDGE, Mass., Oct.... Read more
Six months post cessation of treatment with MB22001, the antidepressant response is sustained with an impressive 72% overall reduction in severity of depression with 58% of patients in complete remission from their depression. Vancouver, British Columbia – TheNewswire - 29 October, 2024 – MindBio Therapeutics Corp. (CSE: MBIO); (Frankfurt: WF6), (the “Company” or “MindBio”), is a leading clinical stage biopharmaceutical company in psychiatric medicine... Read more
Results show CT1812 dramatically slowed cognitive decline in patients with lower levels of plasma p-tau217, an important biomarker of Alzheimer’s disease pathology
ADAS-Cog 11 scores showed 95% slowing of decline
MMSE scores showed 108% slowing of decline
Pre-specified analysis from SHINE study presented by Dr. Michael Woodward at CTAD 2024
Company hosting investor webinar on October 30, 2024 to review findings PURCHASE, N.Y., Oct. 29, 2024 (GLOBE NEWSWIRE) --... Read more
It is estimated that 10-15% of people in the United States have IBS SAN FRANCISCO, CA / ACCESSWIRE / October 29, 2024 / Jaguar Health, Inc.(NASDAQ:JAGX) ("Jaguar") family company Napo Pharmaceuticals ("Napo") today announced that the abstracts are now available for two independent investigator-initiated studies of crofelemer, Napo's novel, plant-based oral prescription drug, that show a benefit in patients with chronic refractory diarrhea and are the subject of poster... Read more
Findings offer potential mechanistic and clinical insights in the development of cellular therapy Lomecel-B™ for mild Alzheimer’s disease (AD)
Lomecel-B™ capacity to inhibit MMP14 correlates with improved clinical and biomarker outcomes in mild AD
Immunomodulatory and pro-vascular effects of Lomecel-B™ in mild AD potentially driven by ability to exert MMP14 inhibition which may protect TIE2 receptor integrity in human AD patients MIAMI, Oct.... Read more
HOUSTON, Oct. 29, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 160+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, announced promising new findings from its artificial thymus organoid program. Recent results from the artificial thymus organoid program showed that fibroblasts... Read more
BRANFORD, Conn. / Oct 29, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that the Company will present at BIO-Europe 2024 in Stockholm, Sweden on Monday, November 4, 2024 at 2:30pm CET (8:30am ET).
The corporate update will highlight Azitra’s updates and progress on its pipeline, including ATR-12 in development for Netherton syndrome... Read more
Data from multiple Phase 1b studies in inflammatory skin conditions demonstrate durable dose-dependent improvements in physician-assessed disease activity and patient-reported outcomes
Biomarker analyses demonstrate plurality of Treg-mediated pathways with potential effect on tissue resident memory T cell populations resulting in sustained efficacy seen in the antigen challenged mouse model and in clinical trials SAN FRANCISCO, Oct. 29, 2024 /PRNewswire/... Read more
RMAT Designation Follows Positive Proof-of-Concept Data from the ALLO-316 TRAVERSE Trial in Adult Patients with Advanced or Metastatic CD70 Positive Renal Cell Carcinoma (RCC) Who Received Prior Immune Checkpoint Inhibitor and VEGF-Targeting Therapy
ALLO-316 Advances Scientific Understanding and Applicability of the Dagger® Technology as the Next-Generation Allogeneic Platform to Maximize the Potential of a Single Infusion of an “Off-the-Shelf” CAR T Produ... Read more
PITTSBURGH, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals, Inc. (Nasdaq: LIPO) (“Lipella” or the “Company”), a clinical-stage biotechnology company focused on addressing serious diseases with significant unmet needs, today announced that CEO Jonathan Kaufman, PhD will be presenting at the 2024 Spartan Capital Investor Conference that is being held on November 4, 2024, at the Pierre Hotel in New York.
Event: Lipella Presentation - 2024 Spartan Capital... Read more
FREEHOLD, N.J., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Chromocell Therapeutics Corporation (“Chromocell”, or the “Company”), (NYSE American: CHRO), a pioneer in the development of non-opioid pain treatment therapeutics, today announced the unveiling of its injectable depot program utilizing peripheral nerve blocks for the treatment of post-operative pain. The depot program is based on the Company’s novel NaV1.7 molecule for treating chronic pain and eye pain.
There... Read more
