GENEVA, SWITZERLAND / ACCESSWIRE / September 18, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that it has completed dosing in its proof-of-concept clinical study of RLF-OD032 for the treatment of phenylketonuria (PKU), a rare inherited...Read more
Daiichi Sankyo and Merck’s patritumab deruxtecan demonstrates a statistically significant progression-free survival improvement in this EGFR-mutated non-small cell lung cancer population with high unmet need following prior EGFR TKI treatment Discussions with global regulatory authorities to be initiated BASKING RIDGE, N.J. & RAHWAY, N.J. / Sep 17, 2024 / Business Wire / The HERTHENA-Lung02 phase 3 trial evaluating patritumab...Read more
Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,2 Kisqali® (ribociclib) significantly reduced the risk of recurrence by 25% vs. endocrine therapy (ET) alone; consistent benefit and a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial, including patients with...Read more
BREA, Calif. and TEL AVIV, Israel, Sept. 17, 2024 /PRNewswire/ -- Beckman Coulter, a clinical diagnostics leader, and Scopio Labs, a medtech company that develops digital cell morphology workflow solutions, today jointly announced expansion of its long-term partnership to include a global distribution agreement of Scopio's Full-Field Bone Marrow Aspirate™ (FF-BMA) Application. Scopio's X100 / X100HT with FF-BMA Application are...Read more
Portage, Michigan, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Stryker (NYSE: SYK), announced that it has completed the previously announced acquisition of care.ai, a privately held company specializing in delivering AI-assisted virtual care workflows, smart room technology and ambient intelligence solutions. “We welcome the care.ai team to Stryker and look forward to working together to accelerate our digital vision to provide customers with...Read more
MARLBOROUGH, Mass., Sept. 17, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the indication for current-generation INGEVITY™+ Pacing Leads – thin wires placed inside the heart and connected to an implantable device – to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single- or dual-chamber...Read more
SPIKEVAX® is the first updated COVID-19 vaccine authorized in Canada for 2024-2025, offering a timely solution to help protect Canadians this fall and winter season. Moderna will promptly begin delivery of updated COVID-19 vaccines to the Public Health Agency of Canada, so there is robust supply available in time for provincial and territorial vaccination campaigns. CAMBRIDGE, MA / ACCESSWIRE / September 17, 2024 / Moderna Inc...Read more
MELBOURNE, Australia, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as a commercial radiopharmaceutical distributor to supply finished unit doses of its PET1 agent, Zircaix®2 (TLX250-CDx) for the imaging of kidney cancer in the United States (U.S.), subject to regulatory approval. In preparation for a...Read more
As part of the DanubeNeuro program, Charles River and CEBINA will accelerate innovative approaches to treating neurodegenerative diseases WILMINGTON, Mass. & VIENNA / Sep 17, 2024 / Business Wire / Charles River Laboratories International, Inc. (NYSE: CRL) and CEBINA GmbH, Central European Biotech Incubator and Accelerator, today announced a strategic collaboration within the acceleration program DanubeNeuro, an initiative focused...Read more
Asset acquisition of Cook Medical’s end-to-end lead management product portfolio strengthens Merit’s existing electrophysiology and CRM business Asset acquisition projected to add approximately $40 million of revenue, on an annualized basis beginning in fiscal year 2025, with a solid growth profile serving an underpenetrated global lead management market Merit reaffirms full-year 2024 financial guidance previously issued on August...Read more
Breakthrough Therapy Designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoint(s) BridgeBio will leverage the benefits of Breakthrough Therapy Designation to expedite the development and regulatory review of infigratinib in the United States and...Read more
LOS ANGELES, Sept. 17, 2024 (GLOBE NEWSWIRE) -- RadNet, Inc. (NASDAQ: RDNT), a national leader in providing high-quality, cost-effective diagnostic imaging services through a network of fully-owned and operated outpatient imaging centers, today announced that Mark Stolper, Executive Vice President and Chief Financial Officer, will be presenting at the Sidoti & Company Small Cap 2024 Virtual Conference on Wednesday, September 18th at...Read more
DUBLIN, Sept. 17, 2024 /PRNewswire/ -- Perrigo Company plc ("Perrigo" or the "Company") (NYSE: PRGO) today announced the closing of a registered public offering by Perrigo Finance Unlimited Company, an indirect wholly-owned finance subsidiary of Perrigo (the "Issuer"), of $715 million aggregate principal amount of the Issuer's 6.125% Senior Notes due 2032 (the "USD Notes") and €350 million aggregate principal amount of the...Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Sept. 17, 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 the acceptance of an abstract on petosemtamab, a Biclonics® targeting EGFR and LGR5, in previously treated (2L+) patients with recurrent/metastatic head and...Read more
Late-breaking oral presentation will discuss the potential of ZL-1503 as a novel treatment for moderate-to-severe atopic dermatitis and other diseases involving the IL-13 and IL-31 pathways ZL-1503 is part of Zai Lab’s internally discovered and developed global pipeline SHANGHAI & CAMBRIDGE, Mass. / Sep 17, 2024 / Business Wire / Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688; “Zai Lab”) today announced that data from a preclinical...Read more
CRANBURY, N.J. / Sep 17, 2024 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that all patients have been enrolled in the global, pivotal Phase 2 clinical trial evaluating RP-A501 to treat male patients with Danon disease. After the two-patient safety run-in,...Read more
TORONTO, Sept. 17, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for oral, once-daily PrORLADEYO® (berotralstat), which is approved in Canada for the routine prevention of attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older. “Providing access to a...Read more
SAN DIEGO, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced the appointment of Michael Vasconcelles, M.D., to its Board of Directors. Dr. Vasconcelles is an accomplished biopharmaceutical executive with more than 25 years of oncology drug development experience and industry...Read more
Phase 1 clinical trial is designed to assess the safety, pharmacokinetics and initial clinical activity of CLN-978 for patients with systemic lupus erythematosus The trial will be conducted in multiple sites in Australia as well as other countries around the world CAMBRIDGE, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic...Read more
URMC increased ultrasound charge capture by 116% following system-wide deployment of Butterfly Network devices and Compass™ workflow software. URMC’s implementation results published on September 16, 2024 in the Journal of Clinical Imaging Science. BURLINGTON, Mass. & NEW YORK / Sep 17, 2024 / Business Wire / Butterfly Network, Inc. (“Butterfly”, “the Company”) (NYSE: BFLY), a digital health company transforming care through the...Read more
Protein large language model (LLM) designed to help enterprises accelerate drug development coming to Google Cloud's Vertex AI Model Garden soon; one of the first-of-its-kind in the industry Model API programmable interface now available for individual scientists and researchers to quickly test and advance work BOSTON, Sept. 17, 2024 /PRNewswire/ -- Ginkgo Bioworks Holdings, Inc. (NYSE: DNA), which is building the leading platform...Read more
Eversense 365 cleared in the U.S. as an integrated continuous glucose monitoring (iCGM) system for people with diabetes With a single sensor, the Eversense 365 system provides one year of use, versus 10-14 days with short-term CGM’s for minimal life disruption Launch expected early in the fourth quarter of 2024 GERMANTOWN, Md. and PARSIPPANY, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American:...Read more
PLYMOUTH MEETING, Pa., Sept. 17, 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 it will present at the following scientific conference: World Congress of Electroporation Oral Presentation by Trevor Smith, VP of Preclinical R&D at...Read more
Capricor to Receive $15 Million Equity Investment at a 20% Premium, as well as $20 Million Upfront Payment upon Signing Definitive Agreement with up to $715 Million in Potential Milestones and a Double-Digit Percentage of Product Revenue Upfront Payment and Investment Extends Cash Runway into 2026 Potential Milestones from Combined Distribution Agreements Now Total approximately $1.5 Billion Capricor Preparing to Meet with EMA to...Read more
WATERTOWN, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on its ongoing Phase 1 clinical trial of VG-3927. The FDA’s decision was based on a complete response...Read more
BOCA RATON, Fla., Sept. 17, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology and inflammation company, today announced that results of additional analysis of blinded data from its AD02 Phase II Alzheimer's Disease (AD) trial demonstrated exceptional performance of the novel cognitive measure EMACC, as well as highly significant correlation between EMACC and the Clinical...Read more
WAYNE, Pa., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced that the first patient has been dosed in Aclaris' Phase 2a clinical trial of ATI-2138, an investigational oral covalent inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase (JAK) 3, for the...Read more
Treatment with OTX-2002 led to controlled downregulation of MYC gene expression and resulted in significant inhibition of tumor growth as a monotherapy and in combination with standard of care agents in preclinical models of HCC Proof-of-concept data for OTX-2002 support potential of epigenomic controllers to effectively target and modulate expression of nearly any human gene, including historically undruggable targets Data further...Read more
Patient survey currently underway in partnership with the HealthTree Foundation; data expected in Q1 2025 TEL AVIV, Israel and WALTHAM, Mass., Sept. 17, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced the launch of...Read more
San Diego, California--(Newsfile Corp. - September 17, 2024) - Thiogenesis Therapeutics, Corp. (TSXV: TTI) ("Thiogenesis" or the "Company") a clinical-stage biotechnology company developing disulfides that are precursors to thiol-active compounds and potent antioxidants targeting unmet pediatric diseases, today announced that Patrice Rioux, M.D., Ph.D., the Company's Chief Executive Officer, has been invited to present this week at the...Read more
BASKING RIDGE, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced treatment of the first patient in the second-line cholangiocarcinoma (“CCA”) cohort of the BOLSTER trial. This follows the recently announced successful...Read more
DALLAS, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today provided an outline of its regulatory pathway strategy to enter the U.S. market with its flagship DeepView® System for burn indication (“DeepView AI®-Burn”). DeepView AI®-Burn,...Read more
ATH-1105 is an orally delivered, positive modulator of the neurotrophic HGF system that is currently in a Phase 1 clinical trial with completion expected by year end 2024 and commencement of dosing of ALS patients expected in 2025 Company announces cost containment measures in alignment with focus on advancing ATH-1105 BOTHELL, Wash., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a clinical stage...Read more
BRAINTREE, Mass., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic Surgical System, today announced that it has successfully reached the midpoint of the ACCESS-PVI pivotal human clinical trial, enrolling and completing the follow up of 50% of the patients participating in the trial to evaluate the LIBERTY® Endovascular Robotic Surgical System. The Company...Read more
HORSHAM, Pa., Sept. 17, 2024 (GLOBE NEWSWIRE) -- STRATA Skin Sciences, Inc. (“STRATA” or the “Company”) (NASDAQ: SSKN), a medical technology company dedicated to developing, commercializing, and marketing innovative products for the treatment of dermatologic conditions, announces that President and CEO Dr. Dolev Rafaeli will present a corporate overview at the iAccess Alpha - Buyside Best Ideas Fall Conference 2024. The conference is...Read more
Early observations suggest that the vehicle-treated Alzheimer's mice exhibit a larger population of reactive astrocytes, while the HT-ALZ treated groups show fewer reactive astrocytes, pointing to a potential breakthrough in the treatment of Alzheimer's. NEW YORK, Sept. 17, 2024 /PRNewswire/...Read more
VANCOUVER, British Columbia, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies and Variational AI, developer of the Enki™ generative artificial intelligence (AI) platform for drug discovery, announced today a research collaboration aimed at leveraging each company’s expertise to identify and...Read more
SAN DIEGO, Sept. 17, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today announced that management will present at the following virtual investor conferences in September: September 19-20: Life Sciences Investor Forum: James Frakes, Interim Chief Executive Officer and Chief Financial Officer and...Read more
Two patients dosed; several additional patients screened for enrollment Trial to evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer TTX-MC138 is an antisense oligonucleotide conjugated to TransCode’s proprietary TTX delivery system designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers Phase 1 clinical trial follows evidence of delivery and pharmacodynamic activity in prior...Read more
BOULDER, CO / ACCESSWIRE / September 17, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
Ainos Plans To Conduct the Study at National Taiwan University Hospital, a Premier Taiwanese Medical Center for HIV Management The U.S. FDA Have Granted Orphan Drug Designation (ODD) for the Company's VELDONA® Low-Dose Oral Interferon Formulation as a Potential Treatment for Oral Warts in HIV-Positive Patients SAN DIEGO, CA / ACCESSWIRE / September 17, 2024 / Ainos, Inc. (NASDAQ:AIMD) (NASDAQ:AIMDW) ("Ainos" or the "Company"), an...Read more
LOS GATOS, CA / ACCESSWIRE / September 17, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering with certain sacroiliac joint (SI Joint) disorders, today announced the closing of its previously announced "reasonable best efforts" public offering with a single health-care focused institutional investor for the purchase and sale of 1,222,850 shares of common stock (or...Read more
Dermata raises approximately $7.8 million in gross proceeds since May 2024 - expected to fund its operations into the second quarter of 2025 SAN DIEGO, CA / ACCESSWIRE / September 17, 2024 / Dermata Therapeutics, Inc. (NASDAQ:DRMA) (NASDAQ:DRMAW) ("Dermata," or the "Company"), a late-stage biotechnology company focused on the treatment of medical and aesthetic skin diseases and conditions, today announcedthe closing of its previously...Read more
TORONTO, Sept. 17, 2024 /CNW/ - Newtopia Inc. ("Newtopia" or the "Company") (TSXV: NEWU) (OTCQB: NEWUF), a tech-enabled habit change provider focused on preventing, slowing, and reversing chronic disease, is pleased to announce the expansion of its long-standing partnership with a global apparel leader for GLP-1 support. The expansion will make available Newtopia's proven GLP-1 Ally & Sustain programs to all employees and spouses...Read more
WEST PALM BEACH, FL, Sept. 17, 2024 (GLOBE NEWSWIRE) -- QHSLab, Inc. (the "Company") (OTCQB: USAQ), a leader in digital health and point-of-care technologies designed to empower clinicians with proactive, value-based healthcare solutions, today shared exciting updates on its Research & Development (R&D) activities, and patient outcomes for the year to date. The Company continues advancing healthcare technology by integrating...Read more
TAR-200 plus cetrelimab effective in reducing tumor size in those with muscle-invasive disease, potentially improving surgical outcomes and lowering risk of recurrence BARCELONA, Spain, Sept. 16, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today interim data from the ongoing Phase 2 SunRISe-4 study showing neoadjuvant treatment with investigational TAR-200 plus cetrelimab (CET) achieved nearly double the...Read more
Longest survival follow-up ever reported for a Phase III immunotherapy trial in this setting WILMINGTON, Del. / Sep 16, 2024 / Business Wire / Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) plus IMJUDO® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not...Read more
Company planning for every eligible baby in the US to have access to BEYFORTUS New BEYFORTUS filling line approved by the U.S. Food and Drug Administration (FDA) to expand manufacturing capacity and help meet demand 2 out of 3 babies get respiratory syncytial virus (RSV) disease1 BRIDGEWATER, N.J., Sept. 16, 2024 /PRNewswire/ -- Sanofi is shipping BEYFORTUS (nirsevimab-alip) 50mg and 100mg Injection doses in the US to private...Read more
Vatroslav Mateljic's innovative approach and commitment to transforming the lives of patients will strengthen Takeda's leadership position in the Canadian biopharmaceutical sector TORONTO, Sept. 16, 2024 /CNW/ - Takeda Canada Inc. ("Takeda Canada") is pleased to announce the appointment of Vatroslav (Vatro) Mateljic as its new General Manager to lead the Canadian operations of Japan's largest pharmaceutical...Read more
Two Oral Presentations Featured Updated Ivonescimab Data from Phase II Studies in CRC and TNBC in Addition to Poster Presentation on HNSCC Encouraging Phase II Data Supports the Continuing Expansion of the Clinical Development of Ivonescimab Outside of Metastatic Non-Small Cell Lung Cancer MIAMI / Sep 16, 2024 / Business Wire / Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for the...Read more
Signatera now has >85 peer-reviewed publications with clinical validation across multiple cancer types and indications AUSTIN, Texas / Sep 16, 2024 / Business Wire / Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today announced the simultaneous publication of three peer-reviewed papers, crossing a milestone of more than 85 peer-reviewed publications on Signatera. This...Read more
Data presented show sensitivities of 88% for colorectal cancer and 31% for advanced precancerous lesions at 90% specificity Scientific insights reflect Exact Sciences’ commitment to closing the screening gap through innovation Results shared alongside evidence supporting multi-cancer early detection approach MADISON, Wis. / Sep 16, 2024 / Business Wire / Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and...Read more
ST. PAUL, Minn., Sept. 16, 2024 /PRNewswire/ -- ScaleReady and Bio-Techne Corporation (NASDAQ: TECH) today announced the launch of the G-Rex optimized ProPakTM GMP Cytokines, ideally tailored to high efficiency closed system cell and gene-modified cell therapy (CGT) manufacturing. The ProPakTM GMP Cytokine product consists of a weldable bag filled with liquid formulated GMP-grade cytokines, specifically interleukin-7 (IL-7) or...Read more
Veteran biopharmaceutical executive from GSK and Eli Lilly brings more than 30 years of experience to Sarepta’s Board CAMBRIDGE, Mass. / Sep 16, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the appointment of Deirdre P. Connelly to its Board of Directors. Ms. Connelly is a well-regarded executive with more than 30 years of experience in the...Read more
TransCon CNP demonstrated AGV superior to placebo with LS mean treatment difference of 1.49 cm/year at Week 52 (p<0.0001) For children aged 5-11 years TransCon CNP demonstrated a change from baseline AGV superior to placebo with LS mean treatment difference of 1.78 cm/year at Week 52 (p<0.0001) Other endpoints supportive that TransCon CNP may provide benefits beyond linear growth TransCon CNP was generally well-tolerated, with...Read more
Cabozantinib continues to demonstrate a significant improvement in progression-free survival versus placebo in patients with advanced neuroendocrine tumors, including across key subgroups Findings were the basis for the supplemental New Drug Application filed with the U.S. Food and Drug Administration for cabozantinib for advanced neuroendocrine tumors ALAMEDA, Calif. / Sep 16, 2024 / Business Wire / Exelixis, Inc....Read more
Latest computer assisted vacuum thrombectomy (CAVT) technologies combine superior catheter design with the latest dual clot detection computer algorithms designed to restore blood flow quickly Lightning Flash™ 2.0 will be the most advanced thrombectomy system on the European market to address venous and pulmonary thrombus Lightning Bolt™ 7 is designed to enhance the ability to rapidly remove blood clots in the arteries with modulated...Read more
Phase 2 updated results for zanidatamab in HER2-positive mGEA included a confirmed objective response rate (cORR) of 84%, duration of response (DoR) of 18.7 months, median progression-free survival (mPFS) of 15.2 months and a Kaplan-Meier–estimated overall survival (OS) of 59% at 30 months DUBLIN, Sept. 16, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced updated data, including median...Read more
CAMBRIDGE, Mass., Sept. 16, 2024 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced that it has commenced an underwritten public offering of $350.0 million of its shares of Class A common stock. All shares are being offered by Nuvalent. The offering is subject to market and other...Read more
SOUTH JORDAN, Utah, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of healthcare technology, today announced positive 6-month findings from the randomized arteriovenous (AV) fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were shown at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) during a FIRST@CIRSE...Read more
HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European...Read more
REDWOOD CITY, Calif., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that management will present at the 2024 Cantor Global Healthcare Conference on Tuesday, September 17, 2024, at 8:00 AM Eastern Time. A live audio webcast and replay of the presentation will be available in...Read more
Strengthens Rare Disease segment as largest driver of future growth, adding approximately $105 million in 2024 revenue on a pro forma basis Adds two durable commercial assets ILUVIEN® and YUTIQ® with significant growth potential, expanding ANI’s foothold in strategic therapeutic area of ophthalmology Anticipated to drive high single-digit to low double-digit accretion in adjusted non-GAAP EPS in 2025 and to be substantially accretive...Read more
TCER® IMA401 is a novel, next-generation, half-life extended bispecific T cell engager directed against an HLA-A*02-presented peptide derived from MAGEA4 and MAGEA8 with high target copy numbers on various solid cancers Data from the first-in-human Phase 1 dose escalation trial demonstrate initial anti-tumor activity and a manageable tolerability profile for TCER® IMA401 monotherapy; patient population includes 35 heavily pre-treated...Read more
CAMBRIDGE, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE). “We are...Read more
DENVER, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InnovAge Holding Corp. (“InnovAge”) (Nasdaq: INNV), a leading Program of All-inclusive Care for the Elderly (PACE) provider, has been selected as a research partner for a national study exploring how to prevent falls by seniors. This September’s National PACE Awareness Month and Falls Prevention Month observances emphasize the impact of this timely and critical work aimed at reducing dangerous...Read more
FRANKLIN, Tenn. / Sep 16, 2024 / Business Wire / Northwest Urgent Care, LLC, a Tucson, Arizona, subsidiary of Community Health Systems, Inc. (NYSE: CYH), has signed an agreement to acquire 10 Arizona urgent care centers from Carbon Health. Northwest Urgent Care, LLC is part of Northwest Healthcare’s integrated healthcare network serving Tucson and its surrounding communities. This strategic acquisition will expand capacity and increase...Read more
Once issued, this patent provides U.S. intellectual property coverage of UroGen’s RTGel® technology with medac lyophilized mitomycin formulation, covering UGN-103 and UGN-104 development programs until December 2041 PRINCETON, N.J. / Sep 16, 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...Read more
ROCKVILLE, Md. and SOUTH SAN FRANCISCO, Calif., Sept. 15, 2024 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, and Kamau Therapeutics, a clinical-stage stem cell therapy gene correction company,...Read more
Global registrational strategy in first-line non-squamous and squamous non-small cell lung cancer (NSCLC) Global registrational strategy in first-line triple-negative breast cancer (TNBC) Initiation of Phase 1b/2 IMM2510/SYN-2510 + chemotherapy combination in first-line NSCLC anticipated in late 2024 in China Initiation of Phase 1b/2 IMM2510/SYN-2510 + chemotherapy combination in first-line TNBC anticipated in early 2025 in China US...Read more
Results continue to demonstrate the importance of ultra-sensitive ctDNA detection in lung cancer and immunotherapy FREMONT, Calif. / Sep 16, 2024 / Business Wire / Personalis, Inc. (Nasdaq: PSNL), a leader in MRD testing, announced findings presented this week at the European Society of Medical Oncology Congress (ESMO) Congress 2024 in Barcelona, Spain. Personalis’ NeXT Personal assay was designed to detect and monitor residual and...Read more
Partnership leverages Korro’s proprietary OPERATM platform to enable its oligonucleotide-directed RNA edits into two undisclosed targets; initially for cardiometabolic diseases Total deal value of up to $530 million in upfront, development, and commercial milestone payments, in addition to tiered royalties and R&D funding CAMBRIDGE, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a...Read more
LEXINGTON, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to advancing neurogenetic medicines, today announced that the joint steering committee with its collaborator Neurocrine Biosciences, Inc. has selected a development candidate in a gene therapy program for the potential treatment of an undisclosed neurological disease. The candidate leverages an intravenously...Read more
MINNEAPOLIS, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Tactile Systems Technology, Inc. (“Tactile Medical”; the “Company”) (Nasdaq: TCMD), a medical technology company providing therapies for people with chronic disorders, today announced that the Pricing, Data Analysis, and Coding (PDAC) contractor for the Centers for Medicare & Medicaid Services (CMS) has approved the use of Healthcare Common Procedure Coding System (HCPCS) code E0651 for...Read more
FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1; new clinical data from the study will be presented at the 21st International Myeloma Society Annual Meeting this month RMAT designation recognizes potential of P-BCMA-ALLO1 to address significant unmet needs of multiple myeloma patients and enables increased dialogue with FDA throughout the development process SAN DIEGO,...Read more
Results delivered in prestigious Proffered Paper oral presentation at ESMO Congress 2024 In patients with any PD-L1 expression (CPS ≥1), efti in combination with KEYTRUDA outperformance is largest in CPS ≥20 with 31.0% ORR (34.5% ORR including partial response after data cut-off) versus 18.5% ORR for KEYTRUDA Efti in combination with KEYTRUDA led to a high durability of response of 17.5 months in patients with any PD-L1 expression and...Read more
SAN DIEGO, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on studies of azenosertib, the Company’s novel, selective, and...Read more
Warner Biddle Appointed as Chief Executive Officer and to Board of Directors, Bringing Over 30 Years of Commercial, Product Planning and Franchise Leadership Experience, Including Successful Launches for CAR T Pioneer in Hematology Christi Shaw, Life Sciences Leader at Multiple Major Pharmaceutical and Biotech Companies and Across Therapeutic Areas, Appointed to Board of Directors Together Strengthen Leadership as Trailblazers of...Read more
QUEENSBURY, N.Y. / Sep 16, 2024 / Business Wire / Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on liver-directed cancer therapies, today announced the presentation of new subgroup analysis data from the FOCUS Phase 3 trial of HEPZATO KIT™ (melphalan/Hepatic Delivery System (HDS)) in patients with metastatic uveal melanoma (mUM). The data were presented by Dr. Matthew Wheater from University Hospital...Read more
Vancouver, British Columbia--(Newsfile Corp. - September 16, 2024) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, announced today that Daniel Mikol, MD, Ph.D., NervGen's Chief Medical Officer, will present at the 63rd International Spinal Cord Society (ISCoS) Annual Scientific Meeting, taking place on September...Read more
Educational event for physicians by physicians; participants heard from an esteemed panel of experts, innovators, and guest speakers Global medtech leaders, Siemens Healthineers and Cook Medical, shared their common vision with Profound of creating a total diagnostic and interventional MR solution for prostate disease TORONTO, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or...Read more
WATERTOWN, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced that management will participate in a fireside chat at the Cantor Global Healthcare Conference on Thursday, September 19, 2024, at 9:45 a.m. ET. To register for the live webcast, please click...Read more
Median Overall Survival remains at 30 months; Objective Response Rate of 36% and Disease Control Rate of 77% 11/53 (21%) of patients experienced 90-100% tumor shrinkage VERSATILE-003 Phase 3 clinical trial planned to begin this year PRINCETON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the...Read more
WALTHAM, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the presentation of longer-term data from its pivotal trial of cosibelimab, its anti-programmed death ligand-1 (“PD-L1”) antibody, in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”) during the European Society for Medical...Read more
Confirmed partial responses (PRs) doubled to four since ASCO GI in MSS CRC patients without liver and peritoneal metastases for overall response rate (ORR) of 24% (4/17) with ADG126 10 mg/kg every three weeks (Q3W) in combination with pembrolizumab Median progression-free survival of 8.5 months observed in patients without liver and peritoneal metastases at the ADG126 10 mg/kg Q3W dose At the 10 mg/kg dose level, 12-month...Read more
A key aspect of Parkinson’s disease (PD) pathophysiology is decreased systemic regulatory T cell (Treg) function with associated neuroinflammation in the nigrostriatal pathway of the brain, including the presence of reactive astrocytes and microglia that have an initiating and progressing role in PD; Subcutaneous injection of COYA 302, an anti-inflammatory, Treg-enhancing combination biologic (comprising low dose interleukin-2 and CTLA-4...Read more
FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, presented final data on Dublin-3 study (2L/3L EGFR wild-type NSCLC) focusing on safety outcomes on September 14, 2024 at European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Full data on Dublin-3 study...Read more
FLORHAM PARK, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage global biopharmaceutical company developing innovative cancer therapies, today presented interim phase 2 data on the 303 Study, a study in 2L/3L non-small cell lung cancer (NSCLC) after disease progression on 1L PD-1/L1 inhibitors with and without chemotherapy, with financial support from Merck &...Read more
Expanded Phase 1 monotherapy study of givastomig, a Claudin 18.2 X 4-1BB bispecific antibody immunostimulant, shows promising single-agent activity in heavily pre-treated patients with gastric cancers expressing Claudin 18.2 at low and high levels The recommended Phase 2 dose for givastomig was determined to be 8-12 mg/kg; givastomig was well tolerated up to the highest study doses A Phase 1b study, evaluating givastomig in...Read more
An ongoing complete response (CR) with an overall response rate (ORR) of 32% achieved across two dosing regimens Underscores ozuriftamab vedotin’s activity in a high unmet need SCCHN patient population The conditionally binding ADC targeting ROR2 was notably well tolerated The Company intends to meet with the FDA to discuss a SCCHN potential registrational trial in 2H 2024 SAN DIEGO, Sept. 16, 2024 (GLOBE NEWSWIRE) -- BioAtla,...Read more
5-year survival rate of 82.6% and 73% reduction in overall risk of death (hazard ratio of 0.27) are the strongest Multikine efficacy results reported to date, reflecting results in patients who met the CEL-SCI confirmatory Registration Study target population criteria and were deemed at low risk for recurrence, therefore not recommended per NCCN guidelines to receive chemotherapy post-surgery Data provide further evidence that the...Read more
PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch anticipated in H1 2025, if approved TEL AVIV, Israel and MIAMI, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket...Read more
Growing Portfolio of Patents Further Advances the Company’s Mission to Develop Fully Implanted Devices for Those Suffering from Significant Hearing Loss WHITE BEAR LAKE, Minnesota, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a hearing health company focused on fully implanted hearing systems, today announces it has been awarded another patent from the US Patent & Trademark Office...Read more
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - September 16, 2024) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has been informed by medac, licensor of Medexus's commercialization rights to treosulfan, that the US Food and Drug Administration has extended the review period for the New Drug Application for treosulfan by three months. The FDA has set a new PDUFA target action date of January 30, 2025. The FDA notified...Read more
Interim safety and biomarker data from the upliFT-D trial in FTD-GRN demonstrated that Dose 1 of PBFT02 achieved robust levels of CSF progranulin in all treated Cohort 1 patients; elevated CSF progranulin levels were sustained up to 12 months post-treatment Dose 1 of PBFT02 continued to be well-tolerated in all patients who received a revised immunosuppression regimen Company to deliver the updated data during a poster presentation at...Read more
LEXINGTON, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its FDA-cleared T2Candida® Panel for pediatric patients. The Company expects to immediately begin marketing and selling the T2Candida Panel...Read more
Of the 20 evaluable ovarian cancer patients, there were 5 PRs Of the 43 evaluable ICI-naïve MSS/MSI-L CRC patients without liver metastasis, there were 3 PRs Biomarker data support proposed mechanism of action of NC410 BELTSVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class...Read more
LOS ALTOS, Calif., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company" or “Unicycive”), today announced that Shalabh Gupta, M.D., Chief Executive Officer will present a corporate update at the Virtual Life Sciences Investor Forum on Thursday, September 19, 2024 at 2:00 p.m. ET in New York, NY. A...Read more
Liquid nitrogen- (LN2) based ProSense® found to have favorable safety compared to argon-based cryoablation systems, as well as being more cost effective and easier to manage Independent study conducted at the European Institute of Oncology (IEO) demonstrates interventional radiology use cases for ProSense® for indications that are approved in various markets across the world CAESAREA, Israel, Sept. 16, 2024 /PRNewswire/ -- IceCure...Read more
MALVERN, Pa., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced enhancements to its NeuroStar Advanced Therapy and proprietary TrakStar® patient data management software, introducing a range of new features aimed at improving patient...Read more
CHICAGO, IL / ACCESSWIRE / September 16, 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 entered into an extension of its existing...Read more
11 out of 16 patients had objective clinical responses, equaling a 69% Overall Response Rate 15 out of the 16 patients had a reduction of their tumors (target lesions) 79% of EVX-01’s vaccine targets triggered a targeted immune response, which compares very favorably to what is seen with other approaches A positive correlation was observed between the AI-Immunology™ platform predictions and neoantigen immune response...Read more
BEIJING, Sept. 16, 2024 /PRNewswire/ -- Concord Medical Services Holdings Limited ("Concord Medical" or the "Company") (NYSE: CCM), a healthcare provider specialized in cancer treatment, research, education and prevention in China, today announced that Guangzhou Concord Cancer Center ("Guangzhou Hospital"), a PRC subsidiary of the Company offering comprehensive cancer care services, has obtained the large medical equipment...Read more
Achieves $5.3 Million First Quarter Revenue, Reaches Milestone Developing Antibodies End-to-End Using LENSai VICTORIA, British Columbia / Sep 16, 2024 / Business Wire / IMMUNOPRECISE ANTIBODIES LTD. (the “Company” or “IPA”) (NASDAQ: IPA), an artificial intelligence-driven biotherapeutic research and technology company, today reported financial results for the first quarter of its 2025 fiscal year (“FY25”), which ended July 31, 2024....Read more
FOSTER CITY, Calif., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced today a poster presentation at the 2024 European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024 in Barcelona, Spain. “We...Read more
Study will aim to establish safety and clinical efficacy PETACH TIKVA, Israel, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced that it received approval from the Israeli Ministry of Health (MoH) to conduct Phase IIa clinical trial with...Read more
LONDON, Sept. 16, 2024 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on the detection of immune responses and diagnosis of viral diseases, today announced that it has entered into an extension of its already existing exclusive distribution agreement with Cosmos Health Inc. (Nasdaq: COSM) ("Cosmos") to commercialize Mpox Virus Real-Time PCR Detection Kits...Read more
SAN FRANCISCO, CA / ACCESSWIRE / September 16, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that Lisa Conte, the company's founder, president and CEO, will present in person on September 19, 2024 at the MedInvest Biotech & Pharma Investor Conference and participate in one-on-one meetings at the event, which is taking place September 18-19 in New York City. Participation Instructions for Jaguar Health's Presentation...Read more
Innovative drug treatment developed in collaboration with SciSparc aims to enhance safety and efficacy in mental health and addiction care Vancouver, Canada, Sept. 16, 2024 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems,...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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Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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