Core Insights - New clinical studies demonstrate the efficacy and safety of Sarclisa administered subcutaneously via an on-body injector (OBI) for relapsed or refractory multiple myeloma (R/R MM) [1][7][10] - The studies presented at the ASCO Annual Meeting show that the OBI method offers non-inferior efficacy compared to traditional intravenous (IV) administration [1][5][10] Study Details - The IRAKLIA phase 3 study is a pivotal non-inferiority trial comparing Sarclisa SC via OBI with Sarclisa IV, both combined with pomalidomide and dexamethasone in adult patients with R/R MM [5][17] - The study reported an overall response rate (ORR) of 71.1% for Sarclisa SC-Pd versus 70.5% for Sarclisa IV-Pd, establishing non-inferiority [8] - The safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower incidence of systemic infusion reactions (1.5% vs. 25%) [9][13] Patient Experience - The OBI is designed to enhance patient comfort and satisfaction, with 70% of patients preferring the OBI over manual injection [13][14] - Patient satisfaction scores were significantly higher for the OBI method, with 74.5% of patients expressing a preference for it [14][15] Future Directions - Sanofi is exploring further applications of Sarclisa SC via OBI in various treatment settings, including front-line therapy for newly diagnosed multiple myeloma patients [15][20] - Data from the IRAKLIA and IZALCO studies will support global regulatory submissions for the OBI delivery method [7][15]

Group 1 - Maxim Group has initiated coverage of CROSSJECT with a BUY recommendation and a target price of €4.00 [2] - The CROSSJECT share price was €1.77 on the date of the research report issuance, May 29, 2025 [3] - CROSSJECT is in advanced regulatory development for ZEPIZURE®, an epileptic rescue therapy, supported by a $60 million contract with BARDA [5][6] Group 2 - CROSSJECT specializes in developing emergency medicines using its needle-free auto-injector ZENEO® platform [5] - The company aims to provide solutions for allergic shocks, adrenal insufficiencies, and other emergency indications [5] - Patrick Alexandre, CEO of CROSSJECT, expressed excitement about the endorsement from Maxim Group and the potential for further developments in the North American market [4]

Press Release CROSSJECT’s ZENEO® needle-free auto-injector consistently matches depth of traditional intramuscular injections and exceeds the standards needle length of currently utilized auto-injectors Injection depth with ZENEO® matches that of 30-mm conventional intramuscular needles, out-performs length of needles imbedded in commercially available needle-based auto-injectors.ZENEO® further demonstrates commercial adoption potential by eliminating usage errors and mimicking traditional intramuscular inj ...

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Jackie Cossmon - ConsultantEric Schlorff - CEOTim Varacek - SVP - Commercial & Business OperationsKevin Chung - Chief Medical OfficerDavid Green - CFONicholas Sherwood - Equity Research Associate Operator Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Con ...

SeaStar Medical Holding (ICU) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the SeaStar Medical First Quarter Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Thank you. I would now like to turn the call over to Jackie K ...

US Physical Therapy (USPH) Q1 2025 Earnings Call May 08, 2025 10:30 AM ET Company Participants Christopher Reading - Chairman & CEOJason Curtis - SVP - Finance & AccountingCarey Hendrickson - Chief Financial OfficerBenjamin Rossi - Equity Research AssociateEric Williams - President & COOJared Haase - Equity Research AssociateConstantine Davides - Managing DirectorMichael Petusky - Managing Director Conference Call Participants Joanna Gajuk - Equity Research AnalystBrian Tanquilut - Equity Research Analyst - ...

Core Viewpoint - BioPorto A/S is set to present its financial results for Q1 2025 during a webcast on May 8, 2025, highlighting its focus on early detection of Acute Kidney Injury (AKI) [1] Company Overview - BioPorto A/S specializes in in vitro diagnostics aimed at improving early detection of AKI, utilizing actionable biomarkers to enhance patient management [2][3] - The company leverages its expertise in antibodies and assay development to create innovative products addressing significant unmet medical needs [2] Product Information - The flagship products of BioPorto are based on the NGAL biomarker, which aids in the risk assessment and diagnosis of AKI, a condition that can lead to severe health consequences if not treated promptly [3] - NGAL tests allow for quicker identification of patients at risk of AKI compared to standard care measurements, facilitating earlier interventions and tailored management strategies [3] Company Facilities and Stock Information - BioPorto operates facilities in Copenhagen, Denmark, and Boston, MA, USA, and is listed on the Nasdaq Copenhagen stock exchange [4]

For more information, visit bioratherapeutics.com or follow the company on LinkedIn. Emerges as a privately held company, with long-term financing to accelerate development of the BioJet™ platform SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Biora Therapeutics, a biotech company developing the first swallowable autoinjector, today announced the successful completion of its court-supervised restructuring. Through the restructuring process, Biora achieved an improved balance sheet with deleveraged debt and s ...

Core Insights - Oragenics, Inc. has submitted its Investigator's Brochure (IB) application for the Phase II clinical trial of ONP-002, a novel intranasal neurosteroid aimed at treating mild traumatic brain injury (mTBI) [1][5] - The Phase II study will assess the feasibility, safety, tolerability, and pharmacokinetics of ONP-002 in mTBI patients, with a focus on cognitive and visual motor testing [2][6] Company Overview - Oragenics is a biotechnology company focused on developing nasal delivery systems for pharmaceutical treatments in neurology and infectious diseases, including therapies for mTBI and Niemann Pick Disease Type C [7] Clinical Trial Details - The Phase II trial is randomized, double-blind, and placebo-controlled, enrolling 40 participants, with 20 receiving ONP-002 and 20 receiving a placebo [6] - Participants will receive nine doses over five days, with the first dose administered within 12 hours of injury [6] Medical Context - Mild TBI, or concussion, is a common form of head trauma with no FDA-approved drug therapies currently available, indicating a significant unmet medical need [4]