—Preparations for the Nebokitug PSC Phase 3 Clinical Trial Advance as Discussions with Potential Strategic Partners Continue— —Achieves FDA Alignment on CMC and Non-Clinical Toxicology Regulatory Path for Nebokitug in PSC— FDA fully approved therapy; the risk that the full data set from the nebokitug study or data generated in further clinical trials of nebokitug may not be consistent with the results of the nebokitug Phase 2 PSC trial; failure to obtain, or delays in obtaining, regulatory approvals for neb ...

MIAMI, June 11, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced the appointment of Dr. James Lee to its scientific advisory board (SAB) to help guide development of PAS-004 for the treatment of ETS2 pathway inflammatory diseases including inflammatory bowel disease (IBD), ulcerative colitis, Crohn’s disease, primary sclerosing cholangitis ...

Spyre Therapeutics Inc (SYRE) FY Conference June 09, 2025 09:20 AM ET Speaker0 Thank you for joining us. I'm Paul Choi, and I cover biotechnology here at the firm. It's our pleasure to welcome Spire, and we have Cameron here on on stage with us. Maybe to to kick it off, Cameron, can just give us a brief overview of Spire and just sort of the key programs and technologies under pending pending the company? Yeah. Speaker1 Of course. And so and thanks for having us. It's a great event as always. So the backgro ...

Verona Pharma (VRNA) 2025 Conference June 04, 2025 11:05 AM ET Speaker0 We're gonna get started with the next session. I'm Andrew Tsai, senior biotech analyst at Jefferies, and it's my pleasure to have the Verona team with me. To my direct left, Chris Martin, CCO, and to his left, David Zaccardale, President and CEO. Welcome both of you. Thanks, Andrew. Thanks. Maybe spend one or two minutes talking about the Verona story. I think a lot of people are familiar, but there are still people unfamiliar with your ...

Company Overview - Upstream Bio, Inc. is a clinical-stage biotechnology company focused on developing treatments for inflammatory diseases, particularly severe respiratory disorders [3] - The company is advancing a monoclonal antibody named verekitug, which targets the receptor for thymic stromal lymphopoietin, a key cytokine involved in inflammatory responses [3] - Verekitug is currently in separate Phase 2 trials for severe asthma and chronic rhinosinusitis with nasal polyps, with plans to initiate development for chronic obstructive pulmonary disease [3] Upcoming Events - Rand Sutherland, MD, CEO of Upstream Bio, will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 11, 2025, at 9:20 a.m. ET [1] - A live webcast of the event will be available on the company's website, with a replay posted afterward [2]

Core Viewpoint - Chemomab Therapeutics has secured new patent protections for its lead product nebokitug in China and Russia, enhancing its intellectual property portfolio and positioning for future commercialization in the treatment of primary sclerosing cholangitis (PSC) [1][2][3] Patent Protections - The State Intellectual Property Office of China issued Patent No. ZL 2018 8 0018207.8, which protects the use of nebokitug in hepatic diseases, including PSC, with coverage extending to 2038 [2] - The Federal Service for Intellectual Property of Russia granted RU Patent 2022125176, which covers various formulations and doses of nebokitug, providing protection until 2041 [3] Clinical Development and Regulatory Pathway - Positive data from the Phase 2 SPRING trial of nebokitug has established a promising clinical profile for treating PSC, which is a debilitating disease with no effective treatments [2] - The FDA has outlined a clear pathway for regulatory approval of nebokitug in PSC, which is significant for the company's future plans [2] - Chemomab is preparing for a potential Phase 3 registrational trial for nebokitug in PSC, following the positive results from earlier trials [6] Company Overview - Chemomab Therapeutics is a clinical-stage biotechnology company focused on developing innovative therapeutics for fibro-inflammatory diseases, with nebokitug being a first-in-class dual activity monoclonal antibody targeting CCL24 [6] - The company has reported positive results from four clinical trials of nebokitug, demonstrating a favorable safety profile and potential for treating severe fibro-inflammatory diseases [6]

Core Viewpoint - Abivax SA reported its financial results for the first quarter of 2025, highlighting a decrease in total operating income and an increase in operating loss, primarily driven by rising research and development expenses [2][3][7]. Financial Highlights - Total operating income for Q1 2025 was €1.0 million, down from €1.2 million in Q1 2024, reflecting a decrease of €0.2 million [3][7]. - Total operating expenses increased, with research and development costs rising to €39.3 million from €35.7 million, an increase of €3.6 million [3][7]. - The operating loss for the quarter was €47.2 million, compared to €44.7 million in the same period last year, marking an increase of €2.5 million [3][7]. - The net loss for the period was €52.4 million, up from €42.9 million in Q1 2024, indicating a rise of €9.5 million [3][7]. Balance Sheet Overview - As of March 31, 2025, the net financial position was €18.5 million, a decrease of €34.9 million from €53.4 million at the end of 2024 [3][5]. - Cash and cash equivalents stood at €103.6 million, down from €144.2 million at the end of 2024, reflecting a decrease of €40.6 million [5][7]. - Total assets decreased to €166.9 million from €205.2 million, a reduction of €38.3 million [5]. Research and Development Focus - R&D expenses increased significantly, with a €3.0 million (736%) rise related to the Crohn's Disease clinical program, driven by the progression of Phase 2b clinical trials for obefazimod [7]. - A €2.7 million (78%) increase in transversal activities was noted, attributed to the expansion of the R&D headcount and new equity awards [7]. - There was a decrease of €1.3 million (-4%) in expenses related to the Ulcerative Colitis clinical program as Phase 3 trials reached full enrollment [7]. Operational Updates - Abivax is focused on developing therapeutics for chronic inflammatory diseases, with its lead drug candidate, obefazimod, currently in Phase 3 clinical trials for ulcerative colitis [2][8]. - The company anticipates being able to finance its operating cash flow requirements into the fourth quarter of 2025 based on current funds and operating assumptions [6].

Core Insights - Aclaris Therapeutics has initiated a Phase 2 trial for bosakitug, an investigational monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), in patients with moderate-to-severe atopic dermatitis (AD) [1][2] - The trial aims to evaluate the efficacy and safety of bosakitug, with top line results expected in the second half of 2026 [1][2] Company Overview - Aclaris Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases [7] - The company has a robust R&D engine and a multi-stage portfolio of product candidates [7] Product Details - Bosakitug (ATI-045) is a humanized anti-TSLP monoclonal antibody that blocks TSLP's interaction with its receptor, preventing the release of proinflammatory cytokines [3] - It exhibits high affinity, potency, and a long residence time, potentially allowing for extended dosing intervals [3] Clinical Trial Information - The Phase 2 trial is randomized, double-blind, and placebo-controlled, involving approximately 90 patients [2] - Primary endpoint is the percent change in Eczema Area and Severity Index (EASI) at week 24, with secondary endpoints including various EASI responses and safety assessments [2] Atopic Dermatitis Context - Atopic dermatitis affects approximately 10 million children and 17 million adults in the U.S., with over 200 million affected worldwide [5] - The condition significantly impacts quality of life, with many patients experiencing moderate to severe symptoms [5] TSLP Significance - TSLP is a key cytokine in the Type 2 immune response, driving inflammation in allergic and inflammatory diseases [4] - It activates downstream targets involved in the inflammatory cascade, making it a relevant therapeutic target [4]

Core Viewpoint - Immunic, Inc. is actively participating in several investor and scientific conferences in June 2025 to present its clinical pipeline and engage with investors [1][3]. Conference Participation - Immunic will present at the Jefferies Healthcare Conference from June 3-5, with CEO Daniel Vitt providing a company overview on June 5 at 4:55 pm ET [1]. - The company will also participate in the 4th RSC Anglo-Nordic Medicinal Chemistry Symposium from June 10-13, where preclinical data on antiviral candidates will be presented [1][3]. - Attendance at the UBS Life Sciences Conference in London is scheduled for June 11, with opportunities for one-on-one meetings [1]. - Immunic's management will engage in partnering activities at the BIO International Convention from June 16-19 in Boston [1]. - The 11th Congress of the European Academy of Neurology will take place from June 21-24 in Helsinki, where data on vidofludimus calcium will be presented [1][3]. - The Accelerating Bio-Innovation Conference will be attended by Dr. Vitt and Mr. Tardio from June 23-25 in Cambridge, MA [1]. Company Overview - Immunic, Inc. focuses on developing orally administered small molecule therapies for chronic inflammatory and autoimmune diseases [3]. - The lead program, vidofludimus calcium (IMU-838), is in phase 3 clinical trials for relapsing multiple sclerosis, with top-line data expected by the end of 2026 [4]. - Vidofludimus calcium acts as a first-in-class nuclear receptor related 1 (Nurr1) activator, providing neuroprotective effects and anti-inflammatory properties [4]. - Other candidates include IMU-856, targeting Sirtuin 6 (SIRT6) for gastrointestinal diseases, and IMU-381, currently in preclinical testing [4].

JENA, Germany, May 28, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced that the Independent Data Monitoring Committee (IDMC) conducting the unblinded interim analysis for the Phase 3 trial for vilobelimab in pyoderma gangrenosum (PG), recommended that the trial be stopped due to futility. This recommendation was based on data analysis of the first 30 patients enrolled in the study, wi ...