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 ...

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 ...

Cardiol Therapeutics to Webcast Virtual Annual General Meeting of Shareholders on May 28th at 4:30 p.m. EDTMay 27, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc.Toronto, Ontario--(Newsfile Corp. - May 27, 2025) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the Company's virtual Annual General M ...

JENA, Germany, May 22, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that the Company will participate in multiple investor conferences in June and July 2025. Jefferies Global Healthcare ConferenceJune 3 - 5, 2025 in New York, NY InflaRx will conduct an investor presentation on June 4th at 7:35 AM ET and will participate in one-on-one investor meetings. A link to register for the ...

Announces successful completion of sub-chronic and chronic toxicology studies for INF904, supporting long-term dosing in future clinical trialsMultiple near-term catalysts anticipated with the potential to substantially de-risk the Company's pipeline addressing multiple sizable marketsInterim analysis for vilobelimab Phase 3 trial in pyoderma gangrenosum (PG), to determine trial size adaptation or futility, remains on schedule with a recommendation expected to be announced at the end of May to early JuneTop ...

JENA, Germany, April 30, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it will report its first quarter 2025 financial and operating results on May 7, 2025, before the market opens. No conference call is planned. About InflaRx InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR tec ...

Cardiol Therapeutics Nominates Dr. Timothy Garnett to Its Board of Directors April 29, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc. Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ("US FDA") to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of th ...

Core Insights - BioVie Inc. has initiated patient enrollment for the Phase 2 SUNRISE-PD clinical trial, which evaluates the safety and efficacy of bezisterim in patients with Parkinson's disease who have not been treated with carbidopa/levodopa, with topline data expected in late 2024 or early 2025 [2][4][7] Company Overview - BioVie Inc. is a clinical-stage company focused on developing innovative drug therapies for neurological and neurodegenerative disorders, including Parkinson's disease, Alzheimer's disease, and long COVID [14][15] - Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer and anti-inflammatory drug candidate that may provide clinical improvements in various disease indications [11][14] Clinical Trial Details - The SUNRISE-PD trial is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study designed to last 20 weeks, with approximately 60 patients randomized to receive either 20 mg of bezisterim or placebo twice daily [4][5] - The trial incorporates a decentralized approach, allowing patients to participate remotely, which broadens access for individuals with Parkinson's disease [4][6][7] Disease Context - Parkinson's disease is characterized by the loss of dopamine-producing neurons, leading to motor and non-motor symptoms, with current treatments primarily providing symptomatic relief without modifying disease progression [3][8][9] - Emerging research indicates that chronic inflammation and insulin resistance play critical roles in the onset and progression of Parkinson's disease, suggesting that targeting these mechanisms may offer new therapeutic avenues [10][12] Support and Collaboration - Patient enrollment for the SUNRISE-PD trial is supported by prominent advocacy groups, including The Michael J. Fox Foundation, Davis Phinney Foundation, and The Parkinson's Foundation, emphasizing the importance of increased patient access to clinical trials [2][7][6]

Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent PericarditisApril 16, 2025 7:27 AM EDT | Source: Cardiol Therapeutics Inc.Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago.Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Ap ...

Core Insights - Santhera Pharmaceuticals has made significant progress in the commercial rollout of AGAMREE® for the treatment of Duchenne Muscular Dystrophy (DMD), with funding from NHS England now available for prescribing in England [1][2] - AGAMREE has received positive final guidance from NICE, and initial sales have already been achieved in Scotland and Wales [1][2] - Kye Pharmaceuticals, a sub-licensee of Catalyst Pharmaceuticals, has received acceptance from Health Canada for AGAMREE's New Drug Submission with Priority Review, potentially leading to its approval as the first treatment for DMD in Canada by the end of 2025 [2] Product Overview - AGAMREE (vamorolone) is a novel drug that binds to the same receptor as glucocorticoids but modifies its downstream activity, positioning it as a dissociative anti-inflammatory drug and an alternative to existing corticosteroids [3][7] - The pivotal VISION-DMD study demonstrated that AGAMREE met the primary endpoint of Time to Stand (TTSTAND) velocity versus placebo (p=0.002) at 24 weeks, with a good safety and tolerability profile [4][5] - Unlike corticosteroids, AGAMREE shows no restriction of growth and has no negative effects on bone metabolism, as indicated by normal serum markers for bone formation and resorption [5] Company Background - Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on developing and commercializing innovative medicines for rare neuromuscular diseases with high unmet medical needs [7] - The company holds an exclusive license for AGAMREE for all indications worldwide and has out-licensed rights for North America to Catalyst Pharmaceuticals and for China and certain Southeast Asian countries to Sperogenix Therapeutics [7][9]