Core Insights - Aclaris Therapeutics is entering a transformative multi-year period with significant milestones expected in 2025 and 2026, focusing on immuno-inflammatory diseases [2] - The company has extended its expected cash runway through the first half of 2028, allowing for continued execution of its clinical programs [2][11] - Aclaris has received positive Phase 2 results from its Chinese partner CTTQ, indicating enhanced potency of its investigational drug bosakitug (ATI-045) [3][5] - The U.S. FDA has cleared the Investigational New Drug (IND) application for ATI-052, a bispecific antibody, paving the way for its clinical trials [7] Pipeline Developments - Bosakitug (ATI-045) is an investigational anti-TSLP monoclonal antibody, with plans to initiate a placebo-controlled Phase 2 trial in atopic dermatitis (AD) in Q2 2025 [5] - ATI-2138, an oral ITK/JAK3 inhibitor, is also set for new clinical trials, with top-line results from a Phase 2a trial in AD expected in June 2025 [6] - Aclaris intends to seek partnerships for the global development of bosakitug in respiratory indications, while maintaining focus on dermatological applications [5] Financial Performance - For Q1 2025, Aclaris reported a net loss of $15.1 million, an improvement from a loss of $16.9 million in Q1 2024 [12] - Total revenue for Q1 2025 was $1.5 million, down from $2.4 million in the same period last year, primarily due to a decrease in royalty payments [12] - Research and development expenses increased to $11.6 million in Q1 2025, driven by costs associated with the bosakitug program [13] Corporate Updates - Aclaris has appointed Dr. Jesse W. Hall as Chief Medical Officer, bringing extensive experience in drug development [10] - The company is exploring additional non-dilutive financing opportunities following the lifting of an injunction against Sun Pharmaceuticals, which may provide a financial asset for monetization [11]

--Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 -- --Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 -- --With positive Phase 2b QUALITY study, Veru plans for end of Phase 2 meeting with FDA to discuss Phase 3 clinical program -- --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical ...

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 ...

NEW YORK, May 2, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in May: May 3-6: Digestive Disease Week (DDW). Two abstracts discussing Immunic's phase 1/1b clinical trial of IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 ...

Blueprint Medicines (BPMC) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Company Participants Jenna Cohen - Vice President of Investor Relations and Global Business CommunicationsKate Haviland - President & CEOPhilina Lee - Chief Commercial OfficerBecker Hewes - Chief Medical OfficerMike Landsittel - Chief Financial OfficerLaura Prendergast - Vice PresidentChristina Rossi - Chief Operating OfficerPaul Jeng - Vice PresidentMichael Yee - Managing DirectorMark Aleynick - Biotechnology Equity ResearchReni Benj ...

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [3] - The Phase 2b QUALITY clinical trial demonstrated a statistically significant 71% relative reduction in lean mass loss for patients receiving enobosarm combined with semaglutide compared to placebo [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass [5] - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [6] - The median total body weight loss in the enobosarm + semaglutide group was 90.6% fat loss compared to 68% in the placebo + semaglutide group, indicating a shift towards greater fat loss [6] Physical Function and Safety - The Stair Climb Test indicated that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline [8] - Safety data for the Phase 2b QUALITY study remains blinded, with no significant differences noted compared to previous studies of enobosarm [9] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, with a safety database consisting of 266 dosed patients [13] - A Phase 2 dose-finding proof of concept study is planned to assess the drug's efficacy in reducing inflammation associated with coronary artery disease [15]

Blueprint Medicines (BPMC) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 Good morning. My name is Angela Lang, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Blueprint Medicines' First Q twenty twenty five Earnings Release and 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 Thank you. Jenna Cohen, you may begin your conference. Speaker1 Thank you, ...

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 ...

Company Overview - Avalo Therapeutics, Inc. is a clinical stage biotechnology company focused on the treatment of immune dysregulation [3] - The company's lead asset is AVTX-009, an anti-IL-1β monoclonal antibody targeting inflammatory diseases [3] Product Information - AVTX-009 is a humanized monoclonal antibody (IgG4) that binds to interleukin-1β (IL-1β) with high affinity and neutralizes its activity [4] - IL-1β is a central driver in the inflammatory process, and its overproduction is implicated in many autoimmune and inflammatory diseases [4] - Inhibition of IL-1β could be effective in treating conditions such as hidradenitis suppurativa and various inflammatory diseases in dermatology, gastroenterology, and rheumatology [4] Upcoming Events - Dr. Garry Neil, CEO of Avalo, will present at the Citizens Life Sciences Conference in New York on May 8, 2025, at 3:00 pm ET [1]

Xencor (XNCR) Update / Briefing April 29, 2025 05:00 PM ET Speaker0 Welcome to today's R and D call hosted by Xencor. At this time, all participants are in a listen only mode. After the speakers' presentation, we will conduct a question and answer session. I will now turn the call over to your host, Charles Lyles, Senior Director of Corporate Communications and Investor Relations. Speaker1 Thank you, and good afternoon. Earlier today, we issued a press release announcing positive interim results from our Ph ...