Vera Therapeutics, Inc. VERA saw its share price surge over 65% during the pre-market trading session on Monday after the company released ORIGIN Phase 3 trial data.Participants treated with atacicept for immunoglobulin A nephropathy (IgAN) achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36.Also Read: Kidney Disease-Foc ...

IBI363 Data Update in ASCO; Clearer Path to Success CITI'S TAKE Innovent updated the data of IBI363 in IO-treated NSCLC, CRC and IO- treated advanced acral and mucosal melanoma at ASCO. IBI363 showed strong efficacy in IO-treated sqNSCLC with an ORR of 43.3% (13/30) (cORR 36.7%) and mPFS of 7.3 mo. We think this data could give investors more confidence in IBI363 beating docetaxel (mPFS ~4 mo and mOS 10- 12 mo) in this setting. IBI363 also showed positive data in 3L/+ MSS/pMMR CRC, with an ORR of 23.5% (16/ ...

UroGen Pharma (URGN) FY Conference May 28, 2025 09:00 AM ET Speaker0 Morning, everyone. I'm Tara Bancroft. I'm one of the senior biotech analysts at TD Cowen. I wanna thank you very much for joining our sixth annual oncology innovation summit. And so to start off the day, in the first session, we have a q and a with UroGen, and it's my pleasure to introduce Liz Barrett, the president and CEO, and Mark Schoenberg, the CMO. So it's a privilege to have you both here. Thank you. Thank you for being here with us ...

CHAMBERS GLOBAL PRACTICE GUIDES Life Sciences 2025 Definitive global law guides offering comparative analysis from top-ranked lawyers China: Law & Practice Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang Global Law Office CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang Global Law Office Contents 1. Life Sciences Regulatory Framework p.6 2. Clinical Trials p.7 3. Marketing Authorisations for Pharmaceuticals or Medical Devices p.10 4. Regulatory Reliance and Fast Tra ...

May 23, 2025 04:34 AM GMT China Healthcare | Asia Pacific CSPC (+): 1) SYS6010 (EGFR ADC) in combo with SYH2051 (Ph1) showed preliminary efficacy for 2L advanced gastrointestinal cancers - mPFS of 5.8 mo in 6 gastric cancer and 4.2 mo in 9 KRAS-wt colorectal cancer pts (data not mature). G3+ TRAE rate of 48% is consistent with earlier AACR data (note), and compares favorably to Biokin's BL-B01D1. In addition, for 2L EGFRm NSCLC treatment, sac- TMT showed cORR of 45.1% and HER3-DXd showed ORR of 35.2%, which ...

Core Viewpoint - ANI Pharmaceuticals, Inc. has initiated a Phase 4 clinical trial to evaluate the safety and efficacy of two dose levels of Purified Cortrophin Gel for treating acute gout flares, marking a significant step in the company's commitment to building scientific evidence for this therapy [1][3]. Company Overview - ANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company focused on developing, manufacturing, and commercializing innovative therapeutics, particularly in rare diseases, ophthalmology, rheumatology, nephrology, neurology, and pulmonology [11]. Clinical Trial Details - The Phase 4 trial will compare two dose levels (40 USP units and 80 USP units) of Cortrophin Gel in a randomized, double-blind study involving up to 160 patients, aiming to enroll 70 evaluable patients per dose group [4][5]. - The primary endpoint is the change in gout pain intensity from baseline at day 3 post-administration, measured by Visual Analog Scale (VAS) [5]. Expert Involvement - Dr. Hyon Choi, a leading physician investigator with extensive experience in gout research, will conduct the trial, emphasizing the need for effective treatments for patients who do not respond adequately to conventional therapies [2][3]. Product Background - Cortrophin Gel is the only ACTH therapy approved by the FDA for acute gout flares and is indicated for short-term administration as an adjunctive therapy during acute episodes [1][7]. - The product has seen steady growth since the launch of a 1-mL vial in October 2023, aimed at increasing access for in-office treatment [3].

Financial Data and Key Metrics Changes - The company is focused on executing the clinical development plan for NurOwn and has received FDA clearance to initiate a pivotal Phase 3b trial for ALS [6][10] - Financial constraints have been acknowledged, but the company has made significant strides in trial preparations despite limited resources [13][25] Business Line Data and Key Metrics Changes - The NurOwn technology platform is central to the company's strategy, with ongoing clinical trials aimed at demonstrating its therapeutic benefits [6][12] - The company is actively negotiating clinical trial agreements with approximately 15 leading clinical centers across the U.S. for the Phase 3b trial [10][25] Market Data and Key Metrics Changes - The ALS community's strong interest in NurOwn is highlighted by the engagement of renowned ALS clinicians and researchers [10] - The company participated in the annual ALF Drug Development Summit, indicating its active involvement in the ALS therapeutic development landscape [12] Company Strategy and Development Direction - The company aims to secure strategic funding to support the trial, with a focus on partnerships and non-dilutive grants [14][26] - Expansion of manufacturing capabilities in the U.S. is a key strategic objective, with plans to announce a letter of intent with a U.S.-based facility [30] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgency for innovative therapeutic options in ALS and the commitment to executing the trial with scientific rigor [11][12] - The company is optimistic about the potential of NurOwn and is preparing for various funding opportunities to ensure timely trial commencement [14][26] Other Important Information - The trial, named "Endurance," is designed to resonate with the ALS community, reflecting the strength and resilience of ALS patients [27] - The company is encouraged by progress in its exosome program, which shows potential in treating respiratory and inflammatory diseases [34] Q&A Session Summary Question: Can you start the trial without proper funding? - Management stated that while significant progress has been made, proper funding is essential to commence the trial [25][26] Question: What is the meaning of the trial name "Endurance"? - The name was chosen to resonate with the ALS community and reflects the company's commitment to delivering a therapeutic option for ALS [27] Question: Will the company also be producing in the U.S.? - The company confirmed plans to expand its manufacturing footprint in the U.S. and will announce a letter of intent with a U.S.-based facility [30] Question: Can you update on any advances in the exosome program? - Management expressed encouragement regarding the exosome program's progress and is preparing to advance it towards clinical development [34] Question: Have you had any communications with FDA regarding stratification by UNC13A? - Management indicated that while the FDA has not approved any biomarker as a surrogate, they are excited about the genetic discoveries and will explore them further [39][40] Question: Can the mechanism of action be used as part of the data package for the next BLA? - Management confirmed that the protective effect observed in cell cultures could support the data package for future filings [43] Question: How many clinical trial sites are you looking to open? - Management confirmed plans to open approximately 15 clinical trial sites and is finalizing agreements to begin patient enrollment [48][50]

BiomX Inc. (NYSE:PHGE) Q1 2025 Earnings Conference Call May 15, 2025 2:00 PM ET Company Participants Marina Wolfson - CFO Jonathan Solomon - CEO Conference Call Participants Joe Pantginis - H.C. Wainwright Yale Jen - Laidlaw & Company Operator Greetings and welcome to the BiomX First Quarter 2025 Financial Results Conference Call. At this time, all participants are in a listen-only mode. The question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference ...

Belite Bio (BLTE) Conference May 15, 2025 12:30 PM ET Speaker0 Hello, and welcome to the Deutsche Bank Depository Seats Virtual Investor Conference, DBVIK. I'm Zafra Ziz from the Deutsche Bank team. I'm pleased to announce our next presentation will be from Elote Bio. Before I introduce our speaker, a few points to note. Please submit your questions in the questions box. Also, all of those presentations will be recorded and can be accessed by the Deutsche Bank website, adr.db.com. At this point, I'm very pl ...

Belite Bio (BLTE) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Company Participants Julie Fallon - Managing DirectorYu-Hsin Lin - Chairman of the Board of Directors & CEONathan L. Mata - Chief Scientific OfficerHendrik Scholl - CMOHao-Yuan Chuang - CFO & DirectorBasma Radwan - Vice PresidentJennifer Kim - Equity Research Director Conference Call Participants Yi Chen - Managing Director & Senior AnalystBruce Jackson - Senior AnalystMichael Okunewitch - Senior Biotechnology Analyst Julie Fallon Hello and th ...