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Based upon observed efficacy and safety profile, Praxis intends to engage with the FDA in an end of Phase 2 meeting and initiate a ulixacaltamide Phase 3 study for the treatment of essential tremor in 2H23 Ulixacaltamide demonstrated improvement in modified Activities of Daily Living (mADL) primary efficacy endpoint relative to placebo that did not…
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Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–IgGenix, Inc., a pre-clinical antibody discovery and development company taking a revolutionary approach to directly address allergic disease, recently presented insights into the potential for IgE antibody re-engineering in shellfish allergy. These data, generated using IgGenix’s novel patented SEQ SIFTER™ single-cell RNA-sequencing discovery platform, were presented…
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Excerpt from the Press Release: EMERYVILLE, Calif. & SINGAPORE–(BUSINESS WIRE)–Biotechnology company Triplebar and cultivated seafood platform company Umami Meats are partnering to co-develop optimized cell lines suitable for large-scale production of cultivated seafood – starting with one of the most popular and critically endangered fish species. Emeryville, Calif.-based Triplebar and Singapore-headquartered Umami Meats signed a…
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For 2023, we’re taking our blog in a new direction with more content directly from our team, more detailed information for our readers answering common questions we get, and helpful expert information and ideas you can use. We hope you enjoy this new approach. For this week, we’re covering an introduction (or refresher) to TrialStat…
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NTLA-2002 is a single dose, in vivo genome editing candidate designed to prevent potentially life-threatening swelling attacks in people with HAE Excerpt from the Press Release: CAMBRIDGE, Mass., March 02, 2023 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced…
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-Combined company to be named Flamingo Therapeutics, focused on advancing Flamingo’s asset danvatirsen in a Phase II trial PEMDA-HN in Head & Neck cancer and IND-ready program targeting MALAT-1 (FTX-001), in oncology- -Merger leverages common synergies of Flamingo and Dynacure, including deep expertise in RNA-targeting and clinical drug development- Excerpt from the Press Release: LEUVEN,…
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Results showed an absolute difference of an additional 7.4 months in median overall survival for LYNPARZA® (olaparib) plus abiraterone in this setting vs. abiraterone alone Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed LYNPARZA®…
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Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 16, 2023 (GLOBE NEWSWIRE) — Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, presented clinical data from VBP101, its Phase 1/2a multicenter, open-label, first-in-human study of trem-cel (previously VOR33) in patients with acute myeloid leukemia (AML). In the first patient, trem-cel maintained hematopoiesis through three…
Read More Excerpt from the Press Release: PHILADELPHIA–(BUSINESS WIRE)–Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, today announced that the first patient has been dosed in the global Phase 2 FORTE clinical trial evaluating FORE8394 with cobicistat in patients with solid or central nervous…
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Over 49 weeks of DNL310 (ETV:IDS) treatment in the Phase 1/2 study, positive changes across measures of exploratory clinical outcomes including VABS-II (adaptive behavior) and BSID-III (cognitive capabilities) scores and global impression scales were observed Interim Phase 1/2 data also suggest that DNL310 improves hearing, as assessed by auditory brainstem response testing Additional biomarker data…
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