Industry News

Agios Announces Publication of Phase 2 Data in The Lancet Demonstrating Safety and Efficacy of PYRUKYND® (mitapivat) in Non-transfusion-dependent α- and β-Thalassemia

08/16/2022

– In Adults with Non-transfusion-dependent α- or β-Thalassemia, PYRUKYND® Induced ≥1.0 g/dL Hemoglobin Increase from Baseline in 16 of 20 (80%) Patients Between Weeks 4-12 – – PYRUKYND® Safety Profile Consistent with Label for FDA-approved Indication in Pyruvate Kinase Deficiency – – Actively Enrolling Phase 3 ENERGIZE and ENERGIZE-T Studies Evaluating PYRUKYND® in Adults with Non-transfusion-dependent and Transfusion-dependent α-…

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Regen BioPharma, Inc. Develops Novel Dedifferentiation Approach for Increasing Efficacy of CAR-T Cells to Treat Solid Tumor

08/16/2022

Company Creates “Younger T Cells” for Fighting Cancer Using its NR2F6 Technology Excerpt from the Press Release: SAN DIEGO, Aug. 11, 2022 /PRNewswire/ — Regen BioPharma, Inc. (OTC PINK: RGBP) (OTC PINK: RGBPP) announced today the filing  with the United States Patent and Trademark Office  of a provisional US patent application covering the Company’s novel approach for…

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Satsuma Pharmaceuticals Announces Completion of Enrollment in SUMMIT Pivotal Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine

08/15/2022

– More than 1,400 subjects randomized –– Satsuma expects to announce topline SUMMIT trial results in Q4 2022 – Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the…

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Orca Bio Announces the Precision-T Phase 3 Study is Open and Enrolling Patients at Transplant Centers Across the U.S.

08/15/2022

– The pivotal Precision-T Study is evaluating the safety and efficacy of Orca Bio’s investigational Orca-T compared to standard of care allogeneic hematopoietic stem cell transplant – – Precision-T is expected to enroll approximately 174 patients across more than 20 clinical trial sites – Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Orca Bio, a late-stage…

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InterVenn Biosciences Announces Start of Enrollment in Colonoscopy Study

08/15/2022

Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–InterVenn® Biosciences, a clinical technology company leveraging glycoproteomics to transform the future of healthcare, today announced the start of enrollment in its prospective cohort study for early detection of colorectal cancer and adenomas. This confirmatory Noninvasive Identification of Colorectal Cancer and Adenomas in Early Stages– better known as…

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Avalo Therapeutics Announces First Patient Dosed in the AVTX-803 Pivotal Trial (LADDER) for the Treatment of Leukocyte Adhesion Deficiency Type II (LAD II)

08/12/2022

Topline Pivotal trial results expected 1H2023 Excerpt from the Press Release: WAYNE, Pa. and ROCKVILLE, Md., Aug. 02, 2022 (GLOBE NEWSWIRE) — Avalo Therapeutics, Inc. (Nasdaq: AVTX), announced the first patient has been dosed in the pivotal LADDER trial (A Phase 3, Randomized, Double-blind, Two-period, Crossover, Withdrawal Study to Assess the Efficacy and Safety of…

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NeuroSense Joins EverythingALS Open Innovation Consortium; Set to Enroll US and EU Patients in Phase IIb Study

08/12/2022

– NeuroSense’s support will aid EverythingALS with ground-breaking patient research in a joint effort to develop treatments – NeuroSense’s CEO to present at EverythingALS’s Expert Talk Series on August 3, 2022; To listen to Mr. Ben-Noon’s Excerpt from the Press Release: LOS ALTOS, Calif. and CAMBRIDGE, Mass., Aug. 2, 2022 /PRNewswire/ — EverythingALS, a patient-focused…

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Sorrento Completes Successfully the SAD Study and Initiates the MAD Phase 1 Study with STI-1558, An Oral M(pro) Inhibitor as a Standalone Treatment and Prevention of COVID-19 without the Ritonavir as Booster

08/11/2022

Single ascending dose (SAD) Phase 1 Study completed in Australia with a maximum dose of 2,000 mg. Pharmacokinetics (PK) were dose proportional and PK modeling and preclinical data support a 600 mg twice daily dose. There were no serious AEs (SAEs) or severe TEAEs and the maximum tolerated dose (MTD) was not reached.  Initiation of…

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Helixmith Announces Topline Results from Double-Blind Placebo Controlled Multicenter Study for TADIOS Involving 100 Subjects Infected with COVID-19

08/11/2022

KEY POINTS TADIOS was determined to be safe and well tolerated Serum levels of IL-1RA changed significantly, a biomarker that has a correlation with severity and mortality during COVID-19 infections Improvement in fatigue observed Excerpt from the Press Release: LA JOLLA, Calif., Aug. 3, 2022  Helixmith announced topline results today from the double-blind placebo controlled…

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Thermo Fisher Scientific Introduces Highly Sensitive Research Assays for Measurable Residual Disease Detection in Myeloid Malignancies

08/10/2022

Ion Torrent Oncomine Myeloid MRD Assays (RUO) are the first NGS-based tests to offer simultaneous DNA and RNA analysis for myeloid MRD assessment Excerpt from the Press Release: CARLSBAD, Calif.–(BUSINESS WIRE)–Thermo Fisher Scientific today launched a next-generation sequencing (NGS)-based assay for research in myeloid measurable residual disease (MRD). As the first NGS-based tests to support…

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