Month: October 2022

Corcept Therapeutics Initiates DAZALS – A Phase 2 Trial in Amyotrophic Lateral Sclerosis (ALS)

10/21/2022

Excerpt from the Press Release: MENLO PARK, Calif., Oct. 11, 2022 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, today announced that it has initiated DAZALS –…

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Mirum Pharmaceuticals Presents Long-Term LIVMARLI® (maralixibat) Data and New Alagille Syndrome Caregiver Burden Analysis at NASPGHAN 2022 Annual Meeting

10/21/2022

– Six-year natural history comparison with maralixibat demonstrates event-free and transplant-free survival in patients with Alagille syndrome (ALGS) – Characterization of four-year growth improvement in Alagille syndrome with maralixibat – New analysis evaluating health-related quality of life impact assessed on caregivers of children with Alagille syndrome – Mirum to host a scientific symposium on the…

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BridgeBio Pharma Presents 12-month Results from Phase 2 Study of BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i (LGMD2i)

10/20/2022

Novel assay developed to assess the extent of alpha-dystroglycan (⍺DG) glycosylation, the core pathology of LDMD2i, from muscle biopsy samples Increase in the ratio of glycosylated αDG to total αDG from baseline towards normal levels, suggesting that the investigational oral therapy, BBP-418, has the potential to address the root cause of LGMD2i Large, sustained reduction…

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Meet with Christopher Kata during the “CRAC – Future Considerations for Conducting Clinical Trials Meeting” November 17th!

10/20/2022

Christopher Kata is once again attending the CRAC – Future Considerations for Conducting Clinical Trials November 17th at the Markland Wood Golf Club. If you’re attending be sure to reach out to Christopher to schedule a one on meeting or search him out at the meeting! Christopher will be delivering a presentation titled “How To…

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BMF-219 Enters the Clinic for KRAS Solid Tumors

10/20/2022

Biomea Fusion announces FDA clearance of Investigational New Drug (IND) application for covalent menin inhibitor BMF-219 in KRAS solid tumors. Biomea Fusion will now initiate a Phase I/Ib clinical trial (COVALENT-102) of BMF-219 as a monotherapy in patients who have unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC) or pancreatic…

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Aligos Therapeutics Initiates Dosing In Healthy Volunteers With siRNA Drug Candidate ALG-125755

10/20/2022

Single ascending doses to be evaluated in healthy volunteers in Q4 2022 Single ascending doses to be evaluated in subjects with chronic hepatitis B beginning in Q1 2023 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 14, 2022 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on…

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New CPDC spinout company aims to become global leader in developing and distributing radiopharmaceuticals

10/19/2022

AtomVie Global Radiopharma is the latest company launched by the OICR-supported centre Excerpt from the Press Release: The Centre for Probe Development and Commercialization’s (CPDC) newest spinout company has now launched as AtomVie Global Radiopharma Inc. On August 24, the Hamilton-based radiopharmaceutical company announced it had closed Series A financing with healthcare investment firm Avego…

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Lyell Immunopharma Announces FDA Clearance of its IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors

10/19/2022

Autologous TIL therapy enhanced with Lyell’s Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function Phase 1 trial to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer Initial data presentation expected…

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Allogene Therapeutics Initiates Industry’s First Allogeneic CAR T Phase 2 Trial

10/19/2022

ALPHA2 Trial, Evaluating ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients, is Designed to Leverage the Ease and Convenience of a Single Dose of ALLO-501A Protocol Supported by Clinical and Translational Data from Phase 1 Trial Indicating Deep Responses are Achievable with a Single Dose of ALLO-501A When Used with a Lymphodepletion Regimen That Includes…

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Verastem Oncology Announces RAMP VS-6766 Clinical Trials and Corporate Update

10/18/2022

FDA Meeting Planned for Q4 to Discuss Regulatory Path Forward Based on Encouraging Results to Date in Ongoing RAMP 201 Trial in LGSOC Results of Part A of RAMP 202 Trial in KRAS G12V-Mutant NSCLC Show VS-6766 ± Defactinib Did Not Meet Criteria to Continue to Expansion Phase RAMP Trials with VS-6766 Combinations in KRAS…

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