Announcements

Exelixis Announces Detailed Results from Phase 3 COSMIC-313 Pivotal Trial in Patients with Previously Untreated Advanced Kidney Cancer at ESMO 2022

09/09/2022

– Cabozantinib in combination with nivolumab and ipilimumab significantly reduced the risk of disease progression or death compared with the combination of nivolumab and ipilimumab – – Median progression-free survival was not yet reached with the combination of cabozantinib, nivolumab and ipilimumab versus 11.3 months with nivolumab combined with ipilimumab – Excerpt from the Press…

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Alume Biosciences Announces First Patient Dosed with ALM-488 in Phase 3 Pivotal Study in Patients Undergoing Head and Neck Surgery

09/06/2022

ALM-488 is a peptide-dye conjugate designed to fluorescently highlight nerves in real time during surgery Excerpt from the Press Release: LA JOLLA, Calif., Aug. 23, 2022 /PRNewswire/ — Alume Biosciences, Inc, a leader in the field of nerve-targeted diagnostics and therapeutics, today announced that the first patient has been dosed in a Phase 3 pivotal…

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Biomea Fusion Presents Additional Preclinical Data Demonstrating Anti-Tumor Activity and Mechanistic Evidence for BMF-219 in Diffuse Large B-Cell Lymphoma and Multiple Myeloma Models at International Myeloma Society Annual Meeting

09/05/2022

Data demonstrated robust anti-tumor activity of BMF-219 and mechanistic evidence for novel inhibition of menin protein in preclinical models of Diffuse Large B-cell Lymphoma (DLBCL) and multiple myeloma (MM). BMF-219 displayed single agent potency, surpassing greater than 90% inhibition at clinically relevant exposures in both DLBCL and MM cell lines and patient-derived samples. A Trial…

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FibroGen Announces Completion of Patient Enrollment in MATTERHORN, a Phase 3 Clinical Study of Roxadustat for the Treatment of Anemia in Patients with Lower Risk Transfusion-Dependent Myelodysplastic Syndromes (MDS)

09/05/2022

– 141 MDS Patients Enrolled –– Topline Data Anticipated 1H:2023 – Excerpt from the Press Release: SAN FRANCISCO, Aug. 26, 2022 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today announced completion of patient enrollment for MATTERHORN, a Phase 3 clinical study of roxadustat for treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS).…

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Geron Announces First Patient Dosed in IMproveMF Phase 1 Combination Study in Frontline Myelofibrosis

09/05/2022

Preclinical data showed synergistic and additive effects of combination imetelstat and ruxolitinib Study intended to explore potential for disease modification with imetelstat in earlier, frontline myelofibrosis setting Single-agent imetelstat currently being studied in a separate Phase 3 trial designed to confirm clinically meaningful benefits observed in relapsed/refractory MF patients in Phase 2 study Excerpt from…

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Annovis Bio Announces First Patient Dosed in Phase 3 Trial in Patients with Early Parkinson’s Disease

09/02/2022

Excerpt from the Press Release: BERWYN, Pa., Aug. 24, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the first patient in the Phase 3 clinical trial evaluating buntanetap in early Parkinson’s Disease (PD) has been dosed. The Phase 3 trial…

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Ranok Therapeutics Announces Initiation of Patient Dosing in a Phase 1/2 Clinical Trial of RNK05047, a First-in-Class BRD4-Targeting CHAMP™ Protein Degrader

09/02/2022

Study will evaluate the first protein degrader developed using Ranok’s innovative CHAMP™ technology in patients with advanced solid tumors or diffuse large B-cell lymphoma (DLBCL) Excerpt from the Press Release: BOSTON & HANGZHOU, China–(BUSINESS WIRE)–Ranok Therapeutics, a clinical-stage biopharmaceutical company that is developing a novel approach to targeted protein degradation for the treatment of cancer…

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Moderna Completes Application To U.S. Food And Drug Administration For Emergency Use Authorization Of Omicron-Targeting Bivalent Covid-19 Booster Vaccine, mRNA-1273.222

09/02/2022

mRNA-1273.222 Targets BA.4/BA.5 Strains of Omicron Variant Pending Authorization, Moderna Ready to Ship Bivalent Booster mRNA-1273.222 in September Clinical Data Available for Moderna’s Bivalent COVID-19 Booster Vaccines Have Met All Primary Endpoints and Support Request for Emergency Use Authorization Excerpt from the Press Release: CAMBRIDGE, MA / ACCESSWIRE / August 23, 2022 / Moderna, Inc.…

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Apellis Announces 24-Month Results Showing Increased Effects Over Time with Pegcetacoplan in Phase 3 DERBY and OAKS Studies in Geographic Atrophy (GA)

09/01/2022

Pegcetacoplan treatment effect accelerated between months 18-24, demonstrating a robust reduction of GA lesion growth compared to sham (all p-values are nominal) DERBY: 36% monthly, p<0.0001; 29% every-other-month (EOM), p=0.0002 OAKS: 24% monthly, p=0.0080; 25% EOM, p=0.0007 Consistent with expectations, no clinically meaningful difference on key functional endpoints observed at 24 months Continued to demonstrate…

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Sight Sciences Introduces the SION™ Surgical Instrument – The First Bladeless Device Used in Goniotomy

09/01/2022

Featuring bladeless technology, SION is designed to facilitate a smooth, gentle goniotomy procedure Excerpt from the Press Release: MENLO PARK, Calif., Aug. 23, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative solutions intended to transform care and improve patients’ lives, today announced the launch…

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