Biopharmaceutical

Onconova Therapeutics Announces Updated Data from Investigator-sponsored Phase 1/2a Trial Evaluating Rigosertib in Combination with Nivolumab in Advanced KRAS-mutated Non-Small Cell Lung Cancer at the ESMO Congress 2022

09/19/2022

Data show an early signal of efficacy in an extensively pre-treated population with 1 complete response and 2 partial responses achieved in 14 evaluable patients Responses achieved in patients with 3 distinct and different KRAS mutations, confirming the MOA of rigosertib being KRAS+ agnostic 4 of 14 (29%) evaluable patients demonstrated disease control The combination…

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Atea to Advance Global Phase 3 Registrational Study of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with COVID-19

09/16/2022

Novel Phase 3 Trial Design to Evaluate Bemnifosbuvir as Monotherapy and Combination Antiviral Therapy for COVID-19 Trial to Focus on High-Risk Patients at Greatest Risk for Disease Progression Trial Expected to Initiate in Fourth Quarter 2022 Conference Call at 8:30 a.m. ET Today Excerpt from the Press Release: BOSTON, Sept. 13, 2022 (GLOBE NEWSWIRE) —…

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Amolyt Pharma Announces Positive Efficacy and Safety Data from First Cohort of Phase 2a Study of AZP-3601 in Patients with Hypoparathyroidism at the American Society for Bone and Mineral Research 2022 Annual Meeting

09/16/2022

– Company to host Key Opinion Leader webinar today, September 12, at 1:30 pm CT/2:30 pm ET – Excerpt from the Press Release: LYON, France and CAMBRIDGE, Mass., Sept. 12, 2022 (GLOBE NEWSWIRE) — Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced positive efficacy and…

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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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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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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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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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Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia

08/30/2022

Excerpt from the Press Release: BOSTON and ATLANTA, Aug. 26, 2022 /PRNewswire/ — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that the U.S. Food and Drug Administration (FDA)…

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Palisade Bio Announces First Patient Enrolled and Dosed in Pivotal Phase 3 Study Evaluating LB1148 for Postoperative Return of Bowel Function

08/29/2022

Excerpt from the Press Release: CARLSBAD, Calif., Aug. 17, 2022 (GLOBE NEWSWIRE) — Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the first patient has been dosed in its Phase 3 study evaluating LB1148 to accelerate the return of bowel function in adult…

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Innovent Announces First Subject Dosed in Phase 1 Study of IBI311 (Anti-IGF-1R Monoclonal Antibody)

08/24/2022

Excerpt from the Press Release: SAN FRANCISCO and SUZHOU, China, Aug. 17, 2022 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first healthy volunteer has been successfully dosed in…

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