Biopharmaceutical

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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…

Read More

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)…

Read More

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…

Read More

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…

Read More

Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

08/18/2022

– Topline Data Expected First Quarter 2023 – Excerpt from the Press Release: DUBLIN, Ireland and FORT WASHINGTON, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the completion of patient enrollment in its…

Read More

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…

Read More