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Corbus Pharmaceuticals Holdings, Inc. reports clinical-stage drug-development news in oncology and obesity. Updates center on CRB-701, a next-generation Nectin-4 antibody-drug conjugate licensed from CSPC Megalith Biopharmaceutical, including data presentations in head and neck squamous cell carcinoma and cervical cancer, FDA interactions and Fast Track designations.
Company news also covers CRB-913, a peripherally restricted oral CB1 inverse agonist for obesity, and CRB-601, an anti-integrin monoclonal antibody targeting TGFβ activation. Recurring items include clinical trial disclosures, medical-meeting presentations, management conference appearances, governance changes and operating or financial results.
Corbus Pharmaceuticals announced the completion of the final visit in their Phase 2b trial of lenabasum for cystic fibrosis, which enrolled 426 participants. The primary endpoint focuses on reducing pulmonary exacerbations (PEx). Topline results are expected in Q3 2020, supported by a $25 million Development Award from the Cystic Fibrosis Foundation. Lenabasum has received Orphan Drug and Fast Track designations from FDA and EMA. Despite currently being unapproved, lenabasum shows promise in reducing inflammation and fibrosis, addressing a significant unmet need in CF treatment.
Corbus Pharmaceuticals (NASDAQ: CRBP) announced progress in its Phase 2b study of lenabasum, aimed at treating cystic fibrosis, with a focus on patients at high risk for pulmonary exacerbations. The study's baseline demographics and disease characteristics were published in the Journal of Cystic Fibrosis. Topline results are expected in late summer 2020. Lenabasum is designed to target the endocannabinoid system, with prior studies showcasing its potential in reducing inflammation and fibrosis. It has shown acceptable safety profiles but remains unapproved for any conditions.
Corbus Pharmaceuticals Holdings (NASDAQ: CRBP) announced the completion of the last subject's final visit in its RESOLVE-1 Phase 3 trial of lenabasum for systemic sclerosis (SSc), a serious autoimmune disease affecting around 200,000 individuals in the U.S., EU, and Japan. The trial's topline results are expected in summer 2020. Lenabasum has received Orphan Drug and Fast Track designations from the FDA, with promising efficacy observed in prior studies. Notably, there are currently no FDA-approved therapies for SSc.
Corbus Pharmaceuticals (NASDAQ: CRBP) announced the publication of two abstracts at the EULAR 2020 E-Congress, scheduled for June 3-6, 2020. The first abstract details pre-clinical data that connects lenabasum to the inhibition of inflammasome activation, while the second outlines baseline characteristics of patients in the RESOLVE-1 study in Europe. Lenabasum is a novel oral drug designed to address inflammation and fibrosis, exhibiting promising results in various studies.
Corbus Pharmaceuticals Holdings (NASDAQ: CRBP) announced that CEO Yuval Cohen will present at two upcoming virtual investor conferences. The 2020 RBC Capital Markets Global Healthcare Conference is scheduled for May 19, 2020, at 10:55 AM EST, and the Jefferies Virtual Global Healthcare Conference will take place on June 4, 2020, at 11:00 AM EST. Both presentations will include a fireside chat discussion and Q&A. Audio webcasts will be available on the Corbus website, with replays archived for 90 days. Corbus focuses on developing therapies targeting the endocannabinoid system for various diseases.
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) reported Q1 2020 financial results, revealing a net loss of approximately $29.7 million and a revenue decrease to $1.8 million. The company reaffirmed that topline results from the Phase 3 RESOLVE-1 study for lenabasum in systemic sclerosis are on track for summer 2020, followed by Phase 2b cystic fibrosis data. A public offering raised $46 million in gross proceeds. Corbus is also preparing for a potential NDA submission and commercial launch of lenabasum while implementing a COVID-19 mitigation plan to maintain clinical study integrity.
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