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CASI Pharmaceuticals reports developments as a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases. Company news centers on clinical and regulatory disclosures, operating and financial results, material agreements, shareholder matters, and capital-structure updates.
Recent corporate-status news also includes Nasdaq delisting proceedings and the transition of trading in the company’s ordinary shares to the OTC market. Governance updates, board and management changes, and actions to streamline U.S. activities form recurring disclosure themes alongside financing and product-regulatory matters.
CASI Pharmaceuticals (NASDAQ: CASI) has announced a stock repurchase program allowing for the buyback of up to USD 10 million worth of its shares, equating to no more than 12,500,000 shares. This initiative, approved by the board, reflects CASI's confidence in its business model and aims to enhance shareholder value. The buyback will occur through open market purchases, subject to market conditions and regulations. Funding will be sourced from corporate funds, including cash on hand.
BioInvent International announced that the Center for Drug Evaluation of China's NMPA approved a Clinical Trial Application (CTA) for CASI Pharmaceuticals to initiate two clinical trials of BI-1206 in patients with non-Hodgkin's Lymphoma (NHL). BI-1206, BioInvent's lead drug candidate, is currently in Phase 1/2 trials using anti-PD1 therapy and other combinations. CASI's Phase 1 trials aim to assess safety and early efficacy. The companies' agreement includes potential milestone payments of up to $83 million and royalties on sales. Trials are expected to begin in H1 2022.
CASI Pharmaceuticals (NASDAQ: CASI) has received approval from the China National Medical Products Administration (NMPA) for its Clinical Trial Application (CTA) regarding BI-1206, a first-in-class fully human monoclonal antibody targeting FcγRIIB. Planned Phase 1 trials will assess BI-1206 as a standalone treatment and in combination with rituximab for various forms of non-Hodgkin's lymphoma (NHL). These trials are set to commence in the first half of 2022, aimed at evaluating safety and early efficacy. This milestone is vital for CASI's development strategy in Greater China.
CASI Pharmaceuticals, a U.S. biopharmaceutical company, will have President Larry Zhang present at the upcoming Jefferies London Healthcare Conference on November 18 and 19. The presentation will be held virtually and available on-demand. This event highlights CASI's commitment to developing innovative therapeutics targeted at unmet medical needs in hematology oncology and other areas.
The company leverages its expertise in the global drug market, focusing on China as a key area for expansion.
CASI Pharmaceuticals reported Q3 2021 revenues of $8.1 million from EVOMELA, a 93% increase year-over-year. The company anticipates full-year revenue growth exceeding 80% compared to 2020. CASI highlighted positive interim data from its partner BioInvent's BI-1206 clinical trial, showing a 50% objective response rate in patients with B-cell non-Hodgkin's lymphoma. Net loss narrowed to $10 million from $16.7 million in Q3 2020. Cash reserves stood at $53.1 million as of September 30, 2021.
CASI Pharmaceuticals, Inc. announced that its partner BioInvent International has released positive interim data from the Phase 1/2a trial of BI-1206, an anti-FcγRIIB antibody combined with rituximab for treating non-Hodgkin's lymphoma. The study reported a 50% objective response rate among 12 patients, with long-lasting complete responses observed. The promising safety profile suggests potential for broader application across various cancers. CASI is responsible for the commercialization of BI-1206 in Greater China and anticipates further developments from BioInvent at the upcoming ASH 2021 meeting.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced a conference call scheduled for November 12, 2021, at 8:00 a.m. EDT to discuss third-quarter highlights. The call, led by the Chairman & CEO, will review the company's business updates and upcoming milestones. Interested parties can join by dialing 1-877-870-4263 (U.S.) or 1-412-317-0790 (international). A replay will be available afterward. CASI focuses on developing therapeutics in China, the U.S., and globally, aiming to address unmet medical needs in hematology-oncology.
CASI Pharmaceuticals (Nasdaq: CASI) announced that Juventas Cell Therapy Ltd. has successfully raised over RMB410 million (approximately $63 million) in a Series C financing round. The funds will be utilized for a new drug application in China and to advance commercialization and research for CNCT19. CASI holds a 12.0098% equity stake in Juventas and aims to co-commercialize CNCT19, a CAR-T therapy targeting CD19 for treating B-cell malignancies. This collaboration emphasizes CASI's commitment to enhancing hematology-oncology therapy access in China.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced that Dr. Alexander Zukiwski, Chief Medical Officer, will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2021, at 12:05 PM (EDT). The presentation will be accessible via CASI's website under 'Events & Presentations', with archived replays available for 90 days. CASI is focused on developing therapeutics in hematology oncology and expanding its reach into global markets, especially China, leveraging its regulatory and commercial expertise.
CASI Pharmaceuticals reported strong financial results for Q2 2021, generating $7.1 million in EVOMELA revenues, a 173% increase from Q2 2020. The company revised its full-year revenue growth guidance to exceed 80% over 2020. The Phase 1 clinical trial for CID-103 has commenced, alongside promising developments in CNCT19 and ongoing patent activities with BioInvent. Despite a net loss of $6.7 million, cash and equivalents stand at $60.4 million, reflecting a strong liquidity position.