Welcome to our dedicated page for Casi Pharmaceuticals news (Ticker: CASI), a resource for investors and traders seeking the latest updates and insights on Casi Pharmaceuticals stock.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) is a clinical-stage biopharmaceutical company whose news flow centers on the development and financing of CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases. Company announcements highlight clinical trial progress in immune thrombocytopenia (ITP) and renal allograft antibody-mediated rejection (AMR), as well as regulatory milestones in the United States and China.
Readers of CASI news can follow updates on its Phase 1 and Phase 1/2 studies, including dose-escalation designs, interim safety and efficacy data, and presentations at major medical meetings such as the American Society of Hematology (ASH) Annual Meeting. Press releases describe how CID-103 is being evaluated across multiple dose cohorts, report on platelet response outcomes in ITP, and discuss regulatory clearances such as FDA IND approvals and Chinese CTA approvals for AMR studies.
CASI’s news also covers corporate and capital markets developments, including convertible note financings, at-the-market equity raises, and Nasdaq listing compliance matters. The company has reported receiving a Nasdaq delisting determination related to market value of listed securities, its subsequent appeal, and an extension granted by a Nasdaq Hearings Panel to regain compliance. Governance changes, such as board appointments and the designation of a Non-Executive Chairman, are also detailed in recent releases.
In addition, CASI issues updates on its product portfolio and regulatory environment in China, including the expiration of the Import Drug Registration License for FOLOTYN and the impact on commercialization in that market. For investors and observers, the CASI news feed provides a consolidated view of clinical data releases, regulatory interactions, financing transactions, governance changes, and business updates that shape the company’s progress with CID-103 and related activities.
CASI Pharmaceuticals reported a strong first quarter of 2022 with $9.0 million in EVOMELA sales, reflecting a 58% year-over-year increase. The company aims to build on its 100% growth target achieved in 2021. In 2022, CASI focuses on advancing its therapeutic portfolio, including the CNCT-19 NDA submission and expected launch in China. Its research investments decreased slightly to $4.0 million, while total cash and cash equivalents stood at $29.3 million.
CASI Pharmaceuticals (Nasdaq: CASI) will host a conference call on May 12, 2022, at 8:00 a.m. EST to discuss its first-quarter 2022 financial results. The call will include updates from the Chairman & CEO on business developments and milestones. Interested parties can join the call by dialing the provided numbers, and a replay will be available afterwards. CASI focuses on developing innovative therapeutics in hematology oncology, particularly in the China market, through its wholly-owned subsidiary in Beijing.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced on March 30, 2022, that it was provisionally identified by the SEC under the Holding Foreign Companies Accountable Act (HFCAA) for using an auditor not subject to PCAOB inspection. This was expected by CASI following their recent Form 10K filing on March 28, 2022. The company is exploring strategic options to comply with HFCAA requirements. CASI focuses on developing therapeutics in oncology, particularly for the Greater China market, leveraging its subsidiary in Beijing.
CASI Pharmaceuticals reported $9.12 million in EVOMELA® revenue for Q4 2021, marking 100% growth for the year, with total revenue reaching $30 million. The company aims for continued growth through its commercial franchise in 2022, with anticipated milestones including NDA filing for CNCT19 and initiation of BI-1206 Phase I trials. Despite increased R&D and marketing costs leading to a net loss of $35.8 million, CASI’s cash position stands at $38.7 million. The company sees EVOMELA as central to its operations moving forward.
CASI Pharmaceuticals (Nasdaq: CASI) announced a conference call scheduled for March 28, 2022, at 8:00 a.m. EDT, to review its financial results for Q4 and the year ended December 31, 2021. The call will be led by the Company's Chairman & CEO, who will discuss business updates and upcoming milestones. Investors can access the call via a local and international dialing system, with a replay option available afterward.
CASI focuses on developing innovative therapeutics in hematology and oncology, primarily targeting the greater China market.
CASI Pharmaceuticals (Nasdaq: CASI) has renewed an exclusive distribution agreement with China Resources Pharmaceutical Commercial Group for EVOMELA® (melphalan) sales in China. This partnership has contributed to rapid revenue growth, reaching $30 million in 2021. The collaboration enhances distribution efficiency, increasing accessibility for healthcare providers and patients. CASI aims to strengthen its market position in China through this agreement and its dedicated hematology oncology sales team.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) reported preliminary unaudited revenues of approximately $9.12 million for Q4 2021 and $30 million for the full year, exceeding its projected $27 million guidance and marking a significant 100% increase from 2020's $15 million. The company anticipates more than 30% growth in EVOMELA revenue for 2022. Key developments include ongoing clinical trials for pipeline products, with a focus on the commercialization of CNCT-19 and approvals for CB-5339 and BI-1206 expected this year.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced that the FDA granted Orphan Drug Designation (ODD) to its partner BioInvent International AB for BI-1206, an investigational antibody targeting follicular lymphoma (FL). This designation supports the ongoing clinical trials for BI-1206, which is being studied in combination with rituximab and Keytruda for treating various lymphomas and solid tumors. Dr. Wei-Wu He highlighted the significance of this designation, noting the potential for innovative cancer therapies and ongoing preparations for clinical studies in China.
CASI Pharmaceuticals announced that the U.S. FDA has granted Orphan Drug Designation to its partner, Juventas Cell Therapy, for CNCT19, a CD-19 directed CAR-T therapy aimed at treating Acute Lymphoblastic Leukemia (ALL). This designation supports the ongoing Phase II trials of CNCT19, which is already approved in China for relapsed/refractory B-ALL and B-NHL. CASI holds worldwide co-commercial rights and plans to commence global commercialization as regulatory advancements occur.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) received a deficiency letter from Nasdaq on December 30, 2021, indicating its stock had closed below the $1.00 minimum bid price for 30 consecutive business days. CASI has until June 28, 2022, to regain compliance by maintaining a bid price of $1.00 or more for 10 consecutive days. If compliance isn't achieved, CASI may seek a second 180-day compliance period or face potential delisting. The company is considering options, including a reverse stock split, and will actively monitor its stock price.