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CASI Pharmaceuticals, Inc. Ordinary Shares - CASI STOCK NEWS

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CASI Pharmaceuticals, Inc. (symbol: CASI) is a biopharmaceutical company dedicated to the development and commercialization of innovative therapeutic and pharmaceutical products in China, the United States, and globally. The company's core focus is on hematology-oncology, tackling unmet medical needs through advanced treatments and collaborative efforts.

CASI’s product pipeline includes:

  • EVOMELA®: Melphalan hydrochloride for injection, used as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma. It is a significant contributor to CASI’s revenue.
  • CNCT19: An autologous CD19 CAR-T cell therapy product designed for patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma. This product, developed in collaboration with Juventas, has recently received market approval in China, marking a critical milestone in cell therapy.
  • CID-103: An anti-CD38 monoclonal antibody for the treatment of multiple myeloma. CID-103 has shown promising preclinical efficacy and safety profiles.
  • FOLOTYN®: Pralatrexate injection, a treatment for relapsed or refractory peripheral T-cell lymphoma in China, demonstrating a significant impact in addressing critical medical needs.
  • BI-1206: A first-in-class FcγRIIB monoclonal antibody under development for relapsed/refractory non-Hodgkin lymphoma in combination with rituximab.
  • CB-5339: An oral novel VCP/p97 inhibitor for the treatment of hematological malignancies and solid tumors, currently preparing for clinical trials in China.

CASI's recent achievements include the successful commercialization of FOLOTYN® in China and receiving regulatory approval for CNCT19. Despite competitive pressures, EVOMELA continues to play a critical role in the treatment of multiple myeloma in China, with nearly 10,000 patients treated in 2023.

The company faced challenges such as decreased revenues due to competition and restructuring but remains committed to advancing its pipeline. CASI is also actively involved in arbitration with Juventas over the commercialization rights of CNCT19, asserting its legal rights vigorously.

CASI's forward-looking strategy involves leveraging its regulatory and commercial competencies in China, combined with its global drug development expertise, to launch innovative therapies and maintain market leadership in hematology-oncology.

For more detailed information, visit www.casipharmaceuticals.com.

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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.

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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.

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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.

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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.

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CASI Pharmaceuticals (Nasdaq: CASI) announced a conference call to discuss its second quarter highlights on August 12, 2021, at 8:00 a.m. ET. The call will provide insights from the Chairman & CEO regarding the company's business updates and future milestones. Investors can join the call using specific dialing options for different regions. CASI focuses on developing innovative therapeutics, particularly in hematology oncology, aiming to expand its market presence in China and globally. More details are available on their official website.

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CASI Pharmaceuticals announced the first patient dosing in a Phase 1 clinical trial evaluating CID-103, an innovative anti-CD38 monoclonal antibody for relapsed or refractory multiple myeloma. This study aims to assess CID-103's safety, tolerability, and clinical activity. Preclinical data indicated promising efficacy and favorable safety compared to existing treatments. The Company is optimistic about CID-103's potential to provide significant patient benefits and accelerate its development path.

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CASI Pharmaceuticals, a U.S. biopharmaceutical company, announced that Dr. Wei-Wu He will present at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 9:30 AM (EST). The event will showcase the company’s focus on developing therapeutics in hematology oncology and other unmet medical needs. A webcast will be available on CASI's website in the 'Investors Relations' section, with replays for 30 days post-event. CASI aims to leverage its expertise in China and the U.S. to become a leader in the biopharmaceutical industry.

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CASI Pharmaceuticals reported a revenue of $5.7 million from EVOMELA for Q1 2021, up from $3.4 million in Q1 2020, with a projected annual growth exceeding 50%. R&D expenses increased to $5.3 million mainly due to the CID-103 project. General and administrative costs rose to $5.5 million, reflecting expanded operations. The net loss for the quarter widened to $13.7 million, compared to $8.2 million in the previous year. The firm raised $32.5 million in capital to enhance its balance sheet.

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CASI Pharmaceuticals (Nasdaq: CASI) announced it will host a conference call on May 13, 2021, at 8:00 a.m. ET to review its first quarter highlights. The call will be led by the company's Chairman & CEO, discussing business updates and upcoming milestones. Interested participants can access the call by dialing the relevant numbers for the U.S., China, or Hong Kong, with a conference ID of 7478587. A replay of the call will also be available. CASI focuses on developing therapeutics for hematology oncology and has a significant presence in the Chinese market.

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CASI Pharmaceuticals reported its 2020 financial results, disclosing revenue of $15 million, up from $4.1 million in 2019, primarily driven by the sales of EVOMELA. The company forecasted over 50% revenue growth in 2021. It completed a public offering raising $32.5 million and highlighted in-licensing of a VCP/p97 inhibitor for treatment of hematological malignancies. However, net loss increased to $47.5 million from $45.4 million due to rising R&D and acquisition costs. The company is focused on expanding its U.S. investor base while preparing for regulatory filings in China.

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FAQ

What is the current stock price of CASI Pharmaceuticals Ordinary Shares (CASI)?

The current stock price of CASI Pharmaceuticals Ordinary Shares (CASI) is $2.65 as of December 20, 2024.

What is the market cap of CASI Pharmaceuticals Ordinary Shares (CASI)?

The market cap of CASI Pharmaceuticals Ordinary Shares (CASI) is approximately 41.3M.

What is CASI Pharmaceuticals' main focus?

CASI Pharmaceuticals focuses on developing and commercializing innovative hematology-oncology therapeutics and pharmaceutical products in China, the United States, and globally.

What are the key products in CASI Pharmaceuticals' pipeline?

CASI's key products include EVOMELA®, CNCT19, CID-103, FOLOTYN®, BI-1206, and CB-5339, targeting various hematological and oncological conditions.

What recent achievements has CASI Pharmaceuticals made?

Recent achievements include the approval of CNCT19 in China, the first dose administration of FOLOTYN® in China, and significant progress in the clinical development of BI-1206 and CB-5339.

How does CASI Pharmaceuticals plan to address competition?

CASI plans to strengthen its commercial and medical marketing strategies, focusing on market leadership for existing products while progressing its innovative pipeline to meet unmet medical needs.

What challenges has CASI Pharmaceuticals faced recently?

CASI faced revenue decline due to generic competition and experienced operational challenges, including restructuring and inventory management issues.

How does CASI Pharmaceuticals leverage its regulatory competencies?

CASI leverages its China-based regulatory and commercial expertise to launch new medicines and drive market adoption, particularly in the Greater China market.

What is the significance of CNCT19's approval in China?

The approval of CNCT19 is a milestone for CASI, representing a significant advancement in cell therapy and providing a novel treatment for relapsed/refractory B-cell acute lymphoblastic leukemia.

What are CASI Pharmaceuticals' plans for CID-103?

CASI plans to advance CID-103 into clinical trials for multiple myeloma in China and has received FDA approval to proceed with trials for autoimmune indications in the US.

What collaborations does CASI Pharmaceuticals engage in?

CASI collaborates with companies like Juventas for cell therapy products and BioInvent for developing novel antibodies, aiming to enhance its product pipeline and market reach.

Where can more information about CASI Pharmaceuticals be found?

More detailed information can be found on the company's official website at www.casipharmaceuticals.com.

CASI Pharmaceuticals, Inc. Ordinary Shares

Nasdaq:CASI

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41.25M
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47.92%
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