CASI Pharmaceuticals shares surge 38.08% premarket after announcing plans to submit IND for CID-103 in kidney transplant AMR treatment.

Casi Pharmaceuticals, Inc. experienced a substantial premarket increase of 38.07% due to the announcement of the company's plan to submit an Investigational New Drug (IND) application to the FDA for CID-103, a promising treatment for antibody-mediated rejection in kidney transplant recipients. The development highlights the potential growth prospects for the company, as the successful submission could lead to increased market visibility and therapeutic pipeline value. This positive news, aligned with the stock's upward movement, contributed to the substantial boost in share price during the premarket session.
Casi Pharmaceuticals, Inc. (NASDAQ: CASI) experienced a notable surge of 38.07% in its premarket stock price on June 26, 2024 [1]. This significant increase followed the announcement of the company's plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CID-103, an anti-CD 38 antibody being developed for the treatment of antibody-mediated rejection (AMR) in kidney transplant recipients [1].

CID-103, a fully human IgG1 anti-CD38 monoclonal antibody, recognizes a unique epitope and has shown promising preclinical results, with an encouraging efficacy and safety profile compared to other anti-CD38 monoclonal antibodies [1]. With the proceeds from a recent private placement financing and existing cash reserves, Casi Pharmaceuticals anticipates having sufficient capital to complete the Phase II clinical trial for AMR by the end of 2024 [1].

The potential market value of this treatment could significantly contribute to Casi Pharmaceuticals' growth prospects. Successful submission of the IND application could lead to increased visibility for the company and its therapeutic pipeline. Moreover, the successful development of CID-103 could potentially expand the company's presence in the nephrology market, which is expected to grow at a compound annual growth rate (CAGR) of 9.3% between 2023 and 2028 [2].

In addition to the IND submission announcement, Casi Pharmaceuticals disclosed that its board of directors had received a preliminary non-binding proposal to acquire the entire business operations of the company in China and related rights in Asia for $40.0 million [1]. Although the proposed transaction is still under evaluation, it highlights the potential value of Casi Pharmaceuticals' pipeline products and the company's strategic importance in the Asian market.

References:
[1] PR Newswire. Casi Pharmaceuticals Announces Plan To Submit IND Application For CID-103, an Anti-CD 38 Antibody in Antibody-Mediated Rejection, and Receipt of a Non-Binding Proposal to Acquire Entire China Business of the Company. https://www.prnewswire.com/news-releases/casi-pharmaceuticals-announces-plan-to-submit-ind-application-for-cid-103-an-anti-cd-38-antibody-in-antibody-mediated-rejection-and-receipt-of-a-non-binding-proposal-to-acquire-entire-china-business-of-the-company-302183227.html
[2] Grand View Research. Nephrology Market Size, Share & Trends Analysis Report By Product (Dialysis Devices, Diagnostics, Drugs), By End-Use (Hospitals, Diagnostic Centers, Home Care), By Region, And Segment Forecasts, 2023 - 2028. https://www.grandviewresearch.com/industry-analysis/nephrology-market