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CASI Pharmaceuticals (CASI)

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Recent press releases and 8-K filings for CASI.

CASI Pharmaceuticals' FOLOTYN® Import Drug License Not Renewed in China
CASI
Profit Warning
  • CASI Pharmaceuticals, Inc. announced that its application to renew the Import Drug Registration License for FOLOTYN® in China was not granted by the National Medical Products Administration (NMPA).
  • The company received a formal notice from the NMPA confirming the non-approval of the renewal application, which was originally submitted in May 2025.
  • Consequently, CASI Pharmaceuticals has ceased the sale of FOLOTYN® in China following the expiration of the current license.
Jan 22, 2026, 2:00 PM
CASI Pharmaceuticals Announces Closing of Second Tranche of Convertible Notes
CASI
Debt Issuance
  • CASI Pharmaceuticals, Inc. completed the issuance of the second tranche of its US$20 million convertible note financing.
  • A US$5 million convertible note was issued to ETP Global III Fund LP, maturing in 36 months with a 12% annual interest rate.
  • The note's conversion price is subject to a floor of US$1 per Share and a cap of US$2 per ordinary Share.
Jan 13, 2026, 2:00 PM
CASI Pharmaceuticals Granted Extension to Meet Nasdaq Listing Requirements
CASI
Delisting/Listing Issues
Management Change
New Projects/Investments
  • CASI Pharmaceuticals received an extension from the Nasdaq Hearings Panel to regain compliance with the Market Value of Listed Securities (MVLS) Rule 5550(b)(2).
  • The company must meet the listing requirement by February 17, 2026, to avoid the suspension of its securities.
  • Nasdaq had initially notified CASI on May 5, 2025, that its MVLS fell below the minimum $35 million requirement.
  • The Panel considered the company's recent efforts, including new CEO and Non-Executive Chairman appointments, focus on CID-103 development, financing initiatives, and planned divestiture of China assets, when granting the extension.
Dec 23, 2025, 9:15 PM
CASI Pharmaceuticals Announces Up to $20 Million Convertible Note Financing
CASI
Debt Issuance
New Projects/Investments
  • CASI Pharmaceuticals, Inc. announced an up to $20 million convertible note financing with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He.
  • The investment is intended to fund a Phase 1 study in China for renal allograft antibody-mediated rejection (AMR) and to advance the development of a stable, high-concentration protein solution for subcutaneous formulation of CID-103.
  • The convertible notes will mature in 36 months and bear an annual interest rate of 12%.
  • The conversion price for the notes is subject to a cap of $2 per ordinary Share and a floor of $1 per Share.
Dec 11, 2025, 2:15 PM
CASI Pharmaceuticals Announces Q3 2025 Results and Nasdaq Delisting Determination
CASI
Earnings
Delisting/Listing Issues
CEO Change
  • CASI Pharmaceuticals reported revenues of $3.1 million for the third quarter of 2025, a 60% decrease compared to the prior year, and a net loss of $10.9 million. As of September 30, 2025, cash and cash equivalents were $4.7 million.
  • The company received a Nasdaq delisting determination on November 5, 2025, for failing to meet the minimum market value of listed securities requirement, and has appealed this decision.
  • CASI is advancing its CID-103 clinical program, with a Phase 1 study for immune thrombocytopenia (ITP) enrolling and dosing, and results to be presented at ASH 2025 on December 7, 2025.
  • David Cory was appointed CEO and Director to the Board, and the company is targeting completion of the divestiture of its China business in Q2 2026.
Nov 14, 2025, 9:30 PM
CASI Pharmaceuticals Appeals Nasdaq Delisting Determination
CASI
Delisting/Listing Issues
  • CASI Pharmaceuticals received a delisting determination from Nasdaq on November 5, 2025, for failing to meet the minimum $35 million market value of listed securities (MVLS) requirement.
  • The company did not regain compliance by the November 3, 2025, deadline, which marked the end of a 180-calendar-day grace period.
  • CASI has appealed the determination and requested a hearing, which will stay the suspension of its securities.
  • The company is actively engaged in dialogue with Nasdaq, aiming to regain compliance and maintain its listing.
Nov 10, 2025, 9:30 PM
CASI Pharmaceuticals Announces Q2 2025 Results and Strategic Divestiture
CASI
Earnings
M&A
New Projects/Investments
  • CASI Pharmaceuticals reported Q2 2025 revenues of $4.2 million and a net loss of $13.4 million. Cash and cash equivalents stood at $6.7 million as of June 30, 2025.
  • The company entered into a definitive agreement to divest its 100% equity interests in two China subsidiaries and certain product licensing rights for an aggregate purchase price of $20.0 million, including assumption of up to $20.0 million of indebtedness.
  • CASI received FDA clearance for its IND application for CID-103 in renal allograft antibody-mediated rejection (AMR) and plans to initiate a Phase 1 study in the third quarter of 2025.
Aug 29, 2025, 8:30 PM
CASI Pharmaceuticals' FOLOTYN® Import Drug Registration License Expires in China
CASI
  • CASI Pharmaceuticals, Inc. announced that its Import Drug Registration License for FOLOTYN® in China expired on August 25, 2025.
  • The Chinese Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) did not grant the company's renewal application for the license.
  • As a direct consequence, CASI Pharmaceuticals will immediately cease the sale of FOLOTYN® in China.
  • The company may, however, continue FOLOTYN® clinical trial activities in China.
Aug 27, 2025, 12:00 AM