KYNB 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• We continue to advance our development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need.

• We have finalized the Phase 3 trial protocol for roxadustat for the treatment of anemia in patients with lower-risk MDS with high transfusion burden and are continuing with preparations for the Phase 3 trial, while evaluating internal development and potential partnership opportunities for this late…

• The U.S. Food and Drug Administration (“FDA”) granted roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.

• Income (loss) from continuing operations per share - basic and diluted

• Our revenue for the three and six months ended June 30, 2026 primarily included $(1.6) million and $1.9 million, respectively, of drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas. As a comparison, our revenue for the three and…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• We continue to advance our development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndromes (“MDS”), a high-value indication with significant unmet medical need. We had a positive Type-C meeting with the U.S. Food and Drug Administration (“FDA”) in July 2025 and reached…

• The FDA granted roxadustat Orphan Drug Designation for the treatment of MDS in December 2025.

• Loss from continuing operations per share - basic and diluted

• Our revenue for the three months ended March 31, 2026 and 2025 primarily included $3.5 million and $2.6 million, respectively, of drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas.

• Operating costs and expenses for the three months ended March 31, 2026 remained relatively flat compared to the same period a year ago primarily as a result of the net effect of the following, respectively:

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended June 30, 2026 that have materially affected, or are reasonably likely to materi…

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• During the quarter ended March 31, 2026, we completed the implementation of an enterprise resource planning (“ERP”) system, with which we expect to improve the efficiency of certain financial and transactional processes. As a result, we have updated the design and documentation of internal controls,…

• Except as described in the previous paragraph, there were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the three months ended March 31, 2026 that have materia…

相对上期新增的文字 · 来源:10-Q · 2026-08-13

• Reference pricing is used by various Europe member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, our partner or we may be required to conduct a clinical trial or other studies that compare the cost-effec…

• If we are unable to maintain compliance with the continued listing requirements of the Nasdaq Capital Market following such a transfer, or if we are unable to transfer and unable to regain compliance with the Nasdaq Global Select Market, our common stock could become subject to delisting. Delisting …

• common stock more difficult for investors, potentially leading to declines in our share price and liquidity. In that event, the risks with respect to delisting include limited trading markets, ineligibility to sell securities under our current S-3 registration statement under certain circumstances, …

相对上期删除的文字 · 来源:10-Q · 2026-05-12

• Within the next year, we may face costs from the wind-up of the Cayman Subsidiary (as defined below), and may not receive some of the AZ Holdbacks (as defined below) related to the sale of FibroGen International and its subsidiaries.

• Reference pricing is used by various Europe member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. In some countries, our partner or we may be required to conduct a clinical trial or other studies that compare the cost-effec…

• Within the next year, we may face costs from the wind-up of the Cayman Subsidiary (as defined below), and may not receive some of the AZ Holdbacks (as defined below) related to the sale of FibroGen International and its subsidiaries.

• As disclosed in our Current Report on Form 8‑K filed in February 20, 2025, we agreed to two holdback amounts from the consideration paid by AstraZeneca Treasury Limited (the “AZ Holdbacks”) in connection with the sale of FibroGen International and its subsidiaries. The AZ Holdbacks were subject to s…

• After the final AZ Holdback is received or finalized, we are planning on winding up FibroGen International (Cayman) Limited (the “Cayman Subsidiary”). The wind‑up involves legal, regulatory, tax, accounting, and administrative steps. The timing, cost, and outcome of these steps are uncertain and may…