RIGL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• To expand our evaluation of olutasidenib in other disease areas with IDH1 mutations, we have strategic development collaborations with MDACC and with CONNECT.

• TAVALISSE net product sales for the three months ended March 31, 2026 were $37.3 million, an increase of $8.8 million, or 31%, compared to $28.5 million for the same period in 2025. The increase was primarily driven by higher volumes and higher price per bottle, as well as a favorable impact from lo…

• GAVRETO net product sales for the three months ended March 31, 2026 were $9.6 million, an increase of $0.6 million, or 7%, compared to $9.0 million for the same period in 2025. The increase was primarily driven by higher price per bottle and, to a lesser extent, higher volumes.

• We advanced the development of our dual IRAK1/4 inhibitor program, following evaluation of single and multiple ascending doses of R289 in healthy subjects. The ongoing Phase 1b open-label, multicenter study evaluates the safety, tolerability and preliminary efficacy of R289 in patients with R/R lowe…

• complete enrollment of the dose expansion phase of the Phase 1b study and select the recommended Phase 2 dose for future clinical studies in the second half of 2026. We anticipate sharing preliminary data from the dose expansion phase of the study by the end of 2026.

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• We have strategic development collaborations with MDACC to expand our evaluation of olutasidenib in AML and other hematologic cancers with IDH1 mutations, and with CONNECT to conduct a Phase 2 clinical trial to evaluate olutasidenib in combination with temozolomide in patients with HGG harboring an …

• For the nine months ended September 30, 2025, net product sales of TAVALISSE were $113.3 million, increased by $39.5 million or 54% compared to $73.8 million net product sales in the same period in 2024. The increase was primarily due to increased quantities sold and higher price per bottle, and par…

• GAVRETO in metastatic RET fusion-positive NSCLC and advanced thyroid cancers

• We began our commercialization and started recognizing revenue from product sales of GAVRETO in late June 2024. For the nine months ended September 30, 2025, net product sales of GAVRETO were $31.9 million, compared to $9.0 million in the same period in 2024. We expect to continue to leverage our ex…

• We advanced the development of our dual IRAK1/4 inhibitor program, following evaluation of single and multiple ascending doses of R289 in healthy subjects. The ongoing Phase 1b open-label, multicenter study evaluates the safety, tolerability and preliminary efficacy of R289 in patients with R/R lowe…

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• In June 2022, we received a notice letter regarding an ANDA submitted to the FDA by Annora, requesting approval to market a generic version of TAVALISSE. The notice letter included a Paragraph IV certification with respect to our US Patent Nos. 7,449,458; 8,263,122; 8,652,492; 8,771,648 and 8,951,50…

• As reported in our Form 10-Q for the first quarter of 2025, in March 2025, we entered into a settlement agreement with Annora resolving patent litigation related to our product TAVALISSE. Under the terms of the settlement agreement, Annora will have a license to sell its generic product in the secon…

相对上期新增的文字 · 来源:10-Q · 2026-05-05

• We may need to add additional qualified personnel and resources to support our commercial activities and expected growth. Our current infrastructure may be inadequate to support our development and commercialization efforts and expected growth. Future growth will impose significant added responsibil…

• •potential failure of the due diligence process to identify significant problems, liabilities or other shortcomings or challenges of an acquired or licensed product candidate or technology, including problems, liabilities or

• other shortcomings or challenges with respect to intellectual property, product quality, partner disputes or issues and other legal and financial contingencies and known and unknown liabilities;

• •inability to integrate the target company or in-licensed asset successfully into our existing business and inability to maintain the key business relationships of the target;

• •in an in-licensing or an asset acquisition of a product that is commercially available in the market, we may not be able to successfully transition the existing patients who are dependent to the acquired or in-licensed product, or successfully enter into a reimbursement coverage contracts that the …

相对上期删除的文字 · 来源:10-Q · 2025-11-04

• While we have substantially increased the size of our organization particularly in our sales force in 2021, we also implemented reductions in workforce particularly in our research and development group in 2021 and 2022. We may need to add additional qualified personnel and resources to support our …

• growth. Future growth will impose significant added responsibilities on members of management, including the need to identify, recruit, maintain and integrate additional employees, and may take time away from running other aspects of our business, including commercialization of our products and deve…

• particular, larger companies with more well-established and diverse revenue streams may have a competitive advantage over us due to their size, financial resources and more extensive clinical development and commercialization capabilities. Furthermore, companies that perceive us to be a competitor m…

• ●potential failure of the due diligence process to identify significant problems, liabilities or other shortcomings or challenges of an acquired or licensed product candidate or technology, including problems, liabilities or other shortcomings or challenges with respect to intellectual property, pro…

• ●inability to integrate the target company or in-licensed asset successfully into our existing business and inability to maintain the key business relationships of the target;