TGTX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• In April 2026, we announced the Phase 3 trial evaluating subcutaneous BRIUMVI completed enrollment and topline data is expected around year-end 2026 or first quarter 2027.

• In March 2026, we entered into a new five-year, $750 million senior secured credit facility with funds managed by Blue Owl Capital. As part of the transaction, we repaid our outstanding $250 million senior secured credit facility, resulting in a net raise of $500 million in non-dilutive capital. The…

• We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development. The following table summarizes the current clinical trial status for our lead drug candidates as of March 2026.

• ● In August 2025, we announced patient enrollment commenced into a randomized Phase 3 pivotal cohort to evaluate a consolidated Day 1 and Day 15 dosing regimen for IV BRIUMVI in the ongoing ENHANCE Phase 3b trial, and in October 2025 we announced the trial completed enrollment.

• ● In February 2026, five-year data from the ongoing open label extension (OLE) of the Phase 3 ULTIMATE I and II studies published in JAMA Neurology.

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• In September 2025, we completed our previously authorized $100 million share repurchase program, which was initially announced in August 2024 (the Prior Share Repurchase Program). Under the Prior Share Repurchase Program, we repurchased a total of 3,502,334 shares of our common stock at an average p…

• We currently license worldwide development and commercial rights, subject to certain limited geographical restrictions, for all of our products under development. The following table summarizes the current clinical trial status for our lead drug candidates as of September 2025.

• Additional BRIUMVI data continues to be presented at major medical meetings. Most recently data was presented at ECTRIMS 2025, including six year long term data from the ULTIMATE I & II Phase 3 trials; updated data from the ENHANCE trial evaluating modified dosing regimens for BRIUMVI in patients wi…

• ● In August 2025, we announced patient enrollment commenced into a randomized Phase 3 pivotal cohort to evaluate a consolidated Day 1 and Day 15 dosing regimen for IV BRIUMVI in the ongoing ENHANCE trial.

• In December 2022, we announced the FDA approval of BRIUMVI for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults, primarily based on results from the ULTIMATE I & II Phase 3 trials. On January 26, 2023, we …

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• ● Biologics carry unique risks and uncertainties, which could have a negative impact on our business.

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• ● Biologics carry unique risks and uncertainties, which could have a negative impact on our business.

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• ● Biologics carry unique risks and uncertainties, which could have a negative impact on our business.

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• In addition, recent legislative and regulatory proposals in the United States have included “most favored nation” (“MFN”) or international reference pricing models that would tie reimbursement or net prices for certain drugs to the lowest price available in other countries. Adoption or expansion of …

• the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate, including, without limitation, as a result of disruptions to our supply chains caused by global health crises, international conflicts …

• We may submit additional information to the FDA which the FDA determines constitutes a major amendment to the application and thereby extends the goal date for determination of approvability of the application;

• Furthermore, legislative and regulatory proposals have been made to expand post-approval requirements, make changes the Orphan Drug Act and related guidance, reform the 340B Drug Pricing Program, and restrict sales and promotional activities for drugs. With respect to the 340B drug discount program,…

• We cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our product candidates, if any, may be. Recent policy changes affecting the FDA have…

相对上期删除的文字 · 来源:10-Q · 2025-11-05

• any shifts in the regulatory focus of the U.S. government as a reflection of changing administrations;

• the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate, including, without limitation, as a result of disruptions to our supply chains caused by global health crises, international conflicts …

• We are currently focusing the majority of our efforts on maintaining approval, improving and commercializing BRIUMVI, developing subcutaneous ublituximab and developing azer-cel for particular indications. As a result, we may fail to capitalize on other indications or product candidates that may ult…

• We are currently focusing the majority of our resources and efforts on maintaining approval, improving and commercializing BRIUMVI and developing subcutaneous ublituximab and azer-cel for particular indications. As a result, we may forego or delay the pursuit of opportunities for other indications o…

• Furthermore, legislative and regulatory proposals have been made to expand post-approval requirements, make changes the Orphan Drug Act and related guidance, reform the 340B Drug Pricing Program, and restrict sales and promotional activities for drugs. With respect to the 340B drug discount program,…

相对上期新增的文字 · 来源:10-Q · 2026-05-06

• ● Biologics carry unique risks and uncertainties, which could have a negative impact on our business.