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Sep 30, 2021
TG Therapeutics Q3 2021 Earnings Report
TG Therapeutics' third quarter results for 2021 were reported, featuring the submission of a BLA for ublituximab in RMS and $2.0 million in UKONIQ revenue.
Key Takeaways
TG Therapeutics reported its Q3 2021 financial results, highlighting the submission of a Biologics License Application (BLA) to the U.S. FDA for ublituximab to treat patients with relapsing forms of multiple sclerosis (RMS). The company generated $2.0 million in net product revenue from UKONIQ sales. The company's cash, cash equivalents and investment securities were $381.4 million as of September 30, 2021.
Submitted a BLA to the U.S. FDA for ublituximab to treat patients with relapsing forms of multiple sclerosis (RMS).
Ublituximab plus UKONIQ® (U2) in Chronic Lymphocytic Leukemia received FDA acceptance of a BLA for ublituximab and a supplemental New Drug Application (sNDA) for UKONIQ.
Launched UKONIQ in the U.S. for the treatment of adult patients with relapsed or refractory marginal zone lymphoma & follicular lymphoma.
Generated $4.3M in total net UKONIQ revenue from launch through the end of Q3 2021, approximately seven months.
Forward Guidance
TG Therapeutics plans to continue the commercialization of UKONIQ, seek FDA approval of U2 in CLL and SLL by March 25, 2022, continue to enroll patients into the ULTRA-V Phase 3 trial, and advance early pipeline candidates.
Positive Outlook
- Continue the commercialization of UKONIQ in R/R MZL and FL and expand commercialization capabilities in preparation for a potential launch of U2 in CLL and ublituximab in RMS.
- Seek to obtain U.S. FDA approval of U2 in CLL and SLL by the PDUFA goal date of March 25, 2022.
- Continue to enroll patients into the newly launched ULTRA-V Phase 3 trial evaluating the triple combination of U2 plus venetoclax.
- Continue to advance our early pipeline candidates including TG-1501 (cosibelimab) our PDL1 inhibitor, TG-1701 our BTK inhibitor and TG-1801 our CD47/CD19 bispecific antibody.
Historical Earnings Impact
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