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TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with UKONIQ™(umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia

NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), at this time introduced the completion of the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, together with UKONIQTM (umbralisib) , the Company’s once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a remedy for sufferers with power lymphocytic leukemia (CLL). The U.S. FDA beforehand granted Fast Track designation to the mixture of ublituximab and umbralisib (U2) for the remedy of grownup sufferers with CLL and orphan drug designation for ublituximab together with umbralisib for the remedy of CLL. The BLA submission was based mostly on the outcomes of the UNITY-CLL trial, a world Phase 3 trial evaluating the mixture of umbralisib plus ublituximab (U2) in comparison with obinutuzumab plus chlorambucil in sufferers with beforehand untreated and relapsed/refractory power lymphocytic leukemia (CLL). Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics acknowledged, “The rapid completion of this BLA submission is a critical step forward in our mission to bring our first proprietary combination regimen to patients with both treatment naïve and relapsed or refractory chronic lymphocytic leukemia. The FDA has previously granted the U2 combination both fast track designation as well as orphan drug designation for patients with CLL and we look forward to continuing to work closely with the FDA with the goal of bringing this novel treatment regimen to patients as quickly as possible.” Mr. Weiss continued, “I want to thank the patients, their families and caregivers, as well as the research teams who participated in the UNITY-CLL trial, and also commend the TG team for their hard work to get this submission completed ahead of schedule.”ABOUT UNITY-CLL PHASE 3 TRIAL UNITY-CLL is a world Phase 3 randomized managed scientific trial evaluating the mixture of ublituximab plus UKONIQ (umbralisib), or U2, to an energetic management arm of obinutuzumab plus chlorambucil in sufferers with each treatment-naïve and relapsed or refractory power lymphocytic leukemia (CLL). The trial randomized sufferers into 4 remedy arms: ublituximab single agent, UKONIQ single agent, ublituximab plus UKONIQ, and an energetic management arm of obinutuzumab plus chlorambucil. A prespecified interim evaluation was carried out to evaluate the contribution of ublituximab and UKONIQ in the U2 mixture arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two mixture arms: the investigational arm of U2 and the management arm of obinutuzumab plus chlorambucil. Approximately 420 topics enrolled to the two mixture arms and roughly 60% of sufferers had been treatment-naïve and 40% had been relapsed or refractory. The main endpoint for this examine was superior progression-free survival (PFS) for the U2 mixture in comparison with the management arm to help the submission of the U2 mixture in CLL. The trial met its main endpoint and outcomes had been introduced at the American Society of Hematology (ASH) Annual Meeting in December 2020. The UNITY-CLL Phase 3 trial is being carried out beneath a Special Protocol Assessment (SPA) settlement with the U.S. Food and Drug Administration (FDA).ABOUT CHRONIC LYMPHOCYTIC LEUKEMIAChronic lymphocytic leukemia (CLL) is the commonest kind of grownup leukemia. It is estimated there might be greater than 20,000 new instances of CLL identified in the United States in 2020 and roughly 45,000 new instances globally in 2020.1,2 Although indicators and signs of CLL might disappear for a time period after preliminary remedy, the illness is taken into account incurable and many individuals would require extra remedy because of the return of malignant cells. ABOUT FAST TRACKFast Track is a program designed to expedite the improvement and overview of medicine that deal with critical circumstances and that exhibit the potential to handle an unmet medical want. Filling an unmet medical want is outlined as offering a remedy the place none exists or offering a remedy that could be probably higher than accessible remedy. A drug that receives Fast Track designation is eligible for extra frequent interactions with the FDA, precedence overview if related standards are met, and rolling submission of the Biologics License Application or New Drug Application.ABOUT ORPHAN DRUG DESIGNATIONOrphan drug designation is granted by the FDA to medication and biologics that are outlined as these supposed for the secure and efficient remedy, prognosis or prevention of uncommon illnesses/issues that have an effect on fewer than 200,000 folks in the U.S. Orphan drug designation supplies sure incentives which can embrace tax credit in direction of the price of scientific trials and prescription drug consumer charge waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the illness for which it has such designation, the product is entitled to orphan product exclusivity. ABOUT TG THERAPEUTICS, INC. TG Therapeutics is a fully-integrated, industrial stage biopharmaceutical firm centered on the acquisition, improvement and commercialization of novel therapies for B-cell malignancies and autoimmune illnesses. In addition to an energetic analysis pipeline together with 5 investigational medicines throughout these therapeutic areas, UKONIQTM (umbralisib) obtained accelerated approval from the U.S. FDA for the remedy of grownup sufferers with relapsed/refractory marginal zone lymphoma who’ve obtained a minimum of one prior anti-CD20-based routine and relapsed/refractory follicular lymphoma who’ve obtained a minimum of three prior strains of systemic therapies. Currently, the Company has packages in Phase 3 improvement for the remedy of sufferers with relapsing types of a number of sclerosis (RMS) and for the remedy of sufferers with power lymphocytic leukemia (CLL) in addition to a number of investigational medicines in Phase 1 scientific improvement. For extra data, go to www.tgtherapeutics.com, and observe us on Twitter @TGTherapeutics and Linkedin.UKONIQTM is a trademark of TG Therapeutics, Inc. ABOUT UKONIQ™ (umbralisib) UKONIQ is the first and solely oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is understood to play an essential position in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in each regular and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of most cancers cells, together with lymphoid malignancies. UKONIQ is indicated for the remedy of grownup sufferers with relapsed or refractory marginal zone lymphoma (MZL) who’ve obtained a minimum of one prior anti-CD20-based routine and for the remedy of grownup sufferers with relapsed or refractory follicular lymphoma (FL) who’ve obtained a minimum of three prior strains of systemic remedy. These indications are accepted beneath accelerated approval based mostly on general response fee. Continued approval for this indication could also be contingent upon verification and outline of scientific profit in a confirmatory trial. IMPORANT SAFETY INFORMATIONInfections: Serious, together with deadly, infections occurred in sufferers handled with UKONIQ. Grade 3 or increased infections occurred in 10% of 335 sufferers, with deadly infections occurring in <1% . The most frequent Grade ≥3 infections included pneumonia, sepsis, and urinary tract an infection. Provide prophylaxis for Pneumocystis jirovecii pneumonia (PJP) and take into account prophylactic antivirals throughout remedy with UKONIQ to stop CMV an infection, together with CMV reactivation. Monitor for any new or worsening indicators and signs of an infection, together with suspected PJP or CMV, throughout remedy with UKONIQ. For Grade 3 or 4 an infection, withhold UKONIQ till an infection has resolved. Resume UKONIQ at the similar or a diminished dose. Withhold UKONIQ in sufferers with suspected PJP of any grade and completely discontinue in sufferers with confirmed PJP. For scientific CMV an infection or viremia, withhold UKONIQ till an infection or viremia resolves. If UKONIQ is resumed, administer the similar or diminished dose and monitor sufferers for CMV reactivation by PCR or antigen take a look at a minimum of month-to-month.Neutropenia: Serious neutropenia occurred in sufferers handled with UKONIQ. Grade 3 neutropenia developed in 9% of 335 sufferers and Grade 4 neutropenia developed in 9%. Monitor neutrophil counts a minimum of each 2 weeks for the first 2 months of UKONIQ and a minimum of weekly in sufferers with neutrophil depend <1 x 109/L (Grade 3-4) neutropenia throughout remedy with UKONIQ. Consider supportive care as applicable. Withhold, cut back dose, or discontinue UKONIQ relying on the severity and persistence of neutropenia.Diarrhea or Non-Infectious Colitis: Serious diarrhea or non-infectious colitis occurred in sufferers handled with UKONIQ. Any grade diarrhea or colitis occurred in 53% of 335 sufferers and Grade 3 occurred in 9%. For sufferers with extreme diarrhea (Grade 3, i.e., > 6 stools per day over baseline) or stomach ache, stool with mucus or blood, change in bowel habits, or peritoneal indicators, withhold UKONIQ till resolved and supply supportive care with antidiarrheals or enteric appearing steroids as applicable. Upon decision, resume UKONIQ at a diminished dose. For recurrent Grade 3 diarrhea or recurrent colitis of any grade, discontinue UKONIQ. Discontinue UKONIQ for life-threatening diarrhea or colitis.Hepatotoxicity: Serious hepatotoxicity occurred in sufferers handled with UKONIQ. Grade 3 and 4 transaminase elevations (ALT and/or AST) occurred in 8% and <1%, respectively, in 335 sufferers. Monitor hepatic operate at baseline and through remedy with UKONIQ. For ALT/AST higher than 5 to lower than 20 instances ULN, withhold UKONIQ till return to lower than 3 instances ULN, then resume at a diminished dose. For ALT/AST elevation higher than 20 instances ULN, discontinue UKONIQ. Severe Cutaneous Reactions: Severe cutaneous reactions, together with a deadly case of exfoliative dermatitis, occurred in sufferers handled with UKONIQ. Grade 3 cutaneous reactions occurred in 2% of 335 sufferers and included exfoliative dermatitis, erythema, and rash (primarily maculo-papular). Monitor sufferers for new or worsening cutaneous reactions. Review all concomitant drugs and discontinue any probably contributing drugs. Withhold UKONIQ for extreme (Grade 3) cutaneous reactions till decision. Monitor a minimum of weekly till resolved. Upon decision, resume UKONIQ at a diminished dose. Discontinue UKONIQ if extreme cutaneous response doesn’t enhance, worsens, or recurs. Discontinue UKONIQ for life-threatening cutaneous reactions or SJS, TEN, or DRESS of any grade. Provide supportive care as applicable. Allergic Reactions Due to Inactive Ingredient FD&C Yellow No. 5: UKONIQ incorporates FD&C Yellow No. 5 (tartrazine), which can trigger allergic-type reactions (together with bronchial bronchial asthma) in sure inclined individuals, steadily in sufferers who even have aspirin hypersensitivity.Embryo-fetal Toxicity: Based on findings in animals and its mechanism of motion, UKONIQ could cause fetal hurt when administered to a pregnant lady. Advise pregnant ladies of the potential threat to a fetus. Advise females and males with feminine companions of reproductive potential to make use of efficient contraception throughout remedy and for a minimum of one month after the final dose.Serious opposed reactions occurred in 18% of 221 sufferers who obtained UKONIQ. Serious opposed reactions that occurred in ≥2% of sufferers had been diarrhea-colitis (4%), pneumonia (3%), sepsis (2%), and urinary tract an infection (2%). Permanent discontinuation of UKONIQ because of an opposed response occurred in 14% of sufferers. Dose reductions of UKONIQ because of an opposed response occurred in 11% of sufferers. Dosage interruptions of UKONIQ because of an opposed response occurred in 43% of sufferers. The commonest opposed reactions (>15%), together with laboratory abnormalities, in 221 sufferers who obtained UKONIQ had been elevated creatinine (79%), diarrhea-colitis (58%, 2%), fatigue (41%), nausea (38%), neutropenia (33%), ALT enhance (33%), AST enhance (32%), musculoskeletal ache (27%), anemia (27%), thrombocytopenia (26%), higher respiratory tract an infection (21%), vomiting (21%), stomach ache (19%), decreased urge for food (19%), and rash (18%).Lactation: Because of the potential for critical opposed reactions from umbralisib in the breastfed baby, advise ladies to not breastfeed throughout remedy with UKONIQ and for a minimum of one month after the final dose.Please go to www.tgtherapeutics.com/prescribing-information/uspi-ukon for full Prescribing Information and Medication Guide. 1 Cancer Stat Facts: Leukemia — Chronic Lymphocytic Leukemia (CLL). National Cancer Institute Surveillance, Epidemiology, and End Results Program web site. https://seer.cancer.gov/statfacts/html/clyl.html. Accessed October 26, 2020.2 EpiCast Report: Chronic Lymphocytic Leukemia – Epidemiology Forecast to 2025. Available at: https://store.globaldata.com/report/gdhcer164-17–epicast-report-chronic-lymphocytic-leukemia-epidemiology-forecast-to-2025/. Cautionary StatementThis press launch incorporates forward-looking statements inside the which means of the U.S. Private Securities Litigation Reform Act of 1995, together with statements referring to the BLA submission of ublituximab together with UKONIQTM (umbralisib), the scientific improvement of our product candidates, and anticipated milestones. In addition to the threat elements recognized infrequently in our studies filed with the U.S. Securities and Exchange Commission, elements that might trigger our precise outcomes to vary materially are the following: threat that the FDA is not going to settle for the BLA submission of ublituximab together with UKONIQ in sufferers with CLL, or if accepted, the threat that the FDA is not going to approve the BLA submission; the threat that quick monitor designation might not really result in a sooner regulatory overview or approval course of; the threat that issues of safety or traits might be noticed in the UNITY-CLL examine or in different research that stop approval of ublituximab together with UKONIQ; the threat that ublituximab together with UKONIQ, or every other product candidates, is not going to be commercially profitable if accepted; the threat that the differentiated tolerability profile for UKONIQ beforehand noticed in scientific trials is not going to be reproduced in the UNITY-CLL trial or every other on-going research; our potential to efficiently and affordably full preclinical and scientific trials; the uncertainties inherent in analysis and improvement; and the threat that the ongoing COVID-19 pandemic and related authorities management measures have an opposed affect on our analysis and improvement plans or commercialization efforts. Further dialogue about these and different dangers and uncertainties could be present in our Annual Report on Form 10-Ok for the fiscal yr ended December 31, 2020 and in our different filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth on this press launch converse solely as of the date of this press launch. We don’t undertake to replace any of those forward-looking statements to replicate occasions or circumstances that happen after the date hereof. This press launch and prior releases can be found at www.tgtherapeutics.com. The data discovered on our web site will not be included by reference into this press launch and is included for reference functions solely. CONTACT: Investor Relations Email: [email protected]: 1.877.575.TGTX (8489), Option 4 Media Relations: Email: [email protected]: 1.877.575.TGTX (8489), Option 6

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