BioCentury | Aug 15, 2020
Product Development

Aug. 14 Quick Takes: Challenge data for CanSino COVID-19 vaccine; plus Warp Speed-McKesson, BioMarin, TG, Solasia-Isofol

...lymphoma treatmentTG Therapeutics Inc. (NASDAQ:TGTX) said FDA has accepted for Priority Review an NDA for umbralisib...
...– Phosphoinositide 3-kinase deltaCSNK1E (CKI-epsilon) – Casein kinase 1 epsilon BC Staff Ad5-nCoV vosoritide (BMN 111, bmn-111) umbralisib (TGR-1202, rp5264) CanSino...
BioCentury | May 6, 2020
Product Development

May 5 Quick Takes: Data propel Adverum, TG, Akebia stocks; plus Tolmar, SRI-Exscientia, Sino-GeoVax

...NASDAQ:TGTX) climbed $4.23 (34%) to $16.69 on Tuesday after CD20 inhibitor ublituximab plus PI3Kδ inhibitor umbralisib...
...VEGF-A - Vascular endothelial growth factor A BioCentury Staff vadadustat (MT-6548, akb-6548) ADVM-022 (AAV.7m8-aflibercept) ublituximab (TG-1101, TGTX-1101, LFB-R603) umbralisib (TGR-1202, rp5264) SRI...
BioCentury | Oct 28, 2019
Clinical News

TG makes case for umbralisib as safer lymphoma option

...for what could be the third PI3Kδ inhibitor to gain FDA approval, TG Therapeutics said umbralisib...
...UNITY-NHL trial. TG Therapeutics Inc. (NASDAQ:TGTX) gained $1.02 (18%) to $6.80 Monday after reporting that umbralisib...
...Targets: PI3Kδ - Phosphoinositide 3-kinase δ; PI3Kγ - Phosphoinositide 3-kinase γ Sandi Wong, Staff Writer umbralisib (TGR-1202, rp5264) TG...
BioCentury | Apr 5, 2019
Clinical News

TG reports response rate of 52% for lymphoma candidate

...supporting the company's decision to seek accelerated approval from FDA by year end for umbralisib (TGR-1202...
...Association for Cancer Research (AACR) meeting in Atlanta, TG Therapeutics Inc. (NASDAQ:TGTX) said once-daily oral umbralisib...
...develop and commercialize umbralisib from Rhizen Pharmaceuticals S.A. (La Chaux-de-Fonds, Switzerland). Brian Moy, Assistant Editor umbralisib (TGR-1202, rp5264) AACR American...
BioCentury | Mar 1, 2019
Clinical News

TG aims for accelerated approval of lymphoma candidate

...TG Therapeutics Inc. (NASDAQ:TGTX) said umbralisib (TGR-1202) met the primary endpoint in a cohort of marginal...
...submit an NDA by year end seeking umbralisib's accelerated approval to treat marginal zone lymphoma. Umbralisib...
...IIb data Milestone: Submit NDA (year end 2019); additional Phase IIb data (2019) Brian Moy umbralisib (TGR-1202, rp5264) Rhizen...
BioCentury | Feb 28, 2019
Clinical News

TG aims for accelerated approval of lymphoma candidate

...TG Therapeutics Inc. (NASDAQ:TGTX) added $1.61 (31%) to $6.80 on Thursday after reporting that umbralisib (TGR-1202...
...submit an NDA by year end seeking umbralisib's accelerated approval to treat marginal zone lymphoma. Umbralisib...
...India to develop and commercialize umbralisib from Rhizen Pharmaceuticals S.A. (La Chaux-de-Fonds, Switzerland). Brian Moy umbralisib (TGR-1202, rp5264) Rhizen...
BioCentury | Sep 28, 2018
Clinical News

TG won't seek accelerated approval of CLL combo

...after the company said it will not seek accelerated approval of ublituximab (TG-1101) plus umbralisib (TGR-1202...
...S.A., La Chaux-de-Fonds, Switzerland TG Therapeutics Inc. (NASDAQ:TGTX), New York, N.Y. Product: Ublituximab (TG-1101); umbralisib (TGR-1202...
...ongoing Milestone: Phase III data (2019); submit regulatory application (2019) Alicia Parker ublituximab (TG-1101, TGTX-1101, LFB-R603) umbralisib (TGR-1202, rp5264) TG...
BioCentury | Sep 25, 2018
Clinical News

TG won't seek accelerated approval of CLL combo; shares sink

...after the company said it will not seek accelerated approval of ublituximab (TG-1101) plus umbralisib (TGR-1202...
...TG said UNITY-CLL's efficacy data remain blinded. Ublituximab is a glycoengineered mAb against CD20, and umbralisib...
...chlorambucil in both treatment-naïve and relapsed or refractory CLL patients. Alicia Parker ublituximab (TG-1101, TGTX-1101, LFB-R603) umbralisib (TGR-1202, rp5264) TG...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

...Fremanezumab Prevent migraine PDUFA date 9/16/18 TG Therapeutics Inc. (NASDAQ:TGTX) / Rhizen Pharmaceuticals S.A. Umbralisib (TGR-1202...
BioCentury | Jun 8, 2018
Clinical News

TG Therapeutics reports Phase II data for umbralisib in CLL

...TG Therapeutics Inc. (NASDAQ:TGTX) said once-daily oral umbralisib (TGR-1202) led to nodal reductions in nearly all...
...Rhizen Pharmaceuticals S.A. (La Chaux-de-Fonds, Switzerland) TG Therapeutics Inc. (NASDAQ:TGTX), New York, N.Y. Product: Umbralisib (TGR-1202...
...Progression-free survival (PFS); safety Status: Phase II data Milestone: Phase III data (2H18) Sandi Wong umbralisib (TGR-1202, rp5264) American...
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