TG Therapeutics changed the design of the GENUINE study last October to eliminate progression-free survival (PFS) as a co-primary endpoint, leaving only overall response rate. The planned enrollment was also cut from 330 to 120 patients. The changes allowed TG Therapeutics to complete the GENUINE study faster, but it also nullified the Special Protocol Assessment (SPA) reached with the FDA spelling out the regulatory requirements for ublituximab's approval.
FDA is often displeased when companies renege on SPAs and fail to provide the previously agreed-upon clinical data necessary for approval.
While TG Therapeutics acknowledges the added risk of the lost SPA, the company still intends to meet with the FDA "to discuss the filing of the data for accelerated approval." The company's supporters argue the nearly doubling of the response rate in ublituximab's favor should be strong enough clinical evidence for FDA to approve.
The question of medical need for previously treated, high-risk CLL patients is the other, simmering issue. TG Therapeutics bears make the point these patients can be treated today with a combination of Rituxan, Roche's long-approved anti-CD20 monoclonal antibody, and Imbruvica. Therefore, ublituximab is not filling an unmet medical need and accelerated approval should be off the table.
Bulls counter with the argument that Rituxan is not specifically approved for use in previously treated, high-risk CLL patients. Doctors prescribe Rituxan/Imbruvica off label. From an FDA perspective, therefore, an unmet medical need still exists.
[TG Therapeutics is a member of the Gnarly Nine. Read more here.]
I had lunch Thursday with a healthcare fund manager and longtime TG Therapeutics shareholder. We talked about the ublituximab CLL-approval controversy. His reaction: Bemused. He owns TG Therapeutics for ublituximab but because he believes the drug will eventually be approved for multiple sclerosis (following the development plan used by Roche to win the approval of ocrelizumab -- another anti-CD20 monoclonal antibody.)
My TG Therapeutics shareholder/lunch date didn't participate in this week's $50 million stock offering, but he suspects (but doesn't know for sure) that the funds who did were also more interested in ublituximab-multiple sclerosis than ublituximab-CLL.
https://www.thestreet.com/story/14036467/1/biotech-stock-mailbag-puma-s-rebound-explained-tg-therapeutics-approval-debate-aurinia-next-steps.html
Recent TGTX News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/06/2024 08:59:11 PM
- TG Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results • GlobeNewswire Inc. • 05/01/2024 11:00:00 AM
- TG Therapeutics to Host Conference Call on First Quarter 2024 Financial Results and Business Update • GlobeNewswire Inc. • 04/30/2024 08:55:29 PM
- TG Therapeutics Announces Additional Data Presentations for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 04/18/2024 11:30:00 AM
- TG Therapeutics Awarded National Contract by the Department of Veterans Affairs for BRIUMVI as the Preferred Anti-CD20 for Relapsing Forms of Multiple Sclerosis • GlobeNewswire Inc. • 04/18/2024 11:00:00 AM
- TG Therapeutics Announces Presentation of Data for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 04/15/2024 11:30:00 AM
- TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting • GlobeNewswire Inc. • 03/08/2024 12:30:00 PM
- TG Therapeutics Announces Presentation of Data for BRIUMVI® in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum • GlobeNewswire Inc. • 03/01/2024 12:30:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 02/29/2024 10:23:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 12:24:56 PM
- TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results • GlobeNewswire Inc. • 02/28/2024 12:00:00 PM
- TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy) • GlobeNewswire Inc. • 02/27/2024 12:30:00 PM
- TG Therapeutics Announces European Launch of BRIUMVI® (ublituximab-xiiy) • GlobeNewswire Inc. • 02/26/2024 12:00:00 PM
- TG Therapeutics to Host Conference Call on Fourth Quarter and Year-End 2023 Financial Results and Business Update • GlobeNewswire Inc. • 02/23/2024 12:30:00 PM
- TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum • GlobeNewswire Inc. • 02/20/2024 12:30:00 PM
- Form 5 - Annual statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/15/2024 02:53:50 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/14/2024 08:30:53 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:23:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/10/2024 12:37:35 PM
- TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones • GlobeNewswire Inc. • 01/10/2024 12:00:00 PM
- Biotech Massively Bid Up Before Opening Bell • AllPennyStocks.com • 01/09/2024 02:20:00 PM
- TG Therapeutics Announces Global License Agreement with Precision BioSciences for the Development and Commercialization of Precision’s Allogeneic CD19 CAR T Cell Therapy Program for the Treatment of Autoimmune Diseases • GlobeNewswire Inc. • 01/09/2024 12:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/08/2024 11:33:18 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/08/2024 11:32:45 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2024 10:00:59 PM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM