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
- New BRIUMVI® (ublituximab-xiiy) Data from the ENHANCE Phase 3b Study Show Rapid 30-Minute Infusions are Well Tolerated in Patients with Relapsing Forms of Multiple Sclerosis • GlobeNewswire Inc. • 09/18/2024 11:15:00 AM
- New Data for BRIUMVI® (ublituximab-xiiy) Demonstrate that 92% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 5 Years of Treatment • GlobeNewswire Inc. • 09/18/2024 11:00:00 AM
- Palantir Technologies, Dell Technologies, and Erie Indemnity Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600 • PR Newswire (US) • 09/06/2024 10:43:00 PM
- TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI at the 2024 European Committee for Treatment and Research in Multiple Sclerosis Annual Meeting • GlobeNewswire Inc. • 09/05/2024 11:30:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/09/2024 08:03:55 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 08/09/2024 08:01:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 11:08:39 AM
- TG Therapeutics Reports Second Quarter 2024 Financial Results and Raises BRIUMVI® (ublituximab-xiiy) Full Year Revenue Guidance • GlobeNewswire Inc. • 08/06/2024 11:00:00 AM
- TG Therapeutics to Host Conference Call on Second Quarter 2024 Financial Results and Business Update • GlobeNewswire Inc. • 08/05/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/17/2024 08:48:08 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/17/2024 07:08:53 PM
- Form PX14A6G - Notice of exempt solicitation submitted by non-management • Edgar (US Regulatory) • 06/10/2024 03:23:35 PM
- TG Therapeutics to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference • GlobeNewswire Inc. • 06/07/2024 11:50:00 AM
- TG Therapeutics to Participate in the Jefferies Global Healthcare Conference • GlobeNewswire Inc. • 06/03/2024 11:30:00 AM
- TG Therapeutics Announces Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting • GlobeNewswire Inc. • 05/31/2024 11:30:00 AM
- TG Therapeutics Announces Schedule of Upcoming Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the 2024 Consortium of Multiple Sclerosis Centers Annual Meeting • GlobeNewswire Inc. • 05/28/2024 11:30:00 AM
- 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
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