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Home » Keywords » TG Therapeutics Inc.

Items Tagged with 'TG Therapeutics Inc.'

ARTICLES

Stock table, gold arrow pointing down
BioWorld Cancer Index (BCI)

Cancer Index takes hit in 2024 amid regulatory setbacks, failures

Feb. 12, 2025
By Amanda Lanier
The BioWorld Cancer Index (BCI) experienced a steep decline in 2024, closing the year down 17.32%. After peaking in late February with an 11.16% gain, the index steadily trended downward, with only brief recoveries that failed to push it back into positive territory. This marked a sharp contrast to 2023, when the BCI soared 76.26% by year-end. In comparison, 2022 saw the index drop by 41.98%, while 2021 closed with a decline of 36.34%.
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FDA Approved stamp

Genentech’s new multiple sclerosis treatment reduces admin time

Sep. 16, 2024
By Lee Landenberger
Genentech’s newly approved multiple sclerosis (MS) injection takes about 10 minutes to administer, dramatically reducing the four to six hours required by its intravenous predecessor. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS on Sept. 13.
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Multiple sclerosis-damaged myelin
Neurology/psychiatric

Azer-cel gets IND clearance in multiple sclerosis

Aug. 12, 2024
Precision Biosciences Inc. has announced that its experimental allogeneic T cell therapy azercabtagene zapreleucel (azer-cel) for the treatment of multiple sclerosis (MS) has received IND clearance from the FDA.
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Test tubes, dropper
Index insights

BioWorld Drug Developers Index bolstered by clinical data, Q4 results

March 6, 2024
By Amanda Lanier
Though down nearly 6% in January, the BioWorld Drug Developers Index (BDDI) rebounded in February, finishing the month with a 4.41% increase and outperforming both the Nasdaq Biotechnology Index (NBI; up 1.33%) and the Dow Jones Industrial Average (DJIA; up 3.47%). In 2023, BDDI concluded the year down 11.35%, trailing behind the NBI and DJIA.
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JPM recap: Biopharma rising to postmarketing challenges in 2024

Jan. 12, 2024
By Jennifer Boggs
“This is a tough business. It’s never a straight line from start to success.” Those words, from Exelixis Inc. CEO Michael Morrissey, during a presentation at the J.P. Morgan Healthcare Conference (JPM), could easily sum up any aspect of the biopharma industry. But with more biopharma firms than ever having reached commercial status, along with the introduction of new therapeutic modalities into the health care market, many are finding the toughest part comes after regulatory approval, whether it’s navigating a competitive landscape, getting payers and physicians on board, or satisfying regulators’ stringent postmarketing requirements. As industry players and observers head home after a busy week in San Francisco, BioWorld offers a brief glimpse at a few firms taking on those post-approval challenges in 2024.
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Briumvi

TG sinks on Q2 ‘miss’ but secures EU launch plans for Briumvi

Aug. 1, 2023
Despite a newly signed $645 million commercialization deal with Neuraxpharm Group for multiple sclerosis drug Briumvi (ublituximab) in Europe, shares of TG Therapeutics Inc. (NASDAQ:TGTX) tanked by 49.3% on Aug. 1 due to a perceived miss in U.S. net sales for the anti-CD20 monoclonal antibody during its first full quarter on the U.S. market.
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Multiple sclerosis, neurons concept art.

Ocrevus grievous for TG in MS? Roche wins with subcu version

July 13, 2023
By Randy Osborne
Although shares of TG Therapeutics Inc. took a hit on word of positive phase III data in multiple sclerosis (MS) from competitor Genentech, a unit of Roche Holding AG, the results may not end up affecting much the market showdown between the CD20 players.
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Briumvi

TG’s anti-CD20 antibody wins FDA nod for MS

Dec. 28, 2022
By Jennifer Boggs
Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).
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Financial chart, downward arrow

Cancer stocks languish amid challenging markets

Dec. 2, 2022
By Karen Carey
All gains made throughout the summer have vanished as the BioWorld Cancer Index (BCI) has hit its lowest point in 2022. Down 41.9% this year, BCI diverged in October from the path taken by both the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA), both of which are moving upward. Still, NBI is down 7.8% and DJIA is down 5.4% for the year.
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Microglia and myelin

Open label: Extension of PDUFA less troubling as TG’s ublituximab makes headway in regulatory talks

Nov. 11, 2022
By Randy Osborne
With labeling discussions begun for TG Therapeutics Inc.’s ublituximab to treat relapsing multiple sclerosis, Wall Street was optimistic about the PDUFA date of Dec. 28 assigned to the glycoengineered CD20 monoclonal antibody. Shares of New York-based TG (NASDAQ:TGTX) closed Nov. 11 at $9.34, up 91 cents, or 10.8%, having risen more than 52% over the previous five days. With late-cycle review talks with the U.S. FDA done, ublituximab seemed well on its way.
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More Articles Tagged with 'TG Therapeutics Inc.'

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