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TG Therapeutics TGTX

8 Posts
Forecast2006
0
By Sriparna Roy and Khushi Mandowara

(Reuters) - TG Therapeutics (NASDAQ:TGTX) Inc said on Wednesday that the U.S. health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up 47% in afternoon trade.

The approval by the U.S. Food and Drug Administration (FDA) widens the number of such drugs available for treating the disorder to three and may help soften the blow to the company's finances from the withdrawal of its lymphatic cancer drug earlier this year.

TG Therapeutics said it was expecting to launch the drug, branded as Briumvi, in the first quarter of 2023, but did not give details on its pricing.

Jefferies analyst Chris Howerton said ahead of the approval that he was expecting the drug to be priced in the range of $30,000 per patient per year. In comparison, Roche's Ocrevus has a current list price of about $68,000 annually.

Multiple sclerosis is a neurological disease in which the immune system attacks the brain cells causing motor disabilities. It affects about 400,000 people in the United States, according to the National Institutes of Health.

Unlike other MS drugs that target T cells, Briumvi belongs to a class of drugs that tackles B cells' role in driving the inflammation that is central to the neurological disease.

The approval, which comes with a warning of infusion reactions from the drug, was based on a late-stage study that showed the drug was effective in reducing the annualized relapse rates in patients.

Ben benieuwd wat ie vandaag doet.

Kind regards,

Forecast
Forecast2006
0
Forecast2006
0

U.S. FDA approves TG Therapeutics' multiple sclerosis drug; shares surge
Stock Markets Dec 28, 2022 03:20PM ET

U.S. FDA approves TG Therapeutics' multiple sclerosis

By Sriparna Roy and Khushi Mandowara

(Reuters) - TG Therapeutics (NASDAQ:TGTX) Inc said on Wednesday that the U.S. health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up 47% in afternoon trade.

The approval by the U.S. Food and Drug Administration (FDA) widens the number of such drugs available for treating the disorder to three and may help soften the blow to the company's finances from the withdrawal of its lymphatic cancer drug earlier this year.

TG Therapeutics said it was expecting to launch the drug, branded as Briumvi, in the first quarter of 2023, but did not give details on its pricing.

Jefferies analyst Chris Howerton said ahead of the approval that he was expecting the drug to be priced in the range of $30,000 per patient per year. In comparison, Roche's Ocrevus has a current list price of about $68,000 annually.

Multiple sclerosis is a neurological disease in which the immune system attacks the brain cells causing motor disabilities. It affects about 400,000 people in the United States, according to the National Institutes of Health.

Unlike other MS drugs that target T cells, Briumvi belongs to a class of drugs that tackles B cells' role in driving the inflammation that is central to the neurological disease.

The approval, which comes with a warning of infusion reactions from the drug, was based on a late-stage study that showed the drug was effective in reducing the annualized relapse rates in patients.
Forecast2006
0
Feb 14, 2023
NEW YORK, Feb. 14, 2023 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations highlighting data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI™ (ublituximab) in adult patients with relapsing forms of multiple sclerosis (RMS), at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum, being held February 23 – 25, 2023, in San Diego, California. Abstracts are now available online and can be accessed on the ACTRIMS meeting website at www.forum.actrims.org. Details of the presentations are outlined below.

Poster Presentation Title: Early, Transient Shift in Hematologic Parameters Observed with Ublituximab in the ULTIMATE I and II Phase 3 Studies

Presentation Date/Time: Thursday, February 23, 7:00 - 7:30 PM PST
Session: Poster Session 1
Abstract Number/Poster Number: 406/P071
Lead Author: Peiqing Qian, MD, Swedish Neuroscience Institute, Seattle, WA

CONTACT:

Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations:
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6

Kind regards,
Forecast
Forecast2006
0
Flinke stijging van de koers van 26,74 % na 4e kwartaalcijfers die beter waren dan de analisten hadden verwacht.
Hoop dat het medicijn BRIUMVI MS patiënten gaat helpen.
Kind regards,
Forecast
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