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Shares of TG Therapeutics (TGTX) jumped 10% on Wednesday, rebounding from five consecutive sessions of declines as investors welcomed positive clinical data for an injectable formulation of its multiple sclerosis treatment, which could enable at-home use.
TG Therapeutics’ multiple sclerosis drug, branded as Briumvi, was approved by the U.S. Food and Drug Administration (FDA) as an intravenous (IV) version in December 2022.
On Wednesday, the company announced positive Phase 1 results for a subcutaneous version of Briumvi, supporting its potential as a more convenient treatment option for patients with relapsing forms of multiple sclerosis (RMS).
The study evaluated a high-concentration injectable formulation of the drug against the currently approved IV version. Results showed favorable data, indicating that the subcutaneous formulation can achieve drug exposure and B-cell depletion levels comparable to the IV version.
More than 100 patients participated in the trial, with over 80 receiving the subcutaneous treatment. The therapy was generally well tolerated, with no new safety concerns identified. Injection-site reactions affected fewer than 5% of patients, while systemic reactions were mostly mild and resolved completely.
The findings support the quarterly dosing regimen currently being studied in a fully enrolled Phase 3 trial. TG Therapeutics said the 400 mg dose used in the study is suitable for potential at-home administration via an autoinjector. Top-line results from the Phase 3 trial are expected in late 2026 or early 2027.
Retail sentiment surrounding TGTX on Stocktwits changed to ‘bullish’ from ‘neutral’ a day earlier.
One user said the company is firmly moving into the “multi-billion sales territory.”
Another user sees potential for the stock to double in value.
The stock has gained around 31% so far this year.
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