What happened
Biotech investors live for the day when one of their companies gets an investigational therapy approved. That happy circumstance occurred very recently for TG Therapeutics (TGTX 2.60%); as a result, the company's share price blasted almost 46% higher this week, according to data compiled by S&P Global Market Intelligence.
So what
On Wednesday, TG Therapeutics divulged the happy news that it earned Food and Drug Administration (FDA) approval for multiple sclerosis (MS) drug ublituximab-xiiy, brand-named Briumvi. The approval covers the treatment of relapsing forms of MS, which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The approval is for adult use.
Briumvi is an infusion drug, the administration of which consists of a day one infusion, a day 15 infusion, and follow-up infusions given every 24 weeks.
In its press release on the FDA's nod, TG Therapeutics quoted its CEO Michael Weiss as saying that "We believe in the importance of treatment alternatives for patients and believe the profile of Briumvi offers unique attributes to patients and physicians alike."
Saying that "We have built a strong commercial team with deep knowledge of the MS landscape," Weiss added that the company plans to launch commercial sales of Briumvi in the first quarter of 2023.
NASDAQ: TGTX
Key Data Points
Now what
Weiss and his team at TG Therapeutics aren't the only people looking forward to Briumvi's debut on the market.
In the wake of the FDA's approval, several analysts either raised their price targets on the stock or reiterated their bullish takes. Among this crowd was Cantor Fitzgerald's Prakhar Agrawal, who in maintaining his overweight (i.e., buy) recommendation at $40 per share wrote that the biotech will benefit from several tailwinds, including having sufficient funding to launch the drug as planned.
