Argenx announced plans to seek FDA approval for an expansion of its Vyvgart treatment for a new group of myasthenia gravis patients who test negative for the specific antibody used to diagnose the autoimmune condition. New study results showed a statistically significant and clinically meaningful improvement in daily living scores, the Netherlands-based biotech said.
The news came as RBC Capital analyst Luca Issi initiated coverage on Argenx with an outperform rating and 850 price target, saying that doctor checks point to accelerating uptake of Vyvgart, according to a write-up on The Fly investment news site. ARGX stock looks set to jump past a buy point at Monday's open.
Label Expansion For Vyvgart
Argenx called the positive study results "a critical advancement in the management of this debilitating and unpredictable disease for patients with limited treatment options." The study identified no new safety concerns, the company said.
Investor's Business Daily's The New America feature profiled Argenx on Aug. 15 following its "blowout" Q2 earnings report on July 31.
The company said in its Q2 earnings statement that it is "working toward the broadest possible label" for Vyvgart for treating both myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). Initial FDA approval came in 2021.
While standard Vyvgart is an intravenous infusion, the company's under-the-skin shot, Vyvgart Hytrulo, won FDA approval in 2023. Approval of the latest delivery method, a prefilled syringe of Vyvgart Hytrulo, came in April and immediately had an impact in broadening physician take-up of the drug.
Earnings soared 731% from a year ago to $3.74 per share in Q2 as revenue surged 98% to $967.2 million, according to FactSet.
RBC said that Argenx is a rarity among biotechs, with both scale (at least $2 billion in sales) and potential to quadruple that by the end of the decade.
ARGX Stock
Argenx rose 3.1% to 680.38 in early Monday stock market action. At today's open, ARGX looks set to reclaim a 678.21 buy point from a 28-week consolidation, according to MarketSurge.
ARGX vaulted 11.9% on its July 31 Q2 earnings report, subsequently hitting an intraday peak of 696.21 on Aug. 5. Subsequently, ARGX has etched out a three-weeks tight pattern, offering another buy point at 696.21.
Be sure to read IBD's The Big Picture column after each trading day to get the latest on the prevailing stock market trend and what it means for your trading decisions.
