LGVN Stock Alert: The Huge FDA News Sending Longeveron to the Moon Today

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One of the biggest moves in the market today belongs to Longeveron (NASDAQ:LGVN). Currently, LGVN stock is up approximately 180% on more than 100 times the average daily volume.

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This sort of outsized move is one that ought to grab investor’s attention. As a clinical-stage biotech company, volatility can be expected. However, the scale of this move today is rather impressive.

Today, Longeveron made a game-changing announcement regarding its Lomecel-B drug. This drug targets a rare, life-threatening heart condition in infants. Accordingly, investors are jumping on this stock’s long-term potential in this pharmaceutical niche.

Let’s dive into what exactly was announced and why investors are so excited.

LGVN Stock Soars on FDA Approval for Key Drug

Longeveron’s announcement today that the Food and Drug Administration (FDA) has approved the company’s Lomecel-B drug for a Rare Pediatric Disease (RPD) designation is massive news. Essentially, a rare pediatric disease designation a big deal.

Should the company’s Lomecel-B drug proceed through clinical trials and be approved for the treatment of this rare heart disease, Longeveron will receive a priority review voucher for this drug. What this means is the company could potentially have this drug, and any subsequent drugs or biologic applications, reviewed within six months, rather than the typical 10 months. This would accelerate the company’s timeline of bringing drugs to market.

Investors appear to be factoring this bullish outlook into LGVN stock. While still early days, recent data provided by the company for its Phase 1 trials appears to have driven this decision. Accordingly, investors have factored in a strong probability that this drug could go to market faster and are upgrading the company’s drug pipeline accordingly.

On the date of publication, Chris MacDonald did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.