Larimar Therapeutics Inc (NASDAQ:LRMR) shares are trading sharply higher Tuesday after the company said the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to its investigational Friedreich's ataxia treatment nomlabofusp.

The designation covers adults and children with the rare disease and was based on data from an ongoing open-label study. Here’s what investors need to know.

• Larimar Therapeutics shares are climbing with conviction. What’s driving LRMR stock higher?

FDA Grants Breakthrough Therapy Status

Breakthrough Therapy status is designed to speed development of drugs that may improve outcomes over current therapies for serious conditions.

Larimar reported that FDA communications following a recent START program meeting support the company's plan to use skin frataxin, or FXN, levels as a potential surrogate endpoint in a Biologics License Application seeking accelerated approval.

LRMR Targets 2026 BLA Submission

The company reiterated that it expects topline data from the study in the second quarter of 2026 and continues to target a June 2026 BLA filing. A global Phase 3 trial is expected to begin screening patients in the same quarter, with first dosing planned for mid-2026. If approved, Larimar is aiming for a U.S. launch in the first half of 2027.

Nomlabofusp is a protein replacement therapy intended to address the underlying frataxin deficiency in Friedreich's ataxia. Larimar noted that safety database adequacy and overall benefit-risk will be evaluated by regulators at the time of the BLA review and that forward-looking statements are subject to clinical, regulatory and financing risks.

LRMR Shows Sustained Upward Momentum

Currently, the stock is trading 13.6% above its 20-day simple moving average (SMA) and 7.4% above its 50-day SMA, indicating strong short-term momentum.

Shares have increased 23.01% over the past 12 months and are positioned closer to their 52-week highs than lows, suggesting a favorable long-term trend.

The RSI is at 33.78, which is considered neutral territory, while the MACD shows a value of -0.1482, below its signal line at -0.1055, indicating bearish pressure on the stock.

The combination of neutral RSI and bearish MACD suggests mixed momentum.

• Key Resistance: $4.00
• Key Support: $3.50

LRMR Shares Skyrocket Tuesday

LRMR Price Action: Larimar Therapeutics shares were up 31.67% at $3.70 at the time of publication on Tuesday, according to Benzinga Pro data.

Image: Shutterstock

• No comments yet. Be the first to comment!