Larimar Therapeutics jumps on FDA Breakthrough Therapy Designation for nomlabofusp

Larimar Therapeutics (LRMR) is up 28.5% today. Here is some analysis on what might have caused this price movement.

Analysis: Shares appear to be rallying after the company said the FDA granted Breakthrough Therapy Designation for nomlabofusp in Friedreich’s ataxia, a regulatory milestone that can de-risk and potentially accelerate the path to market. The update also reiterated a targeted June 2026 BLA submission timeline, which likely boosted investor expectations around accelerated approval.

Details:

The FDA granted Breakthrough Therapy Designation for nomlabofusp for adults and children with Friedreich’s ataxia, based on available clinical data from an ongoing open-label study.

The company reiterated plans to submit a Biologics License Application seeking accelerated approval in June 2026, with skin frataxin (FXN) proposed as a surrogate endpoint under an accelerated approval framework.

Topline open-label study data intended to support the planned BLA are expected in Q2 2026, keeping near-term focus on upcoming clinical/regulatory deliverables.

The company outlined plans for a global Phase 3 confirmatory study to be underway around the time of submission, with a targeted U.S. launch in the first half of 2027 if approved.

Sources:

GlobeNewswire, Larimar Therapeutics, SEC

Disclaimer: This price movement analysis was generated with the help of AI. Please double-check the information provided for mistakes.

$LRMR Hedge Fund Activity

We have seen 68 institutional investors add shares of $LRMR stock to their portfolio, and 72 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

RA CAPITAL MANAGEMENT, L.P. removed 6,045,351 shares (-100.0%) from their portfolio in Q4 2025, for an estimated $23,032,787
OPALEYE MANAGEMENT INC. removed 3,720,867 shares (-100.0%) from their portfolio in Q4 2025, for an estimated $14,176,503
RTW INVESTMENTS, LP added 3,125,000 shares (+inf%) to their portfolio in Q4 2025, for an estimated $11,906,250
ADAGE CAPITAL PARTNERS GP, L.L.C. added 1,900,000 shares (+inf%) to their portfolio in Q3 2025, for an estimated $6,137,000
AIGH CAPITAL MANAGEMENT LLC added 1,000,000 shares (+100.0%) to their portfolio in Q4 2025, for an estimated $3,810,000
BLUE OWL CAPITAL HOLDINGS LP added 970,650 shares (+16.6%) to their portfolio in Q4 2025, for an estimated $3,698,176
ALYESKA INVESTMENT GROUP, L.P. removed 959,348 shares (-50.8%) from their portfolio in Q4 2025, for an estimated $3,655,115

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

$LRMR Analyst Ratings

Wall Street analysts have issued reports on $LRMR in the last several months. We have seen 3 firms issue buy ratings on the stock, and 0 firms issue sell ratings.

Here are some recent analyst ratings:

Oppenheimer issued a "Outperform" rating on 10/02/2025
Baird issued a "Outperform" rating on 09/30/2025
Wedbush issued a "Outperform" rating on 09/30/2025

To track analyst ratings and price targets for $LRMR, check out Quiver Quantitative's $LRMR forecast page.

$LRMR Price Targets

Multiple analysts have issued price targets for $LRMR recently. We have seen 3 analysts offer price targets for $LRMR in the last 6 months, with a median target of $11.0.

Here are some recent targets:

Andreas Argyrides from Oppenheimer set a target price of $21.0 on 10/02/2025
Joel Beatty from Baird set a target price of $7.0 on 09/30/2025
Laura Chico from Wedbush set a target price of $11.0 on 09/30/2025

This article is not financial advice. See Quiver Quantitative's disclaimers for more information. Note that there may be inaccuracies due to mistakes in ticker-mapping, and other anomalies.