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Larimar (LRMR) Up on Lifting of Partial Clinical Hold on FA Study
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Larimar Therapeutics, Inc. (LRMR - Free Report) announced that the FDA has removed the partial clinical hold on its nomlabofusp (CTI-1601) clinical program following a review of the phase II dose exploration study data. Shares of the company were up 8.5% on May 21 following the announcement of the news.
Larimar’s lead pipeline candidate, nomlabofusp, is being developed for the treatment of patients with Friedreich’s ataxia (FA). The candidate is designed to potentially address frataxin deficiency, which is the underlying cause of this rare, progressive and fatal disease of the nervous system.
In February 2024, the company completed the four-week, placebo-controlled phase II dose exploration study evaluating nomlabofusp in patients with FA. Treatment with nomlabofusp was generally well-tolerated throughout the four-week treatment period in the study.
The abovementioned review by the FDA comprised data from both the 25 mg and 50 mg cohorts in patients who received daily dosing of nomlabofusp for 14 days, followed by dosing on alternate days until day 28.
Per the company, at day 14, all the patients (with quantifiable levels at baseline and day 14) who were treated with nomlabofusp (50 mg) achieved frataxin levels in skin cells of more than 33% of the average level seen in healthy volunteers, while three patients achieved more than 50% of the average level seen in healthy volunteers.
Shares of Larimar have increased 73.4% year to date against the industry’s decrease of 6.5%.
Image Source: Zacks Investment Research
Nomlabofusp (25 mg) is currently being evaluated in the ongoing open label extension (OLE) study in patients with FA. The OLE study will initially investigate daily subcutaneous injections of nomlabofusp (25 mg) in the given patient population.
The company plans to dose escalate to nomlabofusp (50 mg) in the OLE study following additional characterization of frataxin pharmacodynamics at the 25 mg dose. Interim data from the OLE study is expected to be announced in the fourth quarter of 2024.
Nomlabofusp has received Rare Pediatric Disease designation, Fast Track designation and Orphan Drug designations from the FDA to treat FA.
In the absence of a marketed product currently, the successful development of nomlabofusp remains the key focus area for Larimar.
We remind investors that Biogen (BIIB - Free Report) currently markets Skyclarys, which is the first approved treatment for FA. The FDA approved the drug in February 2023, while it was approved in Europe in February 2024.
The acquisition of Reata Pharmaceuticals in September 2023 added this newly approved rare disease drug to Biogen’s portfolio.
Per Biogen, the U.S. launch of Skyclarys is progressing and the EU launch is currently underway.
In the past 60 days, estimates for Entera Bio’s 2024 loss per share have narrowed from 75 cents to 25 cents. Year to date, shares of ENTX have surged 298.4%.
ENTX’s earnings beat estimates in three of the trailing four quarters and missed the same once, the average surprise being 6.50%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87. Year to date, shares of MRNS have plunged 87.8%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.
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Larimar (LRMR) Up on Lifting of Partial Clinical Hold on FA Study
Larimar Therapeutics, Inc. (LRMR - Free Report) announced that the FDA has removed the partial clinical hold on its nomlabofusp (CTI-1601) clinical program following a review of the phase II dose exploration study data. Shares of the company were up 8.5% on May 21 following the announcement of the news.
Larimar’s lead pipeline candidate, nomlabofusp, is being developed for the treatment of patients with Friedreich’s ataxia (FA). The candidate is designed to potentially address frataxin deficiency, which is the underlying cause of this rare, progressive and fatal disease of the nervous system.
In February 2024, the company completed the four-week, placebo-controlled phase II dose exploration study evaluating nomlabofusp in patients with FA. Treatment with nomlabofusp was generally well-tolerated throughout the four-week treatment period in the study.
The abovementioned review by the FDA comprised data from both the 25 mg and 50 mg cohorts in patients who received daily dosing of nomlabofusp for 14 days, followed by dosing on alternate days until day 28.
Per the company, at day 14, all the patients (with quantifiable levels at baseline and day 14) who were treated with nomlabofusp (50 mg) achieved frataxin levels in skin cells of more than 33% of the average level seen in healthy volunteers, while three patients achieved more than 50% of the average level seen in healthy volunteers.
Shares of Larimar have increased 73.4% year to date against the industry’s decrease of 6.5%.
Image Source: Zacks Investment Research
Nomlabofusp (25 mg) is currently being evaluated in the ongoing open label extension (OLE) study in patients with FA. The OLE study will initially investigate daily subcutaneous injections of nomlabofusp (25 mg) in the given patient population.
The company plans to dose escalate to nomlabofusp (50 mg) in the OLE study following additional characterization of frataxin pharmacodynamics at the 25 mg dose. Interim data from the OLE study is expected to be announced in the fourth quarter of 2024.
Nomlabofusp has received Rare Pediatric Disease designation, Fast Track designation and Orphan Drug designations from the FDA to treat FA.
In the absence of a marketed product currently, the successful development of nomlabofusp remains the key focus area for Larimar.
We remind investors that Biogen (BIIB - Free Report) currently markets Skyclarys, which is the first approved treatment for FA. The FDA approved the drug in February 2023, while it was approved in Europe in February 2024.
The acquisition of Reata Pharmaceuticals in September 2023 added this newly approved rare disease drug to Biogen’s portfolio.
Per Biogen, the U.S. launch of Skyclarys is progressing and the EU launch is currently underway.
Zacks Rank & Stocks to Consider
Larimar currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector are Entera Bio Ltd. (ENTX - Free Report) and Marinus Pharmaceuticals, Inc. (MRNS - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Entera Bio’s 2024 loss per share have narrowed from 75 cents to 25 cents. Year to date, shares of ENTX have surged 298.4%.
ENTX’s earnings beat estimates in three of the trailing four quarters and missed the same once, the average surprise being 6.50%.
In the past 60 days, estimates for Marinus Pharmaceuticals’ 2024 loss per share have narrowed from $2.44 to $1.87. Year to date, shares of MRNS have plunged 87.8%.
MRNS’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same once, the average surprise being 3.27%.