Intellia (NTLA) Begins Dosing in Phase III ATTR Amyloidosis Study
Intellia Therapeutics, Inc. NTLA announced that it has dosed the first patient in the phase III MAGNITUDE study evaluating its investigational in vivo genome-editing candidate, NTLA-2001, for the treatment of transthyretin (ATTR) amyloidosis, a rare and fatal disease that can lead to heart failure.
The double-blind and placebo-controlled MAGNITUDE study will evaluate the safety and efficacy of NTLA-2001 in patients with ATTR amyloidosis with cardiomyopathy.
The company started dosing in the phase III MAGNITUDE study after interim data from a phase I study showed that treatment with a single dose of NTLA-2001 led to deep and durable reductions of the TTR protein responsible for the disease.
If the data from the MAGNITUDE study is found to be positive, it will enable regulatory filings for the drug across the world.
Shares of Intellia have plunged 28.5% in the past year compared with the industry’s decline of 8.1%.
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In October 2023, the FDA cleared NTLA’s investigational new drug application to move NTLA-2001 into clinical studies for the treatment of ATTR amyloidosis with cardiomyopathy.
If successfully developed and upon potential approval, NTLA-2001 will become the first one-time gene editing treatment for ATTR amyloidosis.
We note that NTLA-2001 is Intellia’s first candidate to enter clinical development. The company is collaborating with Regeneron Pharmaceuticals REGN for developing NTLA-2001.
NTLA-2001 is part of the company’s co-development and co-promotion agreement with Regeneron.
While NTLA is the lead party in the deal over NTLA-2001, REGN shares 25% of the development costs and commercial profits.
Intellia is also evaluating NTLA-2001 to treat hereditary ATTR amyloidosis with polyneuropathy. The company is currently gearing up for a pivotal phase III study of the candidate in this additional indication.
Zacks Rank & Stocks to Consider
Intellia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. ADMA and ANI Pharmaceuticals, Inc. ANIP, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. In the past year, shares of ADMA have rallied 93.2%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once. ADMA delivered an average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have surged 71.6%.
Earnings of ANI Pharmaceuticals beat estimates in each of the trailing four quarters. ANIP delivered a four-quarter average earnings surprise of 109.06%.
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