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Intellia's (NTLA) HAE Therapy Granted RMAT by the FDA
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Shares of IntelliaTherapeutics (NTLA - Free Report) were up almost 4% on Mar 21, as the company announced that its candidate, NTLA-2002, received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
Shares of Intellia have plunged 43.3% in the past year compared with the industry’s 14.2% decline.
Image Source: Zacks Investment Research
NTLA-2002 is Intellia’s in vivo CRISPR-based investigational therapy candidate evaluated in phase I/II study to treat hereditary angioedema (HAE). It aims to prevent HAE attacks by suppressing the plasma kallikrein activity.
The company has also initiated patient screening in the phase II portion of the phase I/II study in New Zealand. It plans to present additional clinical data on safety, durability and attack rates across all cohorts from the phase I study, later in 2023.
The RMAT designation provides the candidate with increased opportunities to meet FDA officials, as well as arrange early meetings to discuss potential surrogate or intermediate endpoints. It opens up early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application (BLA).
Earlier, NTLA-2002 had also received orphan drug designation from the FDA, and the Innovation Passport from the United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”).
Intellia is developing CRISPR/Cas9-based therapies for multiple indications. Its another candidate, NTLA-2001, is being evaluated for the treatment of ATTR amyloidosis.
Kala Pharmaceuticals’ loss per share estimates have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024, in the past 60 days. KALA’s shares have plunged 80.1% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
CRISPR Therapeutics' 2023 loss per share estimates have narrowed from $8.21 to $7.54, in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP’s shares have plunged 29.2% in the past year.
Jasper Therapeutics’ loss per share estimates have narrowed from $1.42 to 61 cents for 2023 and from $1.6 to 59 cents for 2024, in the past 60 days. JSPR’s shares have plunged 43.2% in the past year.
JSPR’s earnings beat estimates in three of the last four quarters and met the mark in one, the average surprise being 3.51%.
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Intellia's (NTLA) HAE Therapy Granted RMAT by the FDA
Shares of Intellia Therapeutics (NTLA - Free Report) were up almost 4% on Mar 21, as the company announced that its candidate, NTLA-2002, received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
Shares of Intellia have plunged 43.3% in the past year compared with the industry’s 14.2% decline.
Image Source: Zacks Investment Research
NTLA-2002 is Intellia’s in vivo CRISPR-based investigational therapy candidate evaluated in phase I/II study to treat hereditary angioedema (HAE). It aims to prevent HAE attacks by suppressing the plasma kallikrein activity.
The company has also initiated patient screening in the phase II portion of the phase I/II study in New Zealand. It plans to present additional clinical data on safety, durability and attack rates across all cohorts from the phase I study, later in 2023.
The RMAT designation provides the candidate with increased opportunities to meet FDA officials, as well as arrange early meetings to discuss potential surrogate or intermediate endpoints. It opens up early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application (BLA).
Earlier, NTLA-2002 had also received orphan drug designation from the FDA, and the Innovation Passport from the United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”).
Intellia is developing CRISPR/Cas9-based therapies for multiple indications. Its another candidate, NTLA-2001, is being evaluated for the treatment of ATTR amyloidosis.
Intellia Therapeutics, Inc. Price and Consensus
Intellia Therapeutics, Inc. price-consensus-chart | Intellia Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Intellia has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector are Kala Pharmaceuticals (KALA - Free Report) , CRISPR Therapeutics (CRSP - Free Report) and Jasper Therapeutics (JSPR - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Kala Pharmaceuticals’ loss per share estimates have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024, in the past 60 days. KALA’s shares have plunged 80.1% in the past year.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
CRISPR Therapeutics' 2023 loss per share estimates have narrowed from $8.21 to $7.54, in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. CRSP’s shares have plunged 29.2% in the past year.
Jasper Therapeutics’ loss per share estimates have narrowed from $1.42 to 61 cents for 2023 and from $1.6 to 59 cents for 2024, in the past 60 days. JSPR’s shares have plunged 43.2% in the past year.
JSPR’s earnings beat estimates in three of the last four quarters and met the mark in one, the average surprise being 3.51%.