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Intellia's (NTLA) HAE Candidate Gets EMA's PRIME Designation
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Intellia Therapeutics, Inc. (NTLA - Free Report) announced that the European Medicines Agency (“EMA”) has granted Priority Medicines (“PRIME”) designation to its pipeline candidate, NTLA-2002, for the treatment of hereditary angioedema (HAE).
HAE is a rare genetic disorder characterized by recurring attacks of severe swelling, which can be painful and even life-threatening at times. NTLA-2002 aims to prevent HAE attacks by suppressing the plasma kallikrein activity.
The EMA grants PRIME designation to support the development of medicines, which target an unmet need. Treatments and therapies that are granted this designation are offered early and proactive support by the regulatory body, including being eligible for an accelerated assessment at the time of applying for marketing authorization.
NTLA-2002 is Intellia’s in vivo CRISPR-based investigational therapy candidate, which is currently being evaluated in a phase I/II study for treating HAE.
In June 2023, Intellia announced updated interim data from the phase I portion of the phase I/II study on NTLA-2002. With a cut-off date of Feb 17, 2023, the interim data indicated that patients suffering from HAE experienced a reduction in attacks following the administration of a single dose of NTLA-2002. Also, an average decrease of 95% in monthly attack rates was observed in all 10 patients after receiving a single dose of NTLA-2002.
The above mentioned PRIME status granted to NTLA-2002 was based on this positive data.
The FDA has already granted Orphan Drug designation and Regenerative Medicine Advanced Therapy designation to NTLA-2002 for the treatment of HAE.
NTLA-2002 also received the Innovation Passport from the United Kingdom Medicines and Healthcare products Regulatory Agency.
Shares of Intellia have declined 14.5% compared with the industry’s decrease of 20%.
Image Source: Zacks Investment Research
Intellia is engaged in developing CRISPR/Cas9-based therapies for multiple indications. The company’s other candidate, NTLA-2001, is being evaluated for the treatment of transthyretin amyloidosis.
NTLA-2001 is part of the company’s co-development and co-promotion agreement with Regeneron Pharmaceuticals (REGN - Free Report) .
While NTLA is the lead party in the deal, REGN shares some of the development costs and commercial profits. Intellia’s collaboration with Regeneron has given a boost to the former to develop its pipeline.
In the absence of a marketed product, successful development of the pipeline candidates remains the key focus for Intellia.
Zacks Rank & Stocks to Consider
Intellia currently carries a Zacks Rank #4 (Sell).
In the past 30 days, estimates for CRISPR Therapeutics’ 2023 loss per share have improved from $4.97 to $4.83. During the same period, loss estimates per share for 2024 have narrowed from $6.62 to $6.45. Year to date, shares of CRSP have risen 9%.
Earnings of CRISPR Therapeutics beat estimates in each of the trailing four quarters, the average surprise being 39.19%.
In the past 30 days, estimates for Deciphera’s 2023 loss per share have remained stable at $2.36. During the same period, the loss estimate per share for 2024 has also remained stable at $2.17. Year to date, shares of DCPH have declined 33.2%.
Earnings of Deciphera beat estimates in two of the trailing four quarters, met the same once, and missed the mark on the other occasion. On average, DCPH delivered an earnings surprise of 1.58%.
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Intellia's (NTLA) HAE Candidate Gets EMA's PRIME Designation
Intellia Therapeutics, Inc. (NTLA - Free Report) announced that the European Medicines Agency (“EMA”) has granted Priority Medicines (“PRIME”) designation to its pipeline candidate, NTLA-2002, for the treatment of hereditary angioedema (HAE).
HAE is a rare genetic disorder characterized by recurring attacks of severe swelling, which can be painful and even life-threatening at times. NTLA-2002 aims to prevent HAE attacks by suppressing the plasma kallikrein activity.
The EMA grants PRIME designation to support the development of medicines, which target an unmet need. Treatments and therapies that are granted this designation are offered early and proactive support by the regulatory body, including being eligible for an accelerated assessment at the time of applying for marketing authorization.
NTLA-2002 is Intellia’s in vivo CRISPR-based investigational therapy candidate, which is currently being evaluated in a phase I/II study for treating HAE.
In June 2023, Intellia announced updated interim data from the phase I portion of the phase I/II study on NTLA-2002. With a cut-off date of Feb 17, 2023, the interim data indicated that patients suffering from HAE experienced a reduction in attacks following the administration of a single dose of NTLA-2002. Also, an average decrease of 95% in monthly attack rates was observed in all 10 patients after receiving a single dose of NTLA-2002.
The above mentioned PRIME status granted to NTLA-2002 was based on this positive data.
The FDA has already granted Orphan Drug designation and Regenerative Medicine Advanced Therapy designation to NTLA-2002 for the treatment of HAE.
NTLA-2002 also received the Innovation Passport from the United Kingdom Medicines and Healthcare products Regulatory Agency.
Shares of Intellia have declined 14.5% compared with the industry’s decrease of 20%.
Image Source: Zacks Investment Research
Intellia is engaged in developing CRISPR/Cas9-based therapies for multiple indications. The company’s other candidate, NTLA-2001, is being evaluated for the treatment of transthyretin amyloidosis.
NTLA-2001 is part of the company’s co-development and co-promotion agreement with Regeneron Pharmaceuticals (REGN - Free Report) .
While NTLA is the lead party in the deal, REGN shares some of the development costs and commercial profits. Intellia’s collaboration with Regeneron has given a boost to the former to develop its pipeline.
In the absence of a marketed product, successful development of the pipeline candidates remains the key focus for Intellia.
Zacks Rank & Stocks to Consider
Intellia currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector include CRISPR Therapeutics AG (CRSP - Free Report) and Deciphera Pharmaceuticals, Inc. (DCPH - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for CRISPR Therapeutics’ 2023 loss per share have improved from $4.97 to $4.83. During the same period, loss estimates per share for 2024 have narrowed from $6.62 to $6.45. Year to date, shares of CRSP have risen 9%.
Earnings of CRISPR Therapeutics beat estimates in each of the trailing four quarters, the average surprise being 39.19%.
In the past 30 days, estimates for Deciphera’s 2023 loss per share have remained stable at $2.36. During the same period, the loss estimate per share for 2024 has also remained stable at $2.17. Year to date, shares of DCPH have declined 33.2%.
Earnings of Deciphera beat estimates in two of the trailing four quarters, met the same once, and missed the mark on the other occasion. On average, DCPH delivered an earnings surprise of 1.58%.