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Intellia (NTLA) Depreciates 27% Over a Month: Here's Why
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Intellia’s (NTLA - Free Report) shares have declined 27% in the past month compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
The primary reason for the decline in Intellia’s share price is the decision passed by the U.S. Patent and Trademarks Office’s (“USPTO”) Patent and Trial Appeal Board (“PTAB”) on Feb 28 with regard to patent interference proceedings between two groups -– the first group consisting of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively referred to as “CVC”) and another group comprising the Broad Institute, Harvard University and the Massachusetts Institute of Technology (jointly called “Broad Institute”). Both Broad Institute and CVC have been engaged in patent disputes with regard to the use of the CRISPR/Cas9 genome editing system in eukaryotic cells, i.e., plants and animals, since 2016.
On Feb 28, the PTAB passed a ruling in favor of Broad Institute stating that it was the first one to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells. This has resulted in the invalidity of CVC’s 14 patent applications.
Intellia Therapeutics has been focused on developing curative therapeutics using the CRISPR/Cas9 technology. NTLA in-licensed exclusive rights for the development and commercialization of CRISPR/Cas9-based human therapeutics from CVC, which explains the share price decline.
Based on the exclusive license from CVC, Intellia has filed multiple patent applications with regard to its technological innovations in CRISPR/Cas9 therapeutics, including delivery applications and product candidates. In a press release issued earlier this month, NTLA stated that the PTAB decision does not impact any of the company’s patent applications that cover its technological innovations, nor does it impact the company’s ability to develop and commercialize CRISPR-based therapeutics in the future.
Meanwhile, Intellia continues to progress rapidly with the development of its pipeline candidates.
Earlier this week, the company announced that its first wholly-owned ex-vivo gene therapy candidate, NTLA-5001, received Orphan Drug designation from the FDA for the treatment of acute myeloid leukemia. NTLA commenced dosing its first patient with NTLA-5001 in a phase I/IIa study in adult participants with persistent or recurrent AML.
Last month, the company along with partner Regeneron Pharmaceuticals (REGN - Free Report) announced positive interim data from the phase I study evaluating its lead in-vivo genome-editing candidate, NTLA-2001, in patients with transthyretin amyloidosis with polyneuropathy (ATTRv-PN). Data from the study demonstrated that patients treated with NTLA-2001 exhibited a dose-dependent reduction in serum TTR levels, achieving mean reductions of 52%, 87%, 86% and 93% at day 28 in the 0.1 mg/kg, 0.3 mg/kg, 0.7 mg/kg, and 1.0 mg/kg dose cohorts, respectively. Both Intellia and Regeneron plan to move forward with a fixed dose of 80 mg and evaluate the same in a dose-expansion cohort of the phase I study, which is expected to start in first-quarter 2022.
We remind investors that Intellia is the lead party for NTLA-2001, while Regeneron shares 25% of development costs and commercial profits. Both Intellia and Regeneron are also developing therapies for hemophilia A and hemophilia B.
Intellia also initiated a phase I/II study evaluating NTLA-2002 for treating hereditary angioedema (“HAE”) in December 2021. NTLA-2002 aims to prevent HAE attacks by suppressing plasma kallikrein activity.
Another company that was impacted by the PTAB decision is CRISPR Therapeutics (CRSP - Free Report) . Similar to Intellia, CRSP also licensed rights from CVC to develop CRISPR-based therapies.
CRISPR Therapeutics’ lead pipeline candidate is CTX001, an investigational ex vivo CRISPR gene-edited therapy that is currently being evaluated in two separate phase III studies for treating transfusion-dependent beta thalassemia (TDT) and sickle cell disease (SCD). Regulatory submission by CRSP for CTX001 in both TDT and SCD indications is expected by 2022-end.
BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 35 cents in the past 30 days. Shares of BDSI have surged 80% year to date.
Earnings of BioDelivery Sciences beat estimates in three of the last four quarters and missed the mark on a single occasion, with the average surprise being 33.7%.
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Intellia (NTLA) Depreciates 27% Over a Month: Here's Why
Intellia’s (NTLA - Free Report) shares have declined 27% in the past month compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
The primary reason for the decline in Intellia’s share price is the decision passed by the U.S. Patent and Trademarks Office’s (“USPTO”) Patent and Trial Appeal Board (“PTAB”) on Feb 28 with regard to patent interference proceedings between two groups -– the first group consisting of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively referred to as “CVC”) and another group comprising the Broad Institute, Harvard University and the Massachusetts Institute of Technology (jointly called “Broad Institute”). Both Broad Institute and CVC have been engaged in patent disputes with regard to the use of the CRISPR/Cas9 genome editing system in eukaryotic cells, i.e., plants and animals, since 2016.
On Feb 28, the PTAB passed a ruling in favor of Broad Institute stating that it was the first one to invent the use of CRISPR/Cas9 genome editing in eukaryotic cells. This has resulted in the invalidity of CVC’s 14 patent applications.
Intellia Therapeutics has been focused on developing curative therapeutics using the CRISPR/Cas9 technology. NTLA in-licensed exclusive rights for the development and commercialization of CRISPR/Cas9-based human therapeutics from CVC, which explains the share price decline.
Based on the exclusive license from CVC, Intellia has filed multiple patent applications with regard to its technological innovations in CRISPR/Cas9 therapeutics, including delivery applications and product candidates. In a press release issued earlier this month, NTLA stated that the PTAB decision does not impact any of the company’s patent applications that cover its technological innovations, nor does it impact the company’s ability to develop and commercialize CRISPR-based therapeutics in the future.
Meanwhile, Intellia continues to progress rapidly with the development of its pipeline candidates.
Earlier this week, the company announced that its first wholly-owned ex-vivo gene therapy candidate, NTLA-5001, received Orphan Drug designation from the FDA for the treatment of acute myeloid leukemia. NTLA commenced dosing its first patient with NTLA-5001 in a phase I/IIa study in adult participants with persistent or recurrent AML.
Last month, the company along with partner Regeneron Pharmaceuticals (REGN - Free Report) announced positive interim data from the phase I study evaluating its lead in-vivo genome-editing candidate, NTLA-2001, in patients with transthyretin amyloidosis with polyneuropathy (ATTRv-PN). Data from the study demonstrated that patients treated with NTLA-2001 exhibited a dose-dependent reduction in serum TTR levels, achieving mean reductions of 52%, 87%, 86% and 93% at day 28 in the 0.1 mg/kg, 0.3 mg/kg, 0.7 mg/kg, and 1.0 mg/kg dose cohorts, respectively. Both Intellia and Regeneron plan to move forward with a fixed dose of 80 mg and evaluate the same in a dose-expansion cohort of the phase I study, which is expected to start in first-quarter 2022.
We remind investors that Intellia is the lead party for NTLA-2001, while Regeneron shares 25% of development costs and commercial profits. Both Intellia and Regeneron are also developing therapies for hemophilia A and hemophilia B.
Intellia also initiated a phase I/II study evaluating NTLA-2002 for treating hereditary angioedema (“HAE”) in December 2021. NTLA-2002 aims to prevent HAE attacks by suppressing plasma kallikrein activity.
Another company that was impacted by the PTAB decision is CRISPR Therapeutics (CRSP - Free Report) . Similar to Intellia, CRSP also licensed rights from CVC to develop CRISPR-based therapies.
CRISPR Therapeutics’ lead pipeline candidate is CTX001, an investigational ex vivo CRISPR gene-edited therapy that is currently being evaluated in two separate phase III studies for treating transfusion-dependent beta thalassemia (TDT) and sickle cell disease (SCD). Regulatory submission by CRSP for CTX001 in both TDT and SCD indications is expected by 2022-end.
Intellia Therapeutics, Inc. Price
Intellia Therapeutics, Inc. price | Intellia Therapeutics, Inc. Quote
Zacks Rank & Stock to Consider
Intellia currently carries a Zacks Rank #4 (Sell). A better-ranked stock in the same sector is BioDelivery Sciences , which holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
BioDelivery Sciences’ earnings per share estimates for 2022 have increased from 33 cents to 35 cents in the past 30 days. Shares of BDSI have surged 80% year to date.
Earnings of BioDelivery Sciences beat estimates in three of the last four quarters and missed the mark on a single occasion, with the average surprise being 33.7%.