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Intellia announces acceptance of IND application for CRISPR/CAS9-based therapy » 07:32
03/31/20
03/31
07:32
03/31/20
07:32
NTLA

Intellia Therapeutics

$12.68 /

+0.75 (+6.29%)

, NVS

Novartis

$81.90 /

+2.65 (+3.34%)

Intellia Therapeutics…

Intellia Therapeutics (NTLA) announced that the U.S. Food and Drug Administration has accepted the Investigational New Drug application submitted by its collaborator, Novartis (NVS), for a CRISPR/Cas9-based engineered cell therapy for the treatment of sickle cell disease. This Phase 1/2 clinical trial will begin investigating OTQ923 in adult patients with severe complications of SCD. OTQ923 is a SCD treatment based on genome editing of hematopoietic stem cells, using CRISPR/Cas9 RNA guides identified through Intellia's cell therapy research collaboration with Novartis. This therapeutic approach results in highly targeted editing of the HSC's DNA to induce fetal hemoglobin expression. The edited cells are returned to the patient, where the expression of HbF is expected to reduce the deleterious effects of sickle hemoglobin. Novartis' IND application triggered a milestone payment to Intellia, and the company is eligible to receive additional downstream success-based milestones and royalties.

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Over a week ago
Conference/Events
Intellia Therapeutics management to meet with SVB Leerink » 04:55
03/05/20
03/05
04:55
03/05/20
04:55
NTLA

Intellia Therapeutics

$14.85 /

+1.41 (+10.49%)

Meeting to be held in…

Meeting to be held in Boston on March 5 hosted by SVB Leerink.

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Conference/Events
Intellia Therapeutics management to meet with SVB Leerink » 15:59
03/03/20
03/03
15:59
03/03/20
15:59
NTLA

Intellia Therapeutics

$13.58 /

+0.15 (+1.12%)

Meeting to be held in…

Meeting to be held in Boston on March 5 hosted by SVB Leerink.

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Over a month ago
Recommendations
Intellia making progress in in-vivo editing, says Oppenheimer » 08:02
02/28/20
02/28
08:02
02/28/20
08:02
NTLA

Intellia Therapeutics

$11.69 /

-0.61 (-4.96%)

Intellia Therapeutics is…

Intellia Therapeutics is making progress in in-vivo editing and ex-vivo engineered T-cells, Oppenheimer analyst Silvan Tuerkcan tells investors in a research note following the company's Q4 results. The NTLA-2001 Investigational New Drug submission remains on track for transthyretin amyloidosis in mid-2020 and preparations are ongoing, adds the analyst. Tuerkcan, however, views Intellia as fairly valued at current levels and keeps a Perform rating on the shares.

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Hot Stocks
Intellia Therapeutics announces upcoming milestones » 08:11
02/27/20
02/27
08:11
02/27/20
08:11
NTLA

Intellia Therapeutics

$12.30 /

+0.18 (+1.49%)

The Company has set forth…

The Company has set forth the following for pipeline progression: ATTR: Submit IND application for NTLA-2001 in mid-2020; Dose first patients in 2H 2020. AML: Submit IND application for NTLA-5001 in 1H 2021. HAE: Nominate a development candidate in 1H 2020. R&D Advancements: Present preclinical data at upcoming scientific conferences in 2020.

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Hot Stocks
Intellia expects cash, cash equivalents to fund expenses through end of 2021 » 08:10
02/27/20
02/27
08:10
02/27/20
08:10
NTLA

Intellia Therapeutics

$12.30 /

+0.18 (+1.49%)

Intellia expects that its…

Intellia expects that its cash, cash equivalents and marketable securities as of December 31, 2019 will enable the Company to fund its anticipated operating expenses and capital expenditure requirements at least through the end of 2021. This expectation excludes any strategic use of capital not currently in the Company's base-case planning assumptions.

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Earnings
Intellia Therapeutics reports Q4 EPS (57c), consensus (56c) » 07:39
02/27/20
02/27
07:39
02/27/20
07:39
NTLA

Intellia Therapeutics

$12.30 /

+0.18 (+1.49%)

Reports Q4 revenue…

Reports Q4 revenue $10.9M, consensus $9.94M. "In 2019, we advanced our full-spectrum strategy, guiding both our in vivo and ex vivo lead programs toward the clinic. We also continued to build on our genome editing and delivery capabilities to enable a rapid succession of candidates," said Intellia President and Chief Executive Officer, John Leonard, M.D. "We are off to a productive start in 2020. We announced the nomination of NTLA-5001, a WT1-directed TCR-T cell therapy for the treatment of AML, and plan to select our third development candidate in the first half of this year, which will be for the treatment of HAE. In addition, in the second half of the year, we expect to begin dosing ATTR patients with NTLA-2001, a potential single-course treatment for ATTR patients. This is anticipated to be the first-ever systemically delivered CRISPR/Cas9-based therapy to enter the clinic, representing an important milestone in our mission to deliver potentially curative therapies from our proprietary modular platform."

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Downgrade
Intellia Therapeutics downgraded to Neutral from Outperform at Wedbush » 07:33
02/14/20
02/14
07:33
02/14/20
07:33
NTLA

Intellia Therapeutics

$15.53 /

-0.065 (-0.42%)

Wedbush analyst David…

Wedbush analyst David Nierengarten downgraded Intellia Therapeutics to Neutral from Outperform with a price target of $16, down from $21 after the company presented updated data from their newly nominated preclinical program in AML and a first look at the company's development program in hereditary angioedema at the Keystone Symposia's Engineering the Genome Conference this week. In a research note to investors, Nierengarten says that while he appreciates HAE as an opportunity for Intellia, the company has also discontinued alpha-1 antitrypsin deficiency and primary hyperoxaluria Type 1.

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Downgrade
Intellia Therapeutics downgraded to Neutral from Outperform at Wedbush » 06:58
02/14/20
02/14
06:58
02/14/20
06:58
NTLA

Intellia Therapeutics

$15.53 /

-0.065 (-0.42%)

Wedbush analyst David…

Wedbush analyst David Nierengarten downgraded Intellia Therapeutics to Neutral from Outperform with a $16 price target.

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Hot Stocks
Intellia presents data from engineered cell therapy, in vivo programs » 07:37
02/10/20
02/10
07:37
02/10/20
07:37
NTLA

Intellia Therapeutics

$13.62 /

-0.535 (-3.78%)

Intellia Therapeutics is…

Intellia Therapeutics is presenting new data from two of its development programs at Keystone Symposia's Engineering the Genome Conference, a joint meeting with the Emerging Cellular Therapies: Cancer and Beyond Conference, taking place Feb. 8-12, 2020, in Banff, Canada. Intellia researchers are presenting data in support of the company's lead engineered cell therapy development candidate, NTLA-5001 for the treatment of the hematological cancer, acute myeloid leukemia. Intellia also is sharing preclinical results for its hereditary angioedema program, which is Intellia's third CRISPR/Cas9 development program, announced in January 2020. NTLA-5001, which is Intellia's first engineered T cell therapy development candidate and is wholly owned, utilizes a T cell receptor-directed approach to target the Wilms' Tumor 1 intracellular antigen for the treatment of AML. The company's WT1-TCR T cell approach aims to develop a broadly applicable treatment for AML patients, regardless of mutational background of a patient's leukemia. The company is presenting data demonstrating that the selection of a natural, high-affinity TCR, in combination with CRISPR-enabled engineering and targeted insertion, results in an engineered T cell capable of specific and potent killing of primary AML blasts. The data being presented at the Keystone conference substantiate the advantages that a homogeneous T cell product developed through CRISPR engineering, like NTLA-5001, may have over traditional T cell engineering approaches. In particular, traditional T cell engineering methods typically result in a T cell product that carries two different TCRs, one endogenous and one transferred, which can pair in various combinations of alpha and beta chains and form mixed TCRs with unknown specificities. Intellia researchers are sharing today that the precise replacement of the endogenous TCR with the transgenic TCR resulted in T cells with improved tgTCR expression levels and in 95% of edited T cells carrying exclusively the desired pairs of the tgTCR alpha and beta chains. This therapeutic TCR profile is expected to yield improved T cell product homogeneity, as researchers showed that Intellia's T cell editing approach results in superior function of the engineered T cells toward WT1-positive targets in vitro. This therapeutic TCR profile is also expected to result in lower reactivity against unwanted targets on normal tissues that could lead to toxicities, including graft-versus-host disease. Researchers identified that the selected lead WT1 TCR exhibits high avidity to its target epitope and shows tight epitope specificity. Being a natural TCR isolated from a healthy donor, it may have a lower cross-reactivity risk than many affinity-matured TCRs. Cells engineered with Intellia's lead WT1 TCR also demonstrated no detectable cytotoxicity toward bone marrow CD34+ cells, which express WT1 at low levels. This is an advantage over current CAR-T cell approaches targeting CD33 or CD123 in AML, which have been shown to induce severe bone marrow toxicity. Furthermore, the data demonstrate that specific and potent killing of WT1-positive primary AML blasts result from T cells expressing Intellia's lead WT1 TCR when cocultured in vitro. This outcome was observed across multiple patient samples that harbor the frequent HLA-A*02:01 allele and that express different WT1 levels as well as AML characteristics. These data validate that the epitope targeted by the lead WT1 TCR, which is distinct from a previously evaluated RMF epitope, is presented efficiently and broadly by AML tumor cells that carry the correct human leukocyte antigen restriction. Intellia's lead WT1 TCR also has the potential to target WT1-positive solid tumors, such as ovarian cancer, glioblastoma, lung cancer and mesothelioma. The company plans to submit an Investigational New Drug application to the U.S. Food and Drug Administration in the first half of 2021 for NTLA-5001 for the treatment of AML. Researchers presented yesterday at the Keystone conference the company's first dataset in support of Intellia's development program for HAE. HAE is a rare genetic disorder characterized by recurring and unpredictable severe swelling attacks in various parts of the body, and is significantly debilitating or even fatal in certain cases. The disease is caused by increased levels of the bradykinin protein. Most patients with HAE have a C1 esterase inhibitor protein deficiency, which normally prevents the unregulated release and buildup of bradykinin. Intellia's HAE treatment hypothesis involves knocking out the kallikrein B1 gene to reduce kallikrein activity, which is involved in the biological pathway for release of bradykinin. Intellia expects this reduction to correlate with a decrease in bradykinin activity, thus, preventing the activation of endothelial cells that causes vascular leakage and angioedema in HAE patients. The data presented at the Keystone conference showed that the knockout of KLKB1 produces in non-human primates a 90% reduction in kallikrein activity, a level that translates to a therapeutically meaningful impact on HAE attack rates. This kallikrein activity reduction was sustained for at least five months in an ongoing NHP study, in a highly reproducible manner observed across both rodent and NHP studies. Similar to its lead in vivo program, for the treatment of transthyretin amyloidosis, Intellia's potential HAE therapy utilizes the company's modular non-viral lipid nanoparticle system to deliver CRISPR/Cas9. Intellia's proprietary LNP-based delivery system includes two basic components: Cas9 messenger RNA and a guide RNA. The gRNA is the only variable portion of the LNP delivery system and is the sole component that needs to be changed from the LNP-based delivery system that forms the foundation of NTLA-2001, Intellia's development candidate for the treatment of ATTR for which the company intends to submit an IND application in mid-2020. Intellia continues to evaluate several potential guide RNAs and expects to nominate a development candidate for HAE in the first half of 2020. Intellia's KLKB1 HAE program is subject to an option by Regeneron to enter into a Co/Co agreement, in which Intellia would remain the lead party.

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