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Nurix (NRIX) Up on Upbeat Initial Data From Phase I Cancer Study
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Nurix Therapeutics, Inc.’s (NRIX - Free Report) shares jumped 26.7% on Apr 9, after the company reported initial findings of clinical responses in the brain for its investigational targeted protein degrader, NX-5948, from the dose escalation stage of its ongoing early-stage study for difficult-to-treat cancer patients. These findings were presented by the company at a medical conference in California.
Nurix’s NX-5948 is an orally available and selective degrader of Bruton’s tyrosine kinase. The phase Ia/Ib study is evaluating the safety and efficacy of daily oral dosing of NX-5948 in patients with relapsed or refractory B-cell malignancies.
The presence of measurable levels ofNX-5948 in the brain was detected in multiple patients with available cerebrospinal fluid (CSF) samples in the early-stage study, who had central nervous system (CNS) tumor involvement.
However, the data presentation included case studies for two patients, one with chronic lymphocytic leukemia (CLL) and the other with primary central nervous system lymphoma (PCNSL), each with CNS involvement. Initial findings demonstrated the therapeutic effect of NX-5948 in the brain, observing clinically meaningful responses in both patients.
Per Nurix, this is a significant breakthrough as no other therapies have been able to demonstrate clinical activity in the brain, to date. This opens options for new therapeutic approaches to treat leukemias and lymphomas with CNS involvement.
Management believes that the brain-penetrating power of NX-5948, along with its encouraging safety and efficacy records to date, suggest that the candidate could potentially become the standard-of-care treatment for B-cell lymphomas and CLL involving the CNS. Moreover, Nurix also stated that NX-5948 could potentially be used as a therapeutic option for autoimmune disorders with CNS involvement, such as multiple sclerosis.
Year to date, shares of NRIX have surged 69.4% against the industry’s 5.4% decline.
Image Source: Zacks Investment Research
In one of the case studies presented by the company, a CLL patient was enrolled in the phase Ia/Ib study with secondary CNS involvement whose disease progressed after prior treatment with both a BCL2 inhibitor in combination with Roche’s (RHHBY - Free Report) Rituxan (rituximab) and AstraZeneca’s (AZN - Free Report) BTK inhibitor, Calquence (acalabrutinib).
Over the NX-5948 treatment period, the CLL patient showed consistent improvement in the condition and demonstrated a confirmed partial response, along with the absence of measurable tumor cells in the CSF, at week 34.
The PCNSL patient in the other case study presented by Nurix was enrolled withthree measurable lesions in the brain, whose disease progressed after first-line treatment with Roche’s Rituxan and second-line treatment with AbbVie and J&J’s Imbruvica (ibrutinib). The patient achieved a complete response at week eight as all three lesions regressed. However, a scan at week 16 revealed the emergence of a new brain lesion.
Per NRIX, despite the disease progression of the PCNSL patient at week 16, positive clinical responses upon treatment with NX-5948 observed to date, support future exploration of NX-5948 both as a monotherapy and in combination with other therapies for primary and secondary CNS lymphoma and leukemia.
The company believes that developing NX-5948 in combination with other therapies has the potential to improve the durability of response, which is intended to prevent the recurrence of the disease.
Roche’s Rituxan is currently approved in the United States and several other countries to treat non-Hodgkin’s lymphoma, CLL and rheumatoid arthritis. Rituxan is co-marketed by Biogen and RHHBY in the U.S. market.
On the other hand, AstraZeneca’s Calquence monotherapy is currently approved on an accelerated basis for the treatment of previously treated adult patients with mantle cell lymphoma. The drug is also approved as a monotherapy or in combination with obinutuzumab to treat previously untreated CLL patients.
In a separate press release, Nurix announced extending its current partnership with Sanofi (SNY - Free Report) for STAT6, a key drug target in type 2 inflammation.
Under the terms of the initial agreement signed in December 2019, Nuris is tasked with leveraging its proprietary drug discovery platform to identify novel agents that use E3 ligases to induce the degradation of specified drug targets.
Sanofi, on the other hand, has been given the option to license drug candidates resulting from Nurix’s efforts for global development and commercialization. NRIX has, however, retained its option to co-develop and co-promote future products in the United States under programs for which it has exercised the option.
For those candidates that Nurix chooses to co-promote and co-develop, both companies will split the U.S. profits and losses equally. NRIX will also be eligible to receive royalties on ex-U.S. sales on all optioned products from Sanofi.
The recent announcement states that Nurix and Sanofi have extended the research term for the ongoing STAT6 program, aiming to nominate a development candidate in the first year of the extended term.
In another press release, Nurix reported its financial results for first-quarter fiscal 2024, which ended on Feb 29. The company reported a loss of 76 cents per share, narrower than the Zacks Consensus Estimate of a loss of 80 cents. NRIX had incurred a loss of 75 cents in the year-ago quarter.
Nurix reported revenues of $17 million in the reported quarter, which also beat the Zacks Consensus Estimate of $15 million, representing year-over-year growth of 31%.
Image: Bigstock
Nurix (NRIX) Up on Upbeat Initial Data From Phase I Cancer Study
Nurix Therapeutics, Inc.’s (NRIX - Free Report) shares jumped 26.7% on Apr 9, after the company reported initial findings of clinical responses in the brain for its investigational targeted protein degrader, NX-5948, from the dose escalation stage of its ongoing early-stage study for difficult-to-treat cancer patients. These findings were presented by the company at a medical conference in California.
Nurix’s NX-5948 is an orally available and selective degrader of Bruton’s tyrosine kinase. The phase Ia/Ib study is evaluating the safety and efficacy of daily oral dosing of NX-5948 in patients with relapsed or refractory B-cell malignancies.
The presence of measurable levels ofNX-5948 in the brain was detected in multiple patients with available cerebrospinal fluid (CSF) samples in the early-stage study, who had central nervous system (CNS) tumor involvement.
However, the data presentation included case studies for two patients, one with chronic lymphocytic leukemia (CLL) and the other with primary central nervous system lymphoma (PCNSL), each with CNS involvement. Initial findings demonstrated the therapeutic effect of NX-5948 in the brain, observing clinically meaningful responses in both patients.
Per Nurix, this is a significant breakthrough as no other therapies have been able to demonstrate clinical activity in the brain, to date. This opens options for new therapeutic approaches to treat leukemias and lymphomas with CNS involvement.
Management believes that the brain-penetrating power of NX-5948, along with its encouraging safety and efficacy records to date, suggest that the candidate could potentially become the standard-of-care treatment for B-cell lymphomas and CLL involving the CNS. Moreover, Nurix also stated that NX-5948 could potentially be used as a therapeutic option for autoimmune disorders with CNS involvement, such as multiple sclerosis.
Year to date, shares of NRIX have surged 69.4% against the industry’s 5.4% decline.
Image Source: Zacks Investment Research
In one of the case studies presented by the company, a CLL patient was enrolled in the phase Ia/Ib study with secondary CNS involvement whose disease progressed after prior treatment with both a BCL2 inhibitor in combination with Roche’s (RHHBY - Free Report) Rituxan (rituximab) and AstraZeneca’s (AZN - Free Report) BTK inhibitor, Calquence (acalabrutinib).
Over the NX-5948 treatment period, the CLL patient showed consistent improvement in the condition and demonstrated a confirmed partial response, along with the absence of measurable tumor cells in the CSF, at week 34.
The PCNSL patient in the other case study presented by Nurix was enrolled withthree measurable lesions in the brain, whose disease progressed after first-line treatment with Roche’s Rituxan and second-line treatment with AbbVie and J&J’s Imbruvica (ibrutinib). The patient achieved a complete response at week eight as all three lesions regressed. However, a scan at week 16 revealed the emergence of a new brain lesion.
Per NRIX, despite the disease progression of the PCNSL patient at week 16, positive clinical responses upon treatment with NX-5948 observed to date, support future exploration of NX-5948 both as a monotherapy and in combination with other therapies for primary and secondary CNS lymphoma and leukemia.
The company believes that developing NX-5948 in combination with other therapies has the potential to improve the durability of response, which is intended to prevent the recurrence of the disease.
Nurix Therapeutics, Inc. Price and Consensus
Nurix Therapeutics, Inc. price-consensus-chart | Nurix Therapeutics, Inc. Quote
Roche’s Rituxan is currently approved in the United States and several other countries to treat non-Hodgkin’s lymphoma, CLL and rheumatoid arthritis. Rituxan is co-marketed by Biogen and RHHBY in the U.S. market.
On the other hand, AstraZeneca’s Calquence monotherapy is currently approved on an accelerated basis for the treatment of previously treated adult patients with mantle cell lymphoma. The drug is also approved as a monotherapy or in combination with obinutuzumab to treat previously untreated CLL patients.
In a separate press release, Nurix announced extending its current partnership with Sanofi (SNY - Free Report) for STAT6, a key drug target in type 2 inflammation.
Under the terms of the initial agreement signed in December 2019, Nuris is tasked with leveraging its proprietary drug discovery platform to identify novel agents that use E3 ligases to induce the degradation of specified drug targets.
Sanofi, on the other hand, has been given the option to license drug candidates resulting from Nurix’s efforts for global development and commercialization. NRIX has, however, retained its option to co-develop and co-promote future products in the United States under programs for which it has exercised the option.
For those candidates that Nurix chooses to co-promote and co-develop, both companies will split the U.S. profits and losses equally. NRIX will also be eligible to receive royalties on ex-U.S. sales on all optioned products from Sanofi.
The recent announcement states that Nurix and Sanofi have extended the research term for the ongoing STAT6 program, aiming to nominate a development candidate in the first year of the extended term.
In another press release, Nurix reported its financial results for first-quarter fiscal 2024, which ended on Feb 29. The company reported a loss of 76 cents per share, narrower than the Zacks Consensus Estimate of a loss of 80 cents. NRIX had incurred a loss of 75 cents in the year-ago quarter.
Nurix reported revenues of $17 million in the reported quarter, which also beat the Zacks Consensus Estimate of $15 million, representing year-over-year growth of 31%.
Zacks Rank
Nurix currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.