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Corvus' (CRVS) Lymphoma Drug Gets Orphan Status, Stock Up
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Corvus Pharmaceuticals, Inc. (CRVS - Free Report) announced that the FDA granted the Orphan Drug Designation to its lead pipeline candidate, soquelitinib, for the treatment of T cell lymphoma.
The FDA generally grants this designation to investigational therapies that address rare medical diseases or conditions affecting fewer than 200,000 people in the United States. The perquisites that come from this designation include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. The company’s shares rose 10.75% on the news.
Soquelitinib (formerly known as CPI-818) is an investigational small molecule drug given orally, designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer cell immune function.
The company is on track to advance the candidate into a phase III registrational clinical study in patients with relapsed peripheral T cell lymphoma (PTCL) in the second quarter of 2024.
In December, CRVS reported new interim data from its phase I/Ib clinical study of soquelitinib in patients with relapsed PTCL. Soquelitinib demonstrated durable anti-tumor activity, evidenced by progression-free survival, duration of response and overall survival rates that exceed current standard of care therapies for patients with relapsed PTCL. The data supports the advancement of soquelitinib into the late-stage registrational clinical trial in PTCL.
Shares of the company have lost 0.7% in the past six months against the industry’s growth of 0.8%.
Image Source: Zacks Investment Research
The phase III study is designed to enroll a total of 150 patients with relapsed PTCL that have received more than or equal to one prior therapy or less than or equal to three prior therapies. Patients will be randomized equally to receive soquelitinib 200 mg two-times a day or standard of care chemotherapy. The primary endpoint will be progression-free survival.
Secondary endpoints will include objective response rate and overall survival.
The successful development of soquelitinib will be a significant boost for this clinical-stage company.
The company also plans to initiate a phase II study in early 2024 with soquelitinib monotherapy in recurrent renal cell cancer (RCC).
Corvus’ second product candidate, ciforadenant, is being evaluated in an open-label phase Ib/II study as a first-line therapy for metastatic RCC, in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The company has collaborated with the Kidney Cancer Research Consortium, which is conducting this study. The phase Ib portion of this trial has been completed and patients are now being enrolled in the phase II portion. The clinical trial is expected to enroll up to 60 patients and the initial data is anticipated in early 2024.
As of Sep 30, 2023, Corvus had cash, cash equivalents and marketable securities of $32.2 million. It sold 2,461,903 shares of its common stock, generating net proceeds of approximately $7.8 million during the nine months ending Sep 30, 2023. Corvus expects full-year 2023 net cash used in operating activities to be between $22 million and $23 million, resulting in a projected cash balance between $27 million and $28 million as of Dec 31, 2023. The company expects its cash to fund operations into late 2024.
Zacks Rank and Stocks to Consider
Corvus currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Puma Biotechnology, Inc. (PBYI - Free Report) , ImmunoGen and Sarepta Therapeutics (SRPT - Free Report) . While PBYI and IMGN currently sport a Zacks Rank #1 (Strong Buy) each, SRPT carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained steady at 69 cents. Over the past year, shares of PBYI have risen 33.2%.
PBYI’s earnings beat estimates in three of the last four quarters and missed the same in one, delivering an average surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 EPS has remained constant at 7 cents. During the same period, the consensus estimate for 2024 EPS has remained constant at 37 cents. Over the past year, shares of IMGN have skyrocketed 617.9%.
In the past 30 days, Sarepta’s 2023 bottom-line estimate has improved from a loss of $6.62 to a loss of $6.57. During the same period, the bottom-line estimate for 2024 has risen from $2.27 to $2.43.
Sarepta’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 48.67%. In the previous reported quarter, its earnings beat estimates by 72.29%.
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Corvus' (CRVS) Lymphoma Drug Gets Orphan Status, Stock Up
Corvus Pharmaceuticals, Inc. (CRVS - Free Report) announced that the FDA granted the Orphan Drug Designation to its lead pipeline candidate, soquelitinib, for the treatment of T cell lymphoma.
The FDA generally grants this designation to investigational therapies that address rare medical diseases or conditions affecting fewer than 200,000 people in the United States. The perquisites that come from this designation include assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. The company’s shares rose 10.75% on the news.
Soquelitinib (formerly known as CPI-818) is an investigational small molecule drug given orally, designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer cell immune function.
The company is on track to advance the candidate into a phase III registrational clinical study in patients with relapsed peripheral T cell lymphoma (PTCL) in the second quarter of 2024.
In December, CRVS reported new interim data from its phase I/Ib clinical study of soquelitinib in patients with relapsed PTCL. Soquelitinib demonstrated durable anti-tumor activity, evidenced by progression-free survival, duration of response and overall survival rates that exceed current standard of care therapies for patients with relapsed PTCL. The data supports the advancement of soquelitinib into the late-stage registrational clinical trial in PTCL.
Shares of the company have lost 0.7% in the past six months against the industry’s growth of 0.8%.
Image Source: Zacks Investment Research
The phase III study is designed to enroll a total of 150 patients with relapsed PTCL that have received more than or equal to one prior therapy or less than or equal to three prior therapies. Patients will be randomized equally to receive soquelitinib 200 mg two-times a day or standard of care chemotherapy. The primary endpoint will be progression-free survival.
Secondary endpoints will include objective response rate and overall survival.
The successful development of soquelitinib will be a significant boost for this clinical-stage company.
The company also plans to initiate a phase II study in early 2024 with soquelitinib monotherapy in recurrent renal cell cancer (RCC).
Corvus’ second product candidate, ciforadenant, is being evaluated in an open-label phase Ib/II study as a first-line therapy for metastatic RCC, in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The company has collaborated with the Kidney Cancer Research Consortium, which is conducting this study. The phase Ib portion of this trial has been completed and patients are now being enrolled in the phase II portion. The clinical trial is expected to enroll up to 60 patients and the initial data is anticipated in early 2024.
As of Sep 30, 2023, Corvus had cash, cash equivalents and marketable securities of $32.2 million. It sold 2,461,903 shares of its common stock, generating net proceeds of approximately $7.8 million during the nine months ending Sep 30, 2023. Corvus expects full-year 2023 net cash used in operating activities to be between $22 million and $23 million, resulting in a projected cash balance between $27 million and $28 million as of Dec 31, 2023. The company expects its cash to fund operations into late 2024.
Zacks Rank and Stocks to Consider
Corvus currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Puma Biotechnology, Inc. (PBYI - Free Report) , ImmunoGen and Sarepta Therapeutics (SRPT - Free Report) . While PBYI and IMGN currently sport a Zacks Rank #1 (Strong Buy) each, SRPT carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has remained steady at 69 cents. Over the past year, shares of PBYI have risen 33.2%.
PBYI’s earnings beat estimates in three of the last four quarters and missed the same in one, delivering an average surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ImmunoGen’s 2023 EPS has remained constant at 7 cents. During the same period, the consensus estimate for 2024 EPS has remained constant at 37 cents. Over the past year, shares of IMGN have skyrocketed 617.9%.
In the past 30 days, Sarepta’s 2023 bottom-line estimate has improved from a loss of $6.62 to a loss of $6.57. During the same period, the bottom-line estimate for 2024 has risen from $2.27 to $2.43.
Sarepta’s earnings beat estimates in each of the last four quarters, delivering an average surprise of 48.67%. In the previous reported quarter, its earnings beat estimates by 72.29%.