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Viracta (VIRX) Up on Orphan Drug Tag for Peripheral Lymphoma
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Viracta Therapeutics (VIRX - Free Report) increased 11.9% during market hours on Sep 7. The upside followed after the company announced that the European Commission (EC) granted Orphan Drug designation (ODD) to the lead combination therapy candidate, nanatinostat and valganciclovir (Nana-val), for peripheral T-cell lymphoma (PTCL).
The EC grants The Orphan Drug designation in the European Union (EU) to a drug or biologic based on a positive opinion of the European Medicines Agency’s (EMA) Committee for Orphan Medical Products (COMP). The ODD is granted to a product candidate intended to treat, prevent or diagnose a rare disease or condition that does not affect more than five in 10,000 people across the EU.
With the EU Orphan Drug designation, Nana-val has now gained eligibility for 10 years of European market exclusivity post EU approval.
The designation also includes incentives, including protocol assistance from the EMA, financial aid depending on the sponsor status and required service in the event of regulatory approval.
The ODD from the European Commission marks Nana-val’s first in Europe and fifth globally.
Previously, Nana-val received ODD from the FDA to treat EBV-positive diffuse large B-cell lymphoma, not otherwise specified (“EBV+ DLBCL, NOS”), post-transplant lymphoproliferative disorders (“PTLD”), plasmablastic lymphoma and T-cell lymphoma.
It has also received Fast-Track designation from the FDA for treating relapsed/refractory (“R/R”) EBV+ R/M NPC.
Shares of Viracta have returned 31.7% in the year-to-date period against the industry’s decline of 25.2%.
Image Source: Zacks Investment Research
Nana-val is an all-oral combination of Viracta’s proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir. The combination is being evaluated in multiple clinical studies in various subtypes of Epstein-Barr virus (EBV)-associated cancers.
It is currently being assessed in a stage 1 pivotal study (NAVAL-1) to treat EBV-positive (EBV+) lymphoma and its subtypes. An update on the initial cohort of the NAVAL-1 study is anticipated in the fourth quarter of 2022. The results could potentially advance the candidate into stage 2 of the NAVAL-1 study. If successful, Viracta is optimistic that top-line data from NAVAL-1 can potentially support multiple new drug application (NDA) filings across various EBV+ lymphoma subtypes.
Nana-val is also being evaluated in an open-label phase Ib/II study for the treatment of EBV+ recurrent or metastatic nasopharyngeal carcinoma (“R/M NPC”) and other EBV+ solid tumors. Preliminary safety and efficacy data from the phase Ib dose escalation portion of the study is expected in the fourth quarter of 2022.
Aerie’s loss per share estimates for 2022 have improved from $1.91 to $1.83 in the past 30 days. The same for 2023 has narrowed down to $1.01 from $1.05 in the same time frame.
Earnings of Aerie beat estimates in three of the trailing four quarters while missing the same in the remaining occasion. The average earnings surprise for AERI is 70.27%.
Catalyst’s earnings per share estimates for 2022 have improved from 67 cents to 70 cents in the past 30 days. The same for 2023 has improved from 79 cents to 85 cents in the same time frame.
Earnings of Catalyst missed estimates in two of the trailing four quarters, were in line in one and beat the same on the remaining occasion. The average negative earnings surprise for CPRX is 5.41%.
Soleno’s loss per share estimates for 2022 have narrowed down from $4.20 to $4.05 in the past 30 days. The same for 2023 has narrowed from $3.00 to $2.10 in the same time frame.
Earnings of Soleno missed estimates in three of the trailing four quarters and were in line on the remaining occasion. The average earnings surprise for SLNO is 11.40%.
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Viracta (VIRX) Up on Orphan Drug Tag for Peripheral Lymphoma
Viracta Therapeutics (VIRX - Free Report) increased 11.9% during market hours on Sep 7. The upside followed after the company announced that the European Commission (EC) granted Orphan Drug designation (ODD) to the lead combination therapy candidate, nanatinostat and valganciclovir (Nana-val), for peripheral T-cell lymphoma (PTCL).
The EC grants The Orphan Drug designation in the European Union (EU) to a drug or biologic based on a positive opinion of the European Medicines Agency’s (EMA) Committee for Orphan Medical Products (COMP). The ODD is granted to a product candidate intended to treat, prevent or diagnose a rare disease or condition that does not affect more than five in 10,000 people across the EU.
With the EU Orphan Drug designation, Nana-val has now gained eligibility for 10 years of European market exclusivity post EU approval.
The designation also includes incentives, including protocol assistance from the EMA, financial aid depending on the sponsor status and required service in the event of regulatory approval.
The ODD from the European Commission marks Nana-val’s first in Europe and fifth globally.
Previously, Nana-val received ODD from the FDA to treat EBV-positive diffuse large B-cell lymphoma, not otherwise specified (“EBV+ DLBCL, NOS”), post-transplant lymphoproliferative disorders (“PTLD”), plasmablastic lymphoma and T-cell lymphoma.
It has also received Fast-Track designation from the FDA for treating relapsed/refractory (“R/R”) EBV+ R/M NPC.
Shares of Viracta have returned 31.7% in the year-to-date period against the industry’s decline of 25.2%.
Image Source: Zacks Investment Research
Nana-val is an all-oral combination of Viracta’s proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir. The combination is being evaluated in multiple clinical studies in various subtypes of Epstein-Barr virus (EBV)-associated cancers.
It is currently being assessed in a stage 1 pivotal study (NAVAL-1) to treat EBV-positive (EBV+) lymphoma and its subtypes. An update on the initial cohort of the NAVAL-1 study is anticipated in the fourth quarter of 2022. The results could potentially advance the candidate into stage 2 of the NAVAL-1 study. If successful, Viracta is optimistic that top-line data from NAVAL-1 can potentially support multiple new drug application (NDA) filings across various EBV+ lymphoma subtypes.
Nana-val is also being evaluated in an open-label phase Ib/II study for the treatment of EBV+ recurrent or metastatic nasopharyngeal carcinoma (“R/M NPC”) and other EBV+ solid tumors. Preliminary safety and efficacy data from the phase Ib dose escalation portion of the study is expected in the fourth quarter of 2022.
Viracta Therapeutics, Inc. Price
Viracta Therapeutics, Inc. price | Viracta Therapeutics, Inc. Quote
Zacks Rank and Other Stocks to Consider
Currently, Viracta has a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the same sector are Aerie Pharmaceuticals , Catalyst Pharmaceuticals (CPRX - Free Report) andSoleno Therapeutics (SLNO - Free Report) ,each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Aerie’s loss per share estimates for 2022 have improved from $1.91 to $1.83 in the past 30 days. The same for 2023 has narrowed down to $1.01 from $1.05 in the same time frame.
Earnings of Aerie beat estimates in three of the trailing four quarters while missing the same in the remaining occasion. The average earnings surprise for AERI is 70.27%.
Catalyst’s earnings per share estimates for 2022 have improved from 67 cents to 70 cents in the past 30 days. The same for 2023 has improved from 79 cents to 85 cents in the same time frame.
Earnings of Catalyst missed estimates in two of the trailing four quarters, were in line in one and beat the same on the remaining occasion. The average negative earnings surprise for CPRX is 5.41%.
Soleno’s loss per share estimates for 2022 have narrowed down from $4.20 to $4.05 in the past 30 days. The same for 2023 has narrowed from $3.00 to $2.10 in the same time frame.
Earnings of Soleno missed estimates in three of the trailing four quarters and were in line on the remaining occasion. The average earnings surprise for SLNO is 11.40%.