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Gilead (GILD) Drugs Get Positive CHMP Opinion for Label Expansion
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Gilead Sciences, Inc. (GILD - Free Report) recently announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a positive opinion to extend the indication of its COVID-19 treatment Veklury (remdesivir).
The CHMP recommended Veklury for treating pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients (four weeks of age and older and weighing at least 3 kgs) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).
The European Commission (“EC”) will review the CHMP recommendation. The potential approval will make Veklury the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen.
This positive opinion was based on the ongoing CARAVAN phase II/III study results. The study demonstrated that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.
We remind investors that Veklury is now recommended by the World Health Organization to treat patients with severe COVID-19. The organization also continues to conditionally recommend Veklury for those with non-severe COVID-19 at the highest risk of hospitalization.
Concurrently, the CHMP issued a positive opinion for Chimeric Antigen Receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel) for adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. A final decision is expected in the coming months.
The positive opinion was based on the landmark ZUMA-7 study wherein 41% of patients demonstrated event-free survival at two years versus 16% for the standard of care. A potential approval will make Yescarta the first CAR T-cell therapy approved for patients in Europe who do not respond to first-line treatment.
Yescarta was first approved in Europe in 2018 and is currently indicated for three types of blood cancer – DLBCL, primary mediastinal large B-Cell lymphoma (PMBCL) and follicular lymphoma (FL).
The stock has lost 9.7% so far in the year compared with the industry's decline of 23.6%.
Image Source: Zacks Investment Research
The use of engineered T cells as a potential cancer treatment is a recent development and is complex but promises potential. Gilead has one more cell therapy in its portfolio – Tecartus.
Earlier this month, the EC approved its other CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL) in patients aged 26 and above.
With its breast cancer drug Trodelvy and its CAR T franchise, Gilead is making efforts to develop its oncology business to diversify its revenue base. However, while this is a lucrative space, competition is formidable from the likes of Novartis’ (NVS - Free Report) CAR-T cell therapy Kymriah (tisagenlecleucel), among others.
In May 2022, Novartis obtained FDA approval for Kymriah to treat adult patients with relapsed or refractory FL after two or more lines of systemic therapy. Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings.
The EC also approved Kymriah for treating adult patients with r/r FL after two or more lines of systemic therapy.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. Earnings surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average beat being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.
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Gilead (GILD) Drugs Get Positive CHMP Opinion for Label Expansion
Gilead Sciences, Inc. (GILD - Free Report) recently announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) adopted a positive opinion to extend the indication of its COVID-19 treatment Veklury (remdesivir).
The CHMP recommended Veklury for treating pediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19 and pediatric patients (four weeks of age and older and weighing at least 3 kgs) with SARS-CoV-2 with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment).
The European Commission (“EC”) will review the CHMP recommendation. The potential approval will make Veklury the only authorized COVID-19 treatment for adolescents at high risk of progressing to severe COVID-19 and pediatric patients with COVID-19 requiring supplemental oxygen.
This positive opinion was based on the ongoing CARAVAN phase II/III study results. The study demonstrated that Veklury was generally well-tolerated among pediatric patients hospitalized with COVID-19, with a high proportion of participants showing clinical improvement and recovery, as well as data from trials in adults.
We remind investors that Veklury is now recommended by the World Health Organization to treat patients with severe COVID-19. The organization also continues to conditionally recommend Veklury for those with non-severe COVID-19 at the highest risk of hospitalization.
Concurrently, the CHMP issued a positive opinion for Chimeric Antigen Receptor (CAR) T-cell therapy Yescarta (axicabtagene ciloleucel) for adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. A final decision is expected in the coming months.
The positive opinion was based on the landmark ZUMA-7 study wherein 41% of patients demonstrated event-free survival at two years versus 16% for the standard of care. A potential approval will make Yescarta the first CAR T-cell therapy approved for patients in Europe who do not respond to first-line treatment.
Yescarta was first approved in Europe in 2018 and is currently indicated for three types of blood cancer – DLBCL, primary mediastinal large B-Cell lymphoma (PMBCL) and follicular lymphoma (FL).
The stock has lost 9.7% so far in the year compared with the industry's decline of 23.6%.
Image Source: Zacks Investment Research
The use of engineered T cells as a potential cancer treatment is a recent development and is complex but promises potential. Gilead has one more cell therapy in its portfolio – Tecartus.
Earlier this month, the EC approved its other CAR T-cell therapy Tecartus (brexucabtagene autoleucel) for the treatment of relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL) in patients aged 26 and above.
With its breast cancer drug Trodelvy and its CAR T franchise, Gilead is making efforts to develop its oncology business to diversify its revenue base.
However, while this is a lucrative space, competition is formidable from the likes of Novartis’ (NVS - Free Report) CAR-T cell therapy Kymriah (tisagenlecleucel), among others.
In May 2022, Novartis obtained FDA approval for Kymriah to treat adult patients with relapsed or refractory FL after two or more lines of systemic therapy. Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings.
The EC also approved Kymriah for treating adult patients with r/r FL after two or more lines of systemic therapy.
Gilead currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. Earnings surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average beat being 2.39%.
Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.