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The biotech sector continues to be in focus with pipeline and regulatory updates. Earnings updates from bigwigs like Biogen (BIIB - Free Report) and Amgen (AMGN - Free Report) also grab the spotlight.
Recap of the Week’s Most Important Stories:
Biogen, Amgen Report Q1 Earnings: Biogen beat on earnings and sales in the first quarter of 2021. However, sales were down year over year on lower sales of Tecfidera and Spinraza, and biosimilar drugs due to increased competition. Earnings too declined due to lower sales. Nevertheless, Biogen raised its annual earnings guidance and reiterated the sales guidance.
However, Amgen missed on earnings and sales in the first quarter of 2021. Lower prices of several drugs and business disruption due to the pandemic hurt sales.
Vertex, CRISPR’s Thalassemia Drug Gets PRIME Designation: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and partner CRISPR Therapeutics (CRSP - Free Report) announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001. The candidate is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy and the designation has been granted for the treatment of transfusion-dependent beta thalassemia (TDT). It was previously granted the PRIME designation for the treatment of sickle cell disease (SCD) in 2020. The designation was granted based on clinical data from the ongoing phase I/II study of CTX001 in patients with TDT.
Bristol Myers Gets Positive CHMP Opinion for Opdivo: Bristol Myers Squibb (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended approval of immuno-oncology drug, Opdivo (nivolumab), for one more indication. The drug, in combination with Yervoy (ipilimumab), has been approved for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).
Separately, the CHMP also recommended the approval of Onureg (azacitidine tablets; CC-486) as maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT). It also announced positive results from two phase III studies evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib.
Gilead to Expand Availability of Remdesivir in India: Gilead Sciences, Inc. (GILD - Free Report) announced that it will lend support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up the production of Veklury (remdesivir) in India. The move comes in response to the rapid increase in COVID-19 cases in India. The drug is approved in the country for restricted emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Gilead will also donate at least 450,000 vials of Veklury to help address the immediate needs of patients in India.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 3.97% in the last five trading sessions. Among the biotech giants, Gilead lost 2.58% during the period. Over the past six months, shares of Alexion have surged 39.22%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMYs Opdivo Gets FDA Nod for Gastric Cancer & Other Updates).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates along with earnings updates.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Image: Bigstock
Biotech Stock Roundup: BIIB, AMGN's Q1 Earnings Updates & Other Pipeline News
The biotech sector continues to be in focus with pipeline and regulatory updates. Earnings updates from bigwigs like Biogen (BIIB - Free Report) and Amgen (AMGN - Free Report) also grab the spotlight.
Recap of the Week’s Most Important Stories:
Biogen, Amgen Report Q1 Earnings: Biogen beat on earnings and sales in the first quarter of 2021. However, sales were down year over year on lower sales of Tecfidera and Spinraza, and biosimilar drugs due to increased competition. Earnings too declined due to lower sales. Nevertheless, Biogen raised its annual earnings guidance and reiterated the sales guidance.
However, Amgen missed on earnings and sales in the first quarter of 2021. Lower prices of several drugs and business disruption due to the pandemic hurt sales.
Vertex, CRISPR’s Thalassemia Drug Gets PRIME Designation: Vertex Pharmaceuticals Incorporated (VRTX - Free Report) and partner CRISPR Therapeutics (CRSP - Free Report) announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to CTX001. The candidate is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy and the designation has been granted for the treatment of transfusion-dependent beta thalassemia (TDT). It was previously granted the PRIME designation for the treatment of sickle cell disease (SCD) in 2020. The designation was granted based on clinical data from the ongoing phase I/II study of CTX001 in patients with TDT.
Bristol Myers Gets Positive CHMP Opinion for Opdivo: Bristol Myers Squibb (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended approval of immuno-oncology drug, Opdivo (nivolumab), for one more indication. The drug, in combination with Yervoy (ipilimumab), has been approved for the first-line treatment of adults with unresectable malignant pleural mesothelioma (MPM).
Separately, the CHMP also recommended the approval of Onureg (azacitidine tablets; CC-486) as maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).
It also announced positive results from two phase III studies evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib.
Bristol Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Gilead to Expand Availability of Remdesivir in India: Gilead Sciences, Inc. (GILD - Free Report) announced that it will lend support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up the production of Veklury (remdesivir) in India. The move comes in response to the rapid increase in COVID-19 cases in India. The drug is approved in the country for restricted emergency use for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Gilead will also donate at least 450,000 vials of Veklury to help address the immediate needs of patients in India.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 3.97% in the last five trading sessions. Among the biotech giants, Gilead lost 2.58% during the period. Over the past six months, shares of Alexion have surged 39.22%. (See the last biotech stock roundup here: Biotech Stock Roundup: BMYs Opdivo Gets FDA Nod for Gastric Cancer & Other Updates).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates along with earnings updates.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>