The biotech sector continues to be in focus with pipeline and regulatory updates. Earnings updates from bigwigs like
Biogen ( BIIB Quick Quote BIIB - Free Report) and Amgen ( AMGN Quick Quote 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 Quick Quote VRTX - Free Report) and partner CRISPR Therapeutics ( CRSP Quick Quote 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 Quick Quote 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 Quick Quote 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
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.
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