It was a low-key start for the volatile biotech sector in 2021 with a primary focus on COVID-19 vaccine updates, as the pandemic continues to create havoc. Meanwhile, collaborations again take center stage in the sector. Other regulatory and pipeline updates too grabbed the spotlight.
: Recap of the Week’s Most Important Stories : Moderna’s Updates on COVID-19 Vaccine Moderna, Inc. ( MRNA Quick Quote MRNA - Free Report) announced that Israel’s Ministry of Health (MOH) has given the authorization to import its COVID-19 vaccine to Israel. The MOH has secured 6 million doses of the COVID-19 vaccine.
announced that it is increasing its base-case global production estimates for its mRNA-based coronavirus vaccine, mRNA-1273, for 2021 by 20% to 600 million doses. Previously, the company’s estimated base-case for the year was 500 million doses. It is continuing to invest and add staff to manufacture up to potentially 1 billion doses for 2021. Moderna expects about 100 million doses to be available in the United States by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter.
Moderna currently carries a Zacks Rank #2 (Buy). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here : Incyte Collaborates With Cellenkos Incyte ( INCY Quick Quote INCY - Free Report) announced a global development collaboration agreement with privately-held clinical-stage biotech company, Cellenkos, Inc., whereby the companies will evaluate the combination of the former’s lead drug, Jakafi (ruxolitinib), and CK0804, Cellenkos’ cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis (MF). The companies plan to initiate a phase Ib single-arm, open-label study to evaluate the combination in patients with MF. The study will be funded by Incyte and operationalized by Cellenkos.
Additionally, Incyte gains an exclusive option to acquire sole rights to develop and commercialize CK0804 and genetically-modified variants of the same in benign and malignant hematology indications. The company also has an option to acquire an exclusive global license to develop and commercialize the program. Per the terms, Cellenkos would be eligible to receive a $20-million licensing fee along with development, regulatory and sales milestones totaling up to $294.5 million for each distinct product under the agreement. It is also entitled to tiered royalties ranging from mid-single digit to low-double digits on approval.
: Bristol Myers’ Application for Opdivo Validated Bristol Myers Squibb ( BMY Quick Quote BMY - Free Report) announced that the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for immuno-oncology drug, Opdivo (nivolumab). The MAA is seeking approval of the drug as an adjuvant treatment for esophageal or gastroesophageal junction (GEJ) cancer in adult patients with residual pathologic disease after neoadjuvant chemoradiotherapy (CRT) and resection. Validation of the application confirms that submission is complete and the EMA’s centralized review process will begin soon.
The EMA also validated the company’s type II Variation MAA for Opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with advanced or metastatic gastric cancer (GC), GEJ cancer or esophageal adenocarcinoma (EAC).
: Calithera Tanks on Study Failure Calithera Biosciences ( CALA Quick Quote CALA - Free Report) plunged after it announced that the CANTATA study on its lead pipeline candidate, telaglenastat, did not achieve its primary goal. Telaglenastat is an investigational, first-in-class, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. The study was evaluating the efficacy and safety of telaglenastat in combination with cabozantinib versus placebo plus cabozantinib in patients with advanced or metastatic renal cell carcinoma (RCC), who have been treated with one or two prior lines of systemic therapy, including at least one vascular endothelial growth factor (VEGF)-pathway targeted anti-angiogenic therapy or the combination of nivolumab and ipilimumab.
The data from the study showed that the combination of telaglenastat and cabozantinib did not meet the primary endpoint of improving progression-free survival (PFS) in the study population as compared to treatment with cabozantinib. Consequently, Calithera will focus its financial resources on the ongoing KEAPSAKE trial, the study of the arginase inhibitor, CB-280, in cystic fibrosis patients, and other pipeline programs. The company will also reduce its workforce by approximately 35% to focus on its ongoing programs.
: Arcturus Wins FDA Allowance for Study on Vaccine Arcturus Therapeutics Holdings Inc. ( ARCT Quick Quote ARCT - Free Report) announced that it has received FDA allowance for its Investigational New Drug (IND) application for the phase II study of its vaccine candidate, ARCT-021, following a review of the data from the phase I/II study. These study results demonstrated favorable tolerability and both humoral and cellular immunogenicity following administration of ARCT-021. The phase II study will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Both older and younger adult participants will be included. Early interim analyses of safety and immunogenicity will be performed to inform dose selection for a phase II study, which the company plans to start by the second quarter of this year, if the phase II study is successful. Performance
The Nasdaq Biotechnology Index gained 0.29% in the last four trading sessions. Among the biotech giants, Gilead gained 5.58% during this period. Over the past six months, shares of Alexion have rallied 38.56%. (See the last biotech stock roundup here:
) Biotech Stock Roundup: COVID-19 Updates From REGN, MYOV Partners With PFE & More What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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