The biotech sector continues to be in focus as the development of antibodies and vaccines for coronavirus is gaining importance with each passing day as the pandemic registers a spike again. Other pipeline and regulatory updates also grabbed the spotlight.
: Recap of the Week’s Most Important Stories : Regeneron's Cocktail Gets EUA for COVID-19 by FDA Regeneron ( REGN Quick Quote REGN - Free Report) announced that the FDA has given Emergency Use Authorization (EUA) to its antibody cocktail, casirivimab and imdevimab, administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19.
The authorization is generally granted to medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. The antibody cocktail is authorized for the treatment of mild-to-moderate COVID-19 in adults, as well as pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. The combination therapy continues to be evaluated in phase II/III studies for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, the phase III open-label RECOVERY study in hospitalized patients in the U.K., and a phase III study for the prevention of COVID-19 in household contacts of infected individuals.
: Gilead Reports Positive Data on HIV Treatment Gilead Sciences, Inc. ( GILD Quick Quote GILD - Free Report) announced positive top-line results from the phase II/III CAPELLA study on lenacapavir. The candidate is being developed as a component of a long-acting regimen in combination with other antiretroviral agents for the treatment of HIV-1 infection. The study is evaluating the candidate in heavily treatment-experienced people with multidrug-resistant HIV-1 infection. In the study, 36 adults with multi-class HIV drug resistance and a detectable viral load while on a failing regimen were randomized 2:1 to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy). The results showed that a statistically significant greater proportion of participants receiving lenacapavir met the primary endpoint of a viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those receiving placebo at the end of the 14-day functional monotherapy period (88% vs. 17%).
Separately, the World Health Organization (WHO) issued a conditional recommendation against the use of its Gilead’s remdesivir in hospitalized COVID-19 patients, regardless of disease severity.
Gilead currently carries a Zacks Rank #3 (Hold). You can see
. the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here : Amgen Terminates Deal With Cytokinetics for Heart Failure Drug Amgen ( AMGN Quick Quote AMGN - Free Report) announced that it has informed Cytokinetics about the termination of their collaboration and its intention to transition the development and commercialization rights for omecamtiv mecarbil and AMG 594 to the latter. Omecamtiv mecarbil is an investigational cardiac myosin activator. It was being evaluated for the potential treatment of heart failure with reduced ejection fraction (HFrEF), in GALACTIC-HF, a phase III study. : Bristol Myers’ Opdivo Approved for ESCC by EC Bristol Myers Squibb ( BMY Quick Quote BMY - Free Report) announced that the European Commission (EC) has approved its blockbuster drug, Opdivo (nivolumab), for the treatment of adults with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) as a second-line treatment after prior fluoropyrimidine- and platinum-based combination chemotherapy. The approval was based on results from the phase III ATTRACTION-3 study, sponsored by Ono Pharmaceutical Co., Ltd. of Japan, which demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) in patients who received Opdivo as compared to chemotherapy. : Alnylam Wins FDA Approval of Oxlumo Alnylam Pharmaceuticals, Inc. ( ALNY Quick Quote ALNY - Free Report) obtained the FDA approval for Oxlumo (lumasiran) injection for subcutaneous use, for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. PH1 is an ultra-rare genetic disease characterized by oxalate overproduction. The FDA approval was primarily based on positive results from the randomized, double-blind, placebo-controlled ILLUMINATE-A phase 3 study. The agency also considered positive interim results from the single-arm, open-label ILLUMINATE-B phase III pediatric study. Last week, the European Commission also granted marketing authorization to Oxlumo for the treatment of PH1 in all age groups. Performance
The Nasdaq Biotechnology Index lost 1.61% in the last five trading sessions. Among the biotech giants, Amgen lost 5.15% during this period. Over the past six months, shares of Alexion have rallied 19.76%. (See the last biotech stock roundup here:
) Biotech Stock Roundup: MRNA's Progress With Coronavirus Vaccine, News From BMY, ALKS What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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