The biotech industry has been in focus over the past week with pipeline and regulatory updates. The development of antibodies and vaccines for COVID-19 continues to grab spotlight as the pandemic rages on.
: Recap of the Week’s Most Important Stories : Regeneron’s Cocktail Approved in the UK Regeneron Pharmaceuticals ( REGN Quick Quote REGN - Free Report) announced that the U.K.’s Medicines and Healthcare products Regulatory Agency (“MHRA”) has granted Conditional Marketing Authorization (CMA) to its antibody cocktail, casirivimab and imdevimab, to prevent and treat acute COVID-19 infection. The cocktail is known as REGEN-COV in the United States and Ronapreve in the U.K. and other countries. The MHRA has also authorized emergency supply of the antibody cocktail to prevent and treat acute COVID-19 infection in people of Northern Ireland. In addition, the antibody cocktail is authorized to treat people across the U.K. who have an existing infection or to prevent COVID-19 infection, including in those who may need ongoing monthly doses if they have a medical condition making them unlikely to respond to or be protected by vaccination.
Regeneron also announced encouraging top-line
data from an ongoing phase II proof-of-concept study evaluating an investigational 8 mg dose of its aflibercept. The trial was designed to investigate the safety, efficacy and tolerability of high-dose aflibercept (8 mg) compared to the existing approved dose of Eylea (2 mg) in treatment-naïve patients with wet age-related macular degeneration (wet AMD). The study met its primary safety endpoint, with no new safety signals observed compared to the currently-approved 2 mg dose of Eylea. Data showed that a higher proportion of patients in the aflibercept 8 mg group had no retinal fluid compared to patients treated with Eylea 2 mg at week 16, the primary efficacy endpoint.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see
. the complete list of today’s Zacks #1 Rank stocks here : Moderna Submits BLA for Vaccine to FDA Moderna ( MRNA Quick Quote MRNA - Free Report) announced that it has completed the rolling submission process for its biologics license application (BLA) to the FDA for the full licensure of its COVID-19 vaccine. The company is seeking approval for active immunization to prevent COVID-19 in individuals aged 18 years and older. As part of the completed BLA submission, Moderna has requested Priority Review designation. The submission began in June. The vaccine is currently available in the United States for individuals aged 18 years and older under an Emergency Use Authorization (EUA) granted by the FDA in December 2020. The company has also filed for an EUA for adolescents aged 12 and above with the FDA. : Shares of Theravance Down on Study Results Theravance Biopharma, Inc. ( TBPH Quick Quote TBPH - Free Report) plunged after the company announced disappointing data from its phase IIb dose-finding induction study of izencitinib, an orally administered, gut-selective pan-Janus kinase (JAK) inhibitor in development for the treatment of ulcerative colitis. The randomized, double-blind, placebo-controlled study did not meet the primary endpoint of change in the total Mayo score or the key secondary endpoint of clinical remission at week 8, relative to placebo. The company is developing izencitinib and other compounds for inflammatory intestinal diseases in collaboration with Janssen Biotech, a subsidiary of Johnson & Johnson. : Shares of BioNTech Jumps on Vaccine Approval BioNTech SE ( BNTX Quick Quote BNTX - Free Report) surged significantly after the company and partner Pfizer ( PFE Quick Quote PFE - Free Report) announced that the FDA approved the BLA for their COVID-19 vaccine — Comirnaty. The vaccine is now approved as a 2-dose series for prevention of COVID-19 in individuals aged 16 years and older. The BLA was granted Priority Review in July 2021. The approval is based on a comprehensive submission package including six-month efficacy and safety data after second dose. The vaccine has been available in the United States following an EUA in December 2020. Both the companies plan to seek licensure of a third, or booster, dose of the vaccine in individuals aged 16 years and older through a supplemental BLA. The companies also intend to submit a supplemental BLA to support potential full FDA approval of Comirnaty in individuals of 12 to15 years of age once the required data out to six months after the second vaccine dose are available. : Shares of CARA Surges on Drug Approval Cara Therapeutics ( CARA Quick Quote CARA - Free Report) soared after the company obtained FDA approval for lead product candidate Korsuva (CR845/difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing hemodialysis. The approval makes the drug the first and only therapy approved by the FDA for the treatment of pruritus associated with CKD in adults undergoing hemodialysis. The approval was supported by positive data from two pivotal late-stage studies — KALM-1, conducted in the United States and the global KALM-2 — as well as supportive data from an additional 32 studies. Korsuva injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe CKD-associated pruritus (CKD-aP) in two phase III studies. Performance
The Nasdaq Biotechnology Index has gained 2.30% in the past five trading sessions. Among the biotech giants, Regeneron gained 5.29% during the period. Over the past six months, shares of Moderna have soared 168.14%. (See the last biotech stock roundup here:
). Biotech Stock Roundup: MRNA Vaccine Updates, Other Regulatory News & Collaborations Image Source: Zacks Investment Research What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.