Quite a few regulatory and pipeline updates grabbed the spotlight in the biotech sector in the past week. The sector has been in focus since the onset of the year due to the coronavirus pandemic and the same continues as the development of antibodies and vaccines is gaining importance with each passing day as the pandemic registers a spike again. Collaboration deals were also in focus. : Recap of the Week’s Most Important Stories : Biogen Collaborates wth Sage Biogen Inc. ( BIIB Quick Quote BIIB - Free Report) entered into a global collaboration and license agreement with Sage Therapeutics, Inc. ( SAGE Quick Quote SAGE - Free Report) for developing and commercializing potential breakthrough therapies in depression and movement disorders. The agreement includes the development of two candidates from Sage Therapeutics’ pipeline — zuranolone (SAGE-217) and SAGE-324. Zuranolone is a late-stage candidate, which will be developed for treating major depressive disorder (“MDD”), postpartum depression (“PPD”) and other psychiatric disorders under the agreement. SAGE-324, a mid-stage candidate, will be developed for treating essential tremor and other neurological disorders. Per the deal, Biogen will pay Sage Therapeutics $875 million in cash as an upfront payment and will make an equity investment worth $650 million by purchasing approximately 6.2 million newly-issued shares of Sage Therapeutics common stock at a price of $104.14 per share. Sage Therapeutics is also eligible to receive up to $1.6 billion in potential milestone payments. The successful development of zuranolone and SAGE-324 will likely complement Biogen’s drug portfolio. : Vertex Gets EC Nod for Combination Drug Vertex Pharmaceuticals Inc. ( VRTX Quick Quote VRTX - Free Report) announced that the European Commission has approved a label expansion of its combination regimen of Symkevi and Kalydeco. The regimen is now approved for treating cystic fibrosis (“CF”) patients aged six to 11 years and who have two copies of the F508del mutation in the CFTR gene or one copy of the F508del mutation and one copy of one of 14 residual function mutations in the CFTR gene that result in residual CFTR activity (P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T). The combo regimen is already approved for treating CF patients aged 12 years or older with the same mutations. Vertex currently carries a Zacks Rank #3 (Hold). You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here : Moderna Requests EUA for Coronavirus Vaccine Moderna ( MRNA Quick Quote MRNA - Free Report) announced that it has completed primary efficacy analysis of the phase III COVE study evaluating its novel coronavirus vaccine candidate, mRNA-1273. Data from the analysis showed that the vaccine achieved an efficacy rate of 94.1% against the COVID-19 infection. Vaccine efficacy against severe COVID-19 was 100%. The company requested an Emergency Use Authorization (EUA) from the FDA and a conditional approval from the European Medicines Agency (EMA) for mRNA-1273. The company also stated that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is scheduled for Dec 17, which will review the safety and efficacy data package for mRNA-1273. Shares surged on the news. : Shares of BioNTech, Pfizer Get Authorization for COVID-19 Vaccine BioNTech SE ( BNTX Quick Quote BNTX - Free Report) are up in premarket trading after the company and partner Pfizer Inc. ( PFE Quick Quote PFE - Free Report) announced that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use to their COVID-19 mRNA vaccine (BNT162b2). The decision was based on a rolling submission, including data from the phase III clinical study, which demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. : Rhythm Gains on Drug Approval Rhythm Pharmaceuticals, Inc. ( RYTM Quick Quote RYTM - Free Report) surged after it obtained the FDA approval of its lead product candidate, setmelanotide, for chronic weight management under the brand name, Imcivree. The drug has been approved for chronic weight management in adult and pediatric patients 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency confirmed by genetic testing. The approval makes Imcivree the first-ever FDA-approved therapy for these rare genetic diseases of obesity. The FDA approval was based on results from the largest studies conducted to date in obesity due to POMC, PCSK1 or LEPR deficiency. Results from the phase III studies showed that 80% of patients with obesity due to POMC or PCSK1 deficiency achieved greater than 10% weight loss and 45.5% of patients with obesity due to LEPR deficiency achieved greater than 10% weight loss after one year of treatment with Imcivree. Performance The Nasdaq Biotechnology Index gained 5.18% in the last four trading sessions. Among the biotech giants, Vertex gained 6.37% during this period. Over the past six months, shares of Bristol-Myers have rallied 5.09%. (See the last biotech stock roundup here: ). Biotech Stock Roundup: REGN’s Cocktail Gets EUA, GILD & AMGN Provide Updates & More What's Next in Biotech? Stay tuned for more pipeline and regulatory 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.
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