BIIB & SAGE Alliance, MRNA, BNTX Coronavirus Updates and more
Numerous regulatory and pipeline updates have caught the attention of the biotech industry over the past week. The sector has been the center of attention since the start of the year due to the coronavirus pandemic and so too as the development of antibodies and vaccines grows in importance with each passing day as the pandemic continues. again records a peak. Collaboration agreements were also in the spotlight.
Recap of the most important stories of the week:
Biogen collaborates with Sage: Biogen Inc. BIIB has entered into a global collaboration and license agreement with Sage Therapeutics, Inc. SAGE for the development and commercialization of 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 an advanced stage candidate, which will be developed for the treatment of major depressive disorder (“MDD”), postpartum depression (“PPD”) and other psychiatric conditions under the agreement. SAGE-324, a mid-term candidate, will be developed for the treatment of essential tremors and other neurological disorders.
Under the deal, Biogen will pay Sage Therapeutics $ 875 million in cash as an upfront payment and make a $ 650 million equity investment by purchasing approximately 6.2 million common shares of Sage Therapeutics newly issued 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 obtains the green light from the EC for a combination drug: Vertex Pharma inc. VRTX announced that the European Commission has approved a label extension of its combined treatment regimen of Symkevi and Kalydeco. The regimen is now approved for the treatment of patients with cystic fibrosis (“CF”) aged six to 11 years who have two copies of the F508del mutation in the CFTR gene or one copy of the F508del mutation and one copy of the one of the 14 residual functional mutations in the CFTR gene which results 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 combined regimen is already approved for the treatment of patients with cystic fibrosis aged 12 years or older with the same mutations.
Vertex currently wears a Zacks Rank # 3 (Hold). You can see The full list of Zacks # 1 Rank (Strong Buy) stocks today here.
Moderna asks EUA for coronavirus vaccine: Moderna MRNA announced that it has completed the primary efficacy analysis of the phase III COVE study evaluating its novel coronavirus vaccine candidate, mRNA-1273. Analysis data showed that the vaccine achieved a 94.1% efficacy rate against COVID-19 infection. The vaccine’s effectiveness against severe COVID-19 was 100%.
The company has applied for emergency use authorization (EUA) from the FDA and conditional approval from the European Medicines Agency (EMA) for mRNA-1273. The company also said the FDA’s Vaccines and Related Biologics Advisory Committee (VRBPAC) meeting is scheduled for Dec. 17, which will review the mRNA safety and efficacy data dossier. -1273. Stocks surged on the news.
BioNTech and Pfizer Obtain Authorization for COVID-19 Vaccine: Actions of BioNTech SE BNTX is on the rise in pre-market exchanges after the company and its partner Pfizer Inc. PFE has announced that the Medicines and Health Products Regulatory Agency (MHRA) in the UK has granted temporary authorization for emergency use of its COVID-19 mRNA vaccine (BNT162b2).
The decision was based on continued submission, including data from the Phase III clinical study, which demonstrated a vaccine efficacy rate of 95% (p
Pace gains on drug approval: Rhythm Pharmaceuticals, Inc. RYTM surged after obtaining 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 aged 6 years and older with obesity due to deficiency of proopiomelanocortin (POMC), proprotein convertase subtilisin / kexin type 1 (PCSK1) or leptin receptor (LEPR) confirmed by genetic testing. .
The approval makes Imciivree the very first FDA-approved treatment for these rare genetic diseases of obesity. FDA approval was based on the results of the largest studies to date on obesity due to POMC, PCSK1 or LEPR deficiency. The results of phase III studies showed that 80% of obese patients due to POMC or PCSK1 deficiency lost more than 10% of weight and 45.5% of obese patients due to LEPR deficiency lost more than 10%. % of weight after one year of treatment. with Imcivree.
Medical – Biomedical and genetic industry 5 years of yield in%
Medical – Biomedical and genetic industry 5 years of yield in%
The Nasdaq Biotechnology index has gained 5.18% over the past four trading days. Among the biotechnology giants, Vertex gained 6.37% over this period. Over the past six months, Bristol-Myers shares have risen 5.09%. (See the latest rundown of biotech stocks here: Biotech Stock Summary: REGN’s Cocktail Gets EUA, GILD and AMGN Provide Updates and More).
What’s the next step in biotechnology?
Stay tuned for more pipeline and regulatory updates.
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