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The Biotech space remained a key area of investors focus as several bigwigs announced quarterly results. While Alexion ALXN reported solid results, Gilead GILD reported dismal numbers. Among other developments over the week, Regeneron REGN and Sanofi announced plans to lower the price of Praluent, while Amgen AMGN received a positive opinion for Prolia.
Recap of Important Stories:
Q1 Progress Report: Companies like Alexion, Gilead and Vertex VRTX, among others reported first-quarter results over the last five trading sessions. While Alexion and Vertex delivered solid results for the quarter, Gilead’s both earnings and sales missed estimates on wider-than-expected decline in HCV franchise.
Following the Q1 results, Alexion raised guidance and also reported positive data on its long-acting C5 complement inhibitor — ALXN1210 which showed that patients with PNH can be effectively and safely switched from treatment with Soliris every two weeks to treatment with ALXN1210 every eight weeks.
A tentative approval will bode well for Alexion (read more: Alexion's Earnings Beat Estimates in Q1, Guidance Up).
Vertex’s first-quarter results were driven by the stellar performance of CF products (read more: Vertex Q1 Earnings Beat on Strong CF Products Sales).
Gilead is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Amgen Gets Positive Opinion For Prolia: Amgen announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion for the marketing authorization of Prolia for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
The CHMP opinion will now be reviewed by the European Commission. Meanwhile, the company’s supplemental Biologics License Application for Prolia for this expanded indication is also under review in the United States with a Prescription Drug User Fee Act action date of May 28, 2018.We note that the drug is already approved in the United States for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
In addition, the CHMP has adopted a positive opinion recommending a label variation for Kyprolis (carfilzomib) to include the final overall survival data from the phase III trial, ASPIRE which demonstrated that the addition of Kyprolis to lenalidomide and dexamethasone (KRd) reduced the risk of death by 21% versus lenalidomide and dexamethasone alone (Rd) and extended OS by 7.9 months in patients with relapsed or refractory multiple myeloma.
Regeneron and partner Sanofi to Cut Praluent Price: Regeneron and partner Sanofi announced that both companies will lower the net price of PCSK9 inhibitor Praluent (alirocumab) injection for more affordable patient access from Express Scripts.Consequently, Praluent will become the exclusive PCSK9 inhibitor therapy on the Express Scripts national formulary. The agreement (effective Jul 1) provides Praluent at lower net price and enables streamlined patient access based on physician attestation.
Meanwhile, the FDA has accepted for priority review the companies’ Biologics License Application for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (“CSCC”) or patients with locally advanced CSCC who are not candidates for surgery. The candidate was granted Breakthrough Therapy designation status by the FDA in September 2017. The target action date is Oct 28, 2018.
Biogen Negotiates Agreement With Neurimmune: Biogen BIIB and Neurimmune announced that the former has exercised its option to further reduce the previously negotiated royalty rates payable on potential future sales of its Alzheimer’s disease candidate, aducanumab.
The candidate is currently in phase III. As a result, Biogen will make a one-time $50 million payment to Neurimmune in exchange for a 5% reduction in the original royalty rates on potential commercial sales of aducanumab. Both companies had earlier announced a 15% reduction in royalty rates. The reduced royalty rates on potential commercial sales of aducanumab will be in the high single digits to low-teens. Biogen licensed the worldwide rights to aducanumab from Neurimmune in 2007.
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index gained 0.83% over the last five trading sessions. Among major biotech stocks, Alexion gained 11.86%. Over the last six months, Regeneron lost 24.13%, while Vertex gained 6.91% (see the last biotech stock roundup here: Biotech Stock Roundup: PRTA Down, AMGN Revises View, BIIB Misses on Sales).
What's Next in Biotech?
Stay tuned for more earnings along with regulatory updates.
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Alexion Pharmaceuticals, Inc. (ALXN) : Free Stock Analysis Report
Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
Biogen Inc. (BIIB) : Free Stock Analysis Report
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