Biotech Stock Roundup: Celgene, Amgen, Vertex Impress in Q3, DRNA Soars on LLY Deal
Earnings took center stage for the biotech sector this week, with quite a few bigwigs like Gilead Sciences GILD, Amgen AMGN, Vertex Pharmaceuticals VRTX and Celgene CELG coming up with third-quarter results. Apart from these, regular pipeline updates and data read outs were also in the news.
Recap of the Week’s Top Stories:
Celgene, Vertex, Amgen Shine in Q3: The going has been good for the biotech bigwigs in the third quarter. Celgene topped both revenue and earnings estimates in Q3 and upped its guidance on a jump in psoriasis drug Otezla sales. Lead drug, Revlimid too maintained momentum for the company. Alexion Pharmaceuticals ALXN too topped earnings estimates but missed on revenues. The company upped its annual guidance though.
Vertex Pharmaceuticals topped both earnings and sales estimates in Q3 on strong cystic fibrosis (CF) product revenues. Amgen also surpassed earnings and sales estimates in Q3. Meanwhile, Gilead Sciences, Inc.’s third-quarter earnings beat estimates, but the year-over-year decline was disappointing as the magnitude of decline in hepatitis C virus (HCV) sales continues to deepen.
Alexion currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s Eylea Succeeds Diabetic Retinopathy Trial: Regeneron Pharmaceuticals, Inc. REGN announced that the phase III trial, PANORAMA, evaluating lead drug Eylea injection in patients suffering from moderately severe and severe non-proliferative diabetic retinopathy (NPDR) met its one-year (52-week) primary endpoint and key secondary endpoints. The data showed that every eight-week and every 16-week dosing groups met primary and key secondary endpoints at one year. We note that the supplemental application for Eylea for the treatment of diabetic retinopathy, based on previously announced 24-week results is currently under FDA review with an action date of May 13, 2019. Concurrently, Regeneron announced that the FDA issued a complete response letter (CRL) regarding the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea pre-filled syringe. The FDA has requested additional information regarding manufacturing and supply processes and the completion of a usability study evaluating a single injection of the Eylea pre-filled syringe in approximately 30 patients. Regeneron plans to resubmit the PAS in early 2019 after collecting necessary information.
Dicerna Soars on Collaboration Deal With Lilly: Shares of Dicerna Pharmaceuticals DRNA surged after the company announced a global licensing and research collaboration with pharma giant Eli Lilly (LLY). Both companies have collaborated for the discovery, development and commercialization of potential new medicines in the areas of cardio-metabolic disease, neurodegeneration and pain. Both companies will use Dicerna's proprietary GalXCRNA interference (RNAi) technology platform to advance new drug targets toward clinical development and commercialization. Per the terms, Dicerna will obtain an upfront payment of $100 million and an equity investment of $100 million. The company is also eligible to receive up to approximately $350 million per target in development and commercialization milestones along with royalties. Dicerna also collaborated with Alexion to discover and develop RNAi therapies for complement-mediated diseases.
Ultragenyx's Late-Stage Candidate Fails: Ultragenyx Pharmaceutical Inc. RARE announced that a late-stage study on pipeline candidate, UX007, failed to meet its goals. The phase III study in patients with glucose transporter type-1 deficiency syndrome (Glut1 DS) experiencing disabling paroxysmal movement disorders did not achieve its primary endpoint. The candidate did not demonstrate a statistically significant reduction in the frequency of paroxysmal movement events with UX007 treatment compared to placebo, and did not demonstrate a meaningful difference between treatment groups. The study failed to meet its key secondary endpoints. Consequently, Ultragenyx plans to discontinue the Glut1 DS development program. The company also stated that it will work with its investigators and patients on a reasonable transition plan for patients with Glut1 DS, who are still on UX007.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology index lost 5% over the last five trading sessions. Among the major biotech stocks, Regeneron lost 10.77% in the last five trading sessions. Over the past six months, shares of Biogen have rallied 11.9% while Celgene has lost 16.9%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB Tops, MACK Plunges, REGN's Asthma Drug Gets FDA Nod)
What's Next in Biotech?
Stay tuned for more earnings results as a few companies are scheduled to report later in the week.
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Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Celgene Corporation (CELG) : Free Stock Analysis Report
Regeneron Pharmaceuticals, Inc. (REGN) : Free Stock Analysis Report
Ultragenyx Pharmaceutical Inc. (RARE) : Free Stock Analysis Report
Alexion Pharmaceuticals, Inc. (ALXN) : Free Stock Analysis Report
Amgen Inc. (AMGN) : Free Stock Analysis Report
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