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Zacks News
The company’s main area of focus is cystic fibrosis (CF). The company’s lead marketed products are Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko/Symkevi (tezacaftor in combination with ivacaftor), Orkambi (lumacaftor in combination with ivacaftor) and Kalydeco (ivacaftor), which are collectively approved to treat the majority of the people with CF in North America, Europe and Australia. Trikafta, Vertex’s triple combination regimen, was approved by the FDA in October 2019 for the treatment of CF in people aged 12 years and older who have at least one F508del mutation. Kaftrio (brand name of Trikafta in EU) was approved in the European Union in August 2020. It is also being evaluated in younger patients in the United States. With approval of Trikafta, Vertex can address a significantly larger CF patient population — almost 90% of patients with CF — in the future. Meanwhile, Vertex is pursuing genetic therapies to address the remaining 10% of CF patients. While CF remains the main area of focus, Vertex is also developing treatments for sickle cell disease, thalassemia and pain management.
Lilly, Teva, Pfizer & Others Await FDA Decisions in September
by Kinjel Shah
FDA grants approval to 34 new treatments this year so far.
The Zacks Analyst Blog Highlights: Amgen, Puma Biotechnology, MannKind, United Therapeutics and Vertex Pharmaceuticals
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Amgen, Puma Biotechnology, MannKind, United Therapeutics and Vertex Pharmaceuticals
Biotech Stock Roundup: AMGN, PBYI Get EC Nod for Their Drugs, MNKD Soars
by Zacks Equity Research
Drug approvals in Europe and other pipeline updates comprise some of the key developments in the biotech sector this week.
Vertex Inks Reimbursement Agreement for Orkambi in Australia
by Zacks Equity Research
Vertex Pharmaceuticals (VRTX) finalizes a reimbursement agreement with Australian government, which will improve the access to the drug.
Vertex Inks Deal With Genomics to Make Serious Disease Drugs
by Zacks Equity Research
Vertex (VRTX) signs a three-year collaboration contract with Genomics to develop novel drug targets for advancing discovery of precision medicines.
Vertex (VRTX) Hits Fresh High: Is There Still Room to Run?
by Zacks Equity Research
Vertex (VRTX) is at a 52-week high, but can investors hope for more gains in the future? We take a look at the company's fundamentals for clues.
Why Is Vertex (VRTX) Up 0.1% Since Last Earnings Report?
by Zacks Equity Research
Vertex (VRTX) reported earnings 30 days ago. What's next for the company? We take a look at earnings estimates for some clues.
4 Biotech Stocks Investors Can Bet on Post Solid Q2 Earnings
by Ekta Bagri
The biotech sector is expected to do well in the second half of 2018. Here we list four top biotech companies, which investors can add to their portfolio.
Mallinckrodt's Stannsoporfin Gets Complete Response Letter
by Zacks Equity Research
Mallinckrodt's (MNK) pipeline candidate, Stannsoporfin gets a Complete Response Letter from the FDA.
Biotech Stock Roundup: Label Expansion of Regeneron's Eylea, Vertex's Kalydeco
by Zacks Equity Research
The biotech sector witnesses a pretty low key week with a handful of regulatory updates. Regeneron secures an FDA approval for the label expansion of its key drug Eylea.
Looking for a Growth Stock? Why It is Time to Focus on Vertex Pharmaceuticals (VRTX)
by Zacks Equity Research
Vertex Pharmaceuticals (VRTX) seems well-positioned for future earnings growth and it is seeing rising earnings estimates as well, coupled with a solid Zacks Rank.
Novo Nordisk Buys Ziylo to Develop Glucose Responsive Insulin
by Zacks Equity Research
Novo Nordisk A/S (NVO) acquires Ziylo Ltd. to speed up the development of glucose responsive insulins in a deal that could exceed $800 million.
Zacks.com highlights: Illumina, Vertex Pharmaceuticals, Surmodics and McDermott International
by Zacks Equity Research
Zacks.com highlights: Illumina, Vertex Pharmaceuticals, Surmodics and McDermott International
Lilly (LLY) Hits 52-Week High, Can the Run Continue?
by Zacks Equity Research
Lilly (LLY) is at a 52-week high, but can investors hope for more gains in the future? We take a look at the company's fundamentals for clues.
4 Winning Stocks With Solid Efficiency Level
by Tirthankar Chakraborty
A company with a favorable efficiency level is expected to provide stellar returns as it is believed to be positively correlated with price performance.
Should Vertex Pharmaceuticals (VRTX) Be On Your Radar Now?
by Zacks Equity Research
Vertex Pharmaceuticals (VRTX) sees solid earnings estimate revisions and looks poised to shock the market, and yet seems overlooked by the investors.
Vertex's Cystic Fibrosis Drug Gets FDA Nod for Children
by Zacks Equity Research
Vertex's (VRTX) cystic fibrosis drug, Kalydeco gets FDA approval to treat children aged 12 months to two years
Bayer Plunges as Monsanto Fined $289M in Roundup Lawsuit
by Zacks Equity Research
Shares of Bayer (BAYRY) crash as its newly acquired company Monsanto was fined $289 million over allegations that its weedkiller caused cancer.
Spectrum (SPPI) Earnings and Sales Miss Estimates in Q2
by Zacks Equity Research
Spectrum (SPPI) reports wider-than-expected loss in the second quarter and misses on revenues. Rolontis successful in second phase III study.
Endo (ENDP) Beats on Q2 Earnings & Sales, Raises Guidance
by Zacks Equity Research
Endo International (ENDP) gains on better-than-expected Q2 results on the back of growth in demand for Xiaflex and momentum in its Sterile Injectables business.
Perrigo (PRGO) Beats on Q2 Earnings, Cuts View, Shares Down
by Zacks Equity Research
Perrigo (PRGO) reports mixed second-quarter 2018 results and lowers revenue and adjusted earnings guidance for 2018.
Sarepta (SRPT) Q2 Loss Narrows, Exondys 51 Drives Sales
by Zacks Equity Research
Sarepta's (SRPT) loss per share is narrower than the Zacks Consensus Estimate while sales also beat the same. Exondys 51 continues its strong performance.
Infinity (INFI) Posts Narrower-Than-Expected Loss in Q2
by Zacks Equity Research
Infinity (INFI) posts narrower-than-expected loss in the second quarter of 2018 and provides update on pipeline candidate, IPI 549.
Horizon Pharma (HZNP) Q2 Earnings & Sales Beat, Shares Rise
by Zacks Equity Research
Horizon Pharma (HZNP) beat earnings and sales estimates in the second quarter of 2018.
Mallinckrodt (MNK) Beats on Q2 Earnings and Sales, Ups View
by Zacks Equity Research
Mallinckrodt (MNK) surges following earnings and sales beat in the second quarter. Increase in annual guidance is impressive as well.