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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.
Spero Posts Preliminary Data on SPR720 for Pulmonary Disease
by Zacks Equity Research
Spero (SPRO) reports preliminary findings from a phase I first-in-human study on SPR720, presently being evaluated for the treatment of nontuberculous mycobacterial pulmonary disease.
Gene Therapy the Next Best Thing: Here's Why (Revised)
by Zacks Equity Research
Recent activities like mergers and collaboration have boosted the gene therapy space this year, the broad and intriguing pipelines shows that the segment is poised to grow.
Biogen's Lupus Candidate Meets Endpoint in Phase II Study
by Zacks Equity Research
Biogen (BIIB) posts favorable top-line results from a phase II study evaluating BIIB059 for treating cutaneous and systemic lupus erythematosus. The study tastes success by achieving its main goal.
Gene Therapy the Next Best Thing: Here's Why
by Zacks Equity Research
Recent activities like mergers and collaboration have boosted the gene therapy space this year, the broad and intriguing pipelines shows that the segment is poised to grow.
Seattle Genetics, Astellas Tie Up With Merck for Cancer Study
by Zacks Equity Research
Seattle Genetics (SGEN) and Astellas team up with Merck for a late-stage study to evaluate the enfortumab vedotin and Keytruda combo in patients with previously untreated metastatic urothelial cancer.
Puma Biotech Expands Pierre Fabre License to Add Countries
by Zacks Equity Research
Puma Biotech (PBYI) stretches its license deal with Pierre Fabre, granting the latter commercial rights to Nerlynx in new countries across Europe and parts of Africa. Stock rallies.
Acorda (ACOR) Down More Than 80% Year to Date: Here's Why
by Zacks Equity Research
Acorda's (ACOR) lead MS drug Ampyra is hit by generic competition in the United States, which is hurting the company's top line of late. Parkinson's disease drug Inbrija seems an ideal replacement.
Biotech Tops in November: Best ETFs & Stocks
by Sweta Killa
The biotech space of the broad healthcare sector outperformed others in November, courtesy of a series of positive news including study results, regulatory backdrop and deal activities.
Incyte's NDA for Pemigatinib Gets FDA's Priority Review Tag
by Zacks Equity Research
The FDA accepts and grants priority review to Incyte's (INCY) new drug application for pemigatinib as a second-line treatment for patients with FGFR2 translocated cholangiocarcinoma.
The Zacks Analyst Blog Highlights: Vertex, Biogen, BioMarin and Alexion
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Vertex, Biogen, BioMarin and Alexion
Should You Invest in the Invesco Dynamic Biotechnology & Genome ETF (PBE)?
by Zacks Equity Research
Sector ETF report for PBE
Why Biotech ETFs Surged in Monday's Trading Session
by Sweta Jaiswal, FRM
Increasing M&A deals, growing AI dominance and favorable regulatory tidings continue to drive the biotech market.
4 Big Drug Stocks Ripe for Takeover After NVS-MDCO Deal
by Kinjel Shah
Here are four stocks that boast promising prospects and are most likely to be takeout targets.
Genomics ETFs Surge on CRISPR's Gene Editing Progress
by Sweta Jaiswal, FRM
The release of encouraging data on the CRISPR/Cas9 gene-editing therapy CTX001 for two severe blood disorders puts emphasis on some genomic ETFs.
Amgen (AMGN) Completes Otezla Buyout, Raises 2019 Guidance
by Zacks Equity Research
Amgen (AMGN) concludes the pending buyout of Celgene's psoriasis drug Otezla to acquire its worldwide rights. The company also hikes its overall 2019 view. Stock gains.
Vertex (VRTX) Gets French Reimbursement for CF Drug Orkambi
by Zacks Equity Research
The French reimbursement for Vertex's (VRTX) cystic fibrosis medicine Orkambi removes a key overhang for the stock.
Vertex Pharmaceuticals Shares March Higher, Can It Continue?
by Zacks Equity Research
As of late, it has definitely been a great time to be an investor Vertex Pharmaceuticals.
The Zacks Analyst Blog Highlights: Alexion Pharmaceuticals, Vertex Pharmaceuticals, Incyte and Regeneron Pharmaceuticals
by Zacks Equity Research
The Zacks Analyst Blog Highlights: Alexion Pharmaceuticals, Vertex Pharmaceuticals, Incyte and Regeneron Pharmaceuticals
Biotech Stock Roundup: MYOV & KRTX Surge, Pipeline Updates From VRTX, CELG & More
by Zacks Equity Research
Key highlights of the past week include regulatory and pipeline updates along with collaboration deals.
Vertex, CRISPR's Gene Editing Drug Shows Positive Early Data
by Zacks Equity Research
Vertex (VRTX) and partner CRISPR Therapeutics announce positive early data from two studies on gene-editing drug CTX001 for the treatment of beta-thalassemia and sickle cell disease.
4 Big Biotech Stocks Worth Considering Post Q3 Earnings
by Zacks Equity Research
We highlight a few principal players from the biotech sector, which are likely to witness a winning run in the near term.
Earnings Estimates Rising for Vertex (VRTX): Will It Gain?
by Zacks Equity Research
Vertex (VRTX) shares have started gaining and might continue moving higher in the near term, as indicated by solid earnings estimate revisions.
Celgene & Acceleron Get FDA Nod for Rare Blood Disorder Drug
by Zacks Equity Research
Celgene (CELG) and partner Acceleron obtain FDA approval for Reblozyl for the treatment of anemia in adult patients with beta thalassemia.
Sarepta (SRPT) Q3 Loss Widens Y/Y, Revenues Beat Estimates
by Zacks Equity Research
Sarepta (SRPT) reports wider year-over-year loss. However, revenues increase year over year.
Arena Pharmaceuticals' (ARNA) Q3 Loss Widens, Revenues Beat
by Zacks Equity Research
Arena Pharmaceuticals (ARNA) incurs wider-than-expected loss in the third quarter of 2019 while revenues beat estimates.