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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.
Biogen's (BIIB) ALS Drug Tofersen Filing Accepted in Europe
by Zacks Equity Research
Biogen's (BIIB) tofersen, if approved, will be the first genetically-targeted treatment for SOD1-ALS in Europe.
GSK's Myelofibrosis Candidate MAA Gets Accepted in Europe
by Zacks Equity Research
GSK's new drug application (NDA) for momelotinib is under standard FDA review, with a decision expected on Jun 16, 2023.
Genmab AS Sponsored ADR (GMAB) Hits Fresh High: Is There Still Room to Run?
by Zacks Equity Research
Genmab AS Sponsored ADR (GMAB) 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.
Roivant (ROIV), Pfizer Form Vant for Inflammatory Disease Drug
by Zacks Equity Research
Roivant Sciences (ROIV), Pfizer's (PFE) new Vant company will take care of funding the global development of RVT-3101 in inflammatory and fibrotic diseases.
Vertex Pharmaceuticals (VRTX) Gains As Market Dips: What You Should Know
by Zacks Equity Research
Vertex Pharmaceuticals (VRTX) closed the most recent trading day at $320.76, moving +1.38% from the previous trading session.
Why Is CRISPR Therapeutics AG (CRSP) Up 0.2% Since Last Earnings Report?
by Zacks Equity Research
CRISPR Therapeutics AG (CRSP) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Lilly's (LLY) Donanemab Betters Biogen's Alzheimer's Drug
by Zacks Equity Research
Data from a phase III early symptomatic Alzheimer's disease study shows that Eli Lilly's (LLY) donanemab leads to a significant reduction of amyloid buildup in the brain and P-tau in the blood after six months.
Is Invesco Dynamic Biotechnology & Genome ETF (PBE) a Strong ETF Right Now?
by Zacks Equity Research
Smart Beta ETF report for PBE
Biogen's (BIIB) Lecanemab Shows Benefit but With Side Effects
by Zacks Equity Research
Detailed data from Biogen (BIIB) and Eisai's Clarity AD shows that treatment with lecanemab in the early stages of Alzheimer's disease reduces the rate of cognitive decline but is associated with adverse events like brain hemorrhage.
AstraZeneca (AZN) Boosts Cell Therapies With Neogene Deal
by Zacks Equity Research
The acquisition of Neogene is set to give AstraZeneca (AZN) access to the latter's next-generation T-cell receptor therapies.
Sarepta's (SRPT) DMD Gene Therapy BLA Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Sarepta's (SRPT) regulatory filing seeking accelerated approval for SRP-9001, a gene therapy for DMD indication. A final decision is expected by May 2023.
BioMarin (BMRN) Up After FDA Scraps AdCom Meet for BLA Filing
by Zacks Equity Research
The FDA decides not to hold an advisory committee meeting for BioMarin Pharmaceuticals' (BMRN) regulatory filing seeking approval for hemophilia A gene therapy, valrox.
AbbVie's (ABBV) Skyrizi Gets EU Nod for Crohn's Disease
by Zacks Equity Research
AbbVie's (ABBV) Skyrizi becomes the first specific IL-23 inhibitor to get approval for Crohn's disease in the European Union.
Merck (MRK) Keytruda Advanced Gastric Cancer Study Meets Goal
by Zacks Equity Research
Top-line data from a late-stage study shows that Merck's (MRK) Keytruda combined with chemotherapy improved overall survival in patients with advanced gastric cancer.
GSK to Withdraw Blenrep From U.S. Market on FDA Request
by Zacks Equity Research
GSK, at the request of the FDA, is set to withdraw the U.S. marketing authorization for Blenrep. The FDA's request comes after the failure of a phase III confirmatory study, DREAMM-3.
Should iShares MSCI USA Min Vol Factor ETF (USMV) Be on Your Investing Radar?
by Zacks Equity Research
Style Box ETF report for USMV
Imago (IMGO) Shares Surge 104% on Buyout Offer From Merck
by Zacks Equity Research
Imago BioSciences (IMGO) to be acquired by pharma-giant Merck (MRK) for $1.35 billion. The transaction is likely to close by first-quarter 2023.
Should You Invest in the VanEck Biotech ETF (BBH)?
by Zacks Equity Research
Sector ETF report for BBH
AbbVie (ABBV) BLA for Epcoritamab Gets FDA Priority Tag
by Zacks Equity Research
The FDA grants priority review status to AbbVie's (ABBV) BLA for epcoritamab for the relapsed/refractory large B-cell lymphoma (LBCL), a form of NHL.
Why Vertex Pharmaceuticals (VRTX) is a Top Value Stock for the Long-Term
by Zacks Equity Research
The Zacks Style Scores offers investors a way to easily find top-rated stocks based on their investing style. Here's why you should take advantage.
Sanofi's (SNY) Rare Anemia Drug Enjaymo Gets EU Approval
by Zacks Equity Research
Sanofi's (SNY) Enjaymo gets approval to treat hemolytic anemia in adult patients with cold agglutinin disease (CAD) in Europe.
VRTX or TECH: Which Is the Better Value Stock Right Now?
by Zacks Equity Research
VRTX vs. TECH: Which Stock Is the Better Value Option?
Merck (MRK) Outpaces Industry YTD: What's in Store for 2023?
by Zacks Equity Research
Strong sales of key products like Keytruda and Gardasil and positive pipeline/regulatory developments keep Merck's (MRK) stock afloat in 2023.
Eli Lilly (LLY) Stock Up 26.7% YTD: What's in Store for 2023?
by Zacks Equity Research
Lilly (LLY) expects to launch five new medicines by 2023-end, including Mounjaro for type II diabetes (already launched) and donanemab for early Alzheimer's disease.
Moderna's (MRNA) Omicron BA.4/5 Booster Jab Study Meets Goal
by Zacks Equity Research
Moderna's (MRNA) Omicron-targeting bivalent COVID vaccines exhibit substantial antibody response compared with an original booster dose of Spikevax.