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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'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.
AstraZeneca's (AZN) 3 Cancer Drugs Get CHMP Nod for Expanded Use
by Zacks Equity Research
The CHMP recommends expanded use of AstraZeneca's (AZN) three key cancer drugs, Lynparza, Enhertu and Imfinzi.
Is iShares Biotechnology ETF (IBB) a Strong ETF Right Now?
by Zacks Equity Research
Smart Beta ETF report for IBB
AstraZeneca's (AZN) Imfinzi/Imjudo Combo Gets Another FDA Nod
by Zacks Equity Research
AstraZeneca (AZN) gets its second FDA approval for the Imfinzi+Imjudo combo in non-small cell lung cancer (NSCLC) indication.
Sanofi (SNY), Regeneron Dupixent Gets CHMP Nod for Skin Disease
by Zacks Equity Research
The CHMP recommends approval of Sanofi's (SNY) Dupixent for the treatment of prurigo nodularis, a chronic inflammatory skin disease.
Jazz's (JAZZ) Q3 Earnings Beat Estimates, New Drugs Drive Sales
by Zacks Equity Research
Jazz's Q3 earnings and sales beat expectations on strong demand for new drugs and drugs added with the GW Pharmaceuticals acquisition. The company raises the mid-point of its 2022 sales guidance.
AstraZeneca's (AZN) Q3 Earnings Beat, EPS Growth View Up
by Zacks Equity Research
AstraZeneca (AZN) beats third-quarter estimates for earnings while sales come in line. AZN raises its 2022 earnings growth guidance, keeping its sales forecast unchanged.