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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.
Rezolute (RZLT) Posts Positive Data From Congenital HI Study
by Zacks Equity Research
Rezolute (RZLT) releases favorable data from the phase IIb RIZE study on its lead candidate RZ358, currently being investigated for congenital hyperinsulinism.
Creative Medical (CELZ) Up 82% on Stem Cell Treatment Data
by Zacks Equity Research
Creative Medical Technology (CELZ) reports positive follow-up data from a pilot study evaluating StemSpine, a patented stem cell treatment for chronic lower back pain.
Pfizer's (PFE) Etrasimod Meets Ulcerative Colitis Study Goals
by Zacks Equity Research
Pfizer's (PFE) late-stage candidate etrasimod achieves statistical significance in its primary endpoint of clinical remission in an ulcerative colitis study.
Novartis' (NVS) Pluvicto Gets FDA Nod for Advanced Prostate Cancer
by Zacks Equity Research
The FDA okays Novartis' (NVS) targeted radioligand therapy Pluvicto to treat PSMA-positive metastatic castration-resistant prostate cancer.
Biotech Stock Roundup: BMY's Drug Approval, MRNA's Vaccine Update & More
by Zacks Equity Research
Pipeline and regulatory updates from Bristol Myers (BMY) and Moderna (MRNA) are a few key highlights from the biotech sector during the past week.
ORIC Stock Plunges on Discontinuation of Oncology Candidate
by Zacks Equity Research
ORIC declines on discontinuation of pipeline candidate ORIC-101 following planned interim analyses of two phase Ib studies.
Vertex (VRTX) to Begin Pivotal Study on Kidney Candidate
by Zacks Equity Research
Vertex's (VRTX) pivotal phase III study on VX-147 targeting a broad patient population with proteinuric kidney disease mediated by two mutations in the APOL1 gene (AMKD) is expected to begin later this month.
Vertex Pharmaceuticals (VRTX) Gains But Lags Market: What You Should Know
by Zacks Equity Research
In the latest trading session, Vertex Pharmaceuticals (VRTX) closed at $251.88, marking a +0.65% move from the previous day.
Merck (MRK) Keytruda Gets Another FDA Nod in Endometrial Cancer
by Zacks Equity Research
Merck's (MRK) Keytruda gets approval for advanced endometrial carcinoma therapy in certain patients who are not suited for curative surgery or radiation.
Vallon (VLON) Plummets as ADAIR Study Misses Primary Goal
by Zacks Equity Research
Vallon Pharmaceuticals (VLON) down as SEAL study evaluating lead investigational product candidate, ADAIR, fails to meet its primary endpoint.
Moderna (MRNA) Up on FDA Filing for Second COVID Booster Jab
by Zacks Equity Research
Moderna (MRNA) seeks the FDA's authorization for a fourth dose of its COVID vaccine in adults who already got an initial authorized booster dose of the same in the United States.
Bristol Myers' (BMY) Opdualag Wins FDA Nod for Melanoma
by Zacks Equity Research
Bristol Myers (BMY) gets FDA approval for a fixed-dose combination of Opdivo (nivolumab) and relatlimab to treat patients 12 years of age or older with unresectable or metastatic melanoma.
Has BioDelivery Sciences International (BDSI) Outpaced Other Medical Stocks This Year?
by Zacks Equity Research
Here is how BioDelivery Sciences International (BDSI) and Vertex Pharmaceuticals (VRTX) have performed compared to their sector so far this year.
Adagene (ADAG) Gets FDA Nod for Cancer Study on ADG126 Combo
by Zacks Equity Research
The FDA grants clearance to Adagene (ADAG) to begin clinical studies on its anti-CTLA-4 mAb, ADG126 in combination with pembrolizumab to treat advanced/metastatic solid tumors.
Catalyst (CPRX) Q4 Earnings Lag Estimates, Revenues Rise Y/Y
by Zacks Equity Research
Catalyst's (CPRX) fourth-quarter 2021 earnings miss estimates while revenues slightly beat the mark.
Vertex Pharmaceuticals (VRTX) Gains But Lags Market: What You Should Know
by Zacks Equity Research
Vertex Pharmaceuticals (VRTX) closed the most recent trading day at $248.52, moving +0.62% from the previous trading session.
AbbVie (ABBV) Inks Deal to Develop COVID Antiviral Treatment
by Zacks Equity Research
AbbVie (ABBV) joins Scripps Research in the latter's SARS-CoV-2 research program to accelerate the development of new antiviral therapies for COVID-19.
Seagen's (SGEN) Cancer Drugs Aid Growth, Stiff Rivalry a Woe
by Zacks Equity Research
Seagen (SGEN) focuses on improving sales of its marketed drugs that are approved for different types of cancer indications. Stiff competition in the target market remains a woe.
Exelixis (EXEL) Announces Final Results From HCC Study
by Zacks Equity Research
Exelixis (EXEL) does not intend to submit a supplemental new drug application to the FDA for Cabometyx in patients with previously untreated advanced hepatocellular carcinoma.
Incyte (INCY) Label Expansion for Ruxolitinib Cream Delayed
by Zacks Equity Research
Incyte' s (INCY) sNDA seeking label expansion of ruxolitinib cream gets extended by three months by the FDA for reviewing additional information.
AnaptysBio's (ANAB) Acne Study on Imsidolimab Fails to Meet Goal
by Zacks Equity Research
AnaptysBio's (ANAB) phase II study evaluating imsidolimab for treating moderate-to-severe acne, fails to show improvement over placebo in top-line primary or secondary endpoints. Shares down.
AstraZeneca's (AZN) Fasenra sBLA for Nasal Polyps Gets CRL
by Zacks Equity Research
The FDA gives CRL to AstraZeneca's (AZN) sBLA for Fasenra for chronic rhinosinusitis with nasal polyps (CRSwNP) for want of additional clinical
Moderna (MRNA) Early-Stage HIV Vaccine Study Begins, Stock Up
by Zacks Equity Research
Moderna (MRNA) starts dosing in an mRNA-based HIV vaccine study.
AstraZeneca (AZN) Stock Up 27% in a Year: What Lies Ahead?
by Zacks Equity Research
AstraZeneca's (AZN) stock has risen 26.9% in the past year compared with an increase of 22.3% for the industry.
Should You Invest in the VanEck Biotech ETF (BBH)?
by Zacks Equity Research
Sector ETF report for BBH