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Zacks News
Amylyx (AMLX) Doses First Patient in Wolfram Syndrome Study
by Zacks Equity Research
Amylyx (AMLX) progresses with the phase II study of pipeline candidate AMX0035 for the treatment of Wolfram syndrome as it doses the first patient.
Merck's (MRK) Keytruda sBLA Accepted by FDA for Gastric Cancer
by Zacks Equity Research
Merck's (MRK) application seeking approval for Keytruda in combination with fluoropyrimidine- and platinum-containing chemotherapy for the early treatment of locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma was accepted by the FDA.
Sarepta Down on Reports of FDA Almost Rejecting DMD Gene Therapy
by Zacks Equity Research
Per a Stat News article, the FDA initially considered rejecting Sarepta's (SRPT) regulatory filing seeking FDA's accelerated approval for DMD gene therapy.
KALA Up on Fast Track Designation to Lead Ocular Candidate
by Zacks Equity Research
KALA gets Fast Track Designation from the FDA for lead candidate KPI-012 to treat persistent corneal epithelial defects.
MAIA Biotechnology (MAIA) Up on Positive Data From NSCLC Study
by Zacks Equity Research
MAIA Biotechnology (MAIA) gains on encouraging data on lead candidate from Part A of its mid-stage study in advanced non-small cell lung cancer.
Exelixis (EXEL) Surges 25.4% so Far in 2023: Here's Why
by Zacks Equity Research
Exelixis' (EXEL) efforts to expand Cabometyx's label and develop additional drugs to expand its portfolio should reap rewards for the company.
Cytokinetics (CYTK) Dips 20% so Far in 2023 on Setbacks
by Zacks Equity Research
Cytokinetics (CYTK) declines 20% in the year so far as it suffers a regulatory setback for its NDA for omecamtiv mecarbil.
Will Bristol Myers (BMY) Gain From New Drugs' Label Expansion?
by Zacks Equity Research
Label expansion of Bristol Myers' (BMY) new drugs should help it somewhat combat the decline in Revlimid sales due to generic competition.
Here's Why You Should Add Ligand (LGND) Stock to Your Portfolio
by Zacks Equity Research
Ligand's (LGND) proprietary platforms enable it to form partnerships with several leading drug companies, providing it with funds through milestone and royalty payments.
Incyte (INCY) Down 9.6% so Far in 2023 on Recent Setbacks
by Zacks Equity Research
Incyte (INCY) shares are down 9.6% in the year so far on pipeline setbacks.
Oncternal (ONCT) Down on Restructuring Plan to Extend Runway
by Zacks Equity Research
Oncternal (ONCT) closes the development program for zilovertamab to extend its cash runway into 2025. Shares are down on the same.
Wall Street Analysts Predict a 53.67% Upside in Ligand (LGND): Here's What You Should Know
by Zacks Equity Research
The mean of analysts' price targets for Ligand (LGND) points to a 53.7% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
bluebird (BLUE) Down on Updates on SCD Therapy, Reports Q4
by Zacks Equity Research
bluebird (BLUE) provides updates on its BLA submission for its experimental gene therapy lovo-cel and reports Q4 results. Shares are down on the same.
Bristol Myers (BMY) Gets Approval of Psoriasis Drug in EU
by Zacks Equity Research
Bristol Myers' (BMY) Sotyktu gets approval from the European Commission to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Novartis (NVS) Kisqali Positive for Early Breast Cancer
by Zacks Equity Research
Novartis (NVS) Kisqali meets primary endpoint of invasive disease-free survival in certain patients with early breast cancer at risk of recurrence.
Incyte (INCY) Receives FDA Approval for Skin Cancer Treatment
by Zacks Equity Research
Incyte (INCY) gets accelerated approval for retifanlimab-dlwr for the treatment of adults with metastatic or recurrent locally advanced merkel cell carcinoma.
Biogen (BIIB) Gets Positive FDA Panel Vote for Tofersen NDA
by Zacks Equity Research
The FDA committee supports an accelerated approval of Biogen's (BIIB) tofersen for treating SOD1-ALS. The committee does not believe the data supports a traditional/standard approval for tofersen.
AbbVie (ABBV) Gets FDA Rejection for Parkinson's Candidate
by Zacks Equity Research
In the CRL, the FDA asks AbbVie (ABBV) for some extra information about the pump device used to administer the Parkinson's disease medicine, ABBV-951.
Gilead (GILD) Announces OS Data on Yescarta From ZUMA-7 Study
by Zacks Equity Research
Gileads Yescarta shows statistically significant improvement in overall survival for initial treatment of R/R LBCL patients versus historical standard of care in curative setting.
Zacks Industry Outlook Highlights CRISPR Therapeutics, Ligand Pharmaceuticals, Theseus Pharmaceuticals and Kala Pharmaceuticals
by Zacks Equity Research
CRISPR Therapeutics, Ligand Pharmaceuticals, Theseus Pharmaceuticals and Kala Pharmaceuticals are part of the Zacks Industry Outlook article.
Gilead (GILD) Exercises Option to License Nurix's Candidate
by Zacks Equity Research
Gilead (GILD) exercises an option under its collaboration agreement with Nurix to license the latter???s investigational targeted protein degrader molecule NX 0479.
4 Biotech Stocks to Consider for Your Portfolio in 2023
by Zacks Equity Research
New drug approvals and pipeline progress should maintain the momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and a solid pipeline progress position CRSP, LGND, THRX and KALA well amid volatility.
Sanofi's (SNY) Dupixent Gets EU Nod for Eczema in Young Kids
by Zacks Equity Research
Sanofi (SNY) and Regeneron's Dupixent becomes the first and only targeted medicine approved to treat severe atopic dermatitis in kids as young as six months old in Europe.
Incyte (INCY) Vitiligo Drug Povorcitinib Positive in Phase II
by Zacks Equity Research
Incyte (INCY) announces positive data on povorcitinib and Opzelura for the treatment of nonsegmental vitiligo.
Merck (MRK) Stock Up 31.6% in a Year: What Awaits in 2023?
by Zacks Equity Research
Strong sales of key products like Keytruda and Gardasil and positive pipeline/regulatory developments should keep Merck's (MRK) stock afloat in 2023.