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Zacks News
Axsome (AXSM) Rides on New Drug Approval & Sunosi Buyout
by Zacks Equity Research
Axsome (AXSM) receives FDA approval for Auvelity to treat major depressive disorder in August. The Sunosi deal and promising pipeline bode well. Stiff competition in the target market remains a woe.
TG Therapeutics (TGTX) Gets FDA Nod for Multiple Sclerosis Drug
by Zacks Equity Research
The FDA approves TG Therapeutics' (TGTX) Briumvi (ublituximab-xiiy) for treating relapsing forms of multiple sclerosis. The company plans to launch the drug in the first quarter of 2023. Stock up.
AstraZeneca's (AZN) Imfinzi+Imjudo Gets Japan Nod for 2 Cancers
by Zacks Equity Research
The Japanese Ministry of Health approves AstraZeneca's (AZN) Imfinzi plus Imjudo for treating advanced liver cancer and lung cancer.
Kala Pharmaceuticals (KALA) Up as FDA Accepts IND for KPI-012
by Zacks Equity Research
The FDA accepts Kala Pharmaceuticals' (KALA) investigational new drug application for pipeline candidate KPI-012 for treating persistent corneal epithelial defect. Stock up.
ACER Down Despite FDA Nod for Urea Cycle Disorders Drug
by Zacks Equity Research
The FDA approves Acer Therapeutics' (ACER) Olpruva (sodium phenylbutyrate) to treat certain patients with urea cycle disorders. Share price falls 33.3% following the announcement.
Zacks Industry Outlook Highlights Gilead Sciences, GSK, Immunocore and Syndax Pharmaceuticals
by Zacks Equity Research
Gilead Sciences, GSK, Immunocore and Syndax Pharmaceuticals are part of the Zacks Screen of the Week article.
4 Top Biotech Stocks Worth Adding to Your Portfolio in 2023
by Zacks Equity Research
New drug approvals and focus on coronavirus treatments should maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and solid pipeline progress position GILD, GSK, IMCR and SNDX well amid the volatility.
Sanofi's (SNY) Dupixent & Vaccines Make the Stock Attractive
by Zacks Equity Research
One can invest in Sanofi (SNY) due to the strong performance of Dupixent, above-market sales growth of the Consumer unit, consistent pipeline innovation and regular accretive collaboration deals.
Has scPharmaceuticals (SCPH) Outpaced Other Medical Stocks This Year?
by Zacks Equity Research
Here is how scPharmaceuticals, Inc. (SCPH) and Syndax Pharmaceuticals (SNDX) have performed compared to their sector so far this year.
Wall Street Analysts Predict a 45% Upside in Syndax (SNDX): Here's What You Should Know
by Zacks Equity Research
The consensus price target hints at a 44.7% upside potential for Syndax (SNDX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
Here's What Could Help Syndax (SNDX) Maintain Its Recent Price Strength
by Zacks Equity Research
If you are looking for stocks that are well positioned to maintain their recent uptrend, Syndax (SNDX) could be a great choice. It is one of the several stocks that passed through our "Recent Price Strength" screen.
Syndax's (SNDX) Leukemia Drug Gets FDA Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy designation to Syndax's (SNDX) revumenib for treating patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement. Stock up.
What Makes Syndax (SNDX) a Good Fit for 'Trend Investing'
by Zacks Equity Research
Syndax (SNDX) made it through our "Recent Price Strength" screen and could be a great choice for investors looking to make a profit from stocks that are currently on the move.
Can Syndax (SNDX) Climb 39% to Reach the Level Wall Street Analysts Expect?
by Zacks Equity Research
The consensus price target hints at a 39.1% upside potential for Syndax (SNDX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.
Incyte (INCY) Outperforms YTD: Will the Momentum Continue?
by Zacks Equity Research
Incyte (INCY) outperforms the biotech industry in the year so far and the momentum should continue in 2023 as well.
Blueprint Medicines (BPMC) Files Ayvakit sNDA for Indolent SM
by Zacks Equity Research
Blueprint Medicines (BPMC) submits a supplemental new drug application for its lead drug, Ayvakit, for the treatment of indolent systemic mastocytosis to the FDA.
Regeneron's (REGN) Libtayo Gets EC Nod for Cervical Cancer
by Zacks Equity Research
Regeneron (REGN) gets EC's approval for the label expansion of PD-1 inhibitor Libtayo for the treatment of adult patients with recurrent or metastatic cervical cancer.
Teva Pharmaceutical (TEVA) Names Richard Francis as New CEO
by Zacks Equity Research
Teva Pharmaceutical (TEVA) appoints Richard Francis as the company's new president and chief executive officer, effective from Jan 1, 2023.
Apellis (APLS) Rises on FDA Acceptance of NDA Amendment for GA
by Zacks Equity Research
The FDA accepts Apellis' (APLS) major amendment to the NDA for pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration. A decision is now due on Feb 26, 2023. Stock up.
Gilead (GILD) Outperforms YTD: Will It Retain the Momentum?
by Zacks Equity Research
Biotech giant Gilead (GILD) outperforms the industry and the S&P 500 Index as its core business maintains momentum despite volatility.
Editas (EDIT) Pauses Eye Disease Study on EDIT-101, Stock Down
by Zacks Equity Research
Editas (EDIT) pauses enrollment in the phase I/II BRILLIANCE study evaluating EDIT-101 for treating blindness due to Leber congenital amaurosis 10. Stock falls.
Immunovant (IMVT) Rises More Than 150% in 3 Months: Here's How
by Zacks Equity Research
Immunovant (IMVT) is making good progress with its lead pipeline candidate, batoclimab, which is being developed for treating myasthenia gravis, thyroid eye disease and other autoimmune diseases.
Bayer (BAYRY) Eylea Label Extension Gets CHMP Positive Opinion
by Zacks Equity Research
Bayer (BAYRY) gets positive recommendation from the CHMP for label extension of ophthalmology drug Eylea for the treatment of preterm infants with retinopathy of prematurity.
Viatris (VTRS) Wins in Court Against AstraZeneca's Symbicort
by Zacks Equity Research
Viatris (VTRS) and its partner win a court decision that invalidates branded drug Symbicort's patent and opens the door for them to launch their generic version of the drug.
Clovis (CLVS) Plummets on News of Possible Bankruptcy Filing
by Zacks Equity Research
Clovis (CLVS) tanks following the possibility of a bankruptcy filing in the near term after recent regulatory developments impacted current revenues and the commercial potential of Rubraca.