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Zacks News
Pfizer's (PFE) Adcetris Meets Survival Goal in Lymphoma Study
by Zacks Equity Research
Pfizer (PFE) plans to seek approval for the eighth indication for Adcetris based on data from the ECHELON-3 study.
Lilly (LLY) Stock Down as FDA Delays Decision on Donanemab
by Zacks Equity Research
The FDA decision on Eli Lilly's (LLY) Alzheimer's candidate, donanemab, was expected in the first quarter of 2024, which has now been delayed.
MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a breakthrough therapy designation to MindMed's (MNMD) MM120 for treating generalized anxiety disorder. Shares rise more than 50% on the news.
Creative Medical (CELZ) Up on Orphan Drug Tag for CELZ-101
by Zacks Equity Research
Creative Medical's (CELZ) CELZ-101 gets FDA's Orphan Drug designation for preventing allograft rejection in type-I diabetes patients undergoing pancreatic islet cell transplantation. Stock rises.
Vanda (VNDA) Falls on FDA's CRL to Hetlioz sNDA for Insomnia
by Zacks Equity Research
Vanda's (VNDA) supplemental new drug application seeking approval for Hetlioz to treat insomnia gets a complete response letter from the FDA.
Nektar (NKTR) Begins Phase IIb Study Rezpeg in Alopecia Areata
by Zacks Equity Research
The placebo-controlled, phase IIb study will investigate the efficacy and safety of Nektar's (NKTR) rezpeg in patients with severe to very severe alopecia areata.
Nektar (NKTR) Q4 Loss Wider Than Expected, Revenue Beat
by Zacks Equity Research
Nektar (NKTR) reports a wider-than-expected loss in the fourth quarter of 2023 while revenue beat estimates.
Arcturus (ARCT) Stock Surges 73% in 3 Months: Here's Why
by Zacks Equity Research
Arcturus' (ARCT) steady progress with its product candidate, ARCT-032, for the treatment of cystic fibrosis is encouraging.
Puma Biotechnology (PBYI) Q4 Earnings & Revenues Lag Estimates
by Zacks Equity Research
Puma Biotechnology's (PBYI) fourth-quarter 2024 earnings and revenues fall shy of estimates. Stock declines.
Mirum's (MIRM) Q4 Earnings Lag Estimates, Revenues Beat
by Zacks Equity Research
Mirum's (MIRM) earnings fall shy of estimates in the fourth quarter of 2023 while revenues beat the same.
Amicus' (FOLD) Q4 Earnings Beat, Revenues Meet Estimates
by Zacks Equity Research
Amicus' (FOLD) fourth-quarter earnings beat estimates while revenues meet the same. Stock down.
Novavax (NVAX) Q4 Earnings & Sales Miss Estimates, Stock Tanks
by Zacks Equity Research
Novavax's (NVAX) fourth-quarter earnings and revenues miss estimates. Stock tanks on moderate revenue guidance for 2024.
Acadia (ACAD) Q4 Earnings Lag, Sales Beat Estimates, Stock Down
by Zacks Equity Research
Acadia's (ACAD) fourth-quarter earnings miss estimates while revenues beat the same. Higher product sales drive year-over-year revenues. Shares fall in after-hours trading.
Apellis (APLS) Q4 Earnings Miss, Revenues Meet Estimates
by Zacks Equity Research
Apellis' (APLS) fourth-quarter 2023 bottom line misses estimates, while the top line meets the same. The newly approved product, Syfovre, drives year-over-year sales.
Theravance's (TBPH) Q4 Earnings & Revenues Surpass Estimates
by Zacks Equity Research
Theravance's (TBPH) fourth-quarter earnings and revenues beat estimates. The company achieves profitability on an adjusted basis during the same time. Stock rises.
Intellia (NTLA) Beats on Q4 Earnings, Provides Pipeline Update
by Zacks Equity Research
Intellia's (NTLA) earnings beat estimates in the fourth quarter while the company reports negative revenues. Management provides developmental and regulatory updates on its key pipeline candidates.
Karuna's (KRTX) Q4 Loss Widens, Focus on Bristol Myers Buyout
by Zacks Equity Research
Karuna's (KRTX) fourth-quarter 2023 earnings and revenues miss estimates. The company is set to be acquired by Bristol Myers.
Repligen (RGEN) Stock Down on Q4 Earnings Miss, Revenues Fall Y/Y
by Zacks Equity Research
Repligen's (RGEN) fourth-quarter 2023 earnings miss estimates and decline year over year. Stock declines.
Earnings Estimates Moving Higher for Vanda (VNDA): Time to Buy?
by Zacks Equity Research
Vanda (VNDA) shares have started gaining and might continue moving higher in the near term, as indicated by solid earnings estimate revisions.
Vanda (VNDA) Rises as FDA Accepts NDA for Gastroparesis Drug
by Zacks Equity Research
The FDA accepts Vanda's (VNDA) new drug application ("NDA") for tradipitant for treating the symptoms of gastroparesis. The company's shares rise in after-hours trading.
Vanda Pharmaceuticals (VNDA) Reports Break-Even Earnings for Q3
by Zacks Equity Research
Vanda (VNDA) delivered earnings and revenue surprises of 100% and 12.78%, respectively, for the quarter ended September 2023. Do the numbers hold clues to what lies ahead for the stock?
After Plunging -7.98% in 4 Weeks, Here's Why the Trend Might Reverse for Vanda (VNDA)
by Zacks Equity Research
The heavy selling pressure might have exhausted for Vanda (VNDA) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.
5 Biotech Stocks to Buy as New Drug Approvals Drive Industry Prospects
by Ekta Bagri
New drug approvals and pipeline progress are likely to help maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and a solid pipeline progress position EXEL, DVAX, ACLX, ANIP and VNDA well amid volatility.
Vanda Pharmaceuticals (VNDA) Lags Q3 Earnings and Revenue Estimates
by Zacks Equity Research
Vanda (VNDA) delivered earnings and revenue surprises of -40% and 8%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
Exelixis (EXEL) Beats Q3 Earnings and Revenue Estimates
by Zacks Equity Research
Exelixis (EXEL) delivered earnings and revenue surprises of 24% and 1.88%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?