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Zacks News
Novartis (NVS) Posts Positive Data From Prostate Cancer Study
by Zacks Equity Research
Novartis (NVS) reports positive data from the phase III VISION study evaluating its radioligand therapy, 177Lu-PSMA-617, in patients with advanced prostate cancer.
Bristol Myers' (BMY) NDA for Mavacamten Accepted by FDA
by Zacks Equity Research
The FDA accepts Bristol Myers' (BMY) new drug application for mavacamten for treating patients with symptomatic obstructive hypertrophic cardiomyopathy.
Exelixis (EXEL) Inks Collaboration Deal to Test XL092 Combo in UC
by Zacks Equity Research
Exelixis (EXEL) signs a collaboration and supply agreement with Merck KGaA and Pfizer to investigate XL092 in combination with Bavencio for treating various forms of urothelial carcinoma.
Ultragenyx's (RARE) IND for mRNA Therapy, UX053 Cleared by FDA
by Zacks Equity Research
The FDA clears Ultragenyx's (RARE) investigational new drug application for UX053 being developed to treat Glycogen Storage Disease Type III.
ACADIA (ACAD) Falls as FDA Finds Deficiencies in Nuplazid sNDA
by Zacks Equity Research
The FDA identifies deficiencies in ACADIA's (ACAD) sNDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with dementia-related psychosis. Stock sinks.
Cara Therapeutics' (CARA) Korsuva NDA Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts Cara Therapeutics (CARA) and Vifor Pharma's NDA for Korsuva injection under a priority review to treat moderate-to-severe pruritus in hemodialysis patients. Shares rise.
Blueprint Medicines (BPMC) Gets EMA Validation for Ayvakyt in SM
by Zacks Equity Research
The EMA validates Blueprint Medicines' (BPMC) Type II variation marketing authorization application for Ayvakyt to treat advanced systemic mastocytosis.
Arena (ARNA) Tumbles as Mid-Stage Gastrointestinal Study Fails
by Zacks Equity Research
Arena's (ARNA) mid-stage study evaluating olorinab in patients with abdominal pain due to irritable bowel syndrome fails to meet primary endpoint.
Kodiak Sciences (KOD) Misses on Q4 Earnings, KSI-301 in Focus
by Zacks Equity Research
Kodiak Sciences (KOD) reports wider-than-expected loss in the fourth quarter of 2020. The company is making good progress with the development of its lead pipeline candidate, KSI-301.
Sarepta (SRPT) Q4 Loss Widens Y/Y, Revenues Beat Estimates
by Zacks Equity Research
Sarepta (SRPT) Q4 revenues increase year over year. The company is progressing well with its pipeline.
Reata (RETA) Beats on Q4 Earnings, Submits Bardoxolone NDA
by Zacks Equity Research
Reata (RETA) reports encouraging fourth-quarter results wherein earnings and sales beat estimates. The company files NDA for lead candidate in Alport syndrome. Stock rises.
Axsome's (AXSM) Q4 Earnings Miss Estimates, Pipeline in Focus
by Zacks Equity Research
Axsome (AXSM) reports wider-than-expected loss in the fourth quarter of 2020. The company files an NDA for AXS-05 to treat major depressive disorder.
Perrigo (PRGO) Misses on Q4 Earnings, to Sell Generic Unit
by Zacks Equity Research
Perrigo (PRGO) reports dismal fourth-quarter 2020 results. The company signs deal to sell its generic drug business for $1.55 billion. Stock up.
Endo's (ENDP) Earnings & Revenues Surpass Estimates in Q4
by Zacks Equity Research
Endo's (ENDP) earnings and sales beat estimates in the fourth quarter.
Bausch's (BHC) Q4 Earnings and Revenues Surpass Estimates
by Zacks Equity Research
Bausch (BHC) reports better-than-expected results for the fourth quarter as the business shows recovery signs from the COVID-19 pandemic.
Repligen (RGEN) Q4 Earnings & Sales Top, 2021 Outlook Bright
by Zacks Equity Research
Repligen (RGEN) reports encouraging fourth-quarter results with sales and earnings beating estimates. The company's guidance for 2021 also beats market expectations. Stock up.
Repligen's (RGEN) Q4 Earnings and Revenues Surpass Estimates
by Zacks Equity Research
Repligen (RGEN) beat estimates for both earnings and revenues in the fourth quarter of 2020.
Viatris (VTRS) Declines on Lackluster Outlook, Announces Dividend
by Zacks Equity Research
Viatris (VTRS) declines after it announces outlook for 2021 and reaffirms strategic commitments.
Repligen (RGEN) Earnings Expected to Grow: What to Know Ahead of Next Week's Release
by Zacks Equity Research
Repligen (RGEN) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Repligen (RGEN) Outpaces Stock Market Gains: What You Should Know
by Zacks Equity Research
In the latest trading session, Repligen (RGEN) closed at $223.39, marking a +1.95% move from the previous day.
Repligen (RGEN) to Report Q4 Earnings: What's in the Cards?
by Zacks Equity Research
On Repligen's (RGEN) fourth-quarter earnings call, investor focus will be on sales performance of its product franchisees - filtration, chromatography, protein and process analytics.
Repligen (RGEN) Outpaces Stock Market Gains: What You Should Know
by Zacks Equity Research
Repligen (RGEN) closed the most recent trading day at $222.06, moving +1.9% from the previous trading session.
Monopar Therapeutics (MNPR) Jumps: Stock Rises 7.4%
by Zacks Equity Research
Monopar Therapeutics (MNPR) saw a big move last session, as its shares jumped more than 7% on the day, amid huge volumes.
Allogene's (ALLO) AlloCAR T Therapy ALLO-715 IND Gets FDA Nod
by Zacks Equity Research
The FDA permits Allogene (ALLO) to initiate an early-stage study on its AlloCAR T therapy candidate, ALLO-715, in combination with SpringWorks' nirogacestat in multiple myeloma patients.
Mirum Pharmaceuticals (MIRM) in Focus: Stock Moves 5.9% Higher
by Zacks Equity Research
Mirum Pharmaceuticals (MIRM) saw a big move last session, as its shares jumped nearly 6% on the day, amid huge volumes.