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Zacks News
Solid Biosciences (SLDB) Stock Up as FDA Clears DMD Drug IND
by Zacks Equity Research
Solid Biosciences (SLDB) gains 28% as the FDA clears SGT-003, a gene therapy candidate, for clinical studies in the treatment of Duchenne Muscular Dystrophy.
Roche (RHHBY) Tecentriq SC Receives Positive CHMP Opinion
by Zacks Equity Research
Roche's (RHHBY) subcutaneous (SC) formulation of immuno-oncology drug Tecentriq gets CHMP's positive recommendation for all approved indications.
Biogen (BIIB) Beats on Q3 Earnings & Sales, Cuts EPS View
by Zacks Equity Research
Biogen (BIIB) beats third-quarter estimates for earnings and sales. It lowers its 2023 EPS guidance range to include the impact of dilution from the Reata acquisition. Stock rises in pre-market.
Halozyme (HALO) Q3 Earnings Top Estimates, Revenues Lag
by Zacks Equity Research
Halozyme's (HALO) third-quarter earnings beat estimates, while revenues miss the same. The company maintains revenue guidance for full-year 2023.
Biogen (BIIB) to Report Q3 Earnings: Will It Beat Estimates?
by Zacks Equity Research
Biogen's (BIIB) sales in the third quarter are likely to have been hurt by lower sales of its multiple sclerosis drugs, while sales of Spinraza are likely to have improved.
Alnylam (ALNY) Swings to Earnings in Q3 on Collaboration Revenues
by Zacks Equity Research
Alnylam (ALNY) reports better-than-expected third-quarter 2023 results, beating both earnings and sales estimates on the back of higher collaboration revenues.
Prothena (PRTA) Q3 Earnings Beat on Collaboration Revenue Hike
by Zacks Equity Research
Prothena (PRTA) delivers earnings of 38 cents in the third quarter, driven by the license and option exercise fee paid by BMY.
Regeneron (REGN) Q3 Earnings & Sales Top, Eylea Sales Decline
by Zacks Equity Research
Regeneron (REGN) beats earnings and sales estimates in third-quarter 2023, fueled by Dupixent. However, sales of the lead drug, Eylea, fall yet again.
Sarepta (SRPT) Q3 Loss Narrower Than Expected, Sales Beat
by Zacks Equity Research
Sarepta's (SRPT) Q3 earnings and sales beat estimates on the back of strong sales for recently approved DMD gene therapy Elevidys.
Blueprint (BPMC) Stock Gains 26% on Q3 Earnings & Sales Beat
by Zacks Equity Research
Blueprint (BPMC) climbs 26% on better-than-expected third-quarter 2023 results, driven by increased Ayvakit sales following the drug's label expansion in the United States.
Novartis (NVS) Tops Q3 Earnings, Ups Operating Income View
by Zacks Equity Research
Novartis (NVS) beats on earnings in the third quarter and raises its annual guidance for core operating income.
Roche (RHHBY) Nine Months' Sales Fall on Lower COVID-19 Test Sale
by Zacks Equity Research
Roche (RHHBY) reports a sales decline in the first nine months of 2023 as COVID-19-test sales continue to dent its top line. Currency rate fluctuations also impact its results.
Roche's (RHHBY) MS Drug Reduces Brain Lesions in Phase II Study
by Zacks Equity Research
Roche (RHHBY) presents new data from a phase II study, which shows that fenebrutinib is brain penetrant and reduces brain lesions in people with relapsing multiple sclerosis.
Tempest (TPST) Up as First-Line Liver Cancer Study Meets Goals
by Zacks Equity Research
Tempest (TPST) skyrockets 2879% on positive new and updated findings from its early-mid-stage study evaluating TPST-1120 in combination with standard-of-care therapies to treat liver cancer.
Roche's (RHHBY) Vabysmo Positive in Late-Stage RVO Studies
by Zacks Equity Research
Roche (RHHBY) Vabysmo maintains vision improvements with extended treatment intervals of up to four months in phase III studies for retinal vein occlusion.
Lineage (LCTX) Up 10% on Upbeat Data From Eye Disease Study
by Zacks Equity Research
Lineage (LCTX) rises 10% on positive imaging analyses results from the phase I/IIa study of OpRegen in patients with geographic atrophy secondary to age-related macular degeneration.
Baudax's (BXRX) Hemophilia A Drug Gets FDA's Orphan Drug Tag
by Zacks Equity Research
FDA grants the Orphan Drug designation to Baudax (BXRX) for its lead pipeline candidate, TI-168, to treat Hemophilia A patients with inhibitors.
PTC Therapeutics (PTCT) to Cut 25% Jobs by January 2024
by Zacks Equity Research
PTC Therapeutics (PTCT) will reduce its workforce in accordance with its strategic prioritization process. It will also submit a re-examination request for the negative CHMP opinion on Translarna.
Ionis (IONS) Inks New Deal With Roche to Develop Novel RNA Drugs
by Zacks Equity Research
Per the agreement, Ionis (IONS) will grant exclusive global rights to Roche to develop and market two novel RNA-therapeutics for Alzheimer's and Huntington's diseases.
Alnylam's (ALNY) Zilebesiran Meets Goals in Mid-Stage Study
by Zacks Equity Research
Alnylam's (ALNY) mid-stage study of zilebesiran in the treatment of hypertension in patients at high cardiovascular risk meets primary and key secondary endpoints.
Roche's (RHHBY) Application for PNH Drug Accepted by FDA
by Zacks Equity Research
Roche (RHHBY) biologics license application seeking approval for crovalimab for paroxysmal nocturnal hemoglobinuria gets FDA acceptance.
AC Immune (ACIU) Surges 43% in the Past 3 Months: Here's Why
by Zacks Equity Research
AC Immune's (ACIU) shares rose 43% over the past three months, driven by rapid progress in the development of its pipeline candidate, ACI-24.060, for neurodegenerative diseases.
Pharma Stock Roundup: J&J's New '23 View After Kenvue Separation, Regulatory Updates
by Kinjel Shah
J&J (JNJ) updates its financial guidance for 2023 after the final separation of Kenvue. Pfizer, BioNTech, Merck and AbbVie announce regulatory developments.
Roche's (RHHBY) Late-Stage Lung Cancer Study Meets Primary Goal
by Zacks Equity Research
Roche's (RHHBY) late-stage ALK-positive non-small cell lung cancer study evaluating Alecensa meets the primary endpoint of disease-free survival.
Regeneron (REGN) Gains 13% in 1 Month on FDA Nod For Eylea HD
by Zacks Equity Research
Regeneron (REGN) gains 13% in a month on the FDA's approval of a higher dose of Eylea and other positive updates.