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Zacks News
Ultragenyx (RARE) Posts Preliminary '22 Results, Gives '23 View
by Zacks Equity Research
Ultragenyx (RARE) reports preliminary product revenues for its marketed drugs, Crysvita, Mepsevii and Dojolvi for the full year 2022. The company issues product revenue guidance for 2023.
Exelixis (EXEL) Announces Preliminary Q4 and 2022 Results
by Zacks Equity Research
Exelixis (EXEL) reports preliminary revenues for the fourth quarter and 2022. It also provides guidance for 2023 and pipeline updates.
Alnylam (ALNY) Posts Strong Preliminary Revenues for 4Q & FY22
by Zacks Equity Research
Alnylam (ALNY) reports strong preliminary product revenues for its marketed drugs, Onpattro, Amvuttra, Givlaari and Oxlumo for the fourth quarter and full year of 2022.
FATE To End Janssen Deal and Prioritize Pipeline Development
by Zacks Equity Research
FATE decides not to continue its collaboration and option agreement with Janssen. The company also conducts a strategic review.
FDA Accepts AstraZeneca (AZN), Sanofi's RSV Antibody BLA
by Zacks Equity Research
The FDA's decision on AstraZeneca (AZN)/Sanofi's (SNY) regulatory filing, seeking approval for using their RSV antibody in all infants, is expected in third-quarter 2023.
Roche's (RHHBY) Cancer Drug Glofitamab Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts and grants priority review to Roche's (RHHBY) biologics license application for glofitamab to treat relapsed or refractory large B-cell lymphoma. The decision is due on Jul 1, 2023.
Geron (GERN) Up on Imetelstat Data on Myelodysplastic Syndromes
by Zacks Equity Research
Geron (GERN) posts positive top-line data from the phase III IMerge study investigating its lead candidate, imetelstat for treating lower risk myelodysplastic syndromes. Shares up.
Phathom (PHAT) Down on Regulatory Update on Vonoprazan NDA
by Zacks Equity Research
Phathom Pharmaceuticals, Inc. (PHAT) declines as the FDA decides to not take any action on Phathom's new drug application (NDA) for vonoprazan for treating erosive esophagitis.
VERA Dips Despite Positive Data From IgA Nephropathy Study
by Zacks Equity Research
VERA posts positive top-line data from the phase IIb ORIGIN study evaluating atacicept for the treatment of IgA nephropathy.
Deciphera (DCPH) Issues Strategic & Corporate Outlook for 2023
by Zacks Equity Research
Deciphera (DCPH) provides a strategic outlook and planned corporate milestones for 2023. The company also posts preliminary fourth-quarter and 2022 revenues.