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Zacks News
Mirum (MIRM)-Takeda Collaborate for Liver Disease Drug in Japan
by Zacks Equity Research
Mirum (MIRM) signs an agreement with Takeda for developing/commercializing maralixibat for Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia, in Japan.
Seagen (SGEN) Gets Early FDA Nod for Tivdak in Cervical Cancer (Revised)
by Zacks Equity Research
The FDA grants accelerated nod to Seagen (SGEN) and Genmab's Tivdak for treating adult patients with recurrent/metastatic cervical cancer with disease progression on or after chemotherapy.
Seagen (SGEN) Gets Early FDA Nod for Tivdak in Cervical Cancer
by Zacks Equity Research
The FDA grants accelerated nod to Seagen (SGEN) and Genmab's Tivdak for treating adult patients with recurrent/metastatic cervical cancer with disease progression on or after chemotherapy.
BeiGene (BGNE) Scores Third FDA Nod for Brukinsa in Lymphoma
by Zacks Equity Research
The FDA grants accelerated nod to BeiGene's (BGNE) Brukinsa for treating adults with relapsed or refractory marginal zone lymphoma. This marks the third approval for the drug in the United States.
RedHill (RDHL) Down on Unsatisfactory Data From COVID-19 Study
by Zacks Equity Research
RedHill (RDHL) posts preliminary top-line data from a phase II/III study evaluating opaganib in hospitalized patients with severe COVID-19 pneumonia. Stocks falls as the study fails to achieve its goal.
Alnylam (ALNY) Files MAA to EMA for Rare Disease Drug Vutrisiran
by Zacks Equity Research
Alnylam (ALNY) submits a marketing authorization application to the EMA for vutrisiran to treat adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
BeiGene's (BGNE) BLA for Tislelizumab in ESCC Accepted by FDA
by Zacks Equity Research
The FDA accepts for review BeiGene's (BGNE) BLA for tislelizumab to treat patients with locally advanced/metastatic esophageal squamous cell carcinoma after prior systemic therapy.
Apellis (APLS) Down on Mixed Data From Studies on GA Candidate
by Zacks Equity Research
Apellis (APLS) posts mixed top-line data from the phase III DERBY and OAKS studies testing pegcetacoplan in adults with geographic atrophy secondary to age-related macular degeneration. Stock falls.
Erasca (ERAS) Inks Deal With Pfizer for Colorectal Cancer Study
by Zacks Equity Research
Erasca (ERAS) signs an agreement with Pfizer for a clinical study, which will evaluate ERAS-007 in combination with encorafenib and cetuximab for BRAF V600E-mutant metastatic colorectal cancer.
Global Blood's (GBT) NDA & sNDA for Oxbryta Get Priority Review
by Zacks Equity Research
The FDA grants priority review to Global Blood's (GBT) sNDA for Oxbryta to treat SCD in children aged four to 11 years, as well as to its NDA for a pediatric weight-based formulation of the drug.