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Zacks News
Axsome (AXSM) Plans NDA Filing for Fibromyalgia Drug in 2022
by Zacks Equity Research
Axsome (AXSM) concludes a favorable pre-NDA meeting with the FDA for AXS-14, which is being developed as a treatment of fibromyalgia. The company will file an NDA in the fourth quarter of 2022.
Exelixis (EXEL) & Bristol Myers Team Up for Genitourinary Cancers
by Zacks Equity Research
Exelixis (EXEL) collaborates with Bristol Myers to evaluate its next-generation tyrosine kinase inhibitor in combination with immuno-oncology therapies in advanced solid tumors.
Gilead (GILD) Gets FDA Nod for Label Expansion of Epclusa
by Zacks Equity Research
Gilead (GILD) obtains FDA approval for the label expansion of HCV drug, Epclusa, to include children as well.
Bristol Myers (BMY) Announces Data on CAR T Cell Therapy Breyanzi
by Zacks Equity Research
Bristol Myers (BMY) announces positive data on CAR T cell therapy, Breyanzi, in the second-line setting for patients with relapsed or refractory large B-cell lymphoma.
Vertex (VRTX) Ends Further Study on AAT Deficiency Candidate
by Zacks Equity Research
Vertex (VRTX) to discontinue further development of AATD candidate, VX-864, as it appears unlikely to benefit patients.
Omeros (OMER) Announces Preliminary Data on MASP-3 Inhibitor
by Zacks Equity Research
Omeros (OMER) announces initial results from a phase I study of OMS906.
Vertex's (VRTX) Trikafta Gets FDA Nod for CF in Children
by Zacks Equity Research
The FDA approves Vertex's (VRTX) triple combination therapy, Trikafta, for treating cystic fibrosis in children aged between six to 11 years.
Arena's (ARNA) Etrasimod Gets FDA's Orphan Drug Tag for EoE
by Zacks Equity Research
The FDA bestows an Orphan Drug status to Arena's (ARNA) lead pipeline candidate, etrasimod, for the treatment of eosinophilic esophagitis.
VBI Vaccines (VBIV) Up on Glioblastoma Drug Fast Track Status
by Zacks Equity Research
VBI Vaccines (VBIV) is developing VBI-1901 as a potential treatment of recurrent glioblastoma patients.
Arena (ARNA) Starts Phase II Study on Coronary Drug Temanogrel
by Zacks Equity Research
Arena (ARNA) is developing temanogrel in a phase II study as potential treatment for coronary microvascular obstruction in patients undergoing percutaneous coronary intervention.
Alexion's (ALXN) PNH Drug Ultomiris Gets FDA Nod for Kids
by Zacks Equity Research
The FDA approves Alexion's (ALXN) Ultomiris for the treatment of PNH in children of one month of age and older as well as adolescents.
bluebird (BLUE) Resumes SCD & TDT Studies as FDA Lifts Hold
by Zacks Equity Research
The FDA lifts the clinical hold on bluebird's (BLUE) studies on LentiGlobin for sickle cell disease and betibeglogene autotemcel for transfusion-dependent thalassemia. Shares rise.
Repligen (RGEN) Down 8.4% Since Last Earnings Report: Can It Rebound?
by Zacks Equity Research
Repligen (RGEN) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Bristol Myers (BMY) Gets EC Nod Opdivo+Yervoy in Mesothelioma
by Zacks Equity Research
The European Commission approves Bristol Myers' (BMY) Opdivo in combination with Yervoy for the first-line treatment of malignant pleural mesothelioma.
Immunovant (IMVT) Reports Narrower-Than-Expected Loss in Q4
by Zacks Equity Research
Immunovant's (IMVT) earnings beat estimates in fourth-quarter fiscal 2021. Focus remains on lead pipeline candidate IMVT-1401. Stock falls.
J&J (JNJ) to Pay $2.5B in Baby Powder Case on Appeal Rejection
by Zacks Equity Research
The U.S. Supreme Court rejects J&J's (JNJ) appeal against a lower court verdict of $2.1 billion in damages in a litigation related to its talc-based baby powder.
Omeros (OMER) Announces Data on Narsoplimab in COVID-19 Patients
by Zacks Equity Research
Omeros (OMER) announces data on critically ill COVID-19 patients treated with lead candidate, narsoplimab.
Novartis (NVS) & Molecular Partners Initiate Study for COVID-19
by Zacks Equity Research
Novartis (NVS) initiates study for investigating its novel DARPin therapeutic candidate, ensovibep (MP0420), for the treatment of COVID-19, in collaboration with Molecular Partners.
Exelixis (EXEL) Reports Encouraging Data From Prostate Cancer Study
by Zacks Equity Research
Exelixis (EXEL) announces encouraging results from the cohort 6 of a phase Ib study of Cabometyx in combination with Tecentriq.
Lilly's (LLY) Tyvyt BLA Accepted for Review by FDA for NSCLC (Revised)
by Zacks Equity Research
Lilly (LLY) and Innovent's sintilimab, a PD-1 inhibitor, is marketed by the brand name of Tyvyt in China for two indications.
Bristol Myers' (BMY) Opdivo-Yervoy Combo Gets Positive CHMP Opinion
by Zacks Equity Research
Bristol Myers' (BMY) Opdivo in combination with Yervoy gets positive CHMP recommendation by the EMA for an additional indication.
Regeneron (REGN)-Sanofi's Libtayo Gets Positive CHMP Opinion
by Zacks Equity Research
Regeneron (REGN) and Sanofi's (SNY) Libtayo gets positive CHMP opinion for two additional indications.
Bristol Myers (BMY) Gets FDA Nod for Another Opdivo Indication
by Zacks Equity Research
Bristol Myers (BMY) gets FDA approval for Opdivo (injection for intravenous use) for adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer.
Zacks Industry Outlook Highlights: Regeneron, Gilead Sciences, Amgen, Biogen, BioNTech, Repligen and Ovid Therapeutics
by Zacks Equity Research
Zacks Industry Outlook Highlights: Regeneron, Gilead Sciences, Amgen, Biogen, BioNTech, Repligen and Ovid Therapeutics
Reata (RETA) Soars on Potential Omaveloxolone NDA Filing
by Zacks Equity Research
The FDA asks Reata (RETA) to submit a pre-NDA meeting request to discuss omaveloxolone study data and cancel its previous request for a more general Type C meeting, boosting chances of an early NDA filing.