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Zacks News
aTyr (LIFE) Surges on Positive Data on Lead Candidate ATYR1923
by Zacks Equity Research
aTyr Pharma (LIFE) soars following the announcement of positive results from its phase Ib/IIa study of its lead candidate, ATYR1923, for pulmonary sarcoidosis.
BOLT Enters Into a Collaboration Agreement With Bristol Myers
by Zacks Equity Research
BOLT collaborates with Bristol Myers to investigate its pipeline candidate BDC-1001 in combination with the latter???s Opdivo.
Horizon (HZNP) Begins Phase IV Study on Tepezza for Chronic TED
by Zacks Equity Research
Horizon (HZNP) enrolls the first patient in a phase IV study evaluating the safety and efficacy of Tepezza for the treatment of chronic (inactive) thyroid eye disease.
RedHill's (RDHL) Opaganib Effective Against Kidney Fibrosis
by Zacks Equity Research
Opaganib, Redhill's (RDHL) candidate for COVID-19, achieves a significant reduction in kidney fibrosis in preclinical studies.
Supernus (SUPN) Seeks Label Expansion for ADHD Drug Qelbree
by Zacks Equity Research
The FDA accepts Supernus' (SUPN) regulatory application seeking label application for Qelbree to include adult patients with ADHD.
Takeda (TAK) Hematology Candidate Fails in Late-Stage Study
by Zacks Equity Research
Takeda's (TAK) pipeline candidate, pevonedistat, fails to achieve statistically significant event-free survival in patients with hematological disorders.
Roche (RHHBY) Withdraws Tecentriq for Breast Cancer in the U.S.
by Zacks Equity Research
Roche (RHHBY) will withdraw Tecentriq for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer in the United States.
BioMarin's (BMRN) Dwarfism Drug Gets Approval in Europe
by Zacks Equity Research
Biomarin Pharmaceutical's (BMRN) Voxzogo is the first medicine in Europe to be approved to treat achondroplasia, the most common form of dwarfism.
Incyte (INCY), MorphoSys Win EC Approval for Lymphoma Drug
by Zacks Equity Research
Incyte (INCY) and partner MorphoSys obtain approval for tafasitamab for adult patients with relapsed or refractory diffuse large B-cell lymphoma by the European Commission.
Repligen (RGEN) Up 16.5% Since Last Earnings Report: Can It Continue?
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.
Dynavax (DVAX) Gains as Medigen Rolls Out COVID-19 Vaccine
by Zacks Equity Research
Dynavax (DVAX) stock gains as partner Medigen announces launch of its COVID-19 vaccine MVC-COV1901 adjuvanted with CpG 1018 of the former.
Axsome's (AXSM) Stock Up Despite FDA Delay on Depression Drug
by Zacks Equity Research
FDA delays decision on Axsome Therapeutics' (AXSM) new drug application for AXS-05, a potential treatment for major depressive disorder.
CARA Drug Wins FDA Nod for Pruritus Associated With CKD
by Zacks Equity Research
CARA gets a significant boost with FDA approval for Korsuva injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
AstraZeneca (AZN) Stops Phase III Study on Ultomiris for ALS
by Zacks Equity Research
AstraZeneca (AZN) stops the phase III CHAMPION-ALS study on Ultomiris for treating adults with amyotrophic lateral sclerosis, following a recommendation from the Independent Data Monitoring Committee.
Gilead (GILD) MAA for HIV Inhibitor Under the EMA's Review
by Zacks Equity Research
Gilead's (GILD) application for an investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, is under review with the European regulatory body.
J&J (JNJ) CEO Alex Gorsky to Resign, Joaquin Duato to Succeed
by Zacks Equity Research
J&J's (JNJ) CEO Alex Gorsky who has led the company for almost a decade resigns. Joaquin Duato to succeed as CEO.
Paratek's (PRTK) Nuzyra Gets FDA's Orphan Drug Tag for NTM
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Paratek's (PRTK) marketed drug Nuzyra for the treatment of infections caused by Nontuberculous Mycobacteria.
Werewolf (HOWL) Up on Deal With Merck for Solid Tumor Study
by Zacks Equity Research
Werewolf Therapeutics (HOWL) inks a collaboration and supply agreement with Merck to evaluate its candidate, WTX-124, in combination with Keytruda, for treating solid tumors. Stock up.
AzurRx (AZRX) Pancreatic Insufficiency Study Meets Endpoints
by Zacks Equity Research
AzurRx (AZRX) is developing lead pipeline candidate as monotherapy and in combination regimen as potential treatment for exocrine pancreatic insufficiency in patients with cystic fibrosis.
Glaxo's (GSK) Jemperli Gets FDA Approval for New Indication
by Zacks Equity Research
The FDA grants accelerated approval to Glaxo's (GSK) Jemperli for treating patients with mismatch repair-deficient recurrent/advanced solid tumors. This is the second approved indication for the drug.
Mei (MEIP) Begins Phase III Study for B-Cell Malignancies
by Zacks Equity Research
Mei Pharma (MEIP) doses first patient in phase III study to evaluate zandelisib plus rituximab in follicular lymphoma or marginal zone lymphoma.
Aurinia (AUPH) Adds Two Candidates, Boosts Immunology Pipeline
by Zacks Equity Research
Aurinia (AUPH) acquires two pre-clinical, novel pipeline programs for the treatment of rare autoimmune, fibrotic and kidney diseases. Yet, the stock price declines.
Agios (AGIO) Rare Disease Drug NDA Gets FDA Priority Review
by Zacks Equity Research
Agios (AGIO) is seeking approval for its lead pipeline candidate, mitapivat, as a potential treatment for PK deficiency.
Travere (TVTX) Announces Data on Rare Kidney Disease Drug
by Zacks Equity Research
Travere (TVTX) announces positive interim data from the ongoing study of its investigational candidate, sparsentan, for the treatment of IgAN, a rare kidney disorder. Resultantly, the stock rises
Moderna (MRNA) Begins Rare Disease Study, Inks Supply Agreement
by Zacks Equity Research
Moderna (MRNA) doses first patient in phase I/II study with mRNA-3705 for the treatment of a rare multi-organ disorder. The company also revises the supply agreement with the Canadian Government for its COVID vaccine.