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Zacks News
Novo Nordisk (NVO) Posts Upbeat Once-Weekly Insulin Icodec Data
by Zacks Equity Research
Novo Nordisk (NVO) announces encouraging new data from its late-stage ONWARDS 1 and 3 studies on once-weekly basal insulin icodec against once-daily comparators at 52 and 26 weeks, respectively.
Amylyx (AMLX) Down on Negative CHMP Opinion for ALS candidate
by Zacks Equity Research
Amylyx's (AMLX) shares plunge on getting a negative opinion from the Committee for Medicinal Products for Human Use for the marketing authorization of AMX0035, used to treat amyotrophic lateral sclerosis.
Recent Price Trend in Akero Therapeutics, Inc. (AKRO) is Your Friend, Here's Why
by Zacks Equity Research
Akero Therapeutics, Inc. (AKRO) made it through our "Recent Price Strength" screen and could be a great choice for investors looking to make a profit from stocks that are currently on the move.
Pfizer's (PFE) Litfulo Receives FDA Nod for Alopecia Areata
by Zacks Equity Research
Pfizer's (PFE) Litfulo becomes the first kinase inhibitor approved for treating severe alopecia areata in adolescents, following FDA's approval.
Pieris (PIRS) Declines as AZN Halts Study of Asthma Candidate
by Zacks Equity Research
Pieris' (PIRS) shares nosedive as its partner decides to discontinue a phase IIa study evaluating elarekibep for treating asthma, based on non-clinical safety data from a toxicology study.
Aeglea (AGLE) Soars 329% on Acquiring Spyre Therapeutics
by Zacks Equity Research
Aeglea's (AGLE) shares surge as it acquires Spyre Therapeutics, a private company that focuses on developing antibody therapeutics for inflammatory bowel disease.
Horizon's (HZNP) Tepezza Study in Japan for TED Meets Goal
by Zacks Equity Research
Horizon (HZNP) announces positive top-line results from its phase III study evaluating Tepezza for treating Thyroid Eye Disease with high disease activity in Japan.
uniQure (QURE) Falls on Mixed Huntington's Disease Study Results
by Zacks Equity Research
uniQure (QURE) stock declines after the company announces mixed results from its biomarkers analysis in the early-to-mid-stage study of AMT-130 in Huntington's disease.
Amgen's (AMGN) Blincyto sBLA Gets FDA Nod in Treating Leukemia
by Zacks Equity Research
Amgen (AMGN) announces full approval of its sBLA for Blincyto as an immune-oncology therapy for treating adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia.
Alderya (ALDX) Stock Declines on Getting CRL for PVRL Candidate
by Zacks Equity Research
Alderya's (ALDX) shares decline on receiving a complete response letter for an investigational candidate, ADX-2191, treating primary vitreoretinal lymphoma.
Denali (DNLI) Provides Update on Hunter Syndrome Study
by Zacks Equity Research
Denali's (DNLI) early-to-mid-stage study of DNL310 shows a robust reduction in neurofilament light levels for patients with MPS II (Hunter syndrome).
Aridis (ARDS) Up on Regulatory Update for Pneumonia Drug
by Zacks Equity Research
Aridis (ARDS) announces that its AR-301 clinical program is eligible for availing the FDA's special pathway for satisfying the unmet medical need of a predefined limited population.
Merck's (MRK) Gastric Cancer Study Fails to Meet a Primary Goal
by Zacks Equity Research
Merck's (MRK) late-stage study evaluating Keytruda in advanced gastric cancer fails to meet one of the primary endpoints.
Verve (VERV) Up 9.9% in a Week on Collaboration With Eli Lilly
by Zacks Equity Research
Verve's (VERV) shares rise on collaboration with Eli Lilly to develop gene editing treatment for cardiovascular disease.
Reata (RETA) Announces FDA's Acceptance of Skyclarys PAS
by Zacks Equity Research
Reata (RETA) gets FDA acceptance for the filing of new drug application supplement approval for Skyclarys' release.
GSK Announces Extension of FDA Review for Rare Blood Therapy
by Zacks Equity Research
GSK announces the FDA's extension of the review period of its new drug application for momelotinib to treat myelofibrosis by three months. A decision is now expected on Sep 16, 2023.
Aldeyra (ALDX) Up On Positive Data From Conjunctivitis Study
by Zacks Equity Research
Aldeyra (ALDX) soars on meeting primary and secondary endpoints in the late-stage study of reproxalap for patients with allergic conjunctivitis.
Iovance (IOVA) Updates on Combo Drug in Advanced Melanoma Study
by Zacks Equity Research
Iovance (IOVA) announces randomizing the first patient in the TILVANCE-301 study evaluating the safety and efficacy of its lifileucel/Keytruda combo therapy in frontline advanced melanoma patients.
Lava (LVTX) Discontinues Hematological Tumor Study, Shares Fall
by Zacks Equity Research
Lava (LVTX) falls 10% due to its decision to discontinue the study on LAVA-051, which is being evaluated for multiple hematological tumors. The company shifts focus to LAVA-1207 in the prostate cancer study.
Blue Water (BWV) Up on Acquisition of 6 FDA-Approved Drugs
by Zacks Equity Research
Blue Water (BWV) soars 62% after declaring its deal to purchase six FDA-approved products for $8.5 million. The agreement will help expand the company's portfolio into cardiology and pain management.
IO Biotech (IOBT) Down Despite Positive Update on Melanoma Study
by Zacks Equity Research
IO Biotech (IOBT) falls 25% despite achieving the clinical milestone of enrolling 225 patients in the advanced melanoma study evaluating the IO102-IO103/Keytruda combo.
Can-Fite (CANF) Up on Namodenoson Progress in Pancreatic Cancer
by Zacks Equity Research
Can-Fite's (CANF) shares rise 11.4% as it reveals its plans of submitting an investigational new drug application. The idea is to initiate expansion studies for namodenoson to treat pancreatic carcinoma.
Recursion (RXRX) Up on Completing REC-994 Study Enrollment
by Zacks Equity Research
Recursion's (RXRX) shares rise as it completes patient enrollment for a mid-stage study of REC-994 to treat cerebral cavernous malformations.
Gracell Biotechnologies (GRCL) Surges 62% in a Week: Here's Why
by Zacks Equity Research
Shares of Gracell (GRCL) increase after it reported positive data from two clinical studies, which evaluated its experimental CAR T cell therapy drug in patients with B-cell non-hodgkin's lymphoma and multiple myeloma.
First Wave (FWBI) Surges 33% on Finishing Enrolment in CF Study
by Zacks Equity Research
First Wave (FWBI) completes enrolment in a mid-stage study evaluating its investigational oral capsule in patients with cystic fibrosis. Topline data from the study is expected next month.