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Zacks News
RARE Submits BLA to the FDA for Sanfilippo Syndrome Gene Therapy
by Zacks Equity Research
Ultragenyx submits a BLA to the FDA seeking the accelerated approval of UX111 for patients with Sanfilippo syndrome type A in the United States.
VRTX Down as Non-Opioid Drug Shows Similar Pain Reduction as Placebo
by Zacks Equity Research
Vertex announces data from a phase II study evaluating its NaV1.8 pain signal inhibitor, suzetrigine, for treating painful lumbosacral radiculopathy. Shares down.
LLY Stock Up as FDA Removes Mounjaro, Zepbound From Shortage List
by Zacks Equity Research
Eli Lilly stock gains as the FDA removes tirzepatide drugs from the drug shortage list following a thorough reevaluation.
MRK's Pivotal Study on Two-Drug, Once-Daily HIV Pill Meets Goals
by Zacks Equity Research
Merck posts positive data from two phase III studies evaluating a two-drug, single-tablet regimen of doravirine/islatravir in adults with HIV-1 infection.
Roche's Prasinezumab Misses Goal in Parkinson's Disease Study
by Zacks Equity Research
The phase IIb PADOVA study, evaluating Roche's prasinezumab in people with early-stage Parkinson's disease, misses the primary endpoint.
MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease
by Zacks Equity Research
The FDA approves Mesoblast's Ryoncil (remestemcel-L) for treating pediatric patients with steroid-refractory acute graft versus host disease. Shares rise.
KRYS Reports Upbeat Initial Data From Lung Cancer Study of KB707
by Zacks Equity Research
Krystal Biotech reports initial data from a phase I/II study showing therapeutic benefit in NSCLC patients treated with its immunotherapy candidate, KB707.
GILD's Trodelvy Gets Second Breakthrough Therapy Tag for Lung Cancer
by Zacks Equity Research
Gilead announces that the FDA grants a second Breakthrough Therapy designation to Trodelvy for the extensive-stage small cell lung cancer indication.
REGN's Eylea HD Shows Non-Inferiority to Eylea in Eye Disease Study
by Zacks Equity Research
Regeneron's phase III study evaluating Eylea HD against stand-of-care Eylea treatment meets the primary endpoint of non-inferior visual gain in RVO patients.
EWTX Stock Rises on Upbeat Data From Rare Muscular Disorder Study
by Zacks Equity Research
Data from a mid-stage study show that treatment with Edgewise's experimental drug reduces levels of a biomarker related to skeletal muscle damage.