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Zacks News
Amylyx Pharmaceuticals, Inc. (AMLX) Q1 Earnings and Revenues Surpass Estimates
by Zacks Equity Research
Amylyx Pharmaceuticals, Inc. (AMLX) delivered earnings and revenue surprises of 107.41% and 24.55%, respectively, for the quarter ended March 2023. Do the numbers hold clues to what lies ahead for the stock?
Amylyx (AMLX) Doses First Patient in Wolfram Syndrome Study
by Zacks Equity Research
Amylyx (AMLX) progresses with the phase II study of pipeline candidate AMX0035 for the treatment of Wolfram syndrome as it doses the first patient.
PDS Biotech (PDSB) Up on Data From HPV-Positive Cancer Study
by Zacks Equity Research
A mid-stage study data shows that treatment with PDS Biotech's (PDSB) lead candidate in advanced HPV-positive cancer patients achieved a median overall survival of 21 months.
Minerva (NERV) Down; FDA Denies Review Schizophrenia Drug NDA
by Zacks Equity Research
Minerva (NERV) confirmed that the FDA's refuse-to-file letter on its regulatory filing, seeking approval for roluperidone, to treat symptoms of schizophrenia remains in effect.
Biohaven Pharma's (BHVN) ALS Study Fail to Meet Both Endpoints
by Zacks Equity Research
Biohaven Pharmaceuticals (BHVN) suffers a setback as verdiperstat fails to meet the primary and secondary endpoints in an ALS study.
Amylyx (AMLX) Secures the FDA's Approval for ALS Drug
by Zacks Equity Research
Amylyx (AMLX) obtains the FDA's approval for its oral, fixed-dose combination therapy for treating adults with amyotrophic lateral sclerosis (ALS) after a few roadblocks.
Biotech Stock Roundup: BMY Surges on Drug Approval, REGN Up on Update & More
by Zacks Equity Research
Regulatory and pipeline updates from BMY and REGN are the key highlights from the biotech sector during the past week.
Amylyx (AMLX) Up 51% After FDA Committee Endorses ALS Drug
by Zacks Equity Research
The FDA's PCNSDAC recommends granting marketing approval to Amylyx's (AMLX) oral drug, which slows the progression of ALS.
Is a Surprise Coming for Amylyx Pharmaceuticals (AMLX) This Earnings Season?
by Zacks Equity Research
Amylyx Pharmaceuticals (AMLX) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.
Biotech Stock Roundup: VRTX's Regulatory Update, TYME Gains on Acquisition & More
by Zacks Equity Research
Regulatory and other updates from Vertex (VRTX) and TYME are a few key highlights from the biotech sector during the past week.
Molina Healthcare (MOH) to Post Q1 Earnings: What's in Store?
by Zacks Equity Research
Molina Healthcare's (MOH) first-quarter results are likely to reflect the benefits of increased membership in the Medicare program.
Teladoc (TDOC) Eyes Q1 Earnings Beat on Rising US Paid Members
by Zacks Equity Research
Teladoc Health's (TDOC) first-quarter 2022 results are likely to reflect improved subscription access fees revenues.