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Zacks News
Vertex (VRTX) Begins Rolling NDA Filing for Acute Pain Drug
by Zacks Equity Research
Vertex (VRTX) begins rolling NDA submission for its investigational non-opioid candidate, suzetrigine, for acute pain management. The submission is expected to be completed in second-quarter 2024.
Bio-Path (BPTH) Rises on Upbeat Updates From Blood Cancer Study
by Zacks Equity Research
Bio-Path (BPTH) gains 30% on encouraging developmental updates from the early-stage study of its investigational candidate, BP1002, to treat acute myeloid leukemia patients.
Roche (RHHBY) Alecensa Wins FDA Nod for Label Expansion
by Zacks Equity Research
Roche (RHHBY) has won FDA approval for Alecensa as an adjuvant treatment, following tumor resection for patients with ALK-positive non-small cell lung cancer.
Sage (SAGE) Down 20% on Parkinson's Study Missing Primary Goal
by Zacks Equity Research
Data from a mid-stage study show that Sage's (SAGE) experimental oral drug failed to show a statistically significant difference in treating patients with Parkinson's disease compared with a placebo.
DiaMedica (DMAC) Up as Stroke Study Dosing Begins Post Relaunch
by Zacks Equity Research
DiaMedica (DMAC) rises 10% as it doses the first patient in the relaunch of its pivotal study evaluating the lead candidate, DM199, to treat acute ischemic stroke.
Vanda (VNDA) Rejects Takeover Interest From Future Pak, Stock Up
by Zacks Equity Research
Vanda's (VNDA) board of directors unanimously rejects takeover proposals from Future Pak to acquire all outstanding shares of Vanda. Shares rise on the news.
Adma Biologics (ADMA) Registers a Bigger Fall Than the Market: Important Facts to Note
by Zacks Equity Research
In the most recent trading session, Adma Biologics (ADMA) closed at $6.04, indicating a -1.95% shift from the previous trading day.
2seventy bio (TSVT) Rises More Than 50% in 3 Months: Here's Why
by Zacks Equity Research
The FDA's recent nod to 2seventy bio's (TSVT) Abecma in earlier lines of treatment for relapsed/refractory multiple myeloma is a positive. Also, the R&D asset divestiture to Regeneron is saving costs.
Are Medical Stocks Lagging Annexon (ANNX) This Year?
by Zacks Equity Research
Here is how Annexon, Inc. (ANNX) and Adma Biologics (ADMA) have performed compared to their sector so far this year.
Intra-Cellular (ITCI) Up as Depression Drug Meets Study Goals
by Zacks Equity Research
Intra-Cellular (ITCI) jumps 23% after achieving key goals in the late-stage study evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD.
GSK Announces FDA Acceptance of New Meningococcal Jab BLA
by Zacks Equity Research
The approval of GSK's 5-in-1 meningococcal ABCWY vaccine candidate, MenABCWY, could provide the broadest meningococcal serogroup coverage and lead to simplified immunization.
bluebird (BLUE) Underperforms Industry YTD Amid Challenges
by Zacks Equity Research
bluebird (BLUE) plunges 25% year to date as it struggles to fuel the growth of its complex and expensive gene therapies.
Aptevo (APVO) Stock Plummets 79% in a Week: Here's Why
by Zacks Equity Research
Aptevo (APVO) plunges after it issues secondary shares, which are not only issued at a significant discount but also substantially dilute the existing shareholder base.
Marinus (MRNS) Down 83% on Lead Drug Falling Short in Seizure Study
by Zacks Equity Research
Interim results from a late-stage study show that Marinus' (MRNS) ganaxolone failed to meet the pre-specified stopping criteria in patients with refractory status epilepticus.
Corcept (CORT) Completes Enrollment in Phase II ALS Study
by Zacks Equity Research
The phase II DAZALS study is evaluating Corcept's (CORT) dazucorilant for treating patients with amyotrophic lateral sclerosis. Enrollment in the study is already complete.
Ultragenyx (RARE) Meets Efficacy Goal in Neuro Disease Study
by Zacks Equity Research
Ultragenyx (RARE) reports positive interim data from the phase I/II study of GTX-102 for Angelman syndrome. However, the stock declines due to safety concerns.
Neumora (NMRA) Down on FDA Clinical Hold on Neurology Drug
by Zacks Equity Research
The FDA places a clinical hold on Neumora's (NMRA) phase I study evaluating NMRA-266 for some types of neuropsychiatric disorders. Shares of the company fall on the news.
J&J (JNJ) Q1 Earnings Beat Estimates, Sales Miss, MedTech Soft
by Zacks Equity Research
J&J (JNJ) beats estimates for first-quarter earnings but misses the same for sales. It tightens its sales and earnings growth expectations for 2024.
Novartis (NVS) Presents Positive Data on Rare Kidney Disease Drug
by Zacks Equity Research
Novartis (NVS) announces encouraging data on Fabhalta from a phase III study for the treatment for the treatment of immunoglobulin A nephropathy, a heterogeneous, progressive, rare kidney disease.
Enlivex (ENLV) Stock Plummets 51% in a Week: Here's Why
by Zacks Equity Research
Enlivex (ENLV) plunges after it shares mixed results from a mid-stage study evaluating its lead drug as a potential treatment for sepsis.
Janux (JANX) Rises Almost 50% in a Week on Buyout Rumors
by Zacks Equity Research
Janux (JANX) stock surges after some reports claim that the company is exploring opportunities for a potential sale following buyout offers from big pharma companies.
Buy These 4 Low-Beta Stocks to Counter Market Volatility
by Nilanjan Banerjee
It is imperative to build a portfolio of low-beta stocks to sail through a volatile market. Trip.com (TCOM), ADMA Biologics (ADMA), Lantheus (LNTH) and Skyward (SKWD) are well-poised to gain.
Regeneron (REGN) Accused of Fraudulent Practices Related to Eylea
by Zacks Equity Research
The U.S. Department of Justice files a complaint against Regeneron (REGN), alleging fraudulent drug pricing practices related to its lead drug, Eylea.
AstraZeneca's (AZN) Fasenra Gets FDA Nod for Asthma in Kids
by Zacks Equity Research
The FDA approves AstraZeneca's (AZN) Fasenra as an add-on maintenance treatment for patients with severe asthma aged six to 11 years.
Candel (CADL) Up as Pancreatic Cancer Drug Gets Orphan Drug Tag
by Zacks Equity Research
Candel (CADL) rallies 43% as the FDA grants the orphan drug designation to its lead candidate, CAN-2409, for treating non-metastatic pancreatic cancer.