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biotechs: Archive

Zacks Equity Research

Pfizer Meets Goal in Non-Muscle Invasive Bladder Cancer Study

Data from a late-stage study shows that treatment with PFE's PD-1 inhibitor when added to BCG improves outcomes in certain bladder cancer patients.

PFENegative Net Change MRKPositive Net Change CSTLPositive Net Change ERASNegative Net Change

Ekta Bagri

Regeneron Stock Plunges 35.6% in Six Months: Fold or Hold?

REGN's Eylea faces a rapid decline in sales, impacting overall performance even though Dupixent maintains momentum. We advise investors to stay on the sidelines for now.

REGNPositive Net Change SNYPositive Net Change RHHBYPositive Net Change AMGNPositive Net Change BAYRYNegative Net Change

Zacks Equity Research

FDA Updates EXEL on Previously Scheduled ODAC Meeting for Cabozantinib

EXEL's sNDA seeking approval of cabozantinib for the treatment of pancreatic neuroendocrine tumors will not be discussed at an ODAC.

MRKPositive Net Change EXELPositive Net Change CSTLPositive Net Change IMCRPositive Net Change

Zacks Equity Research

ADMA Stock Catapults 275.7% in a Year: How Should You Play the Stock?

ADMA Biologics performance in the past twelve months has been phenomenal. While the prospects remain sound, the exceptional rally witnessed by the stock might limit any further gain.

GRFSPositive Net Change ADMANegative Net Change TAKPositive Net Change

Zacks Equity Research

SANA Stock Surges 152% in a Week on Upbeat Initial Diabetes Study Data

Sana stock soars in a week following positive initial data from a first-in-human study of investigational cell therapy, UP421, in diabetes patients.

HALOPositive Net Change CTMXNegative Net Change CSTLPositive Net Change SANAPositive Net Change

Zacks Equity Research

NTLA Announces Strategic Reorganization & Job Cuts in 2025, Stock Down

Intellia Therapeutics stock falls after the company announces key milestones for 2025. It plans to reduce the current workforce by 27%.

REGNPositive Net Change PBYIPositive Net Change NTLANegative Net Change CTMXNegative Net Change

Zacks Equity Research

FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab

JNJ's filing seeks the FDA's approval for nipocalimab to treat generalized myasthenia gravis in a broad population of antibody-positive patients.

JNJPositive Net Change CTMXNegative Net Change ARGXPositive Net Change CSTLPositive Net Change

Zacks Equity Research

Biotech Stock Roundup: NMRA Plunges on Study Failure, HOTH, VIR Soar on Study Data & More

NMRA and HOTH are in the spotlight in the biotech sector on study data announcement.

TEVAPositive Net Change CPRXNegative Net Change HOTHNegative Net Change VIRNegative Net Change NMRAPositive Net Change

Zacks Equity Research

VIR Stock Up on Early Safety & Efficacy Data on Two Cancer Candidates

Vir Biotechnology posts encouraging initial data from phase I studies evaluating VIR-5818 and VIR-5500 in heavily pretreated patients with various solid tumors.

PBYIPositive Net Change CTMXNegative Net Change CSTLPositive Net Change VIRNegative Net Change

Zacks Equity Research

HALO Raises 2025 Financial Guidance, Keeps 2024 View, Stock Up

Halozyme reiterates full-year 2024 financial guidance and raises its financial outlook for 2025. Shares rise.

RHHBYPositive Net Change JNJPositive Net Change HALOPositive Net Change PBYIPositive Net Change

Zacks Equity Research

DNLI's Hunter Syndrome Drug Gets Breakthrough Therapy Designation

Denali obtains Breakthrough Therapy Designation for its experimental candidate, tividenofusp alfa (DNL310), for the treatment of pateints with Hunter syndrome.

SNYPositive Net Change BIIBNegative Net Change HALOPositive Net Change DNLINegative Net Change

Zacks Equity Research

NVO Stock Up 3% as UBS Upgrades Company Rating From Neutral to Buy

Novo Nordisk stock gains 3% as analysts at UBS upgrade the company's rating from Neutral to Buy based on strong brand recognition of Ozempic and Wegovy.

NVOPositive Net Change LLYPositive Net Change HALOPositive Net Change CSTLPositive Net Change

Zacks Equity Research

CPRX Stock Rises 17% on Settling Firdapse Patent Litigation With Teva

Catalyst stock gains 17% as it settles Firdapse patent litigation with Teva protecting the drug's exclusivity in the United States till Feb. 25, 2035.

TEVAPositive Net Change HALOPositive Net Change CPRXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

FDA Accepts Agios' sNDA for Pyrukynd in Thalassemia

If approved, AGIO's Pyrukynd will be the first oral therapy for all thalassemia subtypes. A final decision is expected by Sep. 7.

RPRXPositive Net Change AGIOPositive Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

Viking Therapeutics Starts Mid-Stage Study on Oral Weight-Loss Drug

The initiation of the phase 2 study is based on early-stage data, which show that patients who received VKTX's obesity pill lost up to 8.2% in body weight after 28 days.

RHHBYPositive Net Change NVOPositive Net Change LLYPositive Net Change VKTXNegative Net Change

Ekta Bagri

Bristol Myers Stock Gains 11.4% in a Year: Time to Buy or Sell?

Bristol Myers stock has performed well in the past year, gaining 11%. We believe there is more room for further growth, and any dip in the share price can be used as a buying opportunity.

BMYNegative Net Change PFENegative Net Change MRKPositive Net Change

Zacks Equity Research

CorMedix Stock Rises on Q4 Preliminary Sales Beating Estimates

CRMD reports $31 million in preliminary sales from its sole marketed product in Q4, surpassing its previous guidance of breaking even by 2024.

PBYIPositive Net Change CRMDPositive Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

FDA Clears PCRX's New Iovera Smart Tip for Expanded Use in Pain Relief

Pacira receives FDA approval for a new iovera Smart Tip aimed at expanding pain management capabilities to deeper nerves like the medial branch nerve.

HALOPositive Net Change PCRXNegative Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

Here's Why You Should Consider Buying Atara Biotherapeutics Stock

Here, we discuss some reasons why buying ATRA stock now may turn out to be a prudent move.

HALOPositive Net Change PBYIPositive Net Change ATRANegative Net Change CSTLPositive Net Change

Zacks Equity Research

HOTH Stock Soars as Skin Toxicity Study in Cancer Patients Meets Goal

Hoth stock soars as a mid-stage study meets the goal, showing significant improvement in skin toxicities related to EFGR inhibitor therapy in all HT-001-treated patients.

HALOPositive Net Change CTMXNegative Net Change HOTHNegative Net Change CSTLPositive Net Change

Zacks Equity Research

Geron Stock Rallies More Than 60% in a Year: Here's Why

FDA's approval of GERN's Rytelo (imetelstat) for treating low- to intermediate-1 risk MDS drives the stock 61.1% higher in the past year.

GERNPositive Net Change HALOPositive Net Change PBYIPositive Net Change CSTLPositive Net Change

Zacks Equity Research

SLDB Stock Up as FDA Clears IND for SGT-212 in Friedreich's Ataxia

Solid Biosciences rises as the FDA clears SGT-212, a gene therapy candidate, for clinical studies for the treatment of Friedreich's ataxia.

BIIBNegative Net Change PBYIPositive Net Change SLDBNegative Net Change LRMRPositive Net Change

Sundeep Ganoria

Vaccine Stocks Jump After CDC Reports First US Bird-Flu Death

The first bird-flu fatality in the United States sparks investor interest in several vaccine makers that are developing experimental H5N1 vaccines.

MRNANegative Net Change NVAXPositive Net Change BNTXNegative Net Change CVACPositive Net Change

Zacks Equity Research

Denali's ALS Study Fails to Meet Primary and Secondary Endpoints

DNLI's DNL343 fails to achieve the primary and secondary endpoints, as observed from an analysis of Regimen G of the phase II/III HEALEY ALS platform trial.

SNYPositive Net Change BIIBNegative Net Change DNLINegative Net Change IMCRPositive Net Change

Zacks Equity Research

GSK's ADC Drug Gets FDA's Breakthrough Tag for Rare Bone Cancer

The FDA bestows a Breakthrough Therapy designation to GSK's antibody-drug conjugate, GSK5764227, for treating relapsed or refractory osteosarcoma.

GSKPositive Net Change PBYIPositive Net Change CTMXNegative Net Change CSTLPositive Net Change