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biotechs: Archive

Zacks Equity Research

argenx (ARGX) Tanks on Top-Line Data From Pemphigus Study

argenx's (ARGX) phase III ADDRESS study, evaluating efgartigimod subcutaneous for treating pemphigus, fails to meet primary and secondary endpoints. Stock falls.

PBYINegative Net Change DERMNegative Net Change ARGXPositive Net Change TRDAPositive Net Change

Ekta Bagri

3 Cancer-Focused Biotechs That Appear Promising Bets for 2024

With the spotlight on oncology-focused companies in the biotech sector in 2023, we discuss three stocks that have a promising oncology portfolio/pipeline for 2024.

BMYPositive Net Change LLYNegative Net Change BGNEPositive Net Change ALLOPositive Net Change TNGXPositive Net Change

Zacks Equity Research

bluebird (BLUE) Stock Down on Raising Additional Capital

bluebird (BLUE) issues shares to raise capital to support the commercialization and manufacturing of its three approved gene therapies. Its shares are down on the dilution of equity.

VRTXNegative Net Change CRSPPositive Net Change TRDAPositive Net Change

Zacks Equity Research

FDA Accepts Merck's (MRK) BLA for 21-Valent Pneumococcal Jab

The FDA grants priority review to Merck's (MRK) filing seeking approval for its 21-valent pneumococcal conjugate vaccine in adults. A final decision is expected in June 2024.

PFEPositive Net Change NVONegative Net Change MRKPositive Net Change GLPGPositive Net Change

Zacks Equity Research

Anavex (AVXL) Rises as CHMP Deems Blarcamesine Eligible for MAA

The CHMP agrees that Anavex's (AVXL) blarcamesine for Alzheimer's disease is eligible for submission for a Union Marketing Authorisation in the EU. Shares rise.

PBYINegative Net Change DERMNegative Net Change AVXLPositive Net Change TRDAPositive Net Change

Zacks Equity Research

Gilead (GILD), Compugen Collaborate for Immunotherapy Program

Gilead (GILD) enters into a license agreement with Compugen for its pre-clinical immunotherapy program.

GILDPositive Net Change CGENPositive Net Change RCUSPositive Net Change ACLXPositive Net Change

Kinjel Shah

4 Drug Stocks Rising More Than 40% in 2023 With Room to Grow

Novo Nordisk (NVO), Journey Medical Corporation (DERM), Lyra Therapeutics (LYRA) and Fusion Pharmaceuticals (FUSN) have returned 40% or higher year to date and have room for more growth in 2024.

NVONegative Net Change DERMNegative Net Change FUSNPositive Net Change LYRANegative Net Change

Zacks Equity Research

CARA's Late-Stage Skin Disease Study Fails, Stock Plummets 49%

CARA discontinues the clinical program of oral difelikefalin for pruritus associated with atopic dermatitis following the failure of dose-finding Part A of the late-stage study. Stock plunges 49%.

AGENPositive Net Change PBYINegative Net Change ADMANegative Net Change

Zacks Equity Research

Invivyd (IVVD) Surges on Positive Data From COVID-19 Study

Invivyd (IVVD) reports positive initial data from the phase III CANOPY study on VYD222 for the prevention of symptomatic COVID-19. Stock shoots up on the news.

PBYINegative Net Change DERMNegative Net Change TRDAPositive Net Change IVVDPositive Net Change

Zacks Equity Research

Arcutis (ARQT) Up on FDA Nod for Zoryve in Seborrheic Dermatitis

The FDA approves Arcutis' (ARQT) NDA for Zoryve topical foam 0.3% for treating seborrheic dermatitis in individuals nine years of age and above.

PBYINegative Net Change DERMNegative Net Change ARQTPositive Net Change TRDAPositive Net Change

Zacks Equity Research

Mirum (MIRM) Down on Failure of Mid-Stage Study on Livmarli

Mirum (MIRM) faces a setback in its efforts to expand its lead drug Livmarli's label for the indication of biliary atresia in patients who have undergone a Kasai surgery.

DVAXPositive Net Change MIRMPositive Net Change TVTXPositive Net Change TRDAPositive Net Change

Zacks Equity Research

Pfizer (PFE) Stock Rises on FDA Nod for Expanded Use of Padcev

The FDA approves Pfizer's (PFE) Padcev in combination with Merck's (MRK) Keytruda for adult patients with advanced bladder cancer. Stock rises 1.6%.

PFEPositive Net Change NVONegative Net Change MRKPositive Net Change PBYINegative Net Change

Zacks Equity Research

Merck (MRK) Gets EU Nod for Expanded Use in Gastric Cancer

Following these approvals, Merck's (MRK) Keytruda is approved for seven gastrointestinal cancers in the European Union. Overall, the drug is approved for 26 indications in the region.

NVONegative Net Change MRKPositive Net Change GLPGPositive Net Change

Zacks Equity Research

Bristol Myers (BMY) Stops Late-Stage Colorectal Cancer Study

Bristol Myers (BMY) decides to discontinue the phase III colorectal cancer study as it was unlikely to meet its primary endpoints upon completion.

BMYPositive Net Change DVAXPositive Net Change TRDAPositive Net Change

Zacks Equity Research

Vertex (VRTX), CRISPR Get Positive CHMP Opinion for Gene-Therapy

Vertex (VRTX) and CRISPR get a positive CHMP opinion, recommending the conditional approval of Casgevy for the treatment of SCD and TDT.

VRTXNegative Net Change EDITPositive Net Change CRSPPositive Net Change

Zacks Equity Research

Biogen's (BIIB) Rare Disease Drug Skyclarys Gets CHMP Nod in EU

Biogen (BIIB) gets positive CHMP opinion recommending marketing authorization to Skyclarys in the EU for the treatment of Friedreich's ataxia in patients aged 16 years and older.

BIIBPositive Net Change PTCTNegative Net Change PBYINegative Net Change ADMANegative Net Change

Ekta Bagri

3 Biotech Stocks Most Wall Street Analysts Are Bullish About

Here we present three biotech stocks, CRSP, ITCI and DVAX, which most analysts on Wall Street are optimistic about. These companies have upside potential for 2024, backed by strong fundamentals.

DVAXPositive Net Change ABBVNegative Net Change CRSPPositive Net Change

Kinjel Shah

5 Big Drug Stocks That May Continue to Outperform in 2024

Novo Nordisk (NVO), Eli Lilly (LLY), Vertex Pharmaceuticals (VRTX), Regeneron (REGN) and GSK (GSK) have been performing well this year. These stocks are poised to keep the momentum alive in 2024.

REGNPositive Net Change GSKPositive Net Change NVONegative Net Change LLYNegative Net Change VRTXNegative Net Change

Zacks Equity Research

Gilead (GILD) Outperforms Industry in 6 Months: What Lies Ahead?

Gilead (GILD) gains 3.7% in six months as its oncology portfolio gains traction and its HIV business maintains momentum.

GSKPositive Net Change DVAXPositive Net Change GILDPositive Net Change TRDAPositive Net Change

Zacks Equity Research

FDA Expands Merck's (MRK) Welireg Label in Renal Cell Carcinoma

Per Merck (MRK), the latest FDA approval to Welireg marks the first time a new treatment has been approved in a novel therapeutic class in advanced renal cell carcinoma since 2015.

MRKPositive Net Change MRNAPositive Net Change GLPGPositive Net Change

Zacks Equity Research

Moderna (MRNA) Soars on Upbeat Data From Cancer Therapy Study

Three-year follow up data from a mid-stage study shows that treatment with Moderna (MRNA)/Merck's cancer combination therapy reduces recurrence/death risk in certain melanoma patients by half.

MRKPositive Net Change MRNAPositive Net Change GLPGPositive Net Change

Zacks Equity Research

NextCure (NXTC) Down on Shelving Plans to Develop Candidate

NextCure (NXTC) plans to focus on developing LNCB74 and stop the development of NC762 to conserve cash. The company's shares decline on the same.

DVAXPositive Net Change MRKPositive Net Change NXTCNegative Net Change TRDAPositive Net Change

Zacks Equity Research

Reneo (RPHM) Plummets 83% on Failure of Metabolic Disorder Study

Reneo (RPHM) loses 83% following the failure of the mid-stage pivotal study of its only pipeline candidate, mavodelpar, to treat primary mitochondrial myopathies in adults. It cuts the workforce by 70%.

AGENPositive Net Change PBYINegative Net Change ADMANegative Net Change

Zacks Equity Research

Apellis (APLS) Falls on Europe Update for Pegcetacoplan in GA

The CHMP may adopt a negative opinion on Apellis' (APLS) intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration in the EU. Stock declines.

PBYINegative Net Change DERMNegative Net Change APLSNegative Net Change TRDAPositive Net Change

Zacks Equity Research

The Zacks Analyst Blog Highlights bluebird, Editas Medicine, Beam Therapeutics and Intellia Therapeutics

bluebird, Editas Medicine, Beam Therapeutics and Intellia Therapeutics are part of the Zacks top Analyst Blog.

BEAMPositive Net Change EDITPositive Net Change NTLAPositive Net Change