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biotechs: Archive

Zacks Equity Research

Zevra (ZVRA) Rises on Update on Niemann-Pick Disease Type C Drug

The FDA will meet with its Genetic Metabolic Diseases Advisory Committee to review Zevra's (ZVRA) new drug application for pipeline candidate arimoclomol. Shares of Zevra gains on the news.

CORTNegative Net Change TRDAPositive Net Change ZVRANegative Net Change

Zacks Equity Research

uniQure (QURE) Soars on New Huntington's Disease Study Data

uniQure (QURE) surges 77% on updated positive interim data from 29 treated patients in the ongoing phase I/II studies of investigational gene therapy, AMT-130, for Huntington's disease.

CGENPositive Net Change QUREPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Athira (ATHA) Completes Dosing in Alzheimer's Study, Stock Up

Athira (ATHA) completes dosing the last patient in the phase II/III LIFT-AD study on fosgonimeton for treating people with mild-to-moderate Alzheimer's disease. Stock gains.

ADPTPositive Net Change RAPTPositive Net Change ATHAPositive Net Change ACRVPositive Net Change

Zacks Equity Research

IDEAYA (IDYA) Up on Upbeat Phase II Bladder & Lung Cancer Data

IDEAYA (IDYA) gains 15% on positive clinical data from its phase II study evaluating the 30 mg monotherapy expansion dose of IDE397 to treat MTAP-deletion urothelial and NSCLC patients.

CGENPositive Net Change IDYAPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Study Shows Lilly's (LLY) Obesity Drug More Effective Than NVO's

Data from a new study, also published on the JAMA website, shows that patients taking Lilly's (LLY) obesity drug are likely to lose more weight than those taking Novo's drug.

NVOPositive Net Change LLYPositive Net Change AMGNNegative Net Change VKTXPositive Net Change

Zacks Equity Research

Mirum (MIRM) Gets EC Approval for Livmarli Label Expansion

The European Commission approves Mirum's (MIRM) Livmarli for the treatment of progressive familial intrahepatic cholestasis in patients three months of age and older.

AVXLNegative Net Change MIRMPositive Net Change RAPTPositive Net Change ACRVPositive Net Change

Zacks Equity Research

HilleVax (HLVX) Tanks as Norovirus Vaccine Study in Infants Fails

HilleVax's (HLVX) phase IIb NEST-IN1 study evaluating HIL-214 for preventing acute gastroenteritis caused by norovirus infection in infants fails to meet its primary efficacy endpoint. Stock falls.

AVXLNegative Net Change RAPTPositive Net Change HLVXNegative Net Change ACRVPositive Net Change

Zacks Equity Research

Kymera's (KYMR) Partner SNY to Expand Ongoing HS and AD Studies

Kymera (KYMR) announces expansion plans of ongoing mid-stage studies on KT-474 (SAR444656) by partner Sanofi.

SNYPositive Net Change ADMAPositive Net Change KYMRPositive Net Change TRDAPositive Net Change

Zacks Equity Research

Adicet (ACET) Up as Kidney Cancer Drug Gets FDA's Fast Track Tag

Adicet (ACET) gains as the FDA grants the Fast Track designation to ADI-270 for the potential treatment of a form of kidney cancer. A phase I study for this indication is set to begin in 2024.

ACETPositive Net Change CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

Zacks Equity Research

Here's Why Sarepta (SRPT) Stock Price Surged 57% YTD

Sarepta (SRPT) surges on the commercial potential of its Elevidys, the first FDA-approved gene therapy for Duchenne muscular dystrophy.

RHHBYPositive Net Change PFEPositive Net Change SRPTPositive Net Change RGNXPositive Net Change SLDBPositive Net Change

Zacks Equity Research

Mirum (MIRM) Rises More Than 30% in Past 3 Months: Here's Why

The recent label expansion of Mirum's (MIRM) lead drug, Livmarli, is expected to drive sales in the upcoming quarters. The company's efforts to build its pipeline beyond Livmarli also hold promise.

MIRMPositive Net Change RAPTPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

Zacks Equity Research

Dianthus (DNTH) Gains 18% in the Past Month: Here's Why

Dianthus (DNTH) shares have rallied 18% in the past month on FDA clearance to initiate a phase II study on its lead candidate, DNTH103, to treat an autoimmune indication. Top-line data is expected in 2026.

CGENPositive Net Change IMVTPositive Net Change ALXOPositive Net Change DNTHPositive Net Change

Ekta Bagri

Gilead (GILD) Loses 17.6% YTD: How Should You Play the Stock?

While Gilead (GILD) has been reeling under pressure year to date due to pipeline setbacks, holding on to this biotech giant will be prudent at current levels.

GSKPositive Net Change GILDNegative Net Change MRUSPositive Net Change

Zacks Equity Research

Apellis' (APLS) Syfovre Boost Sales, Regulatory Setbacks a Woe

Apellis' (APLS) revenues rise on the back of the robust uptake of Syfovre for the GA indication. However, the recent regulatory setback in the EU for pegcetacoplan to treat GA is a woe.

CGENPositive Net Change APLSPositive Net Change ALXOPositive Net Change ALGSPositive Net Change

Zacks Equity Research

GSK Buys Flu, COVID mRNA Jab Rights From Partner CureVac

GSK revamps its existing collaboration deal with partner CureVac, converting it from a collaboration deal into a licensing agreement related to mRNA vaccine candidates for COVID-19 and influenza.

GSKPositive Net Change RAPTPositive Net Change CVACPositive Net Change ALGSPositive Net Change

Zacks Equity Research

Roche's (RHHBY) Combo Therapy Misses Lung Cancer Study Goals

Roche (RHHBY) announces that its mid to late-stage lung cancer study evaluating the tiragolumab combination therapy compared with Keytruda fails to meet primary endpoints.

RHHBYPositive Net Change MRKPositive Net Change CGENPositive Net Change ALXOPositive Net Change

Zacks Equity Research

Biotech Stock Roundup: GSK, CVAC Revise Agreement, Updates From MRNA, RNAC & More

GSK and CureVac (CVAC) are in the spotlight following a restructuring of their vaccine agreement.

GSKPositive Net Change MRNAPositive Net Change RCKTNegative Net Change CVACPositive Net Change RNACPositive Net Change

Sundeep Ganoria

NVO, LLY Slip After Study Links Obesity Drug Use to Vision Loss

A new study led by investigators of a Harvard-affiliated teaching hospital found that Novo Nordisk's (NVO) GLP-1 drugs Ozempic and Wegovy could be linked to rare cases of vision loss.

NVOPositive Net Change LLYPositive Net Change AMGNNegative Net Change VKTXPositive Net Change

Zacks Equity Research

Cartesian (RNAC) MG Study Meets Goals, Stock Down on Other Updates

Cartesian (RNAC) announced that the phase IIb study in MG patients has achieved its primary endpoints. However, the stock nosedives following an equity financing announcement.

NERVPositive Net Change ARGXNegative Net Change ALXOPositive Net Change RNACPositive Net Change

Zacks Equity Research

Moderna (MRNA) Secures BARDA Funding for Bird Flu Vaccine

Moderna (MRNA) expects this funding to help support the development of its mRNA-based pre-pandemic vaccine against the H5 influenza virus, which is responsible for causing avian influenza or bird flu.

MRNAPositive Net Change NVAXPositive Net Change CVACPositive Net Change

Zacks Equity Research

Vertex (VRTX) NDA for Vanza Triple Therapy Accepted by FDA

The FDA accepts Vertex's (VRTX) new drug application for vanza triple therapy for people living with cystic fibrosis aged six years and above. A decision is due on Jan 2, 2025.

VRTXNegative Net Change RAPTPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

Zacks Equity Research

Annovis (ANVS) Up as Its Lead Candidate Meets Goals in PD Study

Annovis (ANVS) surges 76% on Jul 2 after meeting the primary and secondary goals with statistical significance in the late-stage PD study of its lead candidate, buntanetap.

CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change ALGSPositive Net Change

Zacks Equity Research

Regeneron (REGN), SNY Win EC Approval for Dupixent for COPD

Regeneron (REGN) and partner Sanofi get approval for their blockbuster drug Dupixent for the chronic obstructive pulmonary disease indication in the EU.

REGNNegative Net Change SNYPositive Net Change NERVPositive Net Change ALXOPositive Net Change

Zacks Equity Research

SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with neurofibromatosis type 1- associated plexiform neurofibromas.

RAPTPositive Net Change ALGSPositive Net Change ACRVPositive Net Change

Sundeep Ganoria

Viking (VKTX) Skyrockets 197% YTD: Is the Stock Worth a Buy?

Despite having no marketed drugs, Viking's (VKTX) stock continues to experience robust price movement, driven by the company's encouraging progress with its pipeline.

NVOPositive Net Change LLYPositive Net Change VKTXPositive Net Change MDGLPositive Net Change