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biotechs: Archive

Zacks Equity Research

Will Strong Livmarli Uptake Continue to Aid MIRM's Revenues in 2026?

Mirum's Livmarli sales surge 70% in the first nine months of 2025. Expanding approvals and commercialization are set to fuel revenue momentum into 2026.

GSKPositive Net Change MIRMPositive Net Change TVTXPositive Net Change

Ahan Chakraborty

Can Higher-Dose Wegovy Help Novo Nordisk Regain Obesity Market Share?

NVO seeks approval for a 7.2 mg Wegovy dose after study data showed stronger weight loss that can challenge Zepbound's U.S. momentum.

NVOPositive Net Change LLYPositive Net Change VKTXPositive Net Change

Zacks Equity Research

EC Approves Label Expansion of INCY's Lymphoma Drug Minjuvi

INCY wins EC approval expanding Minjuvi's label, adding a new indication for relapsed or refractory follicular lymphoma after prior therapy.

NVSNegative Net Change QGENNegative Net Change INCYNegative Net Change

Zacks Equity Research

PCSA Stock Soars on Upbeat Clinical Update From Breast Cancer Study

Processa Pharmaceuticals stock jumps 122% after a phase II update shows NGC-Cap delivers higher active metabolite exposure with comparable safety in breast cancer.

RHHBYNegative Net Change CRMDPositive Net Change PCSAPositive Net Change CSTLNegative Net Change

Zacks Equity Research

INSM Stock Plummets on Sinus Study Failure, Adds New Pipeline Asset

Insmed sinks nearly 20% after Brinsupri failed a phase IIb sinus study, while the company adds a new monoclonal antibody asset to expand its pipeline.

INSMPositive Net Change ANIPPositive Net Change CRMDPositive Net Change

Ekta Bagri

5 Biotech Stocks to Watch for Potential Upside

New drug approvals and encouraging pipeline progress should maintain momentum in the Zacks Biomedical and Genetics industry despite the uncertain macroeconomic environment. A strong portfolio and solid pipeline progress position ARQT, FOLD, ANIP, TNGX and PCRX in this volatile sector.

ARQTPositive Net Change FOLDPositive Net Change PCRXPositive Net Change ANIPPositive Net Change TNGXPositive Net Change

Kanishka Das

CRMD vs. PBYI: Which Small-Cap Biotech Stock Is the Better Buy?

CorMedix's DefenCath sales and Melinta deal raise growth stakes while Puma Biotechnology's Nerlynx-led breast cancer franchise aids growth.

PFEPositive Net Change PBYIPositive Net Change CRMDPositive Net Change

Zacks Equity Research

GSK's Exdensur Gets FDA Nod for Severe Asthma Treatment

GSK secures FDA approval for Exdensur, the first twice-yearly biologic for treating severe asthma with an eosinophilic phenotype.

GSKPositive Net Change ANIPPositive Net Change CRMDPositive Net Change CSTLNegative Net Change

Sundeep Ganoria

Pfizer Issues Soft 2026 View: What Does It Mean for the Stock's Future?

PFE's soft 2026 outlook spooks investors, with revenue and EPS guidance trailing expectations as COVID-19 demand fades and patent losses mount.

PFEPositive Net Change NVOPositive Net Change LLYPositive Net Change SMMTPositive Net Change

Zacks Equity Research

RZLT Stock Plummets 79% Month to Date: Here's What You Need to Know

Rezolute shares collapse 79% so far in December after a phase III hyperinsulinism study of its only pipeline candidate miss primary and key secondary endpoints.

ANIPPositive Net Change CRMDPositive Net Change RZLTPositive Net Change CSTLNegative Net Change

Zacks Equity Research

AZN, Daiichi's Enhertu Gets FDA Nod for First-Line Breast Cancer

AstraZeneca's Enhertu wins FDA nod as a first-line treatment for HER2-positive metastatic breast cancer.

AZNPositive Net Change ANIPPositive Net Change CRMDPositive Net Change CSTLNegative Net Change

Zacks Equity Research

SNY Stock Down on Double Trouble With Multiple Sclerosis Drug

Sanofi shares slide after the FDA again delays its review of its MS drug tolebrutinib, and a phase III study fails to hit its primary endpoint.

SNYPositive Net Change ANIPPositive Net Change CRMDPositive Net Change

Zacks Equity Research

FOLD Shares Hit 52-Week High: Time to Buy, Sell or Hold the Stock?

Amicus hits a 52-week high after an 87.6% six-month surge, driven by strong Galafold sales and rising uptake of Pombiliti + Opfolda.

SNYPositive Net Change TEVAPositive Net Change FOLDPositive Net Change

Zacks Equity Research

KYTX Stock Rallies 23% on Upbeat Stiff Person Syndrome Study Data

Kyverna Therapeutics shares jump 23% after a registrational phase II study of miv-cel meets primary and all secondary efficacy goals for treating stiff person syndrome.

ANIPPositive Net Change CRMDPositive Net Change CSTLNegative Net Change KYTXPositive Net Change

Zacks Equity Research

CHMP Backs EU Approval of MRNA's New COVID-19 Vaccine mNexspike

CHMP backs EU approval of Moderna's next-generation mNexspike COVID-19 vaccine, with a final European Commission decision expected shortly.

MRNAPositive Net Change ANIPPositive Net Change CRMDPositive Net Change CSTLNegative Net Change

Sundeep Ganoria

How AbbVie's Pipeline Is Lining Up Key Product Launches

ABBV is lining up multiple late-stage launches, from Rinvoq label expansions to Parkinson???s and oncology assets nearing FDA decisions.

JNJPositive Net Change LLYPositive Net Change ABBVPositive Net Change

Zacks Equity Research

GILD's Bictegravir and Lenacapavir Regimen for HIV Meets Primary Goal

Gilead said its once-daily bictegravir/lenacapavir tablet met non-inferiority vs Biktarvy in phase III ARTISTRY-2, paving the way for filings.

GSKPositive Net Change GILDPositive Net Change FOLDPositive Net Change CRMDPositive Net Change

Zacks Equity Research

FDA Approves J&J's Akeega for Expanded Use in Prostate Cancer

JNJ secures FDA approval to expand Akeega into earlier-stage prostate cancer, backed by strong phase III data and a first-of-its-kind precision combo.

GSKPositive Net Change JNJPositive Net Change ANIPPositive Net Change CRMDPositive Net Change

Zacks Equity Research

CHMP Backs Higher-Dose Wegovy as Novo Nordisk Seeks 2026 EU Approval

NVO gains CHMP backing for a higher-dose Wegovy, paving the way for potential EU approval in 2026 as study data show stronger weight loss.

NVOPositive Net Change LLYPositive Net Change VKTXPositive Net Change GPCRNegative Net Change

Zacks Equity Research

GSK's Nucala for COPD and Depemokimab for Asthma Get CHMP Nod in EU

GSK gets CHMP backing for Nucala in COPD and depemokimab in asthma, setting up possible Europe approvals in 2026 for IL-5 therapies.

GSKPositive Net Change ANIPPositive Net Change CRMDPositive Net Change CSTLNegative Net Change

Zacks Equity Research

RCUS Stock Down on Decision to Discontinue GILD Partnered Study

Arcus halts the late-stage STAR-221 study for futility, dealing a setback to its domvanalimab program with Gilead. Stock down.

GILDPositive Net Change FOLDPositive Net Change CRMDPositive Net Change RCUSPositive Net Change

Ekta Bagri

BMY Gains 13.1% in Three Months: Buy, Sell or Hold the Stock?

BMY shares are rebounding after a strong Q3, lifted by rising demand for Opdivo, Reblozyl and Camzyos, even as legacy drugs face generic pressure.

BMYPositive Net Change PFEPositive Net Change MRKPositive Net Change

Zacks Equity Research

Eli Lilly's Next-Generation Obesity Drug Secures First Phase III Win

LLY's retatrutide posts strong weight-loss and pain-reduction results in its first Phase III study, boosting investor optimism.

PFEPositive Net Change NVOPositive Net Change LLYPositive Net Change VKTXPositive Net Change

Ahan Chakraborty

NVO Down 42% Year to Date: Is This an Indication to Sell the Stock?

Novo Nordisk stock plunges 42% so far in 2025 as GLP-1 competition, price cuts, guidance trims and restructuring plans cloud growth and elevate execution risks.

NVOPositive Net Change LLYPositive Net Change VKTXPositive Net Change GPCRNegative Net Change

Zacks Equity Research

Can Opdivo's Label Expansions Help Bristol Myers Sustain Its Momentum?

BMY gets a priority FDA review for Opdivo's use in previously untreated advanced Hodgkin lymphoma, reinforcing its oncology momentum.

RHHBYNegative Net Change BMYPositive Net Change MRKPositive Net Change