Back to top

biotechs: Archive

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.

AZNNegative Net Change ANIPNegative Net Change CRMDNegative 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.

SNYNegative Net Change ANIPNegative Net Change CRMDNegative 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.

SNYNegative Net Change TEVANegative Net Change FOLDNegative 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.

ANIPNegative Net Change CRMDNegative 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.

MRNANegative Net Change ANIPNegative Net Change CRMDNegative 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 LLYNegative Net Change ABBVNegative 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.

GSKNegative Net Change GILDNegative Net Change FOLDNegative Net Change CRMDNegative 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.

GSKNegative Net Change JNJPositive Net Change ANIPNegative Net Change CRMDNegative 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.

NVONegative Net Change LLYNegative Net Change VKTXNegative Net Change GPCRPositive 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.

GSKNegative Net Change ANIPNegative Net Change CRMDNegative 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.

GILDNegative Net Change FOLDNegative Net Change CRMDNegative 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.

BMYNegative Net Change PFENegative Net Change MRKNegative 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.

PFENegative Net Change NVONegative Net Change LLYNegative Net Change VKTXNegative 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.

NVONegative Net Change LLYNegative Net Change VKTXNegative Net Change GPCRPositive 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 BMYNegative Net Change MRKNegative Net Change

Zacks Equity Research

Kymera's Eczema Drug Gets Fast Track Designation in the United States

KYMR gains momentum as the FDA grants Fast Track to KT-621 for moderate to severe atopic dermatitis, boosting the stock and advancing its Type 2 pipeline.

SNYNegative Net Change GILDNegative Net Change KYMRNegative Net Change

Zacks Equity Research

GSK Gets FDA Nod for Blujepa in Uncomplicated Urogenital Gonorrhea

GSK wins FDA approval for Blujepa, a new oral antibiotic treatment option for uncomplicated urogenital gonorrhea.

GSKNegative Net Change ANIPNegative Net Change CRMDNegative Net Change CSTLNegative Net Change

Sundeep Ganoria

Here's How AMGN Benefits From FDA Nod to Uplizna in Myasthenia Gravis

AMGN gains momentum as Uplizna wins FDA approval for generalized myasthenia gravis, adding a twice-yearly dosing option in a crowded autoimmune market.

JNJPositive Net Change AMGNNegative Net Change ARGXPositive Net Change

Zacks Equity Research

GSK's Risvutatug Rezetecan Gets FDA's Orphan Drug Tag in Lung Cancer

GSK gains FDA Orphan Drug Designation for risvutatug rezetecan, adding momentum to its fast-advancing solid-tumor pipeline.

GSKNegative Net Change ANIPNegative Net Change CRMDNegative Net Change CSTLNegative Net Change

Kanishka Das

CRMD Up More Than 40% YTD: Time to Buy, Sell or Hold the Stock?

CorMedix surges on strong DefenCath uptake as sales climb while the Melinta acquisition expands and diversifies its commercial portfolio.

PFENegative Net Change AMPHNegative Net Change CRMDNegative Net Change

Zacks Equity Research

Roche's Breast Cancer Drug Cuts Risk of Death by 30% in Phase III

RHHBY's giredestrant cuts the risk of invasive disease recurrence or death by 30% in phase III, fueling momentum for a next-generation endocrine therapy.

RHHBYNegative Net Change LLYNegative Net Change ANIPNegative Net Change CRMDNegative Net Change

Ahan Chakraborty

Can Eli Lilly Sustain Its Obesity Momentum as Newer Players Emerge?

LLY leans on tirzepatide and a deep late-stage pipeline to defend its obesity momentum as new rivals make rapid progress in the development of their GLP-1 therapies.

NVONegative Net Change LLYNegative Net Change GPCRPositive Net Change

Zacks Equity Research

Implied Volatility Surging for ANI Pharmaceuticals Stock Options

Investors need to pay close attention to ANIP stock based on the movements in the options market lately.

ANIPNegative Net Change

Zacks Equity Research

WVE Stock Surges More Than 180% in a Week: What Is Driving This Rally?

Wave Life Sciences' shares jump 183% as early INLIGHT data on weight-loss drug WVE-007 show notable visceral fat cuts and gains in lean mass.

NVONegative Net Change LLYNegative Net Change WVENegative Net Change

Sundeep Ganoria

Here's How AbbVie's Oncology Drugs are Aiding Top-line Growth

ABBV's expanding oncology lineup, spanning new solid tumor drugs and rising Venclexta sales, is helping drive steady top-line growth.

AZNNegative Net Change PFENegative Net Change MRKNegative Net Change ABBVNegative Net Change