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biotechs: Archive
AZN, Daiichi's Enhertu Gets FDA Nod for First-Line Breast Cancer
by Zacks Equity Research
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
biotechs
SNY Stock Down on Double Trouble With Multiple Sclerosis Drug
by Zacks Equity Research
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
biotechs medical pharmaceuticals
FOLD Shares Hit 52-Week High: Time to Buy, Sell or Hold the Stock?
by Zacks Equity Research
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
biotechs
KYTX Stock Rallies 23% on Upbeat Stiff Person Syndrome Study Data
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
CHMP Backs EU Approval of MRNA's New COVID-19 Vaccine mNexspike
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals vaccines
How AbbVie's Pipeline Is Lining Up Key Product Launches
by Sundeep Ganoria
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
biotechs medical pharmaceuticals
GILD's Bictegravir and Lenacapavir Regimen for HIV Meets Primary Goal
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
FDA Approves J&J's Akeega for Expanded Use in Prostate Cancer
by Zacks Equity Research
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
biotechs medical
CHMP Backs Higher-Dose Wegovy as Novo Nordisk Seeks 2026 EU Approval
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
GSK's Nucala for COPD and Depemokimab for Asthma Get CHMP Nod in EU
by Zacks Equity Research
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
biotechs medical
RCUS Stock Down on Decision to Discontinue GILD Partnered Study
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
BMY Gains 13.1% in Three Months: Buy, Sell or Hold the Stock?
by Ekta Bagri
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
biotechs medical pharmaceuticals
Eli Lilly's Next-Generation Obesity Drug Secures First Phase III Win
by Zacks Equity Research
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
biotechs medical pharmaceuticals
NVO Down 42% Year to Date: Is This an Indication to Sell the Stock?
by Ahan Chakraborty
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
biotechnology biotechs medical pharmaceuticals
Can Opdivo's Label Expansions Help Bristol Myers Sustain Its Momentum?
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Kymera's Eczema Drug Gets Fast Track Designation in the United States
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
GSK Gets FDA Nod for Blujepa in Uncomplicated Urogenital Gonorrhea
by Zacks Equity Research
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
biotechs
Here's How AMGN Benefits From FDA Nod to Uplizna in Myasthenia Gravis
by Sundeep Ganoria
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
biotechs medical pharmaceuticals
GSK's Risvutatug Rezetecan Gets FDA's Orphan Drug Tag in Lung Cancer
by Zacks Equity Research
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
biotechs medical
CRMD Up More Than 40% YTD: Time to Buy, Sell or Hold the Stock?
by Kanishka Das
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
biotechs
Roche's Breast Cancer Drug Cuts Risk of Death by 30% in Phase III
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Can Eli Lilly Sustain Its Obesity Momentum as Newer Players Emerge?
by Ahan Chakraborty
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
biotechnology biotechs medical pharmaceuticals
Implied Volatility Surging for ANI Pharmaceuticals Stock Options
by Zacks Equity Research
Investors need to pay close attention to ANIP stock based on the movements in the options market lately.
ANIPNegative Net Change
biotechnology biotechs medical
WVE Stock Surges More Than 180% in a Week: What Is Driving This Rally?
by Zacks Equity Research
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
biotechs medical pharmaceuticals
Here's How AbbVie's Oncology Drugs are Aiding Top-line Growth
by Sundeep Ganoria
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
biotechs medical pharmaceuticals