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biotechs: Archive

Zacks Equity Research

SPRO Stock Soars 245% on GSK-Partnered UTI Drug Meeting Study Goal

SPRO shares surge after GSK-partnered oral drug hits phase III goal early, paving the way for FDA filing and a shift in cUTI treatment options.

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Zacks Equity Research

U.S. Govt. Cancels $766M Funding Contract for Moderna's Bird Flu Shot

The government scraps funding deal for MRNA's bird flu shot, despite encouraging safety and efficacy data from early clinical studies on the vaccine.

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Zacks Equity Research

CADL Up as FDA Grants RMAT Status to CAN-2409 in Prostate Cancer

Candel stock rises as FDA grants RMAT tag to CAN-2409 after phase III success in prostate cancer. BLA submission is planned at the end of 2026.

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Ekta Bagri

Bristol Myers Loses 20.7% in 3 Months: Buy, Sell or Hold the Stock?

BMY slides 20.7% in 3 months despite strong Q1 and raised outlook, as generic pressure and pipeline setbacks weigh on investor sentiment.

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Zacks Equity Research

Eli Lilly to Expand Pain Pipeline With $1B SiteOne Buyout Offer

LLY inks $1B deal to acquire SiteOne, adding phase II-ready pain drug STC-004 to strengthen its neuroscience pipeline.

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Zacks Equity Research

RCKT Stock Tanks on Patient Death in Danon Disease Study

Rocket Pharmaceuticals plunges after a patient death in its Danon disease study, prompting a voluntary dosing pause. The FDA puts a clinical hold on the study.

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Zacks Equity Research

VSTM Stock Soars 22% in a Month on Ovarian Cancer Combo Drug Approval

Verastem Oncology jumps 22% on FDA nod for Avmapki Fakzynja, the first approved KRAS-mutant LGSOC therapy, with strong early data in a pancreatic cancer study.

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Ekta Bagri

ADMA Biologics vs. Grifols: Which Plasma Therapy Stock Is the Better Buy?

At current levels, GRFS scores over ADMA with cheaper valuation, a broad portfolio, and strong EPS growth estimates despite the latter's robust Asceniv-driven momentum.

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Sundeep Ganoria

Novo Nordisk vs. Viking Therapeutics: Which GLP-1 Stock Has More Upside?

With VKTX surging on clinical results and NVO investing to cement market share, investors face a high-stake GLP-1 showdown.

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Zacks Equity Research

AZN Gets CHMP Nod for Imfinzi in Muscle-Invasive Bladder Cancer

AstraZeneca wins CHMP nod for Imfinzi combo in muscle-invasive bladder cancer, based on data from the phase III NIAGARA study.

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Zacks Equity Research

Prothena's Late-Stage Study for AL Amyloidosis Fails, Stock Down

PRTA shares drop 22% after ending birtamimab development as a phase III study fails to meet primary or secondary endpoints in AL amyloidosis.

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Ahan Chakraborty

RXRX vs. SDGR: Which AI-Powered Drug Discovery Stock Has More Upside?

Recursion Pharmaceuticals and Schrodinger leverage their respective AI drug discovery platforms to potentially develop distinguished therapeutic candidates.

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Zacks Equity Research

GSK Gets CHMP Nod for Blenrep Combos in Multiple Myeloma

GSK wins CHMP nod for Blenrep combos in relapsed or refractory multiple myeloma. A decision in the EU is expected in the third quarter of 2025.

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Zacks Equity Research

SpringWorks Gets CHMP Nod for Mirdametinib in Rare Disease

SWTX wins CHMP backing for mirdametinib in NF1-PN. EU nod is expected in the third quarter of 2025.

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Zacks Equity Research

MRNA Seeks FDA Nod for Updated COVID-19 Vaccine

Moderna files with FDA for updated Spikevax aimed at the LP.8.1 variant, which makes up 70% of U.S. COVID-19 cases.

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Zacks Equity Research

Roche Gets CHMP Nod for Itovebi Combo in the EU for Breast Cancer

RHHBY's Itovebi combo wins CHMP backing for PIK3CA-mutated breast cancer, showing strong survival benefits in phase III INAVO120 study.

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Zacks Equity Research

GILD Announces Positive Data on Trodelvy in First-Line Breast Cancer

Gileads Trodelvy shows significant improvement in PFS in phase III ASCENT-03 trial for first-line metastatic TNBC, reinforcing potential as backbone therapy.

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Sundeep Ganoria

3 Stocks Targeting Weight Loss Market With Cannabinoid-Based Therapies

NVO, CRBP and SKYE are tapping into the booming obesity market with novel CBD-based therapies, offering alternatives amid intensifying GLP-1 competition.

NVONegative Net Change LLYNegative Net Change CRBPPositive Net Change SKYEPositive Net Change

Zacks Equity Research

Bayer Gets CHMP Nod for Eylea 8 mg in the EU for 2 Major Eye Diseases

BAYRY's Eylea 8 mg gets CHMP nod in EU, promising 6-month dosing for nAMD and DME with strong 3-year efficacy and safety data.

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Zacks Equity Research

EXEL Reports Superior Efficacy Data From Kidney Cancer Study Cohort

Exelixis' zanzalintinib/Opdivo combo shows superior efficacy for treating kidney cancer in an expansion cohort of the phase Ib/II STELLAR-002 study.

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Zacks Equity Research

Is it a Good Idea to Invest in Immunocore Stock Right Now?

IMCR revenues surge on robust Kimmtrak sales performance. The momentum is likely to continue in 2025.

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Zacks Equity Research

FDA Approves GSK's Nucala for Expanded Use in COPD

GSK's Nucala wins FDA nod for COPD with eosinophilic phenotype, marking its fifth indication and strengthening its respiratory portfolio.

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Ekta Bagri

Biotech Stock Roundup: BMRN to Acquire INZY, NVAX Gains on Vaccine Approval & More

BMRN and NVAX are in the spotlight this week following announcement agreement and regulatory update.

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Zacks Equity Research

MRNA Stock Down on Withdrawal of FDA Filing for COVID-Flu Combo Shot

Moderna's voluntary withdrawal of the filing stems from the FDA's request for vaccine efficacy data from a phase III study on the experimental flu shot.

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Zacks Equity Research

CGON Stock Rallies 27% in a Month on Bladder Cancer Study Success

CG Oncology stock surges 27% in a month following superior efficacy data from its phase III study of cretostimogene for a bladder cancer indication.

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