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biotechs: Archive

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.

PFEPositive Net Change MRNANegative Net Change NVAXNegative Net Change BNTXPositive Net Change

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.

AZNNegative Net Change RHHBYNegative Net Change PFEPositive Net Change BAYRYPositive Net Change

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.

NVSPositive Net Change PFEPositive Net Change MRKPositive Net Change GILDPositive Net Change

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.

NVOPositive Net Change LLYNegative Net Change CRBPNegative Net Change SKYENegative 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.

REGNPositive Net Change BAYRYPositive Net Change HALOPositive Net Change AMRNNegative Net Change

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.

BMYPositive Net Change BAYRYPositive Net Change EXELPositive Net Change AMRNNegative Net Change

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.

BMYPositive Net Change CRMDNegative Net Change IMCRPositive Net Change

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.

BMRNNegative Net Change MRNANegative Net Change NVAXNegative Net Change PRMEPositive Net Change

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.

SNYNegative Net Change PFEPositive Net Change MRNANegative Net Change NVAXNegative Net Change

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.

JNJPositive Net Change MRKPositive Net Change IBRXPositive Net Change CGONPositive Net Change

Zacks Equity Research

ARMP Soars 72% in a Month Following Infectious Disease Study Success

Armata Pharmaceuticals stock surges 72% in a month following superior efficacy results from a phase Ib/IIa study of AP-SA02 for treating an infectious disease.

BAYRYPositive Net Change HALOPositive Net Change AMRNNegative Net Change ARMPPositive Net Change

Kinjel Shah

AMGN Down 10% in 3 Months: How to Play the Stock as Tariff Woes Linger

AMGN's consistent top-line growth, an interesting pipeline and rising estimates are good enough reasons to stay invested in the stock for now.

JNJPositive Net Change NVOPositive Net Change LLYNegative Net Change AMGNPositive Net Change

Sundeep Ganoria

MRNA, PFE Stocks Jump Despite FDA's Stricter Standards for COVID-19 Shots

Though the new FDA rules limit access to COVID-19 booster vaccines, the commitment to high-risk groups lifts Moderna, Pfizer and BioNTech stocks.

PFEPositive Net Change MRNANegative Net Change BNTXPositive Net Change

Ekta Bagri

Gilead Sciences vs GSK: Which HIV Drugmaker is a Smarter Buy Now?

At current levels, we recommend prospective investors to opt for GSK as compared to GILD on the back of a strong and wide portfolio, upcoming product launches, promising pipeline candidates and recent positive estimate revisions

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Zacks Equity Research

BIAF Stock Rises Post Q1 Earnings Despite Revenue Decline

bioAffinity's first-quarter 2025 results show CyPath Lung sales growth and cost cuts despite a drop in total revenues and a wider quarterly net loss.

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Zacks Equity Research

CRISPR Therapeutics Inks Collaboration Deal to Develop siRNA Therapies

CRSP enters into a strategic partnership with Sirius Therapeutics for developing novel siRNA Therapies.

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Zacks Equity Research

REGN Signs $256M Buyout Deal With 23andMe to Boost Genomics Research

Regeneron is set to acquire 23andMe assets for $256 million to boost genetic drug discovery. The transaction is expected to close by third-quarter 2025.

REGNPositive Net Change BAYRYPositive Net Change HALOPositive Net Change ALLONegative Net Change

Ekta Bagri

Amgen vs Bristol Myers: Which Biotech Giant Has Better Prospects?

At current levels, we believe AMGN scores above BMY, buoyed by solid fundamentals and recent positive estimate revisions.

BMYPositive Net Change AMGNPositive Net Change

Zacks Equity Research

Novo Nordisk Shares Dip 3% on Sudden CEO Transition Announcement

NVO stock declines 3% as the company announces that Lars Fruergaard Jorgensen will be stepping down as the CEO.

NVOPositive Net Change LLYNegative Net Change AMGNPositive Net Change VKTXPositive Net Change

Zacks Equity Research

NVAX Stock Surges on Securing FDA Approval for COVID-19 Vaccine

The FDA grants full approval to Novavax's protein-based COVID-19 vaccine after nearly a two-month delay, albeit with some new conditions.

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Zacks Equity Research

ACAD Stock Soars as US Court Rules in Favor of Key Nuplazid Patent

Acadia stock jumps 27% after winning a key patent case for Nuplazid, which will protect the drug's U.S. sales from generic erosion till 2038.

BAYRYPositive Net Change HALOPositive Net Change ACADPositive Net Change NTLANegative Net Change

Zacks Equity Research

BioMarin Offers to Buy Inozyme for $270M to Boost Enzyme Therapy Biz

BMRN's acquisition of INZY is set to add a late-stage enzyme replacement therapy for a rare genetic condition. The deal is likely to be closed by September.

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Zacks Equity Research

Incyte Gets FDA Approval for Zynyz in New Cancer Indication

The FDA approves INCY's Zynyz both as monotherapy and in combination with chemotherapy for treating advanced anal cancer.

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