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biotechs: Archive

Zacks Equity Research

ATRA Stock Down After FDA Issues CRL for Rare Blood Cancer Candidate

Atara stock plunges 41% upon the FDA issuance of a CRL against its BLA for Ebvallo to treat EBV+ PTLD. The company is also facing a severe cash crunch.

BMRNNegative Net Change ATRANegative Net Change CTMXNegative Net Change CSTLPositive Net Change

Sundeep Ganoria

CRISPR Therapeutics Stock Falls 34% in a Year: Time to Buy or Sell?

The fall in CRSP stock can be attributed to a lack of pipeline updates. Despite securing approval for its first marketed product in early 2024, CRSP is yet to record product sales.

VRTXNegative Net Change BEAMPositive Net Change NTLANegative Net Change CRSPPositive Net Change

Zacks Equity Research

MIRM Shares Rise 12% in a Week on Robust Preliminary 2024 Results

Mirum stock rallies this week on upbeat preliminary 2024 results, the 2025 outlook and anticipated pipeline goals.

VYGRPositive Net Change CTMXNegative Net Change MIRMNegative Net Change CSTLPositive Net Change

Zacks Equity Research

Biotech Stock Roundup: MRNA, NTLA Down on Updates, SAGE Up on Biogen's Offer & Other Updates

MRNA and NTLA are down this week after providing financial and strategic updates.

REGNPositive Net Change GSKPositive Net Change MRNANegative Net Change NTLANegative Net Change

Zacks Equity Research

InflaRx Stock Rises 8% on Conditional EC Nod for COVID-19 Drug

IFRX stock gains 8% on EC nod for Gohibic, under exceptional circumstances, to treat adult patients with COVID-19-induced ARDS.

BMRNNegative Net Change CTMXNegative Net Change IFRXPositive Net Change CSTLPositive Net Change

Zacks Equity Research

ACAD Seeks EU Nod for Rett Syndrome Drug, Outlines 2025 Pipeline Goals (Revised)

Acadia files regulatory application for trofinetide to treat Rett syndrome in EU. The company also outlines other pipeline goals for 2025-2026.

ACADNegative Net Change VYGRPositive Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug

JNJ's regulatory filing seeks the FDA's approval for TAR-200, a drug-device combination for treating certain bladder cancer patients.

JNJPositive Net Change MRKPositive Net Change IBRXNegative Net Change

Sundeep Ganoria

NVO, VKTX Stocks Fall as Lilly's Zepbound, Mounjaro Sales Slow Down

Shares of several obesity drugmakers dip after LLY lowered its revenue outlook for 2024 amid slower-than-expected sales growth of its tirzepatide products in Q4.

NVOPositive Net Change LLYPositive Net Change AMGNPositive Net Change VKTXNegative Net Change

Zacks Equity Research

Kymera Provides Pipeline Objectives for 2025, Stock Gains

KYMR outlines plans to advance its immunology candidates. As of Dec. 31, 2024, KYMR had $850 million in cash that should fund its operations into mid-2027.

SNYPositive Net Change BMRNNegative Net Change CSTLPositive Net Change KYMRPositive Net Change

Zacks Equity Research

ACAD Seeks EU Nod for Rett Syndrome Drug, Outlines 2025 Pipeline Goals

Acadia files regulatory application for trofinetide to treat Rett syndrome in EU. The company also outlines other pipeline goals for 2025-2026.

ACADNegative Net Change VYGRPositive Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

MDGL Stock Down 10% on Disappointing Preliminary Q4 Rezdiffra Sales

Madrigal stock slides 10% as the preliminary Q4 Rezdiffra sales figures failed to impress investors.

BMRNNegative Net Change CTMXNegative Net Change MDGLNegative Net Change CSTLPositive Net Change

Zacks Equity Research

TGTX Announces 2024 Preliminary Results, 2025 Goals, Shares Rise

TG Therapeutics reports preliminary fourth-quarter and full-year 2024 product revenues. It also provides revenue guidance for 2025 and other pipeline goals.

TGTXNegative Net Change VYGRPositive Net Change CTMXNegative Net Change CSTLPositive Net Change

Kinjel Shah

JNJ, GSK, LLY Announce M&A Deals at JP Morgan Conference

J&J announces a big deal to acquire neuroscience company ITCI for $14.6 billion, while Lilly and GSK announce smaller deals.

GSKPositive Net Change JNJPositive Net Change LLYPositive Net Change

Zacks Equity Research

Regeneron Reports Eylea Sales, Provides Other Pipeline Updates

REGN announces business updates at the J.P. Morgan Healthcare Conference. The company also reports sales for Eylea and Eylea HD (on a preliminary basis).

REGNPositive Net Change SNYPositive Net Change RHHBYPositive Net Change BAYRYNegative Net Change

Zacks Equity Research

SWTX Announces 2024 Preliminary Results, 2025 Goals, Stock Down

SpringWorks reports preliminary fourth-quarter and full-year 2024 product revenues. It also provides updates across the commercial portfolio and other pipelines.

VYGRPositive Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

Moderna Stock Plummets 17% on 2025 Sales Guidance Slash

The crash in MRNA stock comes after the company slashed its outlook for 2024 and 2025 sales and also announced an expanded cost-cutting initiative.

MRKPositive Net Change MRNANegative Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

Blueprint Stock Soars 18% on Encouraging 2025 Growth Strategy

BPMC stock rallies 18% on the company's optimistic 2025 outlook encompassing Ayvakit sales growth and pipeline progress.

HALOPositive Net Change CTMXNegative Net Change CSTLPositive Net Change

Ekta Bagri

5 Biotech Stocks Worth Adding to Your Portfolio in 2025

New drug approvals and pipeline progress are likely to help maintain the momentum for the Zacks Biomedical and Genetics industry despite the uncertain macro environment. A strong portfolio and solid pipeline progress position INCY, BMRN, EXEL, HALO and BPMC well in this volatile sector.

INCYPositive Net Change BMRNNegative Net Change EXELNegative Net Change HALOPositive Net Change

Zacks Equity Research

Intra-Cellular Therapies Stock Up 34% on J&J's $14.6B Buyout Offer

JNJ is set to acquire ITCI for $132 per share in cash. The transaction is likely to close before this year's end.

JNJPositive Net Change SDZNYNegative Net Change

Zacks Equity Research

Biogen Offers to Buy Remaining Stake in Sage Therapeutics

Biogen offers to buy the remaining stake in Sage Therapeutics for $7.22 per share. SAGE stock rises.

BIIBNegative Net Change PBYIPositive Net Change CSTLPositive Net Change

Zacks Equity Research

ITCI Stock Rises 15% on Settling Caplyta Patent Litigation With Sandoz

Intra-Cellular stock gains 15% as it settles Caplyta patent litigation with Sandoz protecting the drug's exclusivity in the United States till July 1, 2040.

CTMXNegative Net Change CSTLPositive Net Change SDZNYNegative Net Change

Zacks Equity Research

Amicus Posts Preliminary 2024 Results, Issues 2025 Outlook

FOLD reports preliminary fourth-quarter and full-year 2024 total revenues. The company also outlines key strategic goals for 2025.

TEVAPositive Net Change FOLDNegative Net Change CTMXNegative Net Change CSTLPositive Net Change

Zacks Equity Research

ALNY Announces Preliminary 2024 Results, 2025 View & Pipeline Goals

Alnylam reports preliminary fourth-quarter and full-year 2024 product revenues. The company expects to deliver adjusted operating income profitability in 2025.

REGNPositive Net Change ALNYPositive Net Change RHHBYPositive Net Change PBYIPositive Net Change

Zacks Equity Research

Exelixis Provides Preliminary 2024 Results and Outlook for 2025

EXEL reports preliminary 2024 revenues. The company also provides guidance for 2025 and other pipeline updates.

BMYNegative Net Change MRKPositive Net Change EXELNegative Net Change IMCRPositive Net Change

Zacks Equity Research

Pfizer Meets Goal in Non-Muscle Invasive Bladder Cancer Study

Data from a late-stage study shows that treatment with PFE's PD-1 inhibitor when added to BCG improves outcomes in certain bladder cancer patients.

PFENegative Net Change MRKPositive Net Change CSTLPositive Net Change ERASNegative Net Change