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biotechs: Archive

Zacks Equity Research

Alnylam (ALNY) Amvuttra & Givlaari Fuel Revenues Amid Competition

Alnylam's (ALNY) Amvuttra and Givlaari sales continue to boost revenues. However, its reliance on collaboration partners and stiff competition remain concerns.

REGNNegative Net Change ALNYPositive Net Change NVSNegative Net Change RHHBYPositive Net Change

Zacks Equity Research

Galapagos (GLPG) Up on FDA Nod to Begin Phase I/II Lymphoma Study

Galapagos (GLPG) rises in pre-market hours on Aug 23, after the FDA nod to begin early to mid-stage study of GLPG5101 for non-Hodgkin lymphoma patients.

ARCTNegative Net Change GLPGPositive Net Change FULCNegative Net Change BVSNegative Net Change

Madhurima Das

Energy Fuels (UUUU) Enters Medical Isotope Market: Buy the Stock?

Energy Fuels (UUUU) buys RadTran to leverage know-how to produce medical isotopes used in cancer treatments. Let us find out whether this can boost the stock.

CCJPositive Net Change UUUUPositive Net Change UECNegative Net Change

Zacks Equity Research

Lexicon (LXRX) Up as FDA Maintains Action Date for Zynquista

The FDA plans to hold an Advisory Committee meeting to give a recommendation for Lexicon's (LXRX) Zynquista (sotagliflozin) on Oct 31, 2024. Stock up.

ILMNPositive Net Change LXRXNegative Net Change FULCNegative Net Change BVSNegative Net Change

Zacks Equity Research

Bristol Myers' (BMY) HCC Combo Drug Accepted for FDA Review

Bristol Myers' (BMY) application seeking approval for the Opdivo/Yervoy combo to treat unresectable hepatocellular carcinoma gets accepted for FDA review.

AZNPositive Net Change BMYNegative Net Change ILMNPositive Net Change ARCTNegative Net Change

Zacks Equity Research

Amicus (FOLD) Banks on Galafold, High Dependence a Concern

Amicus' (FOLD) lead drug, Galafold, is witnessing solid sales uptake so far. The approval for Pombiliti + Opfolda also aids sales. However, overdependence on Galafold for revenues remains a concern.

ILMNPositive Net Change FOLDNo Net Change FULCNegative Net Change BVSNegative Net Change

Zacks Equity Research

Dr. Reddy's (RDY), Kainomyx Sign Potential Deal for Malaria Drug

Dr. Reddy's (RDY) is gearing up to potentially collaborate with Kainomyx to jointly develop an affordable anti-malarial drug.

RDYPositive Net Change ILMNPositive Net Change ARCTNegative Net Change HLNPositive Net Change

Zacks Equity Research

Xenon (XENE) Focuses on Neuro Candidate Amid Pipeline Woe

Xenon's (XENE) clinical studies of azetukalner in epilepsy and other neurological disorders are progressing well. However, any setback is set to hurt the stock in the absence of a deep pipeline.

ILMNPositive Net Change NBIXPositive Net Change ARCTNegative Net Change XENENegative Net Change

Zacks Equity Research

Lilly (LLY) Up 3% on Obesity Drug Cutting Diabetes Risk

Eli Lilly (LLY) reports data from a late-stage study that found that long-term treatment with Zepbound reduces the risk of progression to type 2 diabetes by 94%.

NVOPositive Net Change LLYNegative Net Change AMGNNegative Net Change VKTXPositive Net Change

Zacks Equity Research

J&J (JNJ) Gets FDA Nod for Chemotherapy-Free Lung Cancer Therapy

The approval is based on late-stage study data wherein treatment with J&J's (JNJ) Rybrevant plus Lazcluze cut the risk of disease progression or death by 30% in certain NSCLC patients.

AZNPositive Net Change JNJPositive Net Change ARCTNegative Net Change FULCNegative Net Change

Ekta Bagri

Biotech Stock Roundup: CRL for REGN, GILD's Drug Approval, LQDA Down on News

Bigwigs Regeneron (REGN) and Gilead Sciences (GILD) are in the spotlight following regulatory updates and drug approval, respectively.

REGNNegative Net Change GILDNegative Net Change INCYNegative Net Change LQDAPositive Net Change

Zacks Equity Research

Regeneron (REGN) Gets CRL From FDA for Multiple Myeloma Drug

Regeneron (REGN) suffers a delay in obtaining FDA approval of linvoseltamab for the treatment of relapsed/refractory multiple myeloma.

REGNNegative Net Change SNYPositive Net Change BAYRYPositive Net Change

Zacks Equity Research

Bristol Myers' (BMY) Breyanzi Label Expansion Application Validated

Bristol Myers' (BMY) application to expand Breyanzi's label for the treatment of adult patients with relapsed or refractory follicular lymphoma gets EMA validation.

BMYNegative Net Change BMRNNegative Net Change KRYSNegative Net Change

Zacks Equity Research

Kymera (KYMR) to Raise $225 Million Through Offering of Shares

Kymera (KYMR) is in the process of selling approximately 2 million shares of common stock at a public offering price of $40.75 per share, along with pre-funded warrants to purchase 3,519,159 shares in the offering.

SNYPositive Net Change BMYNegative Net Change KRYSNegative Net Change KYMRPositive Net Change

Andrew Rocco

Massive Weight Loss Market: Viking (VKTX) is Best-in-Breed

Viking Therapeutics (VKTX) has developed a best-in-breed GLP-1 drug. The company is poised to gain a large portion of the massive weight loss drug market.

NVOPositive Net Change LLYNegative Net Change SBUXPositive Net Change MCDPositive Net Change SHAKNegative Net Change

Zacks Equity Research

Liquidia (LQDA) Down on FDA Delaying Full Approval for Yutrepia

The FDA grants tentative approval to Liquidia's (LQDA) inhaled powder for two lung disorder indications. Full approval may be granted after May 2025, when the regulatory exclusivity of a competing product expires.

UTHRPositive Net Change ARCTNegative Net Change LQDAPositive Net Change FULCNegative Net Change

Zacks Equity Research

GSK's ADC Drug for Lung Cancer Gets FDA's Breakthrough Tag

The FDA bestows a Breakthrough Therapy Designation to GSK's B7-H3-targeted antibody-drug conjugate, GSK5764227, for relapsed/refractory extensive-stage small-cell lung cancer.

GSKNegative Net Change ILMNPositive Net Change FULCNegative Net Change BVSNegative Net Change

Zacks Equity Research

AbbVie (ABBV) Gets Nod in EU for Lymphoma Drug's Expanded Use

AbbVie's (ABBV) Tepkinly gets conditional approval in the EU to treat third-line patients with relapsed or refractory follicular lymphoma as a second indication.

ILMNPositive Net Change ARCTNegative Net Change ABBVNegative Net Change GMABPositive Net Change

Sundeep Ganoria

CRISPR (CRSP) Loses 24% YTD: How Should You Play the Stock?

Despite gaining regulatory approvals in many countries for the first ever CRISPR-based gene therapy, investors should remain wary of investing in CRISPR Therapeutics' (CRSP) early-stage pipeline.

VRTXNegative Net Change BEAMNegative Net Change EDITNegative Net Change CRSPNegative Net Change

Ekta Bagri

ADMA Biologics (ADMA) Hits 52-Week High: More Room to Grow?

The ADMA Biologics (ADMA) stock surges in a month on impressive second-quarter results. It has recently hit its 52-week high with more room for growth.

GRFSNegative Net Change ADMAPositive Net Change TAKPositive Net Change

Andrew Rocco

WHO Declares Monkeypox Public Emergency: 5 Mpox Stocks to Watch

Is the next pandemic here. With health officials declaring Monkeypox a public health emergency, investors need to be watching Monkeypox-related stocks.

APDNPositive Net Change TNXPNegative Net Change EBSPositive Net Change GOVXNegative Net Change VRAXNegative Net Change

Zacks Equity Research

Mirum (MIRM) Banks on Livmarli, Overdependence a Concern

Mirum's (MIRM) lead drug, Livmarli, continues to generate steady sales. The recent label expansion of the drug should drive sales further. However, overdependence on Livmarli for revenues is a concern.

ILMNPositive Net Change FULCNegative Net Change MIRMNegative Net Change

Zacks Equity Research

AN2 Therapeutics (ANTX) Plunges 66% in a Month: Here's Why

AN2 Therapeutics (ANTX) falls 66% in a month after terminating its mycobacterium avium complex lung disease study of epetraborole due to unsatisfactory efficacy results.

ILMNPositive Net Change ARCTNegative Net Change ANTXPositive Net Change FULCNegative Net Change

Zacks Equity Research

Gilead (GILD) Obtains FDA Approval for PBC Drug Livdelzi

Gilead (GILD) wins FDA nod for seladelpar for the treatment of primary biliary cholangitis (PBC) on an accelerated basis.

GSKNegative Net Change BMYNegative Net Change GILDNegative Net Change KRYSNegative Net Change

Zacks Equity Research

Incyte (INCY) Announces Data on Monjuvi, FDA Approval for GVHD Drug

Incyte???s (INCY) late-stage study on tafasitamab for patients with relapsed or refractory follicular lymphoma meets its goal. FDA approves axatilimab for the treatment of chronic graft-versus-host disease.

NVSNegative Net Change INCYNegative Net Change SNDXPositive Net Change KRYSNegative Net Change