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biotechs: Archive

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 SNYNegative Net Change BAYRYNegative 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.

BMYPositive Net Change BMRNNegative Net Change KRYSNegative Net Change TSVTNegative 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.

SNYNegative Net Change BMYPositive Net Change KRYSNegative Net Change KYMRNegative 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.

NVONegative Net Change LLYNegative Net Change SBUXNegative Net Change MCDNegative 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.

UTHRNegative Net Change ARCTPositive Net Change LQDAPositive Net Change FULCPositive 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 ILMNNegative Net Change FULCPositive 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.

ILMNNegative Net Change ARCTPositive Net Change ABBVNegative Net Change GMABNegative 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.

VRTXPositive 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 ADMANegative 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.

APDNNegative 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.

ILMNNegative Net Change FULCPositive Net Change MIRMPositive 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.

ILMNNegative Net Change ARCTPositive Net Change ANTXNegative Net Change FULCPositive 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 BMYPositive Net Change GILDPositive 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 INCYPositive Net Change SNDXPositive Net Change KRYSNegative Net Change

Zacks Equity Research

FDA Expands AstraZeneca's (AZN) Imfinzi Label in Lung Cancer

This approval is based on late-stage study data, which shows that treatment with AstraZeneca's (AZN) Imfinzi reduced the risk of recurrence by 32% in certain non-small cell lung cancer patients.

AZNPositive Net Change MRKPositive Net Change ARCTPositive Net Change FULCPositive Net Change

Sundeep Ganoria

Medicare Releases Negotiated Prices on 10 Expensive Drugs

Following negotiations between Medicare and participating drug companies, some of the world's biggest medicines will see price cuts of 38-79%. These lowered prices will be going into effect in 2026.

AZNPositive Net Change NVSNegative Net Change BMYPositive Net Change JNJNegative Net Change MRKPositive Net Change AMGNNegative Net Change

Zacks Equity Research

Kodiak (KOD) Q2 Loss Narrower Than Expected, Pipeline in Focus

Kodiak (KOD) reports a narrower-than-expected loss for the second quarter of 2024. The company provides updates regarding its pipeline development plans.

ILMNNegative Net Change KODNegative Net Change FULCPositive Net Change

Zacks Equity Research

Axsome (AXSM) Banks on Auvelity & Sunosi to Fuel Growth

Axsome's (AXSM) depression drug, Auvelity, is driving the company's top line. The acquisition of Sunosi from Jazz diversifies its commercial opportunity. Stiff competition in the target market is a woe.

JAZZNegative Net Change ACADNegative Net Change AXSMPositive Net Change

Zacks Equity Research

Vertex (VRTX) Stock Outperforms Industry YTD: Here's Why

Vertex's (VRTX) CF sales are expected to remain strong despite a slight slowdown in the growth rate. Casgevy and suzetrigine (if approved) are set to provide the necessary diversification from the CF franchise.

VRTXPositive Net Change MRNANegative Net Change CRSPNegative Net Change

Zacks Equity Research

AstraZeneca (AZN) Imfinzi Combo Gets EU Nod for Uterine Cancer

AstraZeneca's (AZN) Imfinzi plus Lynparza for treating certain patients with primary advanced or recurrent endometrial cancer is approved in the EU based on data from the phase III DUO-E study.

AZNPositive Net Change MRKPositive Net Change IMTXNegative Net Change TRDAPositive Net Change

Zacks Equity Research

Lexicon (LXRX) to Reprioritize Portfolio, Slash Jobs, Stock Up

Lexicon (LXRX) announces a portfolio reprioritization plan to focus on reducing operational expenses and driving the growth of the commercial portfolio. Shares rise.

ILMNNegative Net Change LXRXPositive Net Change FULCPositive Net Change TRDAPositive Net Change

Zacks Equity Research

Ascendis (ASND) Up on FDA Nod for Hormone Therapy Yorvipath

The FDA approves Ascendis' (ASND) Yorvipath (palopegteriparatide) as the first and only treatment for hypoparathyroidism in adult patients. Shares rise.

ILMNNegative Net Change ASNDNegative Net Change FULCPositive Net Change TRDAPositive Net Change

Zacks Equity Research

Evotec (EVO) Rises 12% on $75M Milestone Payment From BMY

A $75 million performance-based and program-based milestone payment has been triggered in favor of Evotec (EVO) under its strategic collaboration with Bristol Myers for molecular glue degraders.

BMYPositive Net Change PFENegative Net Change EVONegative Net Change TRDAPositive Net Change

Zacks Equity Research

Syros (SYRS) Falls 62% on Phase II Leukemia Study Termination

Syros (SYRS) plummets 62% after the decision to discontinue the leukemia study of its investigational candidate, tamibarotene, due to a low likelihood of success per a planned futility analysis.

ABBVNegative Net Change SYRSNegative Net Change IMTXNegative Net Change TRDAPositive Net Change

Zacks Equity Research

FATE Q2 Earnings Beat on Lower Expenses, Collaboration Revenues Grow

FATE reports a lower-than-expected loss on higher revenues and lower operating expenses in the second quarter of 2024.

FATENegative Net Change KRYSNegative Net Change TRDAPositive Net Change