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biotechs: Archive
Regeneron (REGN) Gets CRL From FDA for Multiple Myeloma Drug
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Bristol Myers' (BMY) Breyanzi Label Expansion Application Validated
by Zacks Equity Research
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
biotechnology biotechs immuno-therapy pharmaceuticals
Kymera (KYMR) to Raise $225 Million Through Offering of Shares
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Massive Weight Loss Market: Viking (VKTX) is Best-in-Breed
by Andrew Rocco
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
biotechnology biotechs
Liquidia (LQDA) Down on FDA Delaying Full Approval for Yutrepia
by Zacks Equity Research
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
biotechs medical pharmaceuticals
GSK's ADC Drug for Lung Cancer Gets FDA's Breakthrough Tag
by Zacks Equity Research
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
biotechs
AbbVie (ABBV) Gets Nod in EU for Lymphoma Drug's Expanded Use
by Zacks Equity Research
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
biotechnology biotechs medical oncology-screening pharmaceuticals
CRISPR (CRSP) Loses 24% YTD: How Should You Play the Stock?
by Sundeep Ganoria
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
biotechs crispr gene-therapy medical pharmaceuticals
ADMA Biologics (ADMA) Hits 52-Week High: More Room to Grow?
by Ekta Bagri
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
biotechnology biotechs medical pharmaceuticals
WHO Declares Monkeypox Public Emergency: 5 Mpox Stocks to Watch
by Andrew Rocco
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
biotechnology biotechs coronavirus vaccines
Mirum (MIRM) Banks on Livmarli, Overdependence a Concern
by Zacks Equity Research
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
biotechs
AN2 Therapeutics (ANTX) Plunges 66% in a Month: Here's Why
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Gilead (GILD) Obtains FDA Approval for PBC Drug Livdelzi
by Zacks Equity Research
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
biotechs medical pharmaceuticals
Incyte (INCY) Announces Data on Monjuvi, FDA Approval for GVHD Drug
by Zacks Equity Research
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
biotechs medical pharmaceuticals
FDA Expands AstraZeneca's (AZN) Imfinzi Label in Lung Cancer
by Zacks Equity Research
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
biotechs medical pharmaceuticals
Medicare Releases Negotiated Prices on 10 Expensive Drugs
by Sundeep Ganoria
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
biotechs medical pharmaceuticals vaccines
Kodiak (KOD) Q2 Loss Narrower Than Expected, Pipeline in Focus
by Zacks Equity Research
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
biotechs earnings
Axsome (AXSM) Banks on Auvelity & Sunosi to Fuel Growth
by Zacks Equity Research
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
biotechs
Vertex (VRTX) Stock Outperforms Industry YTD: Here's Why
by Zacks Equity Research
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
biotechs
AstraZeneca (AZN) Imfinzi Combo Gets EU Nod for Uterine Cancer
by Zacks Equity Research
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
biotechnology biotechs medical oncology-screening pharmaceuticals
Lexicon (LXRX) to Reprioritize Portfolio, Slash Jobs, Stock Up
by Zacks Equity Research
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
biotechs
Ascendis (ASND) Up on FDA Nod for Hormone Therapy Yorvipath
by Zacks Equity Research
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
biotechs
Evotec (EVO) Rises 12% on $75M Milestone Payment From BMY
by Zacks Equity Research
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
biotechs medical pharmaceuticals
Syros (SYRS) Falls 62% on Phase II Leukemia Study Termination
by Zacks Equity Research
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
biotechnology biotechs medical oncology-screening pharmaceuticals
FATE Q2 Earnings Beat on Lower Expenses, Collaboration Revenues Grow
by Zacks Equity Research
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
biotechnology biotechs cell-therapy earnings medical