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biotechs: Archive
Jasper Therapeutics (JSPR) Surges 110% in a Month: Here's Why
by Zacks Equity Research
Jasper Therapeutics (JSPR) surges after it provides business updates that highlight the company's progress with its pipeline. Multiple data readouts are expected throughout this year.
NVONegative Net Change SRPTPositive Net Change CTMXPositive Net Change JSPRNegative Net Change
biotechs medical
Travere (TVTX) Stock Up More Than 30% in 3 Months: Here's Why
by Zacks Equity Research
Travere (TVTX) is on track to file an sNDA to the FDA to convert the accelerated approval for lead drug, Filspari, to full approval for IgAN in first-quarter 2024.
REGNNegative Net Change PBYINegative Net Change CTMXPositive Net Change TVTXPositive Net Change
biotechs
Here's Why Investors May Bet on BioMarin (BMRN) Stock Now
by Zacks Equity Research
Here, we discuss some reasons why investing in BioMarin (BMRN) stock now may turn out to be a more prudent move than ever.
REGNNegative Net Change BMRNNegative Net Change PBYINegative Net Change CTMXPositive Net Change
biotechs
Biotech Stock Roundup: GILD Down on Study Results, INBX Gains on Sanofi Deal & More
by Zacks Equity Research
Gilead Sciences (GILD) and Inhibrx (INBX) are in the spotlight on regulatory and pipeline updates.
SNYNegative Net Change GILDNegative Net Change EXELNegative Net Change INBXNegative Net Change
biotechnology biotechs pharmaceuticals
Unicycive (UNCY) Up on Positive Hyperphosphatemia Study Update
by Zacks Equity Research
Unicycive (UNCY) rises after the encouraging progress in the late-stage development of its lead candidate, OLC, for the hyperphosphatemia indication. The NDA submission is expected around mid-2024.
PBYINegative Net Change ADMAPositive Net Change CTMXPositive Net Change UNCYPositive Net Change
biotechnology biotechs medical pharmaceuticals
Outlook (OTLK) Surges 31% on Regulatory Update for AMD Study
by Zacks Equity Research
Outlook (OTLK) stock rises after aligning with the FDA regarding the protocols of a non-inferiority study of ONS-5010 for AMD. The study is set to become the basis for BLA resubmission by 2024-end.
REGNNegative Net Change PBYINegative Net Change ADMAPositive Net Change OTLKNegative Net Change
biotechnology biotechs medical pharmaceuticals
Inhibrx (INBX) Up 6% on Sale of Rare Disease Drug to Sanofi
by Zacks Equity Research
Sanofi (SNY) will acquire Inhibrx (INBX) for nearly $2.2 billion. Post-acquisition, it will retain the rare disease drug and spin out all other pipeline programs into a newly-traded public company.
SNYNegative Net Change NVONegative Net Change CTMXPositive Net Change INBXNegative Net Change
biotechs medical pharmaceuticals
Lisata (LSTA) Stock Up More Than 35% in 3 Months: Here's Why
by Zacks Equity Research
Lisata (LSTA) is progressing well with the development of its lead investigational product candidate, LSTA1, which targets several cancer indications.
REGNNegative Net Change PBYINegative Net Change CTMXPositive Net Change LSTANegative Net Change
biotechs
Mirum (MIRM) Banks on Livmarli Sales Despite Recent Setback
by Zacks Equity Research
Mirum's (MIRM) lead drug, Livmarli, continues to generate steady sales. The company's efforts to expand the label of the drug are also encouraging. However, pipeline setback remains a concern.
REGNNegative Net Change PBYINegative Net Change CTMXPositive Net Change MIRMNegative Net Change
biotechs
Gilead (GILD) Down as NSCLC Study Fails to Meet Primary Goal
by Zacks Equity Research
Gilead Sciences' (GILD) phase III study evaluating Trodelvy (sacituzumab govitecan) in previously treated metastatic NSCLC fails to meet its primary endpoint. Shares decline on the same.
REGNNegative Net Change GILDNegative Net Change IMGNPositive Net Change ABBVNegative Net Change
biotechnology biotechs pharmaceuticals
Pharvaris (PHVS) Up as FDA Lifts Clinical Hold on HAE Program
by Zacks Equity Research
Pharvaris (PHVS) rises 6% after the FDA lifts the clinical hold on the investigational candidate, deucrictibant, for the prophylactic treatment of HAE attacks.
PBYINegative Net Change ADMAPositive Net Change ACADPositive Net Change PHVSNegative Net Change
biotechnology biotechs medical pharmaceuticals
Here's Why You Should Add Xenon (XENE) to Your Portfolio Now
by Zacks Equity Research
Xenon's (XENE) late-stage studies in epilepsy are progressing well. The company is also gearing up to initiate a late-stage study for the MDD indication in 2024.
PBYINegative Net Change ADMAPositive Net Change ACADPositive Net Change XENENegative Net Change
biotechnology biotechs medical pharmaceuticals
FDA Demands "Boxed Warning" to CAR T-Cell Therapy Labels
by Ekta Bagri
The FDA directs companies like NVS, BMY, GILD and others to add "boxed warning" to the labels of their CAR T-cell immunotherapies after it identified adverse events.
NVSNegative Net Change BMYNegative Net Change JNJNegative Net Change GILDNegative Net Change LEGNNo Net Change
biotechnology biotechs pharmaceuticals
AstraZeneca's (AZN) Imfinzi Combo Meets Liver Cancer Study Goal
by Zacks Equity Research
Data from a late-stage shows that AstraZeneca's (AZN) cancer combination therapy reduces the risk of disease progression or death in certain liver cancer patients by 23%.
AZNNegative Net Change NVONegative Net Change SRPTPositive Net Change CTMXPositive Net Change
biotechs medical pharmaceuticals
Edgewise (EWTX) Rallies 35% on Issue of New Common Stock
by Zacks Equity Research
Edgewise (EWTX) will issue secondary shares to raise $240 million in gross proceeds. The capital will be used to fund key initiatives, including the potential commercial launch of lead pipeline drugs.
NVONegative Net Change SRPTPositive Net Change CTMXPositive Net Change EWTXPositive Net Change
biotechs medical
Alvotech (ALVO) Up on BLA Update for Two Biosimilar Candidates
by Zacks Equity Research
The FDA concludes the reinspection of Alvotech's (ALVO) facility in Iceland. The company believes that it may receive approval for biosimilar candidates, AVT02 and AVT04, in the United States. Stock rises.
JNJNegative Net Change PBYINegative Net Change CTMXPositive Net Change ALVONegative Net Change
biotechs
Should You Add Marinus (MRNS) Stock to Your Portfolio Now?
by Zacks Equity Research
Here, we discuss some reasons why investing in Marinus Pharmaceuticals' (MRNS) stock may turn out to be a prudent move.
REGNNegative Net Change PBYINegative Net Change MRNSPositive Net Change FUSNPositive Net Change
biotechs pharmaceuticals
Verastem (VSTM) Up 8% on Fast Track Tag for NSCLC Combo Therapy
by Zacks Equity Research
Verastem's (VSTM) avutometinib/Lumakras combination therapy gets the FDA's Fast Track designation to treat KRAS G12C-mutant metastatic NSCLC patients. The stock gains 8% in response.
AMGNNegative Net Change PBYINegative Net Change ADMAPositive Net Change VSTMNegative Net Change
biotechnology biotechs medical oncology-screening pharmaceuticals
ADC Therapeutics (ADCT) Rises 43% in a Month: Here's Why
by Zacks Equity Research
ADC Therapeutics (ADCT) surges after it provides business updates that highlight the company's progress with its pipeline. Multiple data readouts are expected throughout this year.
NVONegative Net Change ADCTPositive Net Change SRPTPositive Net Change CTMXPositive Net Change
biotechs medical
Mesoblast (MESO) Up on Rare Pediatric Disease Tag for Heart Drug
by Zacks Equity Research
Mesoblast's (MESO) Revascor (rexlemestrocel-L) gets FDA's Rare Pediatric Disease designation for treating children with congenital heart disease. Shares rise in after-hours trading.
REGNNegative Net Change PBYINegative Net Change MESOPositive Net Change CTMXPositive Net Change
biotechs
Exelixis (EXEL) Reports Positive EU Patent Ruling for Cabometyx
by Zacks Equity Research
Exelixis (EXEL) gets a favorable ruling from the European Patent Office in a lawsuit related to its oral oncology drug, Cabometyx.
TEVAPositive Net Change EXELNegative Net Change PBYINegative Net Change ADMAPositive Net Change
biotechnology biotechs medical pharmaceuticals
Syros (SYRS) Stock Surges 200% in 3 Months: Here's Why
by Zacks Equity Research
Syros (SYRS) is progressing well with the development of its pipeline candidate, tamibarotene, targeting two different cancer indications.
REGNNegative Net Change PBYINegative Net Change CTMXPositive Net Change
biotechs
Vor Bio (VOR) Up on Positive Update From AML Cell Therapy Study
by Zacks Equity Research
Vor Bio (VOR) stock gains after dosing the first patient in its phase I/II study of novel cell therapy, VCAR33 (Allogenic), to treat AML. The company extends its cash runway into the second half of 2025.
PBYINegative Net Change ADMAPositive Net Change ACADPositive Net Change VORPositive Net Change
biotechnology biotechs cell-therapy medical pharmaceuticals
MAIA Soars 20% on Interim Results From Lung Cancer Study
by Zacks Equity Research
MAIA Biotechnology (MAIA) reports updated results from a mid-stage study. Patients treated with its lead drug achieved disease control rates that were well-sustained compared with previous scans.
REGNNegative Net Change NVONegative Net Change CTMXPositive Net Change MAIAPositive Net Change
biotechs medical
Instil (TIL) Stock Rises More Than 20% in a Week: Here's Why
by Zacks Equity Research
Instil's (TIL) recent deal with a collaborator to carry out preclinical manufacturing feasibility studies on its ITIL-306 program is a positive.
REGNNegative Net Change PBYINegative Net Change CTMXPositive Net Change TILNegative Net Change
biotechs