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biotechs: Archive
FDA Accepts GSK's BLA for Blenrep Combos in Multiple Myeloma
by Zacks Equity Research
The FDA accepts GSK's BLA seeking approval of Blenrep combinations for treating relapsed/refractory multiple myeloma. A decision is due on July 23, 2025.
GSKPositive Net Change SPRONegative Net Change CSTLPositive Net Change IMCRNegative Net Change
biotechs
FDA Begins Review of Alnylam's sNDA for Expanded Amvuttra Use
by Zacks Equity Research
ALNY reports submitting an sNDA in the United States, seeking the label expansion of Amvuttra to treat ATTR amyloidosis with cardiomyopathy.
ALNYPositive Net Change NVSPositive Net Change ALLOPositive Net Change BBIOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Exelixis Stock Surges 25% in a Month: Time to Buy or Sell?
by Zacks Equity Research
EXEL's shares move north 25% in a month on the back of strong third-quarter results and raised outlook. We are optimistic about the stock as we believe there is room for growth.
MRKPositive Net Change EXELNegative Net Change SPRONegative Net Change CSTLPositive Net Change
biotechnology biotechs medical pharmaceuticals
HALO Withdraws Acquisition Bid for EVO, Reaffirms '24 View, Stock Up
by Zacks Equity Research
Halozyme withdraws its proposal to acquire Evotec for 11 euro per share in cash. The company maintains its 2024 revenue guidance. Shares up.
HALOPositive Net Change SPRONegative Net Change EVONegative Net Change CSTLPositive Net Change
biotechs
J&J Seeks FDA Nod for Subcutaneous Tremfya as Induction Regimen in UC
by Zacks Equity Research
If approved, JNJ's Tremfya will be the first IL-23 inhibitor to offer a choice of subcutaneous or intravenous use as induction treatment in ulcerative colitis.
JNJPositive Net Change LLYPositive Net Change ABBVPositive Net Change
biotechs medical pharmaceuticals
Do Options Traders Know Something About Regeneron (REGN) Stock We Don't?
by Zacks Equity Research
Investors need to pay close attention to Regeneron (REGN) stock based on the movements in the options market lately.
REGNPositive Net Change
biotechnology biotechs medical
Novartis Raises Sales Outlook for Mid-Term, Acquires Kate Therapeutics
by Zacks Equity Research
NVS expects sales to witness a CAGR of 6% during 2023-2028, up from the earlier projection of 5%. The company acquires Kate Therapeutics to strengthen its portflio of gene therapies.
NVSPositive Net Change PFEPositive Net Change GILDNegative Net Change
biotechnology biotechs medical pharmaceuticals
Novo Nordisk Plunges 25% in 3 Months: How to Play the Stock
by Ahan Chakraborty
Despite the current downward trend of NVO, it is a good stock to retain in one's portfolio for long-term gains due to strong demand for its GLP-1 drugs.
NVOPositive Net Change LLYPositive Net Change AMGNPositive Net Change VKTXNegative Net Change
biotechnology biotechs medical pharmaceuticals
Replimune Stock Rallies on BLA Filing for Melanoma Combo Drug
by Zacks Equity Research
REPL stock soars after submitting a BLA to the FDA seeking accelerated approval for its lead candidate, RP1, in combination with Opdivo for advanced melanoma.
BMYPositive Net Change PFEPositive Net Change REPLPositive Net Change ALLOPositive Net Change
biotechnology biotechs medical oncology-screening pharmaceuticals
Innovations Support QIAGEN Shares Despite Macroeconomic Concerns
by Zacks Equity Research
To support internal growth, QGEN heavily invests in R&D for the menu expansion of its key platforms.
RMDPositive Net Change HAEPositive Net Change QGENPositive Net Change GMEDPositive Net Change
biotechs medical
VKTX Stock Loses Over $1B in a Month: How to Play the Stock?
by Sundeep Ganoria
The plunge in Viking Therapeutics' share price can be attributed to the rising competition in the sector to secure a position in the booming obesity market.
AZNPositive Net Change NVOPositive Net Change LLYPositive Net Change VKTXNegative Net Change
biotechs medical pharmaceuticals
Biotech Stock Roundup: SAGE, INCY Suffer Setbacks, JAZZ Wins Oncology Drug Approval & More
by Zacks Equity Research
SAGE and INCY suffer setbacks due to the failure of HD and CSU studies, respectively.
INCYPositive Net Change JAZZPositive Net Change PYXSPositive Net Change
biotechnology biotechs medical pharmaceuticals
JAZZ Secures FDA Approval for Ziihera in Biliary Tract Cancer
by Zacks Equity Research
Following the FDA's approval, Jazz's Ziihera becomes the first dual HER2-targeted bispecific antibody and chemotherapy-free treatment approved for biliary tract cancer.
JAZZPositive Net Change CTMXPositive Net Change SPRONegative Net Change CSTLPositive Net Change
biotechs medical
PBYI Begins Phase II Study on Alisertib Combo in Breast Cancer
by Zacks Equity Research
Puma Biotechnology starts the phase II ALISCA-Breast1 study on alisertib for treating hormone receptor-positive, HER2-negative metastatic breast cancer.
PBYIPositive Net Change SPRONegative Net Change CSTLPositive Net Change IMCRNegative Net Change
biotechs
Pfizer Secures Approval for Hemophilia Drug Hympavzi in the EU
by Zacks Equity Research
Following approval from the European Commission, PFE's Hympavzi becomes the first hemophilia medicine in the European Union to be administered via a pre-filled, auto-injector pen.
PFEPositive Net Change BMRNNegative Net Change NVOPositive Net Change QUREPositive Net Change
biotechs medical pharmaceuticals
SLN Stock Down Despite Cholesterol Drug Lowering Lipoprotein Levels
by Zacks Equity Research
Silence Therapeutics stock falls despite lowering lipoprotein levels in a phase II study of zerlasiran likely due to concerns regarding its competitive profile.
PFEPositive Net Change AMGNPositive Net Change ALLOPositive Net Change SLNNegative Net Change
biotechnology biotechs medical pharmaceuticals
GSK Drug for Rare Disease-Related Itch Meets Goal in Phase III Study
by Zacks Equity Research
The GLISTEN study evaluating GSK's candidate, linerixibat, for treating cholestatic pruritus related to primary biliary cholangitis meets the primary endpoint.
GSKPositive Net Change GILDNegative Net Change MIRMPositive Net Change CSTLPositive Net Change
biotechs
CRISPR Therapeutics Stock Falls 7% in Two Weeks: Time to Hold or Sell?
by Sundeep Ganoria
The decline in CRSP's share price could be due to the beating the drug/biotech sector has been taking in the past couple of months, resulting from pipeline setbacks and guidance cuts.
VRTXPositive Net Change BEAMPositive Net Change EDITPositive Net Change CRSPPositive Net Change
biotechs crispr medical pharmaceuticals
FATE Presents Encourgaing Data From Lupus Study, Stock Gains
by Zacks Equity Research
Fate Therapeutics presents promising data on FT819 showing the first patient treated experienced a favorable clinical experience, achieved drug-free clinical remission, and continues on-study.
FATEPositive Net Change SPRONegative Net Change CSTLPositive Net Change IMCRNegative Net Change
biotechnology biotechs medical pharmaceuticals
ACRS Stock Up on Licensing Deal With Biosion for Two Immunology Drugs
by Zacks Equity Research
Aclaris stock surges on inking an exclusive license agreement with Biosion for global rights to two of the latter's pipeline candidates, BSI-045B and BSI-502.
PFEPositive Net Change GILDNegative Net Change ACRSPositive Net Change ALLOPositive Net Change
biotechnology biotechs medical pharmaceuticals
CHMP Endorses AstraZeneca's Tagrisso for Expanded Use in NSCLC
by Zacks Equity Research
The CHMP's opinion is based on late-stage data, which show that treatment with AZN's Tagrisso extends progression-free survival by more than three years in certain NSCLC patients.
AZNPositive Net Change CTMXPositive Net Change SPRONegative Net Change CSTLPositive Net Change
biotechs medical pharmaceuticals
Eyenovia Stock Tumbles on Termination of Phase III Myopia Study
by Zacks Equity Research
EYEN stock craters on the decision to terminate late-stage myopia study of MicroPine following negative feedback from an independent Data Review Committee.
PFEPositive Net Change GILDNegative Net Change ALLOPositive Net Change
biotechnology biotechs medical pharmaceuticals
ALNY Reports Sustained 6-Month Efficacy Data From Amyloidosis Study
by Zacks Equity Research
Alnylam shares interim phase I amyloidosis study data on nucresiran, showing rapid TTR reduction sustained for six months after a single dose.
ALNYPositive Net Change PFEPositive Net Change GILDNegative Net Change ALLOPositive Net Change
biotechnology biotechs medical pharmaceuticals
CHMP Endorses J&J's Rybrevant-Lazcluze Combo for Use in NSCLC
by Zacks Equity Research
The CHMP's opinion is based on late-stage study data, which show that treatment with JNJ's combo drug reduces the risk of disease progression or death by 30% in certain NSCLC patients.
AZNPositive Net Change JNJPositive Net Change SPRONegative Net Change CSTLPositive Net Change
biotechs medical pharmaceuticals
Bull Of The Day: Tactile Systems Technology (TCMD)
by Brian Bolan
This stock consistently beats the number and treats underdiagnosed chronic diseases that could get more attention with the changes coming to the government
TCMDPositive Net Change
biotechnology biotechs medical medical-devices