Back to top

biotechs: Archive

Zacks Equity Research

Vanda (VNDA) Falls on FDA's CRL to Hetlioz sNDA for Insomnia

Vanda's (VNDA) supplemental new drug application seeking approval for Hetlioz to treat insomnia gets a complete response letter from the FDA.

VNDAPositive Net Change ANIPPositive Net Change ADMAPositive Net Change INDVPositive Net Change

Zacks Equity Research

Gilead (GILD) & MRK's HIV Oral Combo Shows Efficacy in Phase II

Gilead (GILD) and Merck's (MRK) phase II study data demonstrates the efficacy of their oral once-weekly combination of islatravir and lenacapavir in maintaining viral suppression in individuals with HIV.

BMYPositive Net Change JNJNegative Net Change MRKNegative Net Change GILDPositive Net Change

Zacks Equity Research

Iterum (ITRM) Plans Early Submission of UTI Drug NDA, Stock Up

Iterum (ITRM) stock rises as the company gears up to submit a regulatory application to the FDA seeking approval for oral sulopenem to treat adult women with uUTIs ahead of schedule.

ACETPositive Net Change ADMAPositive Net Change FGENNegative Net Change ITRMNegative Net Change

Zacks Equity Research

REGENXBIO (RGNX) Soars 15% on Interim Data From DMD Study

Data from an early-stage study shows that treatment with REGENXBIO's (RGNX) investigational Duchenne therapy RGX-202 demonstrates early evidence of strength and motor function improvement.

SRPTPositive Net Change ADMAPositive Net Change RGNXPositive Net Change SLDBPositive Net Change

Zacks Equity Research

Alnylam (ALNY), Roche's Blood Pressure Drug Meets Study Goal

Data from a mid-stage study shows that Alnylam (ALNY) and Roche-partnered zilebesiran, when added to standard-of-care, lowers blood pressure significantly in adults with mild-to-moderate hypertension.

GSKPositive Net Change ALNYPositive Net Change RHHBYPositive Net Change ADMAPositive Net Change

Zacks Equity Research

Bayer (BAYRY) Q4 Earnings Top, Crop Science Unit Drives Revenues

Bayer (BAYRY) beats earnings estimates in the fourth quarter of 2023, primarily driven by increased sales of Crop Science and Pharmaceuticals products.

REGNPositive Net Change JNJNegative Net Change BAYRYPositive Net Change ADMAPositive Net Change

Zacks Equity Research

Here's Why You Should Invest in Aldeyra (ALDX) Stock Now

Here, we discuss some reasons why investing in Aldeyra Therapeutics (ALDX) stock now may turn out to be a prudent move.

ALDXPositive Net Change COLLNegative Net Change LYRAPositive Net Change INDVPositive Net Change

Zacks Equity Research

Novo Nordisk (NVO) Down Despite Kidney Outcomes Study Success

Novo Nordisk (NVO) declines 3% despite achieving the primary endpoint with statistical significance in the FLOW outcomes study evaluating the efficacy of Ozempic 1 mg to treat CKD indication.

NVONegative Net Change ACETPositive Net Change ADMAPositive Net Change ETNBPositive Net Change

Zacks Equity Research

Akero (AKRO) Up on Upbeat Week 96 Data From Liver Disease Study

Akero (AKRO) reports positive results from its mid-stage study of efruxifermin in pre-cirrhotic metabolic dysfunction-associated steatohepatitis patients at week 96. The stock gains 12%.

ACETPositive Net Change ADMAPositive Net Change AKROPositive Net Change ETNBPositive Net Change

Benjamin Rains

Finding Cheap Stocks Under $10 to Buy in March

Along with the cheap price tags, the stocks we learn how to search for earn strong Zacks Ranks, driven by improving earnings outlooks

ADMAPositive Net Change ALITPositive Net Change

Zacks Equity Research

FDA Lifts Clinical Hold on Iovance's (IOVA) Lung Cancer Study

The FDA removes the clinical hold on Iovance's (IOVA) mid-stage study on LN-145 in certain NSCLC patients after reviewing the company's proposal for additional safety measures and monitoring.

ACETPositive Net Change PBYIPositive Net Change ADMAPositive Net Change IOVANegative Net Change

Zacks Equity Research

Arcturus (ARCT) Stock Surges 73% in 3 Months: Here's Why

Arcturus' (ARCT) steady progress with its product candidate, ARCT-032, for the treatment of cystic fibrosis is encouraging.

ARCTNegative Net Change VNDAPositive Net Change KNSAPositive Net Change INDVPositive Net Change

Zacks Equity Research

J&J (JNJ) Secures Full FDA Nod for Rybrevant in Lung Cancer

The approval is based on data from a late-stage study wherein treatment with J&J's (JNJ) Rybrevant plus chemotherapy reduced the disease-progression risk or death by 61% in certain NSCLC patients.

JNJNegative Net Change ACETPositive Net Change PBYIPositive Net Change ADMAPositive Net Change

Zacks Equity Research

Viatris' (VTRS) Generic Declines in Q4, Yupleri Sales Rise

Viatris (VTRS) stock down after posting weaker-than-expected results from its generics business. Nevertheless, the guidance for 2024 looks encouraging.

ACETPositive Net Change PBYIPositive Net Change ADMAPositive Net Change VTRSNegative Net Change

Zacks Equity Research

Ocuphire (OCUP) to Report Q4 Earnings: What's in the Cards?

Ocuphire (OCUP) is expected to provide updates on the clinical development of its lead retinal product candidate, APX3330, to treat diabetic retinopathy, in fourth-quarter 2023 earnings release.

VTRSNegative Net Change CGEMNo Net Change

Zacks Equity Research

Puma Biotechnology (PBYI) Q4 Earnings & Revenues Lag Estimates

Puma Biotechnology's (PBYI) fourth-quarter 2024 earnings and revenues fall shy of estimates. Stock declines.

PBYIPositive Net Change VNDAPositive Net Change KNSAPositive Net Change INDVPositive Net Change

Zacks Equity Research

Amarin's (AMRN) Q4 Earnings and Revenues Surpass Estimates

Amarin's (AMRN) fourth-quarter 2023 earnings and revenues beat estimates. Vascepa's sales in the United States decline year over year.

ACETPositive Net Change AMRNPositive Net Change PBYIPositive Net Change ADMAPositive Net Change

Zacks Equity Research

Xenon (XENE) Q4 Earnings Top Estimates, Pipeline in Focus

Xenon (XENE) reports mixed fourth-quarter 2023 financial results, wherein earnings beat estimates but revenues missed the same. Its development programs for XEN1101 in epilepsy and MDD are progressing well.

ACETPositive Net Change ADMAPositive Net Change XENEPositive Net Change AKROPositive Net Change

Zacks Equity Research

Pacira (PCRX) Q4 Earnings Match, Exparel Sales Drive Revenues

Pacira (PCRX) reports fourth-quarter 2023 results, wherein earnings match and revenues beat estimates, driven by strong Exparel sales.

ACETPositive Net Change PCRXPositive Net Change ADMAPositive Net Change AKROPositive Net Change

Zacks Equity Research

Sarepta (SRPT) Q4 Earnings Beat Estimates, Revenues Up Y/Y

Sarepta's (SRPT) Q4 earnings and sales beat estimates on the back of strong sales for recently-approved DMD gene therapy Elevidys.

RHHBYPositive Net Change ACETPositive Net Change SRPTPositive Net Change PBYIPositive Net Change

Zacks Equity Research

Catalyst (CPRX) Q4 Earnings & Sales Beat Estimates, Stock Up

Catalyst (CPRX) reports encouraging fourth-quarter results, driven by Firdapse and Fycompa sales. The stock gains in the pre-market session.

ACETPositive Net Change CPRXNegative Net Change PBYIPositive Net Change ADMAPositive Net Change

Zacks Equity Research

Mirum's (MIRM) Q4 Earnings Lag Estimates, Revenues Beat

Mirum's (MIRM) earnings fall shy of estimates in the fourth quarter of 2023 while revenues beat the same.

PBYIPositive Net Change VNDAPositive Net Change MIRMPositive Net Change INDVPositive Net Change

Zacks Equity Research

Amicus' (FOLD) Q4 Earnings Beat, Revenues Meet Estimates

Amicus' (FOLD) fourth-quarter earnings beat estimates while revenues meet the same. Stock down.

FOLDPositive Net Change PBYIPositive Net Change VNDAPositive Net Change INDVPositive Net Change

Zacks Equity Research

Novavax (NVAX) Q4 Earnings & Sales Miss Estimates, Stock Tanks

Novavax's (NVAX) fourth-quarter earnings and revenues miss estimates. Stock tanks on moderate revenue guidance for 2024.

NVAXNegative Net Change PBYIPositive Net Change VNDAPositive Net Change INDVPositive Net Change

Zacks Equity Research

Iovance's (IOVA) Q4 Earnings & Sales Fall Short of Estimates

Iovance (IOVA) reports dismal earnings in the fourth quarter. Management is in the process of commercially launching the recently approved melanoma drug Amtagvi in the United States.

ACETPositive Net Change PBYIPositive Net Change ADMAPositive Net Change IOVANegative Net Change