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biotechs: Archive

Zacks Equity Research

Will Ayvakit Aid Blueprint Medicines (BPMC) Amid Rivalry?

Blueprint Medicines (BPMC) expects its lead drug, Ayvakit, which is approved to treat rare cancer and other rare diseases, to generate incremental sales and combat stiff competition.

RHHBYNegative Net Change BPMCNegative Net Change DCPHNegative Net Change ZLABPositive Net Change

Zacks Equity Research

Iovance (IOVA) Focuses on Seeking Nod for Melanoma Therapy

Iovance (IOVA) is progressing with its pipeline development. Management, after many delays, initiated a rolling BLA filing with the FDA for its lead candidate in metastatic melanoma.

BMYPositive Net Change MRKNo Net Change CLLSNegative Net Change IOVANegative Net Change

Zacks Equity Research

Will Seagen's (SGEN) Portfolio of Drugs Help Combat Rivalry?

Seagen (SGEN) expects its portfolio of marketed drugs, which are approved for various cancer indications, to generate incremental sales and combat stiff competition.

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Sweta Killa

Top-Ranked ETFs That Beat the Market in Q3

After logging the best month since July 2020, the Wall Street rally fizzled in August on aggressive Fed rate hike speculation. This has pushed the major indices to end the quarter with losses.

UUPPositive Net Change XLYNegative Net Change XBINegative Net Change IGNPositive Net Change CTEXNegative Net Change

Zacks Equity Research

Why Novavax's (NVAX) COVID Vaccine Struggles for Market Share?

Despite being the first protein-based COVID-19 vaccine in many markets, Novavax's (NVAX) delayed product launch severely affected the company's prospects.

PFENegative Net Change MRNANegative Net Change NVAXNegative Net Change BNTXNegative Net Change

Zacks Equity Research

Can Biogen (BIIB) Navigate Multiple Challenges & Grow Again?

Most of Biogen's (BIIB) key drugs are facing declining sales. Despite these challenges, we are hopeful that potential new product launches such as lecanemab, zuranolone and additional biosimilars can help revive growth.

NVSNegative Net Change BIIBNegative Net Change RHHBYNegative Net Change SAGEPositive Net Change

Zacks Equity Research

BioMarin (BMRN) Refiles BLA With FDA for Hemophilia Gene Therapy

If approved, BioMarin's (BMRN) valoctocogene roxaparvovec will be the first gene therapy for hemophilia A in the United States. The FDA filing also incorporates BMRN's responses to the CRL issued to the BLA in 2020.

SNYNegative Net Change BMRNPositive Net Change SESNNegative Net Change MORFNegative Net Change

Zacks Equity Research

Sarepta (SRPT) Seeks FDA Nod for DMD Gene Therapy Candidate

If approved, Sarepta's (SRPT) SRP-9001 will be the first gene therapy for DMD indication in the United States. The company seeks approval for gene therapy under the accelerated pathway.

SNYNegative Net Change RHHBYNegative Net Change SRPTNegative Net Change MORFNegative Net Change

Zacks Equity Research

Deciphera (DCPH) Rises 90% in the Past 6 Months: Here's Why

Deciphera's (DCPH) Qinlock, approved for treating advanced gastrointestinal stromal tumors, has seen strong uptake since its approval. The recent restructuring initiative is saving costs.

BPMCNegative Net Change APTONegative Net Change DCPHNegative Net Change ORICNegative Net Change

Zacks Equity Research

Amylyx (AMLX) Secures the FDA's Approval for ALS Drug

Amylyx (AMLX) obtains the FDA's approval for its oral, fixed-dose combination therapy for treating adults with amyotrophic lateral sclerosis (ALS) after a few roadblocks.

SNYNegative Net Change DVAXPositive Net Change AMLXNegative Net Change BOLTNegative Net Change

Zacks Equity Research

Horizon (HZNP) Completes Enrollment in Phase IV TED Study

Horizon (HZNP) completes enrollment in the phase IV study evaluating Tepezza for the treatment of thyroid eye disease in patients with a low clinical activity score.

HZNPPositive Net Change ATRANegative Net Change APTONegative Net Change ORICNegative Net Change

Zacks Equity Research

Biotech Stock Roundup: BIIB's AD Drug Data & REGN, IONS, VRTX's Updates

Regulatory and pipeline updates from BIIB and IONS are the key highlights from the biotech sector during the past week.

REGNPositive Net Change SNYNegative Net Change BIIBNegative Net Change VRTXPositive Net Change IONSNegative Net Change

Zacks Equity Research

EMA Accepts Moderna's (MRNA) Filing for Omicron BA.4, BA.5 Booster

The EMA accepts Moderna's (MRNA) regulatory filing seeking authorization for bivalent COVID-19 booster vaccine, mRNA-1273.222, designed to target the Omicron BA.4 and BA.5 subvariants.

PFENegative Net Change MRNANegative Net Change MORFNegative Net Change BNTXNegative Net Change

Ekta Bagri

LLY & PRTA in Spotlight on BIIB-Eisai's AD Drug Data

The success of Biogen (BIIB)-Eisai's AD candidate in a big phase III study makes investors optimistic about the prospects of other AD candidates as well.

BIIBNegative Net Change RHHBYNegative Net Change LLYPositive Net Change PRTAPositive Net Change

Zacks Equity Research

Stock Market News for Sep 29, 2022

Wall Street closed sharply higher on Wednesday rebounding from a six-day losing streak.

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Zacks Equity Research

Vertex (VRTX), CRISPR to Seek FDA Nod for Hemoglobinopathy Therapy

Vertex (VRTX) and partner CRISPR intend to start a rolling BLA submission with the FDA for their gene therapy in thalassemia and sickle cell disease indications by November 2022.

SNYNegative Net Change VRTXPositive Net Change CRSPNegative Net Change MORFNegative Net Change

Ekta Bagri

Bet on These 4 Biotech Stocks With Bright Prospects

New drug approvals and pipeline development should maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and pipeline progress position AGEN, CVAC, IMCR and DVAX well amid the volatility.

DVAXPositive Net Change AGENPositive Net Change CVACNegative Net Change IMCRNegative Net Change

Zacks Equity Research

Seagen (SGEN) Inks Deal With LAVA Therapeutics for LAVA-1223

Seagen (SGEN) signs an exclusive agreement with LAVA Therapeutics to develop and commercialize the latter's preclinical asset, LAVA-1223, targeting EGFR-expressing solid tumors.

RHHBYNegative Net Change SGENNegative Net Change APTONegative Net Change LVTXPositive Net Change

Zacks Equity Research

Emergent (EBS) Acquires Worldwide Rights to Smallpox Antiviral

Emergent (EBS) completes the acquisition of worldwide rights to Tembexa, an FDA-approved smallpox oral antiviral for all ages, from Chimerix.

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Zacks Equity Research

Atea (AVIR) Dengue Candidate Gets Fast Track Designation

Atea Pharmaceuticals (AVIR) obtains Fast Track Designation in the United States for AT-752 for the treatment of dengue virus infection.

DVAXPositive Net Change MRKNo Net Change AVIRNegative Net Change BOLTNegative Net Change

Zacks Equity Research

Intercept (ICPT) Stock Gains 13% in 3 Months: Here's Why

Intercept (ICPT) gains 13% in the past three months on positive regulatory and pipeline updates.

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Zacks Equity Research

Ionis' (IONS) Hypercholesterolemia Drug Not to Enter Phase III

Ionis (IONS) posts data from the phase IIb SOLANO study on ION449 for treating hypercholesterolemia. Though the study met the primary endpoint, ION449 will not advance into phase III development.

AZNNegative Net Change NVSNegative Net Change BIIBNegative Net Change IONSNegative Net Change

Zacks Equity Research

Spero (SPRO) Skyrockets 168% on Licensing Deal With GSK

The exclusive licensing agreement with GSK will fund Spero's (SPRO) existing operations and extend its current cash runway beyond 2024.

GSKNegative Net Change PFENegative Net Change SPROPositive Net Change MORFNegative Net Change

Zacks Equity Research

Why Novavax (NVAX) Stock Was Down 13% on Thursday

Novavax (NVAX) sinks to a new record level 52-week low after analysts at JP Morgan cut the 12-month target price on the stock by more than $100.

PFENegative Net Change MRNANegative Net Change NVAXNegative Net Change BNTXNegative Net Change

Zacks Equity Research

Biotech Stock Roundup: GILD, BMY's Regulatory News, BLUE's Therapy Approval & More

Regulatory and pipeline updates from BMY and GILD are the key highlights from the biotech sector during the past week.

ALNYNegative Net Change BMYPositive Net Change GILDPositive Net Change BLUEPositive Net Change ELOXNegative Net Change