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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.
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.
Seagen (SGEN) expects its portfolio of marketed drugs, which are approved for various cancer indications, to generate incremental sales and combat stiff competition.
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.
Despite being the first protein-based COVID-19 vaccine in many markets, Novavax's (NVAX) delayed product launch severely affected the company's prospects.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
biotechs: Archive
Will Ayvakit Aid Blueprint Medicines (BPMC) Amid Rivalry?
by Zacks Equity Research
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
biotechs
Iovance (IOVA) Focuses on Seeking Nod for Melanoma Therapy
by Zacks Equity Research
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
biotechs medical
Will Seagen's (SGEN) Portfolio of Drugs Help Combat Rivalry?
by Zacks Equity Research
Seagen (SGEN) expects its portfolio of marketed drugs, which are approved for various cancer indications, to generate incremental sales and combat stiff competition.
SNYNegative Net Change RHHBYNegative Net Change SGENNegative Net Change LVTXPositive Net Change
biotechs
Top-Ranked ETFs That Beat the Market in Q3
by Sweta Killa
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
alt-energy biotechs consumer-discretionary etfs tech-stocks
Why Novavax's (NVAX) COVID Vaccine Struggles for Market Share?
by Zacks Equity Research
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
biotechs medical vaccines
Can Biogen (BIIB) Navigate Multiple Challenges & Grow Again?
by Zacks Equity Research
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
biotechs
BioMarin (BMRN) Refiles BLA With FDA for Hemophilia Gene Therapy
by Zacks Equity Research
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
biotechs gene-therapy medical
Sarepta (SRPT) Seeks FDA Nod for DMD Gene Therapy Candidate
by Zacks Equity Research
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
biotechs gene-therapy medical
Deciphera (DCPH) Rises 90% in the Past 6 Months: Here's Why
by Zacks Equity Research
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
biotechs
Amylyx (AMLX) Secures the FDA's Approval for ALS Drug
by Zacks Equity Research
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
biotechnology biotechs pharmaceuticals
Horizon (HZNP) Completes Enrollment in Phase IV TED Study
by Zacks Equity Research
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
biotechs
Biotech Stock Roundup: BIIB's AD Drug Data & REGN, IONS, VRTX's Updates
by Zacks Equity Research
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
biotechnology biotechs pharmaceuticals
EMA Accepts Moderna's (MRNA) Filing for Omicron BA.4, BA.5 Booster
by Zacks Equity Research
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
biotechs medical messenger-rna vaccines
LLY & PRTA in Spotlight on BIIB-Eisai's AD Drug Data
by Ekta Bagri
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
biotechnology biotechs pharmaceuticals
Stock Market News for Sep 29, 2022
by Zacks Equity Research
Wall Street closed sharply higher on Wednesday rebounding from a six-day losing streak.
BIIBNegative Net Change
biotechs
Vertex (VRTX), CRISPR to Seek FDA Nod for Hemoglobinopathy Therapy
by Zacks Equity Research
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
biotechs crispr gene-therapy medical
Bet on These 4 Biotech Stocks With Bright Prospects
by Ekta Bagri
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
biotechnology biotechs
Seagen (SGEN) Inks Deal With LAVA Therapeutics for LAVA-1223
by Zacks Equity Research
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
biotechs
Emergent (EBS) Acquires Worldwide Rights to Smallpox Antiviral
by Zacks Equity Research
Emergent (EBS) completes the acquisition of worldwide rights to Tembexa, an FDA-approved smallpox oral antiviral for all ages, from Chimerix.
EBSNegative Net Change CMRXNegative Net Change ATRANegative Net Change APTONegative Net Change
biotechs
Atea (AVIR) Dengue Candidate Gets Fast Track Designation
by Zacks Equity Research
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
biotechnology biotechs pharmaceuticals
Intercept (ICPT) Stock Gains 13% in 3 Months: Here's Why
by Zacks Equity Research
Intercept (ICPT) gains 13% in the past three months on positive regulatory and pipeline updates.
ICPTNegative Net Change VKTXPositive Net Change BOLTNegative Net Change
biotechnology biotechs pharmaceuticals
Ionis' (IONS) Hypercholesterolemia Drug Not to Enter Phase III
by Zacks Equity Research
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
biotechs
Spero (SPRO) Skyrockets 168% on Licensing Deal With GSK
by Zacks Equity Research
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
biotechs medical
Why Novavax (NVAX) Stock Was Down 13% on Thursday
by Zacks Equity Research
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
biotechs messenger-rna vaccines
Biotech Stock Roundup: GILD, BMY's Regulatory News, BLUE's Therapy Approval & More
by Zacks Equity Research
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
biotechnology biotechs