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biotechs: Archive
Moderna (MRNA) Secures FDA Nod for mRNA-Based RSV Vaccine
by Zacks Equity Research
The RSV vaccine is Moderna???s (MRNA) second FDA-approved product. Once the vaccine secures the CDC's recommendation, it will be launched in the 2024-2025 respiratory virus season.
GSKPositive Net Change PFEPositive Net Change MRNAPositive Net Change
biotechs medical messenger-rna pharmaceuticals vaccines
Novartis (NVS) Reports Positive Long-Term Data on CSU Drug
by Zacks Equity Research
Novartis (NVS) reports phase III data that confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria.
NVSPositive Net Change RHHBYPositive Net Change KRYSPositive Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Gilead's (GILD) Urothelial Cancer Study Did Not Meet Its Primary Goal
by Zacks Equity Research
Gilead Sciences, Inc.'s (GILD) confirmatory TROPiCS-04 study on Trodelvy in locally advanced or metastatic urothelial cancer fails to achieve its primary endpoint.
GILDNegative Net Change ABBVPositive Net Change KRYSPositive Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Ultragenyx (RARE) DTX401 Meets Goals in Metabolic Disorder Study
by Zacks Equity Research
Ultragenyx (RARE) reports meeting primary and secondary endpoints in the late-stage study of its investigational gene therapy, DTX401, to treat glycogen storage disease type Ia.
RAREPositive Net Change ENTXNegative Net Change ANVSNegative Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Biogen (BIIB) Gets EU Approval for Rare Disease Drug Qalsody
by Zacks Equity Research
Biogen's (BIIB) Qalsody is the first therapy approved to treat a rare genetic form of ALS in Europe
BIIBPositive Net Change HRTXPositive Net Change IONSNegative Net Change BVSPositive Net Change
biotechs
FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD
by Zacks Equity Research
Per the FDA, the data submitted by Sanofi (SNY)/Regeneron (REGN) for Dupixent in COPD indication constitutes a major amendment to its previously-submitted data. A final decision is expected by Sep 27.
REGNNegative Net Change SNYPositive Net Change VRNAPositive Net Change
biotechs medical pharmaceuticals
J&J's (JNJ) Oral Pill Improves Depression & Insomnia Symptoms
by Zacks Equity Research
Data from a late-stage study shows that treatment with J&J's (JNJ) experimental drug met all study endpoints in depression patients with insomnia symptoms.
JNJPositive Net Change HRTXPositive Net Change MRNSPositive Net Change ARQTPositive Net Change
biotechs medical
Bristol Myers (BMY) Gets EC Nod for Opdivo Label Expansion
by Zacks Equity Research
Bristol Myers' (BMY) Opdivo combination regimen receives the European Commission's approval for the first-line treatment of unresectable or metastatic urothelial carcinoma.
BMYNegative Net Change NERVPositive Net Change MRNSPositive Net Change KRYSPositive Net Change
biotechs
Immunovant (IMVT) Falls as Q4 Earnings Miss, Pipeline in Focus
by Zacks Equity Research
Immunovant (IMVT) declines 5% on dismal fourth-quarter fiscal 2024 results. The company names IMVT-1402 as its new lead candidate to initiate several studies for autoimmune indications.
BHVNPositive Net Change ENTXNegative Net Change IMVTPositive Net Change ALXOPositive Net Change
biotechnology biotechs earnings medical pharmaceuticals
Insmed (INSM) Stock Soars 118% on Upbeat Lung Disease Drug Data
by Zacks Equity Research
Data from a late-stage study shows that treatment with Insmed's (INSM) brensocatib reduced episodes of worsening disease symptoms in patients with bronchiectasis, a chronic lung condition.
INSMNegative Net Change HRTXPositive Net Change MRNSPositive Net Change ARQTPositive Net Change
biotechs medical
AstraZeneca (AZN) Falls on Failure to Meet NSCLC Study OS Goal
by Zacks Equity Research
AstraZeneca's (AZN) shares decline as it fails to achieve statistically significant overall survival data in a late-stage NSCLC study on Dato-DXd compared with docetaxel.
AZNPositive Net Change ENTXNegative Net Change ANVSNegative Net Change ALXOPositive Net Change
biotechnology biotechs medical oncology-screening pharmaceuticals
Prothena (PRTA), Bristol Myers Tie Up for Second Neuro Candidate
by Zacks Equity Research
Prothena (PRTA) announces that Bristol Myers is exercising its option for the second time, thereby in-licensing exclusive global rights for PRX019 to potentially treat neurodegenerative diseases.
BMYNegative Net Change PRTAPositive Net Change ANVSNegative Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Candel (CADL) Stock Skyrockets 431% Year to Date: Here's Why
by Zacks Equity Research
Candel (CADL) surges 431% in the year-to-date period, driven by positive developmental and regulatory updates from the clinical program for CAN-2409 across two different cancer indications.
ENTXNegative Net Change ANVSNegative Net Change ALXOPositive Net Change CADLPositive Net Change
biotechnology biotechs medical pharmaceuticals
Moderna (MRNA) Stock Outperformed Industry YTD: Here's Why
by Zacks Equity Research
Shares of Moderna (MRNA) are being driven by encouraging pipeline updates and plans for potential product launches.
MRKPositive Net Change MRNAPositive Net Change HRTXPositive Net Change ARQTPositive Net Change
biotechs medical messenger-rna pharmaceuticals vaccines
Mirum's (MIRM) Livmarli Aids Sales but Overdependence Concerns
by Zacks Equity Research
Mirum's (MIRM) lead drug, Livmarli, continues to generate steady sales. The recent label expansion of the drug should drive sales further. However, overdependence on Livmarli for revenues is a concern.
NERVPositive Net Change MRNSPositive Net Change KRYSPositive Net Change MIRMPositive Net Change
biotechs
Apellis (APLS) Posts Upbeat One-Year Kidney Diseases Study Data
by Zacks Equity Research
Apellis (APLS) reports positive one-year data from the mid-stage study evaluating systemic pegcetacoplan to treat two rare and debilitating kidney diseases.
APLSPositive Net Change ENTXNegative Net Change ANVSNegative Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Novartis (NVS) Presents Positive Data on Renal Drugs at ERA
by Zacks Equity Research
Novartis (NVS) presents data on Fabhalta in adult patients with C3 glomerulopathy and atrasentan in those with IgA nephropathy (IgAN) at the ERA.
NVSPositive Net Change KRYSPositive Net Change MORPositive Net Change ALXOPositive Net Change
biotechnology biotechs pharmaceuticals
Merus (MRUS) Surges 36% on Head & Neck Cancer Antibody Data
by Zacks Equity Research
Data from an earlier cut-off date shows that treatment with Merus' (MRUS) combination therapy achieved a 60% response rate in patients with head and neck cancer.
HRTXPositive Net Change MRNSPositive Net Change MRUSPositive Net Change ARQTPositive Net Change
biotechs medical
Verastem (VSTM) Up on Upbeat Early Pancreatic Cancer Study Data
by Zacks Equity Research
Verastem (VSTM) gains 57% post-market on achieving a confirmed partial response in 83% of first-line patients treated with novel combo therapy in the initial cohort of its phase I/II pancreatic cancer study.
VSTMPositive Net Change ENTXNegative Net Change ANVSNegative Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Bicycle Therapeutics (BCYC) Up as PIPE Funding Set to Make $555M
by Zacks Equity Research
Bicycle Therapeutics (BCYC) gains 10% upon entering a PIPE financing agreement with multiple institutional investors, which is expected to generate gross proceeds of $555 million.
ENTXNegative Net Change BCYCPositive Net Change ANVSNegative Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals
Puma Biotechnology (PBYI) Falls 38% in 3 Months: Here's Why
by Zacks Equity Research
Sales of Puma Biotechnology's (PBYI) sole marketed drug, Nerlynx, have been declining in recent quarters. Stiff competition in the target market is also a woe.
RHHBYPositive Net Change PBYIPositive Net Change MRNSPositive Net Change KRYSPositive Net Change
biotechs
Candel (CADL) Reports Upbeat Data From Lung Cancer Study
by Zacks Equity Research
Candel's (CADL) CAN-2409 prolongs overall survival in a phase II study for treating patients with advanced non-small cell lung cancer who are non-responsive to immune checkpoint inhibitor therapy.
NERVPositive Net Change MRNSPositive Net Change KRYSPositive Net Change CADLPositive Net Change
biotechs
Iovance (IOVA) Up 5% on Updated Data From Melanoma Study
by Zacks Equity Research
Iovance (IOVA) shares updated data from a mid-stage study, which showed that treatment with its combination therapy achieved an objective response rate of 65% in frontline advanced melanoma.
HRTXPositive Net Change MRNSPositive Net Change IOVAPositive Net Change ARQTPositive Net Change
biotechs medical pharmaceuticals
Why Cytokinetics (CYTK) Stock Price Was Down 17% on Thursday
by Zacks Equity Research
Cytokinetics (CYTK) declines after announcing plans for raising about a billion dollars in funding.
NVSPositive Net Change BMYNegative Net Change RPRXPositive Net Change CYTKPositive Net Change
biotechs medical pharmaceuticals
Regeneron (REGN) Announces Positive Data on Oncology Candidate
by Zacks Equity Research
Regeneron's (REGN) REGN7075, in combination with its oncology drug Libtayo, generates anti-tumor responses in patients with microsatellite-stable colorectal cancer.
REGNNegative Net Change RHHBYPositive Net Change BAYRYPositive Net Change ALXOPositive Net Change
biotechnology biotechs medical pharmaceuticals