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biotechs: Archive

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Novartis (NVS) Reports Positive Long-Term Data on CSU Drug

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 KRYSNegative Net Change ALXONegative Net Change

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Gilead's (GILD) Urothelial Cancer Study Did Not Meet Its Primary Goal

Gilead Sciences, Inc.'s (GILD) confirmatory TROPiCS-04 study on Trodelvy in locally advanced or metastatic urothelial cancer fails to achieve its primary endpoint.

GILDPositive Net Change ABBVPositive Net Change KRYSNegative Net Change ALXONegative Net Change

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Ultragenyx (RARE) DTX401 Meets Goals in Metabolic Disorder Study

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 ANVSPositive Net Change ALXONegative Net Change

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Biogen (BIIB) Gets EU Approval for Rare Disease Drug Qalsody

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 IONSPositive Net Change BVSNegative Net Change

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FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD

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.

REGNPositive Net Change SNYPositive Net Change VRNAPositive Net Change

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J&J's (JNJ) Oral Pill Improves Depression & Insomnia Symptoms

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 MRNSNegative Net Change ARQTNegative Net Change

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Bristol Myers (BMY) Gets EC Nod for Opdivo Label Expansion

Bristol Myers' (BMY) Opdivo combination regimen receives the European Commission's approval for the first-line treatment of unresectable or metastatic urothelial carcinoma.

BMYPositive Net Change NERVPositive Net Change MRNSNegative Net Change KRYSNegative Net Change

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Immunovant (IMVT) Falls as Q4 Earnings Miss, Pipeline in Focus

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.

BHVNNegative Net Change ENTXNegative Net Change IMVTNegative Net Change ALXONegative Net Change

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Insmed (INSM) Stock Soars 118% on Upbeat Lung Disease Drug Data

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 MRNSNegative Net Change ARQTNegative Net Change

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AstraZeneca (AZN) Falls on Failure to Meet NSCLC Study OS Goal

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 ANVSPositive Net Change ALXONegative Net Change

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Prothena (PRTA), Bristol Myers Tie Up for Second Neuro Candidate

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.

BMYPositive Net Change PRTAPositive Net Change ANVSPositive Net Change ALXONegative Net Change

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Candel (CADL) Stock Skyrockets 431% Year to Date: Here's Why

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 ANVSPositive Net Change ALXONegative Net Change CADLPositive Net Change

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Moderna (MRNA) Stock Outperformed Industry YTD: Here's Why

Shares of Moderna (MRNA) are being driven by encouraging pipeline updates and plans for potential product launches.

MRKPositive Net Change MRNANegative Net Change HRTXPositive Net Change ARQTNegative Net Change

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Mirum's (MIRM) Livmarli Aids Sales but Overdependence Concerns

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 MRNSNegative Net Change KRYSNegative Net Change MIRMNegative Net Change

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Apellis (APLS) Posts Upbeat One-Year Kidney Diseases Study Data

Apellis (APLS) reports positive one-year data from the mid-stage study evaluating systemic pegcetacoplan to treat two rare and debilitating kidney diseases.

APLSNegative Net Change ENTXNegative Net Change ANVSPositive Net Change ALXONegative Net Change

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Novartis (NVS) Presents Positive Data on Renal Drugs at ERA

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 KRYSNegative Net Change MORPositive Net Change ALXONegative Net Change

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Merus (MRUS) Surges 36% on Head & Neck Cancer Antibody Data

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 MRNSNegative Net Change MRUSNegative Net Change ARQTNegative Net Change

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Verastem (VSTM) Up on Upbeat Early Pancreatic Cancer Study Data

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.

VSTMNegative Net Change ENTXNegative Net Change ANVSPositive Net Change ALXONegative Net Change

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Bicycle Therapeutics (BCYC) Up as PIPE Funding Set to Make $555M

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 ANVSPositive Net Change ALXONegative Net Change

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Puma Biotechnology (PBYI) Falls 38% in 3 Months: Here's Why

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 MRNSNegative Net Change KRYSNegative Net Change

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Candel (CADL) Reports Upbeat Data From Lung Cancer Study

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 MRNSNegative Net Change KRYSNegative Net Change CADLPositive Net Change

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Iovance (IOVA) Up 5% on Updated Data From Melanoma Study

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 MRNSNegative Net Change IOVANegative Net Change ARQTNegative Net Change

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Why Cytokinetics (CYTK) Stock Price Was Down 17% on Thursday

Cytokinetics (CYTK) declines after announcing plans for raising about a billion dollars in funding.

NVSPositive Net Change BMYPositive Net Change RPRXPositive Net Change CYTKNegative Net Change

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Regeneron (REGN) Announces Positive Data on Oncology Candidate

Regeneron's (REGN) REGN7075, in combination with its oncology drug Libtayo, generates anti-tumor responses in patients with microsatellite-stable colorectal cancer.

REGNPositive Net Change RHHBYPositive Net Change BAYRYPositive Net Change ALXONegative Net Change

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Do Options Traders Know Something About Amicus (FOLD) Stock We Don't?

Investors need to pay close attention to Amicus (FOLD) stock based on the movements in the options market lately.

FOLDNegative Net Change