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argenx Meets Primary Endpoint in Phase II Celiac Disease Study
argenx SE ARGX announced positive top-line data from a phase II study evaluating FB102, an investigational therapy in adults with celiac disease. Celiac disease is a chronic autoimmune condition triggered by gluten, a protein found in whea…
EDIT Set to Begin First-in-Human Study in Hypercholesterolemia
Editas Medicine EDIT announced that it has received approval to initiate the first-in-human phase I/II Strive clinical study of EDIT-401, its investigational in vivo gene-editing candidate for heterozygous familial hypercholesterolemia (He…
ARGX Stock Down on Stopping Late-Stage Autoimmune Disease Study
argenx ARGX suffered a clinical setback after deciding to discontinue the late-stage UNITY study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with moderate-to-severe Sjögren's disease. The…
Here's Why You Should Add LPCN Stock to Your Portfolio Now
Lipocine LPCN is an emerging specialty pharmaceutical company focused on developing oral therapies for diseases with significant unmet medical needs. The company offers a mix of an approved commercial product, a potentially differentiated…
Ultragenyx to Sell Rare Pediatric Disease PRV for $210M to Boost Cash
Ultragenyx Pharmaceutical RARE has entered into a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) for $210 million. The transaction is expected to provide the rare-disease drugmaker with a meaningful inf…
ETON Stock Surges 108% in Six Months: Here's What You Need to Know
Shares of Eton Pharmaceuticals ETON have gained about 108% over the past six months compared with the industry's 0.7% growth, fueled by growing investor confidence in the company's strong commercial execution, rapid revenue growth and an e…
AGIO Stock Sinks 29% in Three Months: Here's What You Need to Know
Shares of Agios Pharmaceuticals AGIO have declined 29% over the past three months despite strong growth in mitapivat sales in the second quarter of 2026. The decline largely reflects setbacks to tebapivat, a key pipeline candidate, which h…
PCRX Expands Exparel Commercial Reach in Europe Through Molteni Deal
Pacira BioSciences PCRX announced an exclusive agreement with Molteni Farmaceutici to distribute and commercialize Exparel (bupivacaine liposome injectable suspension) in the EU and the United Kingdom. Molteni is an Italian specialty pharm…
Ultragenyx's Gene Therapy for Sanfilippo Syndrome Wins EMA Validation
Ultragenyx Pharmaceutical RARE announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for the investigational gene therapy rebisufligene etisparvovec (also known as UX111) to treat mu…
Novo's Denecimig BLA Review Delayed by FDA Facility Remediation Work
Novo's NVO denecimig biologics license application (BLA) review in the United States is facing an extended timeline after the FDA informed the company that the review of the investigational therapy for haemophilia A remains ongoing. The FD…
Novo's Wegovy Pill Shows Weight Loss After Switching From Injections
Novo's NVO oral Wegovy (semaglutide) is showing real-world weight-loss benefits among adults with overweight or obesity who switched from injectable GLP-1 therapies. Data from the OCTANE study found that people moving from Eli Lilly's LLY…
Merck Inks $2.1B Deal With Chinese Biotech to Expand Oncology Pipeline
Merck MRK has entered into an exclusive global licensing agreement with SciBrunch Therapeutics, a China-based biotech company, for SPR2015, an investigational preclinical oral KRAS G12D (ON) inhibitor. Under the deal, Merck obtained exclus…
Acadia's Daybue Patent Allowance Extends U.S. Protection to March 2041
Acadia Pharmaceuticals ACAD has strengthened the intellectual property protection surrounding trofinetide, marketed in the United States as Daybue, following a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO). The allo…
ACAD Stock Down 13% as Phase II Alzheimer's Study Misses Primary Goal
Acadia Pharmaceuticals ACAD announced phase III-enabling top-line results from the phase II portion of the RADIANT study evaluating remlifanserin for the treatment of hallucinations and delusions associated with Alzheimer's disease psychos…
IMVT Ends Cutaneous Lupus Erythematosus Program, Stock Down
Immunovant IMVT announced top-line data from a proof-of-concept study that evaluated its lead and sole pipeline asset, IMVT-1402 (imeroprubart), a next-generation neonatal fragment crystallizable receptor (FcRn) inhibitor, for the treatmen…
Vertex Posts Positive Phase II Data on Kidney Disease Drug
Vertex Pharmaceuticals VRTX announced positive data from the phase IIb AMPLIFIED study, which evaluated its investigational drug, inaxaplin, for the treatment of patients with APOL1-mediated kidney disease ("AMKD") and modest proteinuria a…
AstraZeneca's Trixeo Secures Approval for Asthma in the EU
AstraZeneca AZN announced that the European Commission has approved its respiratory drug, Trixeo Aerosphere, for a new indication. The drug is approved in the European Union (EU) as a maintenance treatment for previously treated asthma pat…
AbbVie's Rinvoq Wins EU Approval in Juvenile Idiopathic Arthritis
AbbVie ABBV announced that the European Commission ("EC") has approved its blockbuster immunology drug, Rinvoq (upadacitinib), for a new indication. The drug is approved in the European Union for the treatment of active polyarticular juven…
Novo's CagriSema Outshines Zepbound in Key Phase III Weight-Loss Study
Novo NVO announced top-line results from two phase III studies evaluating once-weekly CagriSema, its investigational fixed-dose combination of cagrilintide and semaglutide, in obesity and type II diabetes (T2D). In the REIMAGINE 5 study, C…
AZN's Klygefa Gets CHMP Nod for Generalised Myasthenia Gravis in EU
AstraZeneca AZN announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of its rare-disease drug, Klygefa (gefurulimab), as an add-on…
Novo's Sogroya Gains CHMP Nod for Idiopathic Short Stature in the EU
Novo NVO announced that its once-weekly growth hormone therapy Sogroya (somapacitan) received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for treating children with idiopath…
Novo's Denecimig Gets CHMP Nod for Hemophilia A in the European Union
Novo NVO announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of denecimig (Mim8) for the treatment of hemophilia A, with or witho…
XENE Files NDA for Epilepsy Drug, Falls on Depression Studies' Setback
Xenon Pharmaceuticals XENE announced that it has submitted a new drug application (NDA) to the FDA for azetukalner, its lead investigational therapy for the treatment of focal onset seizures (FOS) in epilepsy. If approved, the company will…
RARE Stock Up 13% on FDA Approval of Sanfilippo Syndrome Gene Therapy
Shares of Ultragenyx Pharmaceutical RARE jumped 12.6% on Thursday after the FDA granted standard full approval to Fayuvi (rebisufligene etisparvovec-hopf), also known as UX111. The one-time gene therapy is approved for treating the neurolo…
Kiniksa Pharmaceuticals Stock Rallies 41% in Three Months: Here's Why
Shares of Kiniksa Pharmaceuticals International KNSA have soared 41% over the past three months, driven by strong sales growth from its leading commercial product, Arcalyst, upward revisions to the company's 2026 revenue outlook and encour…
Novo Expands AI Push With Anthropic Deal to Accelerate Drug Discovery
Novo NVO is expanding its artificial intelligence (AI) capabilities through a new collaboration with Anthropic to accelerate drug discovery and development of new medicines. Under the agreement, Novo will use Anthropic's models and Claude…
Gilead Expands Lenacapavir Access With New PAHO Deal in Latin America
Gilead Sciences GILD has signed an agreement with the Pan American Health Organization (PAHO) to accelerate access to twice-yearly lenacapavir for HIV prevention across PAHO Member States in Latin America and the Caribbean. The agreement w…
GSK Inks $750M Deal to Add Experimental Blood Cancer Therapy
GSK plc GSK has entered into an agreement to acquire an investigational trispecific T-cell engager (TCE) from Chimagen Biosciences, a privately held biotechnology company. Under the agreement, GSK will pay Chimagen an upfront payment in ex…
GSK Presents Jideytro Data for Potential Use in First-Line NSCLC
GSK plc GSK announced positive data from the registrational phase I/II ARROS-1 study evaluating its oncology drug, Jideytro (zidesamtinib), for the first-line treatment of patients with advanced or metastatic ROS1-positive non-small cell l…
AbbVie's Atogepant Meets Goal in Late-Stage Menstrual Migraine Study
AbbVie ABBV announced positive top-line data from the phase III LUNA study, which evaluated atogepant, an oral calcitonin gene-related peptide receptor antagonist, for preventive treatment of menstrual migraine in adult women. Menstrual mi…
Bayer Secures FDA Nod for Sevabertinib's First-Line Use in NSCLC
Bayer BAYRY announced that the FDA has granted approval to sevabertinib through an accelerated pathway for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have…
SMMT Stock Soars on NSCLC Drug Survival Data Beating Keytruda in China
Summit Therapeutics SMMT stock climbed 17.3% on Thursday after its Chinese partner Akeso reported positive overall survival (OS) results for ivonescimab in a head-to-head phase III study against Merck's MRK blockbuster oncology drug, Keytr…
Krystal Stock Gains 13.4% in a Month: What Is Driving the Rally?
Shares of Krystal Biotech KRYS have risen 13.4% over the past month compared with the industry's 8.2% growth, fueled by improving investor confidence in the company's commercial performance and its expanding pipeline of genetic medicines.Z…
FDA Accepts UTHR's sNDA for Tyvaso in Idiopathic Pulmonary Fibrosis
United Therapeutics UTHR recently announced that the FDA has accepted its supplemental new drug application (sNDA) for review, seeking approval for expanded use of its marketed drug, nebulized Tyvaso, in idiopathic pulmonary fibrosis (IPF)…
RARE Stock Down 46% as Phase III Angelman Syndrome Study Misses Goals
Ultragenyx Pharmaceutical RARE stock is down 46% in premarket trading today after the company reported that the late-stage study evaluating its investigational antisense oligonucleotide candidate, apazunersen (GTX-102), for Angelman syndro…
AZN's Tagrisso Plus Orpathys Study in First-Line NSCLC Meets Goal
AstraZeneca AZN announced positive data from the phase III SANOVO study evaluating Tagrisso (osimertinib) plus Orpathys (savolitinib) in treatment-naïve patients with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC) w…