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INSM Stock Slides on CFO Exit, Reiterates '26 Sales View
Shares of Insmed INSM declined nearly 7% on Monday after the company announced that its chief financial officer (CFO), Sara Bonstein, will step down from her role effective Oct. 30. The departure came as a surprise to investors, given Bons…
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…
Novartis Strengthens RNA Therapeutics Pipeline With $7.8B Abogen Deal
Swiss pharma giant Novartis NVS entered into a licensing and option agreement with China-based Abogen Biosciences in a bid to expand its presence in RNA-based therapeutics. The deal gives Novartis exclusive worldwide rights to Abogen's lea…
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…
UTHR Prevails in LQDA's Yutrepia Patent Dispute, Stock Up Nearly 13%
United Therapeutics UTHR announced that it has received a favorable ruling in its patent litigation against Liquidia Technologies LQDA concerning the latter's lead product, Yutrepia, a dry-powder inhaled formulation of treprostinil. UTHR s…
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's Tulisokibart Meets Endpoints in Hidradenitis Suppurativa Study
Merck MRK announced that the phase IIb MK-7240-012 study, which evaluated its investigational pipeline candidate, tulisokibart, in patients with moderate to severe hidradenitis suppurativa ("HS"), has met the primary endpoint. HS is a chro…
NVO's Ozempic Outshines LLY's Mounjaro in Lowering Cardiovascular Risk
Novo NVO announced new real-world data from the COMPETE SWITCH Cardiovascular (CV) study comparing treatment strategies in adults with type II diabetes (T2D) who were already receiving a 1-mg dose of Ozempic (semaglutide) injection. The an…
Here's Why You Should Add URGN Stock to Your Portfolio Now
UroGen Pharma URGN is emerging as a commercial-stage biotech with an expanding presence in uro-oncology. The company has two marketed products, Zusduri and Jelmyto, and a pipeline that could support additional growth in bladder cancer and…
Here are two stocks with buy rank and strong momentum characteristics for investors to consider today, September 30th: Stepan SCL: This company, which is a major manufacturer of specialty and intermediate chemicals used in a broad range of…
AbbVie Wins FDA Nod for New Parkinson's Disease Drug Juvmo
AbbVie ABBV announced that the FDA has approved tavapadon as a once-daily oral treatment for Parkinson's disease (PD). The drug, which will be marketed under the brand name Juvmo, will be commercially launched next month. Per the company,…
KOD Stock Soars 178% on Positive Wet AMD Data as BLA Filing Nears
Shares of Kodiak Sciences KOD have surged 178% following the announcement of positive top-line data from the phase III DAYBREAK study on its key pipeline candidate, Zenkuda (tarcocimab tedromer). The study evaluated Zenkuda and tabirafusp-…
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…
Teva's Branded Drugs Take Center Stage in Its Growth Strategy
Teva Pharmaceutical Industries Limited's TEVA business was heavily dependent on generic medicines for decades. That model provided scale but also exposed the company to intense price competition, product commoditization and periodic revenu…
FDA Expands Merck's Welireg Label for a New Kidney Cancer Indication
Merck MRK announced that the FDA has expanded the label of its oral cancer drug Welireg (belzutifan) for a third indication in advanced renal cell carcinoma (RCC), the most common type of adult kidney cancer. The drug has been approved in…
MIRM Secures FDA Nod for an Ultra-Rare Bone Disorder Therapy
Mirum Pharmaceuticals MIRM announced that its oral pill zilurgisertib secured FDA approval for the treatment of fibrodysplasia ossificans progressiva (FOP) in patients aged 12 years and older. The drug will be marketed under the name Atebr…
LLY's Olumiant Gets FDA Nod for Expanded Use in Pediatric Hair Loss
Eli Lilly and Company LLY announced the FDA approval of Olumiant (baricitinib), a once-daily oral therapy, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA). The FDA decision expands Olumian…
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…
LLY's Onswik Wins FDA Nod as a Once-Weekly Basal Insulin for T2D
Eli Lilly and Company LLY secured FDA approval for Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin to treat adults with type II diabetes (T2D). It is approved for use along with diet and exercise to help control blood suga…
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…
CBAK Energy Technology Stock And 2 Top Penny Stocks To Watch
Global inflation is expected to stay above central bank targets into 2027, and the OECD sees more rate hikes as likely. Cash sitting on the sidelines could lose real buying power if that happens. Investors looking for stocks under US$5 wit…
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…
FDA Accepts Insmed's Filing Seeking Label Expansion for Arikayce
Insmed INSM announced that the FDA has accepted a regulatory filing seeking label expansion for Arikayce in mycobacterium avium complex (MAC) lung disease. The FDA has granted the filing priority review, shortening the review period by fou…
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…