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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 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…
Shares of Precigen PGEN have witnessed a sharp increase in the past three months, driven by growing investor optimism surrounding the strong commercial performance of the company's sole marketed drug, Papzimeos (zopapogene imadenovec-drba)…
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…
For Immediate Release Chicago, IL – October 5 2026 – Zacks.com announces the list of stocks and ETFs featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the fin…
The three benchmark Wall Street indexes delivered mixed performance for the week ended October 2, 2026. The Dow Jones Industrial Average fell 1.26%, while the S&P 500 declined 0.27%. The Nasdaq Composite, however, gained 0.45%. Stocks face…
Wall Street has remained volatile over the past few months. Major indexes have hit record highs multiple times but have given up substantial gains as investors' sentiment remains low amid ongoing tensions in the Middle East and high inflat…
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 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…
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…
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,…
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 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…
Mirum Pharmaceuticals MIRM announced that the phase III portion of the AZURE-1 study evaluating its pipeline candidate, brelovitug, for the treatment of patients with chronic hepatitis delta virus (HDV) has met its primary endpoint. Data f…
Keros Therapeutics KROS announced that it has dosed the first patient in the phase II study evaluating its lead pipeline candidate, rinvatercept, in patients with Duchenne muscular dystrophy (DMD). The open-label, multi-cohort basket study…
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…
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…
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…
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…
Precigen (PGEN) is back in focus after the United States Food and Drug Administration granted platform technology designation to its AdenoVerse immunotherapeutic platform, which underpins the recently approved PAPZIMEOS therapy. The recent…
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…
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…
Merck MRK announced positive top-line data from the phase IIb/III BRUNELLO study, which evaluated its investigational pipeline candidate, remigromig (MK-3000, formerly EYE103), for treating adult patients with diabetic macular edema ("DME"…
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…
Precigen PGEN is focused on building long-term growth visibility beyond its commercial-stage Papzimeos franchise through its AdenoVerse platform. While Papzimeos is currently driving the company's revenue growth, the platform's clinical pr…
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 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…
Amgen AMGN announced positive top-line data from the phase III OASIZ 301 study evaluating dazodalibep in adults with Sjögren's disease and moderate-to-severe systemic disease activity. Sjögren's disease is a systemic autoimmune disease tha…
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 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…
Alkermes ALKS announced positive top-line data from a phase I proof-of-concept study evaluating its novel, investigational orexin 2 receptor (OX2R) agonist, ALKS 7290, for the treatment of attention-deficit hyperactivity disorder (ADHD). T…
Johnson & Johnson JNJ announced positive top-line data from a pivotal phase III study evaluating Caplyta (lumateperone) for treating manic episodes, with or without mixed features, in adults with bipolar I disorder. More on JNJ's Latest St…
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…
Merck MRK announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use ("CHMP") has issued a positive opinion recommending approval of a combination of its blockbuster PD-L1 inhibitor, Keytruda (pembr…
Corcept Therapeutics CORT announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Lifyorli (relacorilant) in combination with nab-pac…
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…