Skip to main content Exclusive news, data and analytics for financial market professionalsLearn more aboutRefinitiv Novo Nordisk slump wipes out last Wegovy-era gains after trial setback February 23, 202611:43 AM UTCUpdated ago By Reuters The logo of pharmaceutical company Novo Nordisk is displayed on a flag in front of its offices in Bagsvaerd, Copenhagen, Denmark, February 4, 2026. REUTERS/Tom Little Purchase Licensing Rights, opens new tab Feb 23 (Reuters) - Novo Nordisk (NOVOb.CO), opens new tab shares ...

Core Insights - The biotech industry experienced significant developments this week, including FDA approvals, clinical trial results, and licensing agreements, indicating a dynamic landscape for investment opportunities and advancements in healthcare [1]. FDA Approvals & Rejections - NRx Pharmaceuticals is on track for FDA approval of NRX-100, with existing clinical data and real-world evidence from over 65,000 patients potentially supporting a New Drug Application (NDA) under Fast Track Designation [2][3]. - Kane Biotech received FDA clearance for its Revyve Antimicrobial Skin and Wound Cleanser, which targets wound bacteria and biofilms, with plans for manufacturing scale-up in 2026 [4][5]. - Johnson & Johnson's RYBREVANT FASPRO received FDA approval for a simplified monthly dosing schedule, enhancing treatment options for patients with advanced non-small cell lung cancer [6][7]. - Spruce Biosciences reported positive feedback from FDA Type B meetings for its enzyme replacement therapy for Sanfilippo syndrome type B, with a targeted BLA filing in Q4 2026 [8][9]. - Moderna's seasonal influenza vaccine submission (mRNA-1010) is under FDA review, with a PDUFA date set for August 5, 2026, aiming for availability in the 2026/2027 flu season [10][11]. - Disc Medicine received a Complete Response Letter (CRL) for its NDA for Biopertin in erythropoietic protoporphyria, citing insufficient correlation with sunlight exposure endpoints [13][14]. - AbbVie and Genentech's combination regimen of VENCLEXTA and Acalabrutinib for chronic lymphocytic leukemia (CLL) received FDA approval, showing a 35% reduction in disease progression risk compared to standard treatment [15][16]. Deals - Theriva Biologics entered an exclusive licensing agreement with Rasayana Therapeutics for SYN-020, receiving a $3 million upfront payment and potential milestone payments totaling up to $38 million [17][18]. - Sensei Biotherapeutics acquired Faeth Therapeutics, expanding its oncology portfolio with the investigational asset PIKTOR, and announced a concurrent private placement of $200 million to advance clinical milestones [19][20]. Clinical Trials - Breakthroughs - Eli Lilly's Taltz and Zepbound combination therapy showed positive results in a Phase 3 trial for plaque psoriasis and obesity, achieving superior outcomes compared to Taltz alone [21][22]. - Zealand Pharma reported positive Phase 1a results for ZP9830, a Kv1.3 channel blocker, demonstrating safety and tolerability in healthy volunteers [23][24]. - Novartis' Remibrutinib met primary endpoints in a Phase 3 trial for chronic inducible urticaria, showing significant response rates compared to placebo [26][27]. - Ocular Therapeutix's AXPAXLI demonstrated superiority over aflibercept in a Phase 3 trial for wet age-related macular degeneration, although stock prices fell due to investor disappointment [28][29]. - Rallybio's RLYB116 Phase 1 study showed promising results for immune platelet transfusion refractoriness, with plans for a Phase 2 trial in 2026 [31][32]. - Teva and Sanofi's Duvakitug Phase 2b trial demonstrated durable efficacy in ulcerative colitis and Crohn's disease, reinforcing the rationale for ongoing Phase 3 programs [35][36]. - Genentech's Gazyva met primary endpoints in a Phase III study for primary membranous nephropathy, showing significant remission rates compared to tacrolimus [38][39].

Company Overview - Zealand Pharma A/S is a biotechnology company focused on advancing medicines for obesity and metabolic health, leveraging over 25 years of peptide R&D expertise and a proprietary data platform utilizing advanced data-driven and AI/ML approaches [2][3] - The company has more than ten drug candidates that have entered clinical development, with two products already on the market and three candidates in late-stage development [3] Annual General Meeting (AGM) Details - The Annual General Meeting for Zealand Pharma will take place on Thursday, March 26, 2026, at 03:00 PM CET / 9:00 AM ET, and will be conducted as a hybrid meeting allowing both electronic and in-person participation [1][2] - The meeting will be hosted electronically via a virtual meeting portal by Computershare A/S, with a physical location at the company's registered office in Søborg, Denmark [2]

Core Insights - Zealand Pharma announced positive Phase 1a topline results for ZP9830, a Kv1.3 channel blocker, indicating favorable safety and tolerability in healthy male participants [2][4] Group 1: Phase 1a Trial Results - The Phase 1a trial was a single ascending dose (SAD) study designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ZP9830 [2][5] - ZP9830 was well tolerated with no dose-limiting safety findings or serious adverse events reported [3][8] - Pharmacokinetic parameters showed a dose-proportional increase, and the intravenous cohort demonstrated high bioavailability of the subcutaneous formulation [3][8] Group 2: ZP9830 Overview - ZP9830 is a selective Kv1.3 channel blocker with potential applications in treating various immune-mediated inflammatory diseases [6][8] - The Kv1.3 channel is selectively upregulated on effector memory T cells, which are involved in autoimmunity and chronic inflammation [6][7] Group 3: Company Background - Zealand Pharma focuses on advancing medicines for obesity and metabolic health, leveraging over 25 years of peptide R&D expertise [8][9] - The company has successfully developed multiple drug candidates, with two products already on the market and three in late-stage development [9]

Core Insights - Zealand Pharma announced positive Phase 1a topline results for ZP9830, a Kv1.3 channel blocker, indicating favorable safety and tolerability in healthy male participants [2][4] Group 1: Phase 1a Trial Results - The Phase 1a trial was a single ascending dose (SAD) study designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ZP9830 [2][5] - ZP9830 was well tolerated with no dose-limiting safety findings or serious adverse events reported [3][8] - Pharmacokinetic parameters showed a dose-proportional increase, and the intravenous cohort demonstrated high bioavailability of the subcutaneous formulation [3][8] Group 2: ZP9830 Overview - ZP9830 is a potent and selective Kv1.3 channel blocker with potential applications in treating various immune-mediated inflammatory diseases [6][8] - The Kv1.3 channel is selectively upregulated on effector memory T cells, which are involved in autoimmunity and chronic inflammation [6][7] Group 3: Company Background - Zealand Pharma is focused on advancing medicines for obesity and metabolic health, leveraging over 25 years of peptide R&D expertise [8][9] - The company has successfully developed more than ten drug candidates, with two products already on the market and three in late-stage development [9]

Press Release – No. 3 / 2026 Zealand Pharma conference call on February 19 at 2pm CET (8am ET) to present full year 2025 financial results Copenhagen, Denmark, February 12, 2026 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, announced that it will host a conference call on February 19, 2026, at 2:00 pm CET (8:00 am ET) following the announcement of financial results for the full year of 2025. Participating in the call will be Pres ...

Core Viewpoint - Zealand Pharma A/S will host a conference call on February 19, 2026, to present its full year 2025 financial results [1] Group 1: Conference Call Details - The call will feature President and CEO Adam Steensberg, CFO Henriette Wennicke, and CMO David Kendall, followed by a Q&A session [2] - A live audio webcast and accompanying slide presentation will be available online [3] - Participants are encouraged to register approximately 10 minutes before the call, and a recording will be accessible on the company's website afterward [4] Group 2: Company Overview - Zealand Pharma A/S is focused on developing medicines for obesity and metabolic health, leveraging over 25 years of peptide R&D expertise and advanced data-driven approaches [5] - The company has over ten drug candidates in clinical development, with two products already on the market and three in late-stage development [6] - Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in Boston, Massachusetts [6]

Company Overview - Zealand Pharma A/S (ZLDPF) shares increased by 6.8% to close at $67.8, following a notable trading volume, contrasting with a 17.6% loss over the past four weeks [1][2] Pipeline Developments - The price increase is linked to growing investor optimism regarding the pipeline candidate petrelintide, aimed at treating overweight or obese individuals with type 2 diabetes. Additionally, the company is developing survodutide for similar patient groups, with several data readouts anticipated in 2026 [2] Financial Expectations - Zealand Pharma is projected to report a quarterly loss of $1.34 per share, reflecting a year-over-year decline of 127.1%. Expected revenues are $9.73 million, marking a significant increase of 654.3% compared to the same quarter last year [3] - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Zealand Pharma is categorized under the Zacks Medical - Biomedical and Genetics industry, where Day One Biopharmaceuticals, another company in the same sector, saw a 2.2% increase in its stock price, closing at $12.34, with a 25.7% return over the past month [5]

Core Viewpoint - Axsome Therapeutics (AXSM) has experienced a significant stock price increase, attributed to positive sales forecasts and the initiation of a new clinical study [2][3]. Group 1: Stock Performance - Axsome Therapeutics shares rose 4.1% to close at $184.5, with trading volume significantly higher than usual, reflecting a 14.6% gain over the past four weeks [1]. - The stock's recent rally is linked to the announcement of preliminary fourth-quarter and full-year 2025 sales figures for its marketed products [2]. Group 2: Financial Expectations - The company is expected to report a quarterly loss of $0.73 per share, which is a year-over-year increase of 24%, while revenues are projected to be $190.18 million, marking a 60.1% increase from the same quarter last year [3]. - Despite the positive revenue growth expectations, the consensus EPS estimate has been revised slightly lower over the past 30 days, indicating a potential negative trend in earnings estimate revisions [4]. Group 3: Industry Context - Axsome Therapeutics is categorized within the Zacks Medical - Biomedical and Genetics industry, which includes other companies like Zealand Pharma A/S (ZLDPF) that has seen a decline of 12.5% over the past month [5]. - Zealand Pharma AS has an unchanged consensus EPS estimate of -$1.34, representing a significant year-over-year decline of 127.1% [6].

Core Insights - Zealand Pharma is entering what it considers the most exciting year in its 25-year history, focusing on addressing the obesity pandemic and related diseases through its newly launched Metabolic Frontier 2030 strategy [1][2]. Company Focus - The company emphasizes the need for significant new innovations to effectively tackle the healthcare challenges posed by the obesity pandemic [2]. - Zealand Pharma aims to position itself as a leading generational biotech company in metabolic health, with a vision to change the landscape for patients suffering from obesity-related conditions [3].