Alumis (ALMS) stock exploded higher on Tuesday after the biotech firm reported promising Phase 3 results for envudeucitinib, its candidate treatment for psoriasis. In the late-stage trial, envudeucitinib helped patients experience symptom improvement that “rank among the strongest reported for an oral therapy,” the company said in its press release. More News from Barchart While ALMS shares reversed nearly half of their intraday gains by market close on Jan. 6, at one point, they were seen trading at a ...

Key Takeaways The EC approved Tremfya for patients aged 6-17 years with plaque psoriasis needing systemic therapy.The PROTOSTAR study met PASI 75 and IGA 0/1 endpoints at 16 weeks.Tremfya drove JNJ sales growth, generating $3.6B in the first nine months of 2025, up 31% year over year.Johnson & Johnson (JNJ) announced that the European Commission (EC) has approved an expanded use of its blockbuster psoriasis drug, Tremfya, in children. Tremfya is now approved to treat pediatric and adolescent patients (aged ...

MONTREAL, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that Health Canada has approved WYNZORA®, a white uniform cream containing 0.05 mg/g of calcipotriol (CAL) and 0.5 mg/g of betamethasone dipropionate (BDP), indicated for the topical treatment of psoriasis vulgaris in adults and adolescents aged 12-17 years for up to 8 weeks.1 Knight obtained the Canadian rights to WYNZORA® through its June 202 ...

Core Insights - Innovent Biologics announced that PECONDLE® (picankibart injection) achieved both primary and key secondary efficacy endpoints in the Phase 3 CLEAR-2 study for moderate-to-severe plaque psoriasis, marking it as the first China-developed IL-23p19 monoclonal antibody to receive market approval from the NMPA in November 2025 [1][11]. Study Design and Results - The CLEAR-2 study was a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial involving 566 participants, focusing on the efficacy of picankibart during maintenance treatment and after withdrawal [2]. - At Week 56, 89.3% of participants in the 100 mg group and 90.1% in the 200 mg group maintained a PASI 90 response, significantly higher than the withdrawal groups [3]. - All key secondary endpoints were met, showing significant improvements in skin clearance and quality of life for participants receiving picankibart compared to those in withdrawal [4]. Efficacy and Safety - Picankibart demonstrated durable efficacy post-withdrawal, with maintenance treatment significantly reducing the risk of losing PASI 90 response compared to withdrawal groups [5]. - The safety profile of picankibart remained favorable throughout the study, with no new safety signals identified [6]. Clinical Implications - The results of the CLEAR-2 study provide critical insights into the necessity of maintenance therapy and the durability of post-withdrawal responses, offering assurance for chronic psoriasis patients [7]. - The successful Phase 3 results validate picankibart's advantages as a next-generation IL-23p19 inhibitor, emphasizing its potential for deep, durable remission and improved quality of life for patients [8]. Background on Psoriasis and Treatment - Psoriasis is a chronic inflammatory disease affecting a significant portion of the population, with moderate-to-severe cases representing nearly 30% of patients [9]. - Current systemic treatments in China include various agents, with biologics, particularly IL-23 inhibitors, gaining prominence due to their efficacy and safety [9]. About PECONDLE® - PECONDLE® is a monoclonal antibody developed by Innovent that targets the IL-23p19 subunit, offering a potential treatment option for psoriasis and other autoimmune diseases [10]. - The product has received approval for treating moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy, with ongoing studies exploring additional indications [11]. Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer and autoimmune disorders, and has launched 17 products to date [12][13].

Core Insights - NoviThera ApS has initiated its first efficacy studies on animals for a novel treatment targeting psoriasis, a chronic inflammatory skin condition [1][9] - The company is focusing on a specific endogenous polypeptide that is hypothesized to be responsible for the pathology of psoriasis, with the aim of reducing or removing it to cure and prevent disease progression [3][10] Company Overview - NoviThera is a majority-owned subsidiary of Nordicus Partners Corporation, which specializes in supporting Nordic and U.S. life sciences companies in establishing themselves in the U.S. market [1][11] - The mission of NoviThera is to research and develop a unique monoclonal antibody as an innovative therapy for psoriasis [10] Research and Development Activities - Two preclinical mouse studies are currently underway to document biological proof of concept for the treatment [8] - The first study involves intradermal injections at the plaque site, treating animals that develop psoriasis with a proprietary monoclonal antibody [8] - The second study is focused on developing a humanized genetic mouse capable of producing the polypeptide, which is unique to humans, to facilitate further animal studies [9] Mechanism of Action - The polypeptide in question is a cathelicidin antimicrobial peptide that plays a crucial role in the innate immune response, exhibiting antimicrobial and immunomodulatory properties [4] - It is involved in the regulation of the immune system and has a pro-inflammatory role in psoriasis, exacerbating inflammation by promoting immune cell activation [5] - The polypeptide binds to self-DNA and self-RNA from damaged keratinocytes, activating plasmacytoid dendritic cells and leading to the production of type I interferons [6][7] Future Plans - After completing the current studies, NoviThera plans to conduct toxicity studies in 2027 and initiate patient testing in 2028 [9]

Core Insights - The U.S. FDA has cleared Oruka Therapeutics' IND application for the Phase 2a trial of ORKA-001 in moderate-to-severe psoriasis, named EVERLAST-A, with initial data expected in the second half of 2026 [1][2] - ORKA-001 is a long-acting anti-IL-23p19 antibody that aims to redefine the standard of care for psoriasis, potentially allowing for once-per-year dosing and higher rates of disease clearance [2][4] Company Overview - Oruka Therapeutics is focused on developing novel biologics to set a new standard for treating chronic skin diseases, particularly plaque psoriasis, with a mission to achieve high rates of complete disease clearance with infrequent dosing [5][6] - The company is advancing a proprietary portfolio of antibodies targeting the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases [5] Clinical Trial Details - The EVERLAST-A trial will enroll approximately 80 patients, randomized 3:1 to receive ORKA-001 or a matching placebo, with the primary endpoint being PASI 100 at Week 16 [2] - Patients achieving PASI 100 at Week 28 will be randomized to either a "no-dose" arm or receive ORKA-001 every six months, providing evidence for yearly dosing and potential extended off-treatment remissions [2] - Interim data from the Phase 1 study and further details on the EVERLAST-A design will be presented at the EADV Congress in September [1][2] Product Information - ORKA-001 is a subcutaneously administered monoclonal antibody with a significantly extended half-life, designed to achieve higher exposures than currently marketed IL-23p19 antibodies [4] - Current therapies for moderate-to-severe psoriasis require dosing four to six times per year, with less than half of patients achieving PASI 100 after four months, whereas ORKA-001 aims for dosing just once or twice a year [4]