Intercept Pharmaceuticals, Inc.

In the Phase III STRATUM trial, 80% of patients succeeded in the treatment by week eight using ZORYVE foam. Credit: Arcutis Biotherapeutics, Inc./GlobeNewswire. Arcutis Biotherapeutics ‘ subsidiary, Arcutis Canada, has received Health Canada’s approval for ZORYVE (roflumilast) topical foam 0.3%, to treat seborrheic dermatitis in patients aged nine years and above. This is the second international approval of ZORYVE, offering a new treatment option to the more than two million Canadians affected by the chronic skin condition. The approval was based on positive outcomes from the pivotal Phase III STRATUM study, along with results from a Phase II long-term open-label extension trial study and a Phase I pharmacokinetic clinical trial. In the vehicle-controlled STRATUM trial, 80% of patients succeeded in the treatment by week eight using ZORYVE foam, with some experiencing disease clearance as early as week two. The foam can provide significant itch relief within 48 hours due to its formulation, designed to administer the medicine effectively without troubling the skin barrier. See Also: FDA approves Astellas’ VYLOY for gastric cancer treatment Intercept’s liver disease drug Ocaliva faces FDA approval delay ZORYVE foam 0.3% is the first topical medication with a new mechanism of action for seborrheic dermatitis approved in Canada in more than two decades. Arcutis president and CEO Frank Watanabe stated: “ZORYVE foam has made a meaningful impact on the lives of individuals living with seborrheic dermatitis since launching in the United States at the beginning of this year, with rapid adoption by both clinicians and patients. We are proud to bring this safe, effective and well-tolerated steroid-free foam to Canada, as there has been a lack of innovation for the treatment of seborrheic dermatitis for decades. “We would like to thank the Canadian investigators and patients who participated in our ZORYVE clinical trials and who played a critical role in bringing this potential best-in-class topical treatment to the United States and Canada markets.” Roflumilast, the active ingredient in ZORYVE, is a highly potent and selective inhibitor of Phosphodiesterase-4 (PDE4), an enzyme known to modulate inflammatory responses in the skin. Arcutis has developed roflumilast’s cream as well as foam formulations to treat dermatologic conditions. The US Food and Drug Administration (FDA) had previously approved ZORYVE foam 0.3% for seborrheic dermatitis in December 2023. The FDA also approved ZORYVE cream for atopic dermatitis in July 2024 .

The Ion Torrent Oncomine Dx Target Test is the first FDA-approved next generation sequencing-based diagnostic. Credits: JHVEPhoto / Shutterstock. Thermo Fisher Scientific has announced that its in vitro diagnostic test, Oncomine, has won US Food and Drug Administration (FDA) approval for use as a companion diagnostic in grade 2 IDH-mutant glioma. As per the 21 October press announcement, Oncomine is now approved to be used to identify patients who are eligible for treatment with Servier Pharmaceuticals’ Voranigo (vorasidenib) tablets. Voranigo, which gained FDA approval in August 2024, is the first and only targeted therapy available for patients with grade 2 IDH-mutant glioma. The French drugmaker gained control over the asset in 2020 after purchasing Agios’ oncology pipeline for $1.8bn in 2020. Agios has since sold its royalty stake in Voranigo to Royalty Pharma for $905m. Under the terms of the agreement, Royalty Pharma will gain a 12% royalty on annual US sales up to $1bn and a 12% royalty on net US sales over $1bn. As a once-daily oral inhibitor of IDH1 and IDH2 enzymes, Voranigo is indicated for use in grade 2 IDH-mutant glioma patients following surgery, including biopsy or gross total resection. The Ion Torrent Oncomine Dx Target Test is the first FDA-approved sequencing-based diagnostic. Oncomine received its first approval as a companion diagnostic in 2017 and subsequently gained approval in August 2022 as a companion diagnostic for identifying non-small cell lung cancer (NSCLC) patients eligible for treatment with Daiichi Sankyo ’s Enhertu (fam-trastuzumab deruxtecan-nxki). See Also: FDA approves Astellas’ VYLOY for gastric cancer treatment Intercept’s liver disease drug Ocaliva faces FDA approval delay Oncomine is also approved for use in cholangiocarcinoma (CCA), medullary thyroid cancer (MTC) and thyroid cancer (TC). Daiichi and AstraZeneca ’s Enhertu has seen several wins this year. The drug gained conditional approval in China earlier this month and a breakthrough therapy designation for a specific type of breast cancer in August 2024. Additionally, in April, the treatment was granted accelerated approval for the treatment of unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive [immunohistochemistry (IHC) 3+] solid tumours. According to GlobalData’s consensus forecasts, Voranigo is expected to generate sales of $37m in 2030. Enhertu is projected to generate total sales of $13bn in 2030. GlobalData is the parent company of Pharmaceutical Technology .

Seaport will use the $225m funding to advance its pipeline of experimental drugs for neuropsychiatric disorders. Credit: eamesBot via Shutterstock. PureTech-founded Seaport Therapeutics has raised $225m in a Series B financing round to support the development of new prodrug treatments for psychiatric disorders. Seaport plans to use the new funds to push forward its pipeline of experimental drugs, including its most advanced candidate, SPT-300, which is being advanced into a Phase IIb trial for major depressive disorder. SPT-300 is an oral prodrug of brexanolone, a neurosteroid compound with known anti-depressant effects. Topline results from Seaport’s SPT-300 Phase IIa proof-of-concept trial were reported in November 2023, where the study met its primary endpoint of salivary cortisol response. The financing was led by General Atlantic, with backing from several other major investors such as T Rowe Price, Foresite Capital, and Goldman Sachs . The latest funding comes after the company’s launch in April 2024, when it secured $100m in initial funding from founding investors ARCH Venture Partners, Sofinnova Investments, Third Rock Ventures, and co-founder Puretech Health . The funding will also support Seaport’s Glyph technology platform, which helps drugs be absorbed more efficiently by using the body’s lymphatic system. This platform could improve the delivery of drugs that have a low bioavailability, or have side effects such as liver enzyme elevations or hepatoxicity, says the company. See Also: FDA approves Astellas’ VYLOY for gastric cancer treatment Intercept’s liver disease drug Ocaliva faces FDA approval delay The company has several other candidates in its pipeline, including SPT-320, an experimental prodrug of agomelatine being advanced into Phase I studies to treat generalised anxiety disorder (GAD). By leveraging Glyph, SPT-320 bypasses liver first-pass metabolism, allowing for lower dosing and reduced liver exposure. Seaport is also developing SPT-348 for mood and neuropsychiatric disorders and has several preclinical programmes under its belt. Prodrugs are medications that start as inactive or less active, and once inside the body, are converted into the active form, usually through natural processes involving enzymes. Prodrugs can be used to enhance drug delivery, minimise side effects, and improve drug solubility and oral bioavailability. In the announcement accompanying the financing, Seaport’s founder Steve Paul said: “The development of important new neuropsychiatric medicines is often halted due to poor drug-like properties or unacceptable tolerability, challenges that our Glyph platform can now uniquely address.” The potential of prodrugs was recently in the spotlight in the case of xanomeline, which initially faced tolerability challenges, but once resolved, was approved Cobenfy (formerly KarXT) for schizophrenia. Xanomeline helps reduce symptoms of schizophrenia, but it can cause unpleasant side effects that include nausea and sweating. Trospium was added to the drug to block these side effects while still allowing xanomeline to work in the brain. Now, Cobenfy is expected to earn $2.99bn in revenues by 2030, as per GlobalData analysis. GlobalData is the parent company of Pharmaceutical Technology. New York-based Terran Biosciences is taking it a step further by developing two prodrug versions of Cobenfy. Terran aims to curb issues surrounding medication adherence by optimising its dosing schedule to a more convenient once-daily oral regimen (TerXT), and a multi-month injectable (TerXT LAI).