Dr. Falk Pharma GmbH

J&J's subcutaneous Darzalex nabs another MM approvalUK biotech VC deals post strong 2025 showingEpidarex raises $145M to fuel early UK-US life science betsTox finding scuttles Phase I study of AstraZeneca heart drugTRexBio raises $50M to fund tissue-targeted Treg therapiesJ&J's subcutaneous Darzalex nabs another MM approvalThe FDA on Tuesday approved Johnson & Johnson's Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (VRd) for adults with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant. The regulatory clearance was based on findings from the Phase III CEPHEUS study, which showed that at a median follow-up of 22 months, patients with MM who received the combination saw an overall negativity rate for minimal residual disease (MRD) of 52.3%, compared with 34.8% for those taking VRd alone. The FDA OK marks Darzalex Faspro's twelfth indication overall, and its fifth in newly diagnosed MM. Last year, the drug was approved in the US and EU for adults with high-risk smouldering MM (see – Spotlight On: J&J's fastest growing drugs).UK biotech VC deals post strong 2025 showing A report from the BioIndustry Association (BIA) suggests that the UK ended 2025 with "clear signs" of renewed momentum and increased investor confidence. The analysis showed that the UK retained its position as Europe's leading national biotech market, representing 30% of all venture financing in the region, despite a 13.2% year‑on‑year drop in venture capital investment, totalling nearly £1.8 billion ($2.5 billion) across 58 deals.The report indicated that despite the start of 2025 being characterised by investor caution, the final quarter delivered a positive shift, with 22 completed deals. In terms of figures, almost 47% of total capital raised last year came from two transactions in the first quarter — Isomorphic Labs and Verdiva Bio — with average deal size rising to £30.8 million, from £18.7 million in 2024."If 2024 was marked by a rebound, 2025 has been a year of caution and strategic maturation," said Jane Wall, managing director of BIA, although she cautioned that "the geopolitical landscape is precarious and the IPO window is entering its fifth year of restricted activity."Epidarex raises $145M to fuel early UK-US life science betsEpidarex Capital has secured more than $145 million in a first close of its fourth fund, as the transatlantic life science venture firm doubles down on company creation and early-stage investing across the UK and US."We believe that the next three years represent a highly attractive window for investing in a new wave of biotech innovation," said managing partner Sinclair Dunlop. Backers include the British Business Bank, Strathclyde Pension Fund, the Scottish National Investment Bank and other international investors.Fund IV will support up to 15 therapeutic and medical device startups built around "breakthrough science" in areas including cardiometabolic, autoimmune and neurological diseases, as well as oncology. The firm said its "strategy is to lead early-stage financings, bridging the equity funding gap to build globally leading companies at scale."Its portfolio includes Apellis Pharmaceuticals, Enterprise Therapeutics, Harpoon Medical, Kynos Therapeutics and Nodthera. Epidarex last raised capital in 2020, closing its third fund at £102.1 million ($141 million).Tox finding scuttles Phase I study of AstraZeneca heart drugAstraZeneca has terminated a Phase I trial of AZD0233, an oral small molecule targeting the CX3CR1 receptor for dilated cardiomyopathy, according to an update posted on ClinicalTrials.gov this week. The first-in-human trial, which enrolled 84 healthy volunteers, was stopped after an "adverse finding in a non-clinical, chronic toxicology study."AZD0233 was positioned as a possible immune-modulating approach to heart failure, aiming to reduce inflammatory cell infiltration in cardiac tissue by selectively targeting CX3CR1, a transmembrane receptor found on certain leukocytes, including monocytes, T cells and NK cellsThe programme entered the clinic in April 2024. Preclinical data published last November in Circulation suggested that modulating CX3CR1 has cardiac protective effects, improving cardiac function in a mouse model of dilated cardiomyopathy.TRexBio raises $50M to fund tissue-targeted Treg therapiesTRex Bio closed a $50-million financing the biotech will use to advance its clinical and preclinical programmes, led by the purpose-engineered TNFR2 agonist TRB-061. The candidate, which is currently in a Phase Ia/b study for atopic dermatitis, is designed to selectively activate regulatory T-cells (Tregs) in inflammatory diseases affecting skin and other barrier tissues. The funding round included new investors Janus Henderson Investors, Balyasny Asset Management and Affinity Asset Advisors, as well as existing backers such as Alexandria Venture Investments, Avego BioScience Capital, Delos Capital, Eli Lilly, Johnson & Johnson Innovation, Pfizer Ventures, Polaris Partners and SV Health Investors.  TRexBio's pipeline also includes TRB-071 and TRB-081, designed to address a range of inflammatory and autoimmune conditions, with Phase I studies expected to start in 2027. The company's programmes have emerged from its Deep Biology Platform, which maps human tissue Treg behaviour to disease processes to identify and characterise novel targets.Anna Bratulic and Elizabeth Eaton contributed to this report.

EPIDAREX CAPITAL ANNOUNCES FIRST CLOSE OF FUND IV, SECURING $145 MILLION TO BUILD NEXT WAVE OF LIFE SCIENCE START-UPS New Fund will target company creation and early-stage investing across the UK and the US Fund backed by new and existing blue chip international investors as Epidarex continues to scale its transatlantic life sciences platformDesigned to translate innovative research into the next generation of life science companies Edinburgh, UK and Bethesda, MD, USA, 27 January 2026 - Epidarex Capital (“Epidarex”), a transatlantic life science venture firm, today announces the first close of Epidarex Capital IV, LP, securing more than $145 million in commitments to build therapeutics and medical device companies. The Fund’s initial investors include the British Business Bank, Strathclyde Pension Fund, the Scottish National Investment Bank, as well as leading family offices, corporates and other international investors. The Fund will invest in high-quality early-stage healthcare innovation based on breakthrough science in the UK and the US, offering new company-building opportunities for top researchers and entrepreneurs. Epidarex’s transatlantic team builds healthcare companies that address major unmet disease needs, including in oncology, cardiometabolic, autoimmune, and neurological conditions, sourcing research from established and emerging research hubs across the UK and US. Epidarex’s strategy is to lead early-stage financings, bridging the equity funding gap to build globally leading companies at scale. The firm partners with top scientists and entrepreneurs and takes an active role in building high-performance leadership teams, shaping strategy and helping companies progress through key value inflection points. Epidarex Capital IV, LP is expected to invest in up to 15 companies. Sinclair Dunlop, Managing Partner at Epidarex, said: “We believe that the next three years represent a highly attractive window for investing in a new wave of biotech innovation. Epidarex Fund IV offers standout innovators an opportunity to secure funding from an experienced early-stage investor. Fund IV will also accelerate breakthrough science and unlock new therapeutic possibilities with meaningful impact for patients and public health.” Christine Hockley, Managing Director and Co-Head of Funds, British Business Bank, said: “We are investing more into UK life sciences, which is one of the eight growth sectors of the UK Industrial Strategy. The Bank is highly active in the sector, having already committed over half a billion into specialist life science funds. However, we will continue to back fund strategies like Epidarex. The UK has a very strong science and research base, so what is needed is investors who specialise in nurturing and scaling those ideas, creating new, IP-rich companies.” Elizabeth Roper, PhD, Managing Partner at Epidarex, added: “This first close reflects strong conviction in Epidarex’s ability to build high-quality life science companies from the earliest stages. We work closely with founders to support them through critical development milestones. Fund IV allows us to continue executing on this strategy. As a longstanding partner to a diverse range of investors, we are excited about the opportunity to continue to build the Epidarex platform.” Epidarex’s transatlantic portfolio includes Apellis Pharmaceuticals, Enterprise Therapeutics, Harpoon Medical, Kynos Therapeutics and Nodthera. These notable investments exemplify the firm’s longstanding ability to build companies with assets of strategic value and to significantly improve patient and public health outcomes. ENDS For more information, please contact: Epidarex Capital:Sinclair DunlopManaging PartnerTel: +44 (0)7767 166156Liz RoperManaging PartnerTel: +44 (0)7810 827481For media enquiries: ICR HealthcareEuropeMary-Jane Elliott / Jessica Hodgson / Ashley Tapp Epidarex@icrhealthcare.comUnited StatesSean Leoussean.leous@icrhealthcare.com Tel: +1 (646) 866 4012 Notes for Editors About Epidarex Capital Epidarex Capital is a transatlantic venture firm that invests in early-stage, high-growth life science companies in under-ventured markets. Epidarex focuses on providing risk capital and expertise to create, support and build young companies, including spinouts, from leading research institutions in both established and emerging life science hubs. The fund’s international management team has a track record of successfully partnering with top scientists and entrepreneurs to develop highly innovative products for the global healthcare market. www.epidarex.comAbout British Business Bank (BBB) The British Business Bank is the UK government’s economic development bank. Established in November 2014, its mission is to drive sustainable growth and prosperity across the UK and to enable the transition to a net zero economy, by improving access to finance for smaller businesses. Its remit is to design, deliver and efficiently manage UK-wide smaller business access to finance programmes for the UK government. www.british-business-bank.co.uk/ About the Scottish National Investment Bank (SNIB) The Scottish National Investment Bank is Scotland’s development bank and exists to provide patient (long-term) debt or equity investments to businesses and projects that support the development of a fairer, more sustainable Scottish economy. Established in November 2020, it is wholly owned by Scottish Government ministers, on behalf of the people of Scotland, but operates independently from government.   www.thebank.scot

Merck (known as MSD outside the United States and Canada) has ended its development partnership with Dr Falk Pharma concerning MK-8690, an investigational monoclonal antibody candidate. MK-8690 (formerly PRA-059) is an investigational anti-CD30 ligand monoclonal antibody originally developed under a co-development and co-commercialisation agreement between Dr Falk Pharma and Prometheus BioSciences, signed in 2020. Prometheus BioSciences was later acquired by Merck in 2023. Under the revised agreement, Dr Falk Pharma and Prometheus BioSciences, now a Merck subsidiary, have ended the collaborative development arrangement. Merck will assume full global rights and sole responsibility for advancing MK-8690’s clinical development. The company has already initiated an early-stage clinical trial to evaluate the candidate’s efficacy and safety profile. In exchange for relinquishing its rights to MK-8690, Dr Falk Pharma will receive an upfront payment of $150m and will remain eligible for additional payments tied to development milestones and royalties on potential future sales in certain markets.