Christopher Cole

Thornhill, Ontario, Canada - October 31, 2020: LEO Pharma Canada sign outside their head office building in Thornhill, Ontario, Canada. LEO Pharma AS is a multinational Danish pharmaceutical company | Image Credit: © JHVEPhoto - stock.adobe.com.

LEO Pharma has entered into a global licensing and transfer agreement with Boehringer Ingelheim for the commercialization and continued development of spesolimab, marketed as Spevigo (1). The monoclonal antibody (mAb) is the first targeted treatment approved for flares of generalized pustular psoriasis (GPP), a rare and potentially life-threatening inflammatory skin condition.

The agreement places LEO Pharma at the helm of Spevigo’s next phase, building on its presence in more than 40 countries—including the United States, Japan, China, and across Europe—where it is approved for the treatment of GPP flares in adults. Regulatory authorizations have also been granted for broader GPP indications in the US, European Union, and China (2).

Targeting an unmet need in rare dermatologic diseases

·LEO Pharma will lead global commercialization and development of Spevigo, expanding its role in rare dermatology drug manufacturing and access.

·The IL-36-targeting monoclonal antibody is advancing beyond GPP, with new development efforts focused on other rare autoinflammatory skin diseases.

·The agreement includes milestones and royalties, highlighting strategic deal-making trends in pharma for rare disease therapies with high unmet need.

Spesolimab is a humanized, selective mAb that blocks activation of the interleukin-36 (IL-36) receptor, a signaling pathway central to the development of several autoinflammatory skin diseases (3–5). In GPP, the IL-36 pathway is considered a critical driver of disease activity, making it a key target for therapeutic intervention.

GPP is a severe and unpredictable condition characterized by widespread sterile pustules, skin inflammation, and systemic symptoms such as fever, fatigue, and in some cases, organ failure (6–10). Patients may experience relapsing or persistent disease with varying intensity, and quality of life is often significantly impaired. Clinical studies show GPP is distinct from plaque psoriasis, with unique underlying pathology and treatment needs (6,7).

Spevigo has been evaluated in the largest clinical development program dedicated to GPP to date (1). It remains the only treatment for GPP flares that specifically targets IL-36 and has been validated in a randomized, placebo-controlled trial. Further investigation is underway to assess its potential in other IL-36-mediated dermatologic diseases with limited treatment options.

Under the agreement, LEO Pharma assumes responsibility for both global commercialization and further clinical development of the drug (1). The company plans to leverage its existing medical dermatology infrastructure to increase awareness and patient access to the treatment.

“Partnering to bring Spevigo to more patients is more than a strategic step—it means the opportunity to help people living with GPP by addressing a disease with limited treatment options and aiming to improve their quality of life,” said Christophe Bourdon, CEO of LEO Pharma (1). “We are inspired by Boehringer Ingelheim’s pioneering efforts and thrilled to build on that foundation.”

The deal is expected to close in the second half of 2025, pending regulatory clearance (1). Boehringer Ingelheim will receive an upfront payment of EUR 90 million, in addition to potential milestone payments and tiered royalties based on commercial performance.

Boehringer Ingelheim’s initial development of Spevigo marked a significant milestone for GPP patients and medical dermatology (1).

“We are immensely proud of what Spevigo represents for people living with GPP and bringing innovation to this community of patients has been a powerful reflection of our purpose to transform lives,” said Shashank Deshpande, chairman of the Board of Managing Directors and head of Human Pharma at Boehringer Ingelheim (1). “Spevigo holds a significant promise, and ensuring it reaches its full potential requires continued focus, and expertise in medical dermatology. With over six decades of singular dedication to this field, LEO Pharma is exceptionally well-positioned to build on the strong foundation we’ve laid.”

GPP remains a highly complex and underserved condition (1). Mortality rates for severe cases can range from 2% to 16%, often due to complications like multisystem organ failure and sepsis. Many patients also experience comorbidities that increase both personal and healthcare system burdens.

Boehringer Ingelheim and LEO Pharma Enter Partnership to Commercialize and Further develop Spevigo (Spesolimab)

European Commission Approves SPEVIGO for New and Expanded Indications in Generalized Pustular Psoriasis

Morita. A.; Strober, B.; Burden, A.D.; et al. 

Efficacy and Safety of Subcutaneous Spesolimab for the Prevention of Generalised Pustular Psoriasis Flares (Effisayil 2): An International, Multicentre, Randomised, Placebo-controlled Trial

Choon, S.; Lebwohl, M.; Marrakchi, S.; et al. 

Study Protocol of the Global Effisayil 1 Phase II, Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Spesolimab in Patients with Generalized Pustular Psoriasis Presenting with an Acute Flare

Bachelez, H.; Choon, S.; Marrakchi, S.; et al. 

Trial of Spesolimab for Generalized Pustular Psoriasis

Pathophysiology of Generalized Pustular Psoriasis

Prinz, J.; Choon, S.; Griffiths, C.; et al. 

Prevalence, Comorbidities and Mortality of Generalized Pustular Psoriasis: A literature Review

Clinical Course and Characteristics of Generalized Pustular Psoriasis

Gooderham, M.; Van Voorhees, A.; Lebwohl, M. 

An Update on Generalized Pustular Psoriasis

Reisner, D.; Johnsson, F.; Kotowsky, N.; et al. 

Impact of Generalized Pustular Psoriasis from the Perspective of People Living with the Condition: Results of an Online Survey

Articles

The IL-36 inhibitor is being explored for additional inflammatory skin conditions, aiming to expand treatment options for underserved patient groups.

LEO Pharma Takes Over Global Development of Spevigo for Rare Skin Disease GPP

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

On July 10, 2025, FDA made public more than 200 previously confidential decision letters—known as Complete Response Letters (CRLs)—issued between 2020 and 2024 for drug and biologic applications that were not approved during their initial review cycle (1). These letters provide detailed reasons why an application could not be approved in its submitted form, including issues related to safety, efficacy, manufacturing deficiencies, and bioequivalence (1). "This action is a double-edged sword," said Biopharm International Editorial Advisory Board Member Steven Walfish, President of Statistical Outsourcing Services. "The transparency should provide consumers and the capital markets with long overdue information to why drugs applications did not meet the threshold for approval. This information will help the industry to understand the current thinking of the agency on certain aspects of the clinical and CMC process. On the other hand, it opens the FDA up to scrutiny that they are not applying the standards in an even-handed manner.”

Previously, the FDA had not routinely shared CRLs publicly. Sponsors often disclosed minimal information when announcing a non-approval. A 2015 cross-sectional study published in 

 found that drug developers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). Moreover, when the FDA recommended a new clinical trial, that fact was left out of sponsor communications in approximately 40% of cases.

The newly released letters are available through the openFDA platform and were redacted to remove trade secrets or confidential commercial information (1). According to the agency, only CRLs tied to subsequently approved products were included in this initial batch. The FDA is reviewing its archives and has indicated it may release additional letters in the future as part of a broader transparency initiative (1,3).

FDA Commissioner Marty Makary, MD, MPH, stated that the move is intended to reduce the “guessing game” for drug developers and investors and help foster more predictable pathways for therapeutic approvals (1).

Critics of the previous system have long pointed to the lack of transparency as a factor in repeated regulatory missteps across the industry. The inability to learn from others’ failures has arguably contributed to inefficiencies in clinical development and strategic planning. The publication of CRLs is expected to give companies and investors deeper insight into the agency’s decision-making process and highlight common pitfalls across clinical, manufacturing, and regulatory domains (4).

However, some observers note that the release raises questions about consistency, timing, and scope. For example, it remains unclear whether future CRLs for non-approved applications will be published or whether sponsors will have input into the redaction process. Legal analysts have also flagged the importance of maintaining confidentiality protections while expanding access to regulatory history (5).

While reactions to the policy shift have been mixed, the publication of CRLs represents a notable change in how the FDA communicates its review decisions and could signal a broader evolution in U.S. regulatory transparency standards.

FDA Embraces Radical Transparency by Publishing Complete Response Letters

Describing the Content of FDA Complete Response Letters and How Sponsors Publicly Report Them: Cross Sectional Study

FDA Releases ‘Initial Batch’ of More Than 200 Drug Rejection Letters

FDA Publishes Hundreds of Complete Response Letters from First Half of the Decade

FDA’s Creation of Public Database of 200 CRLs Raises Questions

FDA says the move boosts regulatory transparency, offering insights into common approval barriers in drug applications and reducing guesswork.

FDA Publishes More Than 200 Complete Response Letters

low angle view of marble dome of United States Capitol building in Washington DC with blue sky and visible architecture features | Image Credit: © Philip - stock.adobe.com

On July 3, 2025, the US House of Representatives passed President Donald Trump’s sweeping tax-cut and spending bill (1). Branded by supporters as a “pro-growth economic catalyst,” the legislation includes provisions that will reshape the strategic and operational landscape for the pharmaceutical and biotechnology sectors.

While headline impacts focus on tax relief and economic stimulus, the bill has deeper implications for drug discovery, development, and manufacturing alongside secondary effects on investment flows, clinical infrastructure, and global supply strategies.

A cornerstone of the bill is the permanent reinstatement of full expensing for domestic R&D activities. This provision, originally introduced in the 2017 Tax Cuts and Jobs Act, had been scheduled to sunset but is now extended indefinitely (2).

The pharmaceutical industry, which typically allocates more than 20% of revenue toward R&D, stands to benefit significantly. Trade associations such as PhRMA have argued that the change will support continued investment in preclinical discovery, platform innovation, and early-stage clinical pipelines (4). However, economists Larry Summers and Michael Linden cautioned that the incentive may disproportionately enhance profits without guaranteeing proportional increases in innovation output (5).

2. Favorable capital deductions and domestic signals

The bill expands accelerated deductions for capital expenditures, a measure favorable to pharmaceutical manufacturers building or upgrading US-based facilities (2). These incentives could benefit producers of complex biologics, sterile injectables, and high-volume generics.

Although the bill itself does not impose trade restrictions, it aligns with prior Trump administration goals to reduce US dependency on foreign pharmaceutical ingredients. Officials have signaled interest in future tariffs or tax adjustments targeting imports from China and India, potentially reshaping where and how APIs and finished dosage forms are sourced (6).

One of the most controversial components of the bill is its proposed reduction in federal Medicaid spending. The legislation introduces work requirements, tightens eligibility, and restructures funding formulas, which the Congressional Budget Office estimates could remove up to 12 million Americans from coverage by 2034 (7).

For biopharmaceutical companies, this poses several risks:

 among low-income populations could constrain revenue from both generics and branded therapies.

generation due to budget-strained hospitals and safety-net systems.

 at academic medical centers dependent on Medicaid reimbursement (3,8).

While the Medicaid program represents a smaller portion of revenue compared with Medicare or commercial payers, these changes could have an outsized impact on market access for innovative therapies and rare disease drugs; Medicaid disproportionately covers vulnerable populations—such as children, low-income patients, and those with rare diseases—who rely on early access to innovative and high-cost therapies.

In addition to these core operational areas, the bill is likely to influence the industry in several less immediately visible but strategically critical ways (

Lower corporate tax rates and greater cash reserves may incentivize pharmaceutical firms to pursue acquisitions of emerging biotech companies, platform developers, and contract development and manufacturing organizations, or CDMOs. This replicates the post-2017 tax cut trend, which saw a surge in life sciences deal activity (4,5).

Lower capital gains taxes increase the after-tax return on successful biotech investments, making high-risk, high-reward startups—like those in messenger RNA, gene editing, and AI-driven discovery—more attractive to venture capital (2). Increased investor liquidity from corporate tax cuts further amplifies available funding for early-stage innovation.

With reduced Medicaid funding and pressure on academic hospitals, sponsors may move trials to commercial centers or global sites (8). Academic and safety-net hospitals, which often serve underrepresented racial, ethnic, and low-income populations, are key recruitment sites for diverse clinical trial participation. If trials shift to commercial centers or affluent regions, access barriers may exclude these groups, reducing population diversity in study data.

Policy signals around reshoring and API self-sufficiency may lead to preemptive changes in global manufacturing strategies (6). Firms may diversify sourcing across geographies or build redundancy to guard against future tariffs or national security-driven restrictions.

As deficits expand (projected at more than $3.4 trillion in the next decade), future political efforts may target cost containment through National Institutes of Health, FDA, or Centers for Medicare & Medicaid Services budget scrutiny (5). There could also be increased calls to streamline drug approval processes, which may affect review timelines and regulatory expectations.

Given the industry's gains from tax relief and capital incentives, lawmakers and advocacy groups may intensify pressure on drug pricing policies, particularly around Medicare negotiation and pricing transparency (7).


Trump’s tax and spending legislation introduces a blend of opportunity and complexity for the pharmaceutical industry. While companies may benefit from increased financial flexibility, they also face strategic risks tied to reduced public coverage, supply chain fragility, and growing societal expectations. Those in the industry should view this moment as one of recalibration, balancing fiscal gains with long-term planning for regulatory, political, and access-related shifts.

Economic Policy That Might Boost U.S. Drug Manufacturing

Key Healthcare Provisions in Trump's Tax Bill

Pharma Tax Dilemma: Trump Push Cuts Redefine Industry

Summers, Miran Highlight Worst- and Best-Case Scenarios for Trump's Megabill.

How Pharmaceutical Tariffs Could Play Out.

Mosbergen, D.; Walker, J.; Essley Whyte, L. 

How Healthcare Cuts in the ‘Big, Beautiful Bill’ Will Affect Americans

Senate’s Trump Tax-Cut Bill Passes: Healthcare Impacts Include Medicaid Cuts, Health Insurance Coverage Losses

The US House of Representatives passed a tax-cut and spending bill with significant implications for the pharmaceutical and biotechnology sectors. Key provisions include the permanent reinstatement of full R&D tax expensing, expanded capital deductions, and potential shifts in global supply strategies. The bill also proposes Medicaid cuts, posing risks to drug utilization and clinical trial infrastructure. Lower corporate tax rates may drive mergers and acquisitions, while reduced Medicaid funding could impact trial site diversity. The legislation presents both opportunities and challenges, requiring strategic recalibration by industry stakeholders.

Trump’s tax bill could reshape drug R&D, manufacturing, Medicaid access, clinical trials, and biotech funding, impacting strategy across the bio/pharmaceutical industry.

9 Implications of Trump’s Tax-Cut and Spending Bill for the Bio/Pharmaceutical Industry

NÜRNBERG / GERMANY - APRIL 7, 2019: Siemens Logo on an office building in Nürnberg. Siemens is a German engineering company | Image Credit: © filmbildfabrik - stock.adobe.com

Siemens AG has completed its $5.1 billion acquisition of Boston-based Dotmatics, a provider of research and development software for the life sciences sector (1). The deal brings Dotmatics under the umbrella of Siemens’ Digital Industries Software division and marks a significant expansion of Siemens’ artificial intelligence (AI)-driven product lifecycle management (PLM) portfolio into the life sciences domain.

Originally announced in April 2025 (2), Siemens described the transaction as a “strategic milestone” that aligns with structural changes in healthcare—such as aging populations, broader access to medical care, and increasing demand for collaborative, data-integrated R&D environments (1). The acquisition is part of Siemens’ ONE Tech Company strategy, aimed at enhancing digital capabilities across high-growth industrial sectors.

·Siemens’ acquisition of Dotmatics enhances AI-driven drug development, connecting R&D to manufacturing through a unified digital thread.

·Dotmatics’ Scientific Intelligence Platform will streamline pharmaceutical workflows, accelerating discovery, development, and production cycles.

·Pharma manufacturers gain access to Siemens’ expanded digital twin and PLM tools, enabling scalable, data-integrated, and compliant operations.

“By acquiring Dotmatics, we’re strategically strengthening our position in Life Sciences and creating a world-leading AI-powered PLM software portfolio as part of Siemens Xcelerator,” said 

Roland Busch, president and CEO of Siemens

 AG (2). “Artificial intelligence has emerged as a transformative force across various industries, and its application in life sciences is becoming increasingly important.”

Connecting R&D to manufacturing in the pharma value chain

The Dotmatics platform centers around its Scientific Intelligence Platform, Luma, which supports AI-powered, multimodal drug development and data contextualization (1). The software facilitates seamless collaboration, connects previously siloed data across R&D and manufacturing, and creates a continuous digital thread through the pharmaceutical development lifecycle.

“With Dotmatics, we’re building a new era of innovation in Life Sciences,” said Busch. “From research through to production—we’re creating a unique, end-to-end digital thread: We combine Dotmatics’ scientific intelligence with our industrial AI technologies and digital twins. This will allow us to help our customers accelerate breakthroughs, reduce development cycles, and bring life-saving pharmaceuticals faster and more affordably to the market.”

For Siemens, the acquisition opens up an additional $11 billion in total addressable market within industrial software (1). Dotmatics is expected to generate more than $300 million in revenue in fiscal year 2025. Siemens projects medium-term revenue synergies of around $100 million annually, scaling up to more than $500 million in the longer term. The acquisition is expected to be immediately accretive to growth, profitability, and cash flow.

“The acquisition of Dotmatics drives strong revenue synergies and is highly profitable and cash generative,” said 

Ralf P. Thomas, chief financial officer of Siemens

 AG (2). “Financing will be provided primarily through the sale of shares in listed companies, including Siemens Healthineers.”

Siemens’ push into scientific innovation

The transaction also reflects the evolution of Dotmatics itself. Formerly known as Insightful Science, the company rebranded as Dotmatics in April 2022 following its acquisition of Protein Metrics and a period of expansion under the ownership of Insight Partners (2). 

, emphasized the strategic alignment in the press release announcing the deal.

“Following an exciting journey with Insight Partners, where Dotmatics achieved remarkable growth and portfolio expansion, we are thrilled to announce our new chapter with Siemens,” said Swalla (2). “Combining our next-generation scientific intelligence platform and industry-leading scientific applications together with Siemens' digital twin and AI capabilities, we’ll drive a new wave of innovation in life sciences R&D.”

Latest in high-profile software acquisitions

The Dotmatics acquisition follows closely on the heels of Siemens’ $10 billion acquisition of Altair Engineering, completed in April (3). That deal brought new simulation, high-performance computing, and AI capabilities into Siemens’ industrial software offerings and was similarly integrated into the Siemens Xcelerator platform.

“We welcome the Altair community of customers, partners and colleagues to Siemens,” Busch said at the time of that acquisition (3). “Adding Altair’s groundbreaking innovations to the Siemens Xcelerator platform will create the world's most complete AI-powered design, engineering and simulation portfolio.”

Together, these back-to-back deals underscore Siemens’ aggressive push into domains in which digital twin technology, data integration, and AI are reshaping complex product development. With Dotmatics and Altair, Siemens now commands an expanded portfolio capable of supporting highly regulated industries like pharmaceuticals with the digital tools needed to meet rising demand, tighter timelines, and greater product complexity.

Siemens Completes Acquisition of Dotmatics

Siemens Acquires Dotmatics, Extending AI Software Portfolio into Life Sciences

Siemens Acquires Altair to Create Most Complete AI-powered Portfolio of Industrial Software

Siemens expands AI-driven pharma software portfolio, integrating Dotmatics’ platform to connect drug research, development, and manufacturing digitally.

Siemens Finalizes $5.1B Dotmatics Acquisition

mainz,Rhineland-Palatinate /germany - 16 07 2022: the biontech company building and flags in mainz germany | Image Credit: © Tobias Arhelger - stock.adobe.com

In a move to reportedly consolidate and expand its capabilities in messenger RNA (mRNA)-based medicine, BioNTech has announced plans to acquire CureVac through an all-stock transaction valued at approximately $1.25 billion (1). The acquisition aims to accelerate the development and manufacturing of next-generation mRNA immunotherapies for oncology and infectious diseases by combining the strengths of the two German-based biotechnology companies.

Strategic fit to strengthen BioNTech’s oncology pipeline

This acquisition forms a cornerstone of BioNTech’s long-term oncology strategy. The company intends to integrate CureVac’s proprietary mRNA platforms and advanced research infrastructure, particularly its R&D and manufacturing facilities in Tübingen, Germany, to complement existing efforts across BioNTech’s immunotherapy programs (1).

·BioNTech's acquisition of CureVac strengthens mRNA cancer immunotherapy R&D and supports its next milestone in oncology strategy execution.

·The deal enhances BioNTech’s proprietary mRNA design, delivery, and manufacturing technologies for advanced therapeutic development.

·CureVac's integration expands BioNTech’s mRNA platform, optimizing formulation and production for future oncology pipeline growth.

“This transaction is another building block in BioNTech’s oncology strategy and an investment in the future of cancer medicine,” said 

, CEO and co-founder of BioNTech (1). “We intend to bring together complementary capabilities and leverage technologies with the goal of advancing the development of innovative and transformative cancer treatments and establishing new standards of care for various types of cancer in the coming years.”

CureVac’s scientific expertise and its progress in mRNA design and lipid nanoparticle delivery systems are expected to support BioNTech’s pan-tumor immunotherapy candidates, including its lead PD-L1xVEGF-A bispecific antibody, 

“To me, this transaction is more than a business decision, it represents a shared commitment to leverage the full potential of mRNA as a disruptive technology to develop transformative therapies with greater scale and speed,” said 

, MD, CEO of CureVac (1). “For more than two decades, both companies have operated with related ambitions, often tackling challenges from different angles. This transaction aims at combining complementary scientific capabilities, proprietary technologies, and manufacturing expertise in the mRNA field under one roof.”

Expanding the mRNA platform in oncology and infectious disease

BioNTech’s acquisition of CureVac reflects a broader ambition to dominate the mRNA therapeutic landscape beyond COVID-19 (1). While BioNTech is best known for co-developing the first approved mRNA vaccine with Pfizer, the company continues to invest heavily in mRNA research targeting various solid tumors and infectious diseases.

CureVac adds to this effort with an R&D pipeline that includes off-the-shelf and personalized mRNA cancer vaccines, and prophylactic vaccine candidates (1). Its technology platforms are built to enhance immunogenicity while maintaining low-dose efficiency—a key factor for scalability and safety. By combining assets, both companies aim to streamline mRNA drug development pipelines and manufacturing workflows, potentially reducing timelines for delivering clinical-stage therapies to patients. The integrated platform will be positioned to support mRNA applications from discovery to commercialization.

The deal, approved unanimously by the boards of both companies, is expected to close in 2025, pending customary regulatory clearances and a minimum 80% share acceptance rate from CureVac shareholders—although BioNTech retains the option to reduce this threshold to 75% (1).

This news comes just 10 days after BioNTech announced a global co-development and co-commercialization agreement valued at up to $11.1 billion for 

 (2). Under that deal, BMS will provide BioNTech with an upfront payment of $1.5 billion and an additional $2 billion in non-contingent anniversary payments through 2028. 

 is also eligible to receive up to $7.6 billion in development, regulatory, and commercial milestones.

BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer

BioNTech to Receive Up to $11.1 Billion in Deal with BMS to Develop Immuno-Oncology Agent.

The acquisition boosts BioNTech’s mRNA design and manufacturing capabilities, accelerating development of next-gen cancer immunotherapies.

CureVac to Be Acquired by BioNTech in $1.25B Deal to Advance mRNA Cancer Therapies

Neurons, Active nerve cells, Conceptual illustration of neuronal cells with bright connecting nodes in the abstract dark space, illustration in high resolution, 3D rendering | Image Credit: © Eric - stock.adobe.com

, has raised €11.25 million (US$12.9 million) in an oversubscribed seed round to advance a novel therapeutic approach targeting treatment-resistant depression (1). The financing round was co-led by 

, and the French Tech Seed Fund managed by 

, on behalf of the French government, under the 

 initiative. Additional participants included 

The company is developing a first-in-class neuroplastogen based on pioneering academic research that aims to restore neuroplasticity without the drawbacks of current treatments like psychedelics or ketamine derivatives (1). This effort targets the intracellular protein Elk1, a central modulator of brain circuits involved in reward and emotional regulation. The approach stems directly from translational work conducted at the 

Linking Neuroscience to Therapeutic Development

·European biotech startup Elkedonia secures €11.25M (US$12.9M) in seed funding, integrating Sorbonne University research with Argobio’s drug development expertise.

·Novel Elk1-targeting antidepressants aim to restore neuroplasticity without sedation or hallucinations, addressing treatment-resistant depression.

·Elkedonia develops first-in-class, non-addictive neuroplastogens that avoid synaptic targets, offering a safer alternative to ketamine-based therapies.

Elkedonia was founded by Argobio, a biotech venture studio focused on translational science, and is built on research led by 

, director of research at CNRS. Her studies have identified Elk1 as a key regulatory protein in brain plasticity, disruptions of which are implicated in depression, PTSD, addiction, and anhedonia (2).

“Trauma, chronic stress, substance abuse and other factors can contribute to major depressive disorders and anhedonia (the inability to experience pleasure), driven by an impaired neuroplasticity,” the company stated (1). “This disruption in the brain’s ability to adapt leads to a breakdown in its normal functioning.”

Elkedonia’s therapeutic platform seeks to inhibit Elk1, restoring neural adaptability without inducing hallucinations, sedation, or dependence. The company points to encouraging findings from preclinical and early clinical research, suggesting that targeting Elk1 may offer rapid antidepressant effects, in contrast to the delayed onset of conventional treatments.

Proceeds from the seed financing will support the optimization of small-molecule Elk1 inhibitors and the development of companion biomarkers (1). These efforts are central to Elkedonia’s strategy to deliver precision medicine in mental health, matching therapies to patient subtypes and tracking treatment response with objective measures.

“I am thrilled to welcome our founding seed investors and thank my colleagues at Argobio for their support in creating Elkedonia,” said 

, CEO and co-founder of Elkedonia (1). “The novelty of our neuroplastogen approach offers a strong value proposition supported by groundbreaking neuroscience research. We are positioned to make a significant impact on the treatment of major depressive disorders, bringing relief to all patients, including young people, adolescents and the elderly. In addition, our development of biomarkers will allow us to pursue a precision medicine for patient selection and treatment efficacy monitoring.”

The company’s focus on treatment-resistant depression addresses a growing and underserved population. Globally, major depressive disorder affects approximately 280 million people, with many patients failing to respond to existing therapies (3). This public health burden is particularly severe among adolescents and young adults, where depression-related suicide is a leading cause of death.

“Major depressive disorder is a large market of 300 million people globally that remains poorly addressed, with roughly one third of patients resistant to currently available treatments,” said 

, chairman of the management board of Argobio and managing partner at Kurma Partners. “Elkedonia serves as a first proof-of-concept for Argobio where we are extremely proud to have identified this opportunity to benefit human health and to have provided industry competencies to accelerate and de-risk product development.”

, investment director at WE Life Sciences, said, “Investing in Elkedonia demonstrates WE Life Sciences' commitment to advancing the best cutting-edge innovations through collaboration with top-tier European life sciences investors. We are proud to support the realization of this promising innovation from Argobio, while fostering its growth in Wallonia, Belgium, a region increasingly recognized for its excellence in health and biotechnology.”

“Bpifrance, as a founding investor of Argobio, is delighted to support the seed round of this promising new venture,” said 

, investment director Life Sciences at Bpifrance. “We are thrilled to develop the foundational research that comes from CNRS at Sorbonne University. This investment underscores our commitment to advancing mental health solutions, which is currently a priority for France.”

Elkedonia Closes EUR 11 Million Seed Round to Advance Neuroplastogens as Novel Therapeutics for Depression and Neuropsychiatric Disorders

Elkedonia will develop first-in-class Elk1 inhibitors for treatment-resistant depression, targeting neuroplasticity without psychedelic side effects.