EDG6 modulators(Sphingosine 1-phosphate receptor Edg-6 modulators), S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators), S1PR3 modulators(Sphingosine 1-phosphate receptor Edg-3 modulators)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases+ [2]

Active Indication

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisMultiple sclerosis relapse+ [1]

Inactive Indication

AsthmaInfluenza, HumanMultifocal acquired demyelinating sensory and motor neuropathy+ [5]

Originator Organization

Novartis Pharma AG

Active Organization

Accord Healthcare SLU

Novartis Pharmaceuticals Corp.Mylan Pharmaceuticals Ltd.

+ [6]

Inactive Organization

Novartis Pharmaceuticals Canada, Inc.

License Organization

Novartis AG

Mitsubishi Tanabe Pharma Corp.

Drug Highest PhaseApproved

First Approval Date

United States (21 Sep 2010),

Multiple sclerosis relapse

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)

Structure/Sequence

Molecular FormulaC19H34ClNO2

InChIKeySWZTYAVBMYWFGS-UHFFFAOYSA-N

CAS Registry162359-56-0

130

Clinical Trials associated with Fingolimod Hydrochloride

NCT06424067

/ RecruitingPhase 2IIT

A Phase II Study of Fingolimod in Patients With Non-Small Cell and Small Cell Lung Cancer

This is a single-institution, open-labeled study using fingolimod (FTY720/Gilenya) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) who have progressed on chemo-immunotherapy. The study design will be a 6 patient safety lead-in with 2 cohorts of patients for efficacy analysis where fingolimod 0.5 mg will be taken orally once daily.

Start Date01 May 2025

Sponsor / Collaborator

The Medical University of South Carolina

IRCT20240701062291N1

/ RecruitingPhase 2IIT

The efficacy of fingolimod in enhancing neurological recovery after traumatic spinal cord injury

Start Date22 Aug 2024

Sponsor / Collaborator

Mashhad University of Medical Sciences

IRCT20200105046010N92

/ RecruitingNot Applicable

Bioequivalence study of Fingolimod 0.5 mg capsule manufactured by Abidi Co (Norabex) versus originator brand Gilenya capsule manufactured by Novartis Co in fasting condition in healthy volunteers

Start Date30 Jan 2024

Sponsor / Collaborator-

100 Clinical Results associated with Fingolimod Hydrochloride

100 Translational Medicine associated with Fingolimod Hydrochloride

100 Patents (Medical) associated with Fingolimod Hydrochloride

5,270

Literatures (Medical) associated with Fingolimod Hydrochloride

31 Dec 2025·Virulence

Ponatinib and other clinically approved inhibitors of Src and Rho-A kinases abrogate dengue virus serotype 2- induced endothelial permeability

Article

Author: Awasthi, Mansi ; Modak, Ayan ; Sobha, Archana ; Sreekumar, Easwaran ; Mishra, Srishti Rajkumar

Severe dengue often presents as shock syndrome with enhanced vascular permeability and plasma leakage into tissue spaces. In vitro studies have documented the role of Src family kinases (SFKs) and RhoA-kinases (ROCK) in dengue virus serotype 2 (DENV2)-induced endothelial permeability. Here, we show that the FDA-approved SFK inhibitors Bosutinib, Vandetanib and Ponatinib, as well as the ROCK inhibitors, Netarsudil and Ripasudil significantly inhibit DENV2-induced endothelial permeability. In cultured telomerase immortalized human microvascular endothelial cells (HMEC-1), treatment with these inhibitors reduced the phosphorylation of VE-Cadherin, Src and myosin light chain 2 (MLC2) proteins that were upregulated during DENV2 infection. It also prevented the loss of VE-Cadherin from the inter-endothelial cell junctions induced by viral infection. In in-vivo studies using DENV2-infected AG129 IFN receptor-α/β/γ deficient mice, ponatinib, when administered 24 h post-infection onwards, demonstrated significant benefits in improving body weight, clinical outcomes, and survival rates. While all virus-infected, untreated mice died by day-10 post-infection, 80% of the ponatinib-treated mice survived, and approximately 60% were still alive at the end of the 15-day observation period. The treatment also significantly reduced disease severity factors such as vascular leakage, thrombocytopenia; mRNA transcript levels of proinflammatory cytokines such as IL-1β and TNF-α; and restored liver function. Comparable effects were observed even when ponatinib treatment was initiated after symptom onset. The results highlight ponatinib as an effective therapeutic option in severe dengue; and also a similar potential for other FDA- approved SFK and ROCK inhibitors.

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Lysophosphatidylcholine induces ceramide synthase-2 expression in primary culture model of astrocytopathy: potential therapeutic target in multiple sclerosis

Article

Author: Pancholi, Bhaskaranand ; Amarjeet ; Abate, Selamu Kebamo ; Mohapatra, Abhipsa ; Babu, Raja ; Garabadu, Debapriya

BACKGROUND:

Multiple sclerosis (MS) is a chronic autoimmune condition that damages the myelin sheath of neurons in the central nervous system, resulting in compromised nerve transmission and motor impairment. The astrocytopathy is considered one of the prominent etiological factor in the pathophysiology of demyelination in MS. The expression level of ceramide synthase-2 (CS-2) is yet to be established in the pathophysiology of astrocytopathy although the derailed ceramide biosynthetic pathways is well demonstrated in the pathophysiology of demyelination. Therefore, in the present study, the expression level of CS-2 has been evaluated in lysophosphatidylcholine (LPC)-challenged primary astrocytes in the presence of anti-demyelinating agents such as Fingolimod, a clinically approved anti-demyelinating drug, and Ursolic Acid (UA), an experimentally accepted anti-demyelinating agent, in MS.

METHODS AND RESULTS:

LPC (150 µg/ml) caused astrocytopathy evident by decrease in percentage of viable astrocytes, increase in percentage of apoptotic astrocytes, increase in the level of reactive oxygen species (ROS), and increase in the level of activated astrocytes. Interestingly, LPC significantly increased the expression level of CS-2 in the primary culture of astrocytes where as fingolimod and UA (1, 10, and 100 µM) were able to attenuate the extent of LPC-induced astrocytopathy in the primary culture model of MS. Further, both the drugs drastically reduced the LPC-induced increase in the level of expression of CS-2 in the astrocytes.

CONCLUSIONS:

These observations indicate the fact that CS-2 could be a potential target in the management of astrocytopathy and astrocytopathy-related neurological disorders including MS. In conclusion, CS-2-targeted drugs could be potential therapeutic options in the management of MS.

01 Oct 2025·Bioactive Materials

Modular assembled biomimetic nanobubbles for synergistic therapy of ischemic stroke via cascade modulation thrombo-inflammatory network

Article

Author: Wang, Yakun ; Li, Mingxi ; Yang, Fang ; Cheng, Chen ; Liu, Hongde ; Tang, Guoyan ; Xu, Xuan ; Wu, Huan

Dynamic pathology-adaptive nanodelivery systems represent a promising frontier in acute ischemic stroke (AIS) therapy. Here, we report a thrombo-inflammatory cascade-targeted biomimetic nanobubble engineered through gas-liquid interfacial modular assembly of platelet membranes and immunomodulator fingolimod (FTY720). Molecular dynamics simulations uncovered a gas-liquid interfacial self-organization mechanism driving the ordered spatial distribution of platelet membrane lipid rafts and amphiphilic FTY720 to fabricate platelet membrane coated FTY720 nanobubble (PFNB). Such modular assembled PFNBs can promote the effective presentation of targeted proteins and drug molecular functions on the biointerface, enabling precise sequential lesion targeting, enhanced blood-brain barrier penetration and inflammatory microglial uptake, significantly improving drug delivery efficiency. Therapeutic efficacy analysis via whole-genome RNA sequencing demonstrated a virtuous cycle between anti-inflammatory regulation and vascular protection, ultimately mitigating the brain tissue damage. Therefore, PFNBs provide a paradigm for the modular construction and biointerface efficacy regulation of multifunctional integrated biomimetic nano-delivery systems, offering promising strategies for multi-target synergistic treatment of AIS.

News (Medical) associated with Fingolimod Hydrochloride

31 Mar 2025

·www.businesswire.com

Cycle Vita™ expands patient support in Multiple Sclerosis (MS) to include BAFIERTAM® (monomethyl fumarate) delayed-release capsules

BOSTON--(BUSINESS WIRE)--Cycle Pharmaceuticals Limited (Cycle) is pleased to announce that Cycle Vita is now available with BAFIERTAM, expanding its patient support services in MS, following the acquisition of Banner Life Sciences, LLC. From April 1, 2025 onwards, new patients starting BAFIERTAM therapy will have access to Cycle Vita, which provides individualized financial, product, process and clinical support to eligible* patients. Existing patients, who started therapy before April 2025, will continue to be supported by Banner Patient Support, and migrated to Cycle Vita in partnership with their healthcare providers. Cycle is committed to supporting patients, and will work to ensure a smooth transition with no disruption to patients’ medication and care. BAFIERTAM is indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.1 It is a unique agent in the fumarates class of disease-modifying therapies, in which administration requires no dietary restrictions and no metabolic conversion. With the addition of BAFIERTAM as Cycle’s second MS product, alongside TASCENSO ODT® (fingolimod), Cycle Vita’s MS-dedicated support services and expert team of Clinical Education Managers are now available to more patients, covering two oral MS medications. To find out more about BAFIERTAM, please visit www.bafiertam.com. To find out more about TASCENSO ODT, please visit www.tascenso.com. To find out more about Cycle Vita, please visit www.cyclevita.life or call 888-360-8482. Indication and Usage BAFIERTAM is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Important Safety Information Contraindications BAFIERTAM is contraindicated in patients With known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. Reactions may include anaphylaxis or angioedema. Taking dimethyl fumarate or diroximel fumarate. Warnings and Precautions Anaphylaxis and Angioedema BAFIERTAM can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms in patients taking dimethyl fumarate (the prodrug of BAFIERTAM) have included difficulty breathing, urticaria, and swelling of the throat and tongue. Patients should be instructed to discontinue BAFIERTAM and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema. Progressive Multifocal Leukoencephalopathy (PML) PML has occurred in patients with MS treated with dimethyl fumarate (the prodrug of BAFIERTAM). PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate (the prodrug of BAFIERTAM) for 4 years while enrolled in a clinical trial. PML has also occurred in patients taking dimethyl fumarate in the postmarketing setting in the presence of lymphopenia (<0.9x10 9 /L). While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8x10 9 /L persisting for more than 6 months. At the first sign or symptom suggestive of PML, withhold BAFIERTAM and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. Herpes Zoster and Other Serious Opportunistic Infections Serious cases of herpes zoster have occurred with dimethyl fumarate (the prodrug of BAFIERTAM), including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis. These events may occur at any time during treatment. Monitor patients on BAFIERTAM for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered. Other serious opportunistic infections have occurred with dimethyl fumarate (the prodrug of BAFIERTAM), including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections. These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear. Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment. Consider withholding BAFIERTAM treatment in patients with herpes zoster or other serious infections until the infection has resolved. Lymphopenia BAFIERTAM may decrease lymphocyte counts. In the MS placebo-controlled trials with dimethyl fumarate (the prodrug of BAFIERTAM), mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable. Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased, but did not return to baseline. Six percent (6%) of dimethyl fumarate patients and <1% of placebo patients experienced lymphocyte counts <0.5x10 9 /L (lower limit of normal 0.91x10 9 /L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with dimethyl fumarate or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x10 9 /L or <0.5x10 9 /L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x10 9 /L for 3.5 years). In controlled and uncontrolled clinical trials with dimethyl fumarate, 2% of patients experienced lymphocyte counts <0.5x10 9 /L for at least 6 months, and in this group, the majority of lymphocyte counts remained <0.5x10 9 /L with continued therapy. Neither BAFIERTAM nor dimethyl fumarate have been studied in patients with preexisting low lymphocyte counts. Obtain a CBC, including lymphocyte count, before initiating treatment with BAFIERTAM, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of BAFIERTAM in patients with lymphocyte counts less than 0.5x10 9 /L persisting for more than 6 months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if BAFIERTAM is discontinued or interrupted because of lymphopenia. Consider withholding treatment from patients with serious infections until resolution. Decisions about whether or not to restart BAFIERTAM should be individualized based on clinical circumstances. Liver Injury Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate (the prodrug of BAFIERTAM) in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed. These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients. Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating BAFIERTAM and during treatment, as clinically indicated. Discontinue BAFIERTAM if clinically significant liver injury induced by BAFIERTAM is suspected. Flushing BAFIERTAM may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials of dimethyl fumarate (the prodrug of BAFIERTAM), 40% of dimethyl fumarate-treated patients experienced flushing. Studies with dimethyl fumarate show that administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dosing may reduce the incidence or severity of flushing. In the BAFIERTAM studies, the presence of food did not impact the incidence of flushing. Serious Gastrointestinal Reactions Serious gastrointestinal reactions, including perforation, ulceration, hemorrhage, and obstruction, some with fatal outcomes, have been reported in the postmarketing setting with the use of fumaric acid esters, including dimethyl fumarate, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation. In controlled clinical trials, the incidence of serious gastrointestinal adverse events was 1% in patients treated with dimethyl fumarate; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%) Monitor patients, promptly evaluate, and discontinue BAFIERTAM for new or worsening severe gastrointestinal signs and symptoms. Adverse Reactions The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate (the prodrug of BAFIERTAM) were flushing, abdominal pain, diarrhea, and nausea. Gastrointestinal adverse reactions: Dimethyl fumarate caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). In clinical trials, the incidence of GI events was higher early in the course of treatment (primarily during the first month) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of patients on placebo discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with dimethyl fumarate. Hepatic transaminases: An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate in clinical trials was seen primarily during the first 6 months of treatment, and most patients with elevations had levels <3 times the upper limit of normal (ULN). Elevations of alanine aminotransferase and aspartate aminotransferase to ≥3 times the ULN occurred in a small number of patients treated with both dimethyl fumarate and in patients on placebo, and were balanced between the groups. There were no elevations in transaminases ≥3 times the ULN with concomitant elevations in total bilirubin >2 times the ULN. Discontinuations due to elevated hepatic transaminases were <1%, and were similar in patients treated with dimethyl fumarate or placebo. Eosinophilia adverse reactions: A transient increase in mean eosinophil counts was seen during the first 2 months of therapy with dimethyl fumarate. For more detailed information, please refer to the full Prescribing Information at www.bafiertam.com/pdf/bafiertam-prescribing-information.pdf. US-MMF-2500017 (March 2025) References BAFIERTAM. Prescribing Information. Banner Life Sciences LLC *Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482. BAFIERTAM® is a registered trademark of Banner Life Sciences, LLC, a company of Cycle Pharmaceuticals. TASCENSO ODT® is a registered trademark of Handa Neuroscience, LLC. Cycle Vita™ is a trademark of Cycle Pharmaceuticals Limited in the US. ©2025 Cycle Pharmaceuticals Limited. All rights reserved. About Cycle Pharmaceuticals Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease patient community. Cycle focuses on rare metabolic, immunological, and neurological genetic conditions. Within neurological conditions, we focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Boston, Massachusetts. For more information, please visit www.cyclepharma.com and follow us on X, LinkedIn and Facebook.

AcquisitionClinical ResultDrug Approval

21 Jan 2025

·www.globenewswire.com

Pharming to nominate biopharmaceutical leader Fabrice Chouraqui as new Executive Director and Chief Executive Officer

Leiden, the Netherlands, January 21, 2025: Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces today that the Board of Directors has nominated Fabrice Chouraqui to become Pharming’s new Executive Director and Chief Executive Officer, succeeding Sijmen de Vries. Pharming will nominate Mr. Chouraqui for the appointment as Executive Director and Chief Executive Officer for a term of four years at an upcoming Extraordinary General Meeting of Shareholders (EGM). Information regarding the EGM, including the notice to convene, will be shared shortly in a separate press release. Upon the appointment of Mr. Chouraqui, Sijmen de Vries will resign from the Board of Directors. To ensure a smooth hand-over of tasks and responsibilities, Mr. de Vries will remain a strategic advisor to the new CEO until December 31, 2025. Dr. Richard Peters, Chairman of the Board of Directors, commented:“After an extensive search, the Board and I are confident that Fabrice Chouraqui is the right candidate to lead Pharming and continue to implement our growth strategy, shaping Pharming into the rare disease company of choice. Fabrice is a deeply experienced global pharmaceutical and biotechnology executive, who brings a wealth of profound global expertise and experience, across the entire biopharmaceutical value chain, to Pharming. On behalf of the entire Board of Directors, I would like to thank Sijmen de Vries for his great commitment to Pharming over the past 16 years and for creating the company that it is today, serving patients and paving the way for delivery on the company’s strategy for growth. We are grateful that Sijmen will continue to be available through the end of the year to ensure a smooth hand-over with Fabrice.” Sijmen de Vries, Chief Executive Officer, commented:“I am very pleased with the nomination of Fabrice Chouraqui as my successor. Fabrice brings strong leadership experience with global pharmaceutical companies and highly innovative biotechnology companies to Pharming. To make way for Fabrice to take over the executive leadership of the Company, I will resign from the Board of Directors upon the appointment of Fabrice by our shareholders. I look forward to supporting Fabrice, working closely together through the remainder of the year, and ensuring a smooth hand-over.” Fabrice Chouraqui commented:“I am honored to have the opportunity to take over the leadership of Pharming, building on the strong foundation and joining at a time when I can help propel the company through its next stage of growth in the rare disease space. I am impressed by Pharming’s growing portfolio of products and commercial opportunities which will pave the way for us to become the rare disease company of choice.” ProfileMr. Fabrice Chouraqui (date of birth: August 1, 1970, French national, U.S. citizen) is a global pharmaceutical executive with a record of value creation at Flagship Pioneering, Novartis and Bristol-Myers Squibb. A purpose-driven leader with a passion for bringing innovative treatments to patients, Mr. Chouraqui has a reputation for building strong followership in organizations. He is scientifically minded, with a deep understanding across the business spectrum, from research and development to access and commercialization, including strong expertise in investor management and business development. Across his career, Mr. Chouraqui has led the launch of treatments in many therapeutic areas, including highly targeted specialty care drugs and large primary care medicines. He consistently demonstrates strategic and innovative thinking to achieve long-lasting results and has a strong record of developing next generation talents and highly diverse teams. Until recently, Mr. Chouraqui was a CEO-Partner at Flagship Pioneering, one of the largest Biotech Venture Capital firms in the US. Mr. Chouraqui also served as CEO of Cellarity, Inc., one of the companies created by Flagship Pioneering. In his CEO capacity, Mr. Chouraqui was leading the development of Cellarity, a company which is driving a radically new approach to drug discovery by working at the intersection of AI and biology. Mr. Chouraqui raised over $250M and attracted world-renowned investors. He initiated a collaboration with Novo Nordisk and had Cellarity recognized as a top biotech to watch by several sources. Today, Mr. Chouraqui holds the position of Executive Chairman at Cellarity. Prior to joining Flagship Pioneering, Mr. Chouraqui spent 10 years at Novartis. He was President of Novartis Pharmaceuticals USA from 2016 to 2019, during which he delivered strong growth despite negative price impact and significantly improved profitability. Promoted to turn around performance after the business suffered issues with recent launches, Mr. Chouraqui developed sophisticated commercial and access capabilities to meet the new market environment. He achieved strong market positions for two significant growth drivers (Cosentyx and Entresto), drove the uptake of the rare disease drug Ilaris, initiated the landmark PIONEER clinical trial in heart failure, and championed several business development initiatives. Mr. Chouraqui moved the organization’s culture from “consensus building, conservative and siloed” to “questioning, experimenting and collaborative.” He also served as Novartis representative on the board of BIO. Before leading the US organization, Mr. Chouraqui was President, Latin America & Canada (2014-2016) for Novartis Pharmaceuticals, responsible for leading a portfolio shift from established primary care medicines to innovative specialty care drugs. He also served as Global Head, Business Franchise Neuroscience (2012-2014). In this role, he relaunched Gilenya (Multiple Sclerosis) following a post-launch regulatory review and made Gilenya the largest growth contributor in the Novartis five-year strategic plan. Mr. Chouraqui also addressed late-stage pipeline gaps with the start of the siponimod program in Secondary Progressive Multiple Sclerosis (approved in 2019) and the identification of business development opportunities, which led to the in-licensing of ofatumumab in MS from GSK (launched as Kesimpta) and a partnership with Amgen on erenumab for migraine (launched as Aymovig). From 2000 to 2010, Mr. Chouraqui held multiple international roles at Bristol-Myers Squibb, ultimately serving as Vice President, Commercial Operations, Asia-Pacific and General Manager, Southeast Asia (2008-2010). He began his career in R&D roles at Roussel Uclaf and Hoechst Marion Roussel, pharmaceutical companies that were predecessors to today’s Sanofi. Mr. Chouraqui earned a MBA from INSEAD and a Doctorate in Pharmacy, a Post-Graduate Degree in Quality Assurance of Medicines, and a MSc in Biological and Medicinal Sciences from University of Paris V. Mr. Chouraqui shall have stepped down as Executive Chairman of Cellarity, Inc., a non-listed company, no later than upon his appointment as the new Executive Director and Chief Executive Officer of Pharming. Thereafter, Mr. Chouraqui intends to serve as a non-executive Board member of Cellarity. Mr. Chouraqui also holds the position of independent Board member of OranoMed, a non-listed (and therefore private) subsidiary of Orano Group. OranoMed is a company specialized in the research and development of Pb-212 based radioligand alpha therapies for the treatment of various types of cancers. The resume of Mr. Chouraqui is available on our website. For further public information, contact:Pharming Group, Leiden, the NetherlandsMichael Levitan, VP Investor Relations & Corporate CommunicationsT: +1 (908) 705 1696E: investor@pharming.com FTI Consulting, London, UKVictoria Foster Mitchell/Alex Shaw/Amy ByrneT: +44 203 727 1000 LifeSpring Life Sciences Communication, Amsterdam, the NetherlandsLeon MelensT: +31 6 53 81 64 27E: pharming@lifespring.nl About Pharming Group N.V. Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific. For more information, visit www.pharming.com and find us on LinkedIn. Forward-Looking Statements   This press release may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples of forward-looking statements may include statements with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, and Pharming's expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory, commercial, competitive and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming's 2023 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release. Pharming does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information. Inside InformationThis press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. Attachments Fabrice Chouraqui Pharming to nominate new Executive Director and Chief Executive Officer_EN_21JAN25

Executive ChangeDrug Approval

13 Jan 2025

·www.pharmaindustrial-india.com

Cycle Pharma Acquires Banner Life Sciences

Cycle Pharmaceuticals has completed the acquisition of Banner Life Sciences which includes its BAFIERTAM® (monomethyl fumarate) product for the treatment of relapsing forms of multiple sclerosis (MS), in adults, approved by the US Food and Drug Administration (FDA). MS affects an estimated 1 million people in the US with around 200 new cases being diagnosed each week.1 Approximately 85 percent of diagnoses are the relapsing-remitting form of the condition and, without treatment, about 50 percent of those progress to the more serious secondary-progressive form within 10 years. BAFIERTAM will become Cycle’s second branded product for the treatment of MS alongside TASCENSO ODT® (fingolimod). As with TASCENSO, BAFIERTAM patients will benefit from Cycle’s industry leading hub program, Cycle Vita™. BAFIERTAM patients will continue to be supported by Banner’s established network during a transition period. The purchase of Banner was funded from cash on hand and demonstrates the capability of Cycle to reinvest in products where it can provide the highest quality medicines and support to patients who need it most. This acquisition comes at a time of increasing attention to the long-standing concern about the substandard quality of generic medicines in the neurology community, as most recently documented in MS by Professor Darin Okuda (UT Southwestern Medical Center, Dallas, TX). “We are delighted to strengthen Cycle’s offer to the MS community by adding BAFIERTAM to our MS product portfolio. We will be able to support more patients via our best-in-class patient support hub Cycle Vita, as well as giving patients full confidence in the medicines they are using to manage their MS,” said James Harrison, CEO of Cycle.

Drug ApprovalAcquisition

100 Deals associated with Fingolimod Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D04187	Fingolimod Hydrochloride	L04AA27	DB08868

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	European Union	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Iceland	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Norway	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis	Australia	Novartis AG	01 Feb 2011
Multiple sclerosis relapse	United States	Novartis Pharmaceuticals Corp.	21 Sep 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	United States	Mitsubishi Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Japan	Mitsubishi Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Japan	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Australia	Mitsubishi Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Australia	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Belgium	Mitsubishi Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Canada	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Canada	Mitsubishi Tanabe Pharma Corp.	22 Dec 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04088630 (FITCH, CTgov)	Early Phase 1	Cerebral Hemorrhage \| Brain Edema \| Hemorrhagic stroke	28	Fingolimod (Fingolimod)	rbixqucmaz = ahrqleoajz vxuzwajxgf (nmmajtztzd, dozszqxxsx - exnzhxxzzt) View more	-	14 Jan 2025
				Fingolimod (Open-label Fingolimod)	rbixqucmaz = stsqctoucn vxuzwajxgf (nmmajtztzd, aditwsmxfy - dcxwsitmys) View more
EAN2024	Not Applicable	lymphopenia \| hypertransaminasemia	50	Fingolimod	wpedcslxhs(awyxqxoscv) = iznrfhfzsi xwucqyfsne (hcijtbwczh ) View more	Positive	28 Jun 2024
				Ozanimod	xihqlertql(pqgufyidll) = ghjbirjzos qyixbnmwpo (vjiqlrinpo ) View more
ACTRIMS2024	Not Applicable	Drug-Related Side Effects and Adverse Reactions	350	Fingolimod	fqpiugknya(sldqsfhkak) = A 39-year-old woman with RRMS since 2003 presented changes in a nevus on her right foot sole in July 2018. It was excised in November 2018, with a report indicating melanocytic proliferation with atypia. Fingolimod was discontinued, and an autologous bone marrow transplant was performed in 2019. She is currently free of disease activity and skin lesions. A 32-year-old man with RRMS since 2010 reported heartburn and regurgitation in November 2018. Laboratory tests showed aspartate aminotransferase at 19, alanine aminotransferase at 42, and gamma-glutamyl transferase at 97, with no other abnormalities. An endoscopy and biopsy revealed a 2.8 cm subepithelial lesion in the cardia, consistent with leiomyoma. He is currently asymptomatic and continues fingolimod therapy. A 35-year-old woman with Diabetes Mellitus and RRMS since 2015, treated with fingolimod since 2018, developed a skin lesion in 2022. Histopathological examination confirmed cutaneous tuberculosis. Antimicrobial management was initiated without discontinuing fingolimod. The skin lesion has resolved, and there is no RRMS activity. A 38-year-old woman with RRMS since 2016, treated with fingolimod since 2018, developed an axillary lymph node in 2022, which was diagnosed as breast cancer. She is currently undergoing chemotherapy for oncology, with no RRMS activity. vzssjwppom (pifsmnhorc )	Positive	29 Feb 2024
ECTRIMS2022	Not Applicable	-	3,840	fingolimod (Patients with FTY rebound)	jfcmghtawj(tokttyabwj) = esyypheyql ybqmhicjda (cunpskfney )	-	12 Oct 2022
ECTRIMS2022	Not Applicable	COVID-19	-	Fingolimod	jcnrcigvdp(lfawwqmwsq) = pdfxiltwuu wankzjnlkh (yjlkqjiqbo ) View more	-	12 Oct 2022
				Siponimod	jcnrcigvdp(lfawwqmwsq) = akxlwjvqza wankzjnlkh (yjlkqjiqbo ) View more
EUPAS24484 \| CLARION (ECTRIMS2021)	Phase 3	Multiple Sclerosis	762	Cladribine tablets 10 mg	yhovxnzvji(qzbjclxlts) = afuxweljrq orgmqybtvr (jjcysbxgxs, 1.3 - 21.1) View more	Positive	12 Oct 2021
				Fingolimod	yhovxnzvji(qzbjclxlts) = afiscsovhp orgmqybtvr (jjcysbxgxs, 1.3 - 21.4) View more
ECTRIMS2021	Not Applicable	Multiple Sclerosis	-	Cladribine	afxmercagk(lcvjjnuewu) = wagvriheua ebaatcdgke (wegquyvucq ) View more	Positive	12 Oct 2021
				Rituximab	afxmercagk(lcvjjnuewu) = zyyoxbmmgf ebaatcdgke (wegquyvucq ) View more
CLARION (ECTRIMS2021)	Not Applicable	Multiple Sclerosis First line	1,597	Cladribine tablets (CladT)	cbvwcymotd(yexktbsesx) = jjyxzorubl sevjrazabn (enutaavycb )	-	12 Oct 2021
				Fingolimod	cbvwcymotd(yexktbsesx) = rdjlmocaix sevjrazabn (enutaavycb )
EAN2021	Not Applicable	COVID-19	-	Cladribine tablets	gvpgvndurg(rdfhnnpggi) = Only one case of mild COVID-19 was recorded in the cladribine cohort, with onset 14 months after last dose bayihsblha (oabcjfdvqj )	-	18 Jun 2021
				Fingolimod
EAN2021	Not Applicable	Multiple Sclerosis	8	Fingolimod (FTY)	jhkmvkukko(sziotpopug) = ybcuwsaeal wgkikgiprb (gycoxtqjcc, 5.9) View more	Positive	18 Jun 2021

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