Fulcrum Therapeutics Appoints New CCO and Regulatory Officer
Fulcrum Therapeutics Enhances Leadership with New Appointments
Fulcrum Therapeutics, Inc. (NASDAQ: FULC), a pioneering clinical-stage biopharmaceutical company committed to developing innovative treatments for genetically defined rare diseases, has announced the strategic appointments of Isabel Kalofonos as Chief Commercial Officer and Heather Faulds as Chief Regulatory Affairs and Quality Assurance Officer. These appointments are pivotal in advancing the lead drug candidate, losmapimod, towards its New Drug Application (NDA) submission and upcoming commercial launch.
Welcoming Isabel Kalofonos to the Team
Isabel Kalofonos joins Fulcrum Therapeutics with an impressive background, most recently serving as Senior Vice President and Chief Commercial Officer at ImmunoGen. Her contributions at ImmunoGen include leading global commercial initiatives for the successful launch of ELAHERE for the treatment of adults suffering from FR?-positive, platinum-resistant epithelial ovarian cancer.
Prior to that, Ms. Kalofonos held various senior roles at Galderma, where she oversaw the launch preparation for NEMLUVIO, a therapy aimed at treating atopic dermatitis. Notably, she was instrumental in the global launch of TAKHZYRO during her time at Takeda Pharmaceuticals. Her extensive experience spans corporate strategy and product launch, contributing to her well-rounded perspective on the biotech industry.
“Losmapimod is positioned to be a potential first-to-market oral therapy for the treatment of FSHD, a progressive and debilitating disease for which there are currently no approved treatments,” remarked Ms. Kalofonos. “Joining Fulcrum at this crucial moment as we prepare for our transition to a commercial-stage organization is exhilarating.”
Heather Faulds: A Key Addition to Regulatory Affairs
Heather Faulds brings over two decades of regulatory and quality assurance experience to Fulcrum. Previously an SVP at Alkermes, she led the regulatory team that secured FDA approval for LYBALVI, a combination therapy addressing schizophrenia and bipolar disorder. Her background also includes significant roles at Scholar Rock and Biogen, where she was part of pivotal drug approvals and regulatory submissions, notably influencing the rapid approval of SPINRAZA for spinal muscular atrophy.
“I am eager to apply my regulatory expertise at Fulcrum to help expedite the delivery of therapies to patients in need,” said Ms. Faulds. “By leveraging our innovative scientific foundation, I look forward to working with this talented team as we gear up for our next stage of growth.”
About Fulcrum Therapeutics
Fulcrum Therapeutics is a committed biopharmaceutical company focused on developing small molecule therapies aimed at treating patients with genetically defined rare diseases. With a robust pipeline, Fulcrum is currently developing two lead programs: losmapimod, aimed at treating facioscapulohumeral muscular dystrophy (FSHD), and pociredir, intended for sickle cell disease (SCD). By utilizing proprietary technologies, Fulcrum seeks to address the underlying causes of genetic diseases.
The Promise of Losmapimod
Losmapimod is a p38?/? mitogen activated protein kinase (MAPK) inhibitor being studied for its potential to slow the progression of FSHD. The drug has demonstrated positive outcomes in the Phase 2b ReDUX4 trial, exhibiting slower disease progression and improved physical function. With its FDA Fast Track and Orphan Drug designations, losmapimod is positioned to potentially transform treatment for FSHD patients.
Understanding FSHD
Facioscapulohumeral muscular dystrophy (FSHD) is a rare, progressive muscle-wasting disorder characterized by weakening and atrophy of skeletal muscles. The disease primarily impacts the face, shoulders, and arms, severely affecting patients' daily activities, mobility, and independence. With around 30,000 affected individuals in the United States, FSHD represents a significant unmet medical need in the realm of muscular dystrophies.
Contact Information
For further inquiries regarding Fulcrum Therapeutics, please contact:
Chris Calabrese
LifeSci Advisors, LLC
ccalabrese@lifesciadvisors.com
917-680-5608
Frequently Asked Questions
1. What recent appointments has Fulcrum Therapeutics made?
Fulcrum Therapeutics has appointed Isabel Kalofonos as Chief Commercial Officer and Heather Faulds as Chief Regulatory Affairs and Quality Assurance Officer.
2. What is the role of Isabel Kalofonos at Fulcrum?
Isabel Kalofonos will lead commercial efforts and is instrumental in preparing for the NDA submission and commercial launch of losmapimod.
3. What is losmapimod targeting?
Losmapimod is being developed as a potential first-to-market oral therapy for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
4. What is FSHD?
FSHD is a serious, rare genetic disorder characterized by muscle weakness and atrophy, primarily affecting the face, shoulder, and upper arm muscles.
5. How can I contact Fulcrum Therapeutics for more information?
You can reach Chris Calabrese at LifeSci Advisors via email at ccalabrese@lifesciadvisors.com or by phone at 917-680-5608.
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