We are pleased to share that the U.S. Food and Drug Administration (FDA) has accepted for filing our New Drug Application (NDA) for DCCR (Diazoxide Choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS) in individuals aged four years and older with hyperphagia, and has designated it for Priority Review. “The FDA’s acceptance of our NDA is a significant milestone, and designating our application for priority review reaffirms that the FDA views PWS as a serious condition. We are immensely grateful to the entire PWS community, including patients, caregivers and advocacy groups, for their ongoing support. We remain committed to continuing to work closely with the FDA through the NDA review process,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno. Read the full press release here: https://lnkd.in/e2_SpC67 #SolenoTherapeutics #PraderWilliSyndrome #PWSAwareness
Soleno Therapeutics, Inc.
Pharmaceutical Manufacturing
Redwood City, California 5,146 followers
Inspired by patients and families around the world, we are advancing much needed therapies for rare genetic disorders.
About us
At Soleno, we are researching and developing medicines to treat rare genetic disorders, beginning with Prader-Willi syndrome (PWS), a life-threatening neurobehavioral, metabolic and endocrine disorder characterized by hyperphagia (insatiable hunger), neurocognitive and behavioral difficulties. Our lead candidate, DCCR, is a Phase 3, once-daily oral tablet under investigation as a potential treatment for PWS. Our priority is to bring the first approved treatment to patients to manage the most burdensome aspects of this devastating disorder.
- Website
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https://soleno.life/
External link for Soleno Therapeutics, Inc.
- Industry
- Pharmaceutical Manufacturing
- Company size
- 11-50 employees
- Headquarters
- Redwood City, California
- Type
- Public Company
- Specialties
- Biopharmaceuticals, Therapeutics for the treatment of rare diseases, and Pharmaceuticals
Locations
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Primary
203 Redwood Shores Parkway
Suite 500
Redwood City, California 94065, US
Employees at Soleno Therapeutics, Inc.
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Jim Mackaness
CFO & COO | Technology & Healthcare
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Lauren Budesheim, MSOD,SPHR
Strategic Human Resources Leader
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Mayank Misra
Advisory Board Member at New Enterprise Ventures, VP of Digital, Insights, & Analytics, Pharmaceutical Marketing Science | Digital Innovation |…
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Anish Bhatnagar
Updates
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In their words: “My son has taught me patience. He has taught me that I am strong enough to battle this with him even on days I wanted to scream and throw in the towel.” - Gary L., PWS Caregiver Your #MyPWSstory could be the encouragement someone else needs. Tell your story & stay connected at https://lnkd.in/ehUZvuXg. #PWSAwareness #RareDisease #Support4PWS
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We are growing our team! We are inspired by the possibility of making a positive impact on the lives of individuals and families facing #PraderWilliSyndrome. If you share our dedication to excellence and our commitment to individuals with PWS, take a look at our open roles: https://lnkd.in/dWPDf_8r #LifeScienceCareers #BiotechCareers #Hiring
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As the summer comes to a close, we extend our thanks to our incredible summer interns. Your ideas, energy, and fresh perspectives have been instrumental in our work to advance a potential treatment for Prader-Willi syndrome. Thank you for your hard work and for sharing your "why" with us. Your contributions have truly made an impact! #PraderWilliSyndrome #SummerInterns
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In Their Words: “To those who live with Prader-Willi syndrome: We see the depth of your hearts, your kindness, your care for others... And in the meantime, we'll be here to share in every race, every laugh, and every milestone.” - Dini R., PWS Caregiver By sharing your #MyPWS story, you too can give words of hope. Share your story & sign up for updates here: https://lnkd.in/essYtaRZ #PWSAwareness #RareDisease #Support4PWS
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#PraderWilliSyndrome (PWS) is a life-threatening, genetic #raredisease characterized by neurobehavioral, metabolic, and endocrine symptoms. A hallmark of PWS is hyperphagia, often mischaracterized as simply “feeling hungry” all the time. In truth, hyperphagia is serious and impacts all aspects of life for a person with PWS and their family. There are currently no approved treatments for hyperphagia in PWS, but there is hope. Learn more and sign up for updates: https://lnkd.in/essYtaRZ #Support4PWS #MyPWSstory
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In Their Words: “My son is only 2.5 years old, yet has shown so much courage and strength... He is super duper special. No matter what, he will always be amazing.” - Sara F., PWS Caregiver By sharing your #MyPWSstory, you too can give words of hope. Share your story & sign up for updates here: https://lnkd.in/essYtaRZ #PWSAwareness #RareDisease #Support4PWS #MyPWSstory
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Stay Informed, Stay Inspired—Sign Up for Updates! 💌 Stay connected and shine a light on #PraderWilliSyndrome. Visit https://lnkd.in/essYtaRZ to join us. #PWSAwareness #Support4PWS
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In Their Words: “I never ceased to be amazed by people with PWS and their tenacity, sense of humor, warmth, friendliness, and togetherness.” - Myles K., PWS Ally By sharing your #MyPWSstory, you too can give words of hope. Share your story & sign up for updates here: https://lnkd.in/essYtaRZ #PWSAwareness #RareDisease #Support4PWS
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Hyperphagia, the hallmark symptom of #PraderWilliSyndrome, is a chronic and life-threatening feeling of intense, persistent hunger, food pre-occupation, and extreme drive to seek and consume food that severely diminishes the quality of life for individuals with PWS and their families. Among many serious consequences, hyperphagia can lead to anxiety, difficulty concentrating, and an inability to regulate thinking and talking about food. Join us in raising awareness about the impact of hyperphagia in PWS by sharing your PWS story at https://lnkd.in/essYtaRZ #PWSAwareness #RareDisease #Support4PWS #MyPWSstory