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Spexis AG (SIX:SPEX) is a publicly-listed Swiss clinical-stage biopharmaceutical company developing rare disease and oncology treatments in indications where new therapeutic options are urgently needed. Spexis AG was launched in December 2021 by the reverse merger of EnBiotix, Inc. (Boston, MA, USA) and Polyphor AG (Allschwil, Switzerland), with EnBiotix shareholders resulting in the majority. Our focus is on chronic respiratory diseases (CRD), and our lead product candidate ColiFin® is P3 ready.
ColiFin® is an inhaled colistimethate sodium product in-licensed from PARI Pharma GmbH for ex-European rights. Approved and marketed in Europe as a front-line therapy in cystic fibrosis (“CF”) patients, ColiFin® already has a proven safety, efficacy, and commercial track record. In the U.S., ColiFin® has Orphan Drug and Qualified Infectious Disease Product (“QIDP”) designations, which together will provide a total of 12 years of market exclusivity from NDA approval. We also have a “Study May Proceed” letter from the FDA regarding a single phase 3 study evaluating ColiFin® in CF patients being sufficient to support a future New Drug Application (“NDA”). The trial design has been endorsed by the Cystic Fibrosis Foundation (CFF) Therapeutic Development Network (TDN), the clinical development arm of the CFF. Of note, the CFF also invested in the pre-merger financing launching Spexis.
Company Details
- Employees
- 19
- Founded
- -
- Address
- Hegenheimermattweg 125, Allschwil,4123,switzerland
- Industry
- Pharmaceutical Manufacturing
- Website
- https://spexisbio.com/
- HQ
- Allschwil
Spexis Ag Questions
Spexis AG's website is https://spexisbio.com/
Spexis AG's LinkedIn profile is https://www.linkedin.com/company/spexis-ltd
Spexis AG has
19 employees.
View email and phone details for 19
employees at Spexis AG.
Spexis AG's industry is
Pharmaceutical Manufacturing
Spexis AG's top competitors are
Solvias,
Bachem,
Bright Peak Therapeutics,
Bioversys Ag,
Santhera Pharmaceuticals,
Alentis Therapeutics,
Idorsia Pharmaceuticals Ltd,
Tillotts Pharma Ag,
Basilea Pharmaceutica,
Actelion (Now Janssen Pulmonary Hypertension).
Spexis AG's categories are Pharmaceutical Manufacturing
Spexis AG's founding year is 1996
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Top Spexis AG Employees
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Dan Hartman
Director, Integrated Development, Global Health At Bill & Melinda Gates Foundation
Seattle, Washington, United States, United States4gmail.com, pfizer.com, gatesfoundation.org, gatesfoundation.org2 +181059XXXXX
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Karsten Marx
♦ Hands-On Cmc Expert In Regulatory Cmc And Technical Cmc ♦ Dsc (Dr. Rer. Nat.) ♦ Raps Certification: Dual (Pharmaceuticals And Medical…
Basel, Basel, Switzerland, Switzerland -
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