Xspray Pharma AB
10.70
SEK
0.00
(0.00%)
ISIN
SE0009973563
Return %
Stock
S&P 500
1Y
-82.08
14.20
3Y
-69.71
81.12
5Y
-80.90
68.34
Capital Structure
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- CEO
- Blake Leitch
- Full Time Employees
- 25
- Sector
- Health technology
- Industry
- Pharmaceuticals: major
- Address
- Scheeles väg 2 Solna AB Sweden 171 65
- IPO Date
- Sep 28, 2017
- Website
- xspraypharma.com
- Similar Companies
- Business
- Xspray Pharma AB (publ) is a pharmaceutical company specializing in the development of improved cancer therapies, particularly protein kinase inhibitors (PKIs) for targeted cancer treatment. Leveraging its proprietary HyNap technology platform, the company develops amorphous, non-crystalline drug candidates designed to enhance clinical efficacy, safety, and patient experience compared to existing crystalline drugs. Its core product portfolio includes Dasynoc (dasatinib), an amorphous version of dasatinib for chronic myeloid leukemia (CML) and acute lymphoblastic leukemia; XS003 (nilotinib), an improved amorphous version of nilotinib for CML; XS008 (axitinib) for kidney cancer; and XS025 (cabozantinib), all developed as enhanced versions of established marketed protein kinase inhibitors. These products target the oncology segment with planned regulatory submissions primarily in the U.S., where the company holds orphan drug status for some candidates. Xspray Pharma operates globally with a focus on the U.S. and European markets and is headquartered in Solna, Sweden. Founded in 2003, it was formerly known as Xspray Microparticles AB before rebranding in 2017. Recent major developments include the FDA acceptance of the New Drug Application (NDA) for XS003 with a Prescription Drug User Fee Act (PDUFA) date set for June 18, 2026. The company plans to resubmit its NDA for Dasynoc in Q4 2024, incorporating FDA feedback from a Complete Response Letter received earlier in 2024, aiming for a U.S. launch in early 2025. Xspray Pharma secured SEK 235 million in financing through a rights issue and a loan to ensure financial flexibility to advance its pipeline and commercial launch preparations. Strategic partnerships include a commercialization agreement for Dasynoc with EVERSANA Life Science Services and a manufacturing partnership with NerPharMa. The company recently settled patent disputes with Bristol-Myers Squibb regarding Dasynoc, enabling smoother market access. These operational expansions underscore Xspray Pharma's strategic push into oncology drug commercialization and clinical development advancements. Xspray Pharma's pipeline targets multiple high-value oncology indications through bioequivalent and patented amorphous formulations that address patent expiry windows of original branded crystalline drugs in the U.S. market, focusing on near-term commercialization and pipeline growth. The company emphasizes reproducible development using its HyNap technology to expedite product development timelines and expand its portfolio. This approach positions Xspray Pharma as a specialty pharma player in the oncology and kinase inhibitor market segment, leveraging innovations in drug formulation to extend market exclusivity and improve patient outcomes.