Xspray Pharma AB

Plus, news about GSK, Novo Nordisk, Tanai Therapeutics, Nomic Bio, Brenus Pharma, Xspray, Achilles Therapeutics, BioXcel Therapeutics and Nuvalent: Ascendis’ $300M offering: The Danish company announced the proposed share sale a few days after disclosing pivotal trial data for its dwarfism drug. — Kyle LaHucik Basilea secures anti-infectives deal with BARDA: The Swiss drugmaker will get $29 million in initial funding from the federal agency to advance development of two antifungal drugs, fosmanogepix and BAL2062. Basilea is eligible for up to $268 million in support under the terms of the multi-year agreement . — Ayisha Sharma GSK chips in with cash for antibiotic resistance organization: The $66 million in new funds will help the Global Antibiotic Research and Development Partnership speed up research into treatments for antibiotic-resistant infections. The UK drugmaker contributed €4.5 million, while the European Commission pledged €20 million. — Ayisha Sharma Novo Nordisk backs Belgian obesity startup: The Wegovy maker and BioGeneration Ventures are among the investors in Tanai Therapeutics’ €6 million seed round. — Kyle LaHucik Nomic Bio’s $42M Series B: The “protein profiling company” raised the money from Amplitude Ventures, AVANT BIO, Lux Capital, Real Ventures, and SR One. — Kyle LaHucik Brenus Pharma’s $25M round: Angelor, Noshaq and Investsud, among others, invested in the French startup’s Series A to support development of its cancer vaccine. — Kyle LaHucik Xspray Pharma to refile cancer drug with the FDA : The Stockholm-based biotech plans to resubmit Dasynoc for the second time in the fourth quarter, with an eye to a potential launch early next year. Xspray’s original NDA was hit with a CRL last year, and the FDA had requested more information related to dosing and a third-party manufacturer. — Ayisha Sharma Achilles Therapeutics undergoes strategic review: The company is stopping work on its TIL-based cNeT program. It is also planning a workforce reduction and other cost-cutting as it explores “new opportunities” for its assets. Its stock $ACHL was up about 30% on Thursday morning. — Jaimy Lee BioXcel Therapeutics is “ deprioritizing sales efforts” for Igalmi, its agitation treatment. — Jaimy Lee Nuvalent ended up raising a total of $575 million in its offering. — Jaimy Lee

STOCKHOLM--( BUSINESS WIRE )-- Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a pharmaceutical company leveraging its proprietary HyNap™ technology to develop enhanced cancer therapies, today announced significant progress following a productive meeting with the U.S. Food and Drug Administration (FDA). The company plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024, incorporating feedback from the Complete Response Letter (CRL) issued by FDA in July 2024. If the FDA sets a two-month review period upon resubmission, the launch of Dasynoc could be expected as early as Q1 2025. The FDA recommends adjustments to Dasynoc's tablet strengths to reduce the risk of medication errors. Although these changes are minor (within normal variability), the FDA has requested new batches to be produced before submission. Xspray Pharma has already initiated production of these batches. The company will also provide further clarification on the manufacturing process to ensure full alignment with the FDA’s requirements. Per Andersson, CEO of Xspray Pharma, commented: “We are very encouraged by the positive and collaborative discussions with the FDA. The new tablet strengths will enhance patient safety by reducing the potential for dosing errors, and we are working diligently to meet all the necessary requirements. Our production process is well underway, and we are on track to resubmit the NDA in Q4 2024.” He continued: “Xspray Pharma is particularly eager to bring Dasynoc to market because of the critical need we have identified in our research. Many patients, especially those relying on pH-altering medications like antacids, face challenges with existing cancer treatments due to inconsistent absorption. Dasynoc’s innovative pH-independent formulation directly addresses this issue, which minimizes the risks associated with fluctuating drug absorption ensuring that patients can receive consistent treatments. We believe this solution will be welcomed by healthcare providers and patients alike, who are in need of more reliable treatment options.” Upon resubmission, Xspray Pharma expects the FDA to assign a new Prescription Drug User Fee Act (PDUFA) date, with a final decision anticipated within two or six months of the resubmission, depending on the review timeline set by the FDA. About Xspray Pharma Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com .

STOCKHOLM--( BUSINESS WIRE )-- A new scientific article, published in the US journal Clinical Pharmacology in Drug Development, shows how Xspray Pharma's HyNap™ technology improves the bioavailability and reduces variability of two important tyrosine kinase inhibitors (TKIs), Dasynoc™ (XS004, dasatinib) and XS005 (sorafenib). Reduced variability generally leads to better safety and can potentially increase treatment effectiveness for patients, ensuring prescribers that their seriously ill patients consistently receive the prescribed dose. The article, entitled “Enhanced Oral Bioavailability and Reduced Pharmacokinetic Variability of Dasatinib and Sorafenib through Hybrid Nanoparticle-Amorphous Solid Dispersion Technology,” highlights that Xspray's amorphous drug formulations achieve bioequivalence at lower doses and with less variability in uptake and thus plasma exposure compared to crystalline reference products. These new data in several hundred people, together with a previous study showing that Xspray's amorphous dasatinib products are not affected by gastric acid-reducing agents, are major improvements for clinical use. Key findings presented in the article: Dasynoc™ (XS004, dasatinib): Bioequivalence at 30% lower dose, with up to 4.8 times less variation in plasma exposure compared to the reference product. XS005 (sorafenib): 45% increase in absorption and up to 2.8 times less variability in plasma exposure compared to the reference product. The publication in a peer-reviewed journal confirms the HyNap technology's potential to improve both efficacy and safety in the treatment of cancer patients. Per Andersson, CEO of Xspray Pharma, comments: “It is significant that our research is recognized in a leading American scientific journal. The publication confirms HyNap technology's ability to improve drug solubility and bioavailability, which we believe will lead to better treatment outcomes and fewer side effects especially for chronically medicated cancer patients.” https://doi.org/10.1002/cpdd.1416 About Xspray Pharma Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com .