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Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma Submits XS003 to the FDA – The Company’s Second Product Candidate from the HyNap Platform

Tue, 19 Aug 2025 10:02:00 -0400

STOCKHOLM--(BUSINESS WIRE)-- Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate XS003 (nilotinib) for the treatment of chronic myeloid leukemia (CML). The application is based on successful studies demonstrating bioequivalence with the reference product Tasigna®. XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, which gives physicians greater predictability when adjusting the dose, enabling more consistent exposure and potentially reducing the risk of side effects. Due to XS003’s improved food interaction profile, the warning about three

Xspray Pharma grants dasatinib license to Handa Therapeutics

Tue, 12 Aug 2025 07:12:13 -0400

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) has signed a license agreement with Handa Therapeutics for commercialization of a dasatinib product in the United States and selected Asian markets, according to a company statement.

Under the non-exclusive license agreement, Xspray will receive up to a double-digit royalty on Handa's net proceeds from the licensed product. The agreement covers certain Xspray patents related to dasatinib, a cancer treatment drug.

This represents the first out-licensing deal from Xspray's patent portfolio. The Stockholm-based pharmaceutical company's lead product candidate Dasynoc, also a dasatinib product, has a FDA review date of October 7, 2025.

The license agreement ensures that

Xspray Pharma grants dasatinib license to Handa Therapeutics

Tue, 12 Aug 2025 07:12:13 -0400

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) has signed a license agreement with Handa Therapeutics for commercialization of a dasatinib product in the United States and selected Asian markets, according to a company statement.

Under the non-exclusive license agreement, Xspray will receive up to a double-digit royalty on Handa's net proceeds from the licensed product. The agreement covers certain Xspray patents related to dasatinib, a cancer treatment drug.

This represents the first out-licensing deal from Xspray's patent portfolio. The Stockholm-based pharmaceutical company's lead product candidate Dasynoc, also a dasatinib product, has a FDA review date of October 7, 2025.

The license agreement ensures that

Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa’s Net Proceeds

Tue, 12 Aug 2025 07:12:00 -0400

Xspray Pharma (“Xspray”) has entered into a license agreement with Handa Therapeutics (“Handa”) granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s net proceeds.

STOCKHOLM--(BUSINESS WIRE)-- This is the first out-licensing from Xspray’s broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company’s core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged.

Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa’s Net Proceeds

Tue, 12 Aug 2025 07:12:00 -0400

Xspray Pharma (“Xspray”) has entered into a license agreement with Handa Therapeutics (“Handa”) granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s net proceeds.

STOCKHOLM--(BUSINESS WIRE)-- This is the first out-licensing from Xspray’s broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company’s core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged.

Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa’s Net Proceeds

Tue, 12 Aug 2025 07:12:00 -0400

Xspray Pharma (“Xspray”) has entered into a license agreement with Handa Therapeutics (“Handa”) granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s net proceeds.

STOCKHOLM--(BUSINESS WIRE)-- This is the first out-licensing from Xspray’s broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company’s core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged.

Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa’s Net Proceeds

Tue, 12 Aug 2025 07:12:00 -0400

Xspray Pharma (“Xspray”) has entered into a license agreement with Handa Therapeutics (“Handa”) granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s net proceeds.

STOCKHOLM--(BUSINESS WIRE)-- This is the first out-licensing from Xspray’s broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company’s core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged.

Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa’s Net Proceeds

Tue, 12 Aug 2025 07:12:00 -0400

Xspray Pharma (“Xspray”) has entered into a license agreement with Handa Therapeutics (“Handa”) granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s net proceeds.

STOCKHOLM--(BUSINESS WIRE)-- This is the first out-licensing from Xspray’s broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company’s core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged.

Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa’s Net Proceeds

Tue, 12 Aug 2025 07:12:00 -0400

Xspray Pharma (“Xspray”) has entered into a license agreement with Handa Therapeutics (“Handa”) granting Handa a non-exclusive license to certain Xspray patents. The license covers commercialization of a dasatinib product in the US market and, at a later stage, selected Asian markets. Under the agreement, Xspray will receive up to a double-digit royalty on Handa’s net proceeds.

STOCKHOLM--(BUSINESS WIRE)-- This is the first out-licensing from Xspray’s broad patent portfolio and marks an important milestone in capitalizing on its intellectual property assets. The company’s core strategy to develop and commercialize improved PKI-drugs using its patented HyNap technology remains unchanged.

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Thu, 19 Sep 2024 06:00:00 -0400

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

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Thu, 19 Sep 2024 06:00:00 -0400

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

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Thu, 19 Sep 2024 06:00:00 -0400

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

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Thu, 19 Sep 2024 06:00:00 -0400

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

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Thu, 19 Sep 2024 06:00:00 -0400

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

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Thu, 19 Sep 2024 06:00:00 -0400

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

Xspray Pharma Announces Positive FDA Meeting and Plans for Dasynoc NDA Resubmission

Thu, 19 Sep 2024 06:00:00 -0400

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