Xspray Pharma AB

Xspray Pharma pledged to resubmit its new drug application for Dasynoc after working through the issues at a third-party manufacturer. Xspray Pharma has taken hit after hit during its repeated efforts to commercialize its leukemia prospect Dasynoc. On its third attempt to win the FDA’s favor, the company has run into yet another setback.The FDA turned down Dasynoc’s latest approval bid in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) with a complete response letter (CRL) after identifying concerns at Xspray’s contract manufacturing organization, Xspray disclosed in an update Wednesday.Although none of the agency’s observations were directed specifically at the Dasynoc production lines, the FDA is holding off on approving any new products made at the CMO's site until the deficiencies are corrected, Xspray said. The manufacturer has already implemented a remediation plan and will meet with the FDA later this year.  “It is unfortunate that manufacturing-related issues beyond our control are delaying our launch,” Xspray CEO Per Andersson said in a statement. “We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed.”The FDA had already signed off on the CMO’s Dasynoc-specific manufacturing lines during a preapproval inspection earlier this year, according to an Xspray update in June. Around that time, Xspray also revised Dasynoc’s proposed tablet strengths, addressing concerns raised in a prior CRL. By now, CRLs are familiar territory for Xspray. In 2023, the FDA shot down the company’s first approval bid based on concerns with Dasynoc’s label and Xspray’s third-party manufacturer. Specifically, the agency asked for clarifying information on the drug’s dosing that could help patients “avoid confusion.”Another CRL, again highlighting the same label comprehension issue and CMO concerns, came in 2024. This time, the FDA suggested a “dialogue” to adapt the labeling strategy, leaving Xspray caught off guard by the “unexpected” requests that delayed its planned September 2024 launch.After its subsequent chat with the FDA, Xspray agreed to make new batches of the drug with an adjusted tablet strength to limit the risk of dosing errors. By April 2025, the company's adjusted plan had gone “according to plan,” Andersson said, emphasizing that the company still had enough funds to take the drug to the FDA finish line. However, it seems that the FDA may be still unsure of the company’s label and product information. Along with the manufacturing issues cited in the recent CRL, the agency also requested information “demonstrating that the discussed product information is appropriate," according to the company. Xspray’s share price has tumbled by roughly 57% since the Wednesday disclosure.Dasynoc (dasatinib), is an “optimized” form of Bristol Myers Squibb’s blockbuster Sprycel that has proven bioequivalence at a 30% lower dose, according to Xspray. BMS and Xspray settled their related patent litigation in 2023, paving the way for what would have been an early market entry for Dasynoc in September 2024. Sprycel went generic last year but still generated $1.3 billion for BMS in 2024.Besides its version of Sprycel, Xspray has a version of Novartis' Tasigna that's expected to undergo an FDA review, according to the company.

Welcome to Endpoints News ’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Xspray Pharma received a complete response letter for its leukemia treatment Dasynoc over issues found at its third-party contract manufacturer, according to a Wednesday release. No issues were directly related to Dasynoc’s production, but the FDA has paused all approvals related to the site as the manufacturer remedies the issues. Oxford Biomedica has paid $4.5 million to acquire a viral vector manufacturing facility in North Carolina from RTP Operating, which is a subsidiary of National Resilience. Parts of the facility will be operational by the first quarter of next year and Oxford Biomedica will hire additional staffers, it said on Tuesday. Lupin is investing $250 million over the next five years to build a new plant in Coral Springs, FL, the company said Wednesday. The facility will make respiratory medicines and will create 200 new jobs by 2030. API manufacturer Axplora’s investments will exceed €100 million ($116.3 million) across its network this year. This features its €60 million expansion in France, €35 million in Italy and €8.5 million in India, according to a Tuesday release Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Ricardo Valdez. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Catalent is partnering with Lisata Therapeutics to develop antibody-drug conjugates, they said on Wednesday. Lisata’s certepetide, which is a type of peptide, will be incorporated into Catalent’s ADC technology. Three service providers are working together to offer their manufacturing services. Sai Life Sciences will provide its API services, Agility Life Sciences will bring its formulation development and Centrix Pharma Solutions will offer its drug development and clinical manufacturing, they said on Wednesday. DNA manufacturer UILT Biotechnologies is relocating its headquarters to CvilleBioHub’s facilities at the North Fork Research Park in Charlottesville, VA, it said on Friday. Cell therapy CDMO Kincell Bio is partnering with Moonlight Bio and will provide clinical manufacturing services for Moonlight’s lead T cell therapy candidate, they announced on Tuesday. A joint venture featuring four companies is planning to build a new manufacturing facility in Japan, which will make drug substances and drug products. The four drugmakers – Mycenax Biotech, Alfresa Holdings Corporation, Kidswell Bio Corporation and Chiome Bioscience — are combining all of their biologics manufacturing capabilities, according to a Monday release.

Xspray Pharma said Wednesday that its application for Dasynoc (dasatinib) to treat chronic myeloid leukaemia and acute lymphoblastic leukaemia was rejected by the FDA due to good manufacturing practice (GMP) observations at the drugmaker's contract manufacturing organisation (CMO). improved version of Sprycel, a second-generation tyrosine kinase inhibitor.Dasynoc is an improved version of second-generation tyrosine kinase inhibitor Sprycel that's designed to not interact with antacids and have greater uptake.  No issues were identified at Xspray's own production line, but the FDA is pausing approvals of products made at the CMO's facility "while corrective actions are being implemented," the company said. The manufacturer has implemented a remediation plan and plans to meet with the US regulator in December. In the complete response letter (CRL), the FDA also requested information from Xspray to ensure "the discussed product information is appropriate.""It is unfortunate that manufacturing-related issues beyond our control are delaying our launch. We have made significant progress in the regulatory review and maintained discussions with the FDA regarding the product information for Dasynoc up to the PDUFA date," said Per Andersson, Xspray's chief executive. "We will now work closely with both the manufacturer and the FDA to expedite the process and enable a resubmission as soon as the corrective actions have been completed."Xspray is the latest in a series of drugmakers to receive a CRL prompted by manufacturing issues. Earlier this month, Fortress Biotech said FDA declined to approve CUTX-101 (copper histidinate) to treat paediatric patients with Menkes disease due to GMP deficiencies, and Biogen's high-dose Spinraza was hit with a similar complaint last month.After the US regulator released hundreds of CRLs in July, a FirstWord analysis found that issues related to chemistry, manufacturing and controls are the most frequent reason the FDA didn't approve a drug, with deficiencies at manufacturing facilities or subpar quality of the manufactured drug product leading to a combined 60% of all rejections (see – Vital Signs: What we learned from the FDA's CRL data dump).