The stocks which are turning bullish on the ASX in the backdrop of some related news are
Mesoblast Limited (ASX: MSB)
Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, recently confirmed that it will file its Biologics License Application (BLA) for approval of Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD) with the U.S. Food and Drug Administration (FDA) in the coming week..
It had earlier received notification from the United States Food and Drug Administration (FDA) subsequent to its Type C meeting during the quarter. The FDA, after further evaluation of the available clinical data from its Phase 3 study MSB-GVHD001, had found it to be suitable to support the submission of the proposed Biologics License Application (BLA) for remestemcel-L. This application is intended for the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
Additionally, formal minutes from the Type B meeting, which took place in February under Mesoblast's existing Regenerative Medicine Advanced Therapy (RMAT) designation, were provided by the FDA. It was conveyed that the FDA supports an accelerated approval pathway for Revascor® (rexlemestrocel-L), Mesoblast's allogeneic mesenchymal precursor cell (MPC) product. This pathway is for patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). In these patients, administration of REVASCOR led to a reduction in inflammation, improvement in left ventricular function, decrease in right ventricular failure, lower hospitalizations, and reduced mortality.
Titomic Limited (ASX: TTT)
Titomic Limited (ASX: TTT) recently secured $1.2m sale to Leading U.S. Innovation Centre, Oregon Manufacturing Innovation Center (OMIC R&D).
In June 2024, Titomic announced its first foray into the oil and gas sector. The sector offers a significant Market Opportunity and, particularly working with industry leaders Woodside and Monadelphous as first customers draws validation.
On 7 May 2024, had announced a significant strategic sale to Triton Systems Inc. (Triton), a U.S.-based company. The sale involves a custom Titomic Kinetic Fusion System (TKF System) valued at USD 808,000 (AUD 1.2 million), which will be delivered within nine months. Triton's investment in the TKF System is part of a larger initiative to develop innovative manufacturing applications. Notably, this transaction represents Titomic's inaugural sale of a TKF System within the United States.
In its Quarterly Report for Q3 FY24, ending 31 March 2024, Titomic disclosed several key developments.
The Koninklijke Landmacht of the Royal Netherlands Army placed an order for 10 D523 cold spray systems, valued at EUR 772,000 (AUD 1.3 million). This order, Titomic's largest for the D523 to date, includes nine units designated to support Ukraine’s military efforts, enhancing battlefield damage repair and extending mission capabilities.
The Volvo Group purchased a D523 for EUR 55,000 (AUD 90,865), reflecting continued expansion within the automotive and heavy equipment Maintenance, Repair, and Overhaul (MRO) sector.
Titomic successfully commissioned the new TKF 3250, an advanced high-pressure cold spray system, at its Melbourne Manufacturing Facility. Engineered by Titomic's automation team, the TKF 3250 enhances upon the TKF 1000 installed at TWI UK, incorporating new precision robotic control software and high-speed coordinated motion hardware.
The joint venture between Titomic and Repkon Machine and Tool Industry and Trade Inc. (Repkon) reached a significant milestone with the formal establishment of the joint venture company. Titomic now holds a 49% stake in the venture, as indicated by the possession of its share certificate.
Source: Company's Report
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