Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD

Written by Customer Service on October 2, 2022. Posted in Public Companies.

NEW YORK, Oct. 02, 2022 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) substantial new information on clinical and potency assay items identified in the Complete Response Letter (CRL) received from FDA in September 2020 to the Biologics License Application (BLA) for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). Mesoblast has maintained an active dialog with the FDA since receiving the CRL, and the substantial new information submitted to the Investigational New Drug (IND) file for remestemcel-L in the treatment of children with SR-aGVHD, as guided by FDA, represents a major milestone in the Company’s...

Myovant Sciences Special Committee of Board Confirms Receipt of Preliminary, Non-binding Proposal from Sumitovant Biopharma and Sumitomo Pharma to Acquire Remaining Shares

Written by Customer Service on October 2, 2022. Posted in Mergers And Acquisitions.

BASEL, Switzerland, Oct. 02, 2022 (GLOBE NEWSWIRE) — Myovant Sciences Ltd. (NYSE: MYOV) (the “Company”) confirmed today that it has received a preliminary, non-binding proposal (the “Proposal”) from Sumitovant Biopharma Ltd. (“Sumitovant”) and Sumitomo Pharma Co., Ltd. (collectively with Sumitovant, “Sumitomo”) to acquire the remaining shares of the Company that Sumitovant does not currently hold, for a price of $22.75 per share in cash. Sumitovant currently holds approximately 52% of the outstanding shares of the Company. The Company’s board of directors has formed a special committee of independent directors comprised of the members of the Audit Committee of the Company (the “Special Committee”) to evaluate and consider the Proposal and any alternatives thereto, with the assistance of its financial and legal advisors. The Special...

Maxim Power Corp. Reports Fire Incident at Milner 2

Written by Customer Service on October 2, 2022. Posted in Public Companies.

CALGARY, Alberta, Oct. 02, 2022 (GLOBE NEWSWIRE) — Maxim Power Corp. (“MAXIM” or the “Corporation”) (TSX: MXG) responded to a fire at its 204 MW Milner 2 (“M2”) facility located near Grande Cache, Alberta. During the afternoon of September 30, 2022, a fire occurred at the M2 facility. Emergency crews were dispatched and quickly extinguished the fire. MAXIM holds safety as its highest priority for its people, community and emergency responders and reports that all personnel involved in the incident are safe. The appropriate authorities have been informed and an investigation as to the cause of the fire and extent of the damage is currently underway. MAXIM is also in the process of evaluating an insurance claim for damages and future lost earnings. As previously reported, the M2 facility has been offline since...

Certified Advisor update

Written by Customer Service on October 2, 2022. Posted in Public Companies.

Copenhagen, Oct. 02, 2022 (GLOBE NEWSWIRE) — Announcement no. 11-2022 Beierholm Corporate Finance P/S, which is approved as Certified Advisor by Nasdaq First North Growth Market Denmark, has been appointed as Certified Advisor for Hypefactors. This takes place in connection with the transaction whereby Oaklins Denmark A/S, which has been Hypefactors’ Certified Advisor, has been acquired by Beierholm, Statsautoriseret Revisionspartnerselskab. —– About Hypefactors A/S Hypefactors is an integrated AI powered Earned Media tech platform to support better media intelligence, reputation and trust management. Hypefactors combine data, analytics, technology and tools to provide a unified and easy-to-use experience. With all the tools to automate and ease the work, and all the facts to document the results. In addition to...

5E Advanced Materials to Host Investor Webcast

Written by Customer Service on October 2, 2022. Posted in Public Companies.

HOUSTON, Oct. 02, 2022 (GLOBE NEWSWIRE) — 5E Advanced Materials, Inc. (Nasdaq: FEAM) (ASX: 5EA) (“5E” or the “Company”), a boron and lithium company with U.S. government Critical Infrastructure designation for its 5E Boron Americas (Fort Cady) Complex, is pleased to invite shareholders and interested parties to an Investor briefing to be held via webcast on Monday, October 3, 2022 at 4:30pm ET (Tuesday, October 4, 2022 at 7:30am Australian Eastern Time). The executive management team will discuss the Small-Scale Boron Facility that is currently in construction, commercial initiatives that focus on boron and lithium product streams, recent corporate updates, and U.S. public markets initiatives. Webcast Details: Time: Monday, October 3, 2022 at 4:30pm ET (Tuesday, October 4, 2022 at 7:30am Australian Eastern Time) Where: Virtual...

New Analysis of SOLOIST-WHF Trial Underscores Sotagliflozin’s Effect on Reducing Recurrent Heart Failure Events

Written by Customer Service on October 2, 2022. Posted in Public Companies.

Data presented at the Heart Failure Society of America annual scientific meeting New analysis adds to growing body of evidence in support of the use of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, in the treatment of heart failure THE WOODLANDS, Texas, Oct. 02, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that a new analysis of results from the SOLOIST-WHF Phase 3 outcomes trial of sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor, was presented at the Heart Failure Society of America (HSFA) Annual Scientific Meeting 2022. The new analysis was presented by Bertram Pitt, M.D., FACC, professor of medicine emeritus at the University of Michigan, School of Medicine, and co-chair for the SOLOIST-WHF trial as well as a member of the Executive Committee for...

Cytokinetics Presents New Data From REDWOOD-HCM OLE in Late Breaking Clinical Trial Session at the HFSA Annual Scientific Meeting

Written by Customer Service on October 2, 2022. Posted in Public Companies.

Figure 1 Change from baseline in KCCQ in REDWOOD-HCM OLE Treatment with Aficamten Associated with Significant Improvements in Symptoms and Quality of Life Additional Data Presented in Poster Session Shows Patients with Worsening Heart Failure and LVEF ≤30% Have Disproportionately High Risk of Heart Failure Hospitalization SOUTH SAN FRANCISCO, Calif., Oct. 02, 2022 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced new data on symptom improvement and quality of life related to treatment with aficamten in REDWOOD-HCM OLE (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM Open Label Extension) in a Late Breaking Clinical Trials session at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Washington, D.C. Previously presented data from REDWOOD-HCM open...

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Day: October 2, 2022