Target $18
Monday, August 14, 2023
Arcturus mRNA JV Partner, ARCALIS, Awarded $115 M Grant by Japan Gov
Arcturus Therapeutics Holdings Inc. (the "Company", "Arcturus", Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that ARCALIS Co., Ltd., its manufacturing joint venture in Japan to support the production of mRNA vaccines and therapeutics, has been awarded $115 million in two separate grants from the Japanese government. The grants will be used to fund the construction of a factory and the purchase of capital equipment to support current Good Manufacturing Practice (cGMP) production of mRNA drug substance and mRNA drug product operations.
https://finance.yahoo.com/news/arcturus-therapeutics-joint-venture-mrna-130000380.html
PDS suffers wider loss as R&D costs mount
NetScientific PLC - London-based investment firm focused on life science, sustainability and technology companies - Portfolio company PDS Biotechnology Corp reports results for the quarter to June 30. Net loss was USD11.5 million, widened from USD5.8 million the year before. Higher loss primarily due to costs incurred in connection with research and development programmes, which more than doubled to USD8.0 million from USD3.8 million. Loss per share of USD0.37 compared to USD0.20 before. Further, PDS reports the successful submission of final clinical protocol and supporting information to the US Food & Drug Administration to initiate phase 3 Versatile-003 trial in the fourth quarter. Adds biomarker data from Versatile-002 will be presented at the European Society for Medical Oncology Congress.
FDIC to propose 'comprehensive' changes to 'regional bank living wills'
A coming regulatory proposal will overhaul how large, regional banks prepare living wills for the event of their own failures, U.S. Federal Deposit Insurance Corporation Chairman Martin Gruenberg said Monday.
The announcement comes as U.S. regulators continue their efforts to strengthen oversight of the banking system, particularly in light of a string of collapses in March that included three of the largest in U.S. history.
"To that end, the FDIC plans to issue a notice of proposed rulemaking in the near future that will be a comprehensive restatement of the rule for notice and comment," Gruenberg said in prepared remarks.
Banks are currently required to submit plans to regulators detailing how they would wind up their businesses should they fail. Gruenberg said Monday that the coming changes would make this planning "significantly more effective."
The FDIC will call for plans that give the regulator more options when overseeing a failed bank's receivership, Gruenberg added, noting that FDIC's "living will" requirements are separate from those currently required for large bank holding companies under 2010 Wall Street reforms.
"The proposed rule would require a bank to provide a strategy that is not dependent on an over-the-weekend sale," Gruenberg said.
Pfizer gets FDA accelerated approval for multiple myeloma treatment
A Pfizer Inc. (PFE) treatment for relapsed or refractory multiple myeloma has received accelerated approval from the U.S. Food and Drug Administration, the pharmaceutical company said Monday. The treatment, Elrexfio, is a bispecific antibody for treatment of advanced multiple myeloma, a blood cancer that affects the plasma cells made in bone marrow. The treatment "provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma," clinical trial investigator Dr. Ajay Nooka, director of the multiple myeloma program at Emory University's Winship Cancer Institute, said in a statement. The FDA's accelerated approval program is designed to shorten review time for drugs that treat serious conditions and fill an unmet medical need. The Elrexfio label contains a boxed warning for neurologic toxicity and cytokine release syndrome, an aggressive immune-system response. Pfizer stock gained 0.5% Monday and is down 29% in the year to date, while the S&P 500 is up 16%.
Biden administration urges colleges to pursue diversity after Supreme Court ruling
The Biden administration on Monday issued new guidance to colleges and universities on how they could still legally encourage racial diversity on their campuses even after the U.S. Supreme Court ended affirmative action in college admissions.
The guidance, from the Education and Justice departments, came after the conservative-majority Supreme Court in June ruled that colleges cannot legally consider race as a factor on its own when deciding whom to admit to their schools.
Democratic President Joe Biden's administration had defended that long-standing practice in the court cases against Harvard University and the University of North Carolina.
The ruling left some questions unanswered, and more legal challenges by conservative activists are expected targeting diversity initiatives in education and corporate America.
Education Secretary Miguel Cardona said promoting campus diversity remained important even after the ruling.
"We know what has happened at colleges, when individual states have banned affirmative action in the past," he told reporters. "Fewer students of color applied, and fewer students of color were admitted. We cannot afford that kind of backpedaling on a national scale."
In guidance documents issued on Monday, his department and the Justice Department said that after that ruling, schools cannot allow their admissions decisions to be influenced by any demographic data related to an applicant's race that they collect.
But the departments said universities may consider how race has affected an applicant's life, such as in an applicant's essay. One example would be if someone wrote what it meant to be the first Black violinist in a youth orchestra.
Universities may also pursue targeted outreach and recruitment to boost enrollment of underrepresented groups and may consider race and other factors like geography, financial resources and family background in doing so, the departments said.
Schools may also re-examine other admissions preferences, such as those given to "legacy" applicants related to alumni or donors' children, which "reduce opportunities for others who have been foreclosed from such advantages," the departments said.
The Education Department's Office of Civil Rights last month opened an investigation into whether Harvard racially discriminates by favoring "legacy" applicants, which civil rights groups say favors white applicants.
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