NA Proactive news snapshot: Humanigen, Co-Diagnostics, Medallion Resources, Acasti Pharma, American Manganese, HIRE Technologies ...

NA Proactive news snapshot: Humanigen, Co-Diagnostics, Medallion Resources, Acasti Pharma, American Manganese, HIRE Technologies ...

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Humanigen Inc (NASDAQ:HGEN) announced Friday that the US Food and Drug Administration said its Emergency Use Authorization (EUA) application for its coronavirus treatment lenzilumab may be sufficient, pending Phase 3 trial data. The agency provided feedback at what is known as a type B meeting, and said that no material changes are needed in the company’s chemistry, manufacturing & controls plan, EUA labeling and the statistical analysis plan. "FDA was very helpful and provided clear guidance on our EUA submission plan,” CEO Cameron Durrant said in a statement. “We are encouraged by our Type B meeting and remain confident in our program and preparedness plans in advance of a potential EUA.” Humanigen also announced that enrollment in the aforementioned Phase 3 study is continuing in the US and Brazil and has now been approved to expand to Mexico.  Co-Diagnostics Inc (NASDAQ:CODX) (FRA:C97) revealed that its CLIA-certified customer Access Genetics LLC dba OralDNA Labs, which uses the company’s flagship Logix Smart COVID-19 kit, has received emergency use authorization (EUA) for its OraRisk COVID-19 RT-PCR test, allowing testing from a saline oral rinse collection. "We are pleased that Co-Diagnostics technology is being used in the first FDA EUA for a test using a simple saline 30-second swish and gargle collection,” Co-Diagnostics CEO Dwight Egan said in a statement. “Because it eliminates the need for a nasal swab, oral rinse technology has the potential to dramatically improve comfort and accessibility of testing in our communities. We believe this authorization by the FDA provides additional confirmation of the quality, versatility, and adaptability of our CoPrimer platform," he added. Medallion Resources Ltd (CVE:MDL) (OTCPINK:MLLOF) said it has 'excellent' working capital following an over-subscribed financing and its receipt of C$741,000 from the exercise of warrants and options during its latest quarter. In the three months to September 30, shareholders exercised warrants and options for gross proceeds of around C$741,000, the rare earths-focused group said in a statement. Both warrants and options were priced between C$0.10 and C$0.32, with an average exercise price of C$0.21 per share. "The recent oversubscribed financing, in combination with the progressive exercise of warrants and options, has provided Medallion with an excellent working capital position,” said Mark Saxon, Medallion's president and CEO in a statement. Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) announced the voting results for the matters at its annual and special meeting of shareholders on September 30, this year, saying that Roderick N. Carter, Jean-Marie (John) Canan, Jan D’Alvise and Donald Olds  were elected as directors for the ensuing year. Among other items, at the AGM, shareholders also passed an advisory (non-binding) resolution approving the compensation of the  named executive officers. KPMG LLP were appointed as its auditors for the ensuing fiscal year and the directors were authorized to fix its remuneration. At the AGM, disinterested shareholders approved amendments to the firm's stock option plan and equity incentive plan. American Manganese Inc (CVE:AMY) (OTCMKT:AMYZF) has welcomed President Trump's signing of an executive order declaring a state of emergency to address America's dependence on China for critical minerals, saying the move will benefit the company. American Manganese holds significant manganese resources and has a patented process to recycle lithium-ion batteries to extract cathode metals, such as lithium, cobalt and nickel - all on the critical materials list. It believes it can help alleviate America's material dependencies on such materials and contribute to a solution. HIRE Technologies Inc (CVE:HIRE) said that the TSX Venture Exchange has accepted documentation related to its C$2.4 million convertible debenture announced on August 10. The Toronto-based recruitment firm sold unsecured convertible debentures with an interest rate of 9% per year that will mature in July 2023. The convertible debentures will be payable semi-annually in arrears either in cash or shares (at the company’s discretion) priced at the volume-weighted average trading price on the TSX Venture Exchange for 20 consecutive trading days ending on the date immediately preceding the date of payment. Holders may convert all or part of the debentures into units priced at C$0.30, comprising one share and one warrant exercisable at $0.60, at any time prior to the maturity date. The company may force the conversion of debentures into units at the conversion price if shares exceed $0.65 over a 10-day consecutive trading period. Seattle-based SōRSE Technology, which powers OneRepublic frontman Ryan Tedder’s hemp-infused sparkling water Mad Tasty and over 40 other products in the red-hot CBD and cannabis space, is breaking the next frontier by delving into cannabinoid drug research and development. The venture capital-backed company’s technology converts oil into SōRSE – a water-soluble emulsion – that can be used to infuse CBD and other functional ingredients into beverages, food, nutraceuticals, and topicals. It turns out, the company’s science may also have medical applications. SōRSE has partnered with Canadian biotech Pascal Biosciences to initiate a clinical trial of Pascal’s PAS-393, a cannabinoid-based cancer therapy. Scientists at SōRSE and Pascal will optimize a cannabinoid formulation and will then test the experimental PAS-393 treatment, to enhance the so-called checkpoint inhibitors that activate the immune system to kill tumor cells.  

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