Qualigen notifies FDA of commencement of FastPack COVID-19 test distribution » 08:0807/0107/01/20
Qualigen Therapeutics has…
Qualigen Therapeutics has submitted an official notification to the FDA to commence sales in the U.S. of the company's FastPack SARS-CoV-2 IgG test for COVID-19 antibodies. This test has already been submitted to the FDA for Emergency Use Authorization or EUA, but the notification enables Qualigen to commence sales even before the FDA considers or formally grants the EUA for the test. Qualigen expects sales and shipments of the new test to begin in mid-July. The FastPack COVID-19 antibody test is a chemiluminescent microparticle test intended for the qualitative detection of SARS-CoV-2 IgG antibodies in blood to identify individuals with an adaptive immune response to the virus that causes COVID-19, indicating recent or prior infection of the disease. The FastPack delivers results in under 10 minutes.
|Over a week ago|
Qualigen Therapeutics signs license agreement with University of Louisville » 08:0406/1006/10/20
Qualigen Therapeutics announced the signing of an exclusive license agreement with the University of Louisville to facilitate development of Qualigen's AS1411 DNA aptamer as a drug candidate for the treatment of COVID-19, the disease caused by the novel coronavirus SARS-CoV-2. AS1411 targets and binds with nucleolin, a human protein utilized by some viruses to enter a cell. Proof-of-concept in vitro studies recently performed at UofL demonstrate that by binding to nucleolin, AS1411 may protect cells from the damaging effects of SARS-CoV-2 infection. Qualigen has held an exclusive license to AS1411 for all fields of use since 2018. The new agreement provides a license under UofL's pending U.S. patent for the use of AS1411 for inhibiting or treating COVID-19. Qualigen has separately been developing ALAN as a drug candidate against cancer, under a previous technology license agreement with UofL. Under the new agreement, Qualigen agreed to pay UofL royalties in the low-to-mid-single-digit percentages on sales of AS1411 anti-COVID-19 products using UofL's technology or patents, and undertook to enter into a sponsored research agreement with UofL for further in vitro and preclinical animal studies with AS1411 as a drug candidate against COVID-19. In previous research, AS1411 was administered to more than 100 human cancer patients and was well tolerated with no evidence of severe side effects. In addition to developing ALAN and pursuing AS1411 as an anti-COVID-19 drug, because nucleolin has been implicated in mediating the uptake, nuclear trafficking and infectiousness of many viruses, Qualigen will also seek to investigate the potential use of AS1411 as a broader spectrum antiviral therapeutic.
|Over a month ago|
Qualigen Therapeutics receives Notice of Allowance for U.S. patent » 08:0106/0406/04/20
Qualigen Therapeutics announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a U.S. patent, which will be issued to the company, titled "Devices and Methods for On-Line Whole Blood Treatment" regarding the company's Selective Target Antigen Removal System technology. STARS is a DNA/RNA-based treatment for the removal of viral and tumor-produced compounds from a patient's blood. The STARS technology utilizes a filtration cartridge designed for use in a standard dialysis machine, and contains aptamer-coated microparticles that bind to specific agents in circulating blood for targeted removal.
Qualigen Therapeutics releases pre-launch supply of its FastPack SARS-CoV-2 kits » 08:1006/0206/02/20
Qualigen Therapeutics announced that the Company has released a pre-launch supply of its proposed FastPack SARS-CoV-2 IgG Immunoassay diagnostic test kits to the University of Louisville to conduct validation studies with hundreds of patient samples, as well as for use in research on COVID-19. SARS-CoV-2 is the virus that causes COVID-19. Qualigen's SARS-CoV-2 IgG immunoassay, for use with its new FastPack PRO System point-of-care diagnostic instruments, is a chemiluminescent microparticle test intended for the qualitative detection of the presence of SARS-CoV-2 IgG antibodies in blood. The FastPack PRO System is an upgraded version of Qualigen's flagship FastPack IP rapid immunoassay diagnostic point-of-care system.
Ritter Pharmaceuticals announces expected closing of merger with Qualigen » 12:3705/2205/22/20
Ritter Pharmaceuticals announced that its pending merger transaction with Qualigen, Inc. is currently expected to close after market hours today, Friday, May 22, 2020. As previously announced, Ritter's stockholders voted to approve the proposals required to complete the merger transaction, including a reverse stock split within a range of 1-for-25 to 1-for-35, as determined by Ritter's board of directors. In connection with these approvals, the board of directors of Ritter has approved a reverse stock split of Ritter's outstanding common stock at a ratio of one new share for every 25 shares outstanding, which is expected to become effective immediately prior to the consummation of the merger. Immediately following the closing, Ritter will be renamed "Qualigen Therapeutics, Inc.," and is expected to trade on The Nasdaq Capital Market on a post-reverse stock split basis under the new ticker symbol "QLGN" beginning on Tuesday, May 26, 2020. Qualigen, Inc. will be a wholly-owned subsidiary of Qualigen Therapeutics, Inc.
Ritter Pharmaceuticals announces stockholder approval of merger proposals » 08:0905/1905/19/20
Ritter Pharmaceuticals announced that, based upon the final vote count certified by the inspector of election for the special meeting of stockholders held on May 18, 2020, its stockholders approved all of the Qualigen, Inc. merger-related proposals, including: the issuance of Ritter common stock and convertible preferred stock pursuant to the Agreement and Plan of Merger, dated as of January 15, 2020, as amended, by and among Ritter, RPG28 Merger Sub, Inc., and Qualigen and the change of control of Ritter resulting from the merger, a reverse stock split of the outstanding shares of common stock of the Company, at a ratio within a range of 1-for-25 to 1-for-35, as determined by the board of directors of the Company, changing the name of Ritter from "Ritter Pharmaceuticals, Inc." to "Qualigen Therapeutics, Inc." and the adoption of Ritter's 2020 Equity Incentive Plan. As previously announced, the boards of directors of both Ritter and Qualigen unanimously approved the merger, which is expected to be consummated in the next few days. In connection with the closing of the transaction, the Company will change its name to "Qualigen Therapeutics, Inc." and the Company's shares are expected to continue trading on The Nasdaq Capital Market under the symbol "QLGN".
Ritter Pharmaceuticals regains compliance with Nasdaq requirement » 08:5605/1105/11/20
Ritter Pharmaceuticals announced that it has received written notice from the Nasdaq Stock Market that the Company has regained compliance with Nasdaq's stockholders' equity requirement for continued listing on the Nasdaq Capital Market. As previously reported, Ritter Pharmaceuticals is holding a special meeting of stockholders this week on May 14, 2020, at which stockholders will be asked to approve various proposals related to the Company's proposed merger with Qualigen, Inc. It is important to note that the merger cannot be consummated without the approval of each of the proposals, including a reverse stock split. While Ritter Pharmaceuticals is now in compliance with the stockholders' equity requirement for continued listing, the combined company will need to conduct the reverse stock split in order to meet Nasdaq's initial listing minimum bid price requirement of $4.00 per share. The Company's stockholders of record as of the close of business on March 26, 2020, which is the record date for the special meeting, will be entitled to participate in the special meeting and vote.
Ritter Pharmaceuticals says proxy firms recommend shareholders vote for merger » 09:2605/0605/06/20
Ritter Pharmaceuticals announced that Institutional Shareholder Services and Glass Lewis, two leading independent research and proxy advisory firms that provide institutional investors with voting assessment and recommendations based on evaluating governance, business, legal, political and accounting risks at public companies, have recommended that Ritter Pharmaceuticals stockholders vote "FOR" the Company's proposed merger with Qualigen and each of the merger proposals to be considered at Ritter Pharmaceuticals' upcoming special meeting of stockholders scheduled for May 14, 2020. In making its recommendation, ISS noted, "In light of the contingent value right, the improved balance sheet, and the opportunity to avoid delisting, the merger with Qualigen appears to be a preferable outcome to the standalone scenario, under which Ritter's future appears uncertain. As such, a vote for the reverse merger is warranted." Ritter Pharmaceuticals stockholders as of the close of business on March 26, 2020, the record date for the special meeting, are eligible to vote and attend the virtual special meeting of May 14, 2020. The Ritter Pharmaceuticals board of directors has recommended that stockholders vote "FOR" each of the proposals. It is important to note that the merger cannot be consummated without the approval of each of the proposals being voted on at the special meeting.
Ritter Pharmaceuticals urges stockholders to vote on Qualigen merger » 07:5604/2804/28/20
Ritter Pharmaceuticals is…
Ritter Pharmaceuticals is urging its stockholders to vote now on the proposed merger with Qualigen, a biotechnology company focused on the development of novel therapeutics for the treatment of cancer and infectious disease, as well as the expansion of its flagship FastPack point-of-care diagnostic platform. "We are urging all of our stockholders to take a few minutes to vote by phone, internet or mail on this important transaction," said Ritter CEO Andrew J. Ritter. "It's also important to note that the merger cannot be consummated without the approval of each of the proposals being voted on at the Special Meeting, including approval of the proposed reverse stock split. The reverse stock split is necessary to ensure that the combined company meets Nasdaq's initial listing minimum bid price requirement, so that it may be listed on Nasdaq following the merger and is a condition to the closing of the merger. Ritter stockholders should also be aware that they will not be subject to a lock-up period following the merger." Ritter stockholders as of the close of business on March 26, 2020, the record date for the Special Meeting, are eligible to vote and attend the virtual Special Meeting. The Ritter board of directors has recommended that the Ritter stockholders vote "FOR" each of the proposals.
|Over a quarter ago|
Ritter Pharmaceuticals trading resumes 09:5001/2101/21/20