|Over a week ago|
Matinas BioPharma announces DSMB approval of first cohort in EnACT study » 06:3310/1910/19/20
Matinas BioPharma Holdings announced that the independent Data and Safety Monitoring Board, or DSMB, of the EnACT study, or Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial, has completed a pre-specified review of the first cohort and unanimously recommended progression to the second cohort of patients. Enrollment in this next randomized EnACT cohort, with 40 active-treatment patients, is expected to begin shortly, with the next DSMB evaluation of safety and efficacy data anticipated to occur in the middle of 2021.
Matinas BioPharma management to meet virtually with BTIG » 07:5210/0210/02/20
Virtual Meeting to be…
Virtual Meeting to be held on October 2 hosted by BTIG.
|Over a month ago|
Maxim Group and M-Vest to co-host a virtual conference » 08:1209/1709/17/20
APLI, CDTX, MTNB, SCYX, TFFP
A Too Quiet…
A Too Quiet Pandemic--Fungal Disease Virtual Conference will be held on September 17.
Matinas, FDA 'aligned' on next steps for MAT9001's Phase 3 development program » 07:0209/1509/15/20
Matinas BioPharma announced the result of its End of Phase 2 Meeting with the U.S. Food and Drug Administration concerning the development and registration pathway for MAT9001, a potential best-in-class prescription omega-3 therapy. The official minutes of the meeting confirmed that the FDA and Matinas are aligned on key next steps for MAT9001's Phase 3 development program and registration pathway for an initial indication to treat severe hypertriglyceridemia, a clinical disorder associated with major complications such as pancreatitis and atherosclerotic cardiovascular disease. The Company remains on track to initiate its Phase 3 program in the first half of 2021. The Company and the FDA agreed on key elements of the Phase 3 program to support a New Drug Application filing, including the requirement for a single 12-week study to support efficacy in SHTG. Moreover, FDA provided flexibility to Matinas in the totality of patient safety data needed to meet regulatory requirements for NDA submission. The Company is evaluating several ways to both meet these requirements and to potentially provide additional data differentiating MAT9001 from other prescription omega-3 drugs.
Matinas BioPharma appoints Natasha Giordano to board of directors » 07:4309/1409/14/20
Matinas BioPharma (MTNB)…
Matinas BioPharma (MTNB) announced the appointment of Natasha Giordano to its Board of Directors as an independent director and a member of the audit committee, effective Monday, September 14, 2020. She has served as President, CEO, and a director of PLx Pharma (PLXP) since January 2016. The Company also announced that Adam Stern will not stand for re-election to the Company's Board of Directors at the Company's Annual Meeting of Stockholders on November 2, 2020, instead transitioning to a consulting role where he will be available to the CEO and the Board of Directors on matters related to overall corporate and financial strategy.
Matinas BioPharma completes enrollment in ENHANCE-IT study » 16:2808/2708/27/20
Matinas BioPharma announced that it has completed enrollment in the ENHANCE-IT study, a second head-to-head comparative study of MAT9001 against Vascepa. The ENHANCE-IT study is assessing MAT9001's effectiveness in reducing triglyceride levels and other important lipid markers, as well as characterizing bioavailability and blood levels of eicosapentaenoic acid and other omega-3 fatty acids. The company expects to have topline data available in the first quarter of 2021.
Matinas BioPharma transferred with an Overweight at Piper Sandler » 16:1408/2508/25/20
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi took over coverage of Matinas BioPharma and kept an Overweight rating on the shares with a price target of $1.80, up from $1.50, which represents 126% potential upside. The company is "leading the path forward" in development of highly purified, prescription-only omega-3 free fatty acid drug, MAT9001, for treatment of cardiovascular and metabolic conditions, Rahimi tells investors in a research note.
Matinas announces publication of results from Phase 1 portion of EnACT study » 07:0708/2008/20/20
Matinas BioPharma Holdings announced the publication of data from the Phase 1 portion of the EnACT study for MAT2203, a novel oral formulation of amphotericin B, investigating its safety and tolerability. The data were published online in Antimicrobial Agents and Chemotherapy, a journal of the American Society of Microbiology, in a manuscript entitled "Safety and tolerability of a novel oral formulation of amphotericin B: Phase I EnACT trial". In the published manuscript, trial investigators reported results from the Phase 1A and 1B portions of the study. They concluded that MAT2203 was well tolerated when given in 4-6 divided daily doses without the toxicities commonly seen with IV amphotericin B. EnACT is a Phase 2 open-label, sequential cohort study of approximately 100 patients, financially supported by the National Institutes of Health, utilizing the Company's LNC platform delivery technology to orally deliver the traditionally IV-only fungicidal drug, amphotericin B. This study is a prospective, randomized trial evaluating the safety, tolerability and efficacy of MAT2203 in HIV-infected patients with cryptococcal meningitis, compared to treatment with standard IV-administered amphotericin B as induction therapy, and then followed by maintenance treatment with MAT2203. As previously reported, the U.S. Food and Drug Administration has designated MAT2203 as a Qualified Infectious Disease Product with Fast Track status for four indications, specifically, the prevention of invasive fungal infections due to immunosuppressive therapy, and the treatment of invasive candidiasis, invasive aspergillus and cryptococcal meningitis. In addition, the FDA has granted orphan drug designation to MAT2203 for the treatment of cryptococcosis.
Matinas BioPharma sees cash on hand sufficient to fund operations into 2023 » 16:1608/1008/10/20
Based on current…
Based on current projections, the company continues to believe that cash on hand is sufficient to fund operations into the first half of 2023.
Matinas BioPharma reports Q2 EPS (3c), consensus (3c) » 16:1508/1008/10/20
Cash, cash equivalents…
Cash, cash equivalents and marketable securities at June 30, 2020 were approximately $68.0M, compared to $27.8M at December 31, 2019.