Today | ||||
Heart Test Laboratories,… Story temporarily locked. | ||||
Greenland Technologies… Story temporarily locked. |
Yesterday | ||||
In this week's "Rising…
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Wednesday | ||||
MamaMancini's… MamaMancini's Holdings announced the appointment of CEO Adam Michaels as Chairman, effective February 1, 2023, concurrent with the retirement of Carl Wolf. | ||||
Agile Therapeutics… Agile Therapeutics provided an update on the Twirla post-marketing studies and status of its ongoing evaluation of the Company's pipeline. Twirla Post-Marketing Studies: As part of Twirla's approval, the United States Food and Drug Administration required the Company to conduct a long-term prospective, multi-center clinical post-marketing requirement study comparing the risks of venous thromboembolism and arterial thromboembolism in new users of Twirla to new users of combined hormonal contraceptives and Ortho Evra generic patches. In January 2023, the FDA agreed with the Company's proposal to address this PMR using electronic health records and insurance claims from a large database from multiple healthcare systems. The FDA also agreed to extend the study timelines. Under these new milestones, interim safety data reporting to the FDA is due in November 2029, and the final PMR study report is scheduled to be submitted to the FDA in November 2035. Status of Pipeline Evaluation: As previously disclosed, all work on Agile's pipeline has been halted since 2021 as the Company concentrates its efforts the commercialization of Twirla. Commercializing Twirla remains the Company's primary focus into 2023; however, the Company has continued to evaluate the potential eventual advancement of the AG200-15 Extended Regimen and the progestin-only patch. "Our primary focus since the launch of Twirla has been the commercial growth of Twirla. We believe, however, that we have potential value in our pipeline and have been evaluating how to prioritize the eventual development of our product candidates. While we do not currently expect to invest significant funds in our pipeline in 2023 as we continue to focus on maintaining capital efficiency and keeping tight control on our operating expenses, we have been using creative approaches to advance the evaluation of our pipeline and prepare for a time when we can move forward," stated, Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics.As part of its evaluation of the AG200-15 Extended Regimen, Agile performed an analysis with a simulated pharmacokinetic model that was used to predict the systemic levonorgestrel and ethinyl estradiol exposure of Twirla if used for twelve consecutive weeks. Data from a previously published clinical phase 1, open-label, randomized clinical trial2 was used for the PK model simulation, which included 36 healthy individuals who used a standard Twirla regimen for three consecutive weeks. |
Tuesday | ||||
Hillstream BioPharma… Hillstream BioPharma announced signing an exclusive option agreement with Dana-Farber Cancer Institute to license technology targeting the MUC1-C oncoprotein. Dana-Farber has granted under an exclusive option agreement to Hillstream Biopharma Inc., certain of its proprietary technology which if converted to an exclusive license agreement, will allow Hillstream to develop anti-MUC1-C antibodies to selectively deliver Hillstream's Quatramer-based lead candidate HSB-1216 targeting CSC by the induction of ferroptosis. This approach combining HSB-1216 with conjugation to MUC1-C antibodies is highly synergistic for the elimination of CSCs, which is needed for long term responses and cures. "We look forward to this unique opportunity to work with Dr. Kufe and Dana-Farber," said Randy Milby, CEO of Hillstream. "This agreement allows Hillstream to leverage our Quatramer platform to advance anti-MUC1-C agents targeting CSCs for the treatment of highly aggressive tumors, which represents a major unmet need for patients." |
Monday | ||||
Trust Stamp announces… Trust Stamp announces that it has integrated the Driver License Data Verification, DLDV, System, offered by the American Association of Motor Vehicle Administrators, AAMVA, into its low code orchestration platform. Now through its low-code solution, Trust Stamp provides commercial and government entities with the real-time capability to verify drivers license/ID information against data from the issuing agency. Trust Stamp has added 24 new customers to its low-code solution since it launched in February 2022. These new customers include 22 banks with over 850 of branches. Trust Stamp President, Andrew Gowasack, said, "As a result of growing fraud losses and unprecedented economic conditions, we are seeing banks focusing on increasing deposits and reevaluating their online enrollment processes. Onboarding must be simple and fast for genuine customers, but difficult for fraudsters who seek to exploit these streamlined processes." | ||||
Dawson James analyst… Dawson James analyst Jason Kolbert initiated coverage of Genprex with a Buy rating and $3 price target. The company's oncology platform utilizes a non-viral Nanoparticle Delivery System and its lead program in oncology, REQORSA Immunogene Therapy, or GPX-001, has been shown to be complementary with targeted drugs and immunotherapies, the analyst tells investors in a research note. REQORSA is currently enrolling clinical patients in two trials initially exploring its utility in NSCLC with a range of agents and the FDA has granted Fast Track Designation for both trials, the firm noted. The company also has developed a gene therapy that is designed to transform alpha cells in the pancreas into functional beta-like cells and its planned phase 1 trial "represents the first-ever gene therapy tested in humans for diabetes," Dawson James said. |