Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that, based on the early efficacy and momentum seen in the enrollment of 33 patients with colorectal cancer (CRC) in its DeFianCe study, it has initiated the 130 patient randomized controlled Part B of the Phase 2 study. The study evaluates Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with standard of care bevacizumab and chemotherapy as a second-line treatment for patients with advanced CRC.
Wednesday, July 12, 2023
Zynex Preliminary Second Quarter 2023 Results
Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, today announced preliminary results for second quarter 2023 and reiterated full-year guidance.
"Zynex continues to see strong growth in our pain management division across device and supply sales. Q2 orders increased 51% over the same period in 2022, providing further proof of our ability to deliver consistently strong profitable growth as we expand sales territories. We are excited by our progress in patient monitoring as that division continues to ramp up. We recently received FDA clearance on our CM-1600 fluid monitor, providing more comfortable and accurate monitoring to patients and hospitals." said Thomas Sandgaard, CEO of Zynex.
"We are confirming our previous estimates for second quarter revenue of $43.5 - $45.5 million and earnings per share between $0.03 - $0.07," said Sandgaard. "Our second quarter revenue estimate is an increase of approximately 21% over the prior year period, and I am pleased with our continued strong momentum, solid order growth, and continued productivity in our sales force."
The Company reiterates its full year 2023 guidance of revenue between $180 - $200 million and earnings per share between $0.40 - $0.50.
https://finance.yahoo.com/news/zynex-reports-preliminary-second-quarter-131500606.html
Centessa starts haemophilia B therapy trial
Centessa Pharmaceuticals has dosed the first subject in its registrational PRESent-2 (AP-0102) study of SerpinPC to treat haemophilia B without inhibitors.
The international, open-label Phase IIb study is designed to assess the safety and efficacy of activated protein C (APC) inhibitor SerpinPC in male subjects with severe haemophilia A (with or without inhibitors) or moderately severe to severe haemophilia B (without inhibitors).
It includes a randomised dose-justification phase (Part 1), and a dose-confirmatory phase (Part 2), both of which last 24 weeks.
A 24-week extension phase (Part 3) is also included, which will further enrol subjects who have completed either Part 1 or Part 2.
Dosages of SerpinPC will be administered subcutaneously every one, two or four weeks to up to 120 adult or adolescent subjects.
Rate of treated bleeds (expressed as an annualised bleeding rate (ABR)) in the observation period compared with the first 24 weeks treated with SerpinPC is the primary efficacy endpoint.
Centessa Pharmaceuticals’ Development chairman Antoine Yver said: “Based on encouraging clinical data from our ongoing Phase IIa study, we believe SerpinPC has the potential to be a first-in-class subcutaneously administered therapy with a differentiated safety profile for persons with haemophilia B, subject to regulatory review and approval.
“We are excited to be evaluating the potential of SerpinPC’s novel mechanism of action in the registrational PRESent-2 study.
“We expect to enroll and dose additional patients across our clinical trial sites and advance toward the interim analysis planned when 36 subjects reach 12 weeks on treatment in Part 1 of the study.”
Centessa is also planning to initiate its registrational PRESent-3 (AP-0103) study for subjects with haemophilia B with inhibitors and anticipates dosing patients this year.
https://www.clinicaltrialsarena.com/news/centessa-first-subject-hemophilia-b/
Liminal: Arrangement Agreement with Structured Alpha LP
Liminal BioSciences minority shareholders to receive US$8.50 in cash per share in "go private" transaction
Liminal BioSciences Inc. ("Liminal BioSciences" or the "Company") (NASDAQ: LMNL) and Structured Alpha LP ("SALP"), a fund managed by Thomvest Asset Management Ltd., today announced that they have entered into a definitive arrangement agreement (the "Arrangement Agreement") under which SALP will acquire all of the issued and outstanding common shares of Liminal BioSciences (the "Common Shares") that it does not already own.
Under the terms of the Arrangement Agreement, Liminal BioSciences shareholders (other than SALP and its affiliates or associates) will receive US$8.50 in cash per Common Share, which represents a premium of approximately 135% over Liminal BioSciences' closing share price on the Nasdaq Capital Market ("Nasdaq") on April 4, 2023, which was the last full trading day prior to the public announcement of SALP's initial non-binding proposal to acquire the remaining Common Shares of Liminal BioSciences that it does not already own, and is $1.00 per Common Share more than SALP's initial non-binding proposal.
"After an extensive process led by a special committee comprised of disinterested and independent directors, we are pleased to have agreed terms on a transaction with SALP that has the full support of the Liminal BioSciences board. The transaction will deliver immediate value and liquidity to our minority shareholders at a substantial premium," said Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. "Reaching this point is a testament to everything that the entire Liminal BioSciences team has accomplished. We look forward to partnering with SALP to continue to pursue our goal of developing and delivering cutting edge treatment to patients."
Healthcare Triangle Launches Ransomware Initiative
Healthcare Triangle, Inc (Nasdaq: HCTI) (“HCTI” or the "Company"), a leader in digital transformation solutions including managed services, cloud enablement, and data analytics for the healthcare and life sciences industries, today announced its launch of a new initiative aimed at preparing healthcare organizations with critical tools and guidance for preventing and responding to ransomware incidents.
Ransomware attacks on the U.S. healthcare sector have more than doubled from 2016 to 2021 and have exposed confidential and protected medical information of nearly 42 million patients.1 Most recently, CalPERS and CalSTRS, the nation’s two largest public pension funds, were attacked with a data breach that exposed personal information on 1.2 million government retirees and beneficiaries. In May, Johns Hopkins University and Johns Hopkins Health experienced a similar cyberattack and data breach. Both incidents have been attributed to a Russian hacker group known as the Cl0p ransomware syndicate. Meanwhile, while large institutions and healthcare systems address major attacks, rural hospitals particularly vulnerable to risk are facing significant budget constraints for ransomware protection and need assistance from the federal government. In response, U.S. Senator Josh Hawley's “Rural Hospital Cybersecurity Enhancement Act” passed through committee on June 14, 2023, and now heads to the Senate floor. Healthcare Triangle applauds this and other actions by the U.S. Congress to address the growing threat of ransomware attacks, including the work of the Joint Ransomware Task Force (JRTF), an interagency effort to reduce ransomware.
Lena Kannappan, head of business, strategy and partnerships for Healthcare Triangle, stated, “Generative AI and data modernization technologies can play a key role in improving patient outcomes and streamlining healthcare operations. However, looming ransomware threats can severely impact patient care, disrupt operations, cause financial losses, put community lives at risk, and force hospitals to shutter operations. With our new ransomware initiative, our Company’s goal is to take a proactive leadership role in educating and equipping rural hospitals, community hospitals, and large health systems in need with critical resources for improving their preparedness, prevention, detection, response, and recovery from ransomware incidents. We are engaged in discussions with several healthcare systems about this initiative and look forward to raising awareness and delivering robust, best-in-class solutions throughout the healthcare and life sciences industries.”
Recursion: Collaboration and $50 Million Investment from NVIDIA
Companies to collaborate on software for biotech and pharmaceutical companies to create improved patient treatments faster
Recursion (NASDAQ: RXRX), a leading clinical stage TechBio company decoding biology to industrialize drug discovery, today announced a $50 million investment by NVIDIA, which was executed as a private investment in public equity (PIPE). Recursion also announced plans to accelerate development of its AI foundation models for biology and chemistry, which, in collaboration with NVIDIA, it intends to optimize and distribute to biotechnology companies using NVIDIA cloud services.
“Our collaboration with NVIDIA represents two best-in-class companies coming together to help solve one of the world’s most difficult challenges, drug discovery,” said Chris Gibson, Ph.D., Co-founder and CEO of Recursion. “With our powerful dataset and NVIDIA’s accelerated computing capabilities, we intend to create groundbreaking foundation models in biology and chemistry at a scale unlike anything that has ever been released in the biological space.”
Recursion plans to utilize its vast proprietary biological and chemical dataset, which exceeds 23 petabytes and 3 trillion searchable gene and compound relationships, to accelerate the training of foundation models on NVIDIA DGX™ Cloud for possible commercial license/release on BioNeMo, NVIDIA’s cloud service for generative AI in drug discovery. NVIDIA will also help optimize and scale Recursion foundation models leveraging the NVIDIA AI stack and NVIDIA’s full-stack computing expertise. BioNeMo was announced earlier this year as a cloud service for generative AI in drug discovery, offering tools to quickly customize and deploy domain-specific, state-of-the-art biomolecular models at-scale through cloud APIs. Recursion anticipates using this software to support its internal pipeline as well as its current and future partners.
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