Navitor Pharmaceuticals, Inc.

The company tightened its financial guidance and nudged up the midpoint while maintaining the ceiling. Abbott now projects full-year diluted earnings-per-share of $3.25 to $3.40, versus its previous estimates of $3.20 to $3.40. Last quarter Abbott saw large gains in its medical device sales that helped push its revenues to just shy of $10 billion—exceeding the company’s expectations and leading it to nudge up its financial forecasts for the long remainder of the year. “Organic sales growth, excluding COVID testing-related sales, was 10.8% in the quarter—which represents the fifth consecutive quarter of double-digit growth,” CEO Robert Ford said during Abbott’s earnings presentation. “The strong start to the year was driven by broad-based growth across the portfolio, including growth of 14% in medical devices and established pharmaceuticals.” The company’s organic measurements of sales growth exclude international currency fluctuations as well as the impacts from its $890 million acquisition of the artery-clearing devicemaker Cardiovascular Systems, which it closed in late April 2023. Still, Abbott’s medical device division’s sales grew by 14.2% on an unadjusted, reported basis—powered by double-digit growth across electrophysiology, neuromodulation and structural heart, areas that saw multiple recent product launches and new regulatory green lights. Diabetes care wasn’t left behind, either. The company’s FreeStyle Libre continuous glucose monitoring system brought in $1.5 billion alone, 22.4% ahead of last year’s quarterly figures. The company recently received a long-awaited U.S. approval for its TriClip implant for tricuspid valve regurgitation, as well as an FDA clearance expanding the reach of its handheld blood test for detecting traumatic brain injuries and concussions. “Structural Heart is an area that we have invested in over the past years in order to create a diversified portfolio that can sustainably deliver double-digit growth,” Ford said on a call with investors. “In the past, we relied almost exclusively on MitraClip—but today the portfolio and growth are more balanced, and reflect the increasing contributions from newer products like Navitor, Amulet and TriClip.” Meanwhile, the company’s Aveir leadless pacemaker system has “rapidly captured market share” in the single-chamber segment, according to Ford, and it’s now making in-roads in dual-chamber pacing following its FDA approval last summer. “This revolutionary technology is helping to deliver growth rates in our rhythm management business that significantly exceed the overall growth in this market,” he said. Elsewhere, diagnostic tests brought in $2.21 billion in worldwide sales, 17.6% below the same quarter last year, which had seen much larger gains in COVID-19 testing revenue. According to Abbott, the first quarter of 2023 brought in $730 million from coronavirus tests, compared to the most recent quarter’s $204 million. When excluding those figures and focusing on the company’s base business, diagnostics grew by 2.7%. Nutrition sales added another $2.07 billion, for a 5.1% increase. The company recently confirmed that it will lay off nearly 200 employees next month with the closure of a Bay Area nutrition facility, following a WARN filing with the state of California, according to reports from The Mercury News and the San Francisco Chronicle. Meanwhile, the established pharmaceuticals division—which maintains a portfolio of various branded generic drugs sold outside the U.S., from its headquarters in Switzerland—reported 3.1% in unadjusted growth, but 13.7% when accounting for currency changes, with a $1.22 billion haul. All told, the company’s first-quarter sales amounted to $9.964 billion. Those numbers have pushed the company to tighten its financial guidance and nudge up the midpoint of the range, though while maintaining the ceiling. Abbott now projects full-year diluted earnings-per-share of $3.25 to $3.40, versus its previous estimates of $3.20 to $3.40. “Last year we were the fastest growing medtech company—and at least from what I've seen, from our guidance and the other guidances in the market, that's what it seems to be again this year,” Ford said on the call. “So that together with a pipeline that's been contributing to an accelerated level, plus great new product approvals—I put all that together and I just feel that this type of performance gives us confidence for the remainder of the year.” “And I believe that, going into the second quarter, there's probably more opportunities than risks as we move forward,” he added. “So that's the framework behind raising our guidance in the first quarter, which is something that we usually don't do. It’s just great performance and great momentum.”

OVERLAND PARK, Kan.--(BUSINESS WIRE)-- Dr. Vince Clinical Research (DVCR), a contract research organization (CRO) specializing in early phase trials, announced the first dosing in a Phase II multicenter trial of SPN-820 in adults with major depressive disorder (MDD). DVCR is acting as the full-service CRO for this trial. MDD is estimated to affect over 17 million adults in the United States, with approximately 30% of these patients being resistant to treatment. Supernus Pharmaceuticals, in collaboration with Navitor Pharmaceuticals, is developing SPN-820 to provide a rapid-onset antidepressant response via oral administration for adult patients with treatment-resistant depression. The compound has a novel mechanism of action that enhances synaptic activity and cellular metabolism in the brain and has demonstrated a rapid onset of action (signal at two hours) in previous clinical studies. Unlike other rapid-onset compounds currently approved or in clinical development, SPN-820 aims to provide rapid antidepressant efficacy without potential dissociative and neurological side effects. Jonathan Rubin, M.D., Supernus Pharmaceuticals’ Chief Medical Officer, stated, “This study allows us to further evaluate SPN-820’s potential rapid onset of effect and the potential to administer this compound once every three days. We are appreciative of the partnership with DVCR for our SPN-820 program.” The Phase II study is being conducted at six U.S. sites and is expected to enroll approximately 50 adult MDD patients. The purpose of the study is to evaluate the efficacy and safety of SPN-820 administered once every three days for a 7-day treatment period. In addition to collecting data from cognitive scales for primary and secondary endpoints, the trial includes multiple pharmacokinetic collections which will be performed during extended study visits. “Our organization is pleased to contribute toward developing new and potentially more effective treatments for depression,” said Brad Vince, DO, DVCR’s CEO and Medical Director. “Furthermore, we are excited to continue our strategic growth in this space, enabling us to partner with sponsors beyond their clinical pharmacology studies.” “It has been a collaborative effort with transparent communication between Supernus, study sites and our team which has brought us to this important milestone in this clinical trial,” says Korey Nevitt, DVCR’s Executive Director of Site Partnerships. “Site identification, feasibility and selection were rapid. This would not have been the case if the sites were not proactive and responsive nor if Supernus’ clinical development team was not as passionate about engaging with the sites. I truly believe this is a testament to the unique model DVCR has developed for successfully managing relationships in multicenter trials.” DVCR looks forward to successfully completing this multisite trial and continuing to offer its unique solution to the biopharmaceutical industry. About Dr. Vince Clinical Research Dr. Vince Clinical Research (DVCR) is a world-class full-service CRO (Contract Research Organization) with a custom-built, green-designed headquarters and research complex encompassing three buildings in Overland Park, KS. DVCR’s complex includes a 90-bed clinical pharmacology unit featuring a combination of luxurious and private research suites and a GMP-compliant pharmacy with positive and negative pressure compounding rooms. DVCR specializes in conducting clinical trials for both healthy normal volunteers and patient populations in a wide variety of early phase trials. By leveraging both technology and one of the country’s most experienced leadership teams, DVCR provides Smarter, Faster Data® to their biopharmaceutical clients. For more information, go to sponsors.drvince.com. Connect with Dr. Vince Clinical Research on LinkedIn and YouTube.

Medtronic Wins FDA Nod for Onyx Frontier DES The Dublin-based company said the device is the latest innovation in the Resolute DES family. Babson Has Friends in High Places The blood-testing startup that's trying to succeed where Theranos failed has expanded its strategic partnership with the sixth largest medtech company in the world. MannKind Acquires Wearable Insulin Device from Zealand Pharma The Danbury, CT-based company said it was picking up the V-Go wearable $10 million. An At-Home Collection Device for Diabetes Risk Testing Labcorp and Weavr teamed up for the development of the at-home-collection device. Medtronic Wants to Ease Your Pain with Closed-Loop Implantable A prospective study will evaluate the long-term performance of a closed-loop algorithm with Medtronic’s investigative rechargeable neurostimulator. Stryker Is Smart to Pursue This Type of Reimbursement CMS recently established a new code for outpatient hospitals and ambulatory surgery centers to report the insertion of Stryker's InSpace balloon implant. Medtronic Touts Cusp Overlap Technique in TAVR Mid-term results of the Optimize PRO clinical study underscores predictability and control using the cusp overlap technique during transcatheter aortic valve replacement (TAVR) with Medtronic TAVR devices. The Robot Will Do Your Angioplasty Now Study results show promise for robotic coronary angioplasties using Robocath's R-One robot. J&J MedTech Lands Clearance for Inhance Shoulder System This clearance is in addition to the system’s already cleared use in anatomic shoulder arthroplasty. Abbott Heart Valve Data Shines at EuroPCR The data support the use of the company's TriClip tricuspid heart valve repair device, and Navitor, Abbott's transcatheter aortic valve implantation system. NeuroOne’s Bid for Long-term Use of Evo sEEG Shot Down by FDA The Eden Praire, MN-based company called the decision disappointing but said it would collect more data and submit for a Special 510 (k). Has Medtech Shifted to a Seller's Strike? Analyst says both the number and dollar volume of medtech M&A deals are likely to drop in 2022, compared to 2021.