Late-Stage Pipeline Wins Boost Investor Confidence in High-Growth Therapeutic Areas
NEW YORK, Aug. 4, 2025 /CNW/ -- As America's population ages, chronic and rare diseases are emerging as a pressing healthcare challenge — one that disproportionately affects older adults. With more than 30 million Americans living with a rare disease, the need for accurate diagnoses and effective treatments is growing urgent. Many of these conditions remain without FDA-approved therapies, and symptoms in seniors are often misattributed to typical aging, leading to years-long diagnostic delays. Recognizing this crisis, the Trump administration's "Make America Healthy Again" initiatives have emphasized improving access to treatments and accelerating medical innovation. Advancing this mission, Soligenix Inc. (NASDAQ: SNGX) (Profile) is making strides with its HyBryte(TM) platform, a novel therapy aimed at treating cutaneous T-cell lymphoma (CTCL), a rare skin cancer that primarily affects older adults. With successful U.S.-based manufacturing of HyBryte's active ingredient now in place, Soligenix exemplifies the kind of domestic innovation poised to make a meaningful impact on this underserved patient population. The company is one of several impressive companies committed to making an impact in the pharmaceutical space, including Pfizer Inc. (NYSE: PFE), Merck & Co Inc. (NYSE: MRK), Bristol-Myers Squibb Co. (NYSE: BMY) and Insmed Inc. (NASDAQ: INSM).
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CTV News
an hour ago
- CTV News
‘I had never seen him' : woman receives tooth-in-eye surgery and see her partner for first time
Watch Over a decade after going blind, a Victoria, B.C., woman's vision has been restored by an operation rarely performed in Canada. Andres Johnson reports.
CTV News
2 hours ago
- CTV News
Another Vancouver-area ER without doctors Monday night
For the second night in a row, there will be no doctors on staff at a Fraser Health emergency department overnight due to staffing issues. In a memo sent just before 6 p.m., the health authority said because of an 'unexpected physician illness,' anyone arriving at Delta Hospital's ER after 7 p.m. will not be seen by a doctor. The 'temporary service interruption' is scheduled to last until 6:30 a.m. Tuesday. Fraser Health said patients who arrive before 7 p.m. will be able to be seen by a doctor before their shift ends at 1:30 a.m. After 7 p.m., nurses will be on site at Delta Hospital to 'support walk-in patients needing basic care, assist with re-direction of care, and/or transfer patients with urgent needs to a neighbouring hospital,' Fraser Health said. Anyone experiencing a life-threatening emergency is asked to call 911 'for transport to the nearest available and appropriate facility.' 'All other Fraser Health Emergency Departments remain open and have emergency physicians on site; however, high numbers of people seeking care and human resources challenges at many of our hospital emergency departments may lead to longer wait times for patients with non-urgent care concerns,' the memo reads. The disruption comes after Mission Memorial Hospital implemented the same 'temporary service interruption' from 5 p.m. Sunday to 8 a.m. Monday. Delta Hospital's ER previously closed overnight for two consecutive nights in February of this year. Mission Memorial Hospital has diverted patients at least four times in 2025. Elsewhere in B.C., the South Okanagan General Hospital in Oliver announced it had to close its emergency department for 23 hours, from 1 p.m. Monday to 12 p.m. Tuesday. Interior Health asked patients to seek emergency care at Penticton Regional Hospital instead.
Globe and Mail
6 hours ago
- Globe and Mail
CVRx (CVRX) Q2 Revenue Jumps 15%
Key Points Revenue (GAAP) rose 15% to $13.6 million, surpassing both company expectations and analyst estimates. Net loss narrowed on a per-share basis to $(0.57) (GAAP), primarily due to a higher share count despite a slight increase in overall losses. These 10 stocks could mint the next wave of millionaires › CVRx (NASDAQ:CVRX), a medical device innovator focused on heart failure therapy, released its second quarter 2025 earnings on August 4, 2025. The most important news was a Revenue (GAAP) increased to $13.6 million, up 15% year-over-year and above analyst expectations of $13.29 million (GAAP). The company also reported a net loss of $14.7 million, or $(0.57) per share (GAAP). While that loss widened slightly, the per-share figure (GAAP) improved due to an increased share count. The quarter reflected strong commercial progress for its Barostim neuromodulation device despite heavy investment in sales and marketing. Results slightly exceeded internal and external expectations, and management narrowed its revenue guidance to a range of $55.0 million to $57.0 million. Metric Q2 2025 Q2 2025 Estimate Q2 2024 Y/Y Change EPS (GAAP) $(0.57) $(0.52) $(0.65) 12.3% Revenue (GAAP) $13.6 million $13.29 million $11.8 million 15.1% Gross Profit $11.5 million N/A N/A Gross Margin 84% 84% 0% Net Loss $14.7 million $14.0 million -5.0% Source: Analyst estimates provided by FactSet. Management expectations based on management's guidance, as provided in Q1 2025 earnings report. About CVRx and Its Core Business CVRx (NASDAQ:CVRX) specializes in developing implantable medical devices for treating heart failure. Its leading product, Barostim, is a neuromodulation device—meaning it delivers targeted electrical pulses to nerves in the carotid artery to improve function of the autonomic nervous system. This system regulates key bodily functions, including blood pressure and heart rate. Barostim is designed to treat patients with heart failure with reduced ejection fraction (HFrEF), providing an option that avoids direct implantation in the heart. The company's commercial priorities are building deep adoption in centers with strong heart failure programs and expanding reimbursement pathways to improve access. Solid clinical evidence and reliable regulatory support have been the company's main success factors, along with educating physicians and patients on Barostim's benefits. Quarter Highlights and Key Developments During the period, total revenue (GAAP) reached $13.6 million, outpacing both the company's guides and Wall Street expectations by over 2%. U.S. heart failure revenue remained the largest contributor, climbing to $12.1 million, with units up to 387 from 339 in the prior year. U.S. sales overall were $12.2 million, also up 15% (GAAP). Across the Atlantic, European revenue grew 19% to $1.3 million (GAAP), but the number of European implant units declined from 63 to 61, signaling some softness in procedural volume despite improved pricing or product mix. Active implanting centers in the U.S. grew to 240, reflecting 13 new centers added in the U.S. during the quarter. U.S. sales territories also grew to 47, up from 45, while European territories held steady at five. U.S. revenue accounted for approximately 89.8% of total sales (GAAP), indicating the company's primary growth engine remains domestic. The company attributes revenue gains to both new account additions and greater utilization per center, while the slightly lower European volumes point to variability in adoption across geographies. Gross profit (GAAP) grew 16% from the prior year, maintaining a gross margin of 84%. On the expense side, research and development (R&D) spending declined 11% to $2.5 million, reflecting lower compensation as resources shifted toward commercial growth. Selling, general, and administrative (SG&A) costs (GAAP) increased 11% to $23.4 million, driven mainly by higher employee compensation, travel, and non-cash stock-based grants, with some relief from lower advertising costs. The higher SG&A, while outpaced by revenue growth, resulted in operating and net losses that remain substantial—operating loss (GAAP) at $14.4 million and net loss (GAAP) at $14.7 million. Multiple reimbursement milestones provided stability for Barostim's future. The Centers for Medicare & Medicaid Services (CMS) proposed to retain Barostim as a covered outpatient procedure at the $45,000 payment level, removing some uncertainty for hospitals and ensuring continued access. In addition, CMS proposed favorable physician payment levels of about $550 for new procedure coding effective in 2026. On the clinical front, highlighted real-world data presented at major cardiology conferences showed large reductions in heart failure hospital visits—down 85% for heart failure, 84% for cardiovascular causes, and 86% for all causes—after Barostim implantation, based on comparisons of hospital visits for 306 Barostim patients in the 12 months prior to implant and an average of almost two years post-implant. These real-world results have been well received by physicians and payers, which it views as an important driver of payer support and future uptake. Furthermore, the company is preparing a large pragmatic randomized controlled trial (RCT), potentially enrolling up to 2,000 patients, to further establish Barostim's efficacy, as discussed in recent management commentary. Although the timing and costs of that effort depend on regulatory approval and payer support, management sees it as a long-term enabler of broader use. The company finished the quarter with $95.0 million in cash and cash equivalents, down from $105.9 million at year end 2024. Net cash used for operations and investing was $8.0 million, showing some improvement from $10.2 million a year ago, but still indicating ongoing cash burn. Long-term debt remained steady at $49.4 million. Looking Ahead: Guidance and Watch Items For fiscal 2025, management narrowed its revenue guidance to $55.0–$57.0 million, tightening the prior range and signaling increased confidence from better visibility into commercial results. The company expects gross margin to remain high at 83–84%. Operating expenses are now projected at $96.0–$98.0 million, a slight increase at the midpoint, reflecting ongoing investments in sales and account growth. Revenue is expected in the range of $13.7–$14.7 million for the next quarter, suggesting continued double-digit revenue growth ahead, as evidenced by a 15% year-over-year increase. Areas to watch in the coming quarters include progress in adding new implanting centers, the effectiveness and productivity of the enlarged sales force, and movement toward scaling revenues faster than expenses. Investors will also monitor any shift in European procedure volumes, cash usage trends, and the company's progress on the planned large RCT, as this trial could both validate Barostim's utility and expand the addressable market if successful. CVRX does not currently pay a dividend. Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted. Where to invest $1,000 right now When our analyst team has a stock tip, it can pay to listen. After all, Stock Advisor's total average return is 1,019%* — a market-crushing outperformance compared to 178% for the S&P 500. They just revealed what they believe are the 10 best stocks for investors to buy right now, available when you join Stock Advisor. See the stocks » *Stock Advisor returns as of August 4, 2025
