Ticker News
$NUWE News
Stored TradersLink news articles and press-release context for this ticker. Discord alerts link into these article pages when full article text is available.
Published Articles
Latest saved alerts
Ensysce enrolls first patient in final stage of PF614‑MPAR‑102 trial
Ensysce (ENSC) announced first-patient enrollment in Part 3 (final stage) of its PF614‑MPAR‑102 study evaluating PF614‑MPAR, an opioid engineered with a built‑in chemical “safety switch” to limit additional drug release and protect against oral overdose. The program has FDA Breakthrough Therapy designation and NIDA support; prior data showed maintained therapeutic plasma levels at normal doses and blunted exposure at supratherapeutic doses, and Part 3 will test the protective profile across a broader range of dosing scenarios.
Nuwellis installs three Aquadex SmartFlow systems at Michigan pediatric center
Nuwellis (NUWE) installed three Aquadex SmartFlow systems at a leading pediatric healthcare provider in Michigan, marking the company’s first pediatric program in the state. The installations are intended to establish clinical protocols and workflows that could drive future consumable utilization and broaden the company’s pediatric critical-care footprint. Nuwellis also completed an FDA pre-submission meeting to seek label expansion from the current 20 kg minimum down to 5 kg, which would materially enlarge the pediatric addressable market if approved.
Nuwellis names Mike McCormick CEO; plans pediatric expansion to ≥5 kg and adds Rendiatech kidney-monitoring tech
Nuwellis appointed Mike McCormick as CEO effective June 30 and issued a shareholder letter outlining priorities: expand commercial momentum in pediatric/critical care, pursue FDA engagement to broaden Aquadex use down to patients ≥5 kg using existing clinical and real‑world data, and integrate the recently acquired Rendiatech kidney‑function monitoring into its ICU portfolio. The company reported Q1 results showing 26% YoY revenue growth and a 70.1% gross margin, said its capital position is strengthened, and reiterated targets of consistent double‑digit revenue growth, margin expansion and reduced cash burn.
NUWE prices $6M offering of 20M shares with heavy warrant package
Nuwellis priced a public offering of 20,000,000 common shares (or pre-funded warrants) with accompanying warrants at $0.30 per share/unit for gross proceeds of ~ $6.0M; the deal includes up to 60,000,000 Series C warrants and 20,000,000 Series D warrants. The offering is being made off an S-1 declared effective June 4 (Rule 462(b) filed June 5); closing is subject to customary conditions and stockholder approvals, and the warrants’ exercisability is contingent on stockholder approval and the effective date of a reverse stock split. Timing: Dilution depends on stockholder approval first, and the press release does not say when that will happen.
Nuwellis files Form SD and posts 2025 Conflict Minerals Report
NUWELLIS, INC. filed SEC Form SD. filed a Form SD under Rule 13p-1 attaching its Conflict Minerals Report for the reporting period January 1, 2025 to December 31, 2025, with the report included as Exhibit 1.01 and made available on the company's website. The report was signed by President and CEO John L. Erb on May 28, 2026.