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ORGO News
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Organogenesis Reports Affinity Trial Results, Significantly Improves Venous Leg Ulcers
Organogenesis published results from a prospective, multicenter, randomized controlled trial evaluating Affinity plus standard of care compared to standard of care alone in the management of complex venous leg ulcers. The results were published in the Journal of Wound Care demonstrating statistically significant improvements in wound closure at weeks 12 and 16 for the Affinity plus standard of care group across two wound duration strata studied. The 206-patient trial, which randomized 1:1 to Affinity plus standard of care or standard of care alone, followed patients for 24 weeks after a four-week run-in period. Across both baseline wound duration strata, which included wounds present for more than 6 months and wounds present for more than 24 months, the Affinity plus standard of care group achieved significantly higher rates of wound closure than standard of care alone at weeks 12 and 16. The venous leg ulcer data set complements existing Affinity evidence in diabetic foot ulcers. "These clinically meaningful results demonstrate the value of Affinity as a protective barrier in challenging VLUs," said Patrick Bilbo, COO of Organogenesis. "Paired with our DFU data, this strengthens the case that Affinity delivers meaningful outcomes for the patients who need it most."
Organogenesis ReNu Biologics License Application Accepted by FDA
Organogenesis announced that the FDA has completed their filing determination and accepted for review the company's biologics license application, or BLA, for ReNu, a cryopreserved, amniotic suspension allograft developed for the treatment of pain in symptomatic knee osteoarthritis. The FDA has set a Prescription Drug User Fee Act target action date of April 24, 2027.
Organogenesis Completes BLA Submission for ReNu
Organogenesis announced the completion of a rolling biologics license application, or BLA, submission to the FDA for ReNu, a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis. Organogenesis initiated the rolling BLA submission in December 2025 with non-clinical modules and has now completed the application with the submission of the clinical and chemistry, manufacturing, and controls modules.
Major Averages Decline as Oil Prices Surpass $117
The major averages were lower near noon, erasing yesterday's gains amid fading hopes of an imminent end to the U.S.-Iran war and oil prices surpassing $117 per barrel. President Trump has established an 8:00 pm ET deadline for the two sides to reach an agreement to reopen the Strait of Hormuz, otherwise the U.S. will attack Iran's power plants and bridges. Trump's recent comments include the president saying on Truth Social, "A whole civilization will die tonight, never to be brought back again. I don't want that to happen, but it probably will."Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:The Centers for Medicare and Medicaid released its 2027 Medicare Advantage payments, with policies project to result in aBroadcomand Alphabetentered into aPershing Square proposed toof Universal Music GroupApple'sfoldable iPhone has encountered setbacks,Organogenesissaid itin its PuraPly study2. WALL STREET CALLS:Armto Equal Weight at Morgan StanleyRosenblattArista Networkson increased confidence in XPO strategyBarringtonFuboTVto Outperform on updated financial outlookCitiWingstopto Buy into potential sales reboundRocket Labto Outperform at Citizens3. AROUND THE WEB:Amazonhas rebuffed requests from its wholesale suppliers for increased payments to cover higher costs, prompting some to pull items from the company's site, Information reportsThe families behind Puig and Estee Lauderare set to meet in New York this week to negotiate the terms of a potential combination of their beauty businesses with the goal of announcing an agreement in the coming weeks, Expansion saysUlta BeautyCEO Kecia Steelman said GLP-1 users are purchasing hair and skincare products to combat the side effects of the weight loss treatments, Business Insiders reportsDelta Air Lineshas hiked its fee for checked bags by $10 for tickets bought starting Wednesday, following similar moves by Unitedand JetBlueamid a surge in jet fuel expenses this year, CNBC saysAnthropic plans to invest $200M in a new venture with private equity firms that looks to sell AI tools to their portfolio companies amid a push for business customers, WSJ reports4. MOVERS:Patterson-UTIgains after reportingn the U.S. in MarchPerrigoincreases in New York after ain Ben Harrington's Betaville blogMach Naturaldeclines after announcing aRedwirelower afterwith a new office in the United KingdomSuzanofalls in New York after BofAthe stock to Neutral5. EARNINGS/GUIDANCE:PrecigenSamsungNeuroneticsfor Q1 and FY26RPM Internationalis expectedon April 8Levi Straussis expectedon April 7INDEXES:Near midday, the Dow was down 0.81%, or 377.95, to 46,291.93, the Nasdaq was down 1.10%, or 241.75, to 21,754.59, and the S&P 500 was down 0.81%, or 53.79, to 6,558.04.
Stock Futures Modestly Lower as Market Sentiment Turns Cautious
Stock futures are modestly lower this morning. Markets are pausing after a four-day rebound, with sentiment turning cautious again as investors head into a key geopolitical deadline. The central driver remains the standoff in the Middle East, specifically the U.S. deadline for Iran to reopen the Strait of Hormuz. With Tehran rejecting both the deadline and ceasefire proposals, markets are now bracing for a potential escalation scenario rather than a negotiated outcome. That shift in expectations is pushing oil back higher and reintroducing the same inflation concerns that drove volatility throughout March.The oil move is once again dictating cross-asset behavior. Higher crude is tightening financial conditions, pressuring equities, and complicating the Federal Reserve outlook.Energy-linked assets are benefiting from the renewed supply shock narrative, while oil-sensitive sectors, particularly airlines and transports, are coming back under pressure. At the same time, defensive pockets of the market are seeing inflows, and health insurers are outperforming following favorable policy updates. Volatility is elevated and that dynamic is keeping risk appetite contained despite the recent bounce.In pre-market trading, S&P 500 futures fell 0.38%, Nasdaq futures fell 0.55% and Dow futures fell 0.30%.Check out this morning's top movers from around Wall Street, compiled by The Fly.HIGHER -Organogenesisup 17% after reporting it has met the primary endpoint in its PuraPly studyHumana, UnitedHealthand CVS Healthup 10%, 8% and 7% respectively after Centers for Medicare & Medicaid Services finalized Medicare payment policy at higher-than-expected ratesBroadcomup 3% after entering into a long-term agreement for the company to develop and supply custom TPUs for Google'sfuture generations of TPUs and a supply assurance agreement for Broadcom to supply networking and other components to be used in Google's next-generation AI racks through up to 2031Casey's General Storesup 1% after being admitted into the S&P 500 indexLOWER -ATN Internationaldown 1% after announcing Brad Martin is stepping down as CEO and member of the company's board of directorsEstee Lauderdown 1% after Spanish newspaper Expansion reported the families behind Puig and Estee Lauder are set to meet in New York this week to negotiate the terms of a potential combination of their beauty businesses with the goal of announcing an agreement in the coming weeksPrecigendown 1% after providing Q1 revenue guidance
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