CAPR News & Events

The major averages closed little changed as markets traded with a more constructive tone in concert with oil prices pulling back. Oil prices, which had surged above $100 and briefly approached $120 per barrel during the escalation of the Iran conflict, are now coming back in after comments from Donald Trump suggesting the military operation could conclude sooner than previously expected. Meanwhile, CBS News' Jennifer Jacobs reported that there are indications Iran is taking steps to deploy mines in the Strait of Hormuz.In other commodity news, gold prices continue their surge amid market volatility. Despite having an up-and-down 2026, the commodity is climbing towards record highs once again.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Nvidiaand Thinking Machines Lab announced a gigawatt-scale strategic partnershipBioNTechannounced plans for anto be established and led by BioNTech co-founders Prof. Ugur Sahin, M.D., and Prof. Ozlem Tureci, M.D.HP Enterprisereportedand provided guidance for Q1 and FY26Kohl'sreportedbut guided for a decrease in Q1 comp salesVail Resortsreportedand cut its FY26 resort reported EBITDA view2. WALL STREET CALLS:Qualcommat Underperform at BofACrowdStriketo Overweight at Morgan StanleyRivianto Buy at TD Cowen into R2 launchNovo Nordiskto Hold at TD CowenB. RileyStrategywith Buy on "unmatched scale"3. AROUND THE WEB:Boeingwill delay deliveries of some e737 MAX planes amid wiring flaws, WSJ reportsExxon Mobilis planning to move its legal home to Texas from New Jersey in a move meant to protect the company from shareholder "abuse," WSJ saysRio Tintois in talks with Mongolia over financial terms at the massive Oyu Tolgoi copper mine, with the government seeking lower loan interest costs and the removal of Rio's annual management fee, WSJ reportsAppleincreased its iPhone production in India by 53% last year and now makes a total of 25% of its devices there, Bloomberg saysAmazon'secommerce business has requested a large group of engineers to meet on Tuesday for a "deep dive" into the influx of outages, with the company stating there has been a "trend of incidents" characterized by a "high blast radius" and "Gen-AI assisted changes," FT reports4. MOVERS:Zevra Therapeuticsgains after, with EPS and revenue beating consensusCapricorincreases after announcing the establishment of a new PDUFANiohigher in New York afterand providing guidance for Q1Centenefalls afterand announcing its ACA enrollment is "still in line" with expectations"Crispr Therapeuticslower after announcing a5. EARNINGS/GUIDANCE:ABM, with CEO Scott Salmirs commenting, "ABM is off to a solid start to FY26"Custom Truck One Source, with EPS beating consensusUnited Natural Foodsand provided guidance for FY26UWM Holdingsraised itsPriority Technologyand provided guidance for FY26INDEXES:The Dow fell 34.29, or 0.072%, to 47,706.51, the Nasdaq gained 1.16, or 0.0051%, to 22,697.10, and the S&P 500 advanced 14.51, or 0.21%, to 6,781.48.

The major averages were higher near noon as markets are trading with a more constructive tone. Investors are reacting to a reversal in the energy shock that dominated markets earlier in the week. Oil prices, which had surged above $100 and briefly approached $120 per barrel during the escalation of the Iran conflict, are now pulling back after comments from Donald Trump suggesting the military operation could conclude sooner than previously expected.Meanwhile, gold prices continue their surge amid market volatility, as the "safe haven" asset rose nearly 2%. Despite having an up-and-down 2026, the commodity is climbing towards record highs once again.Get caught up quickly on the top news and calls moving stocks with these five Top Five lists.1. STOCK NEWS:Nvidiaintends to launch an open-source AI agent platform,BioNTechannounced plans forto be established and led by BioNTech co-founders Prof. Ugur Sahin, M.D., and Prof. Ozlem Tureci, M.D.HP Enterprisereportedand provided guidance for Q1 and FY26Kohl'sreportedbut guided for a decrease in Q1 comp salesVail Resortsreportedand cut its FY26 resort reported EBITDA view2. WALL STREET CALLS:Qualcommat Underperform at BofACrowdStriketo Overweight at Morgan StanleyRivianto Buy at TD Cowen into R2 launchNovo Nordiskto Hold at TD CowenB. RileyStrategywith Buy on "unmatched scale"3. AROUND THE WEB:Exxon Mobilis planning to move its legal home to Texas from New Jersey in a move meant to protect the company from shareholder "abuse," WSJ saysRio Tintois in talks with Mongolia over financial terms at the massive Oyu Tolgoi copper mine, with the government seeking lower loan interest costs and the removal of Rio's annual management fee, WSJ reportsAppleincreased its iPhone production in India by 53% last year and now makes a total of 25% of its devices there, Bloomberg saysAmazon'secommerce business has requested a large group of engineers to meet on Tuesday for a "deep dive" into the influx of outages, with the company stating there has been a "trend of incidents" characterized by a "high blast radius" and "Gen-AI assisted changes," FT reportsA groundstop for all JetBlueflights was canceled within an hour on Tuesday by the U.S. Federal Aviation Administration, FAA, after JetBlue said it resolved a "system outage," Reuters reports4. MOVERS:Zevra Therapeuticsgains after, with EPS and revenue beating consensusCapricorincreases after announcing the establishment of afor dermiocel BLANiohigher in New York afterand providing guidance for Q1Centenefalls afterfor FY26 and announcing its ACA enrollment is "still in line" with expectations"Crispr Therapeuticslower after announcing a5. EARNINGS/GUIDANCE:ABM, with CEO Scott Salmirs commenting, "ABM is off to a solid start to FY26"Custom Truck One Source, with EPS beating consensusUnited Natural Foodsand provided guidance for FY26UWM Holdingsfor Q1Priority Technologyand provided guidance for FY26INDEXES:Near midday, the Dow was up 0.48%, or 229.12, to 47,969.92, the Nasdaq was up 0.58%, or 131.24, to 22,827.19, and the S&P 500 was up 0.39%, or 26.81, to 6,822.80.

Capricor Therapeutics announced that the U.S. Food and Drug Administration has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy cardiomyopathy. The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act target action date of August 22, 2026. The Company received a Complete Response Letter from the FDA in July 2025. Following submission of data and supporting documentation from the HOPE-3 clinical trial, the FDA resumed review of the application and assigned a PDUFA target action date of August 22, 2026. At this time, the FDA has not identified any potential review issues in its response to the Company. Capricor also expects to be eligible to receive a Priority Review Voucher upon potential approval of Deramiocel.

The Food and Drug Administration review process for accelerated approvals was meant to drugs for rare diseases to pass the approval process, clearing the drugs based on early biological signs instead of waiting years for definitive proof of real-world outcomes, David Wainer of The Wall Street Journal. Now, however, the accelerated approval pathway isn't closed but has become much narrower and harder to predict. Recently, the FDA issued a string of rejections, including Regenxbio's (RGNX) gene therapy for Hunter Syndrome and Disc Medicine's (IRON) treatment for a blood disorder. In some cases, the agency reversed its own guidelines provided to the companies. In 2025, the FDA greenlighted only nine accelerated approvals, down from 20 in 2024. Other companies in the space include: uniQure (QURE), Moderna (MRNA), Replimune (REPL), and Capricor (CAPR).