U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensure
Advisory Committee meeting scheduled for July 30, 2025
Mid-cycle meeting recently completed with no significant issues or major deficiencies; late-cycle meeting planned for mid-July
Biologics License Application remains under priority review with PDUFA target action date of August 31, 2025
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the successful completion of the U.S. Food and Drug Administration’s (FDA) Pre-License Inspection (PLI) of its San Diego manufacturing facility for Deramiocel, the Company’s lead cell therapy candidate with a Biologics License Application (BLA) under FDA review for potential approval in the treatment of Duchenne Muscular Dystrophy (DMD). The inspection concluded with a Form 483 containing several observations. The Company has submitted its responses to the FDA, none of which required material changes to the cGMP process or facility. The observations were primarily related to routine quality systems and documentation practices. The Company is confident that the facility will meet the necessary requirements to support product licensure and, pending approval, commercial launch.
“This inspection outcome is a major regulatory milestone, particularly in a field where standards are exceptionally high,” said Linda Marbán, Ph.D., Capricor’s Chief Executive Officer. “It reflects the strength of our manufacturing capabilities and positions us well as we advance toward potential approval. With the FDA Advisory Committee meeting now scheduled, we look forward to the opportunity to present the totality of evidence supporting the approval of Deramiocel for the treatment of Duchenne muscular dystrophy. With all key review activities progressing on track, we remain focused on delivering this much-needed therapy to the Duchenne community.”
The FDA informed Capricor of its intent to hold the Advisory Committee meeting on July 30, 2025, although that date is pending confirmation by the FDA. At the time of the mid-cycle review, no significant issues or major deficiencies were noted. A late-cycle meeting is planned for mid-July 2025. The BLA for Deramiocel remains under priority review with a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025.
Detailed in an article published in JAMA Psychiatry was written by a former Justice Department lawyer and a scientist who worked on an opioid commission
The optics for California Democrats—particularly far-left Los Angeles Mayor Karen Bass and Governor Gavin Newsom—have turned negative. Their characterization of the riots as "mostly peaceful" is increasingly being contradicted by viral X footage of looting, vehicle fires, and street-level chaos. Public sentiment appears to be shifting, with growing scrutiny on the role of well-funded far-left NGOs allegedly involved in organizing the unrest.
On Tuesday night, Mayor Bass was forced to impose a curfew on downtown Los Angeles—a move that stands in stark contrast to earlier claims from California Democrats that the protests were "mostly peaceful."
Meanwhile, a federal judge denied California's request for an immediate restraining order that would temporarily prohibit the Trump administration from using the Marines and the National Guard in the state.
🚨JUST IN: Judge Breyer has DENIED Newsom's emergency motion to block Trump's deployment of the National Guard, opting to set a hearing for Thursday. pic.twitter.com/S4CXuZFDod
About 700 Marines have been activated to assist federal personnel and property and join the 2,100 members of the California National Guard who are boots on the ground in securing the L.A. metro area.
On Wednesday morning, Attorney General Pam Bondi addressed reporters in the White House driveway about the Trump administration's decision to deploy Marines and National Guard troops to stop the social unrest sparked by far-left NGOs.
"Right now, we're the ones keeping California safe. If Gavin Newsom won't do it — we will," Bondi told reporters.
Bondi continued, "Today we wanted them to declare - they didn't declare an economic disaster with all the businesses affected by the unrest, which would've allowed the US Small Business Administration to come in and help and give federal aid to all these businesses."
"We've all seen the news—drugstores being robbed, looted, even the Apple Store just got hit. We're watching this unfold live," Bondi said, adding, "And to me, this isn't just looting—we're applying the Hobbs Act. We're treating it as robbery to protect Californians. If you loot a store, we're charging you with robbery under the Hobbs Act. That carries a maximum sentence of 20 years in prison," she said.
More critically, Bondi's team—alongside FBI Director Kash Patel—must launch a thorough investigation into the rogue far-left NGOs that are providing organizational or logistical support for these riots. Equally important is examining whether these NGO-linked color revolutions are being influenced or financed by foreign actors with the intent of destabilizing the nation from within.
The core objective of any color revolution is to shift public sentiment, but in the Democrats' informational war against Trump, that shift has yet to materialize. In fact, polling trends are moving in the opposite direction!
* * *
In a bizarre twist, after spending much of the past week pleading just how peaceful the LA riots hugfest has been, and slamming Trump for deploying the national guard to the city after the local police was ordered to stand down, moments ago LA mayor Karen Bass announced that a curfew will be put into effect for one square mile of downtown Los Angeles following four nights of violent, chaotic protests and looting, during which the LAPD arrested more than 150 people.
LA MAYOR: "I have declared a local emergency & issued a curfew for downtown Los Angeles."
"Last night, there were 23 businesses that were looted."
The curfew will extend from 8 pm to 6 am and will extend for several days.
But before anyone gets ideas that this was a sincere gesture meant to protect the lives of innocent civilians, keep in mind that the mayor explicitly wanted to highlight just how contained the curfew zone will be. It will apply to the area of downtown from the 5 Freeway to the 110 Freeway and from the 10 Freeway to where the 110 Freeway and the 5 Freeway merge, Bass said. In other words, see - the rest of LA is perfectly safe. Well, we'll see.
The mayor made the announcement Tuesday evening after suggesting earlier in the day that she would consider a curfew if violence broke out again. It did.
The curfew comes as arrests have increased every night since protests began in response to the Trump administration’s immigration crackdown in Southern California.
No one was arrested by Los Angeles police on Friday night, but 27 were arrested Saturday, 40 were arrested Sunday, and 114 were arrested Monday, according to Los Angeles Police Chief Jim McDonnell. Some would call it a wave of escalating peace.
Bass and other elected officials in Los Angeles have repeatedly asked protesters to remain nonviolent and refrain from spray-painting graffiti or otherwise vandalizing or burglarizing businesses. But each morning, new, often explicit, graffiti has adorned buildings across downtown. Oh, and of course, the looting did not help to demonstrate just how peaceful the illegal LA immigrant communists are.
So, to summarize leftist governance:
Let rioters rage
Call it “peace”
Impose curfews to protect your narrative, not your citizens
And when reality contradicts ideology, they don’t change policies—they change the vocabulary. “Mostly peaceful” is the mask they put on urban ruin.
Canada’s unemployment rate rose to 7% in May — its highest in over eight years, excluding the pandemic — with just 8,800 jobs added, according to theFinancial Post..
Full-time employment increased by 58,000, offset by a decline in part-time work. Private sector jobs grew by 61,000, while public sector employment fell by 21,000 due to fewer temporary hires after April’s federal election.
The Financial Post writes that manufacturing lost 12,200 jobs last month, contributing to a four-month decline of 55,000. Transportation and warehousing also shed 15,000 positions. Employment grew in wholesale and retail trade, utilities, finance, and real estate but dropped in manufacturing, public administration, and accommodation and food services.
Economists say the rise in unemployment is partly due to U.S. tariffs dampening hiring, with trade-sensitive regions like Windsor (10.8% jobless rate) and Oshawa (9.1%) hit hardest. Indeed Canada noted job postings have remained steady since February but are lower in trade-impacted areas.
“The impact of tariffs shows up in the industry pattern and regional unemployment pattern,” said Leslie Preston, senior economist at Toronto-Dominion Bank. “The manufacturing sector was down 12,200, as was transportation and warehousing (-15,000).”
Preston said manufacturing has lost a total of 55,000 jobs over the past four months.
Youth unemployment reached 20.1%, reflecting the start of the summer job market. The employment rate held steady at 60.8%, with total hours worked unchanged from April but up 0.9% from a year ago. Average hourly wages rose 3.4% year-over-year.
Bank of Canada policymakers are closely watching these developments, holding rates at 2.75% last week amid inflation concerns. In a note, Andrew Grantham, senior economist with the Canadian Imperial Bank of Commerce, said: “We expect that the gradual rise in joblessness will continue into the second half of the year, with positive developments regarding U.S. tariffs and some further interest rate cuts from the Bank of Canada required to help stabilize conditions before year-end and bring a reduction in the unemployment rate again in 2026.”
Still, economists said the larger trend of the rising unemployment rate could mean further rate cuts by the Bank of Canada during the second half of this year, with the jobless rate expected to peak above seven percent.
In what is reportedly thefirst real test of the tariff terror pass-through impact on the average American, today's CPI print was expected to rise modestly following survey after survey suggesting the fecal matter is about to strike the rotating object... just like every mainstream media economist warned.
Higher Prices
ISM Manufacturing prices expanded to 69.8, the highest since June 2022.
ISM Services ticked up to 65.1 in April, the highest since January 2023.
S&P Global US Manufacturing firms increased their output prices by the greatest degree since early 2023.
S&P Global US Services prices advanced.
Richmond Fed manufacturing showed prices received rose to 2.65 from 2.34 in March.
New York Fed manufacturing prices received edged up to 28.7 from 22.4 in March.
Philadelphia Fed manufacturing report showed prices received gained to 30.7 compared to 29.8 in March.
Kansas City Fed manufacturing prices received surged to 29, up from 15 in March.
Kansas City Fed non-manufacturing showed selling prices rose in April.
Dallas Fed manufacturing outlook report showed prices received for finished goods advanced to 14.9, up from 6.3 in March.
Dallas Fed services selling prices rose to 8.4 from 5.2 in the prior month.
Chicago PMI showed prices expanded at a faster pace in April.
So what did we get?
A nothingburger... again... as headline and core CPI both printed below expectations.
Headline CPI rose just 0.1% MoM in May (+0.2% MoM exp), inching higher to +2.4% YoY (from +2.3% YoY in April)...
Source: Bloomberg
Energy deflation dominated the headline CPI...
Source: Bloomberg
CPI increased 0.1% MoM after rising 0.2 percent in April; Over the last 12 months, the all items index increased 2.4 percent before seasonal adjustment. The index for all items less food and energy rose 0.1% in May, following a 0.2% increase in April.
The index for shelter rose 0.3% in May and was the primary factor in the all items monthly increase. The food index increased 0.3% as both of its major components, the index for food at home and the index for food away from home also rose 0.3% in May.
In contrast, the energy index declined 1.0% in May as the gasoline index fell over the month.
Indexes that increased over the month include medical care, motor vehicle insurance, household furnishings and operations, personal care, and education.
The indexes for airline fares, used cars and trucks, new vehicles, and apparel were among the major indexes that decreased in May.
CPI rose 2.4% for the 12 months ending May, after rising 2.3% in April. The all items less food and energy index rose 2.8% over the last 12 months. The energy index decreased 3.5% for the 12 months ending May. The food index increased 2.9% over the last year.
Core CPI was even more disappointing for the average PhD pundit as it rose 0.1% MoM (well below the +0.3% MoM expected), flat with April's +2.8% YoY - the lowest since March 2021...
Source: Bloomberg
Goods prices deflated...
Source: Bloomberg
Some more details on core CPI which rose 0.1% in May, following a 0.2% increase in April.
The shelter index increased 0.3% over the month.
The index for owners’ equivalent rent rose 0.3% in May and the index for rent increased 0.2 percent.
The lodging away from home index fell 0.1% in May.
The medical care index increased 0.3% over the month, following a 0.5% increase in April.
The index for hospital services increased 0.4% in May and the index for prescription drugs rose 0.6%.
The physicians’ services index fell 0.3% over the month.
The motor vehicle insurance index rose 0.7% in May, after rising 0.6% in April.
The index for household furnishings and operations increased 0.3% over the month.
The personal care index increased 0.5% in May, and the education index rose 0.3%.
In contrast, the index for airline fares fell 2.7% in May, after declining 2.8% in April.
The used cars and trucks index fell 0.5% over the month, and the new vehicles index (-0.3%) and apparel index (-0.4%) also declined.
Shelter inflation keeps falling...
May Rent inflation 3.81% YoY, down from 3.98% in April, lowest since Jan 2022.
May Shelter inflation 3.86% YoY, down from 3.99% in April, lowest since Nov 2021
On a YoY basis, Services cost price increases continue to slow while Goods prices accelerate very (very) modestly...
Source: Bloomberg
So, we guess we will just have to wait for NEXT MONTH to see the hyperinflationary hellscape that so many TV pundits told us would occur after Trump's terror tariffs were imposed.
Pharma is interested in using artificial intelligence in their digital dealings with healthcare professionals and patients, but most feel unprepared to forge ahead with the technology.
That is the conclusion of the latest edition of the Digital Reality Check survey – carried out by Graphite Digital – which found that only 13% of digital decision-makers in pharma said they were very prepared for AI adoption to power this type of digital experience.
Obstacles to being prepared include data privacy, integration with existing systems, and the high cost of adoption, according to the report, which is based on polling of 100 pharma industry digital leaders. Compliance concerns and a lack of expertise are also holding back progress, with 77% of those polled saying they were "somewhat prepared" to deploy AI in digital customer engagement.
That is because the transformation to digital in this area looks very different, according to Michelle Killick, senior director of global transformation design at Pfizer, who contributed to the report.
"This is more than ever, not about striving for perfection from the outset, this requires a mindset to dive in, test, learn and iterate," she commented. "This technology is changing faster than perhaps anything we have seen before."
Asked where AI is having the biggest impact in digital engagement, around half (49%) of respondents said it was in data analytics and customer insights, suggesting that pharma "is leaning on AI to make sense of complex datasets and uncover actionable trends," said Graphite Digital.
Meanwhile, just over a third (36%) of the executives pointed to personalisation and patient journey optimisation as the second-ranked area of impact, just ahead of the use of conversational AI and chatbots (34%).
"Pharma is making early moves to apply AI to customer experiences – not just in R&D, but in how it engages HCPs and patients," said Graphite Digital chief executive Rob Verheul, who cautioned however that at the moment "it feels like the 'ugly duckling' phase: some trials and prototypes, but a long way from the integrated, value-add experiences needed."
Looking to the future, the top areas of investment were enhancing data-driven insights and analytics (68%) and digital marketing and advertising (66%), as well as AI-powered content creation (62%).
Many are also investing in the delivery elements of the customer experience, such as customer engagement and support (50%), although only a quarter (26%) are focusing on user experience (UX) and digital design, which Graphite Digital says "suggests untapped potential."
Verheul said: "There's huge potential here. With the right focus and collaboration, pharma can move past the barriers and start delivering meaningful, AI-powered experiences that truly serve its customers."