(RTTNews) - Asian stock markets are trading mostly lower on Wednesday, following the mixed cues from Wall Street overnight, as surging crude oil prices renewed global inflationary pressures amid the re-escalation in the Middle East conflict following the U.S. rejection of Iran's
(RTTNews) - Asian stock markets are trading mostly lower on Wednesday, following the mixed cues from Wall Street overnight, as surging crude oil prices renewed global inflationary pressures amid the re-escalation in the Middle East conflict following the U.S. rejection of Iran's
Earnings Call Insights: Capricor Therapeutics (CAPR) Q1 2026 Management view Linda Marbán said the “most significant development” is that “our biologics license application, or BLA, for deramiocel is currently under active review by the FDA with a PDUFA target action date of August 22, 2026,” adding that the resubmission was accepted as “Class II” and that “there has been a significant number of i...
Earnings Call Insights: Capricor Therapeutics (CAPR) Q1 2026 Management view Linda Marbán said the “most significant development” is that “our biologics license application, or BLA, for deramiocel is currently under active review by the FDA with a PDUFA target action date of August 22, 2026,” adding that the resubmission was accepted as “Class II” and that “there has been a significant number of information requests from the FDA to Capricor, all of which we have been able to provide answers to.” Marbán highlighted HOPE-3 efficacy and how it may shape labeling, saying the trial “met its primary efficacy endpoint… with an approximate 54% reduction in disease severity at 12 months and a p-value of 0.029,” and that LVEF showed an “approximate 91% slowing of disease progression” in all evaluable patients and “an approximate 120% slowing of disease and achieved a p-value of 0.01” in the cardiomyopathy subset. Marbán emphasized new real-world and imaging endpoints discussed for labeling: “The Duchenne Video Assessment of eat 10 bites… showed statistically significant improvement in treated patients versus placebo,” and “the cardiac MRI data demonstrated a significant stabilization in the progression of cardiac fibrosis in treated patients versus placebo.” Marbán framed the May 7 lawsuit against NS Pharma/Nippon Shinyaku as access- and economics-driven: “The core problem is related to pricing,” and she said the agreement’s pricing would create “potentially hundreds of thousands of dollars in reimbursement shortfalls per dose,” while also stating, “The FDA review process and the PDUFA date are unaffected by this lawsuit.” Marbán described commercialization build-out and leadership additions, saying Capricor “already have a Senior Vice President of Market Access” and “have now secured a Chief Commercial Officer, who will join us in the next few weeks.” Anthony Bergmann summarized liquidity and burn, saying, “As of March 31, 2026, we maintained a strong balance sheet with appr...
matejmo/iStock via Getty Images Xometry's ( XMTR ) share price surged after the company reported significantly better than expected first-quarter results and raised full-year guidance. The growth acceleration is noteworthy given that it came against a more difficult comparable period. Xometry also announced a collaboration with Siemens that could help to drive growth and improve margins. I previou...
matejmo/iStock via Getty Images Xometry's ( XMTR ) share price surged after the company reported significantly better than expected first-quarter results and raised full-year guidance. The growth acceleration is noteworthy given that it came against a more difficult comparable period. Xometry also announced a collaboration with Siemens that could help to drive growth and improve margins. I previously suggested that Xometry's growth story was still intact, despite recent share price weakness. While I felt that Xometry's 2026 guidance was overly cautious, I didn't expect the company's growth to accelerate. Xometry's fundamentals now look stronger than ever, but its valuation is also starting to look stretched again. While there is still uncertainty around Xometry's long-term margins, the Siemens collaboration suggests the company's competitive positioning is solidifying. As a result of this and the improved near-term outlook, I feel that Xometry is still attractively priced, even at current levels. Market Conditions Xometry's business was strong across industries in the first quarter, which is not surprising given the apparent improvement in macro conditions and the company's meaningful growth acceleration in the quarter. Figure 1: Manufacturing Business Conditions (source: Created by author using data from The Federal Reserve) Somewhat surprisingly, recent strength hasn't translated into a surge in hiring. While this could signal a lack of confidence in current growth, I tend to think it indicates that Xometry is now reaping the benefit of past investments, leading to a period of relatively efficient growth. Figure 2: Xometry Job Openings (source: Revealera.com) Looking further ahead, Xometry likely still has a large growth runway due to the fragmented and underpenetrated custom manufacturing market. I continue to believe that as baby boomers retire, there will be an opportunity to consolidate manufacturing activity currently performed by a large number of small manu...