BridgeBio's 15min chart triggers KDJ Death Cross, bearish Marubozu formation observed.

BridgeBio's 15-minute chart has exhibited a bearish trend, as evidenced by a KDJ Death Cross and a Bearish Marubozu at 09/29/2025 10:45. This suggests that the momentum of the stock price is shifting towards the downside, with potential for further decreases. Sellers are currently in control of the market, and it is likely that the bearish momentum will continue.

BioCardia Inc. has announced its plans to request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the pathway to approval for its CardiAMP cell therapy system. The company aims to submit the meeting request by the end of the fourth quarter of 2025, with the focus on the product's approvability based on available clinical data. CardiAMP is an investigational autologous cell therapy designed to treat ischemic heart failure (HF).

The company is currently evaluating CardiAMP in the pivotal phase 3 CardiAMP HF clinical trial (NCT02438306), which, although it did not meet its primary endpoints, has shown promising results. BioCardia believes several factors could pave the way for approval, including the breakthrough therapy designation previously granted to CardiAMP by the FDA, longer-term follow-up data from the CardiAMP HF trial, and the FDA's prior 510(k) approval of Marrowstim, a primary component of CardiAMP. Additionally, the company is planning to submit a DeNovo 510(k) application for the Helix Transendocardial Delivery System (Helix) to the FDA in the third quarter of 2025.

BioCardia also expects a clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to take place in the fourth quarter of 2025. If aligned with the agency, the company may submit for market approval of CardiAMP in Japan. This potential approval could be influenced by other applications for allogeneic cell therapies to treat the same clinical indication expected to require chronic immunosuppression and open chest surgical delivery of cells.

Data from the CardiAMP HF trial, presented earlier this year at the American College of Cardiology 74th Annual Scientific Session & Expo, showed a study-wide increase in survival and decrease in major adverse cardiac and cerebrovascular events (MACCE), although the primary composite efficacy endpoint did not reach statistical significance. Compared to patients receiving optimized heart failure medication alone, those treated with CardiAMP experienced fewer heart death equivalents, a relative risk reduction in nonfatal MACCE, and a clinically meaningful improvement on the Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ).