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BioCardia (BCDA) Gains FDA Nod for ARDS Cell Therapy Study

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BioCardia, Inc. (BCDA - Free Report) announced that the FDA has approved its investigational new drug (“IND”) application to initiate a clinical study on its pre-clinical pipeline candidate, BCDA-04. The company is planning to initiate a phase I/II study that will evaluate the candidate in patients recovering from acute respiratory distress syndrome (“ARDS”) due to COVID-19.

The company is planning to start the study in the third quarter of 2022.

The phase I portion of the study will evaluate increasing dosage of BCDA-04 to find an optimal dose of the candidate. The phase II portion of the study will evaluate the optimal dose of the candidate in adult patients recovering from ARDS due to COVID-19.

BioCardia’s BCDA-04 is an allogenic stem cell therapy that will be administered intravenously. Similar cell therapies investigated by the National Institute of Health as well as other per companies provide a significant body of compelling clinical results.

The company stated that after the administration of BCDA-04, the cells in the therapy migrate to the lungs for local therapeutic benefit. It believes that the anti-inflammatory nature of these mesenchymal stem cells may have a positive impact on ARDS patients.

Shares of BioCardia have gained 2.6% so far this year against the industry’s decrease of 13.9%.

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Several other companies like Novartis (NVS - Free Report) , Mesoblast Limited (MESO - Free Report) and Enlivex Therapeutics (ENLV - Free Report) are also developing cell therapies for treating ARDS.

In 2021, Novartis entered into an exclusive worldwide license and collaboration agreement with Mesoblast for the development, commercialization and manufacturing of the latter’s cell therapy candidate, remestemcel-L, for the treatment of ARDS, including that associated with COVID-19. Novartis and Mesoblast are currently evaluating the candidate in a phase III study.

Enlivex initiated a phase II study last year to evaluate its off-the-shelf cell therapy, Allocetra. Enlivex is evaluating the candidate in patients with severe and critical COVID-19 with ARDS. It expects to provide top-line data from the study in the second quarter of 2022.

These candidates are likely to provide competition to BioCardia’s BCDA-04 following potential approvals.

Apart from its ARDS cell therapy, BioCardia has a strong pipeline of autologous cell therapies. The company is developing these cell therapies as potential treatments for ischemic heart failure and chronic myocardial ischemia with refractory angina.

Zacks Rank

BioCardia currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.