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BioCardia, Inc.

BCDA
Richly ValuedBiotech · Clinical
FDA catalysts, PDUFA dates & pipeline intelligence
$1.06
▼ -0.03 · -2.75%

Financials

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52W LOW $0.7552W HIGH $1.80
Volume
162.40 K
Value Traded
185.50 K
Short % Float
7.48%
+1.92%Week
-3.64%1 Month
+15.87%3 Month
-10.17%6 Month
-98.39%5 Year
-100%All Time

Cash Data

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Key Stats

Market Cap
16.05 M
EPS (TTM)
-0.48
P/E Ratio
-
Ent. Value
11.93 M
Total Shares
15.14 M
Float Shares
11.54 M
Insiders
23.74%
Institutions
9.03%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
PDUFA
2026
Example Drug
Treatment for example condition requiring FDA review
Phase 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

BCDA Catalyst Timeline

Dated clinical, regulatory and corporate events for BioCardia, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for BioCardia, Inc.

624Total events
26Upcoming
99Tier-1 (high impact)
2015 to 2029Coverage

Upcoming catalysts 2

T2Other Regulator Milestone
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CardiAMPFiled
T2PMDA Milestone
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Event history 50

●Timing GuidanceHelixFiledPresentation
BioCardia completed revised De Novo Pre-Submission to FDA CDRH for Helix Catheter approval
●R&D DayPresentation
BioCardia to present at H.C. Wainwright 28th Annual Global Investment Conference
●Timing GuidancePresentation
BioCardia conference presentation expected to be available beginning September 11, 2026
●Oral PresentationPresentation
BioCardia conference presentation prerecorded, available beginning September 11, 2026
●R&D DayPresentation
BioCardia conference presentation prerecorded and available beginning September 11, 2026
▲FDA Feedback ReceivedHelixFiledFDA Meeting
FDA confirms Pre-Submission Meeting minutes for Helix
●Quarterly UpdateCorporate
Reported Q2 2026 financial results and filed Form 10-Q
▲Enrollment UpdateTrial
CardiAMP HF II trial actively enrolling; three additional patients expected to qualify this month
ischemic heart failure of reduced ejection fractionsource ↗
▲FDA Feedback ReceivedHelixFiledFDA Meeting
FDA confirmed and accepted BioCardia's summarized meeting minutes for Helix De Novo pre-submission
▲FDA Feedback ReceivedFDA Meeting
FDA confirmation of meeting minutes supporting follow-on De Novo pre-submission for Helix
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How BCDA actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2025-03-30CardiAMP (autologous cell therapy) Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

D21 / 100
Pipeline Score
$1M
Pipeline Value
Richly Valued
Valuation Signal
1
Drugs Scored
0.1x
rNPV / MCap
Top 93%
Micro Cap
(rank 612 of 658)
Percentile Rank
BioCardia, Inc. faces pipeline headwinds (21/100), with $94M risk-adjusted pipeline value, led by Autologous cell therapy in Heart Failure, Systolic (Phase 3), but cash runway is a concern.
Showing 1 of 1 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Autologous cell therapy Cell therapyCompletedNCT02438306Heart Failure, SystolicPhase 3 COMPLETED 125Jun 1, 2025
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Clinical Trial Results

Readouts, endpoints and source filings for every BCDA program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
CardiAMP
Breakthrough
Chronic Myocardial Ischemia2026-05-21exercise tolerance increase: 179 seconds; angina reduction: 82%Read MoreBioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Results Presented at EuroPCR Showed Durable Improvements in Exercise Tolerance with Reduced Angina FrequencyRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Altman PeterDirector, Officer (President and CEO)Buy 1,000 384,885 held$1.03 09/29/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
No hedge fund reported a 13F position in BCDA for Q2 2026.
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Shares held by hedge funds each quarter, and who bought or sold.

BCDA Institutional Ownership Trends

Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
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Per-expiry call and put volume, open interest, put-call ratios and implied volatility.
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Real-Time Option Chain

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Competitive positioning

How BCDA ranks across every disease it competes in

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See how BCDA ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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BCDA News

BCDA
Oct 7, 2026
BCDAConferences/Events
▼ -2.7%today

BioCardia Presents CardiAMP HF II Trial Design at Heart Failure Society of America Annual Scientific Meeting

BioCardia, Inc. will present the CardiAMP HF II trial design at the Heart Failure Society of America Annual Scientific Meeting. The trial aims to evaluate the efficacy of high-dose autologous cell treatment for patients with ischemic heart failure. The FDA has approved a category B designation for the CardiAMP cell therapy system, which may support future FDA approval.

Read more →
BCDA
Oct 1, 2026
BCDAFDA Updates

BioCardia Files Revised De Novo Pre-Submission for FDA Approval of Helix™ Catheter

BioCardia has submitted a revised De Novo pre-submission to the FDA for its Helix catheter, aimed at therapeutic and diagnostic delivery to the heart. The FDA has indicated two pathways for marketing clearance and raised no safety concerns. If approved, Helix could be the first of its kind, backed by extensive clinical data from prior trials.

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BCDA
Sep 23, 2026
BCDAFDA Updates

BioCardia Confirms Timing and Provides Update on FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin Submission

BioCardia, Inc. has announced updates regarding its regulatory submissions for the CardiAMP therapy and Helix delivery platform. The company is preparing for a Shonin submission in Japan and is actively enrolling participants in the CardiAMP HF II clinical study, which may support a Pre Marketing Application. Additionally, BioCardia plans to submit a De Novo pre-submission for the Helix system to the FDA.

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BCDA
Sep 10, 2026
BCDAConferences/Events

BioCardia to Present CardiAMP Regulatory and Corporate Progress at H.C. Wainwright 28th Annual Global Investment Conference

BioCardia, Inc. will present its CardiAMP regulatory and corporate progress at the H.C. Wainwright 28th Annual Global Investment Conference. CEO Peter Altman will discuss advancements towards regulatory approval in Japan and the U.S., the ongoing CardiAMP HF II pivotal trial, and the company's innovative delivery platforms. The conference will take place from September 14-16, 2026, in New York City.

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BCDA
Aug 24, 2026
BCDAFDA Updates

BioCardia Announces FDA Confirms Helix Transendocardial Delivery Catheter Meeting Minutes Supporting Follow-On De Novo Pre-Submission for Approval

BioCardia has received FDA confirmation regarding the Helix Transendocardial Delivery Catheter's Pre-Submission Meeting. The FDA accepted the meeting minutes from May 2026, allowing BioCardia to proceed with a follow-on pre-submission for Helix. This could lead to approval through the De Novo pathway, enhancing the development of its therapeutic agents.

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BCDA
Aug 12, 2026
BCDAGeneral
▲ +5.6%on this news

BioCardia Reports Second Quarter 2026 Business Highlights and Financial Results

BioCardia, Inc. reported positive developments in its second quarter 2026 results, highlighting support from regulatory agencies in Japan and the U.S. for its CardiAMP Cell Therapy. The company is preparing for a regulatory submission in Japan and actively enrolling patients in clinical trials. Financially, BioCardia raised $4.9 million and reported a decrease in net loss compared to the previous year.

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BCDA
Aug 5, 2026
BCDAConferences/Events

BioCardia to Host Q2 2026 Financial Results and Corporate Update Conference Call on August 12, 2026

BioCardia, Inc. announced a conference call scheduled for August 12, 2026, to discuss its Q2 financial results and provide a corporate update. The call will include a question-and-answer session, allowing participants to engage with management. Interested parties can register online to receive dial-in details or listen via a live webcast.

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BCDA
Jun 18, 2026
BCDAGeneral

BioCardia Letter to Stockholders on 2026 Priorities and Strategic Opportunities

BioCardia's CEO, Peter Altman, outlined the company's strategic priorities in a letter to shareholders, emphasizing the submission for CardiAMP Cell Therapy approval in Japan as a key focus. The company aims to address the needs of ischemic heart failure patients and leverage its innovative delivery systems. With a recent capital raise, BioCardia is well-positioned for upcoming milestones and potential partnerships.

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BCDA
Jun 8, 2026
BCDAGeneral
▼ -10.7%on this news· ran to -23% by day 3

BioCardia Announces $4.4 Million Financing

BioCardia, Inc. has successfully raised $4.4 million through the sale of shares, which is expected to extend its cash runway into the first quarter of 2027. This funding will support the anticipated submission of CardiAMP Cell Therapy to the Japan PMDA in Q4 2026. The company continues to develop its innovative cell therapies for cardiovascular and pulmonary diseases.

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BCDA
Jun 5, 2026
BCDAFDA Updates
▲ +12.1%on this newsshared move

FDA Confirms CardiAMP HF II May Support Premarket Approval of CardiAMP Cell Therapy for Ischemic HFrEF

BioCardia, Inc. announced that the FDA's minutes from a recent meeting indicate that the ongoing CardiAMP Heart Failure II Trial may support the Premarket Approval of the CardiAMP Cell Therapy for ischemic heart failure with reduced ejection fraction (HFrEF). This therapy utilizes the patient's own bone marrow cells and aims to improve heart function. The FDA's recognition of the trial's potential is significant for the treatment of HFrEF, which affects a large patient population.

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BCDA
May 28, 2026
BCDAFDA Updates

BioCardia Announces Japan PMDA Record Of Advice Supports Regulatory Submission For Approval Of CardiAMP Cell Therapy For Ischemic Heart Failure

BioCardia has received support from Japan's PMDA for the regulatory submission of CardiAMP Cell Therapy aimed at treating ischemic heart failure. The PMDA confirmed the credibility of clinical trial outcomes and outlined requirements for the submission. The therapy could potentially benefit around 20,000 patients in Japan, highlighting an urgent clinical need.

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BCDA
May 21, 2026
BCDAPhases

BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Results Presented at EuroPCR Showed Durable Improvements in Exercise Tolerance with Reduced Angina Frequency

BioCardia has announced promising results from their CardiAMP Cell Therapy in a trial for Chronic Myocardial Ischemia, presented at the EuroPCR conference. The trial's open-label cohort demonstrated durable improvements in exercise tolerance and a significant reduction in angina frequency among patients treated with the novel therapy. Participants showed an average increase in exercise tolerance by 179 seconds and an 82% reduction in angina episodes within six months of treatment. These findings support the continued clinical development of CardiAMP therapy as an innovative solution for patients suffering from refractory angina.

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BCDA
May 19, 2026
BCDAConferences/Events
▲ +5.6%on this newsshared move

BioCardia to Participate in a Fireside Chat at the Alliance Global Partners (A.G.P) Healthcare Company Showcase

BioCardia, Inc. will participate in a virtual fireside chat at the A.G.P. Healthcare Company Showcase on May 20, 2026, at 11:40 AM ET. The company is known for its innovative cellular and cell-derived therapeutics aimed at treating cardiovascular and pulmonary diseases. Investors can register to attend the event and learn more about BioCardia's advancements.

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BCDA
May 15, 2026
BCDAGeneral
▼ -7.3%on this news· ran to -17% by day 1shared move

BioCardia Reports First Quarter 2026 Business Highlights and Financial Results

BioCardia, Inc. reported its Q1 2026 financial results, highlighting significant progress in its CardiAMP cell therapy for ischemic heart failure. The company received positive feedback from both the FDA and PMDA regarding the therapy's safety and efficacy. BioCardia is advancing towards regulatory approval in Japan and has ongoing clinical trials in the U.S. Despite a net loss of $2.3 million, the company remains optimistic about its future prospects.

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BCDA
May 11, 2026
BCDAConferences/Events

BioCardia to Host Q1 2026 Financial Results and Corporate Update Conference Call on May 15, 2026

BioCardia, Inc. will host a conference call on May 15, 2026, to discuss its Q1 financial results and provide a corporate update. The call will include a formal presentation followed by a question-and-answer session. Participants can register online to receive dial-in information, and a replay will be available after the call.

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BCDA
May 8, 2026
BCDAFDA Updates

BioCardia and FDA Align on Helix Transendocardial Delivery Catheter Clearance Pathways

BioCardia announced a successful Pre-Submission Meeting with the FDA regarding its Helix Transendocardial Delivery Catheter System. The FDA identified two potential pathways for marketing clearance and expressed no concerns regarding safety or performance. The preferred route aligns Helix approval with the CardiAMP cell therapy system for heart failure treatment.

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BCDA
Apr 28, 2026
BCDAFDA Updates

BioCardia Announces Allowance of Japanese Patent on Proprietary Heart3D™ Fusion Imaging Software for Procedure Planning and Realtime Navigation During CardiAMP Cell Therapy Procedures

BioCardia has announced the allowance of a Japanese patent for its Heart3D Fusion Imaging software, which aids in treatment planning and navigation during CardiAMP Cell Therapy procedures. This technology is designed to enhance the visualization of the heart using 3D imaging techniques. The company is also preparing for regulatory submissions in Japan and the U.S. following positive consultations with authorities.

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BCDA
Apr 20, 2026
BCDAFDA Updates
▲ +5.9%on this news

BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure

BioCardia, Inc. has received positive feedback from Japan's PMDA regarding its CardiAMP Cell Therapy for ischemic heart failure. The agency believes the clinical data is likely sufficient for market clearance. The meeting confirmed the acceptability of foreign clinical data and outlined the next steps for potential filing in Japan.

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BCDA
Apr 2, 2026
BCDAFDA Updates

BioCardia Files Request for Meeting With FDA to Discuss Accelerated Approval Pathway for CardiAMP® System in Ischemic Heart Failure

BioCardia has submitted clinical study data to the FDA and requested a meeting to discuss the accelerated approval pathway for its CardiAMP System, aimed at treating ischemic heart failure. The company aims to receive feedback on its proposed submission based on positive safety and efficacy data from its trials. The CardiAMP System has shown promising results, particularly in high-risk patients, demonstrating significant reductions in cardiac events.

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About BioCardia, Inc.

Sunnyvale, CA 21 employees biocardia.com
Headquarters320 SOQUEL WAY, SUNNYVALE, CA, 94085
Founded1994
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