BioCardia Inc (BCDA)

BioCardia Shares Rally After FDA Supports Regulatory Path for Heart Failure Therapy (BCDA)June 5, 2026 10:31 AM
IH Market News BioCardia Inc. (NASDAQ:BCDA) shares surged 26.2% in premarket trading on Friday after the company announced that the U.S. Food and Drug Administration had confirmed a regulatory pathway that could support future market approval of its CardiAMP Cell Therapy System. The update relates to the company’s ongoing CardiAMP Heart Failure II Trial, which is evaluating a treatment for patients suffering from ischemic heart failure with reduced ejection fraction (HFrEF). FDA Confirms Potential Route to Premarket Approval According to BioCardia, the FDA’s Center for Biologics Evaluation and Research provided official meeting minutes indicating that data from the ongoing study may contribute to a future Premarket Approval (PMA) application. PMA is the FDA’s most stringent regulatory review process for medical devices and is generally required for products considered to carry higher levels of risk. The process is intended to demonstrate both safety and effectiveness before a device can be commercially marketed in the United States. CardiAMP Trial Seen as Key Step Toward Commercialization The CardiAMP Cell Therapy System is designed to treat patients with ischemic heart failure and reduced ejection fraction, a serious cardiovascular condition that affects a large patient population. BioCardia noted that the FDA generally expects two well-designed clinical studies when reviewing therapies intended for major medical indications such as HFrEF. The company believes the current CardiAMP Heart Failure II Trial could serve as one of the studies needed to support a future PMA submission. Large Potential Patient Population Management estimates that more than one million patients in the United States could potentially benefit from the CardiAMP therapy if approved. The company also highlighted that the FDA has previously determined the treatment system to be safe, an assessment that helped support reimbursement for participants enrolled in CardiAMP HF clinical trials through the Centers for Medicare and Medicaid Services. CEO Highlights Unmet Medical Need Chief Executive Officer Peter Altman said patients with ischemic heart failure continue to face limited treatment options. “Patients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options,” Altman stated. He added, “FDA recognizes this need and the strengths in our completed CardiAMP HF clinical data to be the first of two trials to support Premarket Approval.” Company Focused on Regenerative Therapies BioCardia develops cell-based and cell-derived therapies targeting cardiovascular and pulmonary diseases. The company’s platform is focused on regenerative medicine approaches designed to improve outcomes for patients suffering from chronic and severe conditions. Investors responded positively to the FDA update, viewing the agency’s confirmation as an important milestone in the regulatory process and a potential step toward eventual commercialization of the CardiAMP Cell Therapy System. Original: BioCardia Shares Rally After FDA Supports Regulatory Path for Heart Failure Therapy (BCDA)

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

2026-06-05 08:00 ET - News Release


SUNNYVALE, Calif., June 05, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).

BCDA......................................p/m

BCDA.............................https://stockcharts.com/h-sc/ui?s=BCDA&p=W&b=5&g=0&id=p86431144783

Somebody throws a 1m candle on this thing and it will go ham lol

Hey monk
Seeing insider buys 
3 separate buyers one was Altman 
One guy bought like 500k common at $1.25

up to12m offering @$1.25

no wonder they relentless selling

SMH

BCDA is today 52w LOW

was todays News somehow bad, was there anything hidden in there
https://finviz.com/news/169285/biocardia-announces-cardiamp-chronic-myocardial-ischemia-trial-top-line-data-of-roll-in-cohort-show-improved-exercise-tolerance-and-reduced-angina-episodes-at-six-month-primary-follow-up

6/30 insider buying, reported yesterday, over 150K shares. Link: http://openinsider.com/search?q=bcda

Today's volume already 100x over yesterday. Sp up 8 cents.

With recent insider buying and granting of a US patent, I think there's a chance this one will move up some.

BCDA under $2

BCDA under $2

BCDA under $3

Yep-feeling trapped. BCDA down a bunch this Friday too, even with new drug approved. Friday seems, in general, to be a take down day as people are doing other things near weekend and MMs can work it down. Stock market is a weird world !

WBUY is always a trap. Staying away from anything Asian;)

You have good nose ! Sold all at $3.33 on guess sell limit--surprise. A couple days of shaking and it goes up some more is my guess. Stuck in WBUY at moment as tried to join party as party was breaking up--lol

Smelling news here.

Going right direction. WooHoo Turtle speed--but right direction now.

MMs finding some sellers for a while. Maybe I try for more shares.

Looks rather soft today as volume is down. So horde of seller is NOT happening is good. I think MMs get bored in 2 days and it creeps back up--my thoughts. I'm not selling unless a pop happens.

BCDA under $5

I think the 7.2mil may come from adding what the warrant holders can do? I don't know. But yes, I think they are going about enlarging the share structure intelligently. We'll see on the 3rd I guess. Weeee!

I made mistake of thinking new shares amounted to 7.2 million. New share amount is 4.8 M As shares priced at $3, this will not dip too far. Some are already added.so not expecting disaster like some stock adding shares.

Looks like their new share offering will be around $3 per share - https://www.globenewswire.com/news-release/2024/08/30/2938478/0/en/BioCardia-Announces-Pricing-of-Upsized-7-2-Million-Public-Offering-Priced-At-The-Market-Under-Nasdaq-Rules.html

Another 2.4 million issued under the same terms - https://ih.advfn.com/stock-market/NASDAQ/biocardia-BCDA/stock-news/94464814/form-s-1mef-registration-adding-securities-to-pr Hope this puppy can still keep treading water. Tomorrow's Friday, depending on who's buying this they may not want to hold over the weekend.

Well, those new shares being issued at half price are going to make it dip. Lot more to do with it than people's fear about it. But I've seen a lot of these Otc's, Pinky's and microcap Biopharma's issue a crapload of new shares right after news and a huge pop and then the share price collapses and people are stuck for months. Sometimes they never recover. The fact that BCDA absorbed them and moved into the 4's at end of day is pretty significant imo. The interest in buying it up in the low 3's means significant money likes the future outlook. Weeeeeeee! Microcap Biopharma!

I think that maybe people read both releases by now. Climbing up nicely. This never should have dipped so low. Some traders got a good deal today.

Interesting, thx. It looks like it might have legs...

At the moment, the trend is more towards $4 than $2
And such orders can be found Level 2 almost everywhere, but mostly these are so-called iceberg orders, where you only see a few thousand but there are hundreds of thousands behind them.
But in this day and age of electronic algorithms, this type of trading is relatively pointless and is no longer done.
Today's trading systems replenish certain positions again and again, buy and sell according to corresponding specifications and forward these promptly to the stock exchanges. This is why you can hardly find any relevant orders in the order books these days.

I have an L2. Volume is brisk right now. No walls set up on the ASK. 1700 shares is the highest. Most are 100 shares which most likely means the MMs aren't showing all of the shares they are selling at that PPS.

Do you have Level 2 on this? Curious what the ask prices are for the top 3-4 market makers. Also wondering if someone is holding out for a giant buy order in the $2something range.

On doing some more research around the inter-webs; Morningstar has given them a 5 star ranking and other ranking sites make it a moderate buy. So, apparently they're not full of crap. If it hangs around $3 for the close I'll be hopeful for it's future. ("it's called an investment", lolzzz thx.)

Also, it's not like the offering was needed to keep the lights on. The money gained from the offering will most likely go toward increased production of the approved product. It's called an investment. The company should realize good profits from the investment.

I have traded so many shares in the last few weeks and months that have issued new shares or announced new shares and closed in these huge volumes within the day.

You can see from the trading that the share wants to rise and will rise in line with the positive approval and the expected increase in profits and income.

It is simply our basic evil with these short addresses that are now headlessly beating up on every share that is even slightly up, regardless of whether there is good or bad news.

But this headless beating on shares very often brings the next 100-200% plus in trading the next day, because they then close the open positions as quickly as possible at all costs and then try the game all over again later out of sheer anger.
It is therefore no wonder why so many of them go bust. Well, it's not their money, but only that of their investors in these funds.

On a more general low float runner note; people always complain about "dilution" in penny stocks. But the reality is, if it's not a complete scam company who are just selling their shares into the pump, they have to issue more shares for there to be an increase in share price with the increase in attention and volume. These things don't really move up much or best case run way up with only a 1.5 million float. If I had got in and was down 30-50% I would just hang around and wait. I'm going to keep an eye on it anyway. An analyst, H.C. Wainright, whoever the hell that is, has put a price target of $25 per share on this thing. So, who knows. cheers!

With a current volume of 26.6 million, they won't wait a few days to see what happens and then issue new shares days later.
With today's volume, these announced new shares are already included three times or more in the volume and they can therefore be completed in one day and then celebrate the approval accordingly in the price the following days and generate a high increase.
There are only shorts at work here who think they can beat down the price with all their might and completely ignore the approval and the very good news that comes with it.
They have to cover their open positions very quickly otherwise the shot could backfire badly.

The total shares outstanding are 1.58 million, the float is 1.5 million. https://finviz.com/quote.ashx?t=BCDA&p=d Those issued shares and 2 types of warrants effectively triple the float. The shares can be bought at $2.47, the pre-funded warrants can be exercised immediately at .001. They can issue them at any time and in any amounts they want; so maybe parcel them out over the coming days, but I don't see how it cannot effect the share price in the near term. Just my non-professional, non-expert opinion. If their suite of catheter tools is something really new and different this will probably make everyone money. It's just going to be a buy and hold instead of a flip. I was going to get in this but saw that S-1 and changed my mind. I don't like to buy and hold. But, no one can predict the future. We'll see in the next couple of days. glta

Glad you see it the way I do. That 2m shares in a drop in the bucket.

With a trading volume of 22 million, what are 2.6 million new shares, they have long since been traded and the share price even rose further in the pre-market after this announcement.

A few shorts are only trading on this news with the new shares and are completely ignoring the top news.
I am sure that the share will turn around well today.

I don't see why the offering of 2,439,024 would tank the PPS the way it did. The offering shouldn't negate the news in the other PR. Maybe it will bounce back today.

BCDA: And indeed it DID, Dude; wherefore, a classic TOILET FLUSH on the Public --- as this Firm ramps-up to DUMP yet more shares onto the Wall Street 'playing field'.

If you're looking at the same screen I am there's a column of "Latest News" just to the right of the message board. The second press release down is a form S-1A released at 6:02am. I believe it has a strong bearing on which direction the price will take.

The News is top, it will bounce back around 5 bucks +

Wonder if it will bounce back over $4. It dropped fast at the bell.

Nice subs! Let's make some money.

NEWS_ BioCardia receives FDA clearance for new product
https://www.investing.com/news/company-news/biocardia-receives-fda-clearance-for-new-product-93CH-3592035

$BCDA +110% @ 4.62 in premarket on volume...

That's what I was thinking as well. Huge market for the drugs approved for sale.