Shares in Echo IQ Ltd (ASX: EIQ) have fallen 48% to after the company failed in its bid to get US Food and Drug Administration (FDA) approval for its heart failure decision support software EchoSolv HF.

Company to regroup after knockback

The medical technology company said in a statement to the ASX that the FDA had issued a Not Substantially Equivalent determination for the application, rather than approving it for use by clinicians.

Echo shares fell as low as 47 cents, however have since rebounded slightly. At the time of writing, they are trading for 69.5 cents.

Echo IQ said it was now considering its options.

The company said:

Upon receipt of the FDA’s determination, Echo IQ, together with its US regulatory and legal advisors, its study partners, and independent statistical experts, has commenced a detailed review of the regulatory matters raised. The Company believes there is a pathway forward for clearance under the 510(k) route and intends to engage with the FDA to further clarify the matters identified in the determination and assess all administrative and regulatory options available to Echo IQ. This process will inform the most appropriate and efficient pathway to progress EchoSolv HF towards US regulatory clearance.

Echo IQ said it remained confident in the clinical rationale underpinning EchoSolv HF, “and the significant unmet clinical need in the identification of patients with heart failure”.

The company said it also planned to continue its broader US commercial strategy, which involved other products.

The company added:

This determination does not impact the FDA-cleared EchoSolv AS platform or its ongoing commercialisation in the US. Echo IQ will continue to advance its US commercial infrastructure, reimbursement pathway, customer pipeline and strategic relationships, providing a platform to support the future commercialisation of EchoSolv HF, subject to obtaining required regulatory clearance. In parallel, Echo IQ will continue to invest in its broader R&D pipeline, including the development of solutions targeting additional disease states and new clinical modalities.

Management to reassess the company’s position

Echo IQ Managing Director Dustin Haines said that while the company was disappointed in the decision, the determination provided the company with detailed feedback, which could be used to potentially take the program forward.

He added:

Our immediate priority is to understand the matters raised in full and determine the most efficient pathway forward. We remain confident in the underlying technology, the clinical rationale for EchoSolv HF and the significant opportunity to improve the identification of patients at risk of heart failure.

The company said it remained well-funded with more than $105 million in cash.

Broker Morgans recently had a speculative buy rating on Echo IQ with a price target of $1.85.

The post Why has this ASX biotech fallen nearly 50% today? appeared first on The Motley Fool Australia.

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Motley Fool contributor Cameron England has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

It has been an interesting morning for Austal Ltd (ASX: ASB) shareholders.

The shipbuilder entered a brief trading pause on Wednesday, which immediately had investors wondering what was coming.

And we didn’t have to wait long.

Austal shares are now up 6.44% to $4.63 after the company released an update on the future of its US business.

Let’s dive right in.

A new offer has landed

According to the release, Austal has received a non-binding proposal from Wildcat Infrastructure to buy Austal USA.

Wildcat has valued the business at between US$1.25 billion and US$1.35 billion on a cash-free, debt-free basis.

The proposal is subject to 4 weeks of due diligence, while Wildcat says it wants to keep the Austal brand and run the US business as a standalone platform.

Austal said its board and advisers will now consider the proposal.

And Wildcat isn’t the only one interested.

South Korea’s Hanwha, which already owns 19.9% of Austal, has offered between US$1.05 billion and US$1.2 billion for the US operations.

So, Wildcat has come in above Hanwha’s range at both ends.

The Australian puts the new proposal at roughly $1.73 billion to $1.87 billion.

Keep in mind, that’s a pretty big number when Austal’s entire market value is currently around $1.95 billion.

Why the US business is attracting interest

Austal’s latest results help explain why buyers are taking a closer look at the US operations.

Group revenue rose 11% to $2.03 billion in FY26, but the company still posted a $53.6 million net loss.

The US division was the main drag, recording an EBIT loss of $202.8 million after provisions linked to several loss-making contracts.

The Australasian business had a much better year.

Revenue climbed 49% to $650.7 million, while EBIT jumped 137% to a record $85.3 million.

So, if Austal does sell the US business, it could leave the group with a large amount of cash and a much stronger Australasian operation.

What happens next?

There is still plenty to play out from here.

Wildcat’s offer is non-binding and it still needs to complete due diligence, while Hanwha may decide to come back with a higher offer of its own.

But having another buyer interested puts Austal in a stronger position as it weighs up what to do with the US business.

Even after today’s rise, Austal shares are still down around 31% in 2026 and roughly 44% over the past year.

That makes the next few weeks worth watching.

The post Austal shares surge 6% as another bidder enters the race appeared first on The Motley Fool Australia.

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Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

If I could get my time machine to work, would I be better off buying $10,000 worth of Westpac Banking Corp (ASX: WBC) or National Australia Bank Ltd (ASX: NAB) shares on 8 September 2023?

Now both S&P/ASX 200 Index (ASX: XJO) bank stocks have outperformed the 24.4% gains posted by the ASX 200 over the last three years.

And, once we add back in there twice annual dividend payouts, they’ve also both beaten the 37.9% gains delivered by the S&P/ASX 200 Gross Total Return Index (ASX: XJT), which includes all cash dividends reinvested on the ex-dividend date.

But which of these big four Aussie banks has led the charge?

Investing $10,000 into NAB shares

Three years ago, I could have picked up NAB shares for $28.65.

Meaning my $10,000 would have gotten me 349 shares in the big four Aussie bank.

As we head into the Wednesday lunch hour today, those same shares are changing hands for $38.21, up 33.4% in three years.

So, what about those dividends?

Well, if I owned the ASX 200 bank stock for the last three years I would have received six fully-franked dividend payments, totalling $5.08 a share.

If we add that back into today’s share price, then the accumulated value of the NAB shares I bought for $28.65 three years ago is now worth $43.29. And the 349 shares I bought for $10,000 are worth an accumulated $15,108.

Not bad.

But what about Westpac?

Buying Westpac shares in September 2023

On 8 September 2023, Westpac shares closed the day trading for $21.17. So, for $10,000, I could have bought 472 Westpac shares.

At time of writing, shares in the ASX 200 bank stock are swapping hands for $34.23 each, up 61.7% in three years.

Now let’s add that passive income back in.

If I owned Westpac shares for the last three years, I would have received the last six fully-franked dividend payments, totalling $4.68 a share.

Adding that back into the current share price, the accumulated value of the Westpac shares I bought three years ago is now worth $38.91. And the 472 shares I bought for $10,000 are worth an accumulated $18,366.

So, while both ASX 200 bank stocks have handily outperformed the benchmark indexes over the last three years, Westpac shares have gained significantly more than NAB shares.

Now, if I can only get that time machine working!

The post $10,000 invested in Westpac and NAB shares 3 years ago is now worth… appeared first on The Motley Fool Australia.

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Motley Fool contributor Bernd Struben has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.