Shares in Echo IQ Ltd (ASX: EIQ) jumped more than 10% after the company said it believed there was a “clear path” to obtaining regulatory approval in the US for its EchoSolv HF technology.

US roadblock not a dead end

Echo IQ shares fell almost 50% last week when the company revealed that the US Food & Drug Administration had issued a Not Substantially Equivalent determination for the company’s application for the approval of clinical use of EchoSolv HF.

But the company, having reviewed the situation, said on Thursday that work was underway with regulatory consultants and legal counsel about attaining regulatory approval.

The company said it “believes there is a clear path forward to obtaining FDA clearance for EchoSolv HF and it’s progressing this as a priority”.

The company added that the approval could be granted “over the coming quarters”.

Echo IQ said regarding the issue:

Following a review of the FDA’s feedback, the Company considers the matters cited to be limited to aspects of statistical analysis supporting the clinical validation. The Company’s assessment has not identified concerns relating to the underlying technology or core functionality of the EchoSolv HF device, and Echo IQ remains confident that clearance remains achievable under the 510(k) route. Echo IQ has identified multiple potential pathways to progress EchoSolv HF towards FDA clearance, including an administrative appeal of the NSE determination, seeking review through the FDA Ombudsman, or submitting a new 510(k) application.

The company said the timelines for an administrative appeal were not strictly defined, “and, in certain circumstances, may be shorter than 90 days”.

Echo IQ added:

If the Company were to file an administrative appeal, it may result in the NSE determination being overturned, the FDA reopening its review and potentially providing clearance of EchoSolv HF, or the FDA requesting that the Company resubmit a 510(k) for clearance, providing clarity on the matters Echo IQ must address to resolve the FDA’s previously identified concerns and obtain clearance.

EchoSolv HF is software that aims to improve the identification of patients at risk of heart failure.

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

Shares bouncing back

Despite falling sharply on the recent news, Echo IQ shares have still appreciated 128% over a 12-month period.

The company’s shares were 10.7% higher at 57 cents on Thursday. They have traded as high as $1.87 and as low as 16.5 cents over the past year.

The company is valued at $381.6 million.   

The post Shares surge as ASX biotech charts road to redemption 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.

CSL Ltd (ASX: CSL) shares have climbed into the green in Thursday lunchtime trade. At the time of writing the ASX biotech shares are up around 1% and are changing hands for $176.50 each.

The shares have now jumped about 31% over the past month alone after rebounding strongly in August following the company’s FY26 results announcement.

CSL reported total revenue of US$15.8 billion and NPAT of US$2.6 billion. It also recorded a net loss after tax of US$2.6 billion for FY26, coming from pre-tax impairments and restructuring costs. The result came in way ahead of guidance and CSL management described FY26 as a ‘reset year’, with FY27 marking a return to growth.

A sectorwide rotation back into ASX healthcare shares has also helped boost CSL shares higher recently.

I think there is a lot of potential for the company to grow over the next few years. CSL is operating in a high-growth market, and its blood plasma division dominates the market for rare blood disorders and immunoglobulin products.

Analysts sentiment has also turned more positive. Market Index data shows the majority have a buy rating on CSL shares. But after the latest rally, the $159.86 average target price now implies a potential 8% downside ahead, at the time of writing.

The past month has seen CSL go from strength to strength, and the share price rebound is impressive.

But there is another ASX biotech stock I’d buy instead.

The ASX biotech stock I have my eye on right now

Telix Pharmaceuticals Ltd (ASX: TLX) is a little different from CSL. The two businesses are major Australian biotech companies but have a vastly different focus, scale, and market position.

CSL focuses on plasma therapies while Telix focuses on radiopharmaceuticals. In terms of size, CSL is a global industry giant with multi-billion-dollar revenues but Telix is a mid-size company in the midst of strong growth.

It’s Telix’s growth opportunities which I find most appealing. 

Its shares are in the spotlight this week after the company announced that its brain cancer imaging drug, Pixclara, has received approval from the US FDA. This makes it the first FET-PET imaging drug cleared for use in glioma and expands Telix’s precision medicine portfolio.

Telix says Pixclara is already the subject of a Phase 3 trial for diagnosis in additional brain conditions, with potential expansion to brain metastases. 

The company said it plans to target market leadership in both imaging and treatment for several high-need cancers.

Telix’s broader pipeline includes late-stage assets in prostate, kidney, and glioblastoma cancers, with a focus on bringing further precision medicine products to both existing and new markets worldwide.

The update came off the back of several other good-news announcements out of Telix so far this year, including an application for key regulatory approval in Europe, several announcements about its growth and development plans, news that FDA had accepted its NDA for TLX101-Px (Pixclara®), and the announcement of a major collaboration with US-based biotech company Regeneron Pharmaceuticals. 

Telix also posted an impressive first-half FY26 result last month. Highlights include a 22% increase in revenue to US$477 million, and a strong gross margin improvement to 55%. Adjusted EBITDA also surged 146% year-on-year to US$52 million.

What do brokers tip next for Telix Pharmaceuticals shares?

I think there is plenty more room for Telix shares to run higher this year. And it looks like brokers agree too.

TradingView data shows that 14 out of 16 analysts have a buy/strong buy rating on the shares. The average $25.48 target price implies a potential 45% upside, while the maximum $30.99 target price suggests the stock could climb 76%, at the time of writing.

The post Forget CSL shares, I’d buy this ASX biotech stock instead appeared first on The Motley Fool Australia.

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

Superannuation funds have had a solid start to the financial year, with the median growth fund growing by 1.1% over the first two months, according to industry research company Chant West.

Volatility not hindering superannuation returns

Chant West said despite concerns around inflation and ongoing geopolitical tensions, superannuation funds gained ground in August with the median growth fund, with 61% to 80% of its funds in growth assets, gaining 0.9%.

Chant West Head of Superannuation Investment Research Mano Mohankumar said the healthy return for August was driven by domestic and global share markets, which in aggregate account for about 55% of a typical growth portfolio.

He added:

Despite some volatility towards the latter part of August, over the full month, developed market international shares advanced 2.5% in hedged terms led by the US. Markets were supported by strong corporate earnings and the tech sector regained momentum after some AI-related companies had been sold down in July. The Australian dollar appreciated over the month, which pulled the 2.5% hedged return back to 0.5% in unhedged terms. On average, super funds have about 70% of international shares unhedged. Emerging markets also finished higher, returning 1.3%.

Mr Mohankumar said Australian shares gained 1.6% over August, falling short of international markets but still a solid result.

A stronger resources sector offset weakness among financial shares, he said.

High growth portfolios led the gains over August with 1.2% growth, with all growth second with 1.1%, and growth third on 0.9%.

Mr Mohankumar said over the long term, superannuation had outperformed its aims.

Since the introduction of compulsory super in July 1992, the median growth fund has returned 8% p.a. The annual CPI increase over the same period is 2.7%, giving a real return of 5.3% p.a. – well above the typical 3.5% target. Even looking at the past 20 years, which includes three major share market downturns – the GFC in 2007-2009, COVID-19 in 2020, and the high inflation and rising interest rates in 2022 – super funds have returned 6.9% p.a., which is still ahead of the typical objective.

Time for a superannuation check-up?

If you’re looking to top up your super, it’s worth reading up on concessional contributions.

Concessional contributions include the amount contributed by your employer, but can also include extra amounts paid into your super on top of that.

This can be tax-effective, as these contributions are taxed at just 15%, meaning you could get tax back at the end of the year if your tax rate is higher than this.

The cap for such contributions, including your employer’s contribution, salary sacrifice amounts, and extra contributions, is $32,500 per year.

The post Superannuation has had a strong start to the year. See how much it’s up already appeared first on The Motley Fool Australia.

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• Forget CSL shares, I’d buy this ASX biotech stock instead
• 5 ASX shares I’d recommend to beginners
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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.