The Telix Pharmaceuticals Ltd (ASX: TLX) share price is in focus today after the company announced the US FDA has granted Fast Track designation for its BiPASS program, which targets earlier and less invasive prostate cancer diagnosis.

What did Telix Pharmaceuticals report?

• Received FDA Fast Track designation for BiPASS, a pre-biopsy prostate cancer imaging program.
• BiPASS evaluates gallium-68 PSMA-PET imaging alongside MRI to guide prostate cancer diagnosis before biopsy.
• Completed Phase 3 patient enrollment for BiPASS, using Illuccix and Gozellix agents.
• Engaged positively with FDA, planning for a new drug application (NDA) to expand access to this imaging method.
• Clinical data shows combining PSMA-PET and MRI can reduce unnecessary biopsies by nearly 50%.

What else do investors need to know?

Telix Pharmaceuticals’ BiPASS program aims to address a significant unmet need. Currently, over three million prostate biopsies are performed worldwide each year, but up to 75% yield negative results, making many procedures unnecessary and stressful for patients.

The FDA’s Fast Track designation means Telix can engage with the regulator more frequently and could have its submission for approval reviewed more quickly. If approved, the BiPASS approach may broaden the use of advanced imaging in prostate cancer care.

In addition, the company’s commercial products, Illuccix and Gozellix, are already approved in multiple global markets for imaging PSMA-positive prostate cancer. However, their use in pre-biopsy diagnosis remains investigational.

What did Telix Pharmaceuticals management say?

Dr. David N. Cade, Group Chief Medical Officer at Telix, said:

Fast Track designation reflects the FDA’s recognition of the potential for BiPASS to address an important unmet need in the prostate cancer diagnostic pathway. We believe gallium-68 PSMA-PET, used alongside MRI, could help physicians make more informed decisions before biopsy, improve diagnostic confidence and potentially reduce unnecessary invasive procedures for patients. This designation supports continued close engagement with the FDA as we advance BiPASS toward an NDA submission.

What’s next for Telix Pharmaceuticals?

Telix plans to submit a new drug application (NDA) for BiPASS to the FDA, seeking approval for use before invasive prostate biopsies. If successful, this could open up a larger market and provide faster, less stressful diagnostic options for many patients.

The business continues to build on a broad pipeline, with late-stage programmes for prostate, brain, and kidney cancers, and aims to establish further growth in international markets.

Telix Pharmaceuticals share price snapshot

Over the past 12 months, the Telix Pharmaceuticals share price has risen 11%, outperforming the S&P/ASX 200 Index (ASX: XJO), which has declined 2% over the same period.

View Original Announcement

The post Telix Pharmaceuticals wins FDA Fast Track for BiPASS prostate cancer imaging appeared first on The Motley Fool Australia.

More reading

• Buy, hold, sell: Telix Pharmaceuticals, Qualitas, Greatland Resources shares
• These are the 10 most shorted ASX shares
• 2 ASX shares UBS says could increase 13% to 37%
• 5 ASX 200 shares upgraded by experts this week
• Buy, hold, sell: New Hope, REA, Telix Pharmaceuticals shares

Motley Fool contributor Laura Stewart 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 Telix Pharmaceuticals. The Motley Fool Australia has recommended Telix Pharmaceuticals. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips. This article was prepared with the assistance of Large Language Model (LLM) tools for the initial summary of the company announcement. Any content assisted by AI is subject to our robust human-in-the-loop quality control framework, involving thorough review, substantial editing, and fact-checking by our experienced writers and editors holding appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content published by The Motley Fool Australia.

Zip Co Ltd (ASX: ZIP) shares are trading around $2.02 on Wednesday.

This means that for the buy now, pay later stock to double from here, it would need to reach $4.04.

That sounds like a big ask. But when I look at where earnings are expected to go over the next few years, I don’t think it is out of the question.

Earnings could do plenty of the work

The first thing I would want to see is Zip delivering on its earnings forecasts.

Consensus estimates point to earnings per share (EPS) of 15 cents in FY27, rising to 18 cents in FY28, and 22 cents in FY29.

That represents a 20% increase between FY27 and FY28, followed by another 22% increase in FY29.

At today’s $2.02 share price, Zip is trading on a P/E ratio of around 13.5 times forecast FY27 earnings. That falls to roughly 11 times FY28 earnings and a little over 9 times FY29 earnings.

I think those numbers explain why I can see a path towards a much higher share price.

If earnings keep climbing while the share price barely moves, Zip shares would become progressively cheaper. At some point, I think investors could become willing to pay more for that growth.

What valuation would $4.04 require?

At $4.04, Zip would trade at roughly 27 times forecast FY27 earnings.

That is much more demanding than today’s valuation.

But against the FY28 estimate, the P/E ratio falls to around 22 times and using FY29 earnings of 22 cents per share, it would be around 18 times.

That does not strike me as an impossible valuation if Zip is still producing robust earnings growth by then.

What would need to go right?

For those forecasts to become reality, Zip needs to keep growing the underlying business.

One part of that is continuing to win a greater share of the payments market in the United States and Australia. If more consumers use Zip and more merchants offer its payment options, transaction volumes should have room to keep expanding.

I would also want to see the customer base continue growing without Zip sacrificing credit quality in pursuit of that growth.

That means keeping bad debts under control as more users and transactions move through the platform.

If Zip can combine rising payment volumes and user growth with disciplined lending, I think the earnings outlook becomes much easier to believe.

And if the company can build a consistent track record of doing that, investors may eventually be prepared to pay a higher multiple for those earnings as well.

Foolish takeaway

I don’t think Zip shares need an extraordinary set of circumstances to double in value.

If Zip keeps taking market share, grows its customer base without letting bad debts get away from it, and reaches EPS of 22 cents by FY29, a $4.04 share price would represent less than 19 times earnings.

For a company still growing strongly at that point, I think that could be achievable.

The post What would it take for Zip shares to double? appeared first on The Motley Fool Australia.

More reading

• 2 ASX shares tipped to grow 100% or more in the next 12 months
• 3 cheap ASX shares I would buy now
• 6 ASX shares set to soar 39% to 135%
• These are the 10 most shorted ASX shares
• Tyro Payments vs Zip: Which ASX Payments Stock Wins?

Motley Fool contributor Grace Alvino 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.

The Vanguard MSCI Index International Shares ETF (ASX: VGS) and the iShares S&P 500 ETF (ASX: IVV) are two ASX exchange-traded funds (ETFs) I would happily buy for the long term.

Both provide instant exposure to some of the world’s biggest companies, but they go about it differently.

If I had $10,000 and could choose only one today, which would I buy?

What do you get with the VGS ETF?

The biggest reason to buy the VGS ETF is diversification.

It invests in around 1,300 stocks across approximately 23 developed countries outside Australia, rather than concentrating entirely on a single overseas market.

The United States still plays a major role, which is why NVIDIA, Apple, and Microsoft sit among its largest holdings. Fellow technology giants Amazon and Alphabet also feature prominently.

But the Vanguard MSCI Index International Shares ETF also spreads investors’ money across markets, including Japan, the United Kingdom, Canada, France, and Switzerland.

I like that approach because investors are not relying entirely on the US stock market continuing to lead global returns.

For someone who wants one broad international ETF, the VGS ETF would be an excellent choice in my view.

What about the IVV ETF?

The iShares S&P 500 ETF takes a narrower approach.

It tracks Wall Street’s S&P 500 Index (SP: .INX), giving investors exposure to around 500 large US companies. Its biggest underlying holdings currently include NVIDIA, Apple, Microsoft, Amazon, Alphabet, Broadcom, and Meta Platforms.

There is clearly plenty of overlap with the VGS ETF.

The difference is that the IVV ETF puts more weight behind these US businesses rather than diluting their influence with companies from other developed markets.

I like that. The US remains home to many of the companies leading major areas of growth, including artificial intelligence, cloud computing, semiconductors, digital advertising, and software.

Of course, that greater exposure to the US also means accepting more concentration. If American shares underperform other developed markets for an extended period, the VGS ETF could benefit from having more money invested elsewhere.

However, I am willing to take that risk because I think the strength of the US businesses inside the IVV ETF gives the fund a compelling long-term growth outlook.

Which ASX ETF would I buy?

The VGS ETF would be my choice for someone prioritising broader international diversification, and I like that it reduces reliance on one country.

But if I had $10,000 and could buy only one, I would choose the IVV ETF.

I am comfortable taking greater exposure to the US market because of the quality and growth potential of the stocks inside it.

The post VGS vs IVV: Which ETF would I buy with $10,000? appeared first on The Motley Fool Australia.

More reading

• How much must I invest in IVV ETF shares to earn a $1,000 passive income in 2027?
• Own US ETFs like IVV or NDQ? Here’s why your dividends are so low
• Invested in ASX IVV or other iShares ETFs? Here’s your next dividend
• 10 top ASX ETFs to watch in 2027
• How I’d build a $50,000 ASX share portfolio today

Motley Fool contributor Grace Alvino 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 Alphabet, Amazon, Apple, Broadcom, Meta Platforms, Microsoft, Nvidia, and iShares S&P 500 ETF. The Motley Fool Australia has recommended Alphabet, Amazon, Apple, Meta Platforms, Microsoft, Nvidia, Vanguard Msci Index International Shares ETF, and iShares S&P 500 ETF. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.