ASX biotech stock Neuren Pharmaceuticals Ltd (ASX: NEU) is flying on Monday.

The ASX biotech stock jumped around 30% to $15.92 in morning trade after announcing a major regulatory breakthrough in Europe for its lead drug, DAYBUE.

Despite today’s rally, Neuren shares remain down approximately 15% in 2026. Over the past 12 months, however, the ASX biotech stock has gained around 17%, comfortably outperforming the S&P/ASX 200 Index (ASX: XJO), which has risen about 3% over the same period.

So, what has investors so excited?

A major step towards European approval

Neuren revealed that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation for DAYBUE following a re-examination process.

The recommendation now moves to the European Commission, which is expected to make a final decision over the coming months.

If approved, DAYBUE would become the first authorised treatment for the neurobehavioral symptoms of Rett syndrome across all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway.

For the ASX biotech stock, the financial implications could be significant.

Why the decision matters

Neuren is a biotechnology company developing treatments for rare neurological disorders.

Its most advanced medicine is DAYBUE (trofinetide), which has been licensed to Acadia Pharmaceuticals Inc (NASDAQ: ACAD) for commercialisation.

If the European Commission grants marketing approval and DAYBUE launches in Europe, Neuren will receive a US$35 million milestone payment following the first commercial sale.

The company would also become eligible for ongoing royalties on net sales and additional milestone payments if future sales targets are achieved.

That prospect helps explain today’s enthusiastic share price reaction.

European approval would open another major market for DAYBUE. Earlier, it launched in the US, creating a fresh revenue stream without Neuren needing to fund sales and marketing itself.

At its FY25 results, the ASX biotech stock reported $65 million in royalty income. It expects further growth in 2026 as DAYBUE sales expand. Acadia has guided for DAYBUE net sales of US$460 to US$490 million this year, implying another strong year of royalty growth for Neuren.

What management said

Neuren CEO Jon Pilcher welcomed the recommendation, saying:

I am so delighted for all stakeholders to see this positive outcome from the CHMP re-examination process recommending marketing authorisation for DAYBU® in the EU. With no approved treatment currently available in the EU, approval of DAYBU® would represent an important step forward for patients, caregivers and the wider Rett syndrome community profoundly impacted by this devastating condition.

What’s next for the ASX biotech stock?

While the CHMP recommendation is an important milestone, it is not the final step.

The European Commission must still formally approve the application, with a decision expected in the coming months.

If that happens, the ASX healthcare share would gain access to one of the world’s largest pharmaceutical markets. It would also unlock valuable milestone payments and recurring royalty income.

For investors, today’s rally reflects growing confidence that DAYBUE is edging closer to another major commercial opportunity.

The post Why this ASX biotech stock is soaring 30% today appeared first on The Motley Fool Australia.

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Motley Fool contributor Marc Van Dinther 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.

There was a time when CSL Ltd (ASX: CSL) could almost do no wrong in the eyes of investors.

But that now feels like a very long time ago.

At the time of writing, the CSL share price is down 1.77% to $112.85.

This comes after the biotech giant released another disappointing update tied to its Vifor business.

It is the latest blow in what has become an absolute brutal period for one of the ASX’s former market darlings.

CSL shares are now down around 34% since the start of 2026 and have fallen more than 50% over the past year.

So, what’s the latest to go wrong?

CSL’s Vifor troubles deepen in Europe

According to the release, CSL said a European Medicines Agency committee has recommended that marketing authorisation for TAVNEOS be revoked in the European Union (EU).

TAVNEOS, also known as avacopan, is sold by CSL Vifor affiliates in the EU and European Economic Area (EEA) under a licence agreement.

The treatment is used for adults with severe, active ANCA-associated vasculitis, a rare disease that causes inflammation in small and medium blood vessels.

The recommendation follows a review into the handling of data in the pivotal Phase 3 ADVOCATE clinical trial, which supported the product’s approval.

CSL said the European Commission will now review the committee’s opinion and make a final decision in due course.

In the meantime, the company expects to stop new patient starts in EU and EEA markets, in line with regulatory guidance.

Management commentary

CSL said it was disappointed with the outcome, but will respect the regulatory process.

Bill Mezzanotte, CSL’s head of research and development, noted that the company recognises this is a difficult moment for the community.

He said:

Patient care remains our highest priority, and we are working closely with regulatory authorities, healthcare professionals and patient organisations.

CSL advised that sales revenue from TAVNEOS is expected to be approximately US$45 million in FY26.

The company will provide more detail on the intellectual property impairment linked to TAVNEOS when it reports its FY26 full-year results on 18 August.

CSL also pointed out that today’s announcement doesn’t change the estimated impairment it provided to investors in May.

Why this still hurts

Despite the setback , keep in mind that TAVNEOS is tiny next to CSL’s broader global operations.

However, Vifor has already been a major frustration for investors after CSL flagged large write-downs earlier this year.

So, another issue from the same part of the business was never going to land well.

CSL is still a global biotech heavyweight, with major plasma, vaccine, and iron deficiency businesses. Its market capitalisation also remains above $54.5 billion, so this isn’t a business suddenly running out of options.

Nonetheless, investor trust has already been severely damaged.

The post Another CSL blow: Why this beaten-up ASX giant is sliding again appeared first on The Motley Fool Australia.

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Forrestania Resources Ltd (ASX: FRS) has agreed to buy the Edna May Gold Hub from Ramelius Resources Ltd (ASX: RMS) in a deal worth $300 million in cash and scrip.

Transformational gold opportunity

Under the deal, Forrestania will pay Ramelius $200 million in cash and $100 million in its own shares for the hub, which includes the 2.9 million tonne per annum Edna May mill, associated infrastructure and the existing 945,000 ounce gold resource.

The company said the deal complements its Lake Johnston processing hub which is currently undergoing refurbishment.

Forrestania Chair David Geraghty said regarding the deal:

This transaction upholds Forrestania’s strategy to consolidate the proven and prospective gold assets in the Forrestania region. Approximately 12 months ago, Forrestania embarked on an aggressive M&A strategy to consolidate stranded high-quality gold assets and underexplored tenure surrounding Edna May. This strategy has been incredibly successful and set Forrestania up for today’s acquisition. Forrestania believes it has the proven development and delivery team that is ready to refurbish, upgrade and commission the 2.9Mtpa Edna May Mill going forward. This work will be completed in conjunction with Forrestania’s commissioning of Lake Johnston which is on-track for late 2026.

Forrestania said it was targeting a restart of the Edna May mill in the first half of 2027.

Forrestania shares were in a trading halt on Monday while the company completed a $300 million capital raise to fund the deal.

The company said it was targeting more than 6 million tonnes of ore processing capacity by the first half of 2027, with the Lake Johnston facility on track for commissioning in the fourth quarter of 2026.

Building a bigger WA footprint

The company added:

With Forrestania already holding significant tenure and JORC Resources surrounding Edna May, the acquisition builds-out its dual processing hub-and-spoke network, increasing Forrestania’s operational flexibility and ensuring the right ore goes to the right mill. With a permitted and existing processing plant and associated infrastructure, Edna May presents a compelling near-term restart opportunity and allows Forrestania to avoid the approvals burden, development timeline and increased capital intensity associated with greenfield developments.

Forrestania shares, which last changed hands for 42.5 cents, are expected to remain in a trading halt until Wednesday, July 1.

The company is currently valued at $569.2 million.

Ramelius shares were up 3% on the news.

Ramelius said in a statement to the ASX, “the transaction provides Ramelius with an opportunity to crystallise value from a non-core asset and further focus resources on its core business”, while also retaining exposure to Edna May through its equity in Forrestania.

The post This ASX gold company’s aggressive M&A program continues with $300 million deal 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.