Here are 5 ASX Biotech Targets Amidst The $230bn Patent Cliff; And Which Big Pharma Companies Could Buy Them!

There are plenty of ASX Biotech Targets that major pharmaceutical companies wanting to minimise the impact of the Patent Cliff could look at.

For those who don’t know what the patent cliff is, it is is one of the most consequential forces in global pharmaceuticals. The concept of a big pharma’s drug losing exclusivity and having to compete with biosimilars is nothing new. But the term ‘cliff’ is applied because of the money that the companies will cumulatively lose between 2025 and 2030 – $230 billion! The term ‘cliff’ is also not new, but the last major ‘cliff’ (2011-12) is nothing compared to this.

By the end of this year, eight of the 13 largest pharmaceutical firms could see 30% or more of their revenue jeopardised, with losses ranging from $6 billion to $38 billion per company. The biggest one is Keytruda that sells over US$30bn a year, although this is not until 2028.

The pharmaceutical industry’s primary answer to this problem — aside from reformulations and lifecycle tricks — is M&A. Total pharma M&A deal value reached $240 billion in 2025, an 81% year-over-year increase, making it the strongest M&A year since 2019. Companies are looking to buy their way into new revenue streams before the cliff arrives. And as they look around the globe for acquirable innovation, Australia’s ASX-listed biotech sector — often overlooked, frequently undervalued, but increasingly world-class in its science — presents a compelling hunting ground.

Without any further ado we will name the ASX biotech targets…and, the companies that could be eyeing them off right now!

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5 ASX Biotech Targets Amidst The $230bn Patent Cliff!

1. Clarity Pharmaceuticals (ASX: CU6)

Potential suitors: Novartis, Eli Lilly, Bristol Myers Squibb

Radiopharmaceuticals are the hottest therapeutic modality in all of oncology right now, and Clarity Pharmaceuticals occupies a genuinely novel niche within the space. While the sector’s marquee names (Novartis’s Lutathera, Eli Lilly’s Pluvicto) use lutetium-177 and gallium-68 as their radioactive isotopes, Clarity has built its entire platform around copper. Clarity’s Targeted Copper Theranostics (TCT) use the SAR (Sarcophagine) chelation technology to bind copper isotopes in a way that prevents leakage into the body — a significant safety advantage over competing approaches. Copper-64 is used for diagnostic imaging and copper-67 for therapy, creating a seamless “theranostic” paired approach.

Clarity’s Phase III AMPLIFY trial evaluating Cu-64 SAR-bisPSMA for the detection of prostate cancer recurrence in patients with biochemical recurrence has now consented in excess of the planned number of participants, following strong demand for study participation at sites in the United States and Australia. PR Newswire That is a remarkable milestone — overenrolment in a Phase III trial signals genuine clinical enthusiasm.

The company’s Co-PSMA investigator-initiated trial, led by Professor Louise Emmett at St Vincent’s Hospital, has already completed enrolment, comparing Clarity’s imaging agent against the standard-of-care 68Ga-PSMA-11 in low-PSA patients. Prostate cancer is a massive commercial market:the American Cancer Society estimates over 313,000 new diagnoses in the US in 2025.

We believe a superior copper-based imaging agent that also doubles as a therapeutic radiopharmaceutical would be enormously attractive to a company wanting to compete with Novartis’s dominant Pluvicto franchise. Clarity also has programs in neuroendocrine tumours (SARTATE, using SSTR2 as the target) which received positive FDA guidance for a Phase III trial in late 2025.

The copper supply chain is increasingly secure, with a new agreement signed with Nusano for industrial-scale copper-67 production beginning in mid-2026. Any of Novartis, Eli Lilly (which has made radiopharmaceuticals a strategic priority), or Bristol Myers Squibb would be logical acquirers.

2. Telix Pharmaceuticals (ASX: TLX / NASDAQ: TLX)

Potential suitors: Pfizer, AstraZeneca, Roche

Telix is the ASX’s flagship radiopharmaceutical company, and at this point it is arguably more acquirer than acquiree, it has been on a remarkable M&A spree of its own! But that doesn’t mean it couldn’t itself become a target for a truly large player. Telix already has an FDA-approved commercial product (Illuccix), which has been approved by the US FDA for prostate cancer imaging.

Telix is generating real revenue, which makes it a fundamentally different risk profile from a pure clinical-stage play. The company has also built an extraordinary manufacturing and distribution infrastructure in North America, having acquired RLS Radiopharmacies, which is America’s only Joint Commission-accredited radiopharmacy network, with over 30 locations.

On the therapeutic pipeline side, Telix is developing TLX591 (lutetium-177 PSMA) for prostate cancer treatment and TLX101 for glioblastoma — a devastating brain tumour with essentially no effective treatments post-recurrence. It has also added a FAP-targeting theranostic program (TLX400) with potential across a broad range of solid tumours, and acquired ImaginAb’s next-generation antibody engineering platform and early-stage therapeutic candidates.

Telix’s fully integrated position across isotope production (ARTMS), bioconjugation (IsoTherapeutics), radiopharmacy distribution (RLS), and clinical development gives any acquirer a truly turn-key radiopharmaceutical operation. Pfizer, which is desperately seeking pipeline assets to replace Eliquis and Ibrance revenue, has identified radiopharmaceuticals as a key strategic pillar. AstraZeneca, which acquired Fusion Pharmaceuticals in 2024, and Roche are also active in the space. Capped at $3.6bn right now but having once been over $10bn, Telix would be a case of getting a quality asset on the cheap.

3. Mesoblast (ASX: MSB/NASDAQ: MESO)

Potential suitors: Johnson & Johnson, Novartis, AbbVie

Mesoblast has spent years being one of the most frustrating biotechs on the ASX. In five words: brilliant science, glacial regulatory progress! But 2024 changed the narrative permanently. A week prior to Christmas in 2024, Ryoncil (remestemcel-L) became the first mesenchymal stromal cell (MSC) therapy approved by the US FDA for any indication sec, specifically for children aged 2 months and older with steroid-refractory acute graft-versus-host disease (SR-aGvHD).

This approval was transformative: it de-risked the entire mesenchymal stromal cell (MSC) platform. Mesoblast has since commenced the US commercial launch of Ryoncil, onboarding transplant centres through a partnership with Cencora, one of the largest specialty pharmaceutical distributors in the country.

But the SR-aGvHD approval is just the beginning. Mesoblast’s rexlemestrocel-L (REVASCOR) is in late-stage development for ischemic heart failure — a multi-billion dollar indication with enormous unmet need — and the company has filed a request for a Type B meeting with the FDA to discuss an accelerated approval pathway. There is also a Phase III program for chronic low back pain due to degenerative disc disease, a condition affecting tens of millions of people with no good current treatments beyond opioids and surgery.

The off-the-shelf nature of Mesoblast’s cells (no donor-recipient matching required) is a critical commercial advantage: it means treatment can happen quickly, without the manufacturing delays that plague autologous cell therapies like CAR-T. The intellectual property portfolio extends through at least 2041 in all major markets, offering a long exclusivity runway. J&J, which just acquired Intra-Cellular Therapies for $14.6 billion in large part to enter the CNS space, or Novartis, which just spent $12 billion on Avidity Biosciences for its neuromuscular cell therapy platform, would both benefit enormously from Mesoblast’s first-mover position in MSC therapy.

4. Neuren Pharmaceuticals (ASX: NEU)

Potential suitors: Acadia Pharmaceuticals (acquirer), J&J, Biogen

Neuren Pharmaceuticals is one of the ASX’s most elegant biotech stories: a lean, capital-efficient company with a royalty-generating approved drug and a deep pipeline in rare paediatric neurodevelopmental disorders — one of the hottest therapeutic areas in all of biopharma.

Neuren’s first drug, trofinetide, is marketed in North America by Acadia Pharmaceuticals as DAYBUE, the first and only FDA-approved treatment for Rett syndrome. Acadia’s guidance for 2026 points to net sales of US$460–490 million, with potential Neuren royalties of A$70–77 million. Motley Fool Australia European approval was expected in Q1 2026, which would open access to an additional 9,000–12,000 patients. A new powder formulation, DAYBUE STIX, was approved by the FDA in December 2025 and is rolling out commercially.

The real prize, however, is NNZ-2591. This second drug candidate targets four rare childhood brain disorders — Phelan-McDermid syndrome, Angelman syndrome, Pitt Hopkins syndrome, and Prader-Willi syndrome — which together represent a patient population approximately five times larger than the Rett syndrome market. Phase 2 trials showed positive results across three of these conditions, and the company has commenced a Phase 3 trial in Phelan-McDermid syndrome while receiving FDA Fast Track designation, which speeds up the review process.

The neurodevelopmental rare disease space is currently white-hot for M&A: J&J acquired Intra-Cellular Therapies for $14.6 billion, Novartis put $12 billion into Avidity, and the field more broadly saw CNS/neurology deal value overtake oncology in 2025 for the first time.

The most obvious acquirer is Acadia itself, which already has the commercial infrastructure, the DAYBUE brand, and a deep relationship with Neuren management — buying Neuren outright would convert its existing royalty liability into wholly-owned assets and give it full ownership of NNZ-2591’s multi-indication opportunity. Alternatively, Biogen, which has built a significant rare neurological disease franchise through Spinraza and Aduhelm, would find Neuren’s profile highly complementary.

5. Imugene (ASX: IMU)

Potential suitors: Merck & Co., Bristol Myers Squibb, AbbVie

Imugene is the highest-risk, highest-optionality name on this list. It is a sprawling, pre-revenue clinical-stage company with arguably too many programs spread across too many modalities — but that complexity conceals some genuinely distinctive assets, and crucially, it is run by serial biotech deal-maker Paul Hopper, who has a compelling track record of delivering exits. Most famously, Hopper was the driving force behind Viralytics, an ASX-listed oncolytic virus company that he sold to Merck for $502 million in 2018 — a deal that was driven in large part by Merck’s desire to combine Viralytics’ oncolytic virus Cavatak with Keytruda. The playbook Imugene is running now looks intentionally similar.

Imugene’s lead oncolytic virus program is CF33-hNIS (VAXINIA), a chimeric vaccinia virus developed by Professor Yuman Fong at City of Hope. CF33 is being developed as a combination treatment with existing checkpoint inhibitors on the market, such as Keytruda, with the idea that combining an oncolytic virus with a checkpoint inhibitor can dramatically increase response rates.

Imugene also has Azer-Cel, an allogeneic (off-the-shelf) CD19-targeting CAR-T therapy that recently reported 100% overall response rate in chronic lymphocytic leukaemia and 80% ORR in marginal zone lymphoma in Phase 1b — exceptional results in anyone’s book. Its B-cell immunotherapy platform includes PD1-Vaxx, which aims to induce antibodies that mimic the effect of Keytruda without the manufacturing complexity of a biologic monoclonal antibody.

Imugene is undercapitalised relative to its ambitions and carries considerable execution risk, but the combination of Hopper’s deal-making credentials, the Keytruda combination angle, and the emerging Azer-Cel data gives this company a plausible pathway to a big pharma conversation, particularly with Merck, which has done the Hopper deal before (the 2018 acquisition of Viralytics) and knows exactly what these assets could mean for the post-2028 Keytruda franchise.