A biotech renaissance

Strong clinical data, record deal activity and renewed investor confidence are driving the next phase of growth and outsized returns.
Charlie Williams

HB Biotechnology

At the end of CY25, following a period of significant policy-driven volatility, we highlighted that once the “clearing events” had passed, the biotech market would return its focus to fundamentals: Clinical data and genuine innovation. As outlined in our previous report, sentiment had shifted materially as tariff and pricing concerns dissipated, allowing investors to re-engage with the underlying science.

This is precisely what transpired over the six months to 30 June 2026. With macro uncertainties largely receding, the biotechnology sector has entered a new phase characterised by a renewed emphasis on quality and clinical outcomes. The strong market performance observed in the second half of CY25 has not only been sustained, but has broadened in participation across both private and public markets.

Against this backdrop, HB Biotechnology has continued to deliver strong performance.

For the financial year ended 30 June 2026, HB Biotech generated a return of 93%[1] (AUD), outperforming the Biotech Index return of 83% (AUD) over the same period, continuing our longer-term track record of outperforming the biotech index.

Following
a period of underperformance compared to major indices in FY25, "clearing
events" have propelled the global biotech market (orange) forward in FY26
with HB Biotech (red) continuing to outperform
the broader biotech market. Data to 30 June 2026.
Following a period of underperformance compared to major indices in FY25, "clearing events" have propelled the global biotech market (orange) forward in FY26 with HB Biotech (red) continuing to outperform the broader biotech market. Data to 30 June 2026.

This outperformance has been driven by a combination of positive clinical readouts, disciplined portfolio construction, and continued M&A activity. Notably, five portfolio companies were acquired during the financial year (out of a portfolio of not more than 20), reinforcing the importance of owning high-quality, strategically relevant assets.

As in prior periods, this highlights a central tenet of biotech investing: while macro conditions may influence sentiment in the short term, long-term performance is ultimately driven by a focus on fundamentals and quality.

Capital Markets Reopen: A Return to Quality IPOs and Financings

One of the clearest manifestations of this return to fundamentals has been the re-opening of capital markets for biotech companies.

After several years of limited new issuances, both IPO activity and follow-on financings accelerated meaningfully into 2026. Importantly, this cycle has been defined not by speculative early-stage businesses, as was often the case during the 2020 – 2021 COVID-led fervour for biotech, but by companies with more advanced pipelines and increasingly robust datasets.

 
Figure 2: Halfway through 2026, Biotech Financings are off to a strong start which, if annualised, are on track for a record year. Source: BiomedTracker, HB Biotech analysis.

Figure 2: Halfway through 2026, Biotech Financings are off to a strong start which, if annualised, are on track for a record year. Source: BiomedTracker, HB Biotech analysis.

A notable feature of this new issuance cycle is the higher average quality of companies coming to market. This is almost certainly a consequence of companies staying private for longer as the IPO window remained shut during 2022 – 2024. Many recent biotech IPOs have featured companies with assets already in Phase 2 or Phase 3 development, reflecting a shift toward later-stage, de-risked opportunities that align more closely with investor demand for tangible clinical validation.

This transition culminated in the largest biotechnology IPO to date, with Parabilis Medicines (NASDAQ:PBLS) raising ~US$770 million. The success of this offering underscores the depth of capital available for high-quality opportunities, even in a more discerning market environment.

Encouragingly, our analysis of global financing activity shows that 2026 is on track to be a record year for biotech financings, on an annualised basis, with year-to-date activity implying total funding of approximately US$155bn if current trends persist. This follows a strong recovery in 2025 and suggests that capital availability for high-quality companies has not only normalised, but is expanding.

M&A Momentum Continues as Big Pharma Confronts the Patent Cliff

The acceleration in M&A that began in 2025 has continued into 2026, driven by the same structural forces we previously identified.

As outlined in our prior report, large pharmaceutical companies face a well-telegraphed loss-of-exclusivity (“LoE”) cliff across several high-revenue products, necessitating proactive pipeline replenishment through external innovation. Indeed, this LoE cycle is a key driver of innovation in the sector and a characteristic that largely defines the investment opportunity in biotech.

This dynamic has remained firmly in place over the past six months, with strategic acquirers continuing to deploy capital at pace. Our analysis of global M&A activity indicates that 2026 is already tracking to be a record year, on an annualised basis, with total deal value implying approximately US$350bn+ of activity if current run rates persist.


Figure 3: The acceleration in M&A that began in 2025, driven by looming Loss of Exclusivity cliffs, has continued into 2026.  2026 is already tracking to be a record year, on an annualised basis. Source: BiomedTracker, HB Biotech analysis.

Figure 3: The acceleration in M&A that began in 2025, driven by looming Loss of Exclusivity cliffs, has continued into 2026. 2026 is already tracking to be a record year, on an annualised basis. Source: BiomedTracker, HB Biotech analysis.

Eli Lilly (NYSE: LLY), boasting a sizable war chest from growing Mounjaro and Zepbound revenues (GLP-1 obesity drugs), has been one of the most active M&A participants, with US$25b deployed across 9 acquisitions in the first 6 months of 2026. Two of these acquisitions were HB Biotechnology portfolio companies: Ventyx (NASDAQ: VTYX) and Centessa (NASDAQ: CNTA).

Consistent with our long-held view, the message from acquirers remains unchanged: innovation is scarce, capital is abundant, and external pipelines are an essential ingredient to sustaining long-term growth for pharmaceutical companies.

Notable Themes throughout FY26

RAS Finally Arrives in Pancreatic Cancer

One of the most important clinical themes to emerge during FY26 was the dawning of a step-change in the treatment of RAS-driven cancers. For decades the RAS oncogene, responsible for driving approximately 90% of pancreatic cancers, was considered one of oncology's most promising but elusive drug targets. During FY26 that changed, with multiple companies demonstrating that effective RAS inhibition can meaningfully alter outcomes in one of the deadliest forms of cancer.

At ASCO 2026, Revolution Medicines (NASDAQ: RVMD) presented mature data for daraxonrasib, its pan-RAS(ON) inhibitor, demonstrating roughly double the expected overall survival in heavily pre-treated pancreatic cancer patients. The results were widely regarded as practice-changing and received a standing ovation during the conference's plenary session. Daraxonrasib is now expected by many clinicians to become a new standard of care in metastatic pancreatic cancer and is currently being evaluated in front-line treatment settings.

As often occurs following a major therapeutic breakthrough, attention has rapidly shifted toward combination approaches that may further improve outcomes and overcome resistance mechanisms. One notable example came from Tango Therapeutics (NASDAQ: TNGX), which reported preliminary Phase 1/2 data combining its PRMT5 inhibitor with daraxonrasib. Although based on a small patient population (n=12) and still early in development, the data were sufficiently encouraging to add more than US$2 billion to Tango's market capitalisation in a single day.

Closer to home, Amplia Therapeutics (ASX: ATX) also reported encouraging pancreatic cancer data during FY26, demonstrating that its FAK inhibitor, narmafotinib, improved overall survival when combined with standard-of-care chemotherapy, including 5 complete responses (from 64 patients / 8% CR rate), an outcome rarely observed in metastatic pancreatic cancer. The announcement resulted in a doubling of the company's share price. Importantly, as the standard of care in pancreatic cancer has arguably changed to include a RAS-inhibitor backbone, Amplia is now developing a strategy to combine narmafotinib with RAS inhibitors, targeting resistance mechanisms that emerge following RAS inhibition.

These developments highlight one of the key advantages of specialist biotechnology investing. Breakthroughs rarely occur in isolation. Once a major therapeutic class emerges, opportunities often develop across a broader ecosystem of combination therapies, resistance pathways and next-generation approaches. At HB Biotechnology we are constantly seeking to invest in companies developing first-in-class and / or best-in-class assets.

Immunology & Inflammation Remains a Strategic Battleground

Another theme we have been actively tracking for several years is the increasing strategic value being placed on differentiated Immunology & Inflammation (I&I) assets.

As previously discussed, HB Biotechnology portfolio company Ventyx Biosciences (NASDAQ: VTYX) was acquired by Eli Lilly in January 2026 for its lead asset targeting the NLRP3 inflammasome—a central inflammatory pathway that has historically proven difficult to target safely and effectively. The acquisition reflects growing industry confidence that next-generation I&I therapies can address large patient populations with significant unmet need.

Another example was AbbVie's acquisition of Apogee Therapeutics (NASDAQ: APGE) for almost US$11 billion, announced in June 2026. Apogee's lead asset, zumilokibart, targets IL-13 and is being developed for diseases such as atopic dermatitis (AD) and asthma. While efficacy in mid-stage trials appears broadly comparable to current market leader, Dupixent, in AD, the potential for dosing every three to six months (compared to monthly administration for Dupixent) has generated considerable interest from physicians, patients and pharmaceutical companies alike. With Dupixent expected to generate approximately US$20 billion in revenue during 2026, even modest market share gains represent a substantial commercial opportunity.

The increasing strategic importance of I&I is evident not only in M&A activity, but also within our own portfolio construction. Exposure to Immunology & Inflammation has increased from approximately 7% of the portfolio three years ago to more than 20% today, reflecting our conviction that this remains one of the most attractive areas of innovation across biotechnology.

The Rise of Chinese Innovation: An Opportunity, Not a Constraint

Another increasingly important theme across the global biotech landscape is the growing influence of Chinese innovation.

While there has been considerable policy debate in the United States regarding potential restrictions on Chinese biotechnology development, we believe that innovation itself is not easily constrained by geopolitical boundaries. China has invested heavily in developing its own biopharmaceutical industry over the past ~10+ years, starting from manufacturing and contract services, through generating fast-follower "me-too" or "me-better" assets (pharmaceuticals) in response to US innovation, but now is increasingly showing true innovation leadership, evidenced by the increasing deal flow of licensing assets from Chinese companies.

From an investment perspective, our focus remains agnostic to geography. We prioritise the quality of the underlying science rather than its origin. That said, commercial success in the world’s most important pharmaceutical market, the United States, typically requires clinical validation in Western (and often US-based) patient populations.

Encouragingly, we are seeing many of our portfolio companies actively engage with Chinese innovation ecosystems, selectively acquiring or licensing complementary assets to strengthen their pipelines. This “global sourcing” approach reflects a pragmatic recognition of where high-quality science is being developed.

At the same time, we acknowledge legitimate geopolitical concerns regarding over-reliance on Chinese manufacturing for critical drug supply chains and active pharmaceutical ingredients (APIs), an issue that was brought into sharp focus during the COVID-19 pandemic. However, we believe attempts to restrict the flow of innovation itself are likely to prove both difficult and counterproductive.

FDA Leadership: Signs of Stabilisation After a Period of Turbulence

Finally, regulatory stability, an area of prior concern, appears to be improving. As discussed in previous reports, the FDA experienced an unusually turbulent period, with leadership changes and internal disruptions leading to perceptions of inconsistency in regulatory decision-making.

Encouragingly, this period now appears to be largely behind us, with the agency beginning to return to a more stable and predictable operating environment. That said, uncertainty remains around the identity and direction of the next FDA Commissioner (the FDA is currently under caretaker leadership by Kyle Diamantas, the prior FDA Deputy Commissioner for Food). We remain hopeful that future leadership will reinforce the agency’s historical role as a science-driven and consistent regulator, providing the clarity and predictability required for efficient drug development.

Outlook for FY27: Fundamentals in the Driver’s Seat

With capital markets re-opened, M&A activity accelerating, and clinical innovation back at the forefront, we believe the biotechnology sector is well positioned for a sustained period of growth. The past year has reinforced a simple truth: When uncertainty clears, markets reward quality, particularly companies with differentiated science and strong clinical data.

Against this backdrop, HB Biotechnology’s portfolio remains well positioned, with a clear focus on high-conviction opportunities where fundamental progress drives value. While cycles in biotech are rarely linear, the combination of available capital, active acquirers, and improving clinical momentum provides a compelling foundation for continued outperformance.


[1] Performance is across all client portfolios, net of fees. Since we invest for clients via Individually Managed Accounts, individual client performance may vary depending on start date and individual client cashflows. Index is the S&P Biotechnology Select Industry Index, TR in AUD.

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While all reasonable care has been taken in the preparation of this information, HB Biotechnology takes no responsibility for any actions taken based on information contained herein or for any errors or omissions. Interested parties should seek independent advice prior to acting on any information presented. Please note past performance is not a reliable indicator of future performance.

Charlie Williams
Managing Director
HB Biotechnology

Charlie Williams is the Managing Director of HB Biotechnology, a specialist global biotech investment firm with a long‑term record of delivering above‑index returns. He brings over 12 years of investment experience focused on domestic and...

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