Moderna’s mRNA cancer breakthrough puts Zydus, Biocon, Dr. Reddy’s in focus

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Moderna’s personalised mRNA cancer therapy clears a key Phase 3 hurdle, sparking fresh investor interest in the global oncology market and Indian pharma players developing Keytruda biosimilars.

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Representational image | Credits: Alamy

Moderna’s shares surged as much as 160% on Wednesday after the US drugmaker and Merck reported a successful Phase 3 trial of their personalised mRNA-based cancer treatment, putting Indian pharma stocks with exposure to Merck’s blockbuster cancer drug Keytruda on investors’ radar ahead of Thursday’s market opening.

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The sharp rally came after Moderna and Merck said their experimental therapy, intismeran autogene, met the main goal of a late-stage trial in melanoma. The treatment is designed using mutations from a patient’s own tumour to train the immune system to recognise and attack cancer cells.

The Phase 3 INTerpath-001 trial involved 1,137 patients with completely resected stage IIB-IV melanoma. Intismeran, given alongside Merck’s Keytruda (pembrolizumab), substantially improved recurrence-free survival and a key secondary measure called distant metastasis-free survival compared with Keytruda alone. No new safety signals were observed.

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Why Moderna’s cancer result matters

Intismeran is designed differently from a conventional cancer drug. Doctors use a sample of a patient's tumour to identify mutations unique to that cancer. The treatment then uses mRNA to teach the immune system to recognise those tumour-specific features and attack cancer cells.

For Moderna, the result is particularly important as investors have been looking for evidence that its mRNA platform can generate major products beyond its COVID-19 vaccine business. Moderna shares rose as much as 160% during Wednesday’s session, while Merck also gained sharply.

Moderna CEO Stéphane Bancel called the results “a pivotal moment for the field of cancer research”, adding that the idea of creating an mRNA treatment specifically for an individual patient’s cancer had previously been “aspirational”.

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Why Indian pharma stocks could be in focus

The Indian market read-through is not a direct benefit from Moderna’s therapy. Intismeran is being developed by Moderna and Merck.

The connection comes through Keytruda (pembrolizumab), the Merck immunotherapy used alongside intismeran in the successful trial. Several Indian drugmakers are developing biosimilars of pembrolizumab, creating a potential read-through from renewed investor attention on the drug and the broader oncology market.

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Zydus Lifesciences

Zydus has the clearest near-term development among the Indian names. It has an exclusive US and Canada licensing and supply agreement with Germany’s Formycon for FYB206, a proposed biosimilar to Keytruda.

In February, Zydus said FYB206 had successfully met the primary objective of its pivotal Dahlia pharmacokinetic study, demonstrating equivalence with Keytruda. The company said the development package was effectively complete and that the milestone cleared the path towards a US FDA filing.

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“FYB206 represents the absolute cornerstone of our strategic entry into the complex North American immuno-oncology market,” Zydus managing director Sharvil P. Patel had said.

Zydus had earlier described the partnership with Formycon as its entry into the North American biosimilar market, with Patel saying the company would “drive significant organisational growth” while expanding access to affordable oncology care.

Biocon

Biocon Biologics announced in January that it would add pembrolizumab, nivolumab and trastuzumab/hyaluronidase to its oncology biosimilar portfolio. The company said the additions would take its oncology portfolio to 17 medicines and represent an opportunity of more than $75 billion.

Biocon Biologics CEO Shreehas Tambe said the company was advancing a “strong pipeline with 17 oncology assets” as it seeks to expand access to affordable cancer medicines.

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Dr. Reddy’s Laboratories

Dr. Reddy’s has entered a global collaboration with Iceland-based Alvotech to co-develop, manufacture and commercialise a biosimilar candidate for Keytruda.

The companies said the drug had global sales of $29.5 billion in 2024, highlighting the size of the opportunity around the product.

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“Oncology has been a top focus therapy area for us,” Dr. Reddy’s CEO Erez Israeli said, adding that the partnership would strengthen the company’s capabilities in oncology.

A Keytruda read-through, not an mRNA play

For Indian investors, Thursday’s focus is therefore likely to be less about direct exposure to Moderna’s mRNA therapy and more about the Keytruda ecosystem.

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The successful trial demonstrates that an individualised cancer treatment can work alongside pembrolizumab, while Zydus, Biocon and Dr Reddy’s are positioning themselves for the future biosimilar market for the same drug.

That makes the three stocks a potential market read-through, rather than direct beneficiaries of Moderna’s cancer therapy. 

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