Roche lines up at the FDA’s 10-yard line with $1.7B Ignyta buyout

Cancer drug powerhouse Roche $RHHBY has swooped in to buy Ignyta $RXDX for $1.7 billion, putting the pharma giant in direct competition with Loxo Oncology $LOXO and its new partners at Bayer.

Ignyta has been grabbing the attention of a booming field with its work in ROS1 and NTRK fusion-positive tumors, winning the FDA’s breakthrough status last May. And it’s engaged in a pivotal Phase II study for its lead drug entrectinib that could put Roche on the 10 yard line at the FDA.

Roche is paying a 74% premium for the stock. And the Ignyta team will stay in its San Diego headquarters for now as it looks for a near term FDA approval.

Roche CEO Severin Schwan has been a reluctant player in the M&A game, but the multinational company can easily afford a buyout like this. Biotech valuations overall have spiked in the last few years, but oncology — with its short path to approvals and potential to nab valuable market niches — has seen some of the biggest upside.

Jonathan Lim

Ignyta and Loxo have both distinguished themselves by taking a tumor-agnostic approach to cancer drug development, focusing on a specific genetic mutation that drives cancer. In the latest update, investigators for the company say that their drug entrectinib — which targets ROS1 fusion genes that drive a thin slice of all NSCLC cases — achieved a 69% overall response rate for lung cancer confirmed by independent observers. And the median progression-free survival rate in the single arm study was 29.6 months.

Significantly, 5 of the 6 patients who had measurable brain metastases demonstrated a response to the drug — something the current ROS1-positive standard of care Xalkori can’t do. And brain metastases are a major threat in lung cancer cases, offering a new avenue to blunt disease progression and improve durability in responses.

Said Ignyta CEO Jonathan Lim:

Ignyta has been singularly focused on developing precisely targeted therapeutics guided by diagnostics for patients with rare cancers. We are excited that Roche, the global leader in both oncology and personalised healthcare, recognises this powerful approach and shares our passion for advancing entrectinib for the benefit of patients.

Roche CEO Severin Schwan Bloomberg via Getty


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