Tuesday, August 9, 2016

Opdivo's Recent Clinical Failure And The Implications For Gilead Science

Summary

Opdivo failed to meet its primary endpoint in the Checkmate-026 clinical trial.

The results led to a dramatic decline in the share price of Bristol-Myers Squibb.

This article discusses the implications going forward, along with the potential for a merger with Gilead Sciences, as proposed by various audience members.

Shares of Bristol-Myers Squibb (NYSE:BMY) have come under enormous selling pressure due to key compound Opdivo's failure in the Ckeckmate-026 trial for the indication of monotherapy in non-small cell lung cancer. The share price of BMY collapses sending shockwaves through the biotech community. The article below will discuss my outlook on BMY along with how the setback affects shares of Gilead Sciences (NASDAQ:GILD).

Opdivo

Opdivo remains the crown jewel of BMY product lineup. Since gaining approval in late 2014, unlike traditional therapies, OPDIVO is a PD-1 (programmed death receptor-1) immunotherapy which aids the patient's immune system to mount an immune response against the tumor and non-tumor cells. The approval of Opdivo has ushered in a new era of oncology treatments with the audacious goal of transforming oncology into a manageable chronic disease similar to the advances in HIV.

The shares of BMY have taken flight, beginning their ascent in October of 2014 as the approval of Opdivo began to be reflected in the value of BMY stock price. The share price of BMY seemed relatively immune to the issues plaguing the biotech industry as they quickly regained the lost ground from the steep sell-off earlier this year. Before the announcement of the preliminary results of the Checkmate-026 trial, BMY marked new highs well above $75 per share. In my view, the market was already pricing in a positive result for the trial with a new indication of monotherapy for NSCLC a near certainty for many. The trial design was quite aggressive with the inclusion of patients with a 5% PD-L1 expression versus chief rival Merck (NYSE:MRK) decision when testing Keytruda to set the cutoff rate at 50%. A meaningful result here for Opdivo would have cemented their lead as a frontline treatment for NSCLC as they would have conclusive data far superior to their primary rival in MRK. My suspicion is until the data is revealed in its entirety, we will not have the complete picture here. Keep in mind, a failure for the indication as a monotherapy treatment does not preclude the widespread use of Opdivo. My suspicion is the IO space will evolve in a similar fashion to the HIV and now HCV marketplace where combination treatments provide optimal results.

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