What happened
After the company updated the timeline for filing its pain-relieving drug for approval from the Food and Drug Administration, and presented early-stage study results for its solid-tumor cancer drug at the 2017 Society for Immunotherapy of Cancer (SITC) annual meeting, Nektar Therapeutics' (NASDAQ: NKTR) shares skyrocketed 124% in November, according to S&P Global Market Intelligence.
So what
On Nov. 7, Nektar Therapeutics reported third-quarter financial results that were bolstered by a $150 million up-front payment from Eli Lilly relating to their partnership on NKTR-358, a pre-clinical-stage autoimmune-disease therapy. The company recognized $128 million of that payment, so revenue grew to $152.9 million from $36.3 million in third-quarter 2016. Operating costs were $83.4 million, up from $69.2 million year over year, and cash and investments finished the quarter at $412.2 million.
IMAGE SOURCE: GETTY IMAGES.
The company's financials weren't the most interesting update included in the third-quarter report, though. Instead, it was news that Nektar Therapeutics plans to file for FDA approval of NKTR-181 by next April. NKTR-181 is a mu-opioid receptor agonist that crosses the blood-brain barrier more slowly than existing opioids, and thus, results in fewer feelings of euphoria.
The company's good news continued later in the month when management reported that its NKTR-214 may help Bristol-Myers Squibb's (NYSE: BMY) Opdivo work better in some patients. NKTR-214 activates cancer-fighting T cells and natural killer cells directly in a tumor, and it boosts PD-1 expression, while Opdivo prevents cancer cells from hijacking PD-1 to avoid detection by the immune system.
In a phase 1/2 study, seven of 11 advanced treatment-naive stage 4 melanoma patients responded to the combination, and 91% had either a complete response, partial response, or stable disease. In first-line advanced kidney cancer patients, six of 13 patients responded to it, and in non-small-cell lung cancer patients, three of four patients responded to it.
Now what
Addiction risks associated with opioid use have regulators and doctors eagerly searching for new pain-treatment options, making this multibillion-dollar market ripe for disruption.
In July, management released phase-3 study data showing that NKTR-181 patients achieved an average pain score reduction of over 65% during the dose titration period and saw significantly improved chronic back-pain relief versus placebo. If all goes to plan, the FDA could be in a position to decide whether to approve NKTR-181 either late next year or early in 2019.