Nectar chief says they have solved the mystery of the catastrophic 'softening' in patient response to '214 – spur a route among investors – Endpoints News
Nectar CEO Howard Robin says his top team has been wondering why the response rates for their closely monitored drug NKTR-214 (grafted leucine) have "softened" over time – with disastrous consequences. But the explanation did not satisfy anyone.
In fact, their shares $ NKTR fell close to 30% after the explanation, shredding around $ 1.5 billion in market capital. And that's not what Robin was looking for.
After a quick review of some pipeline updates, the CEO came all the way down to solving the mystery. By studying the different patient cohorts, the team determined that patients who had started treatment with the drugs produced in batches 1 and 3 demonstrated marked improvement over patients starting on batches 2 and 5.
Howard Robin Twitter [19659005] "We have identified the root cause of the physical differences between these parties that we now know stem from a single suboptimal group of process intermediates that was used to produce only these two lots – solder 2 and 5 – of the 22 lots we 39; I have done so to this day. "
None of the bad substances are used in ongoing clinical trials – suggesting that the softening issue will not be repeated. And Nectar has shaken the production team as a result of their embarrassing setback. [19659002] The reaction was not attenuated.
Oh my, $ NKTR thinks some patients in trials (from two batches) received suboptimal product and this led to m expressing responses. This is crazy.
– Brad Loncar (@bradloncar) August 8, 2019
Nectar executives have a bad habit of talking into holes. On Thursday night, they cemented the rep.
None of this is likely to sit well with their Bristol-Myers Squibb partners, who paid $ 1.85 billion in cash and shares to partner with Nektar on this drug.
This latest development comes right on the heels of the FDA's decision to drop opioid applications, at least for now. And it left their NKTR-181 pain program in limbo just as biotechnology set up a subsidiary to handle the marketing campaign – following an expected approval.
