InvestorsHub Logo
Followers 52
Posts 3345
Boards Moderated 0
Alias Born 10/26/2013

Re: None

Monday, 11/20/2017 7:50:48 AM

Monday, November 20, 2017 7:50:48 AM

Post# of 3283
Surprisingly positive SPPI article from The Motley Fool! Past MTF articles would acknowledge something positive about Spectrum but give a big BUT to make the article a little more negative than positive or at least neutral. This one, I have to say, is pretty positive.

Spectrum Pharmaceuticals, Inc.: Overcoming resistance

Signs that this company's commercial-stage disappointments are finally gaining steam pushed the stock up partway through the year. While that's certainly good news, this stock's 482% explosion so far in 2017 is mostly attributable to exciting results from 11 patients treated with an experimental lung-cancer drug candidate.

Spectrum's poziotinib thrilled investors because it looks like a potential solution to a family of genetic mutations that help tumors resist popular therapies that inhibit epidermal growth factor receptor (EGFR) activity. AstraZeneca launched Tagrisso to help patients overcome one type of EGFR inhibitor resistance just two years ago, and sales of the drug are already on a $1 billion annualized run rate.

Spectrum's poziotinib looks like it does Tagrisso's job plus a lot more, which means a successful launch could lead to over $1 billion in annual sales. That said, the drug is in early-stage clinical trials, and we still don't know how long we'll need to wait before the company will be ready to submit an application to the FDA.

Reports of tumor shrinkage among all 11 patients treated should convince the FDA to sign off on a pivotal trial for poziotinib, but it looks like the company isn't going to wait for a meeting with regulators. Spectrum recently started an 87-patient trial that looks suspiciously similar to studies that have led to accelerated approvals of breakthrough cancer therapies in recent years. If the FDA later decides to allow the new trial to support an application, poziotinib could be ready to launch as soon as the end of next year, although sometime in early 2020 would be reasonable.

https://www.fool.com/investing/2017/11/19/3-biotech-stocks-to-be-thankful-for-this-year.aspx