Another day completes in the biotechnology sector and brings with it a flurry of volatility across a wide range of companies in the space. Here is a look at some of the biggest movers early week, what is driving the action in each, and where we expect each one to go near term based on the inputs that have played into action so far.
The two companies that were looking at today are Clovis Oncology, Inc. (NASDAQ:CLVS) and Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL).
So, let’s kick things off with Clovis.
This one is a data-driven move. Clovis announced on Monday that one of its oncology assets, a drug called Rubraca, had turned out positive results from a phase 3 trial investigating its impact in patients with ovarian cancer. Many reading will likely already be familiar with this one; it’s actually already approved in this indication and is becoming a well-established ovarian cancer drug pretty quickly. The current approval, however, is limited to a particular subset of ovarian cancer patients – those with a mutation in BRCA genes, and those that have already undergone two or more chemotherapies. The latest trial was an attempt to prove that the drug can also be effective in a wider portion of this oncology population, and, as per the news, the attempt seems to have been a success.
The numbers equated to a hazard ratio (HR) of 0.23 (which was the way that the company defined the primary endpoint for the study) in BRCA mutated patients, which equated to a progression-free survival (PFS) by investigator review of 16.6 months, as compared to 5.4 months for placebo. A secondary endpoint, defined as PFS by a blinded independent central review, came in even stronger. Clovis reported an HR of 0.20 equating to a PFS of 26.8 months for the active arm compared to 5.4 months for placebo.
That’s incredibly strong data.
So far, all we really know is that the company intends to submit a Supplemental New Drug Application (sNDA) in an attempt to get the drug approved as a therapy for patients who have undergone just one round of chemotherapy (as opposed to the currently required two) within four months. Supplemental applications are generally little bit quicker on the turnaround than their parent NDA type submissions, so with a four-month submission target, we will probably be looking at first quarter next year as an FDA approval period.
As a side note, the company ran up on this news to the tune of 50%, but took a hit on a subsequent announcement that it will seek to raise $250 million by way of equity issue. Markets generally sell off on any equity issue announcements based on the dilutive impact that such raises have on current shareholders, and Clovis was pretty calculated in its announcing of its intentions right after putting out positive phase 3 data. The announcement wasn’t enough to dampen sentiment too substantially, however, and has resulted in just a few percentage points wiped from highs.
Next up, Rigel.
This one is another classic biotechnology move.
The company announced on Monday that the FDA in the US has accepted its NDA for one of his lead development assets, a drug called TAVALISSE (fostamatinib disodium), which is currently targeting approval in patients with a condition called chronic or persistent immune thrombocytopenia (ITP).
It’s worth noting here that this sort of acceptance doesn’t equate to approval – a misinterpretation that those new to the biotechnology space commonly fall foul of – it simply means that the application is complete and that the agency is willing to review it in its current format.
Alongside an approval notice, we generally see a PDUFA date, which is the date by which the FDA intends to form a decision on a drug – one way or the other. In this instance, Rigel has a PDUFA date of April 17, 2018 for TAVALISSE. That’s at the outside range of the 8 to 10 months generally regarded as standard, but despite markets having to wait a while before getting a decision, Rigel is trading up on the news.
At last close (Monday night), the company was up a little over 11% on the announcement. Chances are that we will see further strength as markets load up ahead of PDUFA over the coming 10 months.