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And…we’re back! I’ve spent the last half a week traveling without Internet, but now I’m back to take on some more writing! Let’s dive into the recent news!
Lilly shows late mixed data for migraine treatment
Company: Eli Lilly (LLY)
Disease: Episodic cluster headache and chronic cluster headache
News: LLY announced findings from two phase 3 studies investigating the use of their calcitonin-related peptide antibody galcanezumab for the treatment of episodic and chronic cluster headaches. In the study evaluating episodic cluster headaches, galcanezumab yielded significant improvement over placebo. This met the study’s primary endpoint. However, the other phase 3 study in chronic headache did not meet its primary endpoint, but further details were not forthcoming.
Looking forward: Overall, while these data are a mixed bag, they represent a net positive for patients, since something like 85% have episodic cluster headaches. Thus, a significant improvement in this population bodes well for galcanezumab. It’s a fair possibility that these data are going to be strong enough to gain approval for this drug, at which point LLY taps into a multibillion dollar unmet need.
Overall, fairly strong news for LLY, but the mixed data do create some uncertainty about the potential approval of this drug.
Aerie Pharmaceuticals eyes the finish line for glaucoma
Company: Aerie Pharmaceuticals (AERI)
Disease: Glaucoma and intraocular hypertension
News: AERI announced the submission of a new drug application to the FDA for their ophthalmic solution branded Roclatan for the treatment of high intraocular pressure related to glaucoma or ocular hypertension. This solution is a fixed-dose mixture of two approved drugs, including AERI’s Rhopress and latanoprost. And the application is supported by findings from two phase 3 trials that demonstrated efficacy over placebo.
Looking forward: Considering this solution is a combination of two available drugs, and considering it is being supported by two different phase 3 trials, it’s difficult to imagine this application failing to launch for AERI. And the mechanism of submission will reduce the time for review from 12 months to 10 months, so that is also good news.
This should make for some good returns for AERI in the long term!
Rexahn inches along in early-stage pancreatic cancer study
Company: Rexahn Pharmaceuticals (RNN)
Disease: Advanced pancreatic cancer
News: RNN announced that their phase 2a study combining RX-3117 (an oral nucleoside analog) and nab-paclitaxel in first-line treatment of patients with advanced pancreatic cancer has recently passed safety monitoring committee review, meaning that the trial will be allowed to proceed. The two drugs will be given at the highest dose for both agents to 40 patients, with a primary endpoint of progression-free survival.
Looking forward: Interesting news, and indicative of the generally iterative nature of clinical-stage biotechs. Every bit of progress is newsworthy. I present this to you since it seems unlikely that RNN is on your radar. So what makes this particular drug special? Currently, a standard treatment option for metastatic pancreatic cancer is nab-paclitaxel (Abraxane) combined with gemcitabine. RX-3117 is similar to the gemcitabine part of that equation, and a fair amount of work has been done to develop better forms of these oral chemotherapeutics. So I think this should put RNN on your radar, as it is easy for these kinds of companies to fly low compared with the sexy immunotherapies and targeted agents.
Should you buy? In a phrase: not yet. However, it’s always important to keep new opportunities on your radar.
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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.