Biotechs are often overlooked once we get into the thick of earnings season, but there are always plenty of biotech stocks with big news looming in the near-term pipeline.
Granted, most of these events are binary in nature, meaning they’ll either turn out really good or really bad for the stocks in question.
Nevertheless, thrill-seeking traders and biotech stocks are a match made in heaven.
Now that you’re up to speed, let’s take a closer look at a few biotechs with news slated for the foreseeable future.
While some of these dates with destiny are a few weeks off, but if history repeats itself these stocks could make trade-worthy moves leading up to the news, as well as dish out some volatility afterwards.
Biotech Stocks to Watch: Merck & Co., Inc. (MRK)
Technically speaking, it’s not a biotech stock, but Merck & Co., Inc. (MRK) is one of the biggest names in pharmaceuticals, and it’s close to unveiling something that could shake things up for a couple of well-known and well-loved biotech stocks.
On Thursday, Merck will hear from the Food and Drug Administration regarding the combination of grazoprevir and elbasvir (in one tablet) as a therapy for several types of hepatitis C.
Per the company’s update from November, the combination of grazoprevir and elbasvir created a meaningful virologic response in 95% of patients with chronic genotypes 1, 4 or 6 hepatitis C infections. In light of a couple other HCV treatment options with price tags approaching six figures, any alternative effective therapy could be well received by the market.
Harvoni and Sovaldi don’t take aim at the exact same set of genotypes, but there’s sizeable overlap.
Biotech Stocks to Watch: Regulus Therapeutics Inc (RGLS)
The original scheduled date for the interim results of RG-101 as a therapy for hepatitis C was mid-February.
Although Regulus Therapeutics Inc (RGLS) didn’t complete enrollment in the phase-2 trial until just a few days ago, it reiterated then that it expects to share those mid-term study results at some point in the middle of the coming month.
It’s worth keeping an eye on.
Hepatitis C remains one of the biggest and best hot buttons among biotech stocks, and any outfit that can come up with some new (and cheaper) competition stands to do well. RG-101 has some potential to do just that.
Although the response rate, or virological response, hasn’t been as strong as some of the recently ballyhooed HCV treatment alternatives, patients and payers like the idea of a potent, single-dose solution.
Biotech Stocks to Watch: BioCryst Pharmaceuticals, Inc. (BCRX)
Hereditary angioedema (HAE) may not be a big market, but to BioCryst Pharmaceuticals, Inc. (BCRX), it is a big deal. The company has been developing avoralstat as a therapy for HAE, and could be updating the market regarding its OPuS-2 trial of the drug soon; final patient visits are slated to end before the end of this month.
The trial is only in phase 2 at this time, so there’s no need to entertain visions of an approval just yet. On the other hand, the market loves to reward biotech stocks as the underlying companies reach key milestones. To that end, small cap BCRX could be driven bullishly if the OPuS-2 has gone well.
The tough part for traders is not knowing the exact date of the update. Hopefully the company will at least give the market some warning that the news is coming.
Biotech Stocks to Watch: Sarepta Therapeutics Inc (SRPT)
Those who have been following the story of Sarepta Therapeutics Inc (SRPT) and its muscular dystrophy drug Eteplirsen have likely given up hope for any approval. But the story isn’t actually over yet.
The agency penned a non binding assessment of the drug that sounded — with a polite, yet, scathing tone — as if an official decision has already been made against the drug.
The market read between the lines that way anyway, judging from the way the stock fell more than 50% in a single day after the FDA released the note. Not even Sarepta seems to think an approval is in the cards come Feb. 26 when the approval committee makes its final ruling.
While an approval may be a lost cause, that’s not quite the point any longer. On Feb. 26 we’re going to be hearing some official explanations from the FDA, but more than that, we’re going to be seeing a lot of approval psychology and gamesmanship at play … perhaps more than we’ve ever seen with most other biotech stocks.
It’s this psychological game that could ultimately determine whether or not Sarepta Therapeutics, Inc. regroups with Eteplirsen, or just abandons it.
It’s still a turnaround story at best right now, but don’t be surprised if a silver lining that starts to emerge from the mess.
Biotech Stocks to Watch: Alder Biopharmaceuticals Inc (ALDR)
There are two trials underway for ALD403, the migraine therapy from Alder Biopharmaceuticals Inc (ALDR). These include a phase-1 test of the drug in a once-per-quarter self-administered format and a phase-2b trial. Given the drug’s efficacy, the near-term update of both tests could move the stock.
The exact date of the updates on ALD403 has not been set. All we know regarding the timing of this news comes from an early January conference call, during which President and CEO Randy Schatzman simply said to look for an announcement at some point in the first quarter of this year.
Taking him at his literal word, this means the news should be posted no later than March 31, if not before. Whenever it comes out, it’s apt to be big for the relatively small Alder Biopharmaceuticals, Inc.
Migraines are an underserved sliver of the healthcare market, and Alder isn’t an especially big company.
Biotech Stocks to Watch: Jazz Pharmaceuticals plc (JAZZ)
It’s not the only drug in its pipeline, but there’s no disputing defibrotide, for the treatment of hepatic veno-occlusive disease, is the focal point for Jazz Pharmaceuticals plc (JAZZ). That’s what makes March 3 such a critical day for JAZZ shareholders.
That’s when the FDA is slated to give the drug a thumbs or a thumbs down, although it should be noted the agency has approved some priority drugs ahead of schedule.
Yes, defibrotide has been given priority status, meaning the FDA is rushing to make a decision because a quicker approval could mean life or death for some patients.
VOD claims the lives of roughly a third of all those who develop the condition, and there’s no effective treatment for it currently available.
Biotech Stocks to Watch: Gilead Sciences, Inc. (GILD)
While Gilead Sciences, Inc. (GILD) has faced controversy with its splashy entrance into the hepatitis C market — Sovaldi and Harvoni are shockingly expensive — that hasn’t prevented the company from pushing ahead to secure an even stronger hold with its HIV portfolio.
In that light, April 7 could be another big day for GILD. That’s when the FDA will make a ruling on the combination of emtricitabine and tenofovir alafenamide (in combination a couple of other therapies) as another means of fighting HIV. This could give Gilead and even stronger hold on the HIV market.
It seems like a scattershot approach, but Gilead Sciences has been fine-tuning various combinations of drugs, and this one looks like it could raise the bar for HIV therapies in a measurable way.
Biotech Stocks to Watch: Insys Therapeutics Inc (INSY)
Insys Therapeutics Inc (INSY) isn’t exactly a giant among biotech stocks, but it’s got something of a relative game changer in the cards scheduled for April 1.
That’s the tentative Prescription Drug User Fee Act date for the FDA to make a final ruling on Dronabinol, an oral solution for the treatment of anorexia in AIDS patients and nausea and vomiting in chemotherapy patients.
It’s a second-line treatment, but an encouraging and much-needed one.
Anorexia poses the biggest immediate risk to 60% of HIV patients, and it’s not at all uncommon for cancer patients undergoing chemotherapy, which poses health risks of its own.
When the first option doesn’t treat the condition, a second option absolutely must be employed.
Biotech Stocks to Watch: BioMarin Pharmaceutical Inc. (BMRN)
Last, but certainly not least, BioMarin Pharmaceutical Inc. (BMRN) aims to report on its phase-3 trials of pegvaliase as a treatment for phenylketonuria sometime in April, if not March.
Phenylketonuria is a birth defect that causes an amino acid called phenylalanine to be over-expressed in the bloodstream. If left untreated, it can lead to brain damage and a variety of other health issues.
Pegvaliase, also called PEG-PAL, has shown measurable efficacy as a therapy for the often overlooked (but not terribly obscure) disease.
It’s also worth noting BioMarin Pharmaceutical has said it plans to offer updates on vosoritide (for achondroplasia) and BMN 270 (a gene therapy product for hemophilia A) at its R&D day in April, which could make April a very exciting month for BMRN fans and followers.
As of this writing, James Brumley did not hold a position in any of the aforementioned securities.