For some investors, they’ve created small fortunes. For others, they’ve brought nothing but misery. For all investors, though, there’s no denying the fact that biotech stocks have kept things interesting if only because they can always supply a binary even traders can treat like a coin toss. The third quarter of 2017 isn’t going to be any different.
To be clear, the quarter that just got underway is a little bit different than the norm in the sense that not any of the major announcements in the queue are outright make-or-break events for their respective stocks; most of the announcements of consequence in the cards will come from the biggest of the biotech stocks that can survive bad news, and won’t likely soar on good news.
Nevertheless, in that the news due during third-quarter represents years of work and perhaps has the potential to shake up their sliver of the biopharma market, traders would be wise to keep tabs on these names.
Here’s a closer look at the top-ten biggest announcements from the biotech arena between now and the end of September, in order of their projected release.
Biotech Stocks to Watch: Amgen (AMGN)
As of the most recent look, the FDA was expected to make a decision on osteoporosis treatment Evenity (or Romosozumab) from Amgen, Inc. (NASDAQ:AMGN) on July 19. That’s only a placeholder date, though.
The actual PDUFA date will likely be pushed back as the company also disclosed a safety concern when it posted Phase 3 results back in May 21. It’s going to take some extra time to sort out the true scope of the observed cardiovascular risk
Evenity is a monoclonal antibody designed for postmenopausal women with elevated risk of fractures. It works well enough, but was linked to a 30% increase in the likelihood of heart attacks for those taking it. In short, the active component of the drug makes it easier for a body’s arteries to clog.
Biotech Stocks to Watch: Dynavax Technologies (DVAX)
Amgen wasn’t the only biopharma name to run into unexpected R&D problems of late. Dynavax Technologies Corporation (NASDAQ:DVAX) has also had a string of trouble with its Heplisav-B, for the treatment of Hepatitis B.
Namely, it received a complete response letter from the FDA back in 2013, and then again in November of last year. In short, the agency needs more clarity on much of the data compiled for the drug’s trials.
Hepatitis B has been a hot button of late. The pharmaceutical industry seemed disinterested for years, with the bulk of the new-drug focus taking aim at hepatitis C. Dynavax wisely took aim at the less-crowded $3 billion market, but has stumbled a few times in its effort to get to the end zone. It will be interesting to see if the company put finally put this one to bed.
There are two dates to watch here. The advisory panel that makes a yes/no recommendation to the FDA will meet on July 28, but the actual PDUFA date is Aug. 20. The FDA’s committee usually takes the advice of the advisory panel.
Biotech Stocks to Watch: Sanofi (SNY)
For as deep and wide as the diabetes epidemic has become, the pharmaceutical industry’s solutions today aren’t all that different than the first insulin Frederick Banting injected into a diabetic back in 1921.
It would be hyperbole to say Sotagliflozin, from Sanofi SA (ADR) (NYSE:SNY) would be a means of outright victory in the war against diabetes. But it would be wrong to dismiss the drug as just another entry into a crowded field.
In two Phase 3 trials it’s shown efficacy as a means of controlling diabetes. Data from a third Phase 3 trial is due sometime in mid-2017, though no firm date has been given yet. Whenever it is released though, Sotagliflozin’s trials could proverbially run the table.
Biotech Stocks to Watch: AbbVie (ABBV)
As was the case with Sanofi, AbbVie Inc (NYSE:ABBV) fans and followers may not necessarily want to etch Aug. 2 in stone. That’s just an estimated PDUFA date for Glecaprevir/Pibrentasvir — AbbVie’s newest hepatitis C treatment.
The drug was granted a priority review back on Feb. 2, which more or less suggests a yes/no decision in early August. Just keep your ears open for a specific date as we approach the date. Glecaprevir, or Pibrentasvir, performed amazingly well in its recently completed phase 3 Expedition trial, achieving a sustained virologic response (at the 12-week mark) in 99% of patients with genotype 1, 2, 4, 5 or 6 chronic hepatitis C.
Between its efficacy and the priority review, Abbvie has good reason to be optimistic.
Biotech Stocks to Watch: Bristol-Myers Squibb (BMY)
Cancer drug Opdivo, from Bristol-Myers Squibb Co (NYSE:BMY), is already on the market for a handful of cancers, but the company may be adding one to the list come Aug. 2. That’s when the FDA is scheduled to make a decision about Opdivo as a treatment for microsatellite instability high (MSI-H) metastatic colorectal cancer.
If approved, it won’t translate into a reversal of fortune for the company. Though this sliver of the cancer market is mostly an underserved one, Bristol-Myers can get along without it. Opdivo is slowly, but surely becoming a highly versatile solution though, nearing $1 billion in quarterly sales as it racks up new approved uses.
As was the case with AbbVie’s Glecaprevir, this indication for Opdivo is under a priority review.
Biotech Stocks to Watch: Pfizer (PFE)
Add Pfizer Inc. (NYSE:PFE) to the list of biotech stocks with approximate/likely PDUFA dates this quarter, but not a firm one yet.
The PDUFA date for Pfizer’s adult lymphoblastic leukemia drug inotuzumab ozogamicin is presently believed to be Aug. 21, based on the priority review granted back on Feb. 21. It may come before that though, as the NDA was accepted following a three-day weekend.
Whenever it happens, know that things thus far have looked favorable for inotuzumab ozogamicin. The drug is a monoclonal antibody, which acts as a delivery vehicle of a separate “warhead” that actually kills cancerous cells. Specifically, inotuzumab ozogamicin binds to a specific antigen found on malignant lymphoblastic leukemia cells, which then pulls an attached cytoxic agent into the cell … where it destroys that cell.
Pfizer isn’t the only pharma name working on the missile/payload idea. Inotuzumab ozogamicin is one of the more compelling applications of the premise though.
Biotech Stocks to Watch: Valeant Pharmaceuticals (VRX)
There are arguably no other biotech stocks out there that need a win more than Valeant Pharmaceuticals Intl Inc (NYSE:VRX) does.
VRX stock is done more than 90% since its September-2015 high for myriad reasons, most of which ended up accurately exposing what a trainwreck the company actually is. It could finally begin a move toward redemption on Aug. 24. That’s when the FDA is expected to make a decision about its latanoprostene bunod for open angle glaucoma.
It won’t be a game-changer in the sense that it’s a breakthrough drug, but a moral victory could work miracles for Valeant. Conversely, a letdown could deflate any budding optimism, and latanoprostene bunod hasn’t been flawless in terms of its path to approval. The company’s first approval request was sent back when the FDA voiced concerns about the treatment’s manufacturing process.
While it’s encouraging that its efficacy wasn’t questioned, Valeant isn’t a company that can afford even the appearance of problems here.
Biotech Stocks to Watch: Celgene (CELG)
Celgene Corporation (NASDAQ:CELG) is yet-another one of those biotech stocks with a drug under priority review.
Namely, AG-221 — also called Enasidenib — for relapsed/refractory acute myeloid leukemia in patients with a isocitrate dehydrogenase 2 (IDH2) mutation will get a thumbs or a thumbs down from the Food and Drug Administration on Aug. 30.
Enasidenib has done pretty well in trials too. For this sliver of the AML market, its overall response rate was 41%, with a complete response in 18% of the patients in the trial.
That’s not an overwhelming result in a superficial sense, but the IDH2 mutation doesn’t give these patients many other great options.
Biotech Stocks to Watch: Mylan (MYL)
Mylan N.V. (NASDAQ:MYL), like Valeant Pharmaceuticals, is a name that needs a high-profile win. Unlike Valeant, it doesn’t need a win to restore revenue growth.
It needs to put a trophy in the trophy case to restore some of the goodwill it lost with investors when its EpiPen debacle dinged its reputation. It may get that chance on Sept. 7. That’s the scheduled PDUFA date for MYL-1401O, which is a biosimilar comparable to HER2+ breast cancer drug Trastuzumab.
It’s a pretty big opportunity. Trastuzumab, perhaps better known as Herceptin, generated $6.8 billion in revenue in 2015.
The introduction of generic biologics will hit their equivalent brand names as they usually do, but even generic biologics command a respectable price. Experts think Trastuzumab and its equivalents will still be collectively driving $4 billion worth of annual sales by 2022.
Biotech Stocks to Watch: Novo Nordisk (NVO)
Last but not least, mark September 29th on your calendar as a possible decision-day for aspart, from diabetes drug king Novo Nordisk A/S (ADR) (NYSE:NVO). Actually, you may want to keep your ears open before Sept. 29. That’s just the last likely PDUFA date for the fast-acting insulin. A decision could actually materialize sooner.
Aspart is another insulin, not unlike several that are already on the market. It’s far more flexible than most though, usable by type 1 and type 2 diabetics, and faster acting than most other choices.
It’s not been a terribly easy road to move down though. Novo Nordisk got a complete response letter from the FDA following its first approval request, with the agency asking for more details about the drug’s immunogenicity.
The CLR looked more procedural than problematic, however. In fact, it’s already been approved in Europe as well as Canada. The insulin market is expected to be worth $39 billion by 2020.
As of this writing, James Brumley did not hold a position in any of the aforementioned securities.