) -- The Biotech Stock Mailbag is open. Jeff H. writes:
I have a long position in Sarepta Therapeutics (SRPT) - Get Report and I'm having a hard time filtering through the many opinions/angles on their latest announcement to file for the new drug application. Seems like it's good news generally, but I can't quite wrap my head around the bad news part of it other than the short term "not approved yet" aspect. What is the real take on this announcement? Is this just the FDA covering themselves but not favoring a superior drug (eteplirsen over drisapersen) publicly while privately thinking it will get approved? Is the waffling on dystrophin endpoint just an excuse since Sarepta is superior in that arena too? I know you've written a little about it since the announcement but wondering if any more Big Picture thoughts have occurred to you. Thanks.
Sarepta announced the intention to seek U.S. approval for eteplirson on July 24. Here's the stock chart, before and after:
Um... Wasn't an early eteplirsen filing supposed to be good news?
I've often said stocks prices can lie, especially over the short term. To say this about the current Sarepta situation would be facile. Even bulls (hand raised) need to acknowledge the significant risks to the eteplirsen early approval thesis. Feel free to label me delusional, but I was pleased with Sarepta's July 24 announcement.
, including the cautious language describing the FDA's apparent uncertainty with dystrophin as an approvable endpoint. The only disappointment, minor, is the eteplirsen filing potentially not being completed until the second quarter 2014.
I still expect FDA to approve eteplirsen on the current phase II data, most likely the six-minute walk benefit rather than purely on dystrophin production. (Although dystrophin data will support the approval.)
On the company's earnings call Thursday, Sarepta CEO Chris Garabedian did a nice job explaining the routes FDA can use to review and approve eteplirsen, including granting full approval. If you've been following the Sarepta story closely, you knew this already. Hopefully, though, Garabedian's explanation resolved the confusion which exists.
Before the eteplirsen filing and FDA review happens,
will be announcing results from a phase III study of drisapersen during the fourth quarter. The companies may also release dystrophin production data from a previous drisapersen phase II study.
I can conjure multiple scenarios for how Sarepta's stock price reacts to these data. Best case for Sarepta: Drisapersen data that are "meh" -- meaning efficacy and toxicity in line with the current view of the drug: Drisapersen
, including kidney toxicity and thrombocytopenia, with extended use.
Worst case for Sarepta: The drisapersen data are super strong, meaning better-than-expected walking improvements with few reported side effects. If this scenario plays out, expect the Sarepta short story to switch to something like this: "With drisapersen data so strong, FDA is no longer under any pressure to approve eteplirsen early. DMD patients will be happy if just drisapersen is approved."
What happens to Sarepta's stock price if the drisapersen phase III study fails? It could surge higher on the view that the most viable DMD competitor is now derailed. Or, Sarepta shares could fall on the view that all exon-skipping technology is now under question.
Lots of optionality to think about as we get closer to the drisapersen data announcement. This is a big deal for Glaxo, Prosensa
Sarepta. The uncertainty helps explain, partially, the significant drop in Sarepta's value following the July 24 announcement.
I should also note that Sarepta will be presenting 96-week data from its eteplirsen study on October at the World Muscle Society meeting. The 48-week data from the same study were just published in the Annals of Neurology.
We're into the segment of the current biotech bubble where old and failed stock-promotion stories get recycled.
is one of these tired stories getting new life.
In the past week, three
contributors have published cringe-worthy ecomiums to Galena and its experimental breast cancer vaccine. The timing is not coincidental. With $27 million in cash and securities on hand at the end of the first quarter, Galena needs more money. The company last sold stock in December 2012, but needs to beef up the bank account to continue funding the NeuVax phase III study and hire a sales team to sell Abstral, its recently acquired cancer pain narcotic. Abstral will be a commercial flop, but Galena will waste a ton of money on it, nonetheless, because the company has nothing else to do.
I've spent quite a bit of time in the past explaining
published by "Regarded Solutions" to get a taste of company-sponsored stock promotion in action. Excellent work, Claire Sojda!
This chart says a lot: Galena totally left out of this summer's big move in the biotech sector:
Speaking of stock promotion, Ken Luskin of Intrinsic Value Asset Management has been on a mission to convince every retail investor in the land to buy shares of Vical ahead of the announcement of results from a phase III study of allovectin-7, the company's skin cancer immunotherapy.
Luskin, last seen holding millions of shares of Eastman Kodak as it plunged into bankruptcy, is now betting big on Vical. On allovectin-7 in a
, Luskin says, "I expect that Allovectin-7 will become one of the best selling cancer drugs of all time."
I don't believe the drug will be successful in this ongoing phase III skin cancer study.
Results expected later this month. Disagreeing with Luskin makes him mad. Very mad. When Luskin finds out that you disagree with him about a stock, he will call and email you to argue his point of view.
He will also post thousands of times -- literally -- on Internet stock message boards. When he fails to convince you that he's right, he will call and email you more, often several times a day. His calls and emails will become more argumentative and hostile. If you ask Luskin nicely to refrain from calling and emailing you, he will yell, accusing you of conspiring with short sellers to manipulate lower the price of his beloved stock.
If you finally lose patience with Luskin and call him a whackadoodle, he will leave you a voice mail just like this one he left me on July 30 at 6:15 pm ET. (Saved on my iPhone.)
Luskin to me:
Hey you little piece of shit. You call me fucking names in public? I'll fucking destroy you. I'll fucking destroy you, you understand you little piece of shit? You be fucking nice! You're too much of a little fucking piece of shit, alright? You fuckhead! You understand? YOU FUCK WITH ME I'LL FUCK YOU UP!
Sorry about the avalanche of F bombs, but all of Luskin's subtleties would be lost without them.
You want more hate mail? Okay, "Johhny" isn't happy with my bearish call on
You will sharing a cell with Steven Cohen. Between your "twitter survey" and your friend who shorts biotech companies, you are doing your personal best to destroy GTX. The SEC will bring you down to your knees as a self promoter of your "short" friends. No matter what you continue to write, the FDA will have the final decision and you will get what you deserve in the end. I hope you get cancer and die from the chemo.
The dying from chemo thing was a nice touch.
As far as I can tell, nothing has changed at
. The company is still flogging the synthetic vaccine and electroporation vaccine delivery technologies of 30 years ago. The other constant is Inovio's relentless self promotion. Two big changes over this time period: 1) Inovio's pipeline products fail or disappear, and 2) one group of disgruntled and money-losing retail investors is replaced by a new crowd of doe-eyed investors believing Inovio has turned the corner. Of course, this is never true. Rinse. Repeat.
Inovio's checkered history is
The recent uptick in interest in Inovio began in July and is tied to the biotech speculation fever which has gripped the market all summer. Take a look at the chart, no one was paying attention to Inovio until July.
Inovio's institutional ownership is 8 percent. Retail investors own 80% of the stock, according to CapitalIQ.
prints irresponsible, nonsense articles like
, speculators and momentum traders jump on board.
Incredibly, Inovio fans the flames by tweeting a link to the article from its corporate Twitter account:
@InovioPharma A looming partnership with Merck provides Inovio shareholders with a worthwhile catalyst.
Looming Merck partnership?!?! Except there isn't one, which probably freaked out the lawyers charged with keeping Inovio out of trouble. The offending tweet was quickly taken down, replaced with this:
Perhaps some of these shenanigans could be forgiven if Inovio possessed a pipeline of therapeutic and prophylactic vaccines worth investing in. It doesn't. The company's pipeline is a mix of preclinical and early-stage vaccines lacking meaningful clinical data.
Inovio's therapeutic vaccine to treat cervical dysplasia in women is the furthest along, but a phase II study has been trying to
. Inovio has promised data early next year, but the study isn't designed to provide any definitive answers about the vaccine's efficacy.
A study of Inovio's leukemia vaccine comes back
Inovio's hepatitis C vaccine failed a proof-of-concept study last spring. No matter because a Hep C vaccine is obsolete already given the looming market entry of remarkably effective pills which will cure the disease in 8-12 weeks.
An HIV vaccine? Seriously?
A flu vaccine? Sure, maybe, but Inovio has no partner. Don't believe in the program unless and until a larger company with credibility takes interest. None have.
Paul L. asks:
Adam, I appreciate the heads up you provide when it comes to FDA approval decisions. It seems like we're not seeing as many of these decisions lately. Do you have an update for your calendar?
I agree, the FDA drug approval cupboard has been a bit bare this summer. Not much action. Here's an updated list of significant FDA drug approval decisions through the end of the year:
Drug/indication: Dolutegravir, HIV
Approval decision date: Aug. 17
Drug/indication: Xiaflex, Peyronie's Disease
Approval decision date: Sept. 6
Drug/indication: Meblez, liver tumors due to ocular melanoma
Approval decision date: Sept. 13
Drug/indication: Otrexup, rheumatoid arthritis
Approval decision date: Oct. 14
Drug/indication: Iluvien, diabetic macular edema
Approval decision date: Oct. 17
Drug/indication: Feraheme, iron deficient anemia
Approval decision date: Oct. 21
Drug/indication: Entereg, post-operative constipation
Approval decision date: Oct. 21
Drug/indication: Sofosbuvir, hepatitis C
Approval decision date: Dec. 6
Drug/indication: Vascepa, mixed dyslipidemia
Approval decision date: Dec. 20
Also remember a few very important and stock-moving FDA advisory panels scheduled for the fall:
Amarin's Vascepa on Oct. 16, Gilead's sofosbuvir on Oct. 25 and
tasimelteon on Nov. 14.
-- Reported by Adam Feuerstein in Boston.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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