Biotech talk/news/rumours and ideas

Prezatch

Agreed yea, it's looking like a rough day for stocks in general on the FTSE and ISEQ and this GNFT decrease is probably follow on from the bad performance on the Nasdaq yesterday evening, particularly the Biotech industry. Hope you got out of MediGene with a bit of profit!

Dubh Geannain

Life sciences firm Malin rises 7.3% in Irish Stock Exchange debut

Shares in Ireland's Malin rose 7.3% on its stock market debut after it raised €330m in one of Europe's biggest life science initial public offerings (IPO).

Malin, set up by a number of executives from Elan to invest in smaller, pre-IPO companies, opened at €10.50 per share on Dublin's ESM market for smaller companies.

This was above the €10 per share issue price.

The Dublin-based company beat its target IPO range of €275-325m, topping the £200m Circassia raised a year ago in the biggest London market biotech debut in years.

...

http://www.rte.ie/news/business/2015/0325/689569-malin-ipo/

RobertKK

JoeyD wrote: »

Agreed yea, it's looking like a rough day for stocks in general on the FTSE and ISEQ and this GNFT decrease is probably follow on from the bad performance on the Nasdaq yesterday evening, particularly the Biotech industry. Hope you got out of MediGene with a bit of profit!

I paid for being greedy, warning to oneself, take profit when it feels too good, instead of 118% profit, took 45% profit instead.
But at least it was a winner.

CNAT who released NASH data today are up 50% pre market.
GNFT next up...

zpehtsfd

RobertKK wrote: »

I paid for being greedy, warning to oneself, take profit when it feels too good, instead of 118% profit, took 45% profit instead.
But at least it was a winner.

CNAT who released NASH data today are up 50% pre market.
GNFT next up...

CNAT :mad:

Nice pullback n biotech. Looking to get some ENTA TTPH ESPR soon.

RobertKK

zpehtsfd wrote: »

CNAT :mad:

Nice pullback n biotech. Looking to get some ENTA TTPH ESPR soon.

Yeah, I owned CNAT before, it annoyed me when I did...

Decent pullback in ESPR. Possible buyout this year.

My shopping list has BLUE, ONCE, GERN - I sold my earlier stake, maybe AGIO which is nicely off its highs, and KITE.
Waiting for the time being.

RobertKK

Genfit misses endpoint, idiots had too many patients with mild NASH.... The placebo group "unexpectedly" improved. The people with more severe NASH did far better than the placebo group, but they really messed it up by not going for more severe cases.
Now it is going to be well down tomorrow, horrible day ahead...
http://news.yahoo.com/genfit-conduct-large-liver-drug-trial-despite-setback-172303179--finance.html
I'm sorry for people here who bought. Biotech is always risky.
The company blame their own trial when they could have gone after more severe cases.
Fibrosis nothing either, probably too short of a trial.
Will put this behind me, and move on. Going to sell early tomorrow. Sorry to my fellow GNFT shareholders.

For ever odd

RobertKK wrote: »

Looks like biotech correction is underway, and my internet was down and was too poor when it did work to do anything with it, it was like slow dial up, when it is normally around 10mb/s.
Seems back to normal now when it is a bit late..



Haven't heard about them but looking them up, quite similar to medigene in one sense in that they too are using dendritic cell therapy for cancer. They however are using a different technique.
Immunotherapy and gene therapy are areas where a lot of hope is being put to defeat cancer once and for all.
Yeah they have pulled back and hit a 52 week low at 23.80 then bounced, given their valuation, a small punt should be ok, same as I did with Medigene.



One word: Volatile :pac:

Bit extreme today even for me....from being up double digits to down double digits, playing on swings and roundabouts, should have sold this morning.
Greed is a terrible thing, and I let greed make me not sell yesterday.
Will likely sell tomorrow. Still have a nice profit but nowhere near as nice as yesterday.
Internet was so bad today, Three must have been doing work on it.



Yes, I don't have a clue how the results will be, the bad results two days ago would have me wary, but maybe the next set of results coming up will be good for a different type of cancer. I don't know.


Cellectis got greedy with their IPO at the worst time possible, they weren't to know they would IPO in the US on the day the correction in bio really got going.
They increased their share offering by 50% and increased the price to over $41. So now down 6%, they got too greedy at the wrong time.
Considering selling my stake in them.

Waiting for Genfit to announce their results still...wish they would just do it. Will likely be selling off all or most (80%) of my shares when they do.

The biotech sell off could last for a few weeks. Cash in one's account might be best right now unless playing a catalyst.

Hi Robert,
I don't know much about biotech , but I am really enjoying this thread, hats off to you for all the research.
If I may point out (and you have already recognized this yourself), maybe you could/ should start using a stop loss or trailing stop loss. It would safeguard you when greed and Internet problems get in the way of all your hard work.
Best of luck.

Markx

What I take from the Genfit press release is that applying the same standards as other recent NASH trials have done, the endpoint is met. Just to highlight a couple of things I saw on page 1 of the press release:

"With correction for this baseline severity and site heterogeneity by a standardized
statistical analysis, GFT505 120mg meets the primary endpoint: Reversal on NASH without worsening of fibrosis, as detailed below."

and

"Early NASH patients with NAS=3 were not included in other recent NASH trials. If the same is done in the GOLDEN-505 study, keeping patients with more severe disease defined by NAS≥4 (n=202), GFT505 120mg demonstrates a doubling of responders on the primary endpoint (22.4% vs 12.7%, p=0.046, RR=1.9), thus providing evidence of a clinically meaningful benefit in patients with more advanced disease."

Obviously it's a carefully crafted press release, however.

moneymad

Alexion Pharmaceuticals, Inc. (ALXN)

Prezatch

RobertKK wrote: »

Genfit misses endpoint, idiots had too many patients with mild NASH.... The placebo group "unexpectedly" improved. The people with more severe NASH did far better than the placebo group, but they really messed it up by not going for more severe cases.
Now it is going to be well down tomorrow, horrible day ahead...
http://news.yahoo.com/genfit-conduct-large-liver-drug-trial-despite-setback-172303179--finance.html
I'm sorry for people here who bought. Biotech is always risky.
The company blame their own trial when they could have gone after more severe cases.
Fibrosis nothing either, probably too short of a trial.
Will put this behind me, and move on. Going to sell early tomorrow. Sorry to my fellow GNFT shareholders.

Not to worry Robert, I wouldn't be too hard on yourself for recommending this stock to people on here or anything. You've clearly done a huge amount of research on the industry, are highly knowledgable and have made some great calls in the past. We were very unfortunate with this one but I for one wouldn't have been investing in Biotech if I wasn't fully prepared to take an 80% loss on it, should it come down to that. Luckily it hasn't been that bad, personally finished down 44% but other stocks in my portfolio have offset that quite a bit for year to date. I look forward to reading up on your views for future stocks!

RobertKK

For ever odd wrote: »

Hi Robert,
I don't know much about biotech , but I am really enjoying this thread, hats off to you for all the research.
If I may point out (and you have already recognized this yourself), maybe you could/ should start using a stop loss or trailing stop loss. It would safeguard you when greed and Internet problems get in the way of all your hard work.
Best of luck.

I can for my investment acount but Davy's are my pension account and they don't have stop loss.
Thanks

Markx wrote: »

What I take from the Genfit press release is that applying the same standards as other recent NASH trials have done, the endpoint is met. Just to highlight a couple of things I saw on page 1 of the press release:

"With correction for this baseline severity and site heterogeneity by a standardized
statistical analysis, GFT505 120mg meets the primary endpoint: Reversal on NASH without worsening of fibrosis, as detailed below."

and

"Early NASH patients with NAS=3 were not included in other recent NASH trials. If the same is done in the GOLDEN-505 study, keeping patients with more severe disease defined by NAS≥4 (n=202), GFT505 120mg demonstrates a doubling of responders on the primary endpoint (22.4% vs 12.7%, p=0.046, RR=1.9), thus providing evidence of a clinically meaningful benefit in patients with more advanced disease."

Obviously it's a carefully crafted press release, however.

Yes but market not buying it, their problem is a trial that they could have easily used more severe cases and not too many mild cases, and they would have met endpoints. Now they are planing on a phase 3 trial with what they should have done for phase 2.

Haven't sold yet, will watch for now. Some strong buying at the moment after the big drop. Up 27% off lows.

RobertKK

JoeyD wrote: »

Not to worry Robert, I wouldn't be too hard on yourself for recommending this stock to people on here or anything. You've clearly done a huge amount of research on the industry, are highly knowledgable and have made some great calls in the past. We were very unfortunate with this one but I for one wouldn't have been investing in Biotech if I wasn't fully prepared to take an 80% loss on it, should it come down to that. Luckily it hasn't been that bad, personally finished down 44% but other stocks in my portfolio have offset that quite a bit for year to date. I look forward to reading up on your views for future stocks!

Thanks.
I sold some of the stock, and will sell the rest. The cheapest I bought at was €40 and the dearest was in the €58s.
I didn't think it would rebound like it did by rising around 27% off its lows, it did look oversold.
Oh well, will move on and keep the cash for hopefully a biotech sell off.
Analysts are keeping high price targets on the stock but there are potential opportunities elsewhere.
Will keep a watch on it.

---

edit: It was a a good buy this morning ...and Genfit are pumping their own stock...

https://twitter.com/genfit_pharma/status/581408207014375425

Fizman

50% down at lunch! Wow. A 2,400 points move south, it would have been a serious short position to take.

Edit: Which makes me think.......are Biotech stocks the perfect straddle trade because of their volatility?

E.g. just before release of data, place a straddle trade. So say Genfit was at 5000 (€50.00) yesterday. Just before the news, place a Sell order @ 4900, and a Buy order @ 5100. Therefore one gets activated upon release of news, good or bad. Then just cancel the one that wasn't hit. Might be worth looking into?

Value Hunter

Fizman wrote: »

50% down at lunch! Wow. A 2,400 points move south, it would have been a serious short position to take.

Edit: Which makes me think.......are Biotech stocks the perfect straddle trade because of their volatility?

E.g. just before release of data, place a straddle trade. So say Genfit was at 5000 (€50.00) yesterday. Just before the news, place a Sell order @ 4900, and a Buy order @ 5100. Therefore one gets activated upon release of news, good or bad. Then just cancel the one that wasn't hit. Might be worth looking into?

Markets tend to gap as most of these results are released pre or after market. E.G the stock goes from €5 to €8 instantly when the market opens.

RobertKK

CEO of Genfit is fighting back, says while endpoints were not met, the trial was successful. That it worked on severe cases and it was cardio protective.
Plans to list on the Nasdaq, but all options are on the table for the company as they need to raise money for a phase 3 trial, they will either partner with a big company and when asked about a sale, refused to comment but all options were open.

bradlente

Second odds post from earlier,been enjoying the thread here too.

A bit irrelevant but I was wondering does anyone have any thoughts on Theranos?I know they're still private right now but they've gotten tonnes of exposure in the mainstream whilst still keeping fairly secretive about everything.

RobertKK

bradlente wrote: »

Second odds post from earlier,been enjoying the thread here too.

A bit irrelevant but I was wondering does anyone have any thoughts on Theranos?I know they're still private right now but they've gotten tonnes of exposure in the mainstream whilst still keeping fairly secretive about everything.

I suspect not, looked at their website and they don't give a fierce amount of info. Using blood to analyse for disease is what I took from it and Elizabeth Holmes the founder and CEO is a very interesting person, now 30 years of age, started the company in 2003 which is valued at about $9 billion of which she owns 50% of.
Company has around 200 different type of tests.
That is a very basic search by me but yeah thanks for bringing this up, interesting, wonder if she will IPO in the future to release some value, or maybe she will simply keep it private.
Started this company at 19 years of age, now that is impressive, given she used money for her education to do so.

RobertKK

zpehtsfd wrote: »

CNAT :mad:

Nice pullback n biotech. Looking to get some ENTA TTPH ESPR soon.

Hope you bought some ESPR before the most recent jump, those shares are strong along with RCPT.
Probably both seen as very strong targets for a buyout.

zpehtsfd

RobertKK wrote: »

Hope you bought some ESPR before the most recent jump, those shares are strong along with RCPT.
Probably both seen as very strong targets for a buyout.

Was hoping for mid-to-low $80's for entry. Will look for a swing short around $112 or so. GL

Value Hunter

Bought some September options with a $2.50 strike on MEIP for $0.35.

RobertKK

Last week used the money from the sales of MDG1 and GNFT to buy some CLVS in mid $74s, some KPTI in the $31s average and AERI also average in the $31s.

Today CLVS got a major upgrade, also seen as a buyout candidate.

I have no Cellectis (ALCLS) but it was a good buy in the €27s, didn't buy, but it up 20%+ since the very recent low.

RobertKK

Nice move by CLVS today (up just under 8%), company going to triple figures and a likely buyout.

BLUE also marches on, I want to get back in for a long term hold.

AAVL up near 5%

IPO by ADRO, an immuno-oncology company, shares up 110% from IPO price.

Value Hunter

My options are up 30% so far, not bad for one week!

RobertKK

Genfit is surging again, up over 37% for the week, based on a Liver conference that takes place next Friday in Vienna, where they wil meet investors and give additional data from the phase 2b trial.
I have no position.

In fairness, it was a super buy after the results, but it was hard then to judge how the stock would perform. Up 69% from recent lows. Just €6 off where it was before phase 2b results.

Prezatch

Another negative article from Mr. Feuerstein:

http://www.thestreet.com/story/13125162/1/genfit-digs-even-deeper-to-find-hidden-benefit-in-fatty-liver-drug.html

LILLE, France (TheStreet) -- Genfit(GNFTF) is once again using heavy mining equipment to dig through the rubble of its fatty liver disease drug GFT505 to find something positive, no matter how ridiculous it looks to everyone else.

At a meeting with investors and analysts, Genfit presented a new analysis of the negative phase II study purporting to show a "marked improvement" in liver fibrosis for nonalcoholic steatohepatitis (NASH) patients responding to GFT505 compared to NASH patients who didn't respond.

Must Read: 13 Volatile Stocks to Buy Right Now if You Are a Risk Taker







Nice try, Genfit. Claiming responders did better than non-responders is an obvious and scientifically meaningless conclusion. That's like saying the overall survival of patients who are alive is longer than patients who are dead.

When results from the phase II study were released last month, Genfit acknowledged that GFT505 demonstrated no improvement in liver fibrosis compared to placebo. A drug meant to benefit NASH patients needs to reduce liver fibrosis. Genfit's GFT505 didn't accomplish this important clinical goal.

For comparison, Intercept Pharmaceuticals'(ICPT - Get Report) drug candidate OCA did reduce liver fibrosis in NASH patients in its successful phase II study.

Also at Friday's meeting, Genfit highlighted a new analysis conducted on 120 patients "with an initial NAFLD Activity Score (NAS) of greater than 4, from centers that randomized at least one patient in each of the study treatment groups."

Did you get all those qualifiers?

In this post-hoc subgroup of 120 patients, GFT505 achieved the primary endpoint of the phase II study -- NASH clearance -- compared to placebo with statistical significance, Genfit said.

Unfortunately, Genfit enrolled 247 NASH patients in the study in which GFT505 failed to improve the NASH clearance rate compared to placebo. The only way Genfit can claim success is by erasing patients from the study. The company still hasn't disclosed the full results from the study.

Intercept Pharma didn't have to remove patients from its NASH study to get positive results. In fact, the Intercept study was stopped early because its drug, OCA, worked so well.

Genfit reiterated its plan to meet with the Food and Drug Administration about GFT505 and begin a phase III study before the end of the year. None of the sugar-coated analyses presented at Friday's meeting suggest the eventual outcome of Genfit's phase III study will be any better than the phase II study.

Andrea B.

Got burnt on $AERI last night. Stop loss did not even kick in. Climbed back a bit today so have adjusted SL and will try to scrape a bit back. Little bit anxious on AAVL. Would love to get an informed probability.
All in AERI it took my MEDG1 profits. Thinking of going back in with some more on MEDG1 on Monday morning. For such a small player, they are constantly coming up high on Frankfurt searches.

RobertKK

Andrea B. wrote: »

Got burnt on $AERI last night. Stop loss did not even kick in. Climbed back a bit today so have adjusted SL and will try to scrape a bit back. Little bit anxious on AAVL. Would love to get an informed probability.
All in AERI it took my MEDG1 profits. Thinking of going back in with some more on MEDG1 on Monday morning. For such a small player, they are constantly coming up high on Frankfurt searches.

A lot got burnt with that, including some very high profile biotech investors. I got burnt too. AERI had great phase 2b data but the phase 3 as you know didn't match, it is very disappointing and quite sickening to see such happen, but these are the risks. Hate when companies then make excuses for why trial didn't match the follow on trial.
I hope there is an investigation into the sell of $14 million worth of shares by a director just days from the data being released. Some claim the person didn't know, others just want an investigation to find out if they did.
Institutes own 84% of AERI too, so there was a lot of pain to go around, unless you were that director...

AAVL needs to be played very carefully as you need to know the risks, recently it became available for options trading. The call options for September go heavily for in the $70s a share which would be for good data, the puts go heavily for $20 if data doesn't match previous data.
It is something one needs to take into consideration, I am going to have an amount in this that takes the worst case scenario into account, I expect good data but you never know and that is why a small amount is enough.
I do like the fact Regeneron own 10% of AAVL, REGN are a great company, will be going over $500 a share soon, from 5 to 500...
I have seen how ONCE use the same type of gene therapy technology as AAVL for a different type of blindness and how it worked in similar early trials.
Know the risks and reward, but always think of the risk, gene therapy (GT) is in its early stages, it is looking very promising but currently there is only one GT drug on the market, but there are a lot of GT drugs in development, I believe it is the future but we have to see how things pan out.

RobertKK

Possibly the most riskiest stock in biotech - CLDN reported last night that it's gene therapy drug failed, was kinda expecting it to, but anyone in that is going to have an AERI sort of day, but worse.
Shares in CLDN reached a high over $28 in the past couple of months, before investors started selling given the risk to close at $13.68 last Friday.
Premarket has the shares down 74% to around $3.50 a share or just under 90% off it's recent highs...

Gene therapy companies will probably have a temporary sell off today, not based on reason, a lot of people didn't want to hold shares of CLDN because they felt the risk was extreme.

That is three high profile failures in a row now with MEIP, AERI and CLDN. Biggest surprise of the three was AERI but holding through data is always risky.

RobertKK

The biotech sell off which was expected seems to be happening.

CLDN failure seemed to start it, then a silly sell off in ONCE over its gene therapy drug not being a cure despite it working. The effects of the gene therapy for blindness wore off over time, but after 5 years the effects of it could still be observed. Basically ONCE didn't live upto its ticker name and one will need more than one treatment over time.
But in the report (not a trial result) it apparently works in making the blind see.
This affected AAVL who use gene therapy for a different type of blindness.
Basically a sell off based on nothing.
But there has been a general biotech sell off recently, it was more than due after near 12 months of gains.

RobertKK

CLVS to new highs as a buyout looks increasingly likely as they have Goldman Sachs involved. Was a good buy last week in the 70s
BLUE off recent highs, but up a lot recently, wouldn't buy at this price, but will have some new data on it's sickle cell disease gene therapy program in June.
AAVL went down to $29 but has rebounded as data expected within 60 days, it either goes to the teens or up heavily depending on data, I'm going to hold shares through data which is risky.
They should rise nicely before data if anyone has them and wants out.