I took a position in Alder Biopharmaceuticals today. They are in P3 with a fairly well de-risked monoclonal for treatment of migraine. They should be reporting results on the first of two P3 trials next month. I think their upside is pretty high.

https://www.google.com/finance?q=NASDAQ%3AALDR&ei=1_oUWfmePMazjAG_-Lb4Dg

If you are interesting in value drivers/milestones, the website below is one I follow.

https://www.biopharmcatalyst.com/calendars/fda-calendar

Awesome thread, as I love to gamble with speculative bios...

I'm currently back in auph...traded it back in September from $2.50-$3.42, then again in March at $4.71 selling along the way until $7. Made good money but obviously left a lot on the table. Now back in last Friday at $7.04 and may hold for awhile.

I'm also in CBMX...really a nice turnaround story. From my dd has really been a dog in the past. Changed management and have really turned things around over the last year. Projecting cash flow and earnings positive by Q4. Increased margins from 51-60% YOY. Specialize in diagnostic lab services, genetic, and miscarriage testing. I've been in since low $3s and bought along the way bringing my average to $4.27. Sold some lots along the way but holding a core position LT. I initially bought based on technical indicators as the chart has been beautiful since the 200 day ma break early January, but now I'm really intrigued by the fundies.

Highway6 said:

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VRTX.

I bought in January on the day my grandson was born with cystic fibrosis on a purely emotional buy because I need to believe that they will discover the cure or at least come up with a treatment for his particular mutations.

They are up 49% to date.

That said, I have a friend whose husband is a venture capitalist in bio tech and he recommended VRTX, too.

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VX-661 may make us both rich men & render the df508 mutation inconsequential simultaneously.

EVERYONE BUY THE **** OUT OF THIS STOCK!!!!!!!!!

Lots of Bios with big days today.

For me, IMGN +20% today and FOLD +6%.

XBI isn't up much though, for some reason.

Could someone breakdown what happens if AUPH's med is approved? Does it go directly into the market since it has no competitor? I'm not familiar with bio stock bit keep seeing AUPH everywhere.

GNVC

I don't follow that company so don't know any specifics on their product or program, but can sum up the steps for them to get to market:

• They need (obviously positive) results from their Phase 3 trial(s). Two replicate trials are almost always required but they could get away with one provided they show substantial evidence of efficacy and the FDA agrees with the approach beforehand
• They need to prepare and file for a marketing application (NDA) - this will likely take 6 months to a year from having Phase 3 data
• The FDA will review in a ~1 year timeframe
• If approved, they will need to ready their supply chain, a sales force, and get other commercialization people and processes in place before launch - this can take up to another year

So as you can see, it will be a good while before they have their product on the market if they are just now in Phase 3. If you are looking at this from an investment standpoint, commercial launch isn't the near term goal. It is a positive Phase 3 data readout. If that happens and a press release issued, you'll see a huge bump. If released results are the first of 2 Phase 3 trials, you wont see quite as great of a bump as if both trials read out together.

That is the value driver, not launch. In fact, this company probably would never launch themselves. They will either find a commercial partner that has the expertise and infrastructure and work out a deal, or they will simply be acquired by a larger company that will take complete control.

HTH.

Regarding AUPH's phase III trial which just completed enrollment, they've announced that one trial should be satisfactory for applications in the US, Europe and Japan that should speed up the process somewhat.

Quote:

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Regulatory pathway forward

On April 7, 2017 we announced the outcome of discussions with both the European Medicines Agency (EMA) and the Pharmaceutical and Medical Devices Agency (PMDA) in Japan regarding the development of voclosporin for the treatment of active LN. Pursuant to these discussions, we believe that the confirmatory data that can be generated from the AURORA trial and the recently completed AURA trial should support regulatory submissions in the US, Europe and Japan.

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The other good news is that the company has enough funds through 2020, so you don't have to worry about the company looking for cash

Quote:

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Financial Results for the First Quarter Ended March 31, 2017

As a result of completing the public offering on March 20, 2017, Aurinia had cash, cash equivalents and short term investments of $202.1 million as at March 31, 2017 compared to $39.6 million as at December 31, 2016. We believe, based on our current plans, that we have the financial resources to complete the AURORA trial and fund operations through 2020.

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Many who invest in the stock are hoping and believing that AUPH will be bought out within a year by a bigger pharma, decreasing your waiting time for return on investment. One potential buyout partner is Merck, who they just reached a licensing deal with for K9 applications

More on $AUPH

Quote:

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About Voclosporin

Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor ("CNI") with clinical data in over 2,200 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action that has the potential to improve near- and long-term outcomes in LN when added to standard of care (MMF). By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses. It is made by a modification of a single amino acid of the cyclosporine molecule which has shown a more predictable pharmacokinetic and pharmacodynamic relationship, an increase in potency, an altered metabolic profile, and potential for flat dosing. The Company anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries.

About Lupus Nephritis (LN)

LN in an inflammation of the kidney caused by Systemic Lupus Erythematosus ("SLE") and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder and affects more than 500,000 people in the United States (mostly women). The disease is highly heterogeneous, affecting a wide range of organs & tissue systems. It is estimated that as many as 60% of all SLE patients have clinical LN requiring treatment. Unlike SLE, LN has straightforward disease outcomes where an early response correlates with long-term outcomes, measured by proteinuria. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced estimated glomerular filtration rate (eGFR), and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease ("ESRD"), thus making LN a serious and potentially life-threatening condition.

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Source

*I'm invested in AUPH

I am new to this as well. If AUPH is bought out by a large pharma within the year, what kind of return on investment would be expected?

AUPH market cap is currently around 578.Million

I expect it to be worth at least 1 Billion. But haven't seen any analysts' evaluations on potential buy outs, but an analyst did give it a PT of 14$ by end of year (take that with a grain of salt)

I like the genetics biotech sector, but have played with others and have bought and sold too early like BEAT or picked the wrong horse with NSPH

NSPH eventually sold out but price was beat down. They do genetic testing for sepsis bacteria which saves 2-3 days, and genetically tells ya what drug works. Its a big deal for people with days or week to live without a solution


TROV/BIOC I'm tracking, they genetically test for cancer and also recommend treatment based on DNA, using a urine or blood sample rather than a tissue sample.


Right now I'm not in anything but that's the sort of biotech I'm into.....much more so than drug companies

DNA testing is a concept where drugs are a dart throwing contest in my view

Igxt

Should have thin film taladafil (cialis) in mkt by end of 2018, already have exclusivity from Eli Lilly

They have other thin film products coming online as well

Watching NWBO carefully. It's been beat down to a pulp lately, but they are now getting very close to the end of their Phase 3 trial for DCVax. They've got a booth lined up at ASCO next month, in addition to a hour-long talk that was just announced today. Extremely high risk/reward on this one IMO.

http://am.asco.org/exhibits/industry-expert-theater

FOLD is starting to move. +8% today and +25% since May 9 earnings.

Also, outlay of $450,000 was spent on Sept $10 calls today. $1 per contract.

I added more at $7.70 towards end of last week.

Did anyone have PUMA? Running up huge the last couple of days!

CavitationAG said:

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Did anyone have PUMA? Running up huge the last couple of days!

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I watched it since I knew their drug was the subject of an Advisory Committee meeting this week. Like everyone else I was waiting for the briefing information to get posted to the FDA website to see FDA's tone around the data and the questions FDA would ask its committee. Within minutes of posting the briefing documents, the stocks skyrocketed.

I don't develop oncology drugs so didn't feel comfortable enough to jump in ahead of the Ad Comm though. Woulda, shoulda, coulda...

love the ideas flowing here. I picked up some small nwbo and arth myself.

today, I sold my cytr for 40% gain, i think it might have more to go but would like to see it drop below .60 before i start slowly buying back in. (if it doesn't then i wont buy back in)

I also added more AUPH today, might be a good day to get a starter position if you havent already, low after the offering is 6.4ish, so I wouldnt be surprised to see it test those levels again.

CLSD is also an interesting stock that i have played before with drugs in P2 and P3, it was just upgraded by analysts to a 20$ PT, currently right below 8$...

CLSD chart looks pretty good...any concern for a raise or are they good on cash to fund the trials?

if you trade bio stocks, are you a drug dealer?

It IPO'd less than a year ago, on 3/31 total cash on hand is just under 23 mil and short-term investments is 54 million.

But, do your own DD, this is their last 10-k:

http://services.corporate-ir.net/SEC.Enhanced/SecCapsule.aspx?c=253669&fid=15006511

badharambe said:

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AUPH market cap is currently around 578.Million

I expect it to be worth at least 1 Billion. But haven't seen any analysts' evaluations on potential buy outs, but an analyst did give it a PT of 14$ by end of year (take that with a grain of salt)

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going the wrong way

IBB and XBI on life support and both looking to test the 200 day...I took 35% of my speculative bio portfolio into cash last Friday. Hopefully this selloff is just creating more buying opportunities, but if the 200 day doesn't hold we may have a massive selloff in the sector.

Ragoo said:

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if you trade bio stocks, are you a drug dealer?

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I don't touch pharm stocks, mainly genetics based one's.

That's especially true for cancer drugs.

Barron's -- No Downside Risk in Biotech

Quote:

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Oppenheimer's Leah Rush Cann notes that biotech stocks are trading at a 30% premium to the market. The group had a price-to-earnings-growth ratio of 1.86 times versus the S&P 500's PEG ratio 1.43x through the end of May. That said, biotech has in the past 19 years traded at an average PEG premium of 97%.

In relation to the S&P, the sector's price-to-earnings ratio expanded from 1998 to 2002, sharply contracted from 2002 to 2010, expanded again from 2011 to 2014 and has been contracting from 2015 to now.

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Anyone feel like researching a big gamble?

AVEO

Pharma company that had the FDA deny their application because they changed patients Between groups. Their drug (which was showing success) is a cancer drug that was extending mortality rates in trials and was showing upside. May be a while though as they have I think one trial in phase three and others in beginning stages. They have also entered into a couple of licensing deals recently.

I really don't know if this is a huge potential as they were once trading around $20 (at 75 cents now) or if it is just a poorly run company.

I have made about 6 grand on it playing on bumps, so I'm using my gains, but I'm way down right now as my cost basis is approx $1.25

CYTR getting murdered after hours! What's happening?! Did a bunch of investors take their ~20% and run?

I've been watching, but don't have any skin in that one yet. I'm thinking there is going to be a huge buy opportunity Monday.

Good thread, keep it going

I had not followed them prior to you mentioning them. Seems like an interesting stock to follow. Sounds like there are quite a few people that believe their drug is the real deal but there has to be a reason for the stock price being so low.

Bought in this morning at $.64/share.

I'll try to come back and update this with more info, but here is a quick list of everything I have in my portfolio plus my "wants" --

$PRTK and $AKAO -- both produce antibiotics that are in Phase III of clinical trials with a promising outlook. PRTK is on the east coast and focuses on Gram-positives, AKAO is on the west coast and focuses on Gram-negatives.

$SGMO -- gene editing with zinc finger or TALON technology. Think of it like CRISPR but without the off target effects. This technology was pre-CRISPR, but everyone jumped on the CRISPR train, however this will become a real therapy much quicker. The company has new leadership and they all are about finding partners and potentially becoming acquired. Already have a deal with Pfizer.

$TGTX -- stopping cancer by focusing in on B-cell malignancies and autoimmune diseases. Produces monoclonal antibodies that target a specific antigen (CD-20) to deplete B cells. Have two studies in phase III and just showed real promising data at the ASCO conference this weekend. The stock shot up to $16 before market open on Monday, but has gone down for some reason to $12. Good buying opportunity here.

Wants --

$INCY
$BLUE
$LOXO

BLUE and LOXO also just showed real promising data from the ASCO conference this past weekend

$RDUS

Potential buyout candidate this summer. Rumors they already have a buyer in Shire pharma

$PTGX
$PIRS

Good new biotechs with novel technologies.

CYTR making a comeback. Picked up some more today.

Was just about to post that. I had picked a little up at .66 so still playing catch up.

I got in at $.64 and $.60