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APRI
While the data release of the RayVa™ Phase 2a study is due in Q3, don't forget that APRI has other irons in the fire, including the launch of Virirec in France and Spain, which just happened in Q2 this year.
The day to day price of the stock has definitely sucked lately, but with a mere 75 million dollar MC, a thick pipeline and cash to fund operations until the end of the year, I won't be looking to reduce at this PPS.
I'll be waiting for the dust to settle and adding to my position.
I don't think Clippard will be the last deal before the deadline for the Mets. The big names...Price, Hamels....they don't need that. They could easily pick up a bat with some genuine pop instead of recycling the likes of K Johnson, J Uribe (who I like) and Cuddyer.
PTN
18-6 is a pretty positive ADCOM vote. And the data is very compelling as well:
In three 24-week randomized Phase 3, six-month, double-blind, placebo-controlled, parallel-group North American studies of premenopausal women with a mean age of 36 years, ADDYI consistently demonstrated a highly statistically significant difference over placebo on three key endpoints, including increase in sexual desire, decrease in distress from the loss of sexual desire and increase in the frequency of satisfying sex.
I plan to hold through the FDA ruling....unless PTN hits 1.40 before the decision.
ARNI
Had a pre-ACSO run from the mid .50's to over a buck. Has been a slow dwindle-down since ASCO with no obvious catalyst to halt the slide.
FPMI .48 on solid early volume. Link back for dd
As a Brewer's fan, I couldn't be happier!! That Mets line up makes the crew's rag arms look like kershaw and greinke! Love to see the brooms out today!
FPMI, a PET imaging company
Volume alert: 210,000 shares traded. Hit a high of .48 before falling back to close at .40. This was an .80 stock a year ago.
Company is consistently quiet, but this line from last week's paid promotion piece at least reiterates that we can expect data soon:
As data from CardioPET’s Phase IIa clinical study is expected to readout this quarter, we expect results in line with the findings of Phase I will be a major catalyst for FPMI shares.
http://ir.baystreet.ca/article.aspx?id=136&1434538833
Their images are pretty impressive compared to the imaging agents that are currently out there.
http://www.fluoropharma.com/
SYN looking robust pre-market:
http://finance.yahoo.com/news/synthetic-biologics-host-microbiome-analyst-105800160.html
New $12 PT from William Blair
http://www.benzinga.com/stock/syn/ratings
Reloaded ARNI again. The PPS has stabilized nicely in this area since the big pop from the mid .50's to over a buck.
Low float, much closer to the 52 week low (.43) than high (1.99) and a handful of ASCO catalysts.
We all know about the Frost with ARNI.
CBLI
The perfect storm: ASCO, low float, 52 week low.
Sold half of my 1.94's at the close.
CBLI in a couple of weeks ago at 1.94
Good R/R into ASCO and September catalyst
Have been adding shares of FPMI at a .36 average. From their Dec 2014 PR: this Phase II trial will be closing on December 15th . To date, FluoroPharma believes it has acquired sufficient patient data allowing for the assessment of the pharmaceutical's safety and quality of FCPHA generated cardiac images in humans.
According to Thijs Spoor, Chairman and CEO of FluoroPharma, "This trial has so far produced data on image quality, the optimal time for imaging after injection, and preliminary data on myocardial blood flow. To date, no major adverse events have been seen with any patients dosed with CardioPET. As we plan for the next development steps, all of this data will now be incorporated into a thorough assessment versus other clinical comparators of SPECT and angiography. It is expected that the full data will be evaluated in a blinded read fashion and then presented early next year."
I'm hoping "early next year" is almost upon us, lol.
This presentation from the company in January lays out the case for their imaging agent pretty convincingly:
http://noble.mediasite.com/mediasite/Play/3023b31663f544ab837cb391662145721d?catalog=4c6a20e5-5fc7-46ee-917e-3aa3a03fba23
The company runs on a tight budget, with only 5 fulltime employees. The shares are trading at a 52 week low, though yesterday's PPS rise was on more volume than usual (40 k shares traded) as of late. The financials aren't very pretty, but the burn rate is low and the 30 million OS is reasonable.
IMO, phase 2 results will show superior images; at .36 a share, the risk/reward is pretty decent...
ARNI smashed the $1 barrier, up %32 on the session
Missed the PTBI run, but another bio I hold came to life today. ARNI jumped a bit on no news with big volume. It's a Phillip Frost holding making a turn north after hitting rock bottom.
Some EU news last week and ASCO approaching.
Hopefully the upward momo continues because it certainly looks like the overall bio bubble has popped.
Check out ARNI
Nice pop! Bio's been a tough play over the past few weeks. Great to see ASCO plays still have some teeth
That sure didn't take long. Tough luck for Ron after management traded Gallardo for 2 popcorn vendors in the off-season....oh yeah, and added Lind.
Looks like it's time to juice up Braunie again if they're going to catch the Cards!
Cry me a river.....I'm a Brewers fan....
Hence the current position. Took a starter here at 56 a few weeks ago....this one and FPMI. Not looking for a quick trade here in either case.
Nope. NVIV mainly uses hardware to address specific spinal injury; STEM is trying to build a case for the efficacy of stem cells, which to date haven't been very successful in late stage trials. STEM is a bounce play for me. Any meaningful results are too far into the future.
IMO, STEM doesn't contend or compete with NVIV in any way.
STEM is a bounce play for me. To date, stem cell treatments haven't panned out in late stage trials (ATHX stage 2 recently for one) Given that STEM has no treatments in phase 3 as of yet, the hope is that they can actually show cause for phase 3 trials to happen sometime in the future...but that's a long way down the road.
STEM
Bought shares in STEM today at .57 on the massive plunge to .61 on this news:
StemCells priced offering of common stock/warrants at $0.70 for fixed combination of one share of common stock and warrant to purchase three-quarters of share of common stock (STEM) : The warrants have an exercise price of $0.85 per share, are exercisable immediately, and will expire five years from the date of issuance. The Company expects to receive gross proceeds of ~$25.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
The company issued this PR last week:
NEWARK, Calif., April 16, 2015 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing novel cell-based therapeutics for treating diseases of the central nervous system with high unmet medical need, announced today that it has completed transplanting the six patients comprising the first cohort of its Phase II Pathway® Study. The first cohort is an open-label dose escalation arm to determine the cell dose to be used for the second cohort of the study. The second cohort of the study is a single-blind arm in 40 patients that will assess efficacy of the Company's proprietary HuCNS-SC® (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI).
"We are breaking new ground with this study," said Stephen Huhn, M.D., FACS, FAAP, vice president, CNS clinical research and CMO at StemCells, Inc. "This is the first controlled study to use neural stem cells with the intent to demonstrate improvement in motor function following spinal cord injury. In this first cohort, we have achieved the highest number of neural stem cells administered into the injured human spinal cord in medical history. We expect to release six month interim data on the first cohort later this year.
"Interest in this study from both physicians and patients has been very encouraging, resulting in the rapid enrollment of this cohort. The Company is using web-based recruitment and, in the first six months, we have seen over 1,500 inquiries and 500 completed questionnaires and over 100 subjects have been reviewed for possible eligibility. Our experience with the first cohort reflects great clinical momentum, as well as the excitement within the spinal cord injury community for potential novel treatments. Detecting evidence of motor improvement in this Phase II study would provide proof-of-concept for this approach in spinal cord injury and would ultimately lead to a therapy that dramatically enhances the quality of life for those afflicted with spinal cord injuries."
While the catalyst bolded above isn't slated until the end of the year, it looks like the company was able to carefully select their 6 patients, which will hopefully result in STEM's treatment working to its fullest potential for the best results for the 6 patients.
Thanks Wade. I think you nailed it: I would think we would see more upside surprises in both earnings and guidence in a bull market.
In 1997, my bro in law churned a pairs-based algorithem that resulted in an annual ROI of between 45 and 122%. All on the long side. Between 2001-2003, the ROI dropped to negative #'s. The algorithem had no positive results when applied to shorting.
PESI
Love the story and the company but I can't get too excited about a happy ending for a stock/company that happens any further than 3-6 months away, ie, the Technetium-99m generator project.
FA will come a knockin' for this bull market. It might be next quarter or next year at this time, but I don't see the ROI in the stock market making any bold moves over the next year...except to the downside...and a falling tide lowers all ships.
Yup. hard to believe the plunge is about the 2014 annual report released after the COB on Friday.......Hope this isn't a repeat of their leaky results release from the dry eye study.....
I'm in for 3k shares....pared down from a 10k purchase...
CANF
I watch the PPS in Tel Aviv will for the story. As I recall, when CANF released data on 2 studies in Dec. 2013, the shares on the Israeli exchanged tanked about 17% before the US markets opened....and just before the company PR'ed the negative results for their dry eye clinical study. The company has some leaky seals, and as usual, those of us on the outside were left holding the bag.
Riding free shares here through the PR release from a $2.34 entry.
What's to like? From the CC:
-Their product is no better than equivalent to PEEK
-The doctor performing and presenting the CASCADE trial wouldn't even endorse the product over PEEK
-They gave no guidance on pricing
-There was a lot of talk of "high-speed drills" and needing to carefully prep the area before implanting the AMDA device
-They're bleeding cash
IMO, there might be a corner to turn here, but it's not looking too likely to me that AMDA will become cash flow positive this year.
AMDA out with a 12 month CASCADE study synopsis comparing their ceramic fusion implant to PEEK standard of care device. The company also released a wretched 10k.
Great example of how not to do a CC. It's 45 minutes long on the website if you have the time/desire. Nominally their device is equivalent to PEEK....barely.....and nominally they proved their endpoint, but either there was very little to get excited about or the presenters need to lay off the halcyon the night before the CC.
52 week range is .47-$8.78. I suspect you'll be able to get in cheaper than the low over the next few weeks/months based on what I just listened to.
AMDA out with a 12 month CASCADE study synopsis comparing their ceramic fusion implant to PEEK standard of care device. The company also released a wretched 10k.
Great example of how not to do a CC. It's 45 minutes long on the website if you have the time/desire. Nominally their device is equivalent to PEEK....barely.....and nominally they proved their endpoint, but either there was very little to get excited about or the presenters need to lay off the halcyon the night before the CC.
52 week range is .47-$8.78. I suspect you'll be able to get in cheaper than the low over the next few weeks/months based on what I just listened to.
That's too bad. The Mets could use a shortstop.
One quarter of no bad news does not a streak make. GV needs to string together 4-5 quarters of solid, no-surprises earnings to earn a PE of 20 or better IMO.
Doesn't sysmex own the rights to anything BIAD produces as part of the MSA? Any details on what BIAD gets, ie, royalties, % etc?
TLTFF .319
Just announced recent financing closed today:
Theralase Technologies Inc. has closed its previously announced public offering of units. On closing, the corporation issued an aggregate of 18,181,817 units at a price of 44 cents per unit for aggregate gross proceeds of approximately $8-million. Each unit consists of one common share of the corporation and one common share purchase warrant. Each warrant entitles the holder to acquire an additional common share at a price of 54 cents for a period of 60 months following the date of issuance.
Corporate presentation here:
https://be201.infusionsoft.com/app/linkClick/1266/9079b32fd47b2b03/359618/0b2926e3c0234eec
I bought a few today on the announcement of the successful financing.
Amazing article. Thanks for posting.
Henceforth, "We don't speak of Wednesday."
You forgot to add, "Henceforth, we don't apologize to our customers either".
Thanks to you Sheff for giving so much of your time and heart to this organisation. It's an honor to donate.
I hope you smash your goal this weekend.
Cheers
SNWV .18 lottery ticket
This one has retraced from the .25 range over the past week on small volume. Last year, the stock was based in the .40 range before falling to .05. It has begun to climb out of the cellar over the past few weeks. The next catalyst is an update on their supplemental trial for their dermaPACE product that treats diabetic foot ulcers. From the Dec 1 press release:
Kevin Richardson, II, Chairman of the board of directors of SANUWAVE, stated, "We are very pleased to have reached this enrollment milestone in the supplemental clinical trial of dermaPACE to treat diabetic foot ulcers. We anticipate having the feedback from the Data Monitoring Committee regarding the 130 patients in the first quarter of 2015 and look forward to updating shareholders at that time."
The DMC will perform an analysis on the entire 130 patient population once the patients have completed the twelve week efficacy analysis period. This is expected to be completed in the first quarter of 2015. After their review of the 130 patients, the DMC may recommend: 1) stopping enrollment because the dermaPACE has met the minimum success criteria as compared to sham-control, 2) increasing enrollment to 170 patients which is the next predefined patient analysis point, or 3) stopping the trial due to poor results.
If the DMC recommends #1, SNWV should easily blow past the old base of the .40's
Encouraging results from the phase 3 IDE trial in 2011:
Patients treated with dermaPACE showed a strong positive trend in the primary endpoint of 100% wound closure. Treatment with dermaPACE increased the proportion of diabetic foot ulcers that closed within 12 weeks by 36%, although the rate of complete wound closure between dermaPACE and Sham-control at 12 weeks in the intention-to-treat (“ITT”) population was not statistically significant at the 95% confidence level used throughout the study (p=0.363). There were 22 out of 107 (21%) dermaPACE subjects who achieved complete wound closure at 12 weeks compared with 15 out of 99 (15%) Sham-control subjects.
In addition to the originally proposed 12-week efficacy analysis, the FDA expressed interest in seeing the efficacy analysis carried over the full 24 weeks of the study. In response, we conducted a series of secondary analyses of the primary endpoint of complete wound closure at 12 weeks and at each subsequent study visit out to 24 weeks. The primary efficacy endpoint of complete wound closure reached statistical significance at 20 weeks in the ITT population with 36% of dermaPACE subjects achieving complete wound closure compared with 23% of Sham-control subjects (p=0.047); in the efficacy evaluable (“EE”) population 38% of dermaPACE subjects achieved complete wound closure beginning at 20 weeks, compared with 21% of Sham-control subjects (p=0.018).
Subjects treated with dermaPACE achieved a significant increase in the rate of complete and/or =90% wound closure. We analyzed a clinically relevant = 90% wound closure endpoint that demonstrated statistical significance (p=0.0161) in favor of dermaPACE subjects (51/107, 48%) compared to patients randomized to receive Sham-control (31/99, 31%).
Within 6 weeks following the initial dermaPACE treatment, and consistently throughout the 24-week period, dermaPACE significantly reduced the size of the target ulcer compared with subjects randomized to receive Sham-control (p<0.05).
Of the subjects who achieved complete wound closure at 12 weeks, the recurrence rate at 24 weeks was only 4.5% in the dermaPACE group compared with 20.0% in the Sham-control group.
Importantly, there were no meaningful statistical differences in the adverse event rates between the dermaPACE treated patients and the Sham-control group. There were no issues regarding the tolerability of the treatment which suggests that a second course of treatment, if needed, is a clinically viable option.
With oil trading in the mid 40's that's the type of brave, timely analysis these clowns are best at: presenting the illusion of insight after they've completely missed the boat...by a lot. And then they arrogantly chime in with the royal "we" after mom and pop have been taken to the cleaners in a sector.
Where was their astute analysis of oil price futures last September? Or were they short the whole time?
Grrrrrrr!
A trickle of good news or even a decent pump piece sends this back to its old .40 base. Positive 1rst q study news and it's off to the .80's