tiktok: Right now 100% of my portfolio is in ETRM and solidly in the black. The downside risk up to ADCOM is miniscule and the upside a 2-3-4 bagger. As far as other stocks I tend to be opportunistic and love to buy ones insanely beaten down.
This morning(4-23) I got my email notice from the FDA updating their upcoming panels with ETRM's 6/17 date added. Expect a PR by ETRM in the next day or so confirming the date. I would be surprised if we don't close at or over $2 by Friday's close.
Detroit-based ProNAi picked up a $59.5 million venture capital round to support its mid-stage DNAi cancer therapy that uses liposomal delivery technology developed by Marina Biotech ($MRNA). ProNAi's lead candidate is its PNT2258, which targets the BCL2 gene to slow the spread of cancer and kill the cells while minimizing side effects with its precise delivery method. For now, ProNAi is working its way through Phase II trials, and the funding round is expected to bring the company through 2016.
CEO Mina Sooch says that's enough cash to get the company through 2016, with plans to pursue partnership talks as well as a discussion with the FDA about potential ways to accelerate the approval process for their lead therapy.
ProNAi is concentrating its efforts on PNT2258, a single stranded oligonucleotide that relies on an in-licensed liposomal technology to deliver the drug. The drug targets the BCL2 gene and has demonstrated signs of positive efficacy in interim Phase II results unveiled at ASH last year. And more Phase II results will be discussed later in the year.
Vivo Capital of Palo Alto, CA led the round, with new investors Frazier Healthcare Ventures, OrbiMed Advisors, Adams Street Partners, RA Capital Management, Caxton Alternative Management, Hopen Life Science Ventures, Sectoral Asset Management, and Janus Capital Management LLC joining in. Existing investors including Capital Midwest Fund, Apjohn Ventures Fund, Amherst Fund, and Grand Angels also participated in the financing round.
I like the fact that the CC is BEFORE the market opens. Many companies schedule CCs AFTER the market closes. I expect analysts to probe who will be presenting at ADCOM for ETRM and whether the company is confident that the FDA briefing papers will not contain any negative surprises; after all, by this time ETRM should have a pretty good read on the FDA's opinion of VBLOC.
adeiflig: I am long ETRM but don't get carried away. Increasing capital by selling more shares IS NOT a poison pill: A company like Medtronic just figures in the extra cash generated by a stock float in their buyout offer.
I sold all my CYTK the day of the reverse split and told everyone I flipped to ETRM. My transparency was booed off the board, but I saved tremendous losses and made a nice profit on ETRM, which I'm still holding up to their 6/17 FDA panel date.
cancunfish: I always was leery about Blum and his ridiculous R/S made me sell my holdings the day of the split and thankfully jumped into ETRM. Blum never gave a damn about the small shareholders.
marketman: I might dip back into CYTK, but not above $4. Amgen is always a big risk.
stocktechdoc: Putin's press secretary is more honest than you with your disinformation. VBLOC showed superiority, just not super superiority. The FDA actually urged ETRM to file for review by a panel. The placebo IS NOT SAFER, as its weight loss is temporary and does nothing to reduce hypertension, diabetes and certain cancers.
wallstreetbuyer: the downturn is over. If you are any kind of small biotech/medical device observer, you should know that surprise catalysts can happen at any time: additional CE mark from EMEA, a partner either in U S or ROW, an upgrade, or even an unsolicited buyout offer.
It appears to me that ETRM left some details out of the original proxy filing to vote on increasing the number of shares in the employee incentive plan. Now they're explaining why they need to increase the employee kitty.
Just like ETRM, FOLD had a meeting with the FDA regarding equivocal results:
Co announced positive 12- and 24-month data from its first Phase 3 study (Study 011) of the oral small molecule chaperone migalastat HCl monotherapy in Fabry patients with amenable mutations. Detailed results are available in a slide presentation that will be shared by the Amicus management team on a conference call today at 8:00 a.m. ET.
As previously reported, patients on migalastat experienced greater reductions in GL-3 as compared to placebo during the initial 6-month period; however, this difference was not statistically significant under the original study primary endpoint (responder analysis with a 50% reduction threshold at month 6). Following a Type C Meeting with the FDA in the second quarter of 2013, and based on feedback from the agency at that meeting, Amicus revised the Statistical Analysis Plan to pre-specify the primary analysis at month 12 as the mean change in GL-3 in patients with amenable mutations in a GLP-validated human embryonic kidney (HEK) cell-based in vitro assay.
I like the fact that ETRM's price recovery has been steady and on decent but not outrageous volume. I pity those poor fools that bought MACK premarket a couple of days ago at a huge premium and are now sitting on huge losses.
The real canary in the mine will be the publishing of the FDA reviewer briefing documents no later than 6/13 and possibly a day or so sooner. The FDA claims to try to post the documents at least 48 hours before the meeting. If after reading the documents the canary is still singing, then we can assume the fat lady will sing.
While the consumer price index rose just 12 percent in the period 2007-2012, one diabetes drug quadrupled in price and another rose by 160 percent, according to the analysis by Los-Angeles based DRX, a provider of comparison software for health plans. Source: Bloomberg.
The pros work on fear and harvest cheap shares. Look at HDY: Closed at 1.28 on 4/28 and an unexpected news release today propels the stock to $4. The price on ETRM is being kept artificially low until the BIG POP. I have no sympathy for those who miss out on ETRM as Mr Market kept open an unusually generous trading window to get cheap shares.
Three days closing at $1.88 is a clear indication of market makers and HF trading desks controlling the stock price. When they are ready they will move the share price over $2.