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Re CLDX
I am happy they aren't talking up the partnership angle much. Those who protest too much about interested parties seem to always have the worst luck in delivering on those promises.
Abraxane + Gem already used off label at several academic centers. JHU in particular.
ARRY Ph2 melanoma data coming this weekend
http://www.melanomacongress.com/docs/Master_Agenda_SMR_Congress.pdf
re PPHM
Pretty interesting stock isnt down more IMO.
I wonder what management is telling people. Looks like some bought 20K April'13 $2.5/5 call spreads today.
Another is BAX. Currently doing a Phase 1 trial of long-acting Advate using NKTR's tech.
I imagine PPHM has been using their ATM these past few weeks at a very high level. A lot of stock still to sell on their ATM
"On December 29, 2010, we entered into an At Market Sales Issuance Agreement (the “December 2010 AMI Agreement”) with McNicoll, Lewis & Vlak LLC (“MLV”), pursuant to which we may sell shares of our common stock at market prices through MLV, as agent, in registered transactions from the Company’s shelf registration statement on Form S-3 (File No. 333-171252) filed with the SEC on December 29, 2010, for aggregate gross proceeds of up to $75,000,000.
During the three months ended July 31, 2012, we sold 2,752,691 shares of common stock at varying market prices under the December 2010 AMI Agreement for aggregate gross proceeds of $1,496,000 before deducting commissions and other issuance costs of $59,000. As of July 31, 2012, aggregate gross proceeds of up to $25,886,000 remained available under the December 2010 AMI Agreement.
As of July 31, 2012, aggregate gross proceeds of up to $175,886,000 remained available under two effective shelf registration statements.
In addition, as of July 31, 2012, we had reserved 16,909,269 additional shares of our common stock which may be issued under our equity compensation plans and outstanding warrant agreements, excluding shares of common stock that could potentially be issued under our current effective shelf registration statements, as further described in the following table:
Number of Shares
Reserved
Common shares reserved for issuance under outstanding option grants and available for issuance under our stock incentive plans 12,252,187
Common shares reserved for and available for issuance under our Employee Stock Purchase Plan 4,437,115
Common shares issuable upon exercise of outstanding warrants 219,967
Total shares of common stock reserved for issuance 16,909,269"
Tivantinib Phase 2 data below. mOS in Tarceva arm was 6.8 months, however, this was with 42% crossover. Note that the MARQUEE trial is only enrolling ECOG PS 0 or 1, so mOS might be slightly higher than 7 months.
http://files.shareholder.com/downloads/ARQL/1961307682x0x408730/e8023dcf-d675-4bb4-bd92-2d84a3a4671c/ARQ197_ESMO2010 final 09-10-10.pdf
Stock is only up because of short sale restriction today. The pain is coming soon enough.
Still waiting on an apology from cjgdaddy, Thurly, and more.
Given some of the things they said to me, Dew and other skeptics, it feels like karma for them.
HEB, CTIC, and ?
Called BS on this company and was attacked by many. Well, guess who was right?
re PPHM - Who is right now?! Told ya PPHM was a bunch of fraudsters
Roche starts a Phase 3 of EXEL's MEK inhibitor in combo with Zelboraf vs Zelboraf in melanoma. I'm gonna assume those ESMO12 data look good.
http://clinicaltrials.gov/ct2/show/NCT01689519?term=GDC-0973&rank=8
I believe Jason Napodano has done a good job highlighting some of the changes they have made. The company has made some adjustments to this newer trial in an attempt to increase the likelihood of success(eg US only sites, 2 arm trial, and using a modified SAPS endpoint), however, I am still a bit skeptical.
http://bionapcfa.blogspot.com/2012/01/will-third-time-be-charm-for-acadia.html
ACAD's drug has a not so hot history of bad trials and discontinuations. Phase II studies in movement disorder and insomnia were discontinued. A Ph2 co-therapy trial was a wash/fail, low dose risperidone+Pima only as good as high dose Risperidone; Phase 3 cancelled when Biovail dumped them. Then you have a failed Phase III in PDP.
Good read here
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3055369/
Re ARRY from May
If YMI fired their CEO, I would probably consider investing. But he's got no credibility in my book
They are really far behind INCY, I find it hard to imagine they can catch up without a significant partner. INCY 10mg BID study should have data at ASH for the alternate Jakafi dosing. They're also already in 3 Phase 2 trials(RA, MF, & psioriasis) with a new JAK 1 specific drug.
They really need to close up shop and liquidate cash to shareholders. TRGT seems to be great at making placebos.
Check #ESMO12 abstracts here - http://abstracts.webges.com/esmo2012/myitinerary
Not entirely. That trade also doesnt appear tied to stock either(or at least that I am aware of). Hard to imagine BMRN trading above $30 if GALNS fails, but might be above $30 by January in that case. Pretty bullish to me.
The largest trade that happened was a 3-way trade
Sold 7200 Jan13 30.0 Puts @ $1.65
Sold 4800 Jan13 50.0 Calls @ $1.20
Bought 4800 Nov12 40.0 Calls @ $3.20
On those Nov'12 options, I spoke to a broker, they claim all of those were sold and tied to stock. Really bullish trade given the potential downside.
Real Advances for KRAS Mutation-Positive NSCLC: Dr. Neal Reviews MEK Inhibitor Selumetinib
http://cancergrace.org/lung/2012/09/15/neal-on-selumetinib-for-kras-mutn-pos/
Great article and highlights the one prickly issue with Selumetinib - it's associated with a nearly 50% chance of being hospitalized from side effects. Does 162 have a more favorable AE profile?
re BMRN
Options activity on Friday was insane. Someone is incredibly bullish on the GALNS data. Betting it is unequivocally positive.
PI3K data coming at ACR and ASH.
Still disagree with the article after today's complete fiasco? The trial failed and the company hid it from investors, plain and simple.
Very odd and suggests a good amount of gross misconduct on their part. The study failed and then they decided to use these extra patients to re-do stage 1? Gimme a break.
CRTX likely gets a CRL for the important CHF indication. The other indication is likely commercially meaningless given the efficacy questions and very small sales of currently approved vaptans.
Theyve been dealing with Lymphoseek CMC issues for about 5+ years now. Amazing how incompetent management is here.
GERN has been involved in far too speculative science that always had a low likelihood of commercial success. Fascinating science, but no real development plans.
What they saw in 1st-line NSCLC doesnt strike me as aberrant. Seeing 6.4 months in PFS isnt that unusual. Maybe Peregrine longs should consider that the company doesnt know how to run randomized studies and that patient selection is important. (Clearly they put the "right" patients in the Bavi arm of the 2nd line study). See a diff of about 1 month not very unusual for PFS, but seeing the control arm in the 2nd line study being different but multiple months is a bright red flag.
Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial.
"There was an approximately 10% improvement in progression-free survival (median, 6.3 v 5.8 months; hazard ratio [HR], 0.902; 95% CI, 0.767 to 1.060; P = .214) and overall survival (OS; median, 12.1 v 11.2 months; HR, 0.922; 95% CI, 0.797 to 1.066; P = .271) in the nab-PC arm versus the sb-PC arm, respectively."
http://www.ncbi.nlm.nih.gov/pubmed/22547591
PFS of 5.75 months in this study
http://meeting.ascopubs.org/cgi/content/abstract/25/18_suppl/7544
PFS of 5.75 months in this study
http://jco.ascopubs.org/content/26/33/5407.full
You act as if Peregrine's data are crystal clean. Many issues that posters have already addressed(large amount of censoring in Bavi arms, ECOG & race imbalances and more).
I applaud Peregrine for pulling a rabbit out of their hat. Their data actually makes me even more skeptical of Bavi
Look at the original docetaxel study that led to approval. 7 months was the median overall survival over 12 years ago! Yet somehow PPHM's control arm underperformed nearly all relevant Phase 3 trials I can find..... The control arm is bogus.
http://jco.ascopubs.org/content/18/10/2095.long
There is a gross imbalance in the study or their enrollment protocols were not followed. I'm sorry PPHM longs won't accept this as a possible scenario.
For example, Herbst et al (2010) (“Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced NSCLC (ZODIAC): a double-blind, randomised, phase 3 trial”) reported median overall survival of 10 months!
ARRY's recent Phase 2 trial in 2nd line NSCLC patients with KRAS mutations on Docetaxel showed median 5.2 months OS. Somehow PPHM in an all-comers trial has a roughly similar OS? No freaking way.
PPHM halted
Used wrong acronym.
Without seeing the patient baseline values, hard to believe the Bavi data at all. 6 months in MOS for 2nd line on DTIC is much too low in my opinion. A recent very large Phase 3 showed 10 months.
PPHM's trial must be severely imbalanced. No way should the control arm be that low.
http://thoracicsymposium.org/Thoracic-Daily/tdaily_detail_97_5.html