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Can't be true, AZN filed a BLA for motavizumab and got a CRL a few yrs ago
No, not even stat sig for PD-L1-positive subgroup. HR 95% CI crossed 1.
OCRX - Do you really want to trust a team that can't use "hazard ratio" properly in a press release?
Comparing valuation vs other companies using revenue multiple is misleading here because IONS revenue line relies on amortization of up-fronts, cash flow will be a better metrics to look at.
Yahoo biopharma news archive page seems dead, anyone has a good alternative? Thanks
http://biz.yahoo.com/n/y/y0022.html
ILMN for EXAS has to be one of the most ridiculous takeout rumors in a while!
Roy & Peter, think you both picked CMRX in your contest portfolio. What do you think of the full Ph3 SUPPRESS data and next step fwd? Thanks
http://files.shareholder.com/downloads/AMDA-1QNA05/1553771389x0x876238/E6BF3107-8B16-487D-B5A7-ED4A905C54E6/Chimerix_BMT_Tandem_Meeting_Presentation_February_2016.pdf
Both TLOG and HSGX moves are typical book marking for the last day of the year.
WRONG! 22% gross to net at end of 2014, and GILD expects that number to reach 46% at end of 2015.
Why would MRK buy a drug that's still on participial clinical hold?
Without that hold lift, the whole program is basically worthless as they can't run any trials longer than 6 months.
ESPR said the two-year carcinogenicity studies were already completed in 2Q14 and they plan to submit to FDA in early 2015.
So basically they know all the animal study data, but they won't disclose it until they submit and hear back from FDA...
Frankly it smells like the data are not 100% clean and they probably need some fighting with the FDA...
ZSPH upsized the offering by ~1M add'l shares, Renaissance Capital information is not accurate.
IDIX-NVS deal was restructured back in 2012, NVS no longer has the option rights but they still own 22% of IDIX.
http://ir.idenix.com/releasedetail.cfm?releaseid=696719
One example that @AndyBiotech mentioned on twitter today is pretty interesting: Pfenex and Phenex are two biotech companies that are both currently on roadshows for financing. Same pronunciation and more confusion?
Pfenex: Biosimilars player just filed for IPO, lead cmpd Lucentis biosimilar;
Phenext: ICPT competitor for NASH, also working on FXR agonist.
My impression was the lawsuit was not about company name, rather it's for the "ALK" used before compound coding...
Frankly it's quite meaningless... If “breakout sessions” webcasts become standard, investment banks will just come up with a post-breakout sessions for off-record meetings, it's just human nature...
Not new, Merck changed the generic name for MK-3475 from lambrolizumab to pembrolizumab in February.
Thanks JQ. For a disease like duchenne, I think they should have shown whether it's well balanced between treatment and placebo arm (age, baseline characteristics, etc), especially given the trial succeeded mainly due to natural history.
It also seems 6 patients on placebo arm were excluded from the primary analysis (Total N=33 on slide 10, only 27 included in slide 13).
Also had a feel similar to Trophos Olesoxime Phase 2/3 SMA data:
http://www.trophos.com/news/pr20140428.htm
ICPT: Not as simple/clear as you thought, check out some comments from BiomedTracker's NASH KOL survey.
$ICPT Another KOL: "increasing LDL is a concern, people don't die of their fatty liver disease they die from MI" http://t.co/GltQNkHVNX ($)
— Edny Inui (@DoctorEdny) May 20, 2014
IPF: Another small molecule in Ph2 that's worth noting is BMY's LPA1 receptor antagonist BMS-986020.
http://clinicaltrials.gov/show/NCT01766817l
BTW: ITMN also has a LPA1 receptor antagonist ITMN-10534 in late-stage pre-clinical development.
EU orphan exclusivity only applies to "similar medicines" w/ "similar indications". Don't think Pirfenidone and Nintedanib are "similar medicines" in this case, different to PLX vs Shire.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000392.jsp&mid=WC0b01ac058061f019
TRx were 10,945 for Olysio for 1Q14. TRx were 61,383 for Sovaldi for 1Q14. (from IMS monthly numbers)
Using Olysio sales as proxy, Sovaldi Q1 sales would be ~$2B.
But Key caveats for that is 20% of Olysio sales were inventory stocking. So it's really a guessing game since no way to accurately model inventory stocking for Sovaldi.
QURE - uniQure/Chiesi's hemophilia program is still in late stage pre-clinical development and won't move into clinic until 2H14, while Baxter/Chatham already has their program in clinic, thus it seems a weak argument to assume that uniqure has an advantage over Baxter that it will be ithe first to market...
The key differentiation will come from clinical data (both safety and efficacy), which we have none from both yet, so it's quite premature to assume any advantage at this point. Just typical sell-side spin IMHO.
ICPT: You should have read the PR more carefully, the 150K over-allotment will also be offered by existing shareholders...
ICPT:
RTRX: I doubt that's the final pricing, more likely quoting "the last reported sale price was $8.30/share" from S-1/A, as someone mentioned on Twitter
RTRX: some weird info in S-1/A on share buyback. (H/T @lomu_j)
Thanks Peter, it's a very interesting discussion you initiated. Just curious how the option strike prices change in an all-stock deal, do they change proportionally at the time of acquisition close?
ARQL - seems like RBC had a bullish notes on it
Reuters Story
ARQL, so what exactly caused this 20% spike? Anything interesting from ESMO late-breakers?
RTRX - Martin previously worked with Jim Cramer, so close to AF's camp. From what I heard, his career at hedge fund world was not particularly successful, I heard rumor (unconfirmed) that he lost lots of money and was eventually fired.