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Musings on design of phase-3 NASH trial: #msg-113816778.
Not sure, insofar as there was nothing really new in the PR or CC. Still, re-iteration of guidance wrt final design of the phase-3 NASH trial is a positive.
so why is stock up...
ICPT’s current pro forma cash balance is $769M less whatever has been burned since 3/31/14:
#msg-113527893
Intercept Announces New FLINT Trial Data Showing OCA Treatment Increases Fibrosis Resolution and Cirrhosis Prevention in High...
Source: GlobeNewswire Inc.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept) announced today the availability of additional post-hoc analyses from the Phase 2b FLINT trial of obeticholic acid (OCA) in patients with nonalcoholic steatohepatitis (NASH) at the International Liver Congress 2015, the 50th Annual Meeting of the European Association for the Study of the Liver (EASL), being held in Vienna, Austria, from April 22-26, 2015. The poster entitled "Obeticholic Acid for NASH: Benefits in a High-Risk Subgroup and the Effects of Concomitant Stain Use" (late-breaker ePoster LP18) is currently available for viewing and will be presented in Room A-09 at 3:30 p.m. CET on Saturday April 25, 2015. The senior authors include Dr. Brent Neuschwander-Tetri, of St Louis University and Dr. Arun Sanyal, former President of the American Association of the Study of Liver Disease, from the NASH Clinical Research Network that conducted the trial.
Advanced liver fibrosis is currently the best predictor of liver-related mortality in patients with NASH, while patients with early disease and concomitant risk factors such as diabetes, obesity or elevated ALT are also at risk of rapid progression to cirrhosis. The efficacy of OCA was evaluated in a high-risk subgroup of NASH patients in the FLINT trial considered more likely to experience liver-related clinical outcomes, defined as patients with a NAFLD activity score (NAS) of at least 4 and either (i) advanced fibrosis (stage 2 or 3), or (ii) early fibrosis (stage 1) together with concomitant diabetes, obesity or elevated ALT. Approximately 80% of the FLINT patients met these high-risk criteria.
In this post-hoc analysis of the high-risk subgroup after 72 weeks of treatment (n=160; OCA=84; placebo=76), a significant percentage of OCA-treated patients experienced complete resolution of their fibrosis (15% OCA vs. 4% placebo, p=0.006). Improvements in fibrosis resolution were observed in OCA-treated patients across all baseline fibrosis stages (stage 1: 31% OCA vs. 11% placebo, stage 2: 16% OCA vs. 3% placebo, stage 3: 3% OCA vs. 0% placebo). Additionally, OCA treatment prevented progression to cirrhosis (2% OCA vs. 7% placebo), but this finding did not achieve statistical significance in this small number of patients. Improvements in cirrhosis prevention were also observed in patients with stage 3 bridging fibrosis (6% OCA vs. 14% placebo) and stage 2 fibrosis (0% OCA vs. 3% placebo).
The results reported today build on previously reported data from post-hoc analyses showing that OCA-treated patients experienced significant improvements in key histologic features of steatohepatitis, including NAS reduction by at least two points (60% OCA vs. 30% placebo, p=0.0004), NASH resolution (18% OCA vs. 5% placebo, p=0.014), and liver fibrosis improvement by at least one stage (39% OCA vs. 21% placebo, p=0.007). These histologic benefits were observed in OCA-treated patients in all subgroups and regardless of baseline fibrosis stage.
The impact of statin use on LDL cholesterol was also evaluated in the FLINT trial population (n=283). In this post-hoc analysis, OCA-treated patients who initiated statins during the FLINT trial (n=26) experienced a rapid reversal of their observed mean LDL increase to below baseline levels, with a mean decrease after 72 weeks of treatment of -18.9 mg/dL. In contrast, other OCA-treated patients with no reported initiation or change in statin therapy experienced an increase in LDL that peaked at week 12 and was sustained over the 72 week treatment period. Patients treated with statins at baseline who maintained statin treatment over the duration of the study (n=50) experienced a mean LDL increase of 8.7 mg/dL at 72 weeks. Patients not treated with statins during the study (n=65) experienced a mean LDL increase of 16.0 mg/dL. Treatment related LDL increases in all groups reversed with treatment discontinuation. This post-hoc analysis suggests that the OCA associated LDL increase appears to reach a maximum peak and plateaus soon after initiation of therapy and that concomitant statin use in NASH patients receiving OCA may ameliorate any treatment-related LDL increases.
"These data add to our understanding of the potential for OCA treatment to reverse fibrosis and prevent progression to cirrhosis, a pharmacologic benefit not previously confirmed in NASH patients," said Dr. Brent Neuschwander-Tetri, the principal investigator of the trial. "Furthermore, the data support the potential for statins to effectively manage LDL in NASH patients, as currently recommended in the AASLD and EASL practice guidelines."
As previously reported in the primary analysis of FLINT, OCA was generally well tolerated. Adverse events were mild to moderate in severity and the incidence in the OCA and placebo treatment groups was similar for all symptoms except pruritus. Compared with placebo, pruritus in OCA-treated patients occurred more frequently (23% vs 6%, p<0.0001). Typically, the pruritus was of moderate intensity and resulted in one patient discontinuation. The incidence of severe or life threatening events was not different between the two treatment groups and most of the events in both groups were deemed to be unrelated to treatment, including all severe or life threatening cardiovascular events. Two deaths occurred in the OCA treatment group; neither was considered related to OCA treatment.
ICPT’s underwriter surprisingly didn’t exercise the “greenshoe” option in full:
#msg-112461201
That also value point.. Thanks.. I was confused either buy or not, but I am going to wait after your message.thanks..
You should wait until they announce the CLOSE of the offering first IMO
I hope it will be 5% tomorrow.. And I am buying ICPT first time.
The post you replied to IS THE REASON!
SMH
Why the stock is down today?? Is this going to be up tomorrow?? Any idea..
Intercept Pharmaceuticals Announces Proposed Offering of Common Stock
6:24 AM ET 3/31/15 | GlobeNewswire
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases, today announced that it is commencing an underwritten public offering of 1,200,000 shares of its common stock. All of the shares in the offering are to be sold by Intercept. The underwriters intend to offer the shares of common stock from time to time for sale in one or more transactions on The Nasdaq Global Select Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. Intercept intends to grant the underwriters a 30-day option to purchase up to an additional 180,000 shares of common stock, on the same terms and conditions.
Intercept intends to use the net proceeds of this offering to support the expansion of its clinical, regulatory, medical affairs and commercial infrastructure in the United States and Europe, the clinical development program for obeticholic acid (OCA) in primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC), the expansion of OCA manufacturing activities, advancement of INT-767 and other preclinical pipeline programs, and the preparation for and potential initiation of the commercial launch of OCA in PBC in the United States and certain European countries in 2016. The balance, if any, will be used for general corporate purposes.
UBS Investment Bank and Citigroup are acting as underwriters in the offering.
A preliminary prospectus supplement relating to the offering has been filed with the Securities and Exchange Commission (the SEC). Copies of the preliminary prospectus supplement may be obtained from the offices of UBS Investment Bank c/o Prospectus Department, 1285 Avenue of the Americas, New York, New York 10019, or by calling 1-888-827-7275; or Citigroup c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, via telephone at 1-800-831-9146 or email at prospectus@citi.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.
The securities described above are being offered pursuant to an automatically effective shelf registration statement on Form S-3 previously filed by Intercept with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat neglected chronic liver diseases. The company's lead product candidate, obeticholic acid (OCA), is a first-in-class agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The FDA has granted OCA breakthrough therapy designation for the treatment of NASH with fibrosis and granted OCA fast track designation for the treatment of patients with PBC who have an inadequate response to or are intolerant of ursodiol. OCA has also received orphan drug designation in both the United States and Europe for the treatment of PBC and PSC. Intercept owns worldwide rights to OCA outside of Japan, China and Korea, where it has out-licensed the product candidate to Sumitomo Dainippon Pharma. Additional information about Intercept is available in the company's public filings, which are available at the SEC's EDGAR database available online at www.sec.gov.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated final terms, timing and completion of the offering; the use of proceeds of the offering; clinical and regulatory developments for OCA, the anticipated timeframe for the commencement, completion and receipt of results from the clinical trials in OCA and for the making of regulatory submissions; the anticipated results of the company's clinical and preclinical trials and other development activities; and Intercept's strategic directives under the caption "About Intercept." Intercept may not be able to complete the offering of common stock on the anticipated terms, or at all. The "forward-looking statements" in this press release are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: whether or not the company will be able to raise capital through the sale of shares of common stock, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed public offering, the impact of general economic, industry or political conditions in the United States or internationally; the initiation, cost, timing, progress and results of Intercept's development activities, preclinical studies and clinical trials; the timing of and Intercept's ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates it may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; Intercept's plans to research, develop and commercialize its product candidates; the election by Intercept's collaborators to pursue research, development and commercialization activities; Intercept's ability to attract collaborators with development, regulatory and commercialization expertise; Intercept's ability to obtain and maintain intellectual property protection for its product candidates; Intercept's ability to successfully commercialize its product candidates; the size and growth of the markets for Intercept's product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; undesirable side effects that may be found in Intercept's product candidates that may delay or prevent regulatory approval or require the company's product candidates to include safety warnings or be taken off the market; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; Intercept's need for and ability to obtain additional financing; Intercept's estimates regarding expenses, future revenues and capital requirements and the accuracy thereof; Intercept's ability to retain key scientific or management personnel; and other factors discussed under the heading "Risk Factors" contained in Intercept's annual report on Form 10-K for the year ended December 31, 2014 filed on March 2, 2015 and in the preliminary prospectus supplement related to the proposed offering filed with the SEC on the date of this press release. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.
CONTACT: For more information about Intercept,
please contact Barbara Duncan or Senthil Sundaram,
both of Intercept Pharmaceuticals at +1-646-747-1000.
Media inquiries: media@interceptpharma.com
Investor inquiries: investors@interceptpharma.com
http://media.globenewswire.com/cache/23024/small/25215.jpg
http://www.globenewswire.com/newsroom/ti?nf=MTMjMTAxMjY5NzMjMjMwMjQ=
This ask just made me super rich of 1999999999 lol
Analysts differ on Intercept after Genfit NASH data
Two analysts differed on the outlook for Intercept (ICPT) after a drug that could compete with the company's flagship product failed to meet its primary endpoint in a study. BACKGROUND: Genfit (GNFTF) yesterday announced that in a trial of its GFT505 NASH treatment, the drug failed to meet the primary endpoint. The company blamed the shortfall on greater than expected improvement in the condition of patents taking placebos. Nonalcoholic Steatohepatitis, or NASH, is a symptom of nonalcoholic fatty liver disease. Intercept's flagship product, OCA, is also a treatment for NASH that is undergoing clinical trials. However, OCA has received "breakthrough therapy designation" from the FDA for the treatment of liver fibrosis patients with NASH. BULLISH TAKE: In a note to investors earlier today, Deutsche Bank analyst Alethia Young wrote that Genfit's drug failed to make an impact on fibrosis histology. OCA's profile in NASH patients with fibrosis has improved relative to GFT-505 following the study. And OCA "is the clear leader in treating patients with NASH that have fibrosis," the analyst stated. Although Genfit's drug did show "early signs" of being able to treat fibrosis, OCA has already shown a statistically significant benefit in fibrosis in an earlier trial, Young noted. The analyst raised her price target on the name to $400 from $300 and kept a Buy rating on the shares. BEARISH TAKE: Genfit's data provides useful information that could enable the company to design a successful Phase III trial that tests its drug on patients similar to those who have participated in Intercept's trial, Leeink analyst Joseph Schwartz stated. In 202 patients with more advanced NASH, Genfit's drug improved NASH symptoms by a statistically significant amount, Schwartz reported. Intercept's OCA reduced the symptoms of analogous NASH patients by a similar amount in a study, but the drug's impact was not statistically significant because of a higher placebo effect, the analyst reported. Consequently, Genfit's drug may have missed its primary endpoint because of the difficulty of measuring NASH in patients with earlier stages of the disease, the analyst wrote. Noting that Genfit, like Intercept, plans to initiate a Phase III study of its drug at the end of this year, Schwartz said that Genfit may not be very far at all behind Intercept. As a result, investors may question the peak market opportunity of Intercept's OCA, according to Schwartz, who kept a Market Perform rating on Intercept. PRICE ACTION: In late morning trading, Intercept rose 2% to $288
I see 5 analyst opins since yesterday ~
Intercept has positive read through from competitor data, says BMO Capital
After Intercept (ICPT) competitor Genfit announced top-line results from a Phase 2 trial of its oral PPAR agonist GFT505 in NASH, BMO Capital says that Genfit's data was disappointing and will consolidate the lead of Intercept's OCA in NASH. The firm reiterates an Outperform rating on Intercept
This will be back over $400 this summer no doubt.
It trades like shit, you were fortune to get in low and that's great for you but the trading pattern is horrible. Not bashing been here for a while now.
POS? I'm up over 100 points in this pos. Get out of here with the spam.
Lol. No idea. It's run pretty hard last little while. 300 seems to be strong resistance. My guess it's getting caught up in the market wide biotech sell off.
what is your take on this pos, are we waiting to see a squeeze of some sort after the shorts are done drawning this pos, After all the upgrades on the price target this pos as received something has to give, i mean the flint results were better than last time there was an improvement and were positive on mostly everthing. there has to be movement upward something this week or when the shorts decide to let this big pos breathe and take off. Wanka tell me something and make my day a little better before i throw pc down to 5th street. lol
lol, Feeling mix emotions right now it wouldn't be pretty i'm just going to take a deep breath wait for the opportunity to get out. thanks
Lol buddy why don't you tell us what you really think
This is a pos always does the same routine even with big and good news this pos tanks. i can't wait to get the fu%&$% out of this pos.
Selling off big time so I'm guessing nothing exciting
Did anyone here in this board have any understanding of the flint results and the out come of positive or not.
Road back to $400!
Low floater of 15.6M shares; steadfast upside mover!
This thing is a beast!!! I was going to buy $220 calls at the beginning of the week and passed
Well maybe that's just the case for me then. Not very many plays I could be up almost 100 points and counting on. I remember this over $400 and we are well on our way.
i been tryin to get back in but looks like it aint happening...
I disagree with that sentiment, of course.
Awesome day. Never have to worry about this stock with the floor in at $175
Further to the point in #msg-111327605:
.@lomu_j In other words, $ICPT has no freaking idea yet about the proper dose for OCA in NASH.
— Roy Friedman (@DewDiligence) March 3, 2015
Musings on ICPT’s 4Q14 CC: #msg-111327605.
Intercept Pharma (NASDAQ:ICPT): Q4 EPS of -$1.63 beats by $0.04.
Revenue of $0.45M (+9.8% Y/Y) beats by $0.02M.
looks like a long wait for me...
you know what they say, money missed is better than money lost. But get ready to miss a lot of money.
Looking into it, but brings strong investor confidence that a floor is established at $176. More capital secured is really good. Buyers piling in down here believing such.
What is the $$ to be used for?
To buy out a small cap to help it become NASH king??
Well that offering came out of left field. Probably see $170-$175 today.
Powerhouse stock
Grab these cheapies
Top analysts have a $500+ target
The reversal is in
Do not like the action right now, this stock should be trading in the 250 by now with this great news,
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