Biotech Stock Mailbag: Furiex, La Jolla Pharma, Sarepta
By: Adam Feuerstein

http://www.thestreet.com/story/12314564/1/biotech-stock-mailbag-furiex-la-jolla-pharma-sarepta.html

great day here....glad I bought last week...enjoy the $$$ guys, and congrats

6:06AM Furiex Pharmaceuticals announces positive top-line results of two pivotal Phase III clinical trials of eluxadoline in patients with IBS-d; studies meet FDA and EMA primary endpoints (FURX) 45.97 :

Co announced top-line results indicating the co's two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d) met both the FDA and the European Medicines Agency (EMA) formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain. These endpoints are aligned with both the current FDA guidance and the 2013 EMA draft guidance for clinical trial evaluation of new medicines for irritable bowel syndrome.
"In just under four years, working closely with regulatory authorities, the team has completed nine Phase I studies, a Phase II dose-ranging trial in approximately 800 patients, and these two large Phase III trials. Additionally, we have completed all toxicology studies and believe we are on schedule, including chemistry and manufacturing work, for an NDA submission by the end of the second quarter of 2014."
Key Findings from Study 3002 (intention-to-treat analysis): Patients receiving eluxadoline demonstrated statistically significantly higher responder rates for the following composite primary endpoints:
For the FDA composite endpoint (response over weeks 1-12), the responder rates were 29.5% for eluxadoline 100 mg, 28.9% for eluxadoline 75 mg and 16.2% for placebo (p <0.001 both doses); and
For the EMA composite endpoint (response over weeks 1-26), the responder rates were 32.6% for 100 mg, 30.4% for 75 mg and 20.2% for placebo (p =0.001 both doses).
With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher rates of stool consistency response over weeks 1-12, namely 100 mg=35.5%, 75 mg=37.0% and placebo=20.9% (p <0.001 both doses), and numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=50.9% vs. placebo=45.3%, p =0.12).
Key Findings from Study 3001 (intention-to-treat analysis):
Patients receiving eluxadoline demonstrated statistically significantly higher response rates for the following primary composite endpoints: For the FDA composite endpoint (response over weeks 1-12), the responder rates were 25.1% for eluxadoline 100 mg (p =0.004), 23.9% for eluxadoline 75 mg (p =0.014) and 17.1% for placebo; and
For the EMA composite endpoint (response over weeks 1-26), the responder rates were 29.3% for 100 mg (p <0.001), 23.4% for 75 mg (p =0.11) and 19.0% for placebo.
With respect to the individual secondary components of the FDA composite endpoint, eluxadoline-treated patients demonstrated significantly higher response rates of stool consistency over weeks 1-12, namely 100 mg=34.3%, 75 mg=30.0% and placebo=22.0% (p <0.009 both doses) and, numerical improvement in pain response rates at 100 mg over weeks 1-12, although this difference did not reach statistical significance (100 mg=43.2% vs. placebo=39.6%, p =0.28).
Furiex will conduct a live conference call and webcast Tuesday, February 4, 2014 at 8:30 a.m. ET to discuss the top-line results.

Wow - I didn't think we would see another move like this ..

$FURX Next $ICPT Has Half the Float of ICPT and Twice the Sales Potential!

7:00AM Furiex Pharmaceuticals enters into a loan agreement for $15 mln and restructures its existing secured loan (FURX) 43.99 : Co announces it has executed a $15 million debt financing transaction with Fred Eshelman, chairman and a 27.5% shareholder of co. In parallel,

Furiex has also entered into a Second Amended and Restated Loan and Security Agreement with MidCap Financial and Silicon Valley Bank to restructure its existing $40 mln credit facility. The restructured agreement defers payment of principal until May 15, 2014 with a flexible amortization schedule linked to Furiex's receipt of alogliptin royalties.

7:03AM Furiex Pharmaceuticals confirms Takeda (TKPYY) received European Marketing Authorization for VIPIDIA; MA triggers a $10 mln milestone payment to FURX (FURX) 42.34 : Co confirmed Takeda Pharma's (TKPYY) announcement that the European Commission has granted Marketing Authorization for VIPIDIA (alogliptin) for the treatment of Type 2 diabetes patients who are uncontrolled on existing therapies and for the fixed-dose combinations VIPDOMET (alogliptin and metformin) and INCRESYNC (alogliptin and pioglitazone). The Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency, issued a positive opinion for these products on July 26, 2013. Under its agreement with Takeda, the MA triggers a $10 million milestone payment to Furiex. Furiex is also eligible to receive tiered royalties on product sales in the EU and potential sales-based milestones.

Ohr Pharmaceutical Appoints June S. Almenoff to Board of Directors
Press Release: Ohr Pharmaceutical Inc. – 24 minutes ago


NEW YORK, May 22, 2013 /PRNewswire/ -- Ohr Pharmaceutical Inc. (OHRP), a pharmaceutical company focused on the development of novel therapeutics for unmet medical needs, today announced the appointment of June S. Almenoff, M.D., Ph.D., to its Board of Directors. Dr. Almenoff has extensive experience in the pharmaceutical industry, working on early and late stage drug development.

"We are delighted to have Dr. Almenoff join Ohr's Board," said Dr. Irach Taraporewala, CEO of Ohr Pharmaceutical. "She offers tremendous expertise in the areas of pharmaceutical research and development, risk management, and product licensing. We look forward to working with June as we continue to achieve significant corporate milestones including the halfway point in enrollment of the Squalamine eye drop phase II clinical trial and our proposed listing on NASDAQ, both expected by midyear."

"I am excited to be joining the board of Ohr," said Dr. June Almenoff. "Ohr has a promising pipeline and excellent team, and I look forward to working with the Board to help drive the company toward future success."

June S. Almenoff, M.D., Ph.D. is President and Chief Medical Officer of Furiex Pharmaceuticals, a pharmaceutical development and collaboration company (FURX:Nasdaq); she serves as the company's Principal Executive Officer and a member of the Board of Directors. Since its inception in 2010, Furiex has completed two successful proof-of-concept programs, one of which has advanced to pivotal Phase III trials. Prior to joining Furiex, Dr. Almenoff had over 12 years of pharmaceutical industry experience at GlaxoSmithKline. During her tenure at GSK, she was a Vice President in the Clinical Safety organization at GSK, where she chaired a Pharma-FDA working group, and she also worked in the area of scientific licensing. While at GSK, Dr. Almenoff led teams that developed several systems for minimizing risk in early- and late-stage drug development, which were recognized by the Wall Street Journal Technology Innovation Award and several other prestigious awards. Prior to joining GSK, Dr. Almenoff was on the faculty of Duke University Medical Center, where she is currently a Consulting Professor of Medicine.

Dr. Almenoff received her B.A. cum laude from Smith College. She graduated from the M.D.-Ph.D. program at the Mt. Sinai School of Medicine and completed a residency in Internal Medicine and a Fellowship in Infectious Diseases at Stanford University Medical Center. Dr. Almenoff is a board-certified Fellow of the American College of Physicians with 10 years of clinical practice experience, and she has authored 50 publications.

About Ohr Pharmaceutical Inc.
Ohr Pharmaceutical Inc. (OHRP) is a pharmaceutical company dedicated to the clinical development of new drugs for underserved therapeutic needs in large and growing markets. The Company is focused on advancing its pipeline products currently in phase II clinical development: Squalamine Eye Drops for the treatment of the wet form of age-related macular degeneration, and OHR/AVR118 for the treatment of cancer cachexia. Additional information on the company can be found at www.ohrpharmaceutical.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and Ohr Pharmaceutical undertakes no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing, and no assurance or warranty can be made that the FDA or Health Canada will approve final testing or marketing of any pharmaceutical product. Ohr's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We disclaim any intent to revise or update publicly any forward-looking statements for any reason.

Contact:
Ohr Pharmaceutical Inc.
Investor Relations:
Tel: (877) 215-4813
Email: ir@ohrpharmaceutical.com

Furiex Pharmaceuticals Management Discusses Q1 2013 Results - Earnings Call Transcript

http://seekingalpha.com/article/1417051-furiex-pharmaceuticals-management-discusses-q1-2013-results-earnings-call-transcript?source=yahoo

Nice...

4:06PM Furiex Pharmaceuticals receives qualified infectious disease product and fast track designations from the U.S. Food and Drug Administration for Avarofloxacin (JNJ-Q2) (FURX) 36.26 -0.73

DAAAAAAAMMMMMMNNNNN!!!!!!

1:25AM Furiex Pharmaceuticals confirms Takeda's (TKPYY) receipt of FDA approval of NESINA and fixed-dose combinations OSENI and KAZANO; Furiex is entitled to receive a $25 mln milestone payment as a result of this approval (FURX) 21.24 : Under its agreement with Takeda, Furiex is entitled to receive a $25 mln milestone payment as a result of this approval, as well as royalties on sales in the United States and potential sales-based milestones. Furiex has already been receiving royalty payments from Takeda for the sale of NESINA and LIOVEL in Japan.

Furiex Reports Third Quarter 2012 Financial Results
Third Quarter 2012 Highlights:

November 1, 2012

Milestone revenue of $10.0 million related to Priligy® regulatory milestones.
Royalty revenue of $5.6 million, an increase of $2.5 million (81.4%) from second quarter 2012.
Amended Loan and Security Agreement providing $30.0 million in additional funding.
Cash and short-term investments balance of $47.8 million as of September 30, 2012.
MORRISVILLE, N.C. (November 1, 2012) - Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today reported its financial and operating results for the quarter ended September 30, 2012.

Furiex recorded third quarter milestone revenue of $10.0 million. These regulatory milestones were related to achievement of new country marketing approvals for Priligy® and became due from the Menarini Group upon closing of the new license agreement on July 30, 2012.

Furiex recorded third quarter royalty revenue of $5.6 million, compared to $1.3 million for the same period in the prior year and $3.1 million in the second quarter of 2012. Royalty revenue included royalties related to Nesina® and Liovel® sales in Japan, and Priligy® sales in various countries outside of the United States.

Research and development expenses were $14.8 million for the quarter ended September 30, 2012, compared to $12.0 million for the same period in the prior year. The increase in research and development expenses from the prior year quarter ended September 30, 2011 was a result of the decision to progress with MuDelta Phase III clinical trials in early 2012 and the costs associated with its continued development, partially offset by decreases in spending for the discontinued PPD-10558 program and completion of the Phase II clinical trial work related to MuDelta and JNJ-Q2.

Third quarter selling, general and administrative expenses were $3.2 million for 2012, compared to $2.1 million for the third quarter of 2011. The increase in selling, general and administrative expenses were due primarily to increases in non-cash stock compensation expense of $0.4 million and increases in consulting expenses of $0.4 million.

Interest expense of $0.8 million for the third quarter of 2012 related entirely to our loan agreement with MidCap Funding III, LLC and Silicon Valley Bank.

Net loss was $3.3 million for the third quarter of 2012, compared to $13.0 million for the third quarter of 2011. The decrease in net loss of $9.7 million during the third quarter of 2012, as compared to the third quarter of 2011, relates to the changes in revenue and expenses previously described.

Net loss per share for the third quarter of 2012 was $0.33, compared to $1.32 for the third quarter of 2011.

"The Furiex team continues to advance the MuDelta Phase III clinical trials," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "We have recruited slightly more than 30% of our targeted patient enrollment needed to complete these pivotal studies."

"We have made significant strides on multiple fronts," added Fred Eshelman, Pharm.D., chairman of Furiex. "MuDelta development remains on track, Nesina and Liovel royalty revenue from Japan continues to ramp up, Takeda has resubmitted New Drug Applications for alogliptin and alogliptin/pioglitazone to the FDA, restructuring of the Priligy agreements is complete and immediately accretive, and we have secured $30 million in additional funding to support operations. We believe we have laid a sound foundation for the development of our product portfolio."

Furiex will conduct a live conference call and webcast Friday, November 2, 2012, at 9:00 a.m. ET to discuss its third quarter 2012 results and financial outlook for 2012 as well as provide an overview of its business and pipeline. A Q&A session will follow. All interested parties can access the webcast through the Presentations & Events link in the Investors section of the Furiex website at www.furiex.com. The webcast will be archived shortly after the call for on-demand replay. The conference call will be broadcast live over the Internet and will also be available using the following direct dial numbers:

Participant dial-in: +1.877.677.9122 (U.S./Canada)
+1.708.290.1401 (International)
Conference ID: 35741137

Furiex Pharmaceuticals (FURX) is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. The company's drug development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a strong, diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner, and two products on the market. The company's mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients.

(click to enlarge)

Insider buys

June Almenoff purchased 1,000 shares on August 14-15 and currently holds 7,000 shares of the company. June Almenoff, M.D., Ph.D., is president and chief medical officer, and serves on the board of directors. She is Furiex's principal executive officer. Dr. Almenoff joined Furiex after a successful 12-year career at GlaxoSmithKline (GSK), and has served as president and chief medical officer of Furiex since its inception in 2010.

Financials

The company reported the second-quarter financial results on August 2 with the following highlights:
Revenue $13.1 million
Net loss $20.8 million
Cash $26.5 million

Upcoming milestones

MuDelta Program Status and Economics

FDA Fast-Tracked, potential for NDA submission in 1H2014

JNJ-Q2: Best-in-class Fluoroquinolone with Potent MRSA Coverage

Phase III ready for both skin and pneumonia indications

NESINA (Alogliptin)

Launched in Japan in 2010; sales trajectory driving FURX royalties
Takeda received complete response letter on April 25th 2012
Takeda believes additional data requested by the FDA can be provided from ongoing clinical trials and ex-US post-marketing data. Project approval by end Takeda's fiscal year 2012.
Filed MAA in the EU in Q2 2012 triggering $10mm milestone for Furiex

My analysis

The stock has a $30.5 price target from the Point and Figure chart. The stock has seen heavy insider buying since May 2011. The stock was reiterated as Buy on May 14 by Ladenburg Thalmann with a $33 price target. I am not arguing with the price target nor planning to take any positions in the stock currently.

http://seekingalpha.com/article/815811-5-pharmaceutical-companies-with-insider-buying-during-august-14-16?source=yahoo

Furiex Pharmaceuticals Announces First Patient Dosed in Phase III Clinical Trials of MuDelta in Diarrhea-Predominant Irritable Bowel Syndrome
Business WirePress Release: Furiex Pharmaceuticals – Tue, Jun 19, 2012 4:06 PM EDT

MORRISVILLE, N.C.--(BUSINESS WIRE)--

Furiex Pharmaceuticals, Inc. (FURX) today announced dosing of the first patient in its Phase III randomized, double-blind, placebo-controlled studies evaluating efficacy, safety and tolerability of MuDelta (JNJ-27018966) in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Furiex is conducting two simultaneous Phase III trials, one with a 52-week treatment period and one with a 30-week treatment period, in study centers in the United States, Canada and United Kingdom. Combined, the trials are expected to enroll approximately 2,250 patients.

Furiex previously announced the successful completion and outcome of its Phase II study to assess the safety and efficacy of an oral formulation of MuDelta in patients with IBS-D. The study achieved statistically and clinically significant results for its primary as well as a number of key secondary endpoints, and demonstrated durable efficacy through the 12-week treatment period.

“MuDelta is a first-in-class compound and we are extremely pleased that the Phase III trials have commenced and look forward to further advancing the development plan for this important therapeutic candidate,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex.

Added Fred Eshelman, Pharm.D., chairman of Furiex, “We believe MuDelta will fill an unmet need for an IBS-D treatment that has efficacy in both pain and diarrhea, a good safety profile and a convenient dosing schedule. It has the potential to create significant value as we progress its development.”

In November 2011, we acquired full exclusive license rights to develop and commercialize MuDelta under our existing development and license agreement with Janssen Pharmaceutica, N.V., or Janssen. Under the terms of our agreement Janssen will be eligible to receive a $5 million milestone payment upon dosing of the fifth patient in the Phase III trial, up to $45 million in regulatory milestone payments and, if approved for marketing, up to $75 million in sales-based milestone payments and sales-based royalties increasing from the mid to upper single digit percentages as sales volume increases. Royalties are to be paid for a period of ten years after the first commercial sale or, if later, the expiration of the last valid patent claim or the expiration of patent exclusivity.

For more details about these trials, please visit www.clinicaltrials.gov.

About MuDelta

MuDelta is a novel, orally active, Phase III investigational agent with combined mu opioid receptor agonist and delta opioid receptor antagonist activity which acts locally in the gut and has very low oral bioavailability, diminishing sedating side effects. This dual opioid activity is designed to treat diarrhea and pain symptoms of IBS-D, without causing the constipating side effects that can occur with mu opioid agonists.

About IBS-D

Diarrhea-predominant irritable bowel syndrome is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 12 million Americans. Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gut and nervous system interact. IBS-D can be extremely debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.

they got a CRL (denied) the stock is trading under 15.00$ right now.

Furiex Confirms Takeda's Receipt of Complete Response Letter from the FDA for Alogliptin and Fixed-Dose Combination Alogliptin and Pioglitazone

MORRISVILLE, N.C., Apr 26, 2012 (BUSINESS WIRE) -- Furiex Pharmaceuticals, Inc. FURX -6.09% today confirmed that Takeda Pharmaceutical Company Limited issued a news release reporting that Takeda has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug applications (NDAs) for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone.

Takeda recently provided post-marketing data from outside the U.S. and has been in discussions with the FDA. The FDA has requested additional data, which Takeda believes it can supply from post-marketing data from outside the U.S., as well as data from its ongoing clinical trial program.

Takeda intends to immediately request a meeting with the FDA to determine the appropriate next steps and is committed to addressing outstanding issues.

"We are disappointed with the FDA decision," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "Our partner Takeda has extensive Phase III data, including interim findings from a cardiovascular outcomes trial and we remain confident in the future potential of alogliptin and alogliptin/pioglitazone for the treatment of type 2 diabetes."

Currently, Furiex receives royalty payments from Takeda for the sale of these alogliptin products, trade names NESINA(R) and LIOVEL(R), in Japan.

About Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. More than 23 million Americans currently live with the disease. Type 2 diabetes is a progressive and chronic condition, and patients should work with a health care professional to manage and monitor their disease. In addition to diet and exercise, patients often need to take multiple medications to help manage blood glucose. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $376 billion in 2010. By 2030, this number is projected to exceed $490 billion

http://www.marketwatch.com/story/furiex-confirms-takedas-receipt-of-complete-response-letter-from-the-fda-for-alogliptin-and-fixed-dose-combination-alogliptin-and-pioglitazone-2012-04-26

6:45AM Furiex Pharmaceuticals confirms Takeda's (TKPYY) receipt of complete response letter from the FDA for alogliptin and fixed-dose combination alogliptin and pioglitazone (FURX) 19.58 : Co onfirmed that Takeda Pharmaceutical (TKPYY) issued a news release reporting that Takeda has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its new drug applications for alogliptin, and the fixed-dose combination therapy alogliptin and pioglitazone. Takeda recently provided post-marketing data from outside the U.S. and has been in discussions with the FDA. The FDA has requested additional data, which Takeda believes it can supply from post-marketing data from outside the U.S., as well as data from its ongoing clinical trial program. Takeda intends to immediately request a meeting with the FDA to determine the appropriate next steps and is committed to addressing outstanding issues. Currently, Furiex receives royalty payments from Takeda for the sale of these alogliptin products, trade names NESINA and LIOVEL, in Japan.

I just bought one call for May to see what would happen to it on approval...This is trading very strange after hours and the fact it hasnt been halted makes me wonder if they got denied? Lately a halt means approved with FDA decisions.

WHOA!!!!!!!!! WTF???

Furiex Announces that the European Commission Endorses Positive Opinion of Priligy™ for the On-Demand Treatment of Premature Ejaculation in all European Union Countries

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Furiex Pharmaceuticals, Inc. (Nasdaq: FURX - News) today announced that the European Commission endorsed the positive opinion adopted by the Committee for Human Medicinal Products (CHMP) on October 18, 2011 for Priligy™ (dapoxetine) 30 mg and 60 mg doses. Pending national approvals, the marketing authorization for the Priligy doses can be granted in the European Union Member States where the drug has not yet been approved, and also in Norway and Iceland. The indication for Priligy approved by the EC is the on-demand treatment of premature ejaculation in men between the ages of 18 and 64.
“We are pleased with the decision of the European Commission,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “This decision will make Priligy, the only approved medication for premature ejaculation, available to a wider market in the EU.”
About Premature Ejaculation
Premature ejaculation (PE) is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. The condition consists of three major components: a short time to ejaculation, lack of ejaculatory control, and negative personal impact, including distress related to rapid ejaculation. A combination of physiological and psychological factors is believed to influence the mechanism of ejaculation. Research suggests serotonin plays a central role in the timing of ejaculation.
About Priligy
Priligy (dapoxetine) is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI) designed to be taken only when needed – one to three hours before sexual intercourse is anticipated – rather than every day. The drug is specifically developed for the on-demand treatment of PE and was extensively evaluated in five randomized, placebo-controlled Phase III clinical trials involving more than 6,000 men with PE and their partners. This is the largest and most comprehensive clinical trial program to date for a drug therapy to treat PE. Priligy is the first oral medication (tablet) to be approved for this condition in a growing number of countries around the world. Priligy is marketed by Janssen-Cilag, a division of Johnson & Johnson.
About Furiex
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of internal and partnered drug programs by advancing them through the drug discovery and development process in a cost-efficient manner. Development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a strong, diversified product portfolio and pipeline with multiple therapeutic candidates including late-stage assets and two products on the market. The company’s mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.

http://finance.yahoo.com/news/Furiex-Announces-European-bw-2802179896.html?x=0

Action comin in here, just now! LOD 20.56$. low volume still thought...

no position for me just watching and doing some DD.

Are you ready????

FURX PDUFA Wed, April 25, 12am – Thu, April 26, 12am
Calendar
FDA Calendar

~ Friday! $FURX ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $FURX ~ Earnings expected on Friday *
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*If the earnings date is in error please ignore error. I do my best.

~ Monday! $FURX ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $FURX ~ Earnings expected on Monday *
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*If the earnings date is in error please ignore error. I do my best.

Furiex Pharmaceuticals Announces Fourth Quarter and Full Year 2011 Earnings Release and Conference Call
Business WirePress Release: Furiex Pharmaceuticals, Inc. – Mon, Jan 23, 2012 4:05 PM EST

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Furiex Pharmaceuticals, Inc. (Nasdaq: FURX - News) will release its fourth quarter and full year 2011 financial results on Tuesday, February 21, 2012, after the market closes. The earnings news release will be available on the Furiex website at www.furiex.com.

On Wednesday, February 22, 2012, at 9 a.m. ET, Furiex will conduct a live conference call and audio webcast to discuss financial results and product portfolio. A Q&A session will follow. The conference call will be broadcast live over the Internet and will also be available using the following direct dial numbers:
Participant dial-in: +1 877 267 0934 (U.S./Canada)
+1 706 643 0961 (International)
Conference ID: 45542437

All interested parties can access the webcast through the Presentations & Events link in the Investors section of the Furiex website at www.furiex.com. The webcast will be archived shortly after the call for on-demand replay.

Furiex Pharmaceuticals, Inc. (FURX) is a drug development collaboration company. The current market price is $15.52 with a one-year analyst price target of $25. This represents a 61.08% upside potential. I love that Furiex is a cash-rich company, with a total cash position on its balance sheet of $54.81 million and total debt of zero. The company has been gaining a lot of momentum recently, due in part to the heavy insider buying. Director Fredric N. Eshelman bought 265,017 shares or $4.2 Million, at $15.97 per share. Mr. Eshelman increased his stake by 19.69% to 1,611,220 shares with this purchase. Also, Chief Financial Officer Marshall H. Woodworth acquired 6,211 shares or $91,799 at $14.78 per share. The large acquisition by key insiders signals a strong buy. It seems they are aware of something that might not yet be reflected in the market price.

http://seekingalpha.com/article/309827-eye-on-these-4-stocks-with-heavy-insider-trading?source=yahoo

1:30PM Furiex Pharmaceuticals confirms Takeda (TKPYY) launches LIOVEL LD and LIOVEL HD, a fixed dose combination of NESINA and ACTOS, for Type 2 Diabetes in Japan (FURX) 15.99 +0.51 : Under Furiex's agreement with Takeda, this launch does not trigger a milestone payment to Furiex. However, Furiex is entitled to receive royalty payments on sales of LIOVEL.

4:11PM Furiex Pharmaceuticals announced successful results from its Phase II proof-of-concept clinical trial of MuDelta; MuDelta met its primary objectives of establishing tolerability, safety and efficacy in a 12-week randomized, double-blind, placebo-controlled study (FURX) 13.74 : Co announces successful results from its Phase II proof-of-concept clinical trial evaluating the safety and efficacy of MuDelta, an investigational oral agent for the treatment of diarrhea-predominant irritable bowel syndrome. IBS-D is a common functional bowel disorder that causes chronic diarrhea and abdominal pain. MuDelta met its primary objectives of establishing tolerability, safety and efficacy in a 12-week randomized, double-blind, placebo-controlled study. The study achieved statistically and clinically significant results for its primary as well as a number of key secondary endpoints. MuDelta also demonstrated durable efficacy through the 12-week treatment period.

Furiex Pharmaceuticals Enters into Loan Agreement for up to $15 Million

Press Release Source: Furiex Pharmaceuticals, Inc. On Thursday August 18, 2011, 4:04 pm EDT

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Furiex Pharmaceuticals, Inc. (Nasdaq:FURX - News) announced today it has entered into a loan agreement with MidCap Financial and Silicon Valley Bank to provide up to $15.0 million in capital through a secured term loan. Furiex intends to use the proceeds to support research and development for its clinical stage compounds JNJ-Q2, MuDelta and PPD10558.

“We are extremely pleased to have successfully closed on this source of capital,” said Marshall Woodworth, chief financial officer, treasurer and assistant secretary of Furiex. “As we progress our pipeline toward important clinical milestones, this transaction provides us with additional financial flexibility to reach our research and development goals.”

The loan agreement is structured in two tranches. The first tranche in the amount of $10.0 million was drawn upon closing of the transaction. The second tranche of $5.0 million only becomes available to the company if a pre-defined Furiex financing event occurs. Both tranches will have interest-only payments for the first 12 months. The first tranche will have principal and interest payments for a subsequent 36 month period. The second tranche will have principal and interest payments for a subsequent 33 or 36 month period, depending upon the date of execution.

8:16AM Furiex Pharmaceuticals confirms Takeda's resubmissions of Alogliptin to the FDA (FURX) 17.47 : Co confirmed that Takeda Pharmaceutical Company has resubmitted two new drug applications for alogliptin to the FDA. One application is for marketing approval of alogliptin, and the second is for the fixed-dose combination therapy alogliptin/pioglitazone