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SGYP intends to conduct meetings with third parties
Form 8-K for SYNERGY PHARMACEUTICALS, INC.
https://biz.yahoo.com/e/170215/sgyp8-k.html
Form 8-K for SYNERGY PHARMACEUTICALS, INC.
________________________________________
15-Feb-2017
Regulation FD Disclosure, Financial Statements and Exhibits
Item 7.01 Regulation FD Disclosure.
On February 15, 2017, Synergy Pharmaceuticals Inc. (the "Company") intends to conduct meetings with third parties in which its corporate slide presentation will be presented. A copy of the presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information in this Item 7.01 and the document attached as Exhibit 99.1 are being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), nor otherwise subject to the liabilities of that section, nor incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Synergy Pharmaceuticals Inc. Corporate Presentation dated February 15, 2017.
I believe that most of the people that bought the 20 million shares at $6.15 are not in for the long haul and are willing to sell in the 20s and 30s for a nice profit.
I believe that once we work though the 20 million shares, we will continue upward. Of course an announcement can move us at anytime. JMO
Synergy Pharmaceuticals: Our Next Investment
Feb. 9.17 | About: Synergy Pharmaceuticals, (SGYP)
Bhavneesh Sharma, MBA
Bhavneesh Sharma, MBA
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Summary
Synergy Pharmaceuticals' common stock has pulled back after FDA approval of Plecanatide for chronic idiopathic constipation.
NDA filing for Plecanatide for irritable bowel syndrome (constipation predominant), IBS-C is expected later in Q1, 2017.
Our first price target is $11.50/common share based on enterprise DCF method (peak $1.7B risk-adjusted revenue from Plecanantide in CIC).
We are buyers of Synergy Pharmaceuticals' (NASDAQ: SGYP) common stock after the pullback seen after FDA approval of Plecanatide for chronic idiopathic constipation (CIC). NDA filing for Plecanatide for irritable bowel syndrome (constipation predominant), IBS-C, is expected later in Q1, 2017.
(Synergy Pharmaceuticals: common stock price chart, from Bloomberg.com)
CIC is expected to affect about 33 million Americans and 14% of the global population (source: 10-Q). The total target market size is about 45 million adult Americans with CIC and IBS-C (source).
Synergy Pharmaceuticals' Plecanatide has shown similar clinical efficacy as rival Ironwood Pharmaceuticals' (NASDAQ:IRWD) Linzess with less side effects like diarrhea and discontinuation rate. Linzess sales were $625 million (2015) and could exceed $1 billion by 2020.
(Efficacy data of Plecanatide in two pivotal phase 3 trials in CIC, source)
Potential competition (source: 10-Q):
Existing therapies: Lubiprostone, Linaclotide, Prucalopride.
In-development therapies: Elobixibat by Albireo Pharma (NASDAQ:ALBO), in phase 3 development in Japan and Asia).
Dolcanatide, the company's second uroguanylin analog is planned to be advanced to a phase 2 trial in mild-to-moderate ulcerative colitis.
Ironwood Pharmaceuticals and Allergan (NYSE:AGN) recently announced that FDA has approved a lower dose (72 mcg/day) of Linzess for the treatment of chronic idiopathic constipation. The news release mentioned that the lower dose also met the statistically significant end-point vs. placebo in the 2 phase 3 trials done earlier. Also, the incidence of diarrhea and diarrhea-related discontinuations was lower in the 72 mcg dose arm (vs. higher 145 mcg/day arm). On searching the medical literature or the company SEC filings, we did not find the details of the efficacy data (like responder rate) or adverse effect profile details (like incidence of diarrhea or diarrhea-related discontinuations). We expect the responder rate in Linzessa 72 mcg/day arm to be lower than Plecanatide 3 mg/day (Plecanatide 3 mg/day showed almost similar responder rate as 145 mcg/day of Linzessa). We still like Synergy Pharmaceuticals.
IBS-C: Positive results from the first phase 3 trial were announced in late 2016. Overall responder rate was 21.5% and 24% in 3 mg and 6 mg dose groups, respectively. The most common adverse effect was diarrhea, which occurred in 3.2% of patients in 3 mg arm and 3.7% patients in 6 mg arm. vs. 1.3% in placebo arm.
Financials and valuation: Synergy Pharmaceuticals raised capital through a recent secondary equity offering of 20.32 million shares at $6.15 each. The company has $205 million of cash reserves (after recent offering) and $76.1M of long-term debt. Expected cash burn is about $30M cash burn per quarter.
At $4500/patient/year cost for Plecanatide (similar to Linzess 145 mcg/d), target U.S. market size for CIC in the U.S.=33M; we modeled peak $1.72B in U.S. revenue in 2026 (at patent expiry). In comparison, peak sales estimate for Linaclotide is $1-2 billion in 2020.
Using enterprise DCF method (discount rate=15% for first 5 years, then 12% and 10% at peak), we calculated risk-adjusted NPV of future revenue from this indication= $2.56B. After adjusting for non-operating assets (including recent offering) and liabilities and using diluted share count, we calculated fair value per common share= $11.50 (our first price target). The company is also an attractive acquisition candidate (potential bidders include Takeda (OTCPK:TKPHF), Allergan, etc.). Subscribers to our premium research service can download the DCF valuation model.
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Disclosure:
This article represents my own opinion and is not a substitute for professional investment advice. It does not represent solicitation to buy or sell any security. Investors should do their own research and consult their financial adviser before making any investment.
Disclosure: I am/we are long SGYP.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
http://seekingalpha.com/article/4044375-synergy-pharmaceuticals-next-investment?page=2
Pivotal Phase 3 Data Results for TRULANCE™ (plecanatide) in the Treatment of Chronic Idiopathic Constipation (CIC) Published in American Journal of Gastroenterology
Business WireFebruary 7, 2017
NEW YORK--(BUSINESS WIRE)--
Synergy Pharmaceuticals Inc. (SGYP) today announced that the American Journal of Gastroenterology has published detailed results from a pivotal Phase 3 trial that demonstrated the efficacy and safety of TRULANCE™ (plecanatide) for the treatment of adults with chronic idiopathic constipation (CIC).
On Jan. 19, TRULANCE was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with CIC. TRULANCE is the first drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human gastrointestinal (GI) peptide that is thought to stimulate fluid secretion within the changing pH environment of the intestine.
“We are very pleased that our pivotal Phase 3 results are appearing in the American Journal of Gastroenterology, as these robust data demonstrate the efficacy and safety profile of TRULANCE, and add momentum to the FDA’s recent approval of TRULANCE,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc. “The publication of these data are a testament to the dedication of our researchers and the hard work of our entire Synergy team, all of whom are excited to be bringing TRULANCE to healthcare providers and their patients with the upcoming launch of this drug.”
TRULANCE will be available in the U.S. this quarter.
“There are millions of CIC patients in the U.S., many of whom suffer with symptoms that remain untreated or fail to respond to current treatments,” said Satish S.C. Rao, M.D., Ph.D., Professor of Medicine and Director, Neurogastroenterology/Motility, Digestive Health Center at Augusta University. “TRULANCE has demonstrated efficacy with a low rate of adverse events, such as diarrhea, providing healthcare providers and their patients with an additional, much needed, new treatment option.”
In this study, diarrhea was the most common adverse event (TRULANCE 3 mg, 5.9%; placebo, 1.3%).
The approved dosing regimen for TRULANCE is 3 mg taken orally, once daily, with or without food at any time of the day. TRULANCE can be swallowed whole or crushed in applesauce for those who are unable to swallow medication.
Synergy has also completed two Phase 3 clinical trials for TRULANCE in irritable bowel syndrome with constipation (IBS-C), with positive top-line results of these trials announced in December 2016. Synergy plans to file a New Drug Application Supplement with Clinical Data (sNDA) this quarter with an expected 10-month review period from submission.
Indications and Usage
TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for the treatment of chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
Trulance™ is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of Trulance should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of Trulance have not been established in pediatric patients less than 18 years of age.
Contraindications
Trulance is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
Trulance is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
Trulance is contraindicated in patients less than 6 years of age. The safety and effectiveness of Trulance in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
Use of Trulance should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of Trulance should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in the two placebo-controlled clinical trials. Severe diarrhea was reported in 0.6% of patients.
If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
In the two combined CIC clinical trials, the most common adverse reaction in Trulance-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
Please click here for Full Prescribing Information.
About Chronic Idiopathic Constipation (CIC)
CIC affects approximately 14 percent of the global population, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult-to-pass and infrequent bowel movements. In addition to physical symptoms including abdominal bloating and discomfort, CIC can adversely affect an individual’s quality of life, including increasing stress levels and anxiety.
About TRULANCE™
TRULANCE™ (plecanatide) is a once-daily tablet approved for adults with CIC and is being evaluated for IBS-C. With the exception of a single amino acid, TRULANCE is structurally related to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin is thought to act in a pH-sensitive manner, targeting GC-C receptors primarily in the small intestine coinciding with areas of fluid secretion.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and commercialization of novel GI therapies. The company has pioneered discovery, research and development efforts on analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary uroguanylin analog platform includes one commercial product TRULANCE (plecanatide) and a second lead product candidate – dolcanatide. For more information, please visit www.synergypharma.com.
Forward-Looking Statement
This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Synergy Pharmaceuticals Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of TRULANCE; growth and opportunity, including peak sales and the potential demand for TRULANCE, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's most recent periodic reports filed with the Securities and Exchange Commission, including Synergy’s Form 10-K for the year ended December 31, 2015. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170207005948/en/
Easy to say after the fact. What if there was a deal and it ran to $10.50. What say you then?
Double digits. JMO eom
We traded over 125 Million dollars worth of stock yesterday. We are starting to close the gap.
We won't go straight up to the $7.00 area. It will be a back and fill process. JMO
Why Synergy Pharmaceuticals Shares Fell 14.6% Today
Investors moved to the sidelines after the company priced a dilutive stock offering.
Todd Campbell
(TMFEBCapital)
Feb 1, 2017 at 5:45PM
A businessman stands in front of a microphone before making an announcement.
IMAGE SOURCE: GETTY IMAGES.
What happened
Synergy Pharmaceuticals (NASDAQ:SGYP) announced a $125 million stock offering yesterday, and shares slipped 14.6% today, after the company announced it's pricing the offering at $6.15 per share.
So what
On Jan. 19, the FDA gave Synergy Pharmaceuticals a green light to launch plecanatide for use in patients diagnosed with chronic idiopathic constipation. An estimated 42 million people are affected by constipation, and many people don't respond to existing therapies.
In preparation for its planned launch, the company has been building out its infrastructure and improving its balance sheet. Last May, the company closed on an approximately 30 million-share offering of common stock that raised gross proceeds of about $89.8 million.
This time around, management is offering of 20,325,204 shares of its common stock at $6.15 per share, before underwriting discounts, commissions, and other expenses associated with the offering. Management expects to close the offering on Feb. 6.
Now what
The company's principal balance on its 7.5% convertible senior notes fell to $79.2 million on Sept. 30, from $159 million on Dec. 31, 2015. The company further improved its financial position by exchanging more than 7.5 million shares for an aggregate principal amount of $20.7 million of those notes last quarter.
Money raised in this offering is earmarked for the commercial launch of plecanatide, which will be sold under the brand name Trulance. Given that the company's going on its own with Trulance, the capital raise makes sense. Synergy Pharmaceuticals faces tough competition from Ironwood Pharmaceuticals (NASDAQ:IRWD) and Allergan's (NYSE:AGN) Linzess, a fast-growing drug with annual sales in the nine-figure range. In Q3, Linzess' U.S. net sales increased 40% year over year to $164 million.
Whether Trulance can elbow its way to some market share won't be known for a few more quarters, so that does make this company's shares a bit risky. However, this market is big, and there may be room for multiple players. In addition, a filing for approval in IBS soon could boost Trulance's addressable market, boosting the drug's peak sales opportunity.
Overall, Synergy Pharmaceuticals burned through $92 million in cash through the first nine months of 2016, and that spending is likely to increase as Trulance's rollout picks up steam. Therefore, investors might want to take a wait-and-see approach to sales before taking the leap and buying.
Something to think about. Most gaps are filled. We gapped down today. I believe that gap WILL BE FILLED.
Synergy just opened an ATM account. Like it long term.
Stock made a nice move today. There is a good chance the shorts were able to cover over the last couple of weeks.
Keep this in mind also, a stock does not go straight up or down.
I first bought at $2.85, not that long ago. Normally a stock will have a 35% to 50% pull back from a big move.
Between $2.85 and $6.85 that is a $4.00 move. A 50% pull back would put us at $4.85. A 35% pull back will put us just about where our low was yesterday.
I don't think we will get there ($4.85) and I think today's move was very healthy. JMO.
I'm holding. Playing with house's money. Looking to go up over double digits.
Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other.
Given the way analysts feel about Synergy Pharmaceuticals right now, this huge implied volatility could mean there’s a trade developing.
100K just crossed the tape
Are Options Traders Betting on a Big Move in Synergy Pharmaceuticals (SGYP) Stock?
Zacks Equity Research
ZacksJanuary 24, 2017
Investors in Synergy Pharmaceuticals Inc. SGYP need to pay close attention to the stock based on moves in the options market lately. That is because the Feb 17th, 2017 $8 Call had some of the highest implied volatility of all equity options today.
What is Implied Volatility?
Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.
What do the Analysts Think?
Clearly, options traders are pricing in a big move for Synergy Pharmaceuticals shares, but what is the fundamental picture for the company? Currently, Synergy Pharmaceuticals is a Zacks Rank #2 (Buy) in the Medical - Drugs industry that ranks in the Top 32% of our Zacks Industry Rank. Over the last 60 days, one analyst has increased earnings estimates for the current quarter, while one analyst has revised estimates downward. The net effect has taken our Zacks Consensus Estimate for the current quarter from a loss of 17 cents per share to a loss of 18 cents in that period.
Given the way analysts feel about Synergy Pharmaceuticals right now, this huge implied volatility could mean there’s a trade developing. Often times, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected
http://finance.yahoo.com/news/options-traders-betting-big-move-133201790.html
If you all could open the links for everyone, it would be helpful.
BTIG Sets Expectations on Synergy Pharmaceuticals Inc (SGYP) Following FDA Approval.
Peter Murray, Editor-January 20, 2017, 5:58 PM EDT
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BTIG analyst Tim Chiang weighed in today on Synergy Pharmaceuticals Inc (NASDAQ:SGYP), after the drug maker reported the achievement of a milestone few biotechnology companies reach—FDA approval of its lead drug, plecanatide, in constipation-predominant irritable bowel syndrome (IBS-C).
With a once-daily dosing profile, and a low incidence of side effects, Chiang believes Trulance will become a meaningful new product in the GI treatment category. His 2017-2020 Trulance sales estimates are $35M, $150M, $330M, and $480M, respectively.
Chiang noted, “We think SGYP’s launch in early 2017 will be targeted at ~20,000 to 25,000 physicians who are high prescribers of Rx treatments in CIC (which accounts for ~70% to 80% of the prescriptions written in the US market), with the Co. utilizing a contract-sales force (Touchpoint) that numbers between 150-200 reps. As a result, we think SGYP’s annual marketing costs for plecanatide will be substantially below what Allergan and Ironwood spend (~$250 million per year) combined on the marketing of Linzess.”
“Rx treatment market for CIC and IBS-C continues to expand; in 2017, we expect sales for Rx treatments to exceed $2 billion. In 2016, Allergan / Ironwood’s Linzess volumes increased by more than 20%, according to our analysis of Symphony Healthcare prescription data,” the analyst added.
Chiang reiterated a Buy rating on SGYP stock, with a price target of $11, which represents a potential upside of 86% from where the stock is currently trading.
The overwhelmingly majority of analysts say SGYP is a “buy.” The average forecast is for the stock to hit $10.5 in the coming months.
According to TipRanks, a site that tracks and ranks analysts on their predictions, Chiang has a yearly average return of 16.6% and a 55% success rate. Chiang has a 37.9% average return when recommending SGYP, and is ranked #308 out of 4365 analysts.
https://www.smarteranalyst.com/2017/01/20/btig-sets-expectations-synergy-pharmaceuticals-inc-sgyp-following-fda-approval/
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Misinformed Synergy Investors, Bashers And Analysts
Jan. 20, 2017 12:32 PM ET|Includes:Synergy Pharmaceuticals, Inc. (SGYP)
Synergy Pharmaceuticals (NASDAQ: SGYP) has just gained FDA approval for their superior drug, Trulance. Unfortunately, the stock is down heavily on the news, and it seems there is a lot of misinformation surrounding just about everything.
The major issue I have is from an article released by Jim Cramer's, "The Street". It should be noted that Allergan (NYSE: AGN) is in Jim Cramer's charitable trust fund. Allergan owns more than 50% of Linzess. In the article, it mentions that JP Morgan Analyst, Anupam Rama, who says, "A key difference is that the current CIC label does not account for pain symptoms, while Linzess' label does". You can find that article here:
https://www.thestreet.com/story/13960531/2/synergy-pharmaceuticals-secures-approval-for-linzess-competitor.html
The quote from the JP Morgan analyst is a prime example of the misinformation being spread. The only reason that the Linzess label talks about pain symptoms is because it is also approved for irritable bowel syndrome with constipation (IBS-C). Pain is associated with IBS-C and not chronic idiopathic constipation (CIC). JP Morgan should expect more from their "analysts". Synergy plans to file a sNDA for the IBS-C indication soon. Approval for IBS-C would be expected in early 2018.
The Street article also mentions that the labels for Linzess and Trulance are the same. The article goes on and notes the side effect of "severe diarrhea" for Trulance. Diarrhea is a side effect for every gastrointestinal drug known to man. Severe diarrhea was seen in 2% of Linzess patients and 0.6% of Trulance patients. See below an image of the differences between these labels:
Other differences between the labels involve taking the medication. One can't crush and swallow Linzess, but patients can crush Trulance and take with apple sauce if they're unable to take medication by swallowing the pill whole. Linzess must be taken on an empty stomach with your first meal coming 30 minutes after taking Linzess. Trulance can be taken at any time of day and with or without food. Linzess also has a strong warning for pregnant patients, while Trulance does not. To call these two labels the same is almost comical.
Investors are also concerned with the fact that Synergy needs to raise cash. It is most advantageous to do a raise when the share price is high. Right now, the share price is not high. An at-the-market, or ATM offering, wouldn't make sense now because a higher share price means more money can be raised. This company, led by the Gabriele Cerrone team of co-Founders, was built to be sold from day one. Gary Jacob, the CEO of Synergy, just adjusted his bonus if the company were to be sold for greater than $2 billion. Even if the company isn't sold I trust the commercial plan for Synergy. Synergy has hired top talent from Shire, Allergan, Pfizer and Salix. Salix was a GI powerhouse and Synergy has those same aspirations. Also, no analyst has ever taken into account the number of patients who would leave Linzess for Trulance. Patients are not happy on Linzess. To close, who's to say Synergy won't attack the OTC market?
Stocks: SGYP
http://seekingalpha.com/instablog/41800456-andydufresne/4951897-misinformed-synergy-investors-bashers-analysts
Synergy Pharmaceuticals Secures Approval for Linzess Competitor
New bowel drug Trulance will be available for patients later this quarter.
Alicia McElhaney
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Jan 20, 2017 10:37 AM EST Linzess, the irritable-bowel-syndrome drug made by Ironwood Pharmaceuticals (IRWD) and Allergan (AGN) , will have to compete with a new pill from Synergy Pharmaceuticals (SGYP) .
Allergan is a holding in Jim Cramer's Action Alerts PLUS Charitable Trust Portfolio. Want to be alerted before Cramer buys or sells AGN? Learn more now.
Late Thursday Synergy secured approval for a new constipation drug that will compete against a similar drug from Ironwood and Allergan, which has already been on the market for four years. The drug, Trulance, has a label that's very similar to Linzess, analysts say.
"We are thrilled with the approval of Trulance because it provides an additional, much-needed, new treatment option to help adults with chronic idiopathic constipation and their health care providers manage this condition," said Gary Jacob, CEO of the company, in a statement.
The company regained nearly all of the ground it lost Thursday in premarket trading Friday, up 1.1%, hitting $6.50 per share.
Meanwhile, Ironwood did not move ahead the of market's open. Allergan shares barely moved ahead of market's open Friday, falling eight cents to $214.50.
The one issue that could affect the uptake of Trulance is the reported side effect of diarrhea.
"We still expect the much lower diarrhea rate for plecanatide [Trulance] vs. Linzess to be instrumental in plecanatide commercial preference and success," analyst John Newman of Canaccord wrote in a note.
Newman predicted that the approval of Trulance 10 days before the FDA's deadline for ruling on the drug was a "positive endorsement" on the part of the FDA.
Newman maintains a buy rating on Synergy, despite FDA warnings about the drug that gave others pause.
JPMorgan analyst Anupam Rama wrote in a note that the firm believes Linzess will still be "more efficacious" than Trulance. This is thanks to the pain relief Linzess provides, on top of helping with constipation.
"Overall, the Trulance label is generally in line with our expectations, and we maintain that Linzess has key points of differentiation," Rama wrote. "A key difference is that the current CIC label does not account for pain symptoms, while Linzess' label does."
Rama has an overweight rating on Ironwood.
Allergan acquired the rights to market Linzess abroad in December 2015, while Ironwood owns the rights to sell the drug in the U.S.
https://www.thestreet.com/story/13960531/1/synergy-pharmaceuticals-secures-approval-for-linzess-competitor.html
3 Little-Known Pharmaceutical Companies to Put on Your Radar
A team of contributors shares their picks for underappreciated pharmas that deserve more attention.
Cory Renauer, Keith Speights, and Brian Feroldi
(TMFang4apples)
Jan 11, 2017 at 3:42PM
Over the past year, the best-performing drugmaker stocks all have had one thing in common: They received very little attention before providing patient investors windfall gains. Being considered insignificant in itself isn't a great reason to scoop up shares of Teligent (NASDAQ:TLGT), Synergy Pharmaceuticals (NASDAQ:SGYP), or Portola Pharmaceuticals (NASDAQ:PTLA), but these three Motley Fool contributors wanted to share some reasons these underappreciated companies belong on your radar.
2. Synergy Pharmaceuticals: Great momentum
Keith Speights (Synergy Pharmaceuticals): Synergy Pharmaceuticals is on a roll. The stock is up nearly 65% in the past six months. Synergy's experimental gastrointestinal drug, plecanatide, is behind the tremendous momentum.
In December, Synergy announced results from two late-stage clinical studies for plecanatide. Both studies evaluated the drug in treating irritable bowel syndrome with constipation (IBS-C). Synergy expects to submit for regulatory approval in the first quarter of 2017.
The U.S. Food and Drug Administration is currently reviewing Synergy's new drug application for plecanatide in treating chronic idiopathic constipation (CIC). The agency is expected to make its decision by Jan. 29.
While anything can happen with the regulatory process, I think Synergy's chances of approval look pretty good. If approved, plecanatide should have a sizable market -- around 14% of people in North America suffer from CIC. Around 4% to 5% of American adults have IBS-C.
http://www.fool.com/investing/2017/01/11/3-little-known-pharmaceutical-companies-to-put-on.aspx?source=yahoo-2&utm_campaign=article&utm_medium=feed&utm_source=yahoo-2
5 Reasons Synergy Pharmaceuticals Should Strike A Distribution Deal With Valeant
Jan.11.17 | About: Synergy Pharmaceuticals, (SGYP)
Jose Solorio
Jose Solorio
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(307 followers)
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Summary
During the next 18 months Synergy's Plecanatide is going to hit the market. How should they approach the launch in order to benefit investors the most?
Valeant is a global powerhouse coming out from a crisis. They have every incentive to negotiate aggressive distribution deals.
Synergy's products are a complement offering to Valeant's key products. Valeant just announced a massive increase in a primary care workforce.
As we have already covered before, Synergy's pharmaceuticals (NASDAQ:SGYP) prospects are better than ever. The company is transitioning out of the speculative play into a potentially rapidly growing GI powerhouse and for that reason we are bullish and just recommended a trade to make up to 9.8% on the next 40 days.
Many bears have argued that sooner rather than later a dilutive stock offering is going to be issued as the launch costs overwhelm Synergy. With $110 million in cash and cash equivalents we think that's a possibility, but not a necessity. We believe striking a partnership with Valeant (NYSE:VRX) is a much better option. This isn't just a recommendation for both companies´management as we believe they are already in talks with each other, but rather a continuation of our bullish thesis for both companies.
The source of our speculation comes from CafePharma. A service similar to LinkedIn for workers of the pharmaceutical industry. This site allows them to start anonymous message threads. Before you discard this source as unreliable, spend some time on the site. Sometimes workers discuss internal policies, air discontentment about managers, talk about layoffs, salaries, work opportunities, etc in an anonymous way. The anonymous characteristics makes it very compelling. Nobody ever knows who leaked what or who is who. No paper trail, no sign in to the site, etc. Not even the site knows who posted what except for their IP address. Sure, you need to take everything you read with a grain of salt, but if there's some truth to the rumors it would seem team members of Valeant have been interviewing at Synergy.
http://seekingalpha.com/article/4036004-5-reasons-synergy-pharmaceuticals-strike-distribution-deal-valeant
A David and Goliath Story: Can Small-Cap Synergy Pharmaceuticals Take on Ironwood Pharmaceuticals?
Has the success of Synergy Pharmaceuticals' plecanatide put Ironwood on the warpath?
David Liang
(Pfoolishly)
Jan 5, 2017 at 10:42AM
TopicsGoliathIrritable bowel syndromesynergy pharmaceuticals
Goats Fighting
Image source: Pixabay.
The past few months have been good to investors in competing companies Ironwood Pharmaceuticals (NASDAQ:IRWD) and Synergy Pharmaceuticals (NASDAQ:SGYP), with shares of both companies up by double digits.
SGYP Chart
SGYP data by YCharts.
Although Ironwood's market cap is near twice that of Synergy, after the past month's 26% pop in Synergy's share price, some investors are worried that Synergy may be out to eat Ironwood's lunch. Does Synergy have more room to run? Or will Ironwood's market share dominance remain unchallengeable? It's time for a deeper dive.
An overview of the gastrointestinal disorders market
Ironwood and Synergy Pharmaceuticals both operate in the gastrointestinal (GI) specialty pharmaceutical space. Specifically, Ironwood (currently) and Synergy (potentially) make products indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). According to Ironwood, as many as 13 million adults suffer from IBS-C and at least 35 million adults suffer from CIC in the United States. This is a large and underserved market, as prescriptions approved by the Food and Drug Administration are only used by around 5% of IBS-C or CIC sufferers. In order to treat these conditions, doctors typically recommend changes to diet and lifestyle as a first step to tackling these gastrointestinal disorders. Should this first step prove ineffective, patients typically then move on to over-the-counter laxatives as a second step to improve their symptoms. However, these patients often continue to suffer from constipation and abdominal pain. There are currently only two prescription drugs approved for this market: Ironwood's once-daily oral Linzess and Sucampo Pharmaceuticals' twice-daily oral Amitiza.
Ironwood's Linzess
Linzess is currently Ironwood's only product and is the market-share leader within IBS-C and CIC. Ironwood and Allergan share a co-promote agreement for Linzess in the U.S. and Europe (where it is trademarked and marketed as Constella). Since gaining approval in 2012, Linzess has been growing rapidly, with sales up 53% for year-end 2015 and 34% year over year in its latest quarter. With sales coming in at $150 million in their latest quarter, management has guided toward over $1 billion in sales of Linzess by 2020. Since its launch, Linzess has treated over 1 million unique patients. However, with more than 40 million potential patients, Ironwood still has much more room to grow. The hiccup comes in the form of Synergy Pharmaceuticals and its FDA approval-pending product plecanatide.
Synergy's plecanatide
Synergy's lead developmental product is plecanatide, a novel uroguanylin analog currently being evaluated for use as a once-daily tablet for CIC and IBS-C. In phase 3 clinical trials, plecanatide demonstrated positive top-line results in patients with CIC. Within this trial, the occurrence of diarrhea was 5.9% for the 3.0 mg dose and 5.5% for the 6.0mg dose of the drug, which compares favorably to 16% for the current market leader Linzess. Just last week, Synergy released positive top-line results from a phase 3 trial of plecanatide in patients with IBS-C. Similar to the CIC trial, the most common adverse event (AE) was diarrhea, which occurred in 5.4% of patients in 3 mg and 4.3% of patients in 6 mg dose groups compared to 0.6% of placebo-treated patients. Plecanatide, therefore, has the potential for similar efficacy to Linzess along with a much better AE profile.
Ironwood fights back
While plecanatide has demonstrated strong efficacy in clinical trials, it must still be approved by the FDA before it becomes a commercial product. To this end, Synergy has submitted plecanatide to the FDA for review with a PDUFA date for the drug in CIC set for Jan. 29, 2017. However, in the face of a potential plecanatide approval, Ironwood has not been sitting on its laurels. Indeed, Ironwood released positive topline data from a phase 3 study of Linzess in a lower dosage form (72 mcg vs the normal 145 mcg capsule) in late 2015. A lower dosage form of Linzess should decrease diarrhea rates, which is the most common AE of Linzess and one of the most important advantages of plecanatide. Ironwood has filed a supplemental New Drug Application with the FDA with an expected PDUFA date of early 2017.
Risk vs. reward
While plecanatide has found success in clinical trials, there are always risks inherent in any investment. For Synergy, with no currently approved drug on the market, the company will continue to burn through cash as it seeks FDA approval. Additionally, there is no guarantee the FDA will approve the drug, and there is no telling how much traction plecanatide could gain to take market share from the larger Ironwood and the much larger Allergan. Finally, even if approved, with only $109 million in cash and cash equivalents on the balance sheet, Synergy will undoubtedly require additional rounds of funding if it expects to commercialize plecanatide. However, for the long-term investor, I believe the combination of a superior product profile and an underserved market makes Synergy a buy.
We covered the gap up this morning
Two Key FDA Decisions to Watch Out for in January 2017
New York-based Synergy Pharmaceuticals Inc. SGYP, which is focused on the development and commercialization of novel gastrointestinal (GI) therapies, has an important regulatory event coming up towards the end of this month with the FDA expected to decide on the approval status of one of the company’s lead pipeline candidates – plecanatide.
The company is looking to get the product approved for the treatment of chronic idiopathic constipation (CIC) with a response expected by Jan 29, 2017. FDA approval would be a transforming event for the company which currently has no approved products in its portfolio. Synergy, a Zacks Rank #3 (Hold) stock, had a good run in 2016 with the company gaining 13.4% compared to a 23% decline for the Zacks-categorized Medical-Drugs industry. The company, in fact, ended 2016 on a positive note with impressive top-line data from a couple of pivotal studies on plecanatide in adult patients with irritable bowel syndrome with constipation (IBS-C). Depending on the FDA’s decision regarding the CIC indication, Synergy will seek approval for the IBS-C indication in the first quarter of 2017. The market opportunity is huge considering about 45 million adults in the U.S. suffer from CIC/IBS-C with the market expected to grow at double digit rates on the back of increased treatment options, market education, an aging population and awareness of gut health.
http://finance.yahoo.com/news/two-key-fda-decisions-watch-134101183.html
3 Under-the-Radar Biotech Stocks to Watch in 2017
Why you should put Akebia Therapeutics, Synergy Pharmaceuticals, and Exact Sciences on your watch list for the new year.
Keith Speights
(TMFFishBiz)
Jan 1, 2017 at 3:02PM
TopicsBiotechnologyErythropoiesisChronic kidney disease
You read plenty about the biggest biotechs on the market. But what about smaller biotechs that have a lot of potential? Akebia Therapeutics (NASDAQ:AKBA), Synergy Pharmaceuticals (NASDAQ:SGYP), and Exact Sciences (NASDAQ:EXAS) might not have huge market caps yet, but they have a lot going for them. Here's why you should watch these three under-the-radar biotech stocks in 2017.
Akebia: Promising anemia pipeline candidate
Sure, Akebia Therapeutics ended 2016 with its shares down by a double-digit percentage. However, the biotech's stock gained nearly 40% in the last half of the year. And Akebia had several positive developments in the recent months that could bode well for the future.
Akebia's lead product candidate, vadadustat, is currently in two late-stage clinical studies for treating anemia related to chronic kidney disease. The independent data-monitoring committee for one of these studies recently reviewed progress to date and recommended moving forward with no changes.
In December, Akebia announced a partnership with large Japanese drugmaker Otsuka Pharmaceutical to commercialize vadadustat in the U.S. The small biotech received $125 million up front and will get another $35 million in the first quarter of 2017. Otsuka will also pay potential milestone payments of up to $765 million. The two companies will split any U.S. revenue for vadadustat if the drug is approved.
The reason I like Akebia is the tremendous potential for vadadustat. Erythropoiesis-stimulating agents (ESAs) such as Aranesp and Epogen are currently the standard of care in treating anemia related to chronic kidney disease. The problem with ESAs, though, is that they can increase hemoglobin levels too much. Vadadustat showed promise in a mid-stage clinical trial for raising hemoglobin levels in anemic patients and maintaining those levels within targeted ranges.
Synergy: Ending 2016 with a bang
As with Akebia, the 2016 stock performance for Synergy Pharmaceuticals might be deceiving at first glance. While Synergy's share price increased only by a small percentage for the full year, the biotech's stock soared 60% in the second half of 2016.
Synergy ended the year with positive results from two different late-stage clinical trials of its lead candidate, plecanatide. Both trials evaluated plecanatide in treating irritable bowel syndrome with constipation, a chronic gastrointestinal disorder that affects up to 5% of U.S. adults.
The company hopes that more good news is just around the corner. A decision by the U.S. Food and Drug Administration (FDA) for potential approval of plecanatide in treating chronic idiopathic constipation (CIC) is expected by Jan. 29, 2017.
My hunch is that Synergy will get a thumbs up from the FDA. Two late-stage clinical studies of plecanatide in treating CIC showed positive results. Another long-term open-label safety study also found low adverse events and low discontinuation rates for patients taking the experimental drug. I think that, if approved, plecanatide should be a big winner for Synergy.
Exact Sciences: Perseverance should pay off
Unlike Akebia and Synergy, Exact Sciences' stock isn't carrying a lot of momentum into the new year. The molecular diagnostics company's share price had more than doubled by late summer, but much of those gains have reversed.
Will the stock rebound in 2017? I think so. There are several currents in Exact Sciences' favor that should pay off over the long run. For one thing, the company's Cologuard DNA screening test for colorectal cancer is winning buy-in from more payers. As of Jan. 1, 2017, the test will be covered by health plans with over 153 million members. That's a huge jump of more than 50 million covered members from just six months ago.
Exact Sciences' efforts to promote Cologuard should be another important factor that helps improve financial results. The company is actively working to engage and educate physicians about its test. As more physicians are informed about Cologuard's accuracy and convenience, sales should pick up. In addition, Exact Sciences has launched direct-to-patient marketing campaigns (including national TV advertisements) that should build patient awareness -- another key way to boost sales.
There is a substantial market opportunity for Cologuard. Nearly half of the population who should be screened for colorectal cancer aren't getting screened. A big reason is patients' concerns about having colonoscopies performed. Cologuard provides a good alternative for individuals who aren't at high risk of colorectal cancer.
Most likely to hit the radar
Of these three stocks, I think that Synergy might be in best position to capture investors' attention in 2017. The biotech has a great potential catalyst in late January with the FDA decision for plecanatide in treating CIC. It wouldn't be a shock to see Synergy gain interest of a larger company looking for an acquisition.
Synergy Pharmaceuticals Inc (NASDAQ:SGYP) Moves Closer To Expanding Plecanatide Label
By Andy Parker -
December 29, 2016
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Synergy Pharmaceuticals Inc
Synergy Pharmaceuticals Inc (NASDAQ:SGYP) has provided an update on topline results from a Phase 3 study of its candidate plecanatide. The study evaluated the efficacy and safety of plecanatide as a treatment for irritable bowel syndrome with constipation (IBS-C) in adults.
The study was carried out over a period of 12 weeks in 1,054 patients in the U.S. in a double-blind, placebo-controlled format. Patients received plecanatide in doses of 3mg or 6mg a day during the 12-week period. The control group also received placebo in the same frequency over the same period of time.
When the 12 weeks were over and the data from the study analyzed, the outcome showed that patients who received plecanatide treatment met the primary endpoint with a statistically significant measure compared to the placebo group.
Expanding the label
The positive outcome from the Phase 3 trial of plecanatide in IBS-C patients paves the way for Synergy to expand the treatment label of the drug. Plecanatide is already under review by the FDA as a treatment for chronic idiopathic constipation (CIC) and decision on the ongoing review is expected on January 29, 2017. Synergy plans to make a Supplement New Drug Application (sNDA) for plecanatide as a treatment of IBS-C in 1Q17.
Addressable market
Expanding the label of plecanatide could yield more sales for Synergy than earlier anticipated. According to data shared by Synergy, up to 5% of the U.S. adult population has IBS-C related complications. That’s a huge addressable market if plecanatide gets regulatory nod for the indication.
Another candidate in the pipeline
Synergy has a rich pipeline. Besides plecanatide, its other late-stage candidate is SP-333 (dolcanatide), which is also targeted at gastrointestinal disease market. SP-333 is being evaluated as a treatment for mild-to-moderate ulcerative colitis in a Phase 1b exploratory study after recently successfully completing a Phase 2 study in patients afflicted by opioid-induced constipation.
Synergy stock rose more than 1% to $5.98 in post-market trading in the last session. The stock earlier slid 0.17% in regular trading. The stock is up more than 4% YTD.
Synergy Pharmaceuticals Inc. (SGYP) PT Raised to $17.00 at Rodman & Renshaw
Posted by Daniel Jordon on Dec 27th, 2016 // No Comments
Synergy Pharmaceuticals logoSynergy Pharmaceuticals Inc. (NASDAQ:SGYP) had its target price hoisted by equities research analysts at Rodman & Renshaw from $16.00 to $17.00 in a report issued on Friday. The brokerage currently has a “buy” rating on the biopharmaceutical company’s stock. Rodman & Renshaw’s price target would indicate a potential upside of 194.63% from the stock’s current price.
Several other analysts also recently commented on the stock. BTIG Research reaffirmed a “buy” rating and issued a $11.00 price objective on shares of Synergy Pharmaceuticals in a report on Friday. Roth Capital reaffirmed a “buy” rating and issued a $6.50 price objective on shares of Synergy Pharmaceuticals in a report on Thursday, December 15th. HC Wainwright set a $16.00 price objective on shares of Synergy Pharmaceuticals and gave the company a “buy” rating in a report on Monday, December 12th. Zacks Investment Research raised shares of Synergy Pharmaceuticals from a “sell” rating to a “hold” rating in a report on Tuesday, December 13th. Finally, Canaccord Genuity set a $13.00 price objective on shares of Synergy Pharmaceuticals and gave the company a “buy” rating in a report on Friday, December 9th. Two research analysts have rated the stock with a hold rating and five have assigned a buy rating to the company’s stock. The stock currently has an average rating of “Buy” and an average price target of $10.36.
Analyst Recommendations for Synergy Pharmaceuticals (NASDAQ:SGYP)
Shares of Synergy Pharmaceuticals (NASDAQ:SGYP) opened at 5.77 on Friday. The company’s market capitalization is $1.04 billion. The firm has a 50-day moving average of $5.21 and a 200-day moving average of $4.77. Synergy Pharmaceuticals has a one year low of $2.50 and a one year high of $6.29.
In related news, major shareholder Paulson & Co. Inc. sold 140,000 shares of the stock in a transaction on Friday, November 4th. The shares were sold at an average price of $4.24, for a total transaction of $593,600.00. The sale was disclosed in a filing with the SEC, which is available through the SEC website. Corporate insiders own 3.60% of the company’s stock.
A number of hedge funds have recently made changes to their positions in SGYP. Teacher Retirement System of Texas increased its stake in shares of Synergy Pharmaceuticals by 29.2% in the third quarter. Teacher Retirement System of Texas now owns 19,485 shares of the biopharmaceutical company’s stock worth $107,000 after buying an additional 4,404 shares during the period. Legal & General Group Plc increased its stake in shares of Synergy Pharmaceuticals by 60.0% in the second quarter. Legal & General Group Plc now owns 29,343 shares of the biopharmaceutical company’s stock worth $109,000 after buying an additional 11,001 shares during the period. Principal Financial Group Inc. increased its stake in shares of Synergy Pharmaceuticals by 82.4% in the second quarter. Principal Financial Group Inc. now owns 31,927 shares of the biopharmaceutical company’s stock worth $121,000 after buying an additional 14,422 shares during the period. Aperio Group LLC increased its stake in shares of Synergy Pharmaceuticals by 48.0% in the third quarter. Aperio Group LLC now owns 22,346 shares of the biopharmaceutical company’s stock worth $123,000 after buying an additional 7,249 shares during the period. Finally, Clinton Group Inc. purchased a new stake in shares of Synergy Pharmaceuticals during the third quarter worth about $125,000. 55.21% of the stock is currently owned by hedge funds and other institutional investors.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals Inc (Synergy) is a biopharmaceutical company focused on the development and commercialization of gastrointestinal (GI) therapies. The Company’s GI platform includes two lead product candidates: plecanatide and dolcanatide. It is engaged in the discovery, research and development involving uroguanylin analogs for the treatment of functional GI disorders and inflammatory bowel disease.
5 Day Chart for NASDAQ:SGYP
Why Synergy Pharmaceuticals Is Jumping 10% Today
Investors are increasingly optimistic that plecanatide can reshape treatment for gastrointestinal disorders.
Todd Campbell
Dec 23, 2016 at 11:29AM
TopicsConstipationIrritable bowel syndromesynergy pharmaceuticals
What happened
After announcing positive results in phase 3 trials evaluating plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C), shares in Synergy Pharmaceuticals (NASDAQ:SGYP) rallied 10% this morning.
So what
Plecanatide is already under review by the FDA for approval in treating patients with chronic idiopathic constipation (CIC). That review is being based upon previously reported phase 3 successes that include a relatively low incidence rate of severe diarrhea when compared to other treatment options.
Today, the company rolled out final phase 3 results showing that plecanatide may also address IBS-C, a condition that affects millions of people.
Preliminary overall response rates in the 3 mg and 6 mg plecanatide arms and placebo arm were 30.2%, 29.5%, and 17.8%, respectively, with a p-value of <0.001.
Unsurprisingly, the most common adverse event was diarrhea, which occurred in 5.4% of patients in 3 mg and 4.3% of patients in 6 mg dose groups versus 0.6% of patients in the placebo arm of the study.
Now what
A FDA decision on plecanatide in CIC is anticipated on Jan. 29. Management expects to file a supplemental approval application for plecanatide's use in IBS-C in the first quarter.
If approved, plecanatide will face off against Ironwood Pharmaceuticals (NASDAQ:IRWD) and Allergan's (NYSE:AGN) Linzess. Linzess' U.S. net sales increased 34% year over year to $150.5 million in Q2 2016, and U.S. net sales increased 40% year over year to $164 million in Q3 2016.
Form 8-K for SYNERGY PHARMACEUTICALS, INC.
22-Dec-2016
Other Events, Financial Statements and Exhibits
Item 8.01 Other Events.
On December 22, 2016, Synergy Pharmaceuticals Inc. (the "Company") issued a press release announcing positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of plecanatide, an investigational once-daily orally-administered compound, in 1,054 adult patients with irritable bowel syndrome with constipation (IBS-C).
The press release is attached as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
99.1 Synergy Pharmaceuticals Inc. Press Release dated December 22, 2016.
2 Red-Hot Biotechs to Buy Ahead of FDA Decisions
Is it worth rolling the dice on Flexion and Synergy?
David Liang
(Pfoolishly)
Nov 29, 2016 at 8:07AM
Gambling
Image source: Pixabay.
Investing in biotech is always a risky business. The chances of a drug making it from phase 1 to FDA approval can be as low as 10%. However, once a drug passes phase 3, investors can breathe more easily as drugs with positive phase 3 trials have a more than 80% chance of being approved by the FDA for commercial use. Investors willing to take on a little risk could be well served by buying into biotechs ahead of these final FDA decisions. With that said, here are two of the best biotech names with FDA approvals anticipated in the next 12 months.
Synergy Pharmaceuticals
Synergy Pharmaceuticals (NASDAQ:SGYP) is a small-cap biotech focused on the development and commercialization of novel gastrointestinal therapies. Synergy's lead product candidate is plecanatide, a once-daily tablet indicated for treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation. In June and July of last year, Synergy released top-line data from a pair of phase 3 pivotal studies testing plecanatide in CIC. Both trials were successful, with the 3-milligram and 6-milligram doses demonstrating strong statistical significance in beating placebo (21% response rate for the 3-milligram dose and 19.5% for the 6-milligram dose, compared to 10% for the placebo group). On this news, Synergy filed a New Drug Application (NDA) with the FDA for review and now has a pending decision due on Jan. 29, 2017.
Should plecanatide be approved for treatment of CIC, it will compete with the current market leader, Allergan plc and Ironwood Pharmaceuticals' collaboratively marketed CIC treatment Linzess. Linzess has been growing like gangbusters with sales up 40% in the third quarter, currently in its fourth year on the market. Ironwood management has projected annual sales of Linzess to surpass $1 billion by 2020. With Linzess commanding the dominant position in CIC, should Synergy's plecanatide be treated as just an also-ran? I, for one, don't believe so. A deeper look into the data reveals that plecanatide has a better adverse event profile compared with Linzess. The most common adverse event, diarrhea, occurred in 5.9% and 5.5% of the tested population for the 3-milligram dose and the 6-milligram dose, respectively. This compares to 16% occurrence of diarrhea for Linzess patients. Given CIC is not a life-threatening condition, lifestyle considerations like tolerability could play a meaningful role in choosing one CIC therapy over another. Given the choice of plecanatide versus Linzess, I think patients would more likely switch to plecanatide.
Stocks that Warrant a Look
Here are a couple of health care stocks that you may want to consider, as our model shows that they have the right combination of elements – a positive Zacks Earnings ESP and a Zacks Rank #1 (Strong Buy), #2 (Buy) or #3 (Hold) – to post an earnings beat this quarter.
Tokai Pharmaceuticals, Inc. TKAI has an Earnings ESP of is +18.42% and it carries a Zacks Rank #3.
Synergy Pharmaceuticals, Inc. SGYP has an Earnings ESP of +18.18% and a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
http://finance.yahoo.com/news/whats-store-merck-kgaa-mkgaf-222910510.html
Emerge Energy Services (EMES)
STOCKS TO BUY: TheStreet Quant Ratings has identified a handful of stocks with serious upside potential in the next 12-months. Learn more.
Emerge Energy Services had a strong day on Wednesday, up $2.01, or 18%, to $13.06, on no news. Volume of 698,000 shares was the biggest in about three weeks. The stock reversed off an intraday low of $11.02, right near support, closing near the high for the day on no news, and boding well for a continuation higher. Watch for a test of recent highs around $14.60, and followed by $18.50.
Emerge Energy Services upgraded to Buy at Wunderlich
Sep 29 2016, 15:46 ET | About: Emerge Energy Services LP (EMES) | By: Carl Surran, SA News Editor [Contact this editor with comments or a news tip]
Emerge Energy Services (EMES +0.2%) is upgraded to Buy from Hold with a $15 price target, lifted from $12, at Wunderlich, which believe the sand market should begin to show improvement in H2.
EMES has significantly improved its balance sheet and is developing and testing multiple sand technologies that could become lucrative and differentiated products going forward, the firm says.
While Wunderlich still believes distributions are not likely in the relative near future, the firm thinks EMES' investment potential has improved significantly as the positive catalysts play out.
http://seekingalpha.com/news/3211625-emerge-energy-services-upgraded-buy-wunderlich
Synergy Pharmaceuticals Announces New Plecanatide Data Presentations at Upcoming Scientific Meeting and Provides Update on IBS-C Program
September 28, 2016
NEW YORK--(BUSINESS WIRE)--
Synergy Pharmaceuticals Inc. (SGYP) today announced that the company will present new data on plecanatide, an investigational compound for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), at the American College of Gastroenterology (ACG) annual scientific meeting at The Venetian in Las Vegas, October 14-19, 2016.
The following two posters will be presented in Hall C on Monday, October 17th from 10:30 a.m.-4:00 p.m. PT with author presentation at the poster from 1:00-2:15 p.m. PT:
P1041A. Efficacy and Safety of Plecanatide in the Treatment of Chronic Idiopathic Constipation (CIC): Pooled Results from Two Phase 3 Studies
*2016 ACG Presidential Poster Award
-- Presenter: Satish S.C. Rao, MD, PhD, Professor of Medicine, Division Chief Fellowship Program Director, Director Digestive Health Center
P1120. Safety and Tolerability of Plecanatide in Patients with Chronic Idiopathic Constipation: Long-term Evidence from an Open-Label Study
-- Presenter: Marianela De La Portilla, MD, Genome Research Group, Miami, FL
Plecanatide is a once-daily, orally-administered compound currently being evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of CIC and the Prescription Drug User Fee Act (PDUFA) target action date for plecanatide is January 29, 2017.
In addition, Synergy has already completed patient recruitment for the two double-blind placebo-controlled phase 3 clinical trials with plecanatide in IBS-C and remains on-track to report top-line data from both trials in the fourth quarter of this year. Pending approval in the CIC indication, Synergy plans to file a New Drug Application Supplement with Clinical Data (sNDA) for plecanatide in IBS-C in the first quarter of 2017 and expects a 10-month review period from submission.
About Chronic Idiopathic Constipation (CIC)
CIC affects 14 percent of the population in North America, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult and infrequent bowel movements. CIC can severely impact people’s daily lives, increasing stress levels and anxiety.
About Plecanatide
Plecanatide is a peptide made up of 16 amino acids and, with the exception of a single amino acid substitution, it is identical to uroguanylin. Plecanatide is the first investigational drug designed to replicate the function of uroguanylin, a naturally occurring and endogenous human GI peptide which acts in a pH-dependent manner targeting GC-C receptors primarily in the proximal small intestine. Plecanatide stimulates fluid secretion and promotes stool consistency necessary to support normal bowel function.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and commercialization of novel GI therapies. The company has pioneered discovery, research and development efforts around uroguanylin analogs for the treatment of functional GI disorders and inflammatory bowel disease. Synergy’s proprietary uroguanylin analog technology platform includes two lead product candidates – plecanatide and dolcanatide. For more information, please visit www.synergypharma.com.
Forward-Looking Statement
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's Form 10-K for the year ended December 31, 2015 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160928005239/en/
Southlake, Texas - September 23, 2016 - Emerge Energy Services LP ("Emerge Energy") today announced that it will conduct a series of investor meetings in New York City on September 27, 2016.
Presentation materials used during these meetings will be posted early on September 27, 2016 to Emerge Energy`s website at www.emergelp.com within the Investor Relations portion of the website under the Webcasts & Presentations section.
About Emerge Energy Services LP
Emerge Energy Services LP (EMES) is a growth-oriented limited partnership engaged in the business of mining, producing, and distributing silica sand, a key input for the hydraulic fracturing of oil and natural gas wells, through its subsidiary Superior Silica Sands LLC.
Forward-Looking Statements
The presentation contains certain statements that are "forward-looking statements." These statements can be identified by the use of forward-looking terminology including "may," "believe," "will," "expect," "anticipate," or "estimate." These forward-looking statements involve risks and uncertainties, and there can be no assurance that actual results will not differ materially from those expected by management of Emerge Energy. When considering these forward-looking statements, you should keep in mind the risk factors and other cautionary statements in Emerge Energy`s Annual Report on Form 10-K filed with the SEC. The risk factors and other factors noted in the Annual Report could cause actual results to differ materially from those contained in any forward-looking statement. Except as required by law, Emerge Energy does not undertake any obligation to update or revise such forward-looking statements to reflect events or circumstances that occur after the date hereof.
PRESS CONTACT
Investor Relations
(817) 865-5830
Synergy Pharmaceuticals to Present at OctoberINVESTfest 2016
Date : 09/23/2016 @ 9:30AM
Source : Business Wire
Stock : Synergy Pharmaceuticals, Inc. (MM) (SGYP)
Quote : 5.58 0.0 (0.00%) @ 8:57AM
Synergy Pharmaceuticals to Present at OctoberINVESTfest 2016
Today : Friday 23 September 2016
Click Here for more Synergy Pharmaceuticals, Inc. (MM) Charts.
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the company will present at the OctoberINVESTfest Conference on Wednesday, September 28, 2016 at 11:30 a.m. Eastern Time at the New York Academy of Sciences in New York.
A live webcast of the presentation will be accessible through the Investor Relations section of the company’s website at www.synergypharma.com. A replay of the webcast will be available on Synergy’s website for 60 days following the conference.
About Synergy Pharmaceuticals Inc.
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of functional GI disorders and inflammatory bowel disease. Synergy discovered, is developing and retains 100% worldwide rights to its proprietary uroguanylin analog technology platform that includes two lead product candidates – plecanatide and dolcanatide. Plecanatide is Synergy’s first uroguanylin analog currently being evaluated for use as a once-daily tablet for chronic idiopathic constipation and irritable bowel syndrome with constipation. Dolcanatide is Synergy’s second uroguanylin analog currently being explored for ulcerative colitis. For more information, please visit www.synergypharma.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160923005125/en/
Synergy Pharmaceuticals
Gem Hopkins, 212-584-7610
VP, Investor Relations and Corporate Communications
ghopkins@synergypharma.com
MeetMe Named a Top Millennial App by comScore Mobile App Report
[Business Wire]
September 16, 2016
NEW HOPE, Pa.--(BUSINESS WIRE)--
MeetMe, Inc. (MEET), a public market leader for social discovery, has been named a top millennial app by comScore Inc.’s 2016 U.S. Mobile App Report. MeetMe ranked number six out of the top 20 apps with the highest concentration of users falling between the ages of 18-34. The ranking was based on apps with greater than 1.5 million monthly active users within that age group.
“We are excited to again be ranked as one of the top mobile apps for millennials,” said Bill Alena, Chief Revenue Officer of MeetMe. “We believe this high ranking reflects our ability to help our advertisers reach this highly coveted demographic.”
About MeetMe, Inc.
MeetMe® is a leading social network for meeting new people in the US and a public market leader for social discovery (MEET). MeetMe makes it easy to discover new people to chat with on mobile devices. With approximately 90 percent of traffic coming from mobile and more than one million total daily active users, MeetMe is fast becoming the social gathering place for the mobile generation. MeetMe is a leader in mobile monetization with a diverse revenue model comprising advertising, native advertising, virtual currency, and subscription. MeetMe apps are available on iPhone, iPad, and Android in multiple languages, including English, Spanish, Portuguese, French, Italian, German, Chinese (Traditional and Simplified), Russian, Japanese, Dutch, Turkish and Korean. For more information, please visit meetmecorp.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including whether our comScore ranking reflects our ability to help our advertisers reach millennial users between the ages of 18-34. All statements other than statements of historical facts contained herein are forward-looking statements. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “project,” “is likely,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Important factors that could cause actual results to differ from those in the forward-looking statements include the risk that our applications will not function easily or otherwise as anticipated, the risk that we will not launch additional features and upgrades as anticipated, the risk that unanticipated events affect the functionality of our applications with popular mobile operating systems, any changes in such operating systems that degrade our mobile applications’ functionality and other unexpected issues which could adversely affect usage on mobile devices. Further information on our risk factors is contained in our filings with the Securities and Exchange Commission (“SEC”), including the Form 10-K for the year ended December 31, 2015 and the Form 10-Q for the quarter ended June 30, 2016. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Synergy Pharmaceuticals
Wednesday's Range: $4.96-$5.32
52-Week Range: $2.50-$7.72
Wednesday's Volume: 5.47 million
Three-Month Average Volume: 2.80 million
Synergy Pharmaceuticals (SGYP) , a biopharmaceutical company, focuses on the development of drugs to treat gastrointestinal disorders and diseases. This stock closed up 8.8% to $5.30 in Wednesday's trading session.
From a technical perspective, Synergy Pharmaceuticals ripped sharply higher on Wednesday right off its 20-day moving average of $4.93 a share with strong upside volume flows. This stock has been uptrending extremely strong over the last six months, with shares ripping higher off its 52-week low of $2.50 a share to its recent high of $5.38 a share. During that uptrend, shares of Synergy Pharmaceuticals have been making mostly higher lows and higher highs, which is bullish technical price action. This rip higher on Wednesday is now quickly pushing this stock within range of triggering a near-term breakout trade. That trade will trigger if this stock manage to take out some near-term overhead resistance at $5.38 a share with high volume.
Traders should now look for long-biased trades in Synergy Pharmaceuticals as long as it's trending above its 20-day moving average of $4.93 a share or above more near-term support at $4.72 a share and then once it sustains a move or close above $5.38 a share with volume that hits near or above 2.80 million shares. If that breakout fires off soon, then this stock will set up to re-test or possibly take out its next major overhead resistance levels at $6 to $6.25, or even $6.50 to $7 a share.
NEW HOPE, Pa.--(BUSINESS WIRE)--
MeetMe, Inc. (MEET), a public market leader for social discovery, announced today that the California Department of Business Oversight has determined that the terms and conditions of the offer and sale of MeetMe common stock in its proposed merger with Skout, Inc. are fair, and that the Department has issued a permit authorizing MeetMe to issue shares of common stock in the merger. The determination was made at the conclusion of a fairness hearing conducted under Section 25121 of the California Corporations Code.
The issuance of the permit will allow for the shares of MeetMe common stock to be issued in reliance upon an exemption from registration afforded by Section 3(a)(10) of the Securities Act of 1933, as amended, such that MeetMe will not need to register such shares under the Securities Act.
The proposed merger remains subject to the approval of Skout’s shareholders and the satisfaction of certain other customary closing conditions. MeetMe expects the acquisition to close in early October 2016.
MeetMe also announced today that it has repurchased approximately $2 million worth of its common stock in the open market since announcing its $15 million share repurchase program on September 6, 2016.
About MeetMe, Inc.
MeetMe® is a leading social network for meeting new people in the US and a public market leader for social discovery (MEET). MeetMe makes it easy to discover new people to chat with on mobile devices. With approximately 90 percent of traffic coming from mobile and more than one million total daily active users, MeetMe is fast becoming the social gathering place for the mobile generation. MeetMe is a leader in mobile monetization with a diverse revenue model comprising advertising, native advertising, virtual currency, and subscription. MeetMe apps are available on iPhone, iPad, and Android in multiple languages, including English, Spanish, Portuguese, French, Italian, German, Chinese (Traditional and Simplified), Russian, Japanese, Dutch, Turkish and Korean. For more information, please visit meetmecorp.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding whether we will close the acquisition of Skout, Inc. as anticipated. All statements other than statements of historical facts contained herein are forward-looking statements. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “project,” “is likely,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Important factors that could cause actual results to differ from those in the forward-looking statements include the risk that our applications will not function easily or otherwise as anticipated, the risk that we will not launch additional features and upgrades as anticipated, the risk that unanticipated events affect the functionality of our applications with popular mobile operating systems, any changes in such operating systems that degrade our mobile applications’ functionality and other unexpected issues which could adversely affect usage on mobile devices. Further information on our risk factors is contained in our filings with the Securities and Exchange Commission, including the Form 10-K for the year ended December 31, 2015 and the Form 10-Q for the quarter ended June 30, 2016. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160915005386/en/
That's funny because I bought some today also, albeit a little bit higher.