• Thu, Jan. 5, 8:30 AM
    • Synergy Pharma (NASDAQ:SGYP) initiated with Outperform rating and $10 (50% upside) price target by Oppenheimer.
    • Trevena (NASDAQ:TRVN) initiated with Outperform rating and $13 (107% upside) price target.
    • C.R. Bard (NYSE:BCR) upgraded to Strong Buy with $265 (17% upside) price target by Raymond James.
    • McKesson (NYSE:MCK) downgraded to Neutral with a $169 (14% upside) price target by JPMorgan.
    • Mylan (NASDAQ:MYL) downgraded to Neutral by Citigroup.
    Thu, Jan. 5, 8:30 AM | 11 Comments
  • Wed, Jan. 4, 5:39 PM
    • Top gainers, as of 5.25 p.m.: SGYP +2.8%. ACHC +2.7%. HLT +1.7%. FSC +1.1%. UAE +1.0%.
    • Top losers, as of 5.25p.m.: KSS -15.0%. M -9.7%. JWN -5.4%. JCP -4.0%. DDS -3.9%.
    Wed, Jan. 4, 5:39 PM | 14 Comments
  • Dec. 22, 2016, 8:01 PM
    • Synergy Pharmaceuticals (NASDAQ:SGYP) is up 11% after hours on robust volume in response to its announcement of positive results in its second Phase 3 clinical trial assessing plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C).
    • The study met its primary endpoint of a statistically valid overall responder (OR) rate versus placebo at week 12. On a preliminary basis, the OR rates in the 3 mg and 6 mg plecanatide arms and placebo arm were 30.2%, 29.5% and 17.8%, respectively (p <0.001 for both).
    • The results echoed the positive results from the first Phase 3, announced two weeks ago.
    • The company's New Drug Application (NDA) seeking approval for plecanatide to treat chronic ideopathic constipation is currently under FDA review with an action date of January 29. Assuming approval, it intends to file a supplemental NDA for IBS-C later in Q1.
    • Plecanatide is the first investigational therapy designed to replicate the activity of uroguanylin, a naturally occurring human gastrointestinal peptide, by working locally in the proximal small intestine to stimulate digestive fluid movement and support regular bowel function.
    • Previously: Synergy Pharma's plecanatide successful in late-stage IBS-C study; shares ahead 17% premarket (Dec. 9)
    Dec. 22, 2016, 8:01 PM | 55 Comments
  • Dec. 22, 2016, 5:36 PM
    Dec. 22, 2016, 5:36 PM | 1 Comment
  • Dec. 13, 2016, 5:25 PM
    Dec. 13, 2016, 5:25 PM | 3 Comments
  • Dec. 9, 2016, 2:23 PM
    • Investors are selling the news as they mull what's next after Synergy's (SGYP -6.8%) successful Phase 3 trial for plecanatide. There's another Phase 3 trial, but those results aren't to be released for several weeks.
    • Also an issue is who might step up for a buyout given the costs associated with bringing the drug to market.
    • Citi's Liav Abraham sees Takeda Pharmaceutical (OTCPK:TKPYY +1.5%) as the most likely buyer in her coverage universe, and the FT today reported the company as willing to spend up to $15B in acquisitions to boost its U.S. presence. Abraham retains her Neutral rating and $4 price target (current price is $5.15).
    • Source: TheFly
    • Related tickers: Ironwood Pharma (IRWD +2.3%), Sucampo Pharma (SCMP +4.3%)
    Dec. 9, 2016, 2:23 PM | 79 Comments
  • Dec. 9, 2016, 9:19 AM
    Dec. 9, 2016, 9:19 AM | 4 Comments
  • Dec. 9, 2016, 9:01 AM
    • The first of two Phase 3 clinical trials assessing Synergy Pharmaceuticals' (NASDAQ:SGYP) plecanatide for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) met its primary endpoint of overall response rate at week 12.
    • Specifically, the percentage of Overall Responders in the 3 mg cohort was 21.5% and 24.0% in the 6 mg cohort, both superior to placebo's 14.2% (p=0.009 and p<0.001, respectively). An Overall Responder was defined as one who experienced at least a 30% reduction in worst abdominal pain and at a least one complete spontaneous bowel movement from baseline, in the same week, for at least 50% of the 12 treatment weeks.
    • The most common adverse event was diarrhea, which occurred in 3.2% and 3.7% of subjects in the 3 mg and 6 mg groups, respectively.
    • Results from a second Phase 3 will be release in the coming weeks.
    • Plecanatide is the first investigational therapy designed to replicate the activity of uroguanylin, a naturally occurring human gastrointestinal peptide, by working locally in the proximal small intestine to stimulate digestive fluid movement and support regular bowel function. It is currently under FDA review for the treatment of chronic idiopathic constipation with an action date of January 29, 2017.
    • Shares are up 17% premarket on increased volume.
    Dec. 9, 2016, 9:01 AM | 85 Comments
  • Dec. 7, 2016, 5:36 PM
    Dec. 7, 2016, 5:36 PM | 4 Comments
  • Nov. 21, 2016, 8:20 PM
    • Synergy Pharmaceuticals (NASDAQ:SGYP) inks exchange agreements with certain holders of its 7.5% Convertible Senior Notes due 2019 under which an aggregate principal amount of ~$20.7M of the Notes and accrued but unpaid interest was exchanged for 7,555,683 shares of common stock which equates $2.74 per common share.
    • Today's close was $5.56.
    Nov. 21, 2016, 8:20 PM | 40 Comments
  • Nov. 9, 2016, 5:34 PM
    Nov. 9, 2016, 5:34 PM | 11 Comments
  • Oct. 17, 2016, 10:11 AM
    • Synergy Pharmaceuticals (SGYP -1.4%presents new long-term safety data of plecanatide, its investigational, orally-administered compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). These data, which were presented at the American College of Gastroenterology (ACG) annual scientific meeting, showed that plecanatide was associated with low adverse events and low discontinuation rates in patients with CIC who received plecanatide (3 mg or 6 mg) once-daily for up to 72 weeks.
    • The most common adverse events in both dose groups in the 2,370-subject trial were diarrhea and urinary tract infection.
    • Synergy also presented plecanatide data from an integrated efficacy and safety analysis which are consistent with findings of two previously presented double-blind, placebo-controlled Phase 3 trials that evaluated more than 2,600 patients with CIC over a 12-week treatment period. These additional analyses confirmed a significantly greater response rate of durable overall complete spontaneous bowel movements (CSBM), a primary endpoint defined by the FDA for regulatory approval in CIC in each of the two plecanatide dose groups (3 mg, 20.5%; 6 mg, 19.8%) when compared to the placebo group (11.5%, p<0.001 for both doses). Secondary endpoints (stool consistency, straining and bloating) were significantly improved compared to placebo.
    • CIC affects 14% of the population in North America. People with CIC have persistent symptoms of difficult and infrequent bowel movements.
    • Plecanatide is the first investigational therapy designed to replicate the activity of uroguanylin, a naturally occurring human gastrointestinal peptide, by working locally in the proximal small intestine to stimulate digestive fluid movement and support regular bowel function.
    Oct. 17, 2016, 10:11 AM | 30 Comments
  • Aug. 26, 2016, 11:00 AM
    Aug. 26, 2016, 11:00 AM | 1 Comment
  • Aug. 8, 2016, 5:07 PM
    Aug. 8, 2016, 5:07 PM | 13 Comments
  • Jul. 15, 2016, 9:17 AM
    • Based on its ongoing dialogue with the FDA and the achievement of its mid-cycle review milestone, Synergy Pharmaceuticals (NASDAQ:SGYP) maintains its optimism that lead product candidate plecanatide will be approved to treat chronic ideopathic constipation (CIC) by its January 29, 2017 PDUFA date.
    • In addition, it will continue patient enrollment in its two current Phase 3 clinical trials assessing plecanatide in irritable bowel syndrome with constipation (IBS-C). The decision was made after trial monitoring showed a slower enrollment pace and an increase in the number of patients not meeting randomization criteria after the screening period prior to starting treatment.
    • Shares are down 8% premarket on average volume.
    Jul. 15, 2016, 9:17 AM | 32 Comments
  • Jul. 15, 2016, 9:16 AM
    Jul. 15, 2016, 9:16 AM