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News Breaks
July 24, 2014
08:12 EDTESPREsperion Therapeutics initiates Phase 2 study of ETC-1002
Esperion Therapeutics announced dosing of the first patient in its Phase 2 clinical study of ETC-1002 in patients with hypercholesterolemia and hypertension, ETC-1002-014. The company expects to announce top-line results from the study in the second quarter of 2015. The randomized, double-blind, parallel group, multicenter ETC-1002-014 study is evaluating parallel doses of ETC-1002 in approximately 144 patients. The primary objective of the study is to assess the LDL-cholesterol lowering efficacy of ETC-1002 monotherapy versus placebo in patients with both hypercholesterolemia and hypertension who are treated for six weeks. Secondary objectives include assessing the effect of ETC-1002 on blood pressure, other lipid and cardiometabolic biomarkers and characterizing the tolerability and safety of ETC-1002.
News For ESPR From The Last 14 Days
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August 27, 2015
18:52 EDTESPROn The Fly: After Hours Movers
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17:58 EDTESPREsperion up 1.9% after FDA approves Amgen cholesterol drug Repatha
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August 19, 2015
14:23 EDTESPREsperion continues decline after Needham downgrade
Shares of Esperion (ESPR) are continuing Tuesday's losses following a downgrade this morning from Needham, with the research firm commenting that the company's cholesterol drug may debut against a somewhat thin addressable treatment population. WHAT'S NEW: Needham's Chad Messer issued a research note on Esperion Therapeutics (ESPR), downgrading the stock to Buy from Strong Buy and cutting his price target to $115 from $130. Messer said that "an important catalyst has passed" for the stock following an update Monday on Esperion's ETC-1002 cholesterol treatment. Additionally, Messer noted that while the FDA will not require a cardiovascular outcomes trial, the drug appears to be headed for a smaller-than-expected initial treatment population. WHAT'S NOTABLE: The Needham downgrade follows commentary from JPMorgan on Tuesday, with analyst Jessica Fye remarking that the good news outweighs the bad for Esperion despite the potentially narrower ETC-1002 label. Research firm Chardan did not appear to share those sentiments, countering that the FDA guidance shared by Esperion on Monday is "clearly inconsistent with recent management and consensus commentary." PRICE ACTION: Esperion shares saw gains of about 10% immediately following Monday's update, but later fell throughout Tuesday and into Wednesday. In intra--day trading Wednesday, shares of the company are down about 10%.
13:30 EDTESPROn The Fly: Top stock stories at midday
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10:00 EDTESPROn The Fly: Analyst Downgrade Summary
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09:19 EDTESPROn The Fly: Pre-market Movers
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07:26 EDTESPREsperion downgraded to Buy from Strong Buy at Needham
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August 18, 2015
16:49 EDTESPROn The Fly: Top stock stories for Tuesday
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13:33 EDTESPROn The Fly: Top stock stories at midday
Repeating yesterday's start, the market began the session in negative territory before recapturing those losses. Early weakness was attributed to a dip in Wal-Mart (WMT) shares after the company's earnings report as well as a selloff in the Chinese market overnight. Heading into the afternoon, the market has drifted back across the flat line, with all three indices negative despite July's housing starts showing the strongest reading in eight years. ECONOMIC EVENTS: In the U.S., housing starts edged up 0.2% in July to 1.206M, outpacing consensus estimates for 1.180M in the best reading since October 2007. Building permits fell 16.3% to 1.119M against expectations for 1.230M from a revised 1.337M in June, while single family starts rose 12.8% and multifamily numbers fell 17.0%. In Europe, Eurozone parliaments are set to vote on Greece's prospective bailout deal this week, with Reuters reporting earlier today that the Austrian parliament has approved the EUR86B agreement. COMPANY NEWS: Shares of National Penn (NPBC) rose nearly 17% to $12.77 after BB&T (BBT) agreed to acquire the company in a $1.8B cash and stock deal. On a conference call discussing the acquisition, BB&T CEO Kelly King called the "very, very synergistic" deal a "compelling use of capital," adding that the company expects to consolidate about 25 branches to help drive annual cost savings of $65M... Wal-Mart (WMT) fell roughly 3.2% to near $69.50 after cutting its full year earnings outlook this morning, with CFO Charles Holley noting that operating profit will see continued pressure. Meanwhile, Home Depot (HD) and Dicks Sporting Goods (DKS) saw respective gains of about 2.3% and 1.8% after their pre-market earnings reports. MAJOR MOVERS: Among the notable gainers was Omeros (OMER), surging more than 69% to $24.58 after releasing positive preliminary data on its Phase 2 trial of OMS721 for the treatment of organ blood clots. Also higher was Inteliquent (IQNT), rising about 19% to $21.24 after announcing a three-year agreement with T-Mobile (TMUS) to provide IP voice services for the carrier. Separately, Lumber Liquidators (LL) has gained almost 5.7% to nearly $15 in afternoon trading after announcing the appointment of Jill Witter as Chief Compliance and Legal Officer. Among the noteworthy losers was Esperion (ESPR), falling over 11% despite rising 5% in pre-market trading after reporting that the ETC-1002 Phase 3 program is on track, adding that the FDA will not require a cardiovascular outcomes trial prior to the drug's potential approval. Also lower was American Apparel (APP), slipping about 1.9% after disclosing "substantial doubt" about its ability to sustain operations during the coming year. INDEXES: Near midday, the Dow was down 40.37, or 0.23%, to 17,504.81, the Nasdaq lost 26.86, or 0.53%, to 5,064.96, and the S&P 500 was lower by 6.02, or 0.29%, to 2,096.41.
10:07 EDTESPRHigh option volume stocks
High option volume stocks: CCOI XONE XDE OMER JMBA URBN W SCCO DKS ESPR FEYE W
09:23 EDTESPROn The Fly: Pre-market Movers
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08:41 EDTESPREsperion update confirms bear thesis, says Chardan
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08:36 EDTESPREsperion update removes a key overhang, says JPMorgan
JPMorgan analyst Jessica Fye believes last night's update from Esperion Therapeutics, which included the FDA not requiring a pre-approval cardiovascular outcomes trial for ETC-1002, removes a key overhang on shares. The initial label will be narrower than previously thought, though, Fye tells investors in a research note. She thinks the good news trumps the bad, however, and keeps an Overweight rating on Esperion.
August 17, 2015
19:00 EDTESPROn The Fly: After Hours Movers
UP AFTER EARNINGS: Fabrinet (FN), up 5.1%. ALSO HIGHER: Esperion Therapeutics (ESPR), up 10.6% after announcing that it is on track to initiate ETC-1002 Phase 3 program by the end of 2015... Seattle Genetics (SGEN), up 3.3% after announcing FDA approval of Adcetris for HL treatment. DOWN AFTER EARNINGS: MasTec (MTZ), down 7.4%... Urban Outfitters (URBN), down 2.3%. ALSO LOWER: Sunedison (SUNE), down 1% after announcing a $500M perpetual convertible preferred stock offering.
17:08 EDTESPREsperion says does not need partner for ETC-1002 approval process
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16:09 EDTESPREsperion says on track to initiate ETC-1002 Phase 3 program by end of 2015
Esperion Therapeutics provided an update from the ETC-1002, or bempedoic acid, end-of-Phase 2 meeting with the U.S. FDA last week. The FDA confirmed that LDL-C remains an "acceptable" clinical surrogate endpoint for the approval of an LDL-C lowering therapy such as ETC-1002 in patient populations who have a high unmet medical need, including patients with heterozygous familial hypercholesterolemia, or clinical atherosclerotic cardiovascular disease, according to Esperion. Based on feedback from the FDA, approval of ETC-1002 in the HeFH and ASCVD patient populations will not require the completion of a cardiovascular outcomes trial. The company continues to plan and initiate a CVOT prior to NDA filing to pursue broader label indications related to cardiovascular disease risk reduction. Esperion remains on track to initiate the ETC-1002 Phase 3 development program by the end of 2015. The program will support a proposed label indication for the use of ETC-1002, an oral, once-daily LDL-C lowering therapy, "as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia, or atherosclerotic cardiovascular disease, who require additional lowering of LDL-C." Approximately nine million patients in the U.S. fall into these two combined categories, said the company. The company plans to continue to evaluate ETC-1002 as an add-on to statins, including at all doses. In Q4, Esperion plans to finalize development plans for the fixed-dose combination of ETC-1002 and ezetimibe and will file a separate Investigational New Drug application with the FDA.

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