Thu, Mar. 17, 5:21 PM
- Thinly traded nano cap CymaBay Therapeutics (NASDAQ:CBAY) is down 16% after hours on robust volume in response to its announcement of results in a Phase 2 pilot study assessing Orphan Drug-tagged MBX-8025 in patients with homozygous familial hypercholesterolemia (HoFH), an inherited disorder characterized by abnormally high levels of bad LDL cholesterol (LDL-C) leading to premature cardiovascular disease.
- The 12-week, open-label, dose escalation trial enrolled 13 HoFH patients. All were receiving ezetimibe [Merck's (NYSE:MRK) Zetia] and were on maximum statin therapy. None were being treated with lomitapide [Aegion's (NASDAQ:AEGN) Juxtapid], mipomersen [Sanofi's (NYSE:SNY) Kynamro] or a PSCK9 inhibitor. The average baseline LDL-C level was 368 mg/dL (optimal level: less than 100 mg/dL). Subjects received 50 mg of MBX-8025 once daily for four weeks.
- Two per-protocol analyses were performed on 12 subjects (one was excluded due to missed apheresis visits). A responder analysis showed three patients experienced a reduction in LDL-C greater than 30%, five patients at least 20% and seven patients at least 15%. The average maximum decrease was 19%. A second analysis, averaging values across all doses and dosing periods, showed an overall average decrease in LDL-C of 10%, with eight subjects showing a mean decrease of 16% and three greater than 20%. Four patients showed a mean increase in LDL-C of 4%.
- Mean PCSK9 was elevated at baseline and increased significantly during treatment by an average of 43%, which was unexpected, and creates the need to assess the combination of MBX-8025 and a PCSK9 inhibitor [Amgen's (AMGN +0.1%) Repatha (evolocumab) or Regeneron (NASDAQ:REGN) and Sanofi's Praluent (alirocumab)] in a pilot study.
- MBX-8025 is an agonist of peroxisome proliferator-activated receptor delta, a nuclear receptor that regulates genes involved in lipid transport, storage and metabolism in liver and muscle.
- Previously: CymaBay product candidate an Orphan Drug for severe hypertriglyceridemia (April 22, 2015)
Thu, Mar. 10, 5:42 PM
- Aegion (AEGN -2.4%) has announced a new $20M share repurchase program good for the remainder of the year, using a "strong cash position" to buy back shares "at prices we continue to believe are attractive.”
- The new authorization will pick up immediately after an existing $20M program is exhausted.
- The company will execute the new program through one or more 10b5-1 plans, allowing for purchases even during times when the company has material nonpublic information, like undisclosed earnings.
- Aegion will make purchase on the open market or otherwise.
- Shares are flat in after-hours trading.
Oct. 7, 2014, 12:45 PM
Aug. 16, 2013, 3:23 PM
- Aegion (AEGN +1.8%) moves up after announcing that its subsidiary, Insituform Technologies USA, has won a $6.7M contract from the Metropolitan St. Louis Sewer District.
- The company previously won two contracts in April valued at approximately $10.4M.
- The project entails Insituform installing over 34 miles of its cured-in-place pipe in wastewater pipelines ranging from 8-inches in diameter to 60-inches in diameter throughout the city of St. Louis and surrounding county, as part of a $.4.6B capital improvement and replacement plan.
Jun. 27, 2013, 12:53 PM
Aegion (AEGN +2.6%) gains after saying its Insituform Technologies unit has been awarded a $16M contract from the City of Baltimore, Maryland to install over 170K feet of its small- and medium-diameter pipe in wastewater pipelines located in urban areas in the north and east portions of the city. Work is expected to begin in Q3, and will take approximately 16 months to complete. Since last December, the City of Baltimore has awarded Insituform over $46M in contracts.| Jun. 27, 2013, 12:53 PM
Jun. 26, 2013, 11:38 AM
Aegion (AEGN -1.3%) has sold its 50% interest in Insituform Rohrsanierungstechniken GmbH to the Danish company Per Aarsleff A/S, for €14M, or about $18.3M. The company was already jointly owned with Aarsleff. In connection with the sale, Insituform-Germany enters into a product supply agreement with AEGN to purchase on an annual basis at least $3.6M of felt cured-in-place pipe liners during a two-year period from June, 2013 to June, 2015.| Jun. 26, 2013, 11:38 AM
Dec. 11, 2012, 2:48 PM
Aegion (AEGN +1.2%) moves up after its Hong Kong subsidiary, Fyfe Hong Kong Ltd., lands a contract valued at $8.5M for the rehabilitation of potable water pipelines for the Government of Hong Kong Water Supplies Department.| Dec. 11, 2012, 2:48 PM
Sep. 4, 2012, 3:39 PMAegion (AEGN +1.5%) trades higher today after saying that its Hong Kong subsidiary received a three-year, $13M contract from the Government of Hong Kong Water Supplies Department for the rehabilitation of potable steel water pipelines. | Sep. 4, 2012, 3:39 PM
Aug. 1, 2012, 3:39 PM
Aegion (AEGN +5.3%), which posted an encouraging Q2 on Monday on improving operating conditions and margins, gets another boost today from an upgrade to Buy at Ladenburg Thalmann. In its note to clients, the firm says the results suggest the plan to return to profitability that management laid out at the end of 2011 is working.| Aug. 1, 2012, 3:39 PM
Oct. 24, 2011, 10:57 AM
Oct. 10, 2011, 12:43 PM
Insituform Technologies (INSU +7.8%) gets a boost from its announcement of of a $10M stock buyback, saying it plans to buy up to $5M through the end of 2011, and the remainder throughout 2012.| Oct. 10, 2011, 12:43 PM
Sep. 30, 2011, 1:58 PMInsituform Technologies (INSU -13.9%) has had an interesting ride over the last 2 days. After getting clobbered yesterday on an earnings warning, shares rallied in late-day trading to close up 1%. But they're crashing again today after Wedbush downgrades them to Neutral, citing "persistent challenges" and "poor earnings visibility." | Sep. 30, 2011, 1:58 PM
Sep. 29, 2011, 8:58 AM
Insituform Technologies (INSU) drops 14.9% after the provider of infrastructure protection technologies and services warns its 2011 EPS will be in a range of $0.90-$1.00, below a consensus of $1.19. The company blames weakness in both its Sewer Rehabilitation and Energy and Mining divisions.| Sep. 29, 2011, 8:58 AM
Sep. 14, 2011, 9:58 AMShares of Insituform Technologies (INSU -7.3%) sink after Oppenheimer downgrades the firm to Underperform from a Perform rating, as poor weather and flooding hurts the piping and sewer business in the near term. Estimates on earnings were slashed to $1.00, well-below the company's guidance of $1.30-$1.40 and consensus estimate of $1.25. | Sep. 14, 2011, 9:58 AM
Aug. 29, 2011, 11:21 AM
Jun. 16, 2011, 4:15 PM
Insituform Technology (INSU -13%) drops after guiding FY11 estimates lower. CEO Joe Burgess says project delays and bad weather hurt its sewer rehabilitation business, and he expects the division to generate significantly less income than anticipated.| Jun. 16, 2011, 4:15 PM