|Healthcare Review: Achillion Pharmaceuticals, Galectin Therapeutics, Pernix, Amedisys, Sarepta Therapeutics|
|By Staff and Wire Reports|
|Tuesday, 12 November 2013 15:00|
Achillion Pharmaceuticals ($ACHN) gets a lift after "reiterating" its HCV pipeline priorities in its Q3 PR. Going forward, the company says it plans to "to engage in regulatory discussions regarding the path forward for sovaprevir" and initiate a "drug-drug interaction study followed by a therapeutic trial" for an ACH-3102/ ACH-2684 combo. For more on all of this, see ACHN's last pipeline update. The company also notes that its current cash position ($173M) should be "more than sufficient to reach several value creating milestones and fund operations for at least two years."
Galectin Therapeutics ($GALT) drops after reporting Q3 results. The company says "five of the eight patients have been enrolled and infused" in a Phase 1 study of GR-MD-02 in NASH. Data from the first cohort of patients is due early next year assuming "all goes as expected." As of September 30, GALT had $9.7M in cash which the company says should last "into Q3 of 2014."
Pernix Therapeutics ($PTX) plunges after reporting Q3 results, erasing big gains posted on Friday. Revenue for the period ticked higher by 1%, although sales of the company's legacy products fell during Q3.The Cypress Hawthorn acquisition makes SG&A a tough compare over Q3 2012.PTX says it has "implemented net personnel reductions which will generate additional annualized savings of approximately $2M."FY13 outlook: Revenue of $80M versus previous guidance of $90-100M.
Amedisys ($AMED) books a $150M accrual in Q3 for its tentative deal with the U.S. DOJ. The settlement was struck without admission of wrongdoing. $145M was added back to get to the company's adjusted results for the period, but even so, CEO William Borne characterizes the results as "below expectations." Borne blames "soft volume in both [the] home health and hospice business units and higher costs."FY13 outlook (this is adjusted to exclude the DOJ accrual): EPS of $0.20-0.25 (versus previous guidance of $0.45-0.55) on revenue of $1.24-1.25B (versus previous guidance of $1.24-1.28B). Consensus is $0.55/share on revenue of $1.28B.
Sarepta Therapeutics ($SRPT) continues to tumble in premarket trading — shares are now down more than 45%.The FDA came down particularly hard on dystrophin's ability to predict clinical benefit: "The disconnect between increased expression of dystrophin and clinical efficacy for drisapersen ... raises considerable doubt about the biomarker," the regulator says, adding that "the quantity of dystrophin that might be necessary to be considered reasonably likely to predict clinical benefit is even less clear." Also questioned is the 6MWT: "Recent natural history data in DMD indicate that a baseline 6MWT e350 meters predicts continued general stability for such patients, not the 75- to 83-meter yearly decline [$SRPT] suggests in the meeting package." Even worse: "The expected variability of 6MWT values appears sufficient to explain differences between arms on which the post-hoc analysis was based."