04.11.2016 08:44:21
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ACHN Tanks, INNL's Acts Fail, LCI In The Crosshair Of Law, ONCE Loses Its Spark
(RTTNews) - Achillion Pharmaceuticals Inc. (ACHN) lost over 28% of its stock value on Thursday after the company announced that "2 cases of self-limited, *ALT elevations (Grade 3 and 4) were observed post-treatment in the mid- and high dose groups in an ongoing phase I multiple ascending dose study of ACH-4471 in healthy volunteers'.
ALT or Alanine transaminase is a liver enzyme and elevated ALT levels indicate liver damage.
Three doses of ACH-4471 namely, 200 mg, 500 mg and 800 mg are being studied in the phase I trial of ACH-4471.
ACH-4471 is being explored for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and other ultra-rare diseases.
ACHN closed Thursday's trading at $4.32, down 28.48%.
Shares of Innocoll Holdings PLC (INNL) slumped over 44% in extended trading on Thursday as the company's two phase III clinical trials of Cogenzia in patients with moderate to severe diabetic foot infections failed to meet the primary endpoint.
Cogenzia is a topically applied, bioresorbable collagen sponge.
In the studies, dubbed COACT-1 and COACT-2, Cogenzia in patients with moderate to severe diabetic foot infections administered in conjunction with systemic antibiotics and wound therapy, the standard of care (SOC), did not meet their primary endpoint of clinical cure of infection after 28 days versus placebo plus SOC or SOC alone.
INNL closed Thursday's trading at $3.50, down 10.26%. In after-hours, the stock was down 44.29% to $1.95.
Shares of Lannett Co. Inc. (LCI) plunged more than 26% on Thursday, following reports that criminal charges may be filed against the company by the end of this year for colluding with other pharmaceutical companies to fix generic drug prices.
According to reports, Mylan NV, Teva Pharmaceutical Industries Ltd, Allergan Plc, Impax Laboratories Inc., Sun Pharmaceutical Industries Ltd., Mayne Pharma Group Ltd., Endo International Plc and Taro Pharmaceutical Industries Ltd. are the other companies named in the price-fixing lawsuit.
LCI closed Thursday's trading at $17.25, down 26.60%. In after-hours, the stock was up 5.80% to $18.25.
Shares of Nxstage Medical Inc. (NXTM) were up 13% on Thursday as the company reported improved third quarter results and upwardly revised outlook for the full year of 2016.
Net loss attributable to stockholders improved to $0.2 million or $0.00 per share on revenue of $92.0 million. This compared with a net loss of $1.7 million or $0.03 per share and revenue of $86.5 million for the third quarter of 2015.
Looking ahead to full-year of 2016, the company now expects revenue to be at the high end of its previously increased guidance range of $360 to $365 million, and a net loss in a range of $4 to $5 million versus its previously revised guidance for a loss at the better end of a range of $7 to $12 million. Analysts polled by Thomson Reuters expect the company to report a loss per share of $0.09 on revenue of $364.72 million.
NXTM closed Thursday's trading at $23.99, up 13.32%.
Shares of Spark Therapeutics (ONCE) were down 13.74% on Thursday after the company announced that 1 participant in its phase 1/2 clinical trial of SPK-9001 for treatment of hemophilia B developed an immune response and a decline in factor IX activity level. This patient, who had not reached 12 weeks post-vector administration, had to be put on a tapering course of corticosteroids.
However, 4 of the seven participants who had reached greater than 12 weeks post-vector administration at the time of abstract submission experienced consistent and sustained factor IX activity levels, with a mean greater than 30% of normal, with no sustained elevation in liver enzyme levels, according to the company.
SPK-9001 is being developed under a collaboration with Pfizer Inc. (PFE).
ONCE closed Thursday's trading at $40.51, down 13.74%.
Trillium Therapeutics Inc. (TRIL) declined 53% on Thursday as investors were spooked by safety issues in 0.3 mg/kg dose cohort of the company's phase 1 study of TTI-621 in patients with relapsed or refractory hematologic malignancies.
According to the company, the trial included 0.05 mg/kg, 0.1 mg/kg and 0.3 mg/kg dose cohorts. In the 0.3 mg/kg dose cohort, 2 of 5 patients experienced reversible, dose-limiting toxicity; 1 patient with G3 elevated ALT/AST and G4 platelet count and a second patient with G4 platelet count who was transfused.
TRIL closed Thursday's trading at $6.85, down 53.08%.
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