Impax extended FDA review a marginal negative, says Wells Fargo Wells Fargo views the FDA's extension of the review period for Impax's Rytary as marginally negative since the data was an expected near-term catalyst for shares. However, Wells notes the FDA did not request any new clinical trials and that the delay provides more time for Impax to resolve the warning letter is previously received. Wells keeps a Market Perform rating on Impax.
News For IPXL From The Last 14 Days
Check below for free stories on IPXL the last two weeks.
On The Fly: Analyst Initiation Summary Today's noteworthy initiations include: A10 Networks (ATEN) initiated with a Buy at BofA/Merrill... Actavis (ACT) initiated with a Buy at Sterne Agee... Allergan (AGN) initiated with a Buy at Sterne Agee... Autohome (ATHM) initiated with a Neutral at Credit Suisse... BitAuto (BITA) initiated with an Outperform at Credit Suisse... Centene (CNC) initiated with a Neutral at UBS... Endo International (ENDP) initiated with a Buy at Sterne Agee... FS Investment (FSIC) initiated with an Overweight at Evercore... Hertz (HTZ) initiated with a Buy at Gabelli... Hilton (HLT) initiated with a Hold at Jefferies... Hospira (HSP) initiated with a Neutral at Sterne Agee... ImmunoGen (IMGN) initiated with a Buy at Canaccord... Impax (IPXL) initiated with a Neutral at Sterne Agee... Imperva (IMPV) assumed with a Neutral at Wedbush... Ingredion (INGR) initiated with an Outperform at Credit Suisse... Laredo Petroleum (LPI) initiated with an Outperform at RW Baird... Lpath (LPTN) initiated with a Buy at Canaccord... MediWound (MDWD) initiated with an Outperform at Oppenheimer... Medivation (MDVN) initiated with a Hold at Canaccord... NPS Pharmaceuticals (NPSP) assumed with a Buy at Canaccord... Nimble Storage (NMBL) initiated with a Market Perform at Raymond James... Regeneron (REGN) initiated with a Buy at Canaccord... Salix (SLXP) initiated with a Buy at Sterne Agee... Sibanye Gold (SBGL) initiated with an Outperform at Imperial Capital... Teva (TEVA) initiated with a Neutral at Sterne Agee... Wipro (WIT) assumed with a Hold at Jefferies.
Impax launches generic Renvela for kidney disease licensed from Sanofi Impax Laboratories (IPXL) is commencing shipment of authorized generic Renvela 800 mg tablets, through Global Pharmaceuticals, Impax's generics division. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Under the terms of a settlement agreement, Sanofi (SNY) company Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets commencing on April 16. Impax continues to pursue approval of its pending Abbreviated New Drug Application for generic Renvela with the FDA.