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[DomRuinart]

Den Rücksetzer halte ich für mächtig übertrieben. Enanta macht Gewinn (KGV: 10, Ständiges Einkommen durch Milestones und Royalties), ist Schuldenfrei, hat Cash bis unters Dach (132 Mio$) und eine mehr als vielversprechende Pipeline. Eine der wenigen Value Aktien im Biotech-Bereich.


AbbVie, Enanta tumble on FDA warning for HCV regimens


Published on Thursday, October 22, 2015

AbbVie Inc. (NYSE:ABBV) shed $5.56 (10%) to $48.27 and Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) plummeted $16.35 (41%) to $23.90 on Thursday after FDA issued a safety warning linking HCV therapies Viekira Pak and Technivie to cases of serious liver injury in cirrhotic HCV patients and required AbbVie to add information regarding liver injury risks to both drugs' labels.

AbbVie told BioCentury the U.S. labels for Viekira and Technivie now include a contraindication for patients with decompensated cirrhosis Child-Pugh class B and C. The label previously did not recommend Viekira for patients with decompensated cirrhosis Child-Pugh class B and was contraindicated in class C.


AbbVie also said Viekira's U.S. label now recommends that physicians evaluate evidence of hepatic decompensation prior to and during treatment in cirrhotic patients.


The agency reviewed AEs reported to the FDA Adverse Event Reporting System (FAERS) database and identified 26 cases of liver injury that were "possibly or probably" related to treatment with Viekira or Technivie. Ten patients experienced hepatic failure that led to liver transplantation or death, and 16 patients experienced varying degrees of liver dysfunction.


FDA said the majority of the reported AEs occurred in patients treated with Viekira who had evidence of advanced cirrhosis prior to starting treatment. Some cases of hepatic failure occurred in patients for whom the drugs are contraindicated or not recommended.


FDA approved Technivie in July in combination with ribavirin to treat non-cirrhotic adults with chronic HCV genotype 4 infection. The regimen includes ombitasvir, an HCV NS5A protein inhibitor; paritaprevir, an HCV NS3/4A protease inhibitor; and ritonavir, an HIV protease inhibitor. Paritaprevir is partnered with Enanta.


All three Technivie components are included in Viekira Pak, which also contains non-nucleoside HCV NS5B polymerase inhibitor dasabuvir. FDA approved Viekira last December with or without ribavirin to treat HCV genotype 1 infection in patients with or without compensated cirrhosis (see BioCentury Extra, July 24).


PBM Express Scripts Holding Co. Inc. (NASDAQ:ESRX) granted exclusive formulary status to Viekira last December in exchange for undisclosed rebates. Spokesperson David Whitrap told BioCentury the PBM will evaluate FDA's safety warning, but said that "at this point, we are not making any changes in our formulary" (see BioCentury Extra, Dec. 22, 2014).


AbbVie lost $9.2 billion in market cap Thursday, while Enanta shed $306 million.


Gilead Sciences Inc. (NASDAQ:GILD), which sells HCV therapies Harvoni ledipasvir/sofosbuvir and Sovaldi sofosbuvir, climbed $5.87 to $107.60 on Thursday, gaining $8.6 billion in market cap


Quelle: BioCentury Publications

[Popeye82]

Antwort auf Beitrag Nr.: 50.915.307 von DomRuinart am 23.10.15 11:05:00

bist Du in BioCentury Mitglied?

[Global-Player83]

Enanta 23,65 Dollar

[DomRuinart]

Mein Reden...

JMP Analyst Thinks Enanta Will Outperform Market, Calls Selloff An Overreaction
October 23, 2015 10:04am
• Shares of Enanta Pharmaceuticals Inc (NASDAQ: ENTA) have declined 51.37 percent over the past three months, hitting a low of $23.90 on Thursday.
• Liisa A. Bayko of JMP Securities has upgraded the rating on the company from Market Perform to Outperform, with a price target of $32.
• Bayko believes that the market has overreacted to the FDA warning on the company’s HCV drug, Viekira Pak.

Analyst Liisa Bayko reported that Enanta Pharma’s shares fell 40 percent following the FDA warning about the risk of serious liver injury in patients with advanced liver disease associated with AbbVie Inc (NYSE: ABBV) and Enanta Pharma’s Viekira Pak.

Related Link: Wall Street Defends AbbVie, Says Reaction Is Overdone

“In our opinion, the sell-off was an over-reaction to the news, as we believe the impact to sales will be modest, particularly as some of the revenue base is secured by exclusive contracts,” Bayko said.

Enanta Pharma’s next-gen combo, which does not contain any of Viekira Pak’s components, is expected to hit the market in 2018. Bayko expects peak sales of $3 billion for the next-gen combo, with 90 percent probability of success on NPV.

In addition, Viekira Pak is expected to contribute royalties of $16 million to the company in the September quarter, on sales of $520 million.

Quelle: Benzinga

[DomRuinart]

Antwort auf Beitrag Nr.: 50.915.562 von Popeye82 am 23.10.15 11:28:02

Nein bin ich nicht, Popeye. Der Artikel war frei zugänglich.
Gruß,

Dom Ruinart