Tag Archives: azn

Medivation Rises On Cancer Drug Data, AstraZeneca Buyout Rumor

Shares of drugmaker Medivation ( MDVN ) hit an eight-month high Monday after it reported successful early-stage cancer data as buyout rumors continued to circle the company. On Sunday at the annual meeting of the American Association for Cancer Research, Medivation said that its drug candidate talazoparib, combined with low-dose chemotherapy, produced a clinical benefit in 23 of 40 patients with heavily pretreated cancers. The company noted that four of seven patients with ovarian cancer showed objective responses, or tumor shrinkage. At the same time, the Times of London reported that big British pharma AstraZeneca ( AZN ) is said to be preparing a bid for Medivation , which currently holds a stellar IBD Composite Rating of 97 thanks to strong growth of its sole marketed product, prostate-cancer drug Xtandi. Late last month, Medivation reportedly hired bankers to deal with buyout attempts, and last week it was said to have rebuffed a bid from Sanofi ( SNY ). Medivation stock rose 4%, above 53, near midday trading on the stock market today . It hit 54.55 intraday. The last time it cracked 54 was back in early August, before biotech stocks crashed. IBD’s Take: How healthy is Medivation’s stock, and how does it stack up vs. rivals? Stifel analyst Thomas Shrader wrote that the latest cancer data will likely make Medivation play even harder to get. “It’s hard to draw too much out of such a small data set from a single center — but these data will only make the company less interested in being acquired without very significant upside to the current value of the Xtandi franchise and at least conditional upside to the current value of the talazoparib franchise,” Shrader wrote in a research note.

Valeant CEO Is Brave; Clovis PT Slashed; Buy Jazz ‘Aggressively’?

Drugmakers and biotechs were on the move Tuesday as Valeant Pharmaceuticals ( VRX ) CEO J. Michael Pearson finally agreed to attend a Senate deposition, and Clovis Oncology ( CLVS ) continued to tumble after an FDA panel didn’t back an accelerated approval for a lung cancer drug. Meanwhile, Jazz Pharmaceuticals ( JAZZ ) and Medivation ( MDVN ) rallied. Valeant CEO J. Michael Pearson said Wednesday he would comply with a congressional subpoena and testify before the Senate Special Committee on Aging on April 18. He didn’t show up to a hearing last week on drug pricing. Valeant shares inched up fractionally in the stock market today despite having  plunged 4% in late trading Tuesday  after the pharmaceutical giant said creditors had submitted a default notice over delays in its annual report. Valeant has until June 11 to file its 10-K annual report or face a default. But a default seems unlikely, as the company said it would file its 10-K by April 29. Clovis shares fell 9% on continued fallout from a Food and Drug Administration panel ruling Tuesday. The independent panel didn’t recommend that Clovis’ lung cancer drug, rociletinib, receive accelerated approval and said the FDA should wait for results from a late-stage trial before making a decision. Clovis lost 5.45% on Tuesday, 4.5% on Monday and 17.7% on Friday, when FDA staff released some documents ahead of the panel meeting. A similar drug from AstraZeneca ( AZN ) received accelerated approval last year. AstraZeneca shares rose 0.6%. Mizuho lowered Clovis’ price target to 15 from 21. Credit Suisse and JPMorgan both downgraded Clovis to neutral from overweight. JPMorgan cut its price target on the stock to 15 from 42 — and down from 110 last November Medivation jumped nearly 7% on takeover buzz. Late Tuesday,  Bloomberg reported that Medivation rejected a takeover attempt from France’s Sanofi ( SNY ). Sanofi is looking to expand its cancer treatment offerings but is currently embroiled in a whistleblower suit over alleged corporate kickbacks. Sanofi shares rose 0.9%. Jazz Pharmaceuticals shares jumped nearly 5% to 146.55, climbing over its 200-day moving average after Cowen released a note saying to “add aggressively” to Jazz positions after a ruling by the U.S. Patent and Trademark Office on Tuesday. The firm has a outperform rating and 190 price target on the stock.

Intercept Pharma Drops On Downgrade, Despite FDA Panel’s Yes Vote

Shares of Intercept Pharmaceuticals ( ICPT ) were falling Friday after Morgan Stanley downgraded the stock, saying that a positive FDA panel vote nonetheless pointed toward a restrictive label for its lead drug. Trading in Intercept stock was halted all day Thursday as the advisory committee discussed obeticholic acid, now branded Ocaliva, eventually resulting in a 17-to-0 vote in favor of approving the drug to treat a rare liver disease called primary biliary cholangitis (PBC). The FDA will make a final decision on the drug, and what recommendations will be on its label, by May 29. Morgan Stanley analyst Andrew Berens wrote in a research note that issues raised during the panel discussion could limit the potential market. “The panel unanimously recommended to approve the drug based on the surrogate endpoint used in the phase 3 trial, but failed to endorse usage in advanced PBC patients given the lack of data supporting efficacy, as well as safety concerns,” Berens wrote as he downgraded Intercept stock to underweight from equal weight and lowered his price target to 80 from 100. “According to external consultants, the primary unmet medical need in this patient population is in patients with advanced or aggressive disease, so this lack of an endorsement by the panel has important commercial implications in our opinion, especially if the label is similarly restrictive,” Berens wrote. Berens added that the panel also expressed reservations about using the drug in patients with advanced cirrhosis, or scarring of the liver, due to signs of liver toxicity at high doses. He wrote that this could have implications for Ocaliva’s much-anticipated future launch in non-alcoholic steatohepatitis (NASH), a market that could potentially bring in billions. “We had previously assumed usage of Ocaliva in up to 20% of cirrhotic patients,” Berens wrote. “Given the concerns voiced by the clinicians and the FDA, we have decreased our penetration into NASH patients with cirrhosis to 5% at peak.” Intercept stock, which rose more than 8% Wednesday to a nearly four-month high, fell by as much as 10% in the stock market today . Shares were down 5.5% midday Friday, near 155. Other analysts generally stuck by their ratings on the stock. RBC Capital Markets analyst Michael Yee wrote that the possible PBC restrictions were in line with his below-consensus sales estimates for that indication, but he added that the company could still be an interesting buyout target for a big pharma name like AstraZeneca ( AZN ) or Sanofi ( SNY ). Credit Suisse analyst Alethia Young still says the PBC launch could beat expectations and wrote that the severe cases may not be that much of the market. “We think perhaps at worst the severe population is 15% of patients,” she wrote in her research note affirming an outperform rating. “Based on the super-group study, Intercept thinks 12% may be a high watermark.”