Tag Archives: biotech

Incyte Plummets After Stopping Trial Of Jakafi In Pancreatic Cancer

Biotech Incyte ( INCY ) tumbled to a 15-month low Thursday after it ended a trial of its lead drug in pancreatic cancer, though its Q4 earnings beat Wall Street estimates. Incyte said that it’s ending a phase-three trial of its drug Jakafi, or ruxolitinib, along with capecitabine (also known as Roche ’s ( RHHBY ) Xeloda) as a second-line treatment for advanced metastatic pancreatic cancer, after an interim analysis showed that it would be futile. Jakafi is sold for the blood cancers myelofibrosis and polycythemia vera, but Incyte is studying it in various solid tumors, including lung, breast and colorectal cancer, in combination with Merck ’s ( MRK ) Keytruda (pembrolizumab) and AstraZeneca ’s ( AZN ) Tagrisso (osimertinib), among other things. Incyte said that it will continue these studies despite the trial failure. Incyte also said that its Q4 revenue, which came from a combination of Jakafi sales, royalties and contract revenue, jumped 97% over the year-earlier quarter to $243.9 million. That’s about $18 million above analysts’ consensus, according to Thomson Reuters. Net income was 29 cents a share, reversing a year-earlier loss and soundly beating consensus of 9 cents. The company did not offer revenue or EPS guidance for this year but said that Jakafi sales should be $800 million to $815 million, up from $601 million last year. It forecast R&D expenses of $620 million to $640 million, plus selling, general and administrative expenses of $255 million to $270 million. Incyte stock was near 56, down nearly 23% in morning trading on the stock market today .

CTI-Baxalta Drug Withdrawn, Removing Potential Incyte Rival

The stock price of biotech CTI BioPharma ( CTIC ) fell to pennies Wednesday after the company said late Tuesday that it had withdrawn its FDA application for pacritinib, a blood-cancer drug that it was developing in partnership with Baxalta ( BXLT ). CTI and Baxalta had filed for approval of pacritinib for myelofibrosis on Jan. 5, but clinical trials of the drug were still underway. On Monday, CTI said that the FDA had placed a partial clinical hold after it had seen “excess mortality and other adverse events in pacritinib-treated patients compared to the control arm” in one of the trials, according to a press release. On Tuesday, CTI said the FDA had placed a full clinical hold on the trials, inducing the companies to withdraw the application and “decide next steps.” The application covered a fairly narrow range of patients — specifically those with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter. However, it did present some potential competition to Incyte ‘s ( INCY ) Jakafi, both in its target and in its class, as both drugs are Janus kinase (JAK) inhibitors. “While we didn’t view CTI/Baxalta’s pacritinib as a significant threat to Incyte’s Jakafi franchise in myelofibrosis, we think the unfortunate and surprising setback of a potential competitor should remove a small overhang on Incyte shares,” wrote Leerink analyst Michael Schmidt in a research note. Incyte stock was up 3% in early afternoon trading on the stock market today , near 74. CTI BioPharma, already beaten down by Monday’s news, was off 40% to 30 cents. Baxalta was up about 2%, perhaps because its future acquirer, Shire ( SHPG ), received an unrelated upgrade from RBC Capital Markets. Analyst Douglas Miehm lifted his rating to outperform from sector perform, writing that the competitive threat to Baxalta’s hemophilia portfolio has been more than accounted for in Shire’s 42% drop in share price since last August. Shire stock also was up about 2%, near 154, early Wednesday afternoon. Image provided by Shutterstock .

Regeneron Q4 Earnings Miss Estimates Amid Slow Praluent Launch

Big-cap biotech Regeneron Pharmaceuticals ( REGN ) hit a 16-month low Tuesday after its Q4 earnings disappointed investors. Last month, Regeneron revealed Q4 sales of its eye drug Eylea, which accounts for the great majority of its revenue. Results announced early Tuesday, though, show that the recently launched cholesterol drug Praluent sold well short of expectations, at $7 million, while collaboration revenue from partner Sanofi ( SNY ) was also lower than expected. Overall, Q4 revenue rose 37% over the year-earlier quarter to $1.1 billion, about $80 million below analyst consensus, according to Thomson Reuters. Earnings of $2.83 a share also missed Wall Street’s average estimate of $3.36. EPS rose just 1% from the year-earlier quarter, breaking a four-quarter streak of double-digit growth. Regeneron last month also guided 2016 expenses, and on Tuesday it added that U.S. Eylea sales should grow 20% this year, which was slightly above analyst consensus for 19% growth. The company does not provide overall revenue or earnings guidance. Evercore ISI analyst Mark Schoenebaum calculated that the implied 2016 earnings guide from the expense forecast is $11.57 to $14.14, which is on the low side of the consensus projection for $13.92. The weak Praluent number, which was less than half the consensus estimate, followed a likewise underwhelming report from Amgen ( AMGN ) on its similar drug Repatha in its Q4 results last month . “This slow start is consistent with the current market feedback about (Praluent’s) initial launch and is certainly going to put pressure on long-term revenue expectations for the product and class,” wrote Leerink analyst Geoffrey Porges in a research note. Regeneron stock dropped as much as 10%, to 350.26, in early trading on the stock market today , its lowest point since October 2014. Shares closed the day down 6.3%, at 365.97, which also is the stock’s lowest closing price since October 2014. Sanofi stock fell a fraction Tuesday, to 38.87.