Tag Archives: biotech

Intercept Pharma Gets Dueling Initiation Reports As FDA Panel Nears

Shares of biotech Intercept Pharmaceuticals ( ICPT ) were up in twice-average volume Wednesday, after two analysts launched coverage ahead of a crucial FDA panel vote. Credit Suisse’s Alethia Young initiated with a buy rating, while Salveen Richter at Goldman Sachs initiated with a neutral rating, though they agreed on the general outlines of the investment thesis. Intercept’s lead drug candidate, obeticholic acid (OCA), is up for an FDA advisory committee discussion on April 7 as a treatment for primary biliary cholangitis (PBC), a rare, chronic liver disease. If approved by the FDA’s May 29 deadline, it would be Intercept’s first commercial product. Young estimates that annual sales for obeticholic acid could hit $259 million in 2018, though Richter forecasts it at only $170 million at peak. Both analysts, however, agree that the really big potential market for OCA is in nonalcoholic steatohepatitis (NASH), a much more common liver disease without a current treatment. That could draw $3.5 billion a year, Richter estimates, but that’s a ways in the future: The next batch of data from the NASH clinical trial isn’t expected until 2018. Between the panel meeting and the NASH data, Richter sees “a dearth of catalysts” to drive Intercept’s stock, leading him to set his price target at 114. Young, however, says approval and launch for treatment of PBC, both in the U.S. and Europe, could provide more upside for the stock. Her peak sales estimate in NASH is almost twice Richter’s at $6.5 billion. She set her price target at 200. Intercept stock rose 5% in early trading on the stock market today , but by early afternoon it was up 1%, near 125.50. Shares hit a 19-month high above 314 last May.

Gilead Sciences Stock Rises As Analysts Still Like HCV Franchise

Big biotech Gilead Sciences ( GILD ) hit a two-month high Monday after two analysts delivered bullish outlooks for the company. On Sunday, RBC Capital Markets analyst Michael Yee lifted his Q1 EPS estimates due to a stock buyback and noted several recent pieces of “incremental” good news. For one, he cited late Friday the successful patent suit brought by Merck ( MRK ) and Ionis Pharmaceuticals ( IONS ), which had resulted in a somewhat lower damages award ($200 million) than Wall Street had expected. He also noted that weekly prescription data from IMS Health ( IMS ) suggest Gilead’s hepatitis C drugs, Sovaldi and Harvoni, were holding up reasonably well in the face of competition from Merck’s Zepatier, which launched in late January. This point was made more emphatically Monday in a research note by Leerink analyst Geoffrey Porges, who called Merck a “pretender to the HCV (hepatitis C  virus) throne.” Porges noted that a survey of top payer plans backed this up. “Seven weeks after the launch of Zepatier, Sovaldi and Harvoni retain a relatively favorable position in 65% of the top 20 largest commercial plans and 70% of the top 10 largest government plans relative to AbbVie ’s ( ABBV ) Viekira Pak (20%, 30%, respectively) and Zepatier (0%, 10%),” Porges wrote. “Further, in the top 20 Medicare plans, while Harvoni is covered by 100% of plans, 85% of plans do not cover Viekira Pak, and none cover Zepatier.” Porges affirmed his outperform rating on Gilead stock, with a price target of 127. In midday trading on the stock market today , Gilead stock was up more than 2%, near 93, and earlier rose above 94. The stock has climbed about 14% from the 20-month low it hit on Feb. 2, but still has a weak IBD Relative Strength Rating of 29, meaning the stock’s performed in the lowest 29% of all stocks the past 12 months, with an emphasis on the most recent six months. Merck stock was down a fraction midday Monday.

Alder BioPharma Migraine Drug Scores In Trial; Stock Spikes

Small biotech Alder BioPharmaceuticals ( ALDR ) soared more than 50% to a two-month high in early trading Monday after its migraine drug candidate succeeded in a mid-stage trial, positioning it to compete with some giant rivals. Alder said that a single intravenous infusion of its monoclonal antibody, ALD403, had significantly reduced migraine days over a 12-week period compared to a placebo. Depending on the dose, between 44% and 57% of patients experienced a 50% reduction in migraine days, while 27% to 33% experienced a 75% reduction. “Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing,” Alder CEO Randall Schatzman said in a statement. “With our commitment to the accelerated development of ALD403 reinforced by today’s positive results, we look forward to advancing our development plan, and assuming FDA approval, independently marketing ALD403 in the U.S. to meet the critical medical needs of the 13 million patients nationwide who are candidates for migraine prevention therapy.” Alder’s decision to market its drug without a big-pharma partner, unusual for a small biotech, could pit it against some very big competitors developing similar drugs. ALD403 is an anti-calcitonin gene-related peptide (CGRP) antibody, similar to migraine candidates being developed by Amgen ( AMGN ), Teva Pharmaceutical Industries ( TEVA ) and Eli Lilly ( LLY ). Alder’s drug is distinguished by its infrequent dosing: Amgen and Teva’s drugs are injected once a month, while Lilly’s is biweekly. It would also be competing against Allergan ‘s ( AGN ) Botox, which is also quarterly but involves 31 separate shots. Credit Suisse analyst Vamil Divan wrote that ALD403’s results seem roughly equivalent to Teva’s in terms of effectiveness, but he did note that there was no significant improvement over the placebo in the number of patients who experienced a 100% reduction in migraine days. Between 4% and 8% of patients on the drug achieved this, which was rather lower than the 16% who had been headache-free in a previous trial. Alder stock, like so many other biotech stocks, had lost more than half its value since touching its all-time peak of 54.90 in July. But in early trading on the stock market today , shares were was up some 52% near 26. Image provided by Shutterstock .