Tag Archives: biotech

Gilead Sciences Gets Price-Target Cut After Cancer Trials Stopped

Big biotech Gilead Sciences ( GILD ) got a price-target cut from investment bank Leerink on Wednesday, after the company cancelled clinical trials on its cancer drug Zydelig due to safety problems. The European Medicines Agency (EMA) said last Friday that it was looking into reports of serious adverse events, including deaths, in Gilead’s trials of Zydelig in various forms of blood cancer. Later, the U.S. Food and Drug Administration said that it was doing the same, and on Monday it issued a notice saying that Gilead had agreed to suspend six trials in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and indolent non-Hodgkin lymphomas (NHLs). Zydelig, first launched in July 2014, is now approved for relapsed CLL and as a third-line treatment for B-cell NHL and SLL. “The FDA is reviewing the findings of the clinical trials and will communicate new information as necessary,” the agency said in its statement. Gilead also said that it’s suspending trials of Zydelig as a front-line treatment for any cancer. On Wednesday, Leerink analyst Geoffrey Porges slashed his peak annual sales estimate on the drug from $935 million to $174 million in 2020, which he estimates will shave 1% to 3% off EPS in the 2017-2020 period. He therefore cut his price target to 127 from 130 while maintaining an outperform rating on Gilead stock. “Though accretive to revenue, oncology accounts for a small portion of Gilead’s total revenue, 93% of which consists of antivirals,” Porges wrote. “We have never been convinced that oncology would become a major franchise for the company, and given these recent events, maintain this outlook.” Gilead stock was up 1% in early trading on the stock market today , near 90, but it’s down more than 10% this year and sports a lowest-possible IBD Accumulation/Distribution Rating of E.

Lilly Changes Endpoint For Alzheimer’s Drug Trial; Stock Falls

Big pharma Eli Lilly ( LLY ) changed its goals for a much-anticipated clinical trial of its Alzheimer’s disease drug Tuesday, sending the stock down in a bad day overall for drug stocks. Lilly’s phase-three trial of its drug solanezumab, called Expedition-3, had previously targeted two primary endpoints: a slowing of cognitive decline, and a slowing of functional decline. On Tuesday, Lilly said it was going to keep cognitive decline as the primary endpoint, but functional decline would become a key secondary endpoint. Lilly is expecting to report its first results from the trial late this year, and make a decision about filing for approval based on the outcome. “Emerging scientific evidence supports the idea that cognitive decline precedes and predicts functional decline in Alzheimer’s disease, particularly in earlier stages of the disease,” Lilly said by way of explanation in its press release. Lilly added that “regulators globally will continue to view both cognitive and functional endpoints as necessary for clinical trials in people with mild Alzheimer’s dementia, and regulatory guidance has been to include these as co-primary endpoints,” so it’s not clear how much difference this will make to the drug’s approvability. Nonetheless, a trial that failed a co-primary endpoint would still be a failed trial. “Sounds like Lilly is doing everything they can to improve the success rate of Expedition-3,” wrote Evercore ISI analyst Mark Schoenebaum in an email to clients. Schoenebaum said Lilly told him the decision wasn’t based on data from the trial itself, which the company hasn’t yet seen. Lilly did analyze data from its earlier solanezumab studies Expedition-1 and Expedition-2, however, “and other datasets in the field.” Schoenebaum added that the phase-three trial of a possible competitor from Biogen ( BIIB ), aducanumab, is using a different test that measures both cognitive and functional decline as its sole primary endpoint. Lilly stock hit a 52-week low of 69.60 on the stock market today , on a day when stocks in general and drug stocks in particular were taking a hit. By midday,  it was down 3.5% near 71. Biogen stock was down 2.5% near 250.

GW Pharma Stock Rockets As Cannabis Drug Fights Epilepsy

Shares of British drugmaker  GW Pharmaceuticals ( GWPH ) more than doubled Monday after the company’s marijuana-based drug succeeded in a late-stage trial against a rare form of epilepsy. GW Pharma said that its drug Epidiolex had reduced convulsive seizures in children with Dravet syndrome, a severe form of childhood epilepsy without a current approved treatment, by 39%, in contrast to to a 13% reduction in the placebo group. Epidiolex is a pharmaceutical form of cannabidiol, one of the active ingredients in the cannabis plant. GW is also testing Epidiolex in Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex, other rare forms of epilepsy. GW Pharma stock was up 118% near 84 in morning trading, a three-month high, reviving a stock that had hit a two-year low last week amid flagging investor confidence. The news also boosted other cannabis-related stocks: Insys Therapeutics ( INSY ) was up 16% near 20, while recent IPO Zynerba Pharmaceuticals ( ZYNE ) soared 68% to a five-month high near 14. Insys is also testing a cannabidiol product in Dravet syndrome, and like GW has received an orphan-drug designation from the FDA, although only one company can win the seven years of market exclusivity under the Orphan Drug Act. Zynerba is developing a form of cannabidiol that can be applied through the skin. Leerink analyst Paul Matteis raised his price target on GW Pharma stock to 130 from 100, saying that Epidolex looks very approvable. “We believe this drug-placebo difference of 26 percentage points is highly clinically significant in the context of (1) the patient population, which had failed at least four or more anti-epileptic drugs and suffered from 13 convulsive seizures per month, and (2) epilepsy in general, where drugs with high teens effect sizes have been approved by FDA,” Matteis wrote in his research note. Matteis added that the group taking Epidiolex did show some side effects to the drug, but the 13% dropout rate due to side effects compared favorably to that of other epilepsy drugs.