Tag Archives: biotech

Regeneron Arthritis Pain Drug Scores In Mid-Stage Trial

Regeneron Pharmaceuticals ( REGN ) said Monday that its experimental antibody for arthritis pain succeeded in a mid-stage trial, but shares were flat in early trading as the results were expected. The study enrolled 421 sufferers of moderate-to-severe hip and knee pain who’d been unsuccessful with standard painkillers. After 16 weeks of treatment, the group taking Regeneron’s fasinumab had improved by more than 3 points on a 10-point pain scale, significantly better than the placebo group. About 17% of the group taking fasinumab experienced adverse events, Regeneron said, including non-inflammatory joint pain, prickling and burning sensations in the skin, numbness and swelling. The investigators also did extensive imaging of the subjects, because the class of medicines to which fasinumab belongs — nerve growth factor (NGF) antibodies — has been associated with joint damage. They wound up excluding 2% of subjects due to imaging results, and five patients among the remainder suffered subchondral insufficiency fractures, or stress fractures on abnormal bones. Regeneron stock was near 377 in early trading on the stock market today . Shares touched an 18-month below 349 in late March, and Regeneron stock has a weak IBD Composite Rating of 47, putting it among the lower half of all stocks on the basis of key metrics such as earnings and sales growth. Regeneron had already signaled that the trial was going well earlier this year by starting a large phase-three trial of the drug, so the results weren’t especially surprising to analysts. It also lost a potential competitor in late March, when Johnson & Johnson ( JNJ ) stopped development of its own NGF antibody fulranumab, which was in late-stage trials for arthritis pain. RBC Capital Markets analyst Adnan Butt wrote at the time that J&J’s decision was based on pipeline prioritization, not on any problems with the drug itself. On Monday, Butt praised the effectiveness of fasinumab in the trial but wrote that the safety “bears watching.” “Overall, should this program succeed, it could be another blockbuster candidate, which unlike others could be an upside driver since it comes with regulatory and mechanistic safety concerns, hence is not a major focus for investors at this time, aside from a development cost and timeline standpoint,” Butt wrote in his research note.

Gilead Sciences Takes Lumps From Wall Street After Q1 Miss

Big biotech Gilead Sciences ( GILD ) got a downgrade and several price-target cuts Friday after its Q1 report missed expectations , sending its stock tumbling. Maxim Group analyst Jason Kolbert downgraded Gilead to hold from buy, noting that the record-breaking launches of hepatitis C drugs Sovaldi and Harvoni were coming up against competition and tough year-over-year comparisons. “New patient numbers increased … but product margins per patient were lower as a result of: 1) increased HCV price competition ( Merck ‘s ( MRK ) Zepatier); 2) an increased discount rate; and 3) higher-than-expected rebate claims,” Kolbert wrote in his research note. “While management believes that HCV products have stabilized (the U.S. market share is at about 90%), we are not so sure.” Leerink analyst Geoffrey Porges lowered his price target on Gilead to 123 from 127 but maintained an outperform rating. He noted that the company still has a huge reserve of cash, and wrote that the HCV franchise was eroding earlier then expected but it was presumed to decline in a few years anyway. “As a result, our EPS estimates fall 8%-10% through 2017, but only 3% beyond,” he wrote in his research note. UBS analyst Marc Goodman also kept his buy rating while lowering his price target to 118 from 130, writing that he’s “willing to have a little patience.” “The (HCV) category still has years ahead of stable patients,” Goodman wrote. “The issue remains; what’s next? … At this valuation, we will try to remain patient.” Gilead stock was down 7.5% in afternoon trading on the stock market today , below 90. On the positive side for Gilead, the company said Friday that the EU’s Committee for Medicinal Products for Human Use, which advises Europe’s equivalent of the FDA, had endorsed approving Odefsey, the company’s newest four-drug combo pill for HIV. The combo includes TAF, known on Wall Street as “son of Viread” as it represents an upgraded version of Gilead’s legacy blockbuster Viread, which is due to go off patent in the near future.

Amgen Legacy Drugs Drive Q1 Beat; Gilead Hep C Juggernaut Stumbles

Big biotech Amgen ( AMGN ) beat Wall Street’s Q1 estimates and raised guidance Thursday after the close, though its stock went sideways in after-hours trading. Its peer Gilead Sciences ( GILD ), however, was down sharply after a weak quarter. Amgen reported adjusted earnings of $2.90 a share, up 17% from the year-earlier quarter and 30 cents ahead of analysts’ consensus, according to Thomson Reuters. Revenue increased 10% to $5.53 billion, more than $200 million above consensus. The company lifted its full-year guidance, though not by quite as much as the Q1 beat. Its EPS range is now $10.85 to $11.20, up from $10.60 to $11. The revenue guide is $22.2 billion to $22.6 billion, vs. $22 billion to $22.5 billion. Last year, Amgen made $10.38 in EPS on $21.66 billion in revenue. Amgen’s best-selling drug Enbrel, for rheumatoid arthritis, beat expectations by growing 24% to $1.39 billion, almost $140 million above consensus, according to Evercore ISI. Its second-biggest drug Neulasta, for neutropenia, modestly beat estimates by gaining 4% to $1.18 billion. On the other hand, some of Amgen’s newer drugs came up short. Cancer drug Kyprolis grew 43% but was still $19 million shy of consensus with $154 million in sales, while newly launched cholesterol drug Repatha continued its underperformance with a $16 million take. Gilead Takes A Hit In Hep C Gilead, meanwhile, reported earnings of $3.03 a share excluding one-time items, up 3% from last year’s Q1 and 12 cents below Wall Street’s average estimate. Revenue rose 2.6% to $7.79 billion, about $325 million below consensus. Gilead nonetheless made no change to its full-year guidance, calling for $30 billion to $31 billion in product sales and 88% to 90% gross margin. Gilead’s blockbuster hepatitis C drugs Harvoni and Sovaldi accounted for most of the shortfall, though for opposite reasons: Harvoni missed badly in the U.S. but outperformed abroad, while Sovaldi did the opposite. Earlier in the day, AbbVie ( ABBV ) reported that Harvoni’s chief competitor Viekira also came up short of consensus, which the company attributed to Merck ‘s ( MRK ) unexpectedly aggressive pricing of recently launched rival Zepatier. (Merck will report its Q1 on May 5.) The quarter also brought a screeching halt to Gilead’s two-year stretch of double- or triple-digit sales and profit growth, starting with the Dec. 2013 launch of Sovaldi. Analysts expect growth will totally flatten unless the company makes a transformative acquisition. Gilead stock was down more than 6% after hours Thursday, after it closed the regular session down 3.7%, at 97.