Tag Archives: regn

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.

How Regeneron’s Eylea Growth, Amgen, Sanofi Deal Figure In Stock

Biotech Regeneron Pharmaceuticals ’ ( REGN ) core ophthalmology business still has huge upside as its Eylea sales grow in treating a variety of eye diseases, says RBC Capital. RBC also says that a legal settlement with Amgen ( AMGN ) over Praluent, a drug intended to lower bad LDL cholesterol, would be a positive. Most of Regeneron’s sales come from Eylea, launched in 2011 to treat age-related vision loss in the elderly. Regeneron aims to build sales of Eylea in the market for treating diabetic macular edema (DME), a cause of blindness in working-age people, as well as a related eye disease affecting older people. “Turning DME into a $2 billion to $3 billion market opportunity is important and likely,” Adnan Butt, an RBC Capital analyst, said in a research report Tuesday. In DME, Eylea competes with Roche Holding ’s ( RHHBY ) Lucentis. Regeneron typically reports earnings in early May. Roche, Novartis ( NVS ) and Bayer ( BAYRY ) report earnings on April 19, 21 and 26, respectively, and their commentary could provide insights into Eylea’s growth, says RBC’s Butt. He says that consensus expectations for the recently launched cholesterol drug Praluent, which had only $7 million in December-quarter sales, still need to come down. Amgen makes a rival drug called Repatha. In March, a federal jury upheld the validity of two Amgen patents related to the cholesterol drug, dealing a blow to Regeneron and partner Sanofi ( SNY ). “A settlement with Amgen could be a positive,” Butt said in the report. He rates Regeneron stock outperform, with a price target of 668. Regeneron stock was up more than 1.5% in early afternoon trading in the stock market today , near 402.50. Amgen reports earnings on April 28, followed by Sanofi on April 29. Their earnings calls could provide reads on the status of Praluent litigation, says Butt. Regeneron stock has plunged 26% in 2016 amid a broad sell-off in biotech stocks, including Celgene ( CELG ) and Gilead Sciences ( GILD ). Regeneron shares touched a six-month low below 349 last month but jumped on April 1 after the company announced strong phase three clinical results for dupilumab, a drug for eczema, an itchy skin condition. Regeneron is developing that drug with Sanofi. “The landmark deal with Sanofi provides $160 million per year to fund antibody discovery for eight years, gives Regeneron 50% of the profit and defers all development costs until the partnership is profitable,” added Butts. Startup Intellia Therapeutics late Monday announced a licensing deal with Regeneron. Cambridge, Mass.-based Intellia has developed “gene editing” technology to treat liver and blood diseases. It plans to go public. Regeneron has an IBD composite rating of 58 out of a possible 99, lower than both Celgene and Gilead. IBD’s Medical-Biomed/Biotech group ranks just No. 108 out of 197 industry groups. That’s down from No. 39 six months ago.  But it’s up 9.8% the past four weeks, 10th best in that span. Anika Therapeutics ( ANIK ), Supernus Pharmaceuticals ( SUPN ) and Ligand Pharmaceuticals ( LGND ) have the highest IBD Composite Ratings within the biotech group.

Regeneron Soars After Drug Clears Eczema, Sparks Market Size Debate

Big biotech Regeneron Pharmaceuticals ( REGN ) and its big pharma partner Sanofi ( SNY ) said Friday that their potential blockbuster eczema drug candidate sailed through late-stage trials and would be submitted for approval in Q3 of this year. Regeneron shares spiked Friday, headed for their best one-day percentage gain in years. Regeneron’s and Sanofi’s drug dupilumab cleared or nearly cleared the symptoms of atopic dermatitis (eczema) in more than a third of patients, compared with less than 10% of patients in the placebo group, in two clinical trials comprising a total of 1,379 people. Patients on dupilumab in general average around a 70% improvement in the Eczema Area and Severity Index (EASI), whereas the placebo group improved in the 30% to 40% range. “There are no approved systemic therapies in the U.S. for people with moderate-to-severe atopic dermatitis, underscoring the clear unmet need,” Sanofi R&D head Elias Zerhouni said in a statement. “In the U.S., where dupilumab in AD (atopic dermatitis) has been granted Breakthrough Therapy designation by the U.S. FDA, we plan to submit a regulatory application in the third quarter of this year and will work to bring this innovative therapy to patients as quickly as possible.” Evercore ISI analyst Mark Schoenebaum wrote that analysts’ consensus peak annual sales estimate for dupilumab is $4 billion, but there’s quite a bit of variation between individual analysts. “We believe that the current debate for dupilumab is focused on the size of commercial opportunity — it is also in late stage studies for severe asthma (where dupilumab demonstrated high efficacy in phase two in an all-comers population) as well as chronic sinusitis with nasal polyps and eosinophilic esophagitis,” Schoenebaum wrote in an email to clients. “A/D is a relatively new market segment and dupilumab is one of the first therapeutic candidates that could address the high unmet need. … The commercial opportunity in severe asthma may be similarly attractive; however, dupilumab will be facing a more crowded competitive landscape in asthma.” Regeneron shares shot up 13.5% in afternoon trading on the stock market today  to about 409, moving over its 50-day moving average for the first time in 2016. Regeneron stock touched a 17-month low below 349 on March 17. Sanofi stock rose a fraction, above 40.