Deutsche still likes Valeant risk/reward, ups price target to $25. Deutsche Bank analyst Gregg Gilbert raised his price target for Valeant Pharmaceuticals to $25 from $23 after giving the company some additional credit for protecting the Xifaxan franchise. The analyst pushed out his generic cliff assumption to 2027 from 2026, which he notes still represents a potential “settlement” scenario with generic competition ahead of patent expiry. It is important to note there could be “significant upside to the theoretical valuation” if Xifaxan grows faster than anticipated, generic competition is delayed beyond 2027, and/or if Valeant is able to protect the franchise with new formulations and indications, Gilbert tells investors in a research note. He continues to like the risk/reward for the stock and keeps a Buy rating on the shares.
Friday, June 1, 2018
Merit Medical selloff overdone: Canaccord
Merit Medical selloff after CFO departure overdone, says Canaccord. Canaccord analyst Jason Mills said the selloff in Merit Medical due to the departure of its CFO is overdone. The analyst said the departure was a surprise to the company as well as Wall Street, leading him to believe its was a personal decision as opposed to something untoward about the company’s financials. Mills reiterated his Buy rating and $60 price target on Merit Medical shares.
Pfizer gets nod for cancer med biosimilar in Europe
Pfizer announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending marketing authorization for TRAZIMERA, a potential biosimilar to Herceptin, for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
PTC gets expanded Duchenne med label in Europe
PTC Therapeutics announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of expanding the indication of Translarna to include ambulatory children aged two to five years with nonsense mutation Duchenne muscular dystrophy, or nmDMD. This broadens the use beyond the current indication which is for ambulatory patients who are over five years of age. This recommendation is based on the CHMP’s review of PTC’s Study 030 trial results which the CHMP concluded demonstrates a positive benefit-risk ratio in this population. In addition to the label expansion, the CHMP has also recommended the renewal of the current marketing authorization of Translarna. PTC’s focus on early patient identification and market readiness have been intensified in anticipation of the CHMP recommendation and the launch of Translarna for patients as young as 2 years of age is planned to start immediately at the time of EC ratification.
Jazz remains ‘top idea’: RBC
RBC analyst Randall Stanicky reiterated an Outperform rating and $194 price target on Jazz Pharmaceuticals after hosting a dinner with Chairman and CEO Bruce Cozadd. In a research note to investors, Stanicky said he left the dinner more confident in targeted business development with a view that a deal is likely in 2018. Overall, the analyst said Jazz remains a top pick and sees “lots” of room to run for the stock.
Immunomedics to start Phase 2 of cancer med trial
Immunomedics announced that the company plans to initiate a Phase 2 pivotal TROPHY U-01 study of sacituzumab govitecan, the company’s lead investigational ADC, as a single agent in patients with locally advanced or metastatic urothelial cancer who have relapsed after a platinum-based regimen and/or immune checkpoint inhibitor therapy. The Phase 2 pivotal study, which is expected to be activated next week, will be a single arm, international, multicenter study that will enroll approximately 100 mUC patients who have received prior platinum-based and CPI treatment. The primary endpoint will be overall response rate, with duration of response, progression-free survival, and overall survival serving as secondary endpoints. Response assessments will be in accordance with RECIST 1.1 and all patients will be centrally reviewed. In addition, the study will also enroll an additional and separate cohort of patients who are cisplatin ineligible and have received prior CPI treatment to evaluate safety and efficacy in an earlier treatment setting.
Viking follows Madrigal NASH lead higher
Shares of the clinical-stage biotech Viking Therapeutics (NASDAQ:VKTX) soared following positive mid-stage trial results for Madrigal Pharmaceuticals‘ (NASDAQ:MDGL) nonalcoholic steatohepatitis (NASH) candidate MGL-3196.
The reason? Viking’s experimental NASH drug, VK2809, reportedly has a similar mechanism of action as MGL-3196. Investors are apparently bidding up Viking’s shares on the belief that VK2809’s mid-stage results will ultimately mirror those of MGL-3196.
However, shares in Intercept Pharmaceuticals (NASDAQ:ICPT), which sports the most advanced NASH candidate, Ocaliva, are down 10.3% at the time of writing. While Ocaliva is well ahead of both MGL-3196 and VK2809 in terms of clinical development, the drug does have some serious safety issues that could negatively impact its commercial uptake if approved.
NASH is widely expected to be the next multibillion-dollar drug market, thanks to the rising rates of obesity worldwide and the fact that there are no approved therapies for this condition. Intercept, Madrigal, and Viking are thus all hoping to beat out far larger competitors, like Allergan, Pfizer, and Gilead Sciences, in this emerging space and gain an all-important first-mover advantage.
Viking’s mid-stage NASH study is set to wrap up next month, according to ClinicalTrials.gov. A top-line data release should thus occur within the next four to six weeks. So, in light of this upcoming clinical catalyst, Viking’s stock appears primed to continue its upward trajectory, even after today’s monstrous move higher.
The long and short of it is that VK2809 should garner significant interest from multiple big pharmas currently vying for a piece of this enormous NASH market. As proof, Madrigal has already bubbled to the top of the buyout-rumor mill after MGL-3196’s breakout success due to the tremendous demand for these drugs. Put simply, it might be a good idea to grab at least a few shares of this promising biotech ahead of this upcoming clinical catalyst.
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