The pivotal Phase 3 data with epidiolex for seizures related to tuberous sclerosis complex are imminent, yet it’s hard to gauge how much investors care, Piper Jaffray analyst Danielle Brill tells investors in a research note. The analyst models a 50% probability of success for tuberous sclerosis complex and sees ~15% share upside if the data support label expansion. However, Brill adds that if safety looks clean and higher doses drive better efficacy, peak sales could be double her $400M estimate, driving potential upside of 20%-25%. If efficacy and/or safety signals occur that prevent label expansion for tuberous sclerosis complex, she estimates share downside of ~15%. This could be “substantially more” with a severe safety signal that broadly prohibits off-label use, however, the analyst adds. Brill has an Overweight rating on GW Pharmaceuticals with a $185 price target.
Tuesday, April 16, 2019
Arrowhead price target raised to $33 from $25 at Piper Jaffray
Piper Jaffray analyst Edward raised his price target for Arrowhead Pharmaceuticals to $33 from $25 after the company received FDA clearance to start a Phase II/III trial of wholly-owned ARO-AAT in Alpha-1 antitrypsin deficiency. The analyst increased his value for ARO-AAT and reiterates an Overweight rating on Arrowhead shares.
Mesoblast’s BLA for remestemcel-L accepted by FDA
Mesoblast announced that the FDA has agreed that Mesoblast can submit on a rolling basis a Biologics License Application, or BLA, for its allogeneic cellular medicine remestemcel-L in children with steroid-refractory acute Graft Versus Host Disease, or SR-aGVHD. Mesoblast will submit each module of the BLA to the FDA on a rolling basis as it is completed. The rolling process will provide opportunity for ongoing and frequent communication, and during this process the Company expects it will be able to adequately address any substantial matters raised by the FDA. Mesoblast has previously received Fast Track designation from the FDA for remestemcel-L in SR-aGVHD and is eligible for priority review once the BLA filing is completed and accepted by the FDA. Mesoblast expects to submit the first module shortly.
Catalent upgraded to Buy from Neutral at UBS
UBS analyst Daniel Brennan upgraded Catalent to Buy and raised his price target to $54 from $43, saying the company’s acquisition of Paragon “significantly increases the exposure to the rapidly growing biologic production market” which he sees as “arguably the most attractive sub segment within the broader life science tools sector today.” The analyst models the deal to be accretive by over 200bps to Catalent’s revenue and EBITDA in the long term and potentially higher in the near term, adding that his price target assumes EBITDA multiple of 14-times – a 2-turn premium to the stock’s long-term average. Brennan further notes that his “recent diligence” suggests that the “bullishness about the gene therapy market is warranted.”
Exact Sciences price target raised to $115 from $109 at UBS
UBS analyst Dan Brennan raised his price target on Exact Sciences to $115 and kept his Buy rating. The analyst cites his findings of the UBS Evidence Lab’s survey of 150 doctors to gauge the outlook for Cologuard and sees the results as “quite positive” in terms of the level of testing per doctor that “reflects significant upside potential.” Brennan adds that he sees the expected market share for Cologuard at “over 50% ahead of what’s implied in his forecasts” when looking further out to 2023.
Johnson & Johnson narrows FY19 adj. EPS view to $8.53-$8.63 from $8.50-$8.65
Consensus $8.58. Raises FY19 revenue growth guidance to 2.5%-3.5% from 2%-3%.
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