Helius Medical announced that the FDA has completed its review of the company’s request for de novo classification and 510 clearance of the Portable Neuromodulation Stimulator, or PoNS, device and has declined the company’s request. In reaching its conclusion, the agency noted that it did not have sufficient information to discern the relative independent contributions of the PoNS device and physical therapy on the improvements from baseline in the effectiveness endpoints observed in the company’s clinical studies. The FDA noted that the company could generate additional data to address its concerns and resubmit its application. In the course of its review of the company’s submission, the FDA recognized that there were no device-related serious adverse events in either of the company’s two clinical trials, and that patients in both the treatment and the sham control arms demonstrated improvements from baseline for all the pre-specified clinical endpoints, including the primary endpoint of responder rate based on Sensory Organization Test score.
Wednesday, April 10, 2019
Premier downgraded to Market Perform from Outperform at SVB Leerink
SVB Leerink analyst David Larsen downgraded Premier to Market Perform from Outperform and lowered his price target on the stock to $36 from $48.
The Medicines Co. likely a buyout target on ‘clean’ data, says Citi
Citi analyst Joel Beatty says The Medicines Co. will likely become a takeover target if its Phase 3 data in Q3 shows “clean safety.” The years of accumulated safety data supports that “clean” Phase 3 results are likely, Beatty tells investors in a research note. The analyst keeps a Buy rating on the shares with a $50 price target. He also believes Medicines’ $173M debt offering likely reflects the increased risk around the Melinta infectious disease partnership. Medicines’ annual filing indicates that Melinta is seeking indemnification to not pay the two $25M deferred payments or the $30M Vabomere milestone payment due to its former owners, says the analyst. If not paid the milestone responsibility falls back onto The Medicines Co., Beatty notes.
Madrigal shares have little takeover premium, says Citi
Citi analyst Joel Beatty sees the Phase 3 trial design confirmed by Madrigal Pharmaceuticals at the end of March as “derisking.” The analyst believes there will be a growing appreciation toward using nonalcoholic steatohepatitis drugs with a strong metabolic component in most patients. Further, there’s little takeover premium currently in Madrigal shares, which could lead to upside in the event that a NASH competitor is acquired, says the analyst. He keeps a Buy rating on Madrigal Pharmaceuticals with a $200 price target.
Stericycle sees ‘realistic potential’ for sustainable growth, says Stifel
After traveling with incoming Stericycle CEO Cindy Miller, Stifel analyst Michael Hoffman noted that she expects to become a sustainable, scalable growth company after making Stericycle smaller and leaner, but said that Miller “is not interested in shrinking to greatness.” Stericycle’s business model is not broken, but it must re-establish it can repeatedly predict its outlook, said Hoffman, who reaffirmed his Buy rating and $70 target price on the stock following the management meeting.
Amgen has $500M drug with Evenity despite box warning, says Jefferies
Jefferies analyst Michael Yee says that despite the inclusion of a boxed warning highlighting the potential increased cardiovascular risk, Evenity is an incremental $500M-plus drug for Amgen. The analyst points out that Forteo did $1.5B despite a warning label for bone cancer. He keeps a Buy rating on Amgen with a $230 price target.
Alexion resumed with an Outperform at Raymond James
Raymond James analyst Steven Seedhouse resumed coverage of Alexion with an Outperform rating and $161 price target, citing what he sees as good visibility into continued growth as the company works to switch patients from Soliris to Ultomiris and pursues subcutaneous follow-on products to extend “existing, successful franchises.” He models upside even without any pipeline contributions, the analyst noted.
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