Cantor Fitzgerald analyst Charles Duncan left investor meetings with Aimmune Therapeutics management with “enhanced conviction” about AR101’s approvability and commercial prospects. He believes the regulatory review with the FDA is “now gaining traction.” The analyst views 2019 and 2020 as being transformational for Aimmune “as it evolves from being development stage to becoming a fully-integrated commercial stage company.” Importantly, the company has sufficient cash to fully fund through the approval and early commercialization in the U.S. and Europe, Duncan tells investors in a research note. He reiterates an Overweight rating on the shares with a $45 price target.
Thursday, April 11, 2019
Helius Medical downgraded to Perform on FDA PoNS update at Oppenheimer
Oppenheimer analyst Steven Lichtman downgraded Helius Medical to Perform from Outperform following the update on the FDA submission for the company’s PoNS, with the agency declining approval and more data needed for resubmission. The next key milestones include the update on U.S. pathway following another expected FDA meeting and potential approvals in Europe/Australia, he contends.
Albireo announces FDA clearance to commence Phase 2 elobixibat trial
Albireo Pharma announced that its investigational new drug application, or IND, has cleared the required 30 day review by the FDA and is in effect for a Phase 2 clinical trial of elobixibat, a once-daily, orally-available ileal bile acid transporter inhibitor, for the treatment of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis.
Otonomy initiates Phase 1/2 OTO-313 trial for patients with tinnitus
Otonomy announced the initiation of a Phase 1/2 clinical trial of OTO-313, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in patients with tinnitus. The randomized, double-blind, placebo-controlled Phase 1/2 study will include an initial safety cohort followed by an exploratory efficacy study that will enroll approximately 50 patients with subjective tinnitus.
Tivity Health initiated at Craig-Hallum
Tivity Health initiated with a Buy at Craig-Hallum. Craig-Hallum analyst Alex Fuhrman started coverage of Tivity Health with a Buy rating and a $30 price target. The analyst believes Tivity’s acquisition of Nutrisystem capitalizes on an aging population and could double or triple EPS.
Iterum Therapeutics to present three posters at ECCMID
Iterum Therapeutics will present three posters at the European Congress of Clinical Microbiology & Infectious Diseases, or ECCMID. The authors reviewed the records of 4,792 patients given oral antibiotics for uncomplicated urinary tract infections, or uUTIs, and assessed the difference in 28-day outcomes for patients with a uUTI whose pathogens were susceptible to empiric therapy versus those who were non-susceptible to therapy, highlighting the risk factors associated with failure. They concluded the most significant risk for treatment failure is treatment of the index infection with an antibiotic to which the organism in a prior infection was resistant. Age, gender and diabetes mellitus also increased the likelihood of treatment failure. Treatment failure and hospitalization rates double with mismatched empiric antibiotic therapy. The more antibiotic class resistance, the higher likelihood of treatment failure.
Guggenheim sees limited upside for Eli Lilly, downgrades to Neutral
As previously reported, Guggenheim analyst Seamus Fernandez downgraded Eli Lilly (LLY) to Neutral from Buy, stating that while he expects updates at the American Diabetes Association meeting to be broadly positive, he sees limited upside for the stock from current levels until Lilly’s overall immunology portfolio and competition from Novo Nordisk’s (NVO) semaglutide franchise is more fully understood. Though he still thinks Eli Lilly has “the best long-term growth profile in US Pharma,” that growth is the broad consensus view, said Fernandez, who removed his price target on the stock but estimates the fair value to be in the range of $125-$135 per share.
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