H.C. Wainwright analyst Oren Livnat says Lipocine yesterday reported “surprisingly strong” liver fat reduction interim data. The analyst reiterates a Buy rating on the shares with a $3 price target. The LPCN-1144 results could justify proceeding to a biopsy confirmed Phase 2a non-alcoholic steatohepatitis trial and inclusion of something for NASH in our valuation, Livnat tells investors in a research note.
Friday, January 18, 2019
Provention Bio initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju started Provention Bio with a Buy rating and $7.50 price target. Provention is a “virtual, rapidly emerging biotechnology company focused on treatment of inflammatory and autoimmune diseases,” Selvaraju tells investors in a research note. He sees “substantial” market opportunities for the company that underserved by existing drugs.
Wells Fargo downgrades Immunomedics on CRL, cuts target to $18 from $44
Wells Fargo analyst Jim Birchenough downgraded Immunomedics to Market Perform from Outperform and cut his price target for the shares to $18 from $44 following yesterday’s Complete Response Letter from the FDA for sacituzumab govitecan in triple negative breast cancer. The CRL may suggest greater complexity of issues to address, Birchenough tells investors in a research note. He recommends taking a “wait-and-see approach” pending better visibility on specific issues and timelines.
Celgene enters strategic collaboration with Obsidian Therapeutics
Obsidian Therapeutics announced a strategic collaboration with Celgene for the discovery and development of novel, regulated cell therapies that utilize Obsidian’s Destabilizing Domain, or DD, technology. Specifically, the collaboration is based on Obsidian’s DD technology for the controlled expression of two immunomodulatory factors, IL12 and CD40L, that have the potential to augment the power of adoptive cell therapies but require precise control to optimize their therapeutic benefit. This multi-year collaboration provides Celgene with the exclusive option to in-license worldwide rights for cell therapy candidates that incorporate DD-regulated IL12 or CD40L for the treatment of cancer. The collaboration includes an upfront payment and equity investment by Celgene, and potential future milestone and royalty payments.
KemPharm to present data from four posters at APSARD
KemPharm announced that research assessing the oral and intranasal human abuse potential, or HAP, of serdexmethylphenidate, or SDX, KemPharm’s prodrug of d-methylphenidate, or d-MPH, as well as new pharmacokinetic, or PK, data for KP415, will be presented in four posters and one oral “data blitz session” at the annual meeting of the American Professional Society for ADHD and Related Disorders, or APSARD. SDX is the major active pharmaceutical ingredient in KP415 and KP484, KemPharm’s co-lead clinical development product candidates intended for the treatment of attention-deficit/hyperactivity disorder, or ADHD, as well as KP879, a newly identified product candidate being developed for the treatment of Stimulant Use Disorder, or SUD. The first poster was a single-dose, single-period study of orally administered KP415 capsules in children 6-12 years of age and adolescents 13-17 years of age. Consistent with prior studies of methylphenidate products, the study found that systemic dose-normalized exposure to d-MPH following oral administration of KP415 was higher in younger children, which appears to be related to lower d-MPH clearance in subjects with lower body weights. The second poster was a Phase 1, open-label, randomized, single-dose, 3-treatment, 3-period crossover study evaluating the PK’s of three clinical doses of KP415 in healthy adults. KP415 produced dose-proportional increases in the rate and extent of d-MPH exposure across a relatively wide range of doses, and steady-state plasma concentrations were achieved prior to the third dose. The third poster also featured as one of eight posters selected to participate in an oral “data blitz session.” This was a Phase 1, randomized crossover, double-blind, single-dose, active- and placebo-controlled study that compared the HAP and PK’s of intranasally administered, or IN, SDX and IN d-MPH HCl in recreational stimulant users with a history of intranasal stimulant use. IN SDX produced lower exposure to d-MPH relative to IN d-MPH HCl, and correspondingly, produced pharmacodynamic effects that were significantly lower than IN d-MPH HCI on multiple abuse-related endpoints, including the primary endpoint of maximal drug liking. Finally, the fourth poster was a Phase 1, randomized crossover, double-blind, single-dose, active- and placebo-controlled study of orally administered SDX in recreational stimulant users. The study found that SDX produced a gradual onset of abuse-related effects and maximal effects which were statistically lower than Focalin XR on all abuse-related endpoints and statistically lower than phentermine on a majority of abuse-related endpoints. KemPharm funded the studies which were conducted at various external clinical facilities.
Edwards Lifesciences upgraded to Buy on pipeline readouts at BofA/Merrill
BofA/Merrill upgraded Edwards Lifesciences (EW) to Buy from Neutral and raised its price target to $190 from $180. Analyst Bob Hopkins expects Edwards’ multiple to move higher as investors digest upcoming pipeline readouts for Low Risk Aortic and Mitral Repair over the next five months. Further, the US Pascal trial requires only a six month followup, indicating that approval could come earlier than expected, the analyst wrote in a note to investors.
https://thefly.com/landingPageNews.php?id=2850859
AnaptysBio price target lowered to $125 from $156 at SunTrust
SunTrust analyst Joon Lee lowered his price target on AnaptysBio to $125, citing increasing competition for its product. The analyst keeps his Buy rating however and expects its stock to show “significant upside from current levels in 2019” ahead of the four major data readouts to follow “already promising” phase 2 proof of concept data in atopic dermatitis and asthma. Lee is overall positive on AnaptysBio’s “proprietary antibody generation platform that is able to mimic natural in vivo process of antibody diversity generation in an in vitro system”.
https://thefly.com/landingPageNews.php?id=2850871
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