Oppenheimer analyst Esther Rajavelu upgraded GW Pharmaceuticals to Outperform from Perform and raised her price target for the shares to $234 from $162. The stock in premarket trading is up 8%, or $14.91, to $195.00. GW last night reported “strong” Epidiolex uptake and more importantly, shared positive topline results from a Phase 3 study of Epidiolex in patients with seizures associated with tuberous sclerosis complex, Rajavelu tells investors in a research note. As a result, the analyst updated her probability of approval in tuberous sclerosis complex to 87% from 41%. The analyst also likes GW’s efforts to broaden the pipeline with open-label studies of CBDV for autism spectrum disorder and Rett syndrome.
Tuesday, May 7, 2019
Eagle Pharmaceuticals sees FY19 R&D spending $32.0M-$36.0M
FY19 R&D spend compares to $38.0M in FY18. Sees FY19 SG&A on a non-GAAP basis, $51.0M-$54.0M, as compared to $43.0M in FY18.
Eagle Pharmaceuticals announces results from RYANODEX study
Eagle Pharmaceuticals announced positive results of its study to evaluate the neuroprotective effects of RYANODEX, or dantrolene sodium, secondary to nerve agent exposure, conducted with the U.S. Army Medical Research Institute of Chemical Defense, or USAMRICD. The study results show a p-value of 0.04 or less compared to the control group in six critical areas of the brain. We believe these results demonstrate the neuroprotective effects of RYANODEX. It has been hypothesized that nerve agent poisoning triggers intracellular calcium release in the body. The study data supports the proposed mechanism of action of RYANODEX, which modulates intracellular calcium in different organs including the brain. “We intend to meet with the FDA to discuss next steps as soon as possible. Given the life-threatening nature of NA exposure, we believe this indication would be evaluated under the FDA’s Animal Rule. If approved, this would be an additional indication for RYANODEX, as we continue to develop additional potential indications and an intramuscular formulation of the drug,” said the company.
Biohaven Pharmaceutical reports Q1 EPS ($1.41), consensus ($1.48)
Cash as of March 31 was $217.4M, compared to $264.2M as of December 31, 2018.
Allergan raises FY19 adjusted EPS view to greater than $16.55, consensus $16.43
Prior view was greater than or equal to $16.36. Raises FY19 revenue view to $15.1B-$15.4B from $15B-$15.3B, consensus $15.2B.
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