Target $72
Thursday, June 27, 2019
FDA OKs Dova’s Doptelet for low blood platelets in ITP patients
The FDA approves Dova Pharmaceuticals’ (NASDAQ:DOVA) supplemental marketing application for DOPTELET (avatrombopag) to include treatment of thrombocytopenia (low blood platelets) in adult patients with chronic immune thrombocytopenia who have failed to sufficiently respond to previous therapy.
The agency approved the thrombopoietin receptor agonist in May 2018 for chronic liver disease patients with thrombocytopenia who are undergoing an invasive procedure (this indication was approved in Europe two days ago).
Shares are up 21% premarket.
Zogenix to refile Fintepla NDA next quarter
Zogenix (NASDAQ:ZGNX) is up 22% premarket on increased volume in response to its announcement that it expects to resubmit its U.S. marketing application next month for FINTEPLA (fenfluramine) for the treatment of seizures associated with a severe type of epilepsy called Dravet syndrome.
In April, the FDA issued a Refusal to File letter to the company citing the need for certain nonclinical studies to enable the assessment of chronic administration of fenfluramine and the correct clinical dataset.
The agency agreed to its plan to refile the application without new chronic toxicity studies. The correct dataset will, of course, be included.
It has rescinded Breakthrough Therapy status since there are now two approved therapies in the U.S. for the indication.
Raymond James positive on Planet Fitness
Raymond James starts off coverage on Planet Fitness (NYSE:PLNT) with an Outperform rating.
“Importantly, we believe PLNT’s differentiated business model and compelling unit economics prove advantageous. Store expansion, increased Black Card membership penetration, and rising royalty rates serve as key growth catalysts that should, in our view, effectively augment PLNT’s sales and profitability,” notes the firm in its morning note.
RJ’s price target of $80 on Planet Fitness is out in front of the sell-side consensus PT of $78.21.
Shares of Planet Fitness are up 0.73% premarket to $72.17.
Atossa’s topical endoxifen shows positive action in mid-stage study
Nano cap Atossa Genetics (NASDAQ:ATOS) is up 29% premarket on robust volume in reaction to positive results from a 90-subject Phase 2 clinical trial assessing daily 20 mg doses of topical Z Endoxifen on mammographic breast density (MBD).
The primary objective was to determine the change in breast density after treatment with topical Endoxifen for up to six months aimed at informing the optimal sample size for a Phase 3 trial.
MBD was reduced by an average of 14.3% in the treatment group compared to placebo (p=0.02). About 70% of patients receiving the 20 mg dose experienced reductions in MBD.
The company says the safety profile was similar to control but 72 participants developed skin rashes and local irritation and did not complete the full six months of dosing.
Atossa believes that the ultimate value proposition of topical Exdoxifen is reducing the number of women who may develop estrogen-dependent breast cancer.
Seelos in-licenses gene therapy for Parkinson’s; shares ahead 17% premarket
Nano cap Seelos Therapeutics (NASDAQ:SEEL) is up 17% premarket on robust volume in reaction to its licensing deal with Duke University for exclusive rights to a CRISPR-based gene therapy for the potential treatment of Parkinson’s disease (PD).
The candidate, named SLS-004, targets a gene called SNCA which encodes alpha-synuclein expression. Elevated levels of wild-type alpha-synuclein are associated with the development of PD.
Financial terms remain confidential.
Arrowhead’s ARO-AAT Fast Track’d for liver disease
The FDA has granted Fast Track designation to Arrowhead Pharmaceuticals’ (NASDAQ:ARWR) ARO-AAT, the RNA interference (RNAi) therapeutic developed as a treatment for a rare genetic liver disease associated with alpha-1 antitrypsin deficiency (AATD).
Arrowhead will initiate SEQUOIA (AROAAT2001), a Phase 2/3 clinical study in the U.S. and Europe, and AROAAT2002, a Phase 2 open-label clinical study in Europe.
The Fast Track designation provides for more frequent interactions with the FDA review team and a rolling review of the NDA.
Shares are up 2% premarket.
Subscribe to:
Posts (Atom)