Today’s Daily Dose brings you news about the near-term catalysts of Catalyst Pharma; progress in Entasis’ gonorrhea study; positive results of Foamix Pharma’s phase III papulopustular rosacea studies; Lannett’s revised revenue outlook; NantKwest’s cancer vaccine trial results; Nu Skin Enterprises’ Q3 financial results and Rennova Health’s reverse stock split.
Catalyst Pharmaceuticals Inc. (CPRX) has an important catalyst to watch out for this month.
The FDA decision on the Company’s Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) is expected on November 28, 2018.
The Company in-licensed the North American Rights to Firdapse from BioMarin Pharmaceutical Inc. (BMRN) in October 2012.
Firdapse received marketing approval in the E.U. for the treatment of Lambert-Eaton myasthenic syndrome in December 2009, and is the first and only approved drug in Europe for this condition.
The drug fetched annual revenue of $18.8 million for BioMarin in 2017.
Firdapse is also being evaluated for the treatment of congenital myasthenic syndromes (CMS) and myasthenia gravis patients with autoantibodies to muscle-specific tyrosine kinase (MuSK), and phase III trials in these indications are underway.
The top-line results from the phase III CMS and MuSK-MG trials are expected in the second half of 2019.
CPRX closed Wednesday’s trading at $3.15, down 2.78%.
Entasis Therapeutics (ETTX), in partnership with GARDP, a not-for-profit research and development organization, is all set to begin a phase III trial of Zoliflodacin for the treatment of uncomplicated gonorrhea in 2019.
The results from a phase II clinical trial evaluating the safety and efficacy of Zoliflodacin in 179 patients with uncomplicated gonorrhea have been published in The New England journal of Medicine (NEJM).
In the study, participants were randomly selected to receive either a single 2- or 3-gram dose of oral Zoliflodacin or a 500 milligram (mg) dose of injectable ceftriaxone. Zoliflodacin is Entasis’ investigational drug while Ceftriaxone is an FDA-approved antibiotic.
Among the 117 per-protocol participants who were evaluated six days after treatment, 98 percent (48 of 49 participants) of those who received the 2-gram Zoliflodacin dose, 100 percent (47 of 47 participants) of those who received the 3-gram dose, and all (21 of 21) of the participants in the ceftriaxone group were considered cured of their urogenital gonorrhea based on culture results.
Zoliflodacin cured all rectal gonorrheal infections (5 of 5 participants who received the 2-gram dose; 7 of 7 participants who received the 3-gram dose) as did ceftriaxone (3 of 3 participants). In treating patients with gonorrhea infections of the throat (pharyngeal), 50 percent of volunteers who received the 2-gram dose (4 of 8 participants) and 82 percent of those who received the 3-gram dose (9 of 11 participants) were cured. All of the participants (4 of 4) in the ceftriaxone group achieved a cure, the Company added.
ETTX closed Wednesday’s trading at $6.41, up 4.91%.
Foamix Pharmaceuticals Ltd.’s (FOMX) phase III program evaluating FMX103 1.5% minocycline foam in the treatment of moderate-to-severe papulopustular rosacea has yielded positive results.
The phase III program, which consisted of Studies FX2016-11 and FX2016-12, met both co-primary endpoints of absolute change from baseline in inflammatory lesion count at Week 12, and Investigator Global Assessment treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline.
Data from study FX2016-13 evaluating the long-term safety of FMX103 are expected to be reported in the first half of 2019.
The Company expects to file an NDA for FMX103 for the treatment of moderate-to-severe papulopustular rosacea in the U.S. in 2019.
FOMX closed Wednesday’s trading at $4.59, up 2.46%.
Lannett Company Inc. (LCI) has boosted its sales outlook for fiscal 2019.
The Company now expects net sales for the year to range between $585 million to $615 million, up from its prior forecast range of $580 million to $610 million.
For the fiscal 2019 first quarter, adjusted net sales were $155.1 million compared with $155.0 million for the first quarter of fiscal 2018.
LCI closed Wednesday’s trading at $4.30, up 0.47%. In after-hours, the stock was up 3.49% to $4.45.
Shares of NantKwest Inc. (NK) soared more than 47% in extended trading on Wednesday, following promising first in human data in advanced solid tumors of NANT Cancer Vaccine.
The NANT Cancer Vaccine is the first simultaneous combination of off the shelf Natural Killer Cells (NK) with endogenous adaptive dendritic, T cell and NK cell activation. The vaccine is intended to induce cancer cell death and at the same time protect and enhance a patient’s immune response against cancer cells with lower toxicity and higher efficacy in comparison with current standards of care.
According to the Company, the NANT Cancer Vaccine demonstrated a disease control of 80% in highly refractory late-stage (4th Line or Greater) advanced metastatic triple negative breast cancer; 90% disease control with median overall survival of 9.5 months in highly refractory late-stage advanced metastatic pancreatic cancer (3rd Line or greater), and 67% disease control with a complete response in one patient in highly refractory patients with advanced metastatic head and neck cancer.
NK closed Wednesday’s trading at $2.71, up 2.26%. In after-hours, the stock was up 47.60% to $4.00.
Novavax Inc. (NVAX) has a couple of catalysts to watch out for in the coming months.
— Final efficacy results from phase III trial of ResVax to protect infants from respiratory syncytial virus disease, dubbed Prepare, are expected to be reported in the first quarter of 2019.
— The top-line data from phase II clinical trial of NanoFlu and End of Phase 2 meeting with the FDA are expected in the first quarter of 2019.
NVAX closed Wednesday’s trading at $1.97, up 3.14%. In after-hours, the stock was down 3.55% at $1.90.
Nu Skin Enterprises Inc. (NUS) has reported strong earnings and revenue for the third quarter of 2018.
Net income for the recent third quarter was $53.1 million or $0.94 per share on revenue of $675.3 million. Analysts polled by Thomson Reuters were expecting revenue of $665.84 million.
In the third quarter of 2017, net income was $41.67 million or $0.76 per share and revenue was $563.7 million.
Looking ahead to the fourth quarter, the Company expects EPS of $1.00 to $1.07, on revenue of $665 million to $685 million. The EPS was $0.33 and revenue was $666.2 million in the fourth quarter of 2017.
For full year 2018, the Company has forecast EPS in the range of $3.48 to $3.55 on revenue of $2.66 billion to $2.68 billion. The EPS was $2.36 and revenue was $2.28 billion in full year 2017.
NUS closed Wednesday’s trading at $72.82, up 0.34%. In after-hours, the stock was down 3.87% at $70.00.
Ra Pharmaceuticals Inc. (RARX) is all set to report topline data from a phase II trial evaluating Zilucoplan for the treatment of generalized myasthenia gravis (gMG) around year-end 2018.
The 12-week trial enrolled a total of 44 patients who were randomized in a 1:1:1 ratio and received daily SC doses of 0.1 mg/kg of Zilucoplan, 0.3 mg/kg of Zilucoplan, or matching placebo. Dosing was completed at the end of October 2018.
RARX closed Wednesday’s trading at $13.80, down 0.07%.
Rennova Health Inc. (RNVA.OB) will implement a 1 for 500 reverse stock split of its outstanding common stock at 5:00 pm, Eastern Time, on November 8, 2018.
The Company’s common stock will open for trading on Friday November 9, 2018, on a post-split basis.
The reverse stock split will reduce the number of shares of the Company’s common stock outstanding from approximately 7.6 billion pre-reverse split shares to approximately 15.3 million post-reverse split.
Sarepta Therapeutics Inc. (SRPT) has offered to sell $500 million in shares of its common stock in an underwritten public offering.
The Company also intends to grant the underwriters a 30-day option to purchase an additional $75 million in shares of its common stock offered in the public offering.
Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Credit Suisse are acting as joint book-running managers of the proposed offering.
In the recent third quarter of 2018, the Company delivered strong EXONDYS 51 sales of $78.5 million, up from $46.0 million for the same period of 2017.
EXONDYS 51 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.
SRPT closed Wednesday’s trading at $144.06, up 5.02%.
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