Shares of Novavax, Inc. (NASDAQ:NVAX) ended Tuesday session in red amid volatile trading. The shares closed down -0.03 points or -1.90% at $1.55 with 4.66 million shares getting traded. Post opening the session at $1.56, the shares hit an intraday low of $1.52 and an intraday high of $1.62 and the price vacillated in this range throughout the day. The company has a market cap of $436.93 million and the numbers of outstanding shares have been calculated to be 271.19 million shares.
Novavax, Inc. (NVAX) announced topline data from two clinical trials of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults. The Resolve(TM) trial, a Phase 3 trial of our RSV F Vaccine in 11,856 older adults (60 years of age and older), did not meet the pre-specified primary or the secondary efficacy objectives, and did not demonstrate vaccine efficacy. Consistent with our previous clinical experience, the vaccine was well tolerated.
Phase 3 Resolve(TM) Trial
The trial was a randomized, observer-blinded, placebo-controlled trial conducted at 60 sites in the United States. The primary objective of the Resolve trial was to demonstrate efficacy in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV msLRTD), as defined by the presence of multiple lower respiratory tract symptoms. The secondary objective of the trial was to demonstrate efficacy of the RSV F Vaccine in reducing the incidence of all symptomatic respiratory disease due to RSV (RSV ARD). Finally, the trial also evaluated the safety of the unadjuvanted, 135 microgram dose of the RSV F Vaccine compared to placebo.
Shares of Catalyst Pharmaceuticals Inc (NASDAQ:CPRX) ended Tuesday session in red amid volatile trading. The shares closed down -0.06 points or -4.96% at $1.15 with 534,871 shares getting traded. Post opening the session at $1.19, the shares hit an intraday low of $1.15 and an intraday high of $1.27 and the price vacillated in this range throughout the day. The company has a market cap of $93.75 million and the numbers of outstanding shares have been calculated to be 82.87 million shares.
Catalyst Pharmaceuticals Inc (CPRX) announced that the journal of Epilepsy & Behavior Case Reports has accepted for publication a case report on the efficacy of CPP-115 in a child with refractory infantile spasms.
The case report presents a child treated with CPP-115 through an investigational new drug protocol who experienced a significant reduction of seizures with no evidence of retinal dysfunction. The research paper made the following conclusions:
The case study suggests sustained efficacy and tolerability of CPP-115 in treating epileptic spasms
It reported reduction in seizure frequency and documented improvements in the EEG interictal and ictal record temporally associated with CPP-115 initiation for this patient
It reported that in the context of refractory infantile spasms and associated morbidity, mortality, and poor neurodevelopmental outcomes, CPP-115 is potentially a promising alternative to vigabatrin therapy
Prior to treatment with CPP-115, the patient had failed ten drugs and the ketogenic diet, and had approximately 100 seizures per day. One year after starting CPP-115 and coming off of clobazam and vigabatrin, the patient’s reported seizures have seen a marked reduction in frequency and his cognition and behavior have improved.