Day: January 10, 2018

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Novavax higher on its promising vaccine

Analyst quadruples Novavax target after sign that RSV vaccine works

Novavax target quadrupled Novavax on signs that RSV vaccine works. Stockwinners.com
Novavax target quadrupled Novavax on signs that RSV vaccine works

This morning, B. Riley FBR analyst George Zavoico raised his price target for Novavax (NVAX) nearly five-fold to $10 after the company announced more details about an informational analysis of Prepare, an ongoing Phase 3 trial of an RSV F vaccine for maternal immunization to protect newborn infants.

This target hike comes just five days after #Zavoico started coverage of the stock with a Buy rating and a $2.25 price target.

PREPARE UPDATE

In slides accompanying a presentation by the company at the 36th annual JPMorgan Healthcare conference, Novavax provided an update on the status of its Phase 3 Respiratory Syncytial Virus vaccine for Infants Via Maternal Immunization clinical trial, dubbed the “Prepare” trial.

Novavax pointed out that an informational analysis was performed in the fourth quarter of 2017, and targeted an efficacy threshold against the primary endpoint at day 90 of more than 40%.

In December, the Data Safety Monitoring Board statistician performed an unblinded analysis and communicated that the RSV F vaccine “successfully met” the criteria, the company highlighted in the slides.

Importantly, Novavax stated that the informational analysis indicated that its RSV F Vaccine is efficacious, and that Phase 3 enrollment should yield pivotal efficacy data by the fourth quarter of 2018 and the first quarter of 2019.

The company expects it to be the first licensed RSV vaccine, with an estimated global peak revenue of over $1.5B.

INCREASING CONFIDENCE IN PREPARE TRIAL

Just five days after initiating coverage of the stock, B. Riley FBR analyst George Zavoico raised his price target for Novavax to $10 from $2.25, while reiterating a Buy rating on the shares.

The target increase comes after the company announced more details about the informational analysis of #Prepare.

The analyst noted that he has learned that the objective of the analysis allowed by the FDA was to determine if the trial vaccine efficacy was greater than 45%, a threshold that he thinks will translate into a successful Phase 3 trial and a commercially viable vaccine.

Overall, Zavoico told investors that the results increase his confidence in a successful outcome of the Prepare trial.

WHAT’S NOTABLE

The company’s maternal immunization program is supported by an $89M grant from the Bill and Melinda Gates Foundation and has also been granted Fast Track designation by the U.S. FDA.

PRICE ACTION:

In late Wednesday’s morning trading, shares of Novavax (NVAX) have jumped 53c, or almost 40%, to $1.86.

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Nvidia launches ‘functionally safe’ AI self-driving platform NVIDIA DRIVE 

Nvidia announces ‘functionally safe’ AI self-driving platform NVIDIA DRIVE 

Nvidia pullback after Q2 beat a buying opportunity. See Stockwinners.com Market Radar for more
Nvidia announces ‘functionally safe’ AI self-driving platform NVIDIA DRIVE

NVIDIA (NVDA) unveiled details of its functional safety architecture for NVIDIA DRIVE, its AI autonomous vehicle platform, which uses redundant and diverse functions to enable vehicles to operate safely, even in the event of faults related to the operator, environment or systems.

The NVIDIA DRIVE architecture enables automakers to build and deploy self-driving cars and trucks that are functionally safe and can be certified to international safety standards, such as ISO 26262.

The NVIDIA DRIVE AV autonomous vehicle software stack performs functions like ego-motion, perception, localization and path planning. To realize fail operation capability, each functionality includes a redundancy and diversity strategy.

For example, perception redundancy is achieved by fusing lidar, camera and radar.

Deep learning and computer vision algorithms running on CPU, CUDA GPU, DLA and PVA enhance redundancy and diversity.

The NVIDIA DRIVE AV stack is a full backup system to the self-driving stack developed by the automaker, enabling Level 5 autonomous vehicles to achieve the highest level of functional safety. Included are lockstep processing and error-correcting code on memory and buses, with built-in testing capabilities.

The ASIL-C NVIDIA DRIVE Xavier processor and ASIL-D rated safety microcontroller with appropriate safety logic can achieve the highest system ASIL-D rating.

NVDA closed at $219.59.

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Avadel Pharmaceuticals receives orphan drug designation for its narcolepsy drug

Avadel receives orphan drug designation for FT 218 for narcolepsy 

Avadel receives orphan drug designation for FT 218 for narcolepsy
Avadel receives orphan drug designation for FT 218 for narcolepsy

Avadel Pharmaceuticals (AVDL) announced that FT 218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of narcolepsy.

FT 218, a once-nightly formulation of sodium oxybate using Avadel’s proprietary Micropump technology, is currently undergoing testing in a Phase III clinical trial for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.

The designation has been granted on the plausible hypothesis that FT 218 may be clinically superior to the same drug already approved for the same indication because FT 218 may be safer due to ramifications associated with the dosing regimen of the previously-approved product.

Mike Anderson, Avadel’s Chief Executive Officer, said, “Receipt of Orphan Drug Designation for FT 218 is meaningful for both Avadel and patients suffering from Narcolepsy.

Narcolepsy is a debilitating and rare sleep disorder for which limited treatment options exist. We look forward to completing our REST-ON Phase III trial this year and are hopeful that FT 218 can provide meaningful benefit to patients and their quality of life over other standards of care.”

Narcolepsy is a long-term neurological disorder that involves a decreased ability to regulate sleep-wake cycles. Symptoms include periods of excessive daytime sleepiness that usually last from seconds to minutes and may occur at any time. About 70% of those affected also experience episodes of sudden loss of muscle strength, known as cataplexy. These spells can be brought on by strong emotions.  Less commonly there may be inability to move or vivid hallucinations while falling asleep or waking up.[1] People with narcolepsy tend to sleep about the same number of hours per day as people without, but the quality of sleep tends to be worse.

AVDL closed at $9.10, it last traded at $9.86.

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Honda recalls 465,000 vehicles with faulty airbag

Honda to recall additional 465,000 vehicles with faulty airbag inflators

Honda to recall additional 465,000 vehicles with faulty airbag inflators. Stockwinners.com
Honda to recall additional 465,000 vehicles with faulty airbag inflators

In the third phase of planned recalls announced by NHTSA in May 2016 and based on recent Defect Information Reports from the airbag inflator supplier Takata (TKTDY), Honda (HMC) will conduct recalls covering approximately 717,000 Honda and Acura automobiles in the United States to replace, for free, Takata passenger front airbag inflators that do not contain a moisture absorbing desiccant.

Excluding vehicles subject to the earlier Takata airbag inflator recalls, approximately 465,000 additional Honda and Acura vehicles in the U.S. will become subject to recall for the first time as a result of this action.

Including the recall announced today, Honda has adequate replacement part supplies to repair all Honda and Acura models currently included in inflator recalls in the United States.

Owners of affected vehicles can seek repair immediately at authorized Honda and Acura dealers.

No additional driver front airbag inflators in Honda or Acura automobiles will be subject to recall in this action, as all potentially affected driver inflators already are subject to prior recalls.

However, some vehicles previously repaired under earlier driver front inflator recalls will now require replacement of those vehicles’ passenger front inflators under this new action.

In addition, 960 Honda Gold Wing Airbag motorcycles from the 2009-2016 model years will be recalled to replace optional Takata non-desiccated airbag inflator modules installed on those vehicles.

Due to the relatively small vehicle population and an adequate supply of replacement inflators, Honda has elected to pull forward the recall of motorcycles that would have been included in Phase 4 of NHTSA’s recall plan (scheduled for January 2019), placing them under recall earlier than required.

With this action, all Honda motorcycles equipped with defective inflators in the U.S. are now eligible for repair. There have been no Takata airbag inflator ruptures involving Honda motorcycles globally.

With this new action, a total of approximately 11.9 million Honda and Acura automobiles have been or now are subject to recall for replacement of a Takata driver and/or passenger front airbag inflator in the United States, with approximately 4,540 Honda motorcycles subject to recall for the replacement of the Takata airbag inflator module.

HMC closed at $36.00

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