FDA OKs Alexion Soliris in rare autoimmune brain, spinal cord disorder

The FDA approves Alexion Pharmaceuticals’ (ALXN +0.9%) Soliris (eculizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who express an antibody called anti-aquaporin-4 (AQP4) (a biomarker for confirming the diagnosis).

NMOSD is a rare autoimmune disorder of the brain and spinal cord characterized by inflammation of the spinal cord (myelitis) and optic nerve (optic neuritis). It occurs in 1-10 per 100,000 individuals worldwide.

https://seekingalpha.com/news/3474379-fda-oks-alexions-soliris-rare-autoimmune-disorder-brain-spinal-cord

Genmab: FDA OKs Combo for Frontline Multiple Myeloma

• DARZALEX (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
• Approval based on Phase III MAIA study

Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX^® (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The supplemental Biologics License Application (sBLA) for this indication was submitted by Genmab’s licensing partner, Janssen Biotech, Inc., under the Real-Time Oncology Review (RTOR) pilot program. In August 2012, Genmabgranted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

https://www.marketscreener.com/GENMAB-1412914/news/Genmab-Announces-U-S-FDA-Approval-of-DARZALEX-daratumumab-in-Combination-with-Lenalidomide-and-28825025/

UnitedHealthcare Hearing to Improve Access to Affordable Hearing Health Care

• UnitedHealthcare Hearing offers more affordable, quality hearing health care options, including access to hearing aids at up to 80 percent less than devices sold through traditional channels
• New business unit to help meet the hearing health needs of all consumers, including people enrolled in UnitedHealthcare individual, employer-sponsored and Medicare Advantage plans
• UnitedHealthcare to donate 20,000 silicone-based, reusable earplugs to police and fire departments across the country as part of a public awareness campaign

UnitedHealthcare has launched UnitedHealthcare Hearing, offering all consumers, including people enrolled in the company’s individual, employer-sponsored and Medicare Advantage plans, greater access to affordable, quality hearing health.

Hearing loss affects millions of Americans, so considering this information and the related tips can help people reduce the risk of developing this chronic condition (Source: UnitedHealthcare).

For millions of people nationwide, UnitedHealthcare Hearing provides access to custom-programmed hearing aids at up to 80 percent less than devices sold through traditional channels. UnitedHealthcare Hearing brings together EPIC Hearing Healthcare, the nation’s largest provider of hearing health benefits, and hi HealthInnovations, a home-delivery hearing health care company.

About 48 million Americans experience some degree of hearing loss, although many do not seek treatment due to cost and lack of coverage. Hearing loss is linked to age and environmental factors, and prolonged and repetitive exposure to loud sounds is contributing to the growing prevalence of noise-induced hearing loss, particularly among people of working age in their 30s, 40s and 50s.

Through EPIC Hearing Healthcare, more employers can provide their employees an expanded portfolio of hearing health benefit plans that include the full spectrum of hearing aid options and a large national network of more than 5,000 credentialed audiologists and hearing health professionals. In addition, nearly 3 million people enrolled in UnitedHealthcare’s Medicare Advantage plans that offer hearing health benefits have more robust coverage. They have access to a broad choice of custom-programmed hearing aids from all major manufacturers, with no out-of-pocket cost for some people and a per-device copay for most starting at $200.ⁱ

hi HealthInnovations sells premium, state-of-the-art hearing aids to people by phone, online or in person at locations nationwide, with personalized support during and after purchase. Through hi HealthInnovations, millions of UnitedHealthcare plan participants – including people with employer-sponsored and individual hearing coverage, as well as people enrolled in most Medicare Advantage plans – can purchase custom-programmed hearing aids starting at a $100 per-device copay for many people.

https://www.marketscreener.com/UNITEDHEALTH-GROUP-14750/news/UnitedHealth-Launch-of-UnitedHealthcare-Hearing-Offers-People-Improved-Access-to-Affordable-Quali-28823624/

Novavax up on accelerated approval pathway in U.S. for NanoFlu

Novavax (NASDAQ:NVAX) is up 10% premarket on increased volume on the heels of its announcement that the FDA is on board with accelerated review status for flu vaccine NanoFlu.

The company plans to launch a Phase 3 study this fall with topline results expected in Q1 2020. If all goes well, a marketing application will follow.

https://seekingalpha.com/news/3474269-novavax-10-percent-premarket-accelerated-approval-pathway-u-s-nanoflu

Novavax to sell manufacturing assets to Catalent for $18M

Aimed at cutting operating costs while it advances NanoFlu and ResVax, Novavax (NVAX +26.9%) has agreed to sell certain manufacturing assets to Catalent Biologics’ (CTLT) Paragon Gene Therapy unit for $18M in cash.

Paragon will also assume the leases on two NVAX product development and manufacturing facilities and will absorb over 100 NVAX employees.

The transactions should close next month.

https://seekingalpha.com/news/3474275-novavax-sell-manufacturing-assets-catalent-18m

Advaxis bails on late-stage study of AXAL in cervical cancer

Citing a sharpened focus on neoantigen-directed immunotherapies, Advaxis (ADXS -4.4%) announces that it will terminate its Phase 3 AIM2CERV trial evaluating axalimogene filolisbac (AXAL) in patients with high-risk locally advanced cervical cancer, adding that it will continue to support its clinical development in other HPV-related cancers.

The company also cited the cost ($80M – 90M) and time (at least three years for initial efficacy data) required to complete the study.

https://seekingalpha.com/news/3474296-advaxis-bails-late-stage-study-axal-cervical-cancer-shares-4-percent

Apellis up on advancement of APL-2

Apellis Pharmaceuticals (APLS +4.4%) is up on below-average volume on the heels of its announcement that enrollment has been completed (80 subjects) in its Phase 3 PEGASUS study evaluating lead candidate APL-2 (pegcetacoplan), compared to Alexion’s Soliris (eculizumab), in patients with paroxysmal nocturnal hemoglobinuria (PNH).

About half of the participants are transfusion-dependent. Topline results should be available in December.

https://seekingalpha.com/news/3474312-apellis-4-percent-advancement-aplminus-2