Search This Blog

Monday, August 5, 2019

Provention’s PRV-031 Breakthrough Therapy for type 1 diabetes risk

The FDA has granted Breakthrough Therapy Designation (BTD) to Provention Bio’s (NASDAQ:PRVB) teplizumab (PRV-031) for the prevention or delay of clinical type 1 diabetes in individuals at-risk of developing the disease.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

AbbVie submits U.S. marketing application for new use of Orilissa

AbbVie (NYSE:ABBV) has filed a marketing application with the FDA seeking approval of Orilissa (elagolix) for the management of heavy menstrual bleeding associated with uterine fibroids.
Small molecule elagolix inhibits gonadotropin-releasing hormone (GnRH) signaling by binding to GnRH receptors in the pituitary gland. GnRH plays a key role in ovulation and the menstrual cycle.
The FDA approved Orilissa a year ago for the management of endometriosis-associated pain.
The company in-licensed elagolix from Neurocrine Biosciences (NASDAQ:NBIX) in June 2010.

Amneal Pharma hit on Q2 miss and guidance cut

Amneal Pharmaceuticals (AMRXQ2 results: Revenues: $404.6M (-2.2%).
Net Loss: ($16.9M) (+11.5%); Loss Per Share: ($0.13) (+13.3%); Non-GAAP Net Income: $26.7M (-61.8%); Non-GAAP EPS: $0.09 (-60.9%); CF Ops: ($87.3M) (-21.9%).
2019 Guidance: Adjusted EBITDA: $425M – 475M from $600M – 650M; Non-GAAP EPS: $0.52 – 0.62 from $0.94 – 1.04.
Shares are down 5% premarket.

FDA clears Mustang Bio’s IND for leukemia med

The FDA has approved Mustang Bio’s (NASDAQ:MBIO) IND application to initiate a multi-center Phase 1/2 clinical trial of MB-102 (CD123 CAR T) in acute myeloid leukemia, blastic plasmacytoid dendritic cell neoplasm and high-risk myelodysplastic syndrome.
MB-102 is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors.

FDA panel Wednesday for Gilead’s Descovy for prevention of HIV infection

The FDA’s Antimicrobial Drugs Advisory Committee will meet Wednesday, August 7, to review and discuss Gilead’s (NASDAQ:GILD) marketing application for Descovy (emtricitabine and tenofovir alafenamide) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV infection.
In the FDA’s summary, it stated that trial data from the DISCOVER study demonstrated Descovy’s non-inferiority to Truvada.
Shares are down 1% premarket on light volume.

Allakos up 77% premarket on positive AK002 data

Thinly traded Allakos (NASDAQ:ALLK) is up 77% premarket on increased volume following its announcement of positive data from a Phase 2 clinical trial, ENIGMA, evaluating lead candidate AK002 in patients with eosinophilic gastritis and/or eosinophilic gastroenteritis.
The study met the primary endpoint, demonstrating a 95% reduction in the number of eosinophils (a type of white blood cell associated with inflammation/infection) in gastrointestinal tissue compared to a 10% increase in the control group (p<0.0001). All secondary endpoints were also met.
On the safety front, the most common treatment-related adverse events were mild-to-moderate infusion-related reactions that occurred in 60% of participants versus 24% for placebo.
AK002 is a monoclonal antibody that selectively targets an eosinophil and mast cell surface receptor called Siglec-8. Inhibiting the receptor dampens the activity of both cell types and mediates inflammation. It is also being developed for urticaria, mastocytosis and allergic conjunctivitis.

CVS’s Amazon-like membership goes nationwide

CVS (NYSE:CVS) is expanding its CarePass program nationwide after testing the pilot in Boston, Philadelphia and Tampa.
Consumers pay $5 a month or $48 annually for free delivery on drugstore products and prescription drugs, discounts on CVS-branded items, a monthly $10 coupon and access to a pharmacy hotline.
“Millennials are time-starved, and we want it to be easier to do business with you,” CVS Pharmacy President Kevin Hourican told CNBC.