FDA signs off on BioXcel IND for study of BXCL501 for opioid withdrawal
Thinly traded micro cap BioXcel Therapeutics (NASDAQ:BTAI) perks up 4% premarket on light volume on the heels of the FDA’s sign-off on a Phase 1b/2 clinical trial, RELEASE, evaluating BXCL501, a sublingual thin film formulation of the sedative dexmedetomidine, for the treatment of opioid withdrawal symptoms.
The candidate is also being developed to treat agitation in schizophrenia and bipolar disorder patients and agitation related to dementia.
Glaxo to spin out consumer business
GlaxoSmithKline (NYSE:GSK) announces that it will separate its consumer healthcare business into a standalone company (with Pfizer).
It says the split, to occur over a two-year timeframe, should deliver £0.7 billion of annual savings by 2022 with improved operating performance.
One-time costs to prepare for the separation should be £600M-700M.
Shares down 3% premarket after its Q4 miss.
Moleculin Bio up 41% premarket on potential accelerated approval of Annamycin
Thinly traded nano cap Moleculin Biotech (NASDAQ:MBRX) jumps 41% premarket on robust volume in reaction to its plan to discuss accelerated approval of Liposomal Annamycin with the FDA and EMA for the treatment of relapsed/refractory acute myeloid leukemia, an Orphan Drug- and Fast Track-tagged indication in the U.S.
It hopes to get sign-off on a single Phase 2 study to support the applications.
USANA Health Sciences OKs $130M share buyback plan
USANA Health Sciences (NYSE:USNA) jumps 20% premarket on light volume in reaction to its $130M share repurchase plan, inclusive of the $30M remaining under the prior authorization.
Merck to sharpen focus on key growth drivers via spinout of non-core units
Aimed at driving strong growth in its key areas of oncology, vaccines, hospital and animal health, Merck (NYSE:MRK) will spin off its women’s health, legacy brands and biosimilars businesses into an as-yet-unnamed publicly traded company.
The company says the move will reduce its human health manufacturing footprint by ~25% and the number of manufactured and marketed products by ~50%. It expects to achieve operating efficiencies greater than $1.5B by 2024 with non-GAAP operating margins of more than 40%.
It plans to use the $8B – 9B special tax-free dividend from the spinout for business development or share buybacks.
75% of the new company’s sales will be generated ex-U.S. Sales growth should be low-single-digits from its base in 2021. Non-GAAP operating margins should be in the mid-30s in the first year post-separation and increase thereafter. It will have $8.5B – 9.5B in initial debt. Cash flow from operations should be sufficiently robust to fund business development, debt repayment and a meaningful dividend (incremental to Merck’s).
Merck will retain its 2020 dividend of $2.44 per share with future increases aimed at an eventual payout ratio of 47 – 50%.
