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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.

https://seekingalpha.com/news/3538492-fda-signs-off-on-bioxcel-ind-for-study-of-bxcl501-for-opioid-withdrawal

Aimmune up 10% premarket on increased Nestlé stake

Aimmune Therapeutics (NASDAQ:AIMT) perks up 10% premarket on average volume in reaction to its announcement that Nestlé Health Science will invest an additional $200M in the company, raising its stake to $473M (25.6% stake).

Nestlé’s investment includes 1M common shares at $31.97 and 525,634 shares of convertible stock (one for ten based on certain conditions) at $319.675.

Closing date is February 7.

Separately, AIMT has in-licensed global rights to Xencor’s (NASDAQ:XNCR) humanized monoclonal antibody, XmAb7195, for the potential treatment of food allergies (renamed AIMab7195).

Under the terms of the agreement, it will pay XNCR $5M upfront, up to $385M in milestones and high single-digit-to-mid-teen royalties on net sales. It will also invest $5M in XNCR stock.

https://seekingalpha.com/news/3538510-aimmune-up-10-premarket-on-increased-nestl-stake

AbbVie’s Rinvoq successful in second late-stage psoriatic arthritis study

AbbVie (NYSE:ABBV) announces positive results from a Phase 3 clinical trial, SELECT-PsA 1, evaluating RINVOQ (upadacitinib) in adults with psoriatic arthritis (PA) who failed to respond adequately to or were intolerant of DMARD (disease modifying anti-rheumatic drug) therapy.

The study met the primary endpoint demonstrating a statistically significant proportion of treated patients achieving ACR20 (20% improvement in PA) at week 12 versus placebo. Specifically, 71% and 79% of participants receiving 15 mg and 30 mg, respectively, of RINVOQ achieved ACR20 compared to 36% in the control arm (p<0.0001).

Both doses of RINVOQ demonstrated non-inferiority to Humira (adalimumab) as measured by ACR20 at week 12 while the 30 mg dose also showed superiority.

No new safety signals were observed.

A sister Phase 3, SELECT-PsA 2, was also successful.

Results will be submitted for presentation at a future medical conference and publication.

The FDA approved the JAK inhibitor in August 2019 for rheumatoid arthritis.

Shares up 1% premarket on light volume.

https://seekingalpha.com/news/3538534-abbvies-rinvoq-successful-in-second-late-stage-psoriatic-arthritis-study

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.

https://seekingalpha.com/news/3538453-glaxo-to-spin-out-consumer-business

Merck slips 1% on Q4 results, spinout planned

Merck (MRK) Q4 results: Revenues: $11,868M (+7.9%).

Net Income: $2,357M (+29.0%); EPS: $0.92 (+33.3%); non-GAAP Net Income: $2,978M (+8.5%); non-GAAP EPS: $1.16 (+11.5%).

Key Product Sales: Keytruda: $3,111M (+45%); Januvia / Janumet: $1,418M (-3%); Gardasil / Gardasil 9: $693M (-17%); Proquad, M-M-R II and Varivax: $481M (+6%); Bridion: $313M (+22%); Isentress / Isentress HD: $223M (-20%); Rotateq: $227M (+21%); Pneumovax 23: $334M (+4%); Simponi: $205M (-7%); Implanon/Nexplanon: $206M (+22%).

2020 Guidance: Revenues: $48.8B – 50.3B vs. $48.65B S&P Capital IQ Consensus; GAAP EPS: $4.57 – 4.72; Non-GAAP EPS: $5.62 – 5.77 vs. $5.54 S&P Capital IQ Consensus.

The company intends to focus on key growth pillars through the spinoff of women’s health, trusted legacy brands and biosimilar products into a new company.

Shares are down 1% premarket.

https://seekingalpha.com/news/3538463-merck-slips-1-on-q4-results-spinout-planned