Bausch Health’s DUOBRII lotion now available in U.S.; shares up 4% premarket

Bausch Health Companies (NYSE:BHC) has launched DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% in U.S. for patients with plaque psoriasis.

The FDA approved DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation.

DUOBRII Lotion is priced at $825 for a a 100-gram tube.

Shares are up 4% premarket

https://seekingalpha.com/news/3473506-bausch-healths-duobrii-lotion-now-available-u-s-shares-4-percent-premarket

Evolus up 8% premarket on AbbVie’s Allergan bid

Evolus (NASDAQ:EOLS) is up 8% premarket, albeit on light volume, on the heels of AbbVie’s $63B bid for BOTOX maker Allergan.

In May, the FDA approved Jeuveau, its product for the treatment of frown lines.

https://seekingalpha.com/news/3473509-evolus-8-percent-premarket-abbvies-allergan-bid

BioPharmX up 60% premarket on positive BPX-04 data

Nano cao BioPharmX (NYSEMKT:BPMX) is up 60% premarket on robust volume in response to positive results from a Phase 2b clinical trial, PRISM, evaluating topical minocycline gel BPX-04 in patients with moderate-to-severe papulopustular rosacea, a skin disorder akin to acne in appearance.

The study met the primary and secondary endpoints, demonstrating a statistically significant improvement in the number of facial inflammatory lesions and a two-grade improvement to clear or almost clear skin from baseline to week 12.

A Phase 3 study is next up.

https://seekingalpha.com/news/3473514-biopharmx-60-percent-premarket-positive-bpxminus-04-data

ANI Pharma launches Ranitidine Capsules

ANI Pharmaceuticals (NASDAQ:ANIP) has launched Ranitidine Capsules, 150mg and 300mg.

The annual U.S. market for this product is ~$40M, according to IQVIA Health.

Ranitidine Hydrochloride is an oral histamine H₂-receptor antagonist with multiple indications.

https://seekingalpha.com/news/3473565-ani-pharma-launches-ranitidine-capsules

Halozyme inks Enhanze deal with NIH unit in HIV

Halozyme (HALO +1.4%) enters into an agreement with the NIH’s National Institute of Allergy and Infectious Diseases’ Vaccine Research Center aimed at leveraging HALO’s ENHANZE drug delivery technology to develop subcutaneous formulations of broadly neutralizing antibodies against HIV.

First up are early-stage studies to assess the safety, tolerability, dose and pharmacokinetics of the two candidates.

Financial terms are not disclosed.

https://seekingalpha.com/news/3473595-halozyme-inks-enhanze-deal-nih-unit-hiv

EMA accepts Pacira’s application for Exparel for postsurgical pain

The European Medicines Agency (EMA) accepts for review Pacira BioSciences’ (NASDAQ:PCRX) marketing application seeking approval for EXPAREL (bupivacaine liposome injectable suspension) for the treatment of postsurgical pain.

The advisory group CHMP should issue an opinion sometime in H2 2020.

https://seekingalpha.com/news/3473521-ema-accepts-paciras-application-exparel-postsurgical-pain

Dova’s Doptelet OK’d in Europe for low blood platelets; shares up 4% premarket

Thinly traded micro cap Dova Pharmaceuticals (NASDAQ:DOVA) is up 4% premarket on light volume on the heels of European Commission approval of DOPTELET (avatrombopag) for severe thrombocytopenia (low blood platelets) in adults with chronic liver disease who are scheduled to undergo an invasive procedure.

The FDA approved it for the indication in May 2018.

https://seekingalpha.com/news/3473539-dovas-doptelet-okd-europe-low-blood-platelets-shares-4-percent-premarket