IBio launches second COVID-19 vaccine program

IBio (NYSEMKT:IBIO) initiates its second COVID-19 vaccine program, IBIO-201, which combines antigens derived from the SARS-CoV-2 spike protein fused with the company’s patented lichease booster molecule (adjuvant).

It launched its first program, IBIO-200, a SARS-CoV-2 Virus-Like Particle vaccine candidate, several months ago.

https://seekingalpha.com/news/3580431-ibio-launches-second-covidminus-19-vaccine-program

Heron’s HTX-011 shows benefit in mid-stage knee replacement study

Heron Therapeutics (HRTX -0.1%) announces the publication of results, online in the Journal of Arthroplasty, from a Phase 2b clinical trial, Study 209, evaluating HTX-011 for postoperative pain relief in patients who have undergone total knee arthroplasty (knee replacement).

HTX-011 showed superior pain reduction compared to placebo or bupivacaine solution through hours 48 – 72 after surgery. Also, more patients treated with HTX-011 were ready for discharge at hours 8, 12 and 24.

HTX-011 is a long-acting, extended-release formulation of the local anesthetic bupivacaine combined with the anti-inflammatory agent meloxicam.

The FDA’s action date for its review of the company’s refiled marketing application is June 26. It received a CRL in April 2019 in response to its original filing citing the need for additional non-clinical information. Its applications in Europe and Canada are under review.

https://seekingalpha.com/news/3580451-herons-htxminus-011-shows-benefit-in-mid-stage-knee-replacement-study

Big pop for XpresSpa

XpreSpa Group (NASDAQ:XSPA) is up 63.89% in early trading to $1.77. Shares traded as high as $2.03 earlier in the session.

The gains for the airport spa chain coincide with airlines starting to increase their flight scheduled dramatically.

Previously: Airlines rally on more positive updates (June 4)

https://seekingalpha.com/news/3580482-big-pop-for-xpresspa

Subcutaneous formulation of J&J’s Darzalex OK’d in Europe

As expected, the European Commission approves a subcutaneous fixed-dose formulation of Johnson & Johnson’s (JNJ -1.1%) Darzalex (daratumumab) for the treatment of multiple myeloma.

In April, the advisory group CHMP adopted a positive opinion backing approval.

Related tickers: Genmab A/S (GMAB -2.1%), Halozyme Therapeutics (HALO -0.7%)

https://seekingalpha.com/news/3580469-subcutaneous-formulation-of-j-and-js-darzalex-okd-in-europe

Esperion’s Nexlizet tablets for LDL-cholesterol lowering now available in U.S.

Esperion (ESPR +2.8%) announces that NEXLIZET (bempedoic acid and ezetimibe) tablets, the first approved oral, non-statin LDL-Cholesterol (LDL-C) lowering combination medicine is now available in U.S. pharmacies.

Additionally, NEXLIZET is introduced with broad payer coverage for both eligible insured patients and those with Medicare Part D at an affordable price and co-pay.

NEXLIZET is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

https://seekingalpha.com/news/3580472-esperions-nexlizet-tablets-for-ldl-cholesterol-lowering-now-available-in-u-s

Jounce regains rights to cancer candidate from Bristol Myers Squibb

Aimed at streamlining its post-Celgene-merger pipeline, Bristol Myers Squibb (BMY +1.0%) has terminated the license agreement and returned global rights to JTX-8064 to Jounce Therapeutics (JNCE +3.0%).

Jounce and Celgene inked their deal in July 2019 under which the former received a nonrefundable upfront payment of $50M.

JTX-8064 is a monoclonal antibody that binds to a protein called LILRB2 receptor. LILRB2 plays a key role in regulating myeloid cell maturation. Blocking its action may boost the antitumor effects of T cell immune checkpoint inhibitors.

https://seekingalpha.com/news/3580481-jounce-regains-rights-to-cancer-candidate-from-bristol-myers-squibb

Kezar Life Sciences Shares Climb

Kezar Life Sciences, Inc. KZR 73.38% shares shot up 98% to $8.86 after the company announced updated results from the Phase 1b portion of the Phase 1b/2 MISSION study, which is evaluating the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus with and without nephritis, showing overall improvements across seven measures of disease activity.
https://www.benzinga.com/news/earnings/20/06/16181816/mid-day-market-update-smartsheet-drops-on-weak-guidance-kezar-life-sciences-shares-climb