Heat Bio making headway in COVID-19 vaccine

Heat Biologics (NASDAQ:HTBX) announces further progress on its COVID-19 vaccine program.

The company has achieved stable co-expression of gp96/nCoV-S protein, as measured by both immunofluorescence and ELISA, in its clinically validated human cell line, enabling selection of the COVID-19 vaccine. These steps are necessary precursors to completion of company’s vaccine in preparation for its manufacture and use in clinical trials.

Heat Bio is on track to complete design and development of the COVID-19 vaccine in July, and expects its gp96/nCoV-2 expressing cell line to be available for clinical-grade manufacturing with partner, Waisman Biomanufacturing, in early August.

https://seekingalpha.com/news/3580407-heat-bio-making-headway-in-covidminus-19-vaccine

AbbVie’s upadacitinib shows durable benefit in rheumatoid arthritis studies

AbbVie (NYSE:ABBV) announces positive long-term results from two Phase 3 clinical trials, SELECT-COMPARE and SELECT-MONOTHERAPY, evaluating Rinvoq (upadacitinib) in rheumatoid arthritis (RA) patients. The data were presented at EULAR.

Patients in the first study who received daily doses of 15 mg of upadacitinib with methotrexate continued to experience improved signs and symptoms of RA at week 72.

Patients in the second trial who received 15 mg of upadacitinib alone each day maintained their improved responses at week 84.

96-week data from another late-stage study, SELECT-EARLY, showed that upadacitinib was effective in inhibiting structural joint damage as monotherapy or in combination with methotrexate.

No new safety signals were observed.

The FDA approved the JAK inhibitor for RA in August 2019. It was approved in Europe in December 2019.

https://seekingalpha.com/news/3580421-abbvies-upadacitinib-shows-durable-benefit-in-ra-studies

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