FDA Approves Merck’s SNDAs For PIFELTRO And DELSTRIGO – Quick Facts

Merck (MRK), known as MSD outside the U.S. and Canada, announced Friday that the U.S. Food and Drug Administration (FDA) approved supplemental New Drug Applications (sNDAs) for PIFELTRO (in combination with other antiretroviral agents) and DELSTRIGO (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection.

These patients are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to PIFELTRO or the individual components of DELSTRIGO.

The FDA’s approval of the sNDAs was based on findings from DRIVE-SHIFT, the Phase 3 randomized, international, multicenter, open-label trial evaluating a switch to DELSTRIGO in virologically suppressed participants (HIV-1 RNA <50 copies/mL) on a baseline regimen for at least six months prior to trial entry with no history of virologic failure.

PIFELTRO (doravirine, 100 mg) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral agents.

DELSTRIGO is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg).

DELSTRIGO and PIFELTRO do not cure HIV-1 infection or AIDS. Both were approved in the U.S. on August 30, 2018 for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment history.

Domino’s To Launch Solar-powered Pizza In Australia

Domino’s Pizza Enterprises Ltd., as part of its renewable energy strategy, plans to launch renewable solar power systems for its stores across Australia. With the move, the company aims to reduce operational impacts on the environment and electricity costs.

The fast-food chain has partnered with Construction, Supply & Service or CSS to launch its strategy through energy demand controllers and renewable solar power systems.

At present, Domino’s’ around 70 stores in the country are equipped with energy demand controllers, which de-energize non-essential electrical equipment during peak power usage. The company said that an additional seven stores are already in the works.

Since implementation at Domino’s Aspley in 2017, the renewable energy solution has helped to record 34 percent reduction in energy usage and 48 percent saving in electricity costs.

Domino’s Ballina, Noarlunga and Kelso are already operating with solar power systems and energy demand controllers. In the past 12 months alone, these stores recorded energy reductions of up to 22 percent and electricity savings of up to 27 percent.

CSS General Manager Earle Strong said, “Solar energy is increasing in popularity for many reasons, by mainly because of its versatility, sustainability and safety benefits.”

Solar power systems are gaining momentum as more and more companies are looking for energy efficient and environmental-friendly solutions for their power needs.

McDermott’s stock rockets after exploring sale of Lummus business, valued at over $2.5 bln

Shares of McDermott International Inc. MDR, -26.85% rocketed 82% in very active premarket trading Friday, after the provider of engineering and construction services to the energy industry said it was exploring the sale of its Lummus Technology business, which has been valued at more than $2.5 billion. Trading volume topped 8.9 million shares, making the stock the most actively traded ahead of the open. The company said it recently received unsolicited approaches to acquire all or part of Lummus, which is a licensor of proprietary petrochemicals, refining, gasification and gas processing technologies. "The process of exploring strategic alternatives is part of our ongoing efforts intended to improve McDermott’s capital structure, and we plan to use the proceeds from any transaction involving Lummus Technology to strengthen our balance sheet," said Chief Executive David Dickson. McDermott said it has retained Evercore as lead advisor on strategic alternatives for McDermott. The stock, which has plummeted 73% this week through Thursday amid concerns the company may be mulling a bankruptcy, has shed 92% over the past 12 months through Thursday, while the SPDR Energy Select Sector ETF XLE, -0.26% has lost 18.5% and the S&P 500 SPX, +0.00% has gained 2.6%.

Gold Futures Modestly Higher On Weak Dollar, Geopolitical Tensions

Gold prices were moving higher Friday morning, riding on a softer dollar and lingering concerns about tensions in the Middle East following last week’s drone attack on Saudi oil facilities.

Traders were also wary of seeking riskier assets while awaiting the developments on trade front. Senior officials from the U.S. and China began discussing trade on Thursday, nearly a couple of months after the previous round talks.

The dollar index, which eased to a low of 98.14, recovered lost ground and was last seen at 98.32, up marginally from previous close.

Gold futures for December were up $5.00, or 0.35%, at $1,511.20 an ounce.

On Thursday, gold futures for December ended down $9.60, or about 0.6%, at $1,506.20, snapping a 3-day winning streak.

Silver futures for December were gaining $0.071, or 0.4%, at $17.955 an ounce, while Copper futures for December were rising $0.0075, or 0.3%, at $2.6160 per pound.

Dave & Buster’s raises quarterly cash dividend to 16 cents a share vs. 15 cents

Dave & Buster’s Entertainment Inc. PLAY, +0.39% said Friday it is board has agreed to raise its quarterly cash dividend to 16 cents a share from 15 cents. The new dividend is payable on Nov. 11 to shareholders of record as of Oct. 11. Shares were not yet active premarket, but have fallen 8% in 2019 to date, while the S&P 500 SPX, +0.00% has gained 20%.