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Novartis’ Ligelizumab Yields Mixed Results In Chronic Spontaneous Urticaria Trials

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Rupee slips 9 paise to 76.15 against U.S. dollar in early trade

Starting off on a tepid note, the rupee traded in a narrow band of 76.13 to 76.16 in early deals at the interbank foreign exchange.

The rupee dropped 9 paise to trade at 76.15 against the U.S. dollar in opening deals on Monday as sustained sell-offs in domestic equities by foreign investors hurt the local currency’s recovery prospects.

Starting off on a tepid note, the rupee traded in a narrow band of 76.13 to 76.16 in early deals at the interbank foreign exchange.

Like domestic equities, which have been in the bear territory of late, the rupee too has given up to pressures created by a host of factors like surging cases of Omicron variant of COVID-19 and weak global sentiment .

Foreign institutional investors continued to offload shares in the capital market on Friday, as they sold equities worth ₹2,069.90 crore, exchange data showed.

Last week, the local unit recorded its fourth weekly decline amid growing concerns over the Omicron variant of coronavirus.

Experts, however, are of the view that as major events of the year are almost done, Forex markets may stay calm in the coming week.

Meanwhile, the U.S. dollar index, which measures the greenback’s strength against the basket of six currencies, rose 0.05% to 96.61.

Brent crude futures, the global oil benchmark, fell 2.23% to $71.44 per barrel.

On the domestic equity market front, the BSE Sensex was down 1,048.11 points or 1.84% at 55,963.63, while the broader NSE Nifty declined 323.75 points or 1.91 % to 16,661.45.

Investors poorer by over ₹11.23 lakh crore in two days of heavy market selloff

The market capitalisation of BSE-listed companies tumbled ₹11,23,010.78 crore to ₹2,52,79,340.30 crore in two days.

Investors became poorer by ₹11,23,010.78 crore in two days as domestic equity market continued to face severe drubbing amid a global selloff.

The BSE benchmark Sensex plunged 1,182.53 points to a low of 55,829.21 in early trade on Monday. The benchmark had tumbled 889.40 points or 1.54% to close at 57,011.74 on Friday.

The market capitalisation of BSE-listed companies tumbled ₹11,23,010.78 crore to ₹2,52,79,340.30 crore in two days.

Investors’ wealth had on Friday shrunk by over ₹4.65 lakh crore as markets suffered a heavy selloff following weak global trends and continued selling by foreign institutional investors.

"The Indian benchmarks made gap-down opening today amid rising Omicron coronavirus cases worldwide. Traders will be cautious with continuous net outflow of foreign funds as Foreign Portfolio Investors (FPIs) have pulled out Rs 17,696 from the Indian markets in December month so far," Gaurav Garg, Head of Research, Capitalvia Global Research Ltd.

Pre-market Movers: ARNA, FHTX, PTPI, BDR, BLUE…

The following are some of the stocks making big moves in Monday’s pre-market trading (as of 07.10 A.M. ET).

In the Green

Arena Pharmaceuticals, Inc. (ARNA) is up over 97% at $98.63
Foghorn Therapeutics Inc. (FHTX) is up over 35% at $16.27
Petros Pharmaceuticals, Inc. (PTPI) is up over 31% at $3.55
bluebird bio, Inc. (BLUE) is up over 17% at $10.49
American Virtual Cloud Technologies, Inc. (AVCT) is up over 15% at $2.64
Puxin Limited (NEW) is up over 12% at $0.36
East Stone Acquisition Corporation (ESSC) is up over 11% at $15.57
Boxlight Corporation (BOXL) is up over 10% at $1.63
Editas Medicine, Inc. (EDIT) is up over 9% at $31.79
Luokung Technology Corp. (LKCO) is up over 8% at $0.84
Bio-Path Holdings, Inc. (BPTH) is up over 6% at $4.95
E-Home Household Service Holdings Limited (EJH) is up over 6% at $2.00
Eros STX Global Corporation (ESGC) is up over 6% at $0.27

In the Red

Blonder Tongue Laboratories, Inc. (BDR) is down over 24% at $0.66
Avenue Therapeutics, Inc. (ATXI) is down over 15% at $1.11
TherapeuticsMD, Inc. (TXMD) is down over 14% at $0.39
Vasta Platform Limited (VSTA) is down over 7% at $4.25
Energy Focus, Inc. (EFOI) is down over 5% at $3.26

Novartis’ Ligelizumab Yields Mixed Results In Chronic Spontaneous Urticaria Trials

Novartis AG (NVS) on Monday announced mixed topline results from its twin phase III trials evaluating Ligelizumab in chronic spontaneous urticaria, dubbed PEARL 1 and PEARL 2.

Chronic spontaneous urticaria, or CSU, is an unpredictable, systemic skin disease, characterized by the spontaneous and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema or both for at least 6 weeks, and affects up to 1 percent of the population at any one time.

The purpose of the PEARL 1 and PEARL 2 trials is to establish efficacy and safety of Ligelizumab in chronic spontaneous urticaria by demonstrating better efficacy over approved CSU drug *Xolair and over placebo. *Xolair is jointly developed by Novartis and Genentech.

Ligelizumab demonstrated superiority compared with placebo at Week 12 in the PEARL 1 and PEARL 2 trials, but failed to demonstrate superiority over Xolair.

The PEARL 1 and PEARL 2 trials are expected to be completed in the second half of 2022.

Commenting on the trial results, John Tsai, M.D., Head of Global Drug Development and Chief Medical Officer, Novartis, said, “We are disappointed that we have been unable to demonstrate superior efficacy for ligelizumab versus standard of care in the treatment of CSU. We will continue to evaluate the potential for ligelizumab to bring benefit to patients in the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.”

NVS closed Friday’s trading at $85.90, down 0.20 percent.