The Daily Biotech Pulse: Novartis Snags Twin FDA Nods, Novavax Positive Vaccine News Continues, Arcutis Psoriasis Application Accepted For Review

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Novartis Receives FDA Nods For Arthritis Treatment And Cholesterol Drug

Novartis AG NVS announced the U.S. Food and Drug Administration has approved Cosentyx for the treatment of active enthesitis-related arthritis in patients four years and older, and active psoriatic arthritis in patients two years and older.

Cosentyx is now the first biologic indicated for ERA and the only biologic treatment approved for both ERA and PsA in pediatric patients in the U.S., the company said.

Separately, the company announced FDA approval of Leqvio, the first and only small interfering RNA therapy to lower low-density lipoprotein cholesterol, with two doses a year, after an initial dose and one at three months.

Leqvio has been licensed from Alnylam Pharmaceuticals, Inc. ALNY by the Medicines Company, which has since then been acquired by Novartis.

Novartis shares were up 0.54% at $86.78 in premarket trading.

Click here to access Benzinga's FDA Calendar

Novavax's COVID-19 Vaccine Found Effective Against Omicron

Novavax, Inc. NVAX announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the omicron variant as well as additional data from its ongoing Phase 2 boost study.

Additionally, new results demonstrated broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.

The company also announced data from the pediatric expansion of its PREVENT-19 Phase 3 trial in the U.S. and Mexico showing robust immune responses in adolescents, including increased IgG and receptor inhibition titers against a wide array of variants, including Omicron, following a 2-dose series.

Responses in adolescents were 2- to 4-fold higher than adults against all evaluated variants.

The stock was up 5.29% at $193 in premarket trading.

Adagene Receives $3M Milestone Payment From Exelixis For Antibody-Drug Conjugate Collaboration

Adagene, Inc. ADAG announced it will receive a $3 million milestone payment from Exelixis, Inc. EXEL for successful nomination of lead SAFEbody candidates for one of its collaboration programs.

The two companies are collaborating for the development of novel masked antibody-drug conjugate candidates leveraging Adagene's proprietary SAFEbody precision masking technology.

Gilead Announces Publication Of Positive Data From Late-Stage Study of Veklury In Non-Hospitalized COVID Patients

Gilead Sciences, Inc. GILD announced publication in the New England Journal Of Medicine, full results from a Phase 3 investigational study evaluating the efficacy and safety of a three-day course of Veklury for intravenous use for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression. The results have also been submitted to the FDA for the potential use of Veklury in earlier stages of disease, including prior to hospitalization.

Arcutis' Psoriasis Drug Application Accepted For Regulatory Review In U.S.

Arcutis Biotherapeutics, Inc. ARQT announced FDA acceptance for review of its new drug application for roflumilast cream for the treatment of psoriasis in adults and adolescents. The FDA assigned the application a PDUFA target action date of July 29, 2022.

The stock was moving up 1.94% to $18.90 in premarket trading.

Verastem Slips On Insider Selling

Verastem, Inc. VSTM shares were pulling back after the company disclosed in multiple filings that insiders, including its CEO, CFO and COO, sold shares in the company.

It was revealed in the filing that the disposals were done to satisfy statutory withholding requirements in connection with the vesting of restricted stock units.

The stock was down 4.38% at $2.18 in premarket trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates


Roivant Sciences Ltd. (ROIV) has filed a prospectus with the SEC regarding sale of 17.41 million shares in the company by selling shareholders from time to time.

The stock was slipping 2.11% to $11.60 in premarket trading.

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