iShares NASDAQ Biotechnology Index Fund (NASDAQ: IBB), Alvarion Ltd. (NASDAQ: ALVR) – The Daily Biotech Pulse: Genfit Spikes On Liver Disease Drug Licensing Deal, Lyell Gets Nod For Solid Tumor Study, Decision-Day For Intra-Cellular, Argenx


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Here is an overview of the main developments in the field of biotechnology over the past 24 hours.

Focus on actions

Merck Announces Positive Data From Advanced Oral COVID-19 Antiviral Therapy Study

Merck & Co., Inc. (NYSE: MRK) and Ridgeback Biotherapeutics announced that the New England Journal of Medicines has published the results of the phase 3 MOVe-OUT trial evaluating molnupiravir, in non-hospitalized high-risk adults with mild to mild COVID-19. moderate, showing early treatment with molnupiravir significantly reduces the risk of hospitalization or death in unvaccinated high-risk adults with COVID-19.

Separately, Merck said that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the approval of Keytruda as monotherapy for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.

Merck shares rose 1.17% to $ 76.80 in pre-market trading.

Lyell Announces FDA Clearance to Launch Phase 1 Investigational Treatment of Solid Tumors

Lyell Immunopharma, Inc. (NASDAQ: LYEL) announced that the U.S. Food and Drug Administration has cleared its investigational new drug application to initiate a Phase 1 clinical trial for LYL797, its first therapeutic candidate incorporating T cell reprogramming technologies for the treatment of solid tumors.

Lyell said he plans to begin screening patients with relapsed / refractory triple-negative breast cancer, who have failed at least two lines of treatment by the end of the first trimester for the phase of. Dose escalation from Phase 1 of the trial and plans to expand the trial to include patients with non-small cell lung cancer when a recommended dose is determined.

The stock rose 4.47% to $ 9.35 in pre-market.

Click here to access Benzinga’s FDA calendar

Allovir’s chief medical officer resigns

AlloVir (NASDAQ: ALVR) announced that Augustin Melian, its chief medical officer, has decided to leave the company at the end of this year. Melian has agreed to work with AlloVir in an advisory capacity to ensure a smooth transition.

Richard Riese, senior vice president of clinical research, will continue to lead the company’s clinical development programs, including overseeing Phase 3 studies for posoleucel, the company said.

Pfizer, BioNTech Files Case to Expand Approval of COVID-19 Vaccine for Adolescents

Pfizer, Inc. (NYSE: PFE) andBioNTech SE (NASDAQ: BNTX) announced that it has submitted an additional biologics license application to the FDA to extend approval of Comirnaty to people aged 12 to 15.

ObsEva Says EMA Committee Recommends Approval For Treatment For Uterine Fibroids

ObsEva SA (NASDAQ: OBSV) announced that the EMA’s CHMP has adopted a favorable opinion recommending the approval of linzagolix, an oral GnRH antagonist for the management of moderate to severe symptoms of uterine fibroids in adult women of childbearing age. procreate.

The shares rose 6.39% to $ 2.33 in pre-market trading.

Genfit Our grants a license to Ispen for a drug against liver diseases and sells a stake in the capital of French biopharma

GENFIT (NASDAQ: GNFT) and Ispen said they have entered into a long-term strategic partnership for a global collaboration between the two companies. The agreement grants Ipsen an exclusive worldwide license to develop, manufacture and market Genfit’s experimental elafibranor treatment for people with primary biliary cholangitis.

The partnership also gives Ipsen access to future clinical programs led by Genfit and combines Genfit’s scientific expertise and proprietary technologies in liver disease with Ipsen’s development and commercialization capabilities.

Ipsen will also buy newly issued shares of Genfit representing 8% after issuance via an investment of 28 million euros ($ 31.73 million).

In addition, Genfit announced the acquisition of the exclusive rights from Genoscience Pharma to develop and commercialize the experimental treatment GNS561 in cholangiocarcinoma in the United States, Canada and Europe, including the United Kingdom and Switzerland.

Genfit shares rose 42.77% to $ 4.74 in pre-market trading.

Aducanumab from Biogen receives negative opinion from EMA committee

Biogen, Inc. (NASDAQ: BIIB) and Eisai Co., Ltd. (PNK: ESALY) announced that EMA’s CHMP has adopted a negative opinion on the marketing authorization application for aducanumab for the treatment of early stages of Alzheimer’s disease, known as cognitive impairment mild due to Alzheimer’s disease and mild dementia of Alzheimer’s disease. This decision is aligned with the committee’s negative trend vote in November 2021. Biogen said it will seek a reconsideration of the opinion by the CHMP.

The shares were down 1.92% to $ 230.99 in pre-market trading.

CASI to buy back $ 10 million in shares

CASI Pharmaceuticals, Inc. (NASDAQ: CASI) announced that its board of directors has approved a share buyback program to repurchase up to $ 10 million of common stock through open market purchases.

The stock was up 3.25% to 79.50 in pre-market.

Navidea Announces Start of Advanced Imaging Agent Study to Predict Response in Rheumatoid Arthritis Patients

Navidea Biopharmaceuticals, Inc. (NYSE: NAVB) announced the launch of the NAV3-33 Phase 3 clinical trial, evaluating tilmanocept Tc99m imaging for the early prediction of response to anti-TNFα therapy in patients with moderate-to-moderate active rheumatoid arthritis. severe.

The stock rose 2.48% to $ 1.24 in pre-market.

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

On the radar

PDUFA dates

The FDA is expected to rule on Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) Caplyta for the Expanded Indication of Bipolar Disorder,

The regulator must also decide on argenx SE (NASDAQ: ARGX) biologic license application for efgartigimod for the treatment of generalized myasthenia gravis.

Earnings

Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN) (before market opens)

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