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

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

Stocks In Focus

Merck Announces Publication Of Positive Data From Late-Stage Study Of Oral COVID-19 Antiviral Treatment

Merck & Co., Inc. MRK and Ridgeback Biotherapeutics announced the New England Journal of Medicines has published findings from the Phase 3 MOVe-OUT trial evaluating molnupiravir, in non-hospitalized high risk adults with mild to moderate COVID-19, showing early treatment with molnupiravir significantly reduced the risk of hospitalization or death in high risk, unvaccinated adults with COVID-19.

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

Merck shares were rising 1.17% to $76.80 in premarket trading.

Lyell Announces FDA Clearance For Initiating Phase 1 Study Of Solid Tumor Investigational Therapy

Lyell Immunopharma, Inc. LYEL announced 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 it expects to begin screening patients with relapsed/refractory triple-negative breast cancer, who have failed at least two lines of therapy by the end of the first quarter for the Phase 1 dose escalation phase 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 was up 4.47% at $9.35 in premarket trading.

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Allovir's Chief Medical Officer To Step Down

AlloVir 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, Clinical Research, will continue to lead the company's clinical development programs, including oversight of the Phase 3 studies for posoleucel, the company said.

Pfizer, BioNTech File For Expanding Approval Of COVID-19 Vaccine For Adolescents

Pfizer, Inc. PFE andBioNTech SE BNTX announced they have submitted a supplemental biologics license application to the FDA for expanding the approval of Comirnaty to include individuals ages 12 through 15 years.

ObsEva Says EMA Committee Recommends Approval Of Uterine Fibroid Treatment

ObsEva SA OBSV announced EMA's CHMP adopted a positive opinion recommending approval of linzagolix, an oral GnRH antagonist for the management of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

The shares were up 6.39% to $2.33 in premarket trading.

Genfit Our-licenses Liver Disease Drug To Ispen, Sells Equity Stake to The French Biopharma

GENFIT GNFT and Ispen said they have entered into a long-term strategic partnership for a global collaboration between the two companies. The agreement gives Ipsen exclusive worldwide license to develop, manufacture and commercialize Genfit's investigational treatment elafibranor, for people living 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 purchase newly issued Genfit equity representing 8% post-issuance through a 28-million-euro ($31.73 million) investment.

Separately, Genfit announced the acquisition of exclusive rights from Genoscience Pharma to develop and commercialize the investigational treatment GNS561 in cholangiocarcinoma in the U.S. Canada and Europe, including the U.K. and Switzerland.

Genfit shares were rising 42.77% to $4.74 in premarket trading.

Biogen's Aducanumab Receives Negative Opinion From EMA Committee

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

The shares were down 1.92% to $230.99 in premarket trading.

CASI To Buy Back $10M Worth Of Shares

CASI Pharmaceuticals, Inc. CASI announced that its board of directors approved a stock repurchase program for the repurchase of up to $10 million of the common stock through open market purchases.

The stock was up 3.25% to 79.50 in premarket trading.

Navidea Announces Commencement Of Late-Stage Study Of Imaging Agent to Predict Response In Rheumatoid Arthritis Patients

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

The stock was up 2.48% to $1.24 in premarket trading.

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.'s ITCI Caplyta for the expanded indication of bipolar disorder,

The regulator is also due to give its verdict on argenx SE's ARGX biologic license application for efgartigimod for the treatment of generalized myasthenia gravis.

Earnings

Sonnet BioTherapeutics Holdings, Inc. SONN (before the market open)