Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
CytomX Mid-Phase Study Of ADC In Lung And Head & Neck Cancer Patients Show Lackluster Efficacy
CytomX Therapeutics, Inc. CTMX announced preliminary Phase 2 results in patients with either advanced squamous non-small cell lung cancer or head and neck squamous cell carcinoma who were treated with CX-2029, an antibody-drug conjugate being co-developed by CytomX and AbbVie, Inc. ABBV.
In the 16 efficacy evaluable patients with sqNSCLC, objective response rate by local investigator was 18.8%, including two confirmed partial responses and one unconfirmed PR. This is below the company's stated target of 20%. In the 25 efficacy evaluable patients with HNSCC, there was one confirmed PR and a DCR of 56%, including one unconfirmed PR.
In premarket trading, the stock was declining 22.17% to $5.02.
DBV Plans to Initiate New Phase 3 Study Of Peanut Allergy Patch, Withdraws EMA Filing
DBV Technologies S.A. DBVT announced plans to initiate a new, pivotal Phase 3 clinical study for a modified Viaskin Peanut patch in children in the intended patient population.
The company also said it has formally notified the European Medicines Agency of its decision to withdraw the Marketing Authorization Application for Viaskin Peanut. The application for Viaskin Peanut was accepted by the EMA in November 2020.
The stock was slipping 19.63% to $2.17 in premarket trading.
ACADIA To Resubmit Regulatory Application For Dementia Drug In Q1
Acadia Pharmaceuticals Inc. ACAD said it plans to resubmit its supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with dementia focused on Alzheimer's disease psychosis. Resubmission of the sNDA is planned for the first quarter of 2022.
The FDA has issued a complete response letter to the application in April.
In premarket trading, the stock was advancing 1.14% to $27.40.
Aldeyra's Dry Eye Disease Drug Flunks Late-Stage Study
Aldeyra Therapeutics, Inc. ALDX said the Phase 3 TRANQUILITY study of 0.25% reproxalap ophthalmic solution, an investigational product candidate for the treatment of dry eye disease, did not meet the primary endpoint of ocular redness. The study, however, met statistical significance for the dry eye disease sign of Schirmer test, a secondary endpoint.
The stock was sliding 38.29% to $4.40 in premarket trading.
Aquestive's Seizure Drug Review To Be Delayed Beyond Dec. 23 PDUFA Date
Aquestive Therapeutics, Inc. AQST announced that the FDA communicated its inability to complete the review of the NDA for Libervant buccal film for the treatment of breakthrough seizures and seizure clusters by the PDUFA date of Dec. 23.
The agency said no additional information from the company is needed at this point in time.
The stock was down 32.8% at $4.18 in premarket trading.
Related Link: The Week Ahead In Biotech (Dec. 19-25): Amgen And Aquestive Regulatory Decisions Key Events Of Holiday-Shortened Week
Aridis Says Antibody Cocktail Effective Against Coronaviruses, Including Omicron Variant
Aridis Pharmaceuticals, Inc. ARDS announced that its fully human monoclonal antibody cocktail AR-701 is broadly reactive against the omicron and other COVID-19 variants, SARS, MERS and seasonal human coronaviruses.
The stock was skyrocketing 94.88% at $4.95 in premarket trading.
Sanofi Inks To Deal To Buy Cancer Biopharma Amunix For Up To $1.23B
Sanofi SNY announced an agreement to acquire Amunix Pharmaceuticals, Inc., an immuno-oncology company, for an upfront payment of approximately $1 billion and up to $225 million upon achievement of certain future development milestones.
Sanofi shares were adding 0.61% to $49.27 in premarket trading.
J&J Unit Gets FDA Nod For 2 Label Expansions For Its Anticoagulant Xarelto
Johnson & Johnson's JNJ Janssen unit said the FDA approved two pediatric indications for Xarelto for the treatment of venous thromboembolism and reduction in the risk of recurrent VTE in patients from birth to less than 18 years after at least five days of initial parenteral anticoagulant treatment, and thromboprophylaxis in children aged two years and older with congenital heart disease who have undergone the Fontan procedure.
ViiV's Long-Acting Pre-Exposure Prophylaxis HIV Treatment Receives FDA Nod
ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK, with Pfizer, Inc. PFE and Shionogi & Co., Ltd. SGIOY as shareholders, announced the FDA approved Apretude, the first and only long-acting injectable pre-exposure prophylaxis option to reduce the risk of sexually acquired HIV-1.
Pfizer Announces Publication Of Positive Results From Late-Stage Study of Heart Failure Drug
Pfizer announced publication of a post-hoc, interim analysis showing that treatment with Vyndaqel/Vyndamax provided a clinically significant survival benefit at five years for patients with transthyretin amyloid cardiomyopathy.
This analysis from the Phase 3 study and its long-term extension study was published in Circulation: Heart Failure.
Alnylam Commences Phase 2 Study Of Lumasiran In Patients With Kidney Stone Disease
Alnylam Pharmaceuticals, Inc. ALNY announced that it has initiated a global Phase 2 study to evaluate the safety and efficacy of lumasiran in patients with recurrent kidney stone disease and elevated urinary oxalate levels.
ANI Gets The Nod For The Generic Version Of Antibiotic Mycobutin
ANI Pharmaceuticals, Inc. ANIP announced that it received FDA approval for the abbreviated NDA for Rifabutin Capsules USP, 150 mg.
ANI's Rifabutin Capsules are the generic version of the reference listed drug Mycobutin.
The stock was climbing 6.41% to $49.99 in premarket trading.
Click here to access Benzinga's FDA Calendar.
Stocks Moving On Insider Transactions
Spruce Biosciences, Inc. SPRB disclosed in SEC filings that chief financial officer Samir Garib, chief medical officer Subaweerage Dias and executive chairman of the board Michael Grey bought shares in the company.
Galera Therapeutics, Inc. GRTX shares gained ground after filings with the SEC showed that Linda West, a director of the company's board, and Robert Beardsley, chief operating officer, exercised an option to purchase shares in the company
The stock was rising 6.6% to $4.04 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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