Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
FDA Committee Votes Against Recommending Approval Of Kidney Disease Drug
Reata Pharmaceuticals, Inc. RETA said the U.S. Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee voted no on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of chronic kidney disease in patients with Alport syndrome and that its benefits outweigh its risks.
"We believe the scientific evidence supports bardoxolone approval in the U.S. for CKD in patients with Alport syndrome, which is one of the most rapidly progressive forms of CKD. We will continue to work with the FDA to answer any questions they may have," said Warren Huff, CEO of Reata. The regulatory application has a PDUFA action date of Feb. 25, 2022.
The stock was slumping 42.98% to $31.03 in premarket trading.
AstraZeneca Receives FDA Authorization For Antibody Cocktail For Prevention Of COVID Infection
AstraZeneca plc. AZN announced the FDA issued an emergency use authorization for its Evusheld, a long-acting antibody cocktail, for the pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.
Orphazyme's Announces Resignation Of Board Member, Chair Of Audit Committee
Orphazyme A/S ORPH said its board member Catherine Moukheibir has stepped down from the position effective Thursday.
Orphazyme has appointed Andrew Mercieca as observer and consultant to the board with the intention that he will be proposed as a member of board at the company's annual general meeting, which is scheduled to be held on April 7, 2022.
Upon election to the board, Mercieca will also take over as chairman of the Audit Committee.
The stock was up 2.99% at $3.1 in premarket trading.
Qiagen To Develop Companion Diagnostic Test For Denovo's Investigational Blood Cancer Drug
Qiagen N.V. QGEN and Denovo Biopharma announced a collaboration to develop a blood-based companion diagnostic test to identify patients expressing Denovo Genomic Marker 1 who are likely to respond to Denovo's investigational cancer drug DB102 for treatment of diffuse large B-cell lymphoma.
Aurinia Announces Positive Long-Term Data For FDA-Approved Lupus Nephritis Drug
Aurinia Pharmaceuticals Inc. AUPH announced positive topline results from the AURORA 2 continuation study evaluating the long-term safety and tolerability of Lupkynis for the treatment of adults with active lupus nephritis, a serious complication in patients with systemic lupus erythematosus.
In combination with background immunosuppressive therapy, Lupkynis is the first and only FDA-approved medicine with three years of pivotal trial results, including long-term safety data, within LN.
The stock was up 7.06% at $22.30 in premarket trading.
Aptinyx Shares Gain Ground On Insider Buying
Aptinyx Inc. APTX disclosed in a filing that its CEO Norbert Riedel bought 100,000 shares in the company.
The stock was adding 4.72% to $2.66 in premarket trading.
Offerings
Relmada Therapeutics, Inc. RLMD announced the pricing of an upsized underwritten public offering of 8.82 million shares of its common stock at a public offering price of $17 per share. The gross proceeds to Relmada from the offering are expected to be approximately $150 million. All of the shares in the offering are being sold by Relmada.
The stock was slipping 6.15% to $17.40 in premarket trading.
Click here to access Benzinga's FDA Calendar.
On The Radar
Clinical Readouts
San Antonio Breast Cancer Symposium Presentations
Ambrx Biopharma Inc. AMAM: Safety and anti-tumor activity of ARX788 in HER2-positive metastatic breast cancer patients whose disease is resistant/refractory to HER2 targeted agents
Oncolytics Biotech Inc. ONCY: data from the Phase 2 study of INCMGA00012 and the oncolytic virus pelareorep in metastatic triple negative breast cancer
ESMO Immuno-Oncology Congress Presentations
Innate Pharma S.A. IPHA: Phase 2 data for monalizumab, cetuximab and durvalumab in first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck
BeiGene, Ltd. BGNE: Safety/tolerability and antitumor activity of sitravatinib plus tislelizumab in patients with PD-(L)1-refractory/ resistant unresectable or metastatic melanoma from a Phase 1b study
IMV Inc. IMV: Phase 2 for maveropepimut-S in advanced ovarian cancer patients
Atara Biotherapeutics, Inc. ATRA: Transitional data from the lowest dose cohorts of Phase 1 clinical study of ATA2271, an autologous CAR-T therapy targeting mesothelin, designed to improve efficacy, persistence and durability of response for patients with advanced mesothelioma
SQZ Biotechnologies Company SQZ: interim results from the highest-dose monotherapy cohort of its Phase 1/2 clinical trial of SQZ-PBMC-HPV, an investigational cell therapy being evaluated in certain patients with advanced or metastatic human papillomavirus positive solid tumors.
Earnings
Applied DNA Sciences, Inc. APDN (after the close)
IPOs
NeuroSense Therapeutics Ltd., NRSN, a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases, such as ALS, Alzheimer's and Parkinson's disease, priced its initial public offering of 2 million units, each consisting of one ordinary share and a warrant representing the right to purchase one ordinary share with an exercise price of $6 per share, at an initial public offering price of $6 per unit, for gross proceeds of $12 million.
NeuroSense's ordinary shares and warrants have been approved for listing on the Nasdaq and will begin trading under the ticker symbols "NRSN" and "NRSNW," respectively.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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