The Daily Biotech Pulse: Legend Biotech, CTI Biopharma Receive FDA Approvals, AbbVie Announces Delay In Skyrizi Review, Editas Gains On CRISPR Patent Resolution

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

Stocks In Focus

Editas Gains On Resolution Of CRISPR Gene Editing Patent Case

Editas Medicine, Inc. EDIT said the U.S. Patent and Trademark Office issued another favorable decision to the Broad Institute of MIT and Harvard involving specific patents for CRISPR/Cas9 editing in human cells. Pending an appeal to the Federal Circuit, this decision ends the U.S. patent interference between the University of California, the University of Vienna and Emmanuelle Charpentier and Broad.

The stock was advancing 9.4% to $18.73 in premarket trading.

Intellia Announces Positive Interim Phase 1 Data For Genomic Editing Therapy In Transthyretin Amyloidosis

Intellia Therapeutics, Inc. NTLA and Regeneron Pharmaceuticals, Inc. REGN announced positive interim data from the Phase 1 clinical study of their lead in vivo genome editing candidate, NTLA-2001, which is being developed as a single-dose treatment for transthyretin amyloidosis.

The interim data include 15 hereditary ATTR amyloidosis with polyneuropathy patients treated across four single-ascending dose cohorts. Treatment with NTLA-2001 led to dose-dependent reductions in serum TTR and achieved maximal reductions by day 28, with mean reductions of 52%, 87% and 86% among the three patients each in the 0.1 mg/kg, 0.3 mg/kg and 0.7 mg/kg dose groups, respectively, and 93% among the six patients in the 1.0 mg/kg dose group, the company said.

Intellia shares were moving down 8.32% to $90.63 in premarket trading.

Legend Biotech's CAR T-Cell Therapy Approved For Blood Cancer

Legend Biotech Corporation LEGN announced that the U.S. Food and Drug Administration has approved its first product, Carvykti (ciltacabtagene autoleucel; cilta-cel), for the treatment of adults with relapsed or refractory multiple myeloma, who have received four or more prior lines of therapy. Legend Biotech has an exclusive worldwide license and collaboration agreement with Johnson & Johnson's JNJ Janssen unit to develop and commercialize cilta-cel in December 2017.

Legend Biotech was seen trading 7.48% higher at $42.55 in premarket trading.

Related Link: The Week Ahead In Biotech (Feb. 27-March 5): Earnings, Multiple Regulatory Decisions Take The Spotlight

AbbVie Announces 3-Month Delay In Review Period For Skyrizi Label Expansion To Include Crohn's Disease

AbbVie, Inc. ABBV said the FDA has extended its review period for Skyrizi for the treatment of moderate to severe Crohn's disease in patients 16 years and older. Decision on the treatment will be now delayed by three months, as the FDA sought time to review additional data submitted by AbbVie, including information about the on-body injector, for this new proposed indication.

Skyrizi has already been approved in plaque psoriasis and psoriatic arthritis.

AbbVie shares were down 0.86% at $146.50 in premarket trading.

CTI Biopharma Announces FDA Approval For Bone Marrow Cancer Treatment In Patients With Lower Platelet Count

CTI Biopharma Corp. CTIC announced FDA approval for Vonjo (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary myelofibrosis with a platelet count below 50 × 109/L. The recommended dosage of Vonjo is 200 mg orally twice daily. It is the first approved therapy that specifically addresses the needs of patients with cytopenic myelofibrosis.

The stock was gaining 10.53% to $2.1 in premarket trading.

Valneva's COVID-19 Vaccine Approved In Bahrain

Valneva SE VALN announced that the National Health Regulatory Authority of the Kingdom of Bahrain has granted emergency use authorization for its inactivated, adjuvanted COVID-19 vaccine, VLA2001. This authorization follows a rolling review process with the Bahraini NHRA.

Last week, the company said it expects recommendation for conditional approval in Europe by the end of March.

The stock was advancing 4.52% to $34.20 in premarket trading.

Earnings

Atea Pharmaceuticals, Inc. AVID reported a jump in fourth-quarter collaboration revenues from $48.63 million in 2020 to $192.18 million in 2021. The earnings per share surged up from 25 cents to $1.34 and exceeded the consensus estimate of 17 cents per share.

The stock was advancing 11.99% to $7.10 in premarket trading.

Heron Therapeutics, Inc. HRTX said its fourth-quarter revenues remained largely unchanged at $20.66 million. The net loss per share narrowed from 68 cents to 54 cents.

The stock was retreating 14.65% to $6.06 in premarket trading.

Click here to access Benzinga's FDA Calendar.

On The Radar

Earnings

• Amarin Corporation plc AMRN (before the market open)
• Amyris, Inc. AMRS (before the market open)
• Epizyme, Inc. EPZM (before the market open)
• Horizon Therapeutics Public Limited Company HZNP (before the market open)
• Intra-Cellular Therapies, Inc. ITCI (before the market open)
• ChemoCentryx, Inc. CCXI (after the market close)
• Inovio Pharmaceuticals, Inc. INO (after the market close)
• Jazz Pharmaceuticals plc JAZZ (after the market close)
• REGENXBIO Inc. RGNX (after the market close)
• Sarepta Therapeutics, Inc. SRPT (after the market close)

Related Link: Moderna Rallies After Q4 Earnings: What 2 Analysts Have To Say About COVID-19 Stock