Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Pfizer, BioNTech File For Authorization Of Second Booster Dose Of COVID-19 Vaccine
Pfizer, Inc. PFE and BioNTech SE BNTX said they have submitted an application to the U.S. Food and Drug Administration for the emergency use authorization of an additional booster dose for adults, 65 years of age and older, who have received an initial booster of any of the authorized or approved COVID-19 vaccines.
Earlier this month, a CDC study found that the duo's COVID-19 vaccine becomes less effective after four months following vaccination.
Pfizer shares were up 0.73% at $52.59 in premarket trading and BioNTech shares were advancing 3.58% to $150.23.
Iovance Gets FDA Approval to Commence Study Of TIL Therapy to Treat Lung Cancer
Iovance Biotherapeutics, Inc. IOVA said the FDA has allowed an investigational new drug application to proceed with its first genetically modified tumor-infiltrating lymphocyte (TIL) therapy, IOV-4001, for the treatment of unresectable or metastatic melanoma and stage 3 or 4 non-small cell lung cancer.
The company expects to start clinical study in 2022 to investigate the safety and efficacy of IOV-4001 to deliver TIL and PD-1 inhibition within a single cancer therapy.
The stock was adding 8.71% to $13.60 in premarket trading.
Click here to access Benzinga's FDA Calendar
Apellis Announces Positive Phase 3 Long-term Data For Retinal Disorder Therapy
Apellis Pharmaceuticals, Inc. APLS announced longer-term data from two Phase 3 studies, which showed that intravitreal pegcetacoplan continued to reduce geographic atrophy lesion growth and demonstrate a favorable safety profile at month 18 for the treatment of GA secondary to age-related macular degeneration.
The company said it plans to include the data in the new drug application it plans to submit to the FDA in the second quarter of 2022.
The stock was advancing 4.99% to $42.05 in premarket trading.
Adagene Receives FDA Clearance to Start Combo Therapy Study In Solid Tumors
Adagene, Inc. ADAG said it has received FDA clearance to proceed with a Phase 1b/2 clinical trial of its monoclonal antibody ADG126, in combination with Merck & Co, Inc.'s MRK Keytruda. The study will evaluate patients with advanced/metastatic solid tumors at multiple sites in the U.S. and Asia Pacific, it added.
In premarket trading, the stock was up 4.33% at $5.06.
Sanofi-Seagen Announce Antibody-Drug Conjugate Collaboration Targeting Cancer
Sanofi SNY and Seagen, Inc. SGEN announced an exclusive collaboration agreement to develop antibody-drug conjugates (ADCs) for up to three cancer targets.
The collaboration will utilize Sanofi's proprietary monoclonal antibody technology and Seagen's proprietary ADC technology. Under the terms of the collaboration, both companies will co-fund global development activities and share equally in any future profits. In addition, Sanofi will make an undisclosed payment to Seagen for each of the three targets as they are selected. The first target under the collaboration has already been designated.
Immunic Promotes Glenn Whaley As CFO
Immunic, Inc. IMUX announced that Glenn Whaley, who has served as Vice President Finance, Principal Financial and Accounting Officer since April 2020, has been promoted to the position of chief financial officer.
Earnings
TRACON Pharmaceuticals, Inc.'s TCON fourth-quarter loss widened from $4.31 million in 2020 to $7.71 million in 2021. Cash, cash equivalents and short-term investments were at $24.1 million as of Dec. 31, 2021.
The stock was tumbling 14.44% to $2.31 in premarket trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates
On The Radar
Clinical Readouts/Presentations
Palisade Bio, Inc. PALI will present at the Society of Gynecologic Oncology Annual Meeting on Women's Cancer, new Phase 2 clinical date related to LB1148 for reduction in adhesions following abdominal and pelvic surgery.
BrainStorm Cell Therapeutics Inc. BCLI is due to present at the Muscular Dystrophy Association Clinical & Scientific Conference Phase 3 data for NurOwn study in amyotrophic lateral sclerosis.
Edgewise Therapeutics, Inc. EWTX will present at the MDA meeting Phase 1 data for EDG-5506 in Becker muscular dystrophy.
Earnings
ImmunoPrecise Antibodies Ltd. IPA (before the market open)
IMV Inc. IMV (before the market open) (before the market open)
Synthetic Biologics, Inc. SYN (after the close)
Eton Pharmaceuticals, Inc. ETON (after the close)
Catalyst Pharmaceuticals, Inc. CPRX (after the close)
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