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Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
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(Biotech Stocks Hitting 52-week Highs Dec. 2)
- Amicus Therapeutics, Inc. (NASDAQ:FOLD)
- Beam Therapeutics Inc (NASDAQ:BEAM)
- Bioanalytical Systems, Inc. (NASDAQ:BASI)
- Cerevel Therapeutics Holdings Inc (NASDAQ:CERE)
- Fate Therapeutics Inc (NASDAQ:FATE)
- Generation Bio Co (NASDAQ:GBIO)
- Idera Pharmaceuticals Inc (NASDAQ:IDRA)
- Infinity Pharmaceuticals Inc. (NASDAQ:INFI)
- Inhibrx Inc (NASDAQ:INBX)
- Intellia Therapeutics Inc (NASDAQ:NTLA)
- Iovance Biotherapeutics Inc (NASDAQ:IOVA)
- Inspire Medical Systems Inc (NYSE:INSP)
- Kymera Therapeutics Inc (NASDAQ:KYMR)
- Larimar Therapeutics Inc (NASDAQ:LRMR)
- Merrimack Pharmaceuticals Inc (NASDAQ:MACK) (reacted to positive outlook for the cancer drug it sold to Ispen, which opens the possibility of realizing potential milestone payments)
- Myovant Sciences Ltd (NYSE:MYOV)
- Ocular Therapeutix Inc (NASDAQ:OCUL)
- Olema Pharmaceuticals Inc (NASDAQ:OLMA)
- Oncorus Inc (NASDAQ:ONCR)
- OncoSec Medical Inc (NASDAQ:ONCS)
- Pfizer Inc. (NYSE:PFE) (announced U.K. regulatory nod for emergency use of its coronavirus vaccine candidate)
- Praxis Precision Medicines Inc (NASDAQ:PRAX)
- Pulse Biosciences Inc (NASDAQ:PLSE)
- Spero Therapeutics Inc (NASDAQ:SPRO)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Dec. 2)
- Histogen Inc (NASDAQ:HSTO)
- Nabriva Therapeutics PLC – ADR (NASDAQ:NBRV) (shares will trade on a reverse-split adjusted basis beginning Thursday)
- Viveve Medical Inc (NASDAQ:VIVE)
Stocks In Focus
Omeros Gains On CMS Ruling For Omridia
Omeros Corporation (NASDAQ:OMER) shares reacted to a Centers for Medicare & Medicaid Services ruling that includes the company's Omridia as a non-opioid pain management drug that functions as a surgical supply instead of being treated under the ambulatory surgical center payment system for 2021.
The stock was up 17.86% premarket Thursday at $14.65.
Lilly To Supply 650K More Doses Of COVID-19 Antibody Treatment To US For $812.5M
Eli Lilly And Co (NYSE:LLY) said the U.S. government has purchased 650,000 additional doses of its neutralizing antibody bamlanivimab 700 mg for $812.5 million.
The doses will be delivered through Jan. 31, 2021, with at least 350,000 of the additional doses delivered in December 2020.
Bamlanivimab recently received emergency use authorization for the treatment of mild-to-moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
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Lilly edged up 0.31% to $145.61 in after-hours trading.
Related Link: The Week Ahead In Biotech: Hematology Conference Gets Underway, Vanda And BioCryst Await FDA Decisions
IMV Reports Positive Midstage Data For Ovarian Cancer T-Cell Therapy
Imv Inc (NASDAQ:IMV) reported updated clinical and translational data from the Phase 2 DeCidE1 study evaluating the safety and efficacy of DPX-Survivac with intermittent low-dose cyclophosphamide in patients with recurrent, advanced platinum-sensitive and platinum-resistant ovarian cancer.
The data shows prolonged clinical benefits alongside favorable tolerability, and translational data linking the observed clinical benefits.
"IMV's targeted T cell therapy continues to elicit a rapid and robust immune response with a demonstration that survivin-specific CD8+ T cells can infiltrate solid cancerous tumors. This could prove to be of significant interest considering that the narrowly focused action of cytotoxic CD8+ T cells allows them to kill single infected cells in tissue without creating widespread tissue damage," said Fred Ors, CEO of IMV.
Taysha's Gene Therapy Receives Rare Pediatric, Orphan Drug Designations For Epilepsy
Taysha Gene Therapies Inc (NASDAQ:TSHA) said it has received both rare pediatric disease and orphan drug designations from the FDA for TSHA-103, an AAV-9-based gene therapy in development for SLC6A1-related epilepsy.
On The Radar
PDUFA Dates
The FDA is due to rule on BioCryst Pharmaceuticals, Inc.'s (NASDAQ:BCRX) NDA for oral, once-daily berotralstat for the prevention of hereditary angioedema attack.
Clinical Readouts
Sutro Biopharma Inc (NASDAQ:STRO) is scheduled to provide at a key opinion leader meeting scheduled for 5 p.m. a clinical update from the dose escalation Phase 1 study of STRO-002, an antibody-drug conjugate, for patients with ovarian cancer. The data will be based a new data cut-off date of Oct. 30.
IPOs
Kinnate Biopharma, a company focused on the development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers, priced its initial public offering of 12 million shares of its common stock at $20 per share.
All of the shares of common stock are being offered by Kinnate. The gross proceeds from the offering are expected to be $240 million Kinnate's shares will begin trading on the Nasdaq under the symbol "KNTE."
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.