Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Dec. 2)
- Amicus Therapeutics, Inc. FOLD
- Beam Therapeutics Inc BEAM
- Bioanalytical Systems, Inc. BASI
- Cerevel Therapeutics Holdings Inc CERE
- Fate Therapeutics Inc FATE
- Generation Bio Co GBIO
- Idera Pharmaceuticals Inc IDRA
- Infinity Pharmaceuticals Inc. INFI
- Inhibrx Inc INBX
- Intellia Therapeutics Inc NTLA
- Iovance Biotherapeutics Inc IOVA
- Inspire Medical Systems Inc INSP
- Kymera Therapeutics Inc KYMR
- Larimar Therapeutics Inc LRMR
- Merrimack Pharmaceuticals Inc 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 MYOV
- Ocular Therapeutix Inc OCUL
- Olema Pharmaceuticals Inc OLMA
- Oncorus Inc ONCR
- OncoSec Medical Inc ONCS
- Pfizer Inc. PFE (announced U.K. regulatory nod for emergency use of its coronavirus vaccine candidate)
- Praxis Precision Medicines Inc PRAX
- Pulse Biosciences Inc PLSE
- Spero Therapeutics Inc SPRO
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Dec. 2)
- Histogen Inc HSTO
- Nabriva Therapeutics PLC – ADR NBRV (shares will trade on a reverse-split adjusted basis beginning Thursday)
- Viveve Medical Inc VIVE
Stocks In Focus
Omeros Gains On CMS Ruling For Omridia
Omeros Corporation 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 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.
Lilly edged up 0.31% to $145.61 in after-hours trading.
IMV Reports Positive Midstage Data For Ovarian Cancer T-Cell Therapy
Imv Inc 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 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
The FDA is due to rule on BioCryst Pharmaceuticals, Inc.'s BCRX NDA for oral, once-daily berotralstat for the prevention of hereditary angioedema attack.
Sutro Biopharma Inc 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.
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."
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