Here's a roundup of top developments in the biotech space over the last 24 hours.
(Biotech Stocks Hitting 52-week Highs Oct. 20)
(Biotech Stocks Hitting 52-week Lows Oct. 19)
Prothena Corporation PLC (NASDAQ:PRTA) said, based on positive signals of efficacy consistent with disease modification in the PASADENA study, it along with Roche Holdings AG Basel ADR Common Stock (OTC:RHHBY) plans to advance prasinezumab into a Phase 2b study in patients with early Parkinson's disease. The study is likely to be initiated in 2021, it added.
The study will further assess the efficacy of prasinezumab by expanding upon the patient population enrolled in PASADENA to include patients with early Parkinson's disease on stable levodopa therapy, Prothena said.
Prothena added that it will earn a $60 million clinical milestone payment upon first patient dosed in this study.
"Prasinezumab is the first anti-alpha-synuclein antibody to advance into confirmatory large study in patients with early Parkinson's disease," Prothena said.
The stock gained 11.01% to $12.50 in after-hours trading.
Xeris Pharmaceuticals Inc (NASDAQ:XERS) said the FDA granted fast track designation for the investigation of XP-0863 (diazepam non-aqueous injection) for the treatment of acute repetitive seizures.
In after-hours trading, the stock was up 9.52% to $5.75.
Molecular diagnostic company OncoCyte Corp (NYSE:OCX) said testing volume of DetermaRx, its lung cancer diagnostic test launched in January, more than doubled quarter-over-quarter to 175 billable samples in the third quarter. The company also noted that it maintained a re-order rate of about 60% and onboard hospitals increased to 67.
The stock added 7.38% to $1.60 in after-hours trading.
Crispr Therapeutics AG (NASDAQ:CRSP) announced positive top-line results from its Phase 1 CARBON trial evaluating the safety and efficacy of CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies.
"While longer follow-up is required, these early data support the potential for CTX110 to become an effective off-the-shelf CAR-T therapy for patients with relapsed or refractory B-cell malignancies," said Joseph McGuirk, an investigator in the study.
The stock was slipping 3% to $103.50 in pre-market trading.
Actinium Pharmaceuticals Inc (NYSE:ATNM) said the National Institutes of Health has awarded it a Small Business Technology Transfer grant to support a clinical collaboration with Memorial Sloan Kettering Cancer Center to study Iomab-ACT, Actinium's CD45-targeting antibody radio-conjugate, for targeted conditioning to achieve lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK.
The CD19 CAR-T has been previously studied by MSK in a Phase 2 trial with chemotherapy conditioning in patients with relapsed or refractory B-cell acute lymphoblastic leukemia or diffuse large B-cell lymphoma.
In pre-market trading, the stock was up 6.67% to $11.68.
Replimune Group Inc (NASDAQ:REPL) announced a proposed public offering of $125 million of shares of its common stock. All shares of common stock in the offering will be offered by the company.
The stock was down 8.06% to $39 in after-hours trading.
Aptinyx Inc (NASDAQ:APTX), which announced a positive mid-stage clinical readout late Tuesday, said it intends to offer and sell 12 million shares of its common stock in an underwritten public offering. All of the shares sold in the offering will be sold by the company.
In after-hours trading, the stock shed 4.54% to $4.10.
Pfizer Inc. (NYSE:PFE) is scheduled to present at the ID Week 2020 full results of a pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.
Abbott Laboratories (NYSE:ABT) (before the market open) Biogen Inc (NASDAQ:BIIB) (before the market open) Edwards Lifesciences Corp (NYSE:EW) (after the close)
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