Shares of Geron Corp. (GERN) rose 9.7% to $2.26 in premarket trading after the U.S. Food and Drug Administration gave fast track designation to a key drug to the company's portfolio.
The Menlo Park, Calif.-based company said its, imetelstat drug was given fast track designation as a potential treatment for adults with transfusion-dependent anemia due to Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are non-del(5q) and who are refractory or resistant to treatment with an erythropoiesis stimulating agent.
Imetelstat was initially developed by Geron and exclusively licensed to Johnson & Johnson's (JNJ) Janssen Biotech Inc. on a worldwide basis.
Tuesday's announcement came a day before Geron is slated to release its third-quarter results.
Meanwhile, shares of Acorda Therapeutics Inc. (ACOR) were down 5.7% to $25.75. The Ardsley, N.Y.-based company reported third-quarter non-GAAP net income of $20.1 million, or $0.43 per diluted share, compared with a net loss of $1.9 million, or $0.04 per diluted share in the year-ago period. Revenue was $141.07 million, compared with $135.61 million.
Acorda president and CEO Ron Cohen said in a statement that the firm plans to resubmit its new drug application for Inbrija in the fourth quarter. The company in August received a refusal to file letter from the FDA regarding its application for Inbrija, a potential treatment for people with Parkinson's disease.
Also on Tuesday, Cohen said the company is on pace to announce top-line results from its Phase 3 study of tozadenant, another potential therapy for Parkinson's disease, in the first quarter of 2018.
Among the other biotech stock movers was Incyte Corp. (INCY) , up 3.3% to $118. The Wilmington, Del.-based firm reported net income of $36 million, or $0.17 per basic and diluted share, compared with net income of $37 million, or $0.20 per basic and $0.19 per diluted share in the same period last year. Revenue was $381.5 million, compared with $269.5 million.
Incyte also got welcomed news as AstraZeneca plc (AZN) said it signing a deal with Incyte under which the two companies will start a final-stage Phase III clinical trial next year for immunotherapy combination treatments to fight lung cancer.
"Expansion of the clinical collaboration with AZN (MP) announced this morning significantly broadens the revenue opportunity set for IDO inhibitor epacadostat, with a Phase III trial planned in combination with Imfinzi in patients with Stage III unresectable non-small cell lung cancer (NSCLC), building on AZN's recent PACIFIC trial success," wrote Michael Schmidt of Leerink Partners in a note Tuesday morning. "Other pipeline items remain on track."
Leerink has an outperform rating on Incyte.
