Price and Volume Movers
CytRx Corporation (NASDAQ: CYTR) announced that following discussions with the FDA it intends to file a rolling New Drug Application (NDA) of aldoxorubicin for the treatment of patients with soft tissue sarcomas (STS) in 4Q 2017. The company earlier released data in July 2016 that showed no significant improvement in Progression Free Survival (PFS) in its Phase 3 trial. However, the company decided to move forward with a NDA submission following the release of data late-November, 2016 of a subset of patients with leiomyosarcoma and liposarcoma (types of STS) that showed an improvement in PFS. Shares closed up Wednesday 18% to $0.52.
AbbVie Inc (NYSE:ABBV) announced after hours that its two Phase 3 trials of its PARP inhibitor, veliparib, did not meet their primary endpoints in patients with squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC).
Sunshine Heart, Inc. (NASDAQ:SSH) shares tumbled 33% to close down at $0.91 following its announcement Wednesday of the pricing of its $8m public offering priced at $1 per unit, with each unit consisting of one share of common stock and one five-year warrant with an exercise price of $1.10 per share.
TherapeuticsMD, Inc. (NYSE MKT: TXMD) provided an update in regard to its New Drug Application (NDA) for TX-004HR for the treatment of pain during intercourse. It noted that it:
...expects that the FDA will finalize an action… including informing the Company of the deficiencies in the NDA identified by the FDA, on or before the originally scheduled Prescription Drug User Fee Act (PDUFA) target action date of May 7, 2017. At this time, the Company is not aware of the nature of the deficiencies in the NDA identified by the FDA. The Company continues to communicate with the FDA to understand the nature of the deficiencies and intends to resolve them as quickly as possible.
While TherapeuticsMD did not explicitly say, one would garner that the release infers that the FDA will reject the company’s NDA. Shares closed up 3.3% to $5.01.
Sorrento Therapeutics, Inc. (NASDAQ: SRNE) shares are up 9% to $1.80 following news after hours that its CEO Henry Ji purchased 100,000 shares during its recent offering.
Other major price movers:
Argos Therapeutics Inc (NASDAQ:ARGS): $0.60; +53%.
Cleveland BioLabs, Inc. (NASDAQ:CBLI): $5.10; +46%.
NewLink Genetics Corp (NASDAQ:NLNK): $19.02; +19%.
Rockwell Medical Inc (NASDAQ:RMTI): $7.85; +12%.
RXi Pharmaceuticals Corp (NASDAQ:RXII): $0.70; +11%.
Nivalis Therapeutics Inc (NASDAQ:NVLS): $2.37; -10%.
Immunomedics, Inc. (NASDAQ:IMMU): $5.80; -9%.
Crispr Therapeutics AG (NASDAQ:CRSP): $17.57; -8%.
MannKind Corporation (NASDAQ:MNKD): $1.12; -8%.
Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): $13.79; -8%.
Pipeline updates below: