BPC April 19 update

​CytRx (CYTR) to file aldoxorubicin NDA 4Q 2017; TherapeuticsMD (TXMD) NDA update

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:

ADVANCERS:

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%.

 

DECLINERS:

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:

Pipeline Database Updates

Drug Stage Catalyst

ABBV
Veliparib
Squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC)

Phase 3 Phase 3 trial did not meet primary endpoints - April 19, 2017.

CYTR
Aldoxorubicin with doxorubicin
Soft tissue sarcomas refractory cancer

Phase 3 Phase 3 PFS data released July 2016 showed no significant improvement in PFS. Second analysis released November 29, 2016 showed improvement in population with leiomyosarcoma and liposarcoma. Rolling NDA to be filed 4Q 2017.

TXMD
Yuvvexy
Moderate-to-severe vaginal pain

CRL CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data. Meeting with FDA planned for November 3, 2017 with NDA to be resubmitted shortly after meeting.

VICL
VCL-HB01 HSV-2 Therapeutic Vaccine
Genital Herpes in Adults

Phase 2 Phase 2 trial initiated September 2016. Enrollment completion announced April 19, 2017 with data due 2Q 2018.