BPC April 11 update

Neurocrine (NBIX) receives FDA Approval for INGREZZA - shares up 19% AH; Contrasting fortunes for Axovant (AXON) and Cytori (CYTX) following pricing of offerings

Price and Volume Movers

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced after-hours Tuesday that the FDA has approved INGREZZA (valbenazine) for the treatment of adults with tardive dyskinesia (TD). INGREZZA is the first and only FDA-approved product indicated for the treatment of adults with TD. Shares are currently up 19% to $49.24 in the after-hour's session following news of no black box in the label, giving it a possible competitive edge.

Axovant Sciences Ltd. (NYSE: AXON) announced the pricing of its underwritten public offering of 6,742,179 shares at a price of $18.54 per share for gross proceeds of approximately $125m. Shares closed up 9% to $20.25.

Cytori Therapeutics, Inc. (NASDAQ:CYTX) also announced that it has priced its underwritten public offering of 8.6m shares at a price of $1.10 per share for gross proceeds of $9.5m. Shares tumbled to close down 35% to $1.12, a new reverse-split adjusted record low.

Windtree Therapeutics, Inc. (Nasdaq: WINT) shares closed up 21% to $1.50. The company announced that Data Safety Monitoring Board (DSMB) has completed its second and final interim safety review of the AEROSURF Phase 2b trial. The trial will continue through to completion with top-line data due mid-2017.

Agile Therapeutics, Inc. (Nasdaq:AGRX) reconfirmed its intention to resubmit its New Drug Application (NDA) for its contraceptive patch, Twirla. The resubmission is due by the end of 2Q 2017. The company noted that in a meeting with the FDA the agency indicated that based on the preliminary information provided by the company, the SECURE trial results appear acceptable for resubmission. Agile reported top-line results from its Phase 3 SECURE clinical trial in January 2017, which investors called below-par, resulting in shares losing almost half their value. Shares closed Tuesday’s session up 5% to $3.11.

Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) shares spiked up in early trading to open up 34% in response to its press release Tuesday morning that it had received minutes from a FDA meeting where the agency supported a single-study New Drug Application (NDA) of TNX-102 SL for the treatment of posttraumatic stress disorder (PTSD). Similar to recent press releases by small cap companies, the content of the release was relatively insignificant and this was evident in shares selling off later in the day to close up just 7% to $4.61.

Other major price movers:


Neothetics Inc (NASDAQ:NEOT): $2.09; +15%.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $6.98; +14%.

MannKind Corporation (NASDAQ:MNKD): $1.38; +10%.

ArQule, Inc. (NASDAQ:ARQL): $1.10; +9%.

Cerecor Inc (NASDAQ:CERC): $0.54; +8%.



Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): $17.16; -13%.

Oncomed Pharmaceuticals Inc (NASDAQ:OMED): $4.95; -11%.

Geron Corporation (NASDAQ:GERN): $2.33; -9%.

Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN): $0.618; -8%.

Aralez Pharmaceuticals Inc (NASDAQ:ARLZ): $1.71; -8%.


Full pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst

Contraceptive patch

PDUFA CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data. NDA resubmitted with PDUFA date of December 26, 2017

CB 2679d/ ISU304
Hemophilia B

Phase 1/2 Phase 1/2 completion of dosing announced June 14, 2017 with data due by the end of 2017.

Cancer - melanoma

Phase 2 Phase 1/2 data released September 10, 2017. 6/9 disease control with one CR. Phase 3 trial to be initiated 1Q 2018.

Trabodenoson and latanoprost

Phase 2 Phase 2 trial failed - noted July 7, 2017.

Tardive dyskinesia

Approved Approved April 11, 2017.

Lefamulin - LEAP 1
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)

Phase 3 Phase 3 data released September 18, 2017 - primary endpoint met.