BPC December 13 update

Proteon shares tumble 75% as another biotech reports disappointing data

Price and Volume Movers

Achaogen, Inc. (NASDAQ:AKAO), which on Monday saw its shares soar over 148%, continued with its surge on Tuesday, with shares closing up 14% on 18x average volume. The company announced yesterday positive data from both its CARE and EPIC Phase 3 trials of plazomicin. Achaogen plans to submit a New Drug Application (NDA) in 2H 2017.

Proteon Therapeutics, Inc. (Nasdaq:PRTO) shares tumbled 75% on 93x average volume following its release that its first Phase 3 trial of vonapanitase (PATENCY-1) did not meet its primary endpoint of improved primary unassisted patency compared to placebo (p=0.254). Enrollment in its second Phase 3 trial, PATENCY-2, is due to be completed in 1Q 2017, with top-line data due 2Q 2018.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that its Phase 2b trial of Clonidine Topical Gel for the management of painful diabetic neuropathy did not meet the primary endpoint. As a result, BDSI is discontinuing further development of the product. Shares closed down 2.5% of being down 15% at the opening of today’s session.

Soligenix, Inc. (Nasdaq: SNGX) announced today the pricing of its public offering of 1,670,000 shares and warrants to purchase up to 2,087,500 shares at a combined offering price of $3.16 for gross proceeds of approximately $5,277,200. The company began trading on The Nasdaq Capital Market under the ticker "SNGX" on December 13, 2016. Shares closed down 34%.

Recro Pharma, Inc. (Nasdaq:REPH) also announced the pricing of its offering of 6.5m shares of at a price of $6 per share for net proceeds of $35.9m. After opening lower, shares closed up 9%.

CytRx Corporation (NASDAQ: CYTR) another company to raise cash, announced that it will offer shares at a price of $0.42 per share with gross proceeds of $8.1m. Shares of the company dropped 17% on 3.5x average volume.

Other price movers (+10%):


Sunshine Heart Inc (NASDAQ:SSH): +53%; 6x average volume.

Northwest Biotherapeutics, Inc (NASDAQ:NWBO): +11%; 3x average volume.

Abeona Therapeutics Inc (NASDAQ:ABEO): +10%; 2x average volume.

Cerecor Inc (NASDAQ:CERC): +10%; 13x average volume.


aTyr Pharma Inc (NASDAQ:LIFE): -23%; 6x average volume.

Apricus Biosciences Inc (NASDAQ:APRI): -20%; 9x average volume.

Atossa Genetics Inc (NASDAQ:ATOS): -11%.

Fibrocell Science Inc (NASDAQ:FCSC): - 13%; 4x average volume.

Peregrine Pharmaceuticals (NASDAQ:PPHM): -12%; 2x average volume.

Full pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst

Vonapanitase (PRT-201) PATENCY-2
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)

Phase 3 Phase 3 enrollment to be completed 1Q 2018. Data due 1Q 2019.

Vonapanitase (PRT-201) PATENCY-1
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)

Phase 3 Phase 3 data released December 13, 2016 - primary endpoint not met.

Clonidine gel
Painful diabetic neuropathy (PDN)

Phase 2b Phase 2b data released December 13, 2016 - primary endpoints not met.

ARX-04 (SAP303)
Moderate-to-severe acute pain following a surgical procedure

PDUFA PDUFA date October 12, 2017. Noted June 7, 2017 that an Advisory Committee Meeting is no longer planned.

Community-acquired bacterial pneumonia (CABP)

Phase 3 Phase 3 data released April 3, 2017 - all endpoints met. Regulatory filing due 1Q 2018.

Ornithine Transcarbamylase (OTC) Deficiency

Phase 1/2 Phase 1/2 initial data due late 2017.

Margetuximab SOPHIA study
Metastatic breast cancer

Phase 3 Phase 3 enrolling. Enrollment of trial to be completed by late 2018.

Limb girdle muscular dystrophy (LGMD) 2B / Adult patients with facioscapulohumeral muscular dystrophy (FSHD)

Phase 1/2 Phase 1b/2 data released December 13, 2016 with further update at EASL April 2017.

Intravenous SCY-078

Phase 1 Clinical hold placed on the initiation of intravenous (IV) SCY-078 until the FDA completes a review of all data. Clinical hold follows three mild-to-moderate thrombotic events in healthy volunteers - announced March 2, 2017. Noted May 8, 2017 that Phase 2 trial to be initiated in 2018.

Crohn’s disease

Phase 3 Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Further analysis July 31, 2017 recommended trial continue as planned.

Retinal scarring

Phase 1/2 Phase 2 completion of enrollment announced June 21, 2017. Data due early 2018.

Connective tissue growth factor (CTGF)

Phase 2 Phase 2 final readout due 2H 2017.

Samcyprone - RXI-SCP-1502
Cutaneous warts

Phase 2 Phase 2 enrollment completed - noted September 6, 2017. Data read outs due before the end of 2017.

Severe acne vulgaris

Phase 3 Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.

Essential tremor

Phase 2 Announced that screening has opened for Phase 2a trial - December 13, 2016. Data due 2H 2017.

Parkinson’s disease (PD)

Phase 2 Phase 2 initiation announced December 13, 2016. Data from Part A data released May 9, 2017. Part B data due 2H 2017.