BPC April 07 update

Biotech Week in Review ~ 04/07/2017; Upcoming catalysts due within the next four weeks

Weekly watchlist

We look back at the some of the major price moving biotech events for the first week of 2Q 2017 while highlighting biotech events due within the next four week.

Paratek Pharmaceuticals Inc (NASDAQ:PRTK), one stock on last week’s watch list for the upcoming quarter, announced Monday that it met both primary and secondary endpoints in its Phase 3 trial of omadacycline for the treatment of patients with community-acquired bacterial pneumonia (CABP). Shares closed Tuesday’s session up 23% to $22.85 before retracing some gains to close the week at $22.48. Paratek intends to submit a New Drug Application (NDA) in 1Q 2018.

Dynavax Technologies Corporation (NASDAQ: DVAX) announced earlier in the week that it has been assigned an Advisory Committee Meeting on July 28, 2017 to review its regulatory filing of HEPLISAV-B. The PDUFA date of August 10, 2017 remains unchanged. The company previously received Complete Response Letters in February, 2013 and November, 2016.

Tuesday saw shares of Corvus Pharmaceuticals Inc (NASDAQ:CRVS) plummet following its presentation of Phase 1/1b trial of CPI-444 at the AACR Meeting. Shares closed down 50% to $10.36 before losing more ground later in the week to close down at $9.54.

NewLink Genetics Corporation (NASDAQ:NLNK) reported interim data from its Phase 2 trial evaluating its IDO pathway inhibitor, indoximod, in combination with checkpoint inhibitors for the treatment of patients with advanced melanoma. Patients with non-ocular melanoma achieved a 59% overall response rate. There was considerable debate on various media in regard to the efficacy of the data with comparisons made to Incyte Corporation (NASDAQ:INCY) and its IDO inhibitor, epacadostat. By the end of the week selling pressure saw shares sold down 30% to $16.19.

Innocoll Holdings PLC (NASDAQ:INNL) announced Wednesday that it will be acquired by Gurnet Point L.P., a healthcare investment fund, initially for $1.75 per share in cash. In addition, a contingent value right (CVR) to be paid out will be dependent on whether or not XARACOLL is approved by the FDA under a favorable label. The company received a Refusal to file letter for its initial New Drug Application (NDA) in late 2016 and intends to resubmit its NDA in late 2017 following the completion of further clinical trials. Shares closed the week up 88% to $2.10.


Biotech Stocks with upcoming catalysts within the next four weeks.

Drug Stage Catalyst

Endometrial cancer

Phase 3 Phase 3 trial did not meet primary endpoint - May 1, 2017.

Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 2 Phase 2 interim data released April 24, 2017. Phase 3 program to commence 4Q 2017 with initial data due 1Q 2019.

Cerliponase alfa
Batten Disease

Approved PDUFA date extended by three months to April 27 2017. Approval announced April 27, 2017.

Tardive dyskinesia

Approved Approved April 11, 2017.

Alzheimer's disease

Phase 2 Phase 2 data released May 1, 2017 - primary endpoint not met.

AIR DNase (PRX-110)
Cystic Fibrosis

Phase 2 Phase 2 interim data released January 3, 2017. Full data released April 12, 2017. Company noted data were positive but results showed efficacy down on January data.

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.