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Thursday, January 9, 2020

AMAG Pharma provides strategic and financial update

AMAG Pharmaceuticals (NASDAQ:AMAGannounces the initiation of a leadership transition, the decision to divest Intrarosa and Vyleesi and financial updates.
William Heiden plans to step down as AMAG’s President and CEO, and a search for his successor is expected to complete by mid-2020.
In addition, CFO Ted Myles will assume the additional role of Chief Operating Officer, effective immediately.
General Counsel Joseph Vittiglio will assume the additional role of Chief Business Officer.
Aiming long-term profitability and enhancing shareholder value, AMAG will divest Intrarosa (prasterone) and Vyleesi (bremelanotide). The Company has received preliminary expressions of interest to acquire/sub-license the rights to these products.
AMAG expects Q4 and FY 2019 total revenue in the range of $86M – 91M and $324M – 329M, respectively.
Q4 and FY 2019 Feraheme revenue in the range of $40M – 42M and $167M  – 169M, respectively.
Q4 and FY 2019 Makena revenue between $24M – 27M and $120M – 123M, respectively.
Q4 and FY 2019 Non-GAAP adjusted EBITDA between ($10M) – $0 and ($60M – $70M), respectively.
The company also reports 2020 outlook:
Total revenue in the range of $230M – 280M.
Non-GAAP adjusted EBITDA between $20M – 50M.
The Company expects to report final financial results for Q4 and FY 2019 in early March.

Medtronic deep brain stimulation system CE Mark’d

Medtronic (NYSE:MDTannounces CE Mark certification for its Percept PC neurostimulator, its Deep Brain Stimulation (DBS) system for the treatment of neurologic disorders such as Parkinson’s disease.

Eagle Pharma refiles Ryanodex application in U.S.

Eagle Pharmaceuticals (NASDAQ:EGRX) has resubmitted its U.S. marketing application for Ryanodex (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke as well as body cooling.
The company received a CRL in July 2017 citing the need for an additional clinical trial.

Enanta to provide R&D and business update for 2020 at annual JPM conference

Enanta Pharmaceuticals (NASDAQ:ENTA) will provide an update on its R&D programs, introduce its newest program in human metapneumovirus (hMPV), as well as provide an update on its business outlook for 2020, during its presentation at the 38th Annual J.P. Morgan Healthcare Conference on January 13, 2020.
The company expects to achieve the following milestones in calendar 2020:
Respiratory syncytial virus (RSV N) – Inhibitor EDP-938 and hMPV Inhibitor Leads.
Data from RSVP Phase 2b adult outpatient study in Q3.
Initiate Phase 2 dose ranging study in pediatric RSV patients and in adult transplant patients with RSV in Q4.
Perform optimization of Enanta’s current nanomolar hMPV inhibitor leads – HBV: Core Inhibitor EDP-514.­
Initiate Phase 1b in nuc-suppressed and viremic HBV patients in Q1 and Q2, respctively.
Non-alcoholic steatohepatitis (NASH) / primary biliary cholangitis (PBC): FXR Agonists EDP-305 and EDP-297
Initiate ARGON-2 Phase 2b study of EDP-305 in NASH by early Q2.­
Phase 2 data from INTREPID study of EDP-305 in PBC in 2Q. ­
Initiate Phase 1 study of EDP-297 (follow-on FXR) in mid-2020.
#JPM20

VBI Vaccines up on 2nd successful Sci-B-Vac study

VBI Vaccines (NASDAQ:VBIV) announces positive results from a second Phase 3 clinical trial, CONSTANT, evaluating lot-to-lot consistency of its Sci-B-Vac hepatitis B vaccine and comparing its safety and immunogenicity to GlaxoSmithKline’s (NYSE:GSK) Engerix-B.
The study met the primary endpoint of lot-to-lot consistency for immune response across three independent consecutively manufactured lots four weeks after the third vaccination.
Sci-B-Vac demonstrated non-inferior immunogenicity to Engerix-B at day 196, one month after the completion of the full course of vaccination with either product.
No new safety signals were observed.
Results from the first Phase 3, PROTECT, were announced in June 2019.
Marketing application submissions in the U.S., Europe and Canada will begin in H2.

NanoViricides up on advancement of shingles candidate

Thinly traded nano cap NanoViricides (NYSEMKT:NNVC) perks up 7% premarket on light volume in response to its announcement that it has completed genetic toxicology testing on NV-HHV-101, a skin cream for the potential treatment of shingles. The data will support an IND application.

Pacira Bio sees FY 2019 net revenue as high as $421M

Pacira BioSciences (NASDAQ:PCRX) has reported preliminary Q4 and FY 2019 net revenues.
Q4 and FY 2019 net revenue of $122.4M and $421M, respectively.
Q4 and FY 2019 EXPAREL net product sales were $116.9M and $407.9M, respectively.
Q4 and FY 2019 iovera° net product sales were $3.2M and $7.9M, respectively.
Q4 royalty revenue was $0.6M and full-year was $2.1M.
The company’s 2019 financial guidance was as follows: EXPAREL and and iovera° net product sales in the range of $400M to $410M and $8M to $10M, respectively.
Pacira expects to report its complete Q4 and FY 2019 financial results in Q1 2020.