Search This Blog

Thursday, January 9, 2020

Analyst action, Jan. 9

Aptose Biosciences (APS CN) initiated with Overweight rating at Piper Sandler. Shares up 2% premarket in U.S. (NASDAQ:APTO).
BioDelivery Sciences (NASDAQ:BDSI) initiated with Overweight rating and $9 (58% upside) price target at Piper Sandler.
BiomX (NYSEMKT:PHGE) initiated with Overweight rating and $16 (67% upside) price target at Cantor Fitzgerald.
Enlivex Therapeutics (NASDAQ:ENLV) initiated with Buy rating and $20 (131% upside) price target at H.C. Wainwright. Shares down 6% premarket.
Karuna Therapeutics (NASDAQ:KRTX) initiated with Market Perform rating and $122 (71% upside) price target at JMP Securities.
Mylan N.V. (NASDAQ:MYL) initiated with Neutral rating with a $21 (flat) price target at Piper Sandler.
Phreesia (NYSE:PHR) initiated with Overweight rating and $32 (18% upside) price target at Cantor.
UroGen Pharma (NASDAQ:URGN) initiated with Neutral rating and $37 (15% upside) price target at National Securities.
DBV Technologies (NASDAQ:DBVT) upgraded to Buy with an $18 (60% upside) price target at Stifel. Shares up 21% premarket on positive three-year Viaskin Peanut data.
Halozyme Therapeutics (NASDAQ:HALO) upgraded to Outperform at BMO.
Madrigal Pharmaceuticals (NASDAQ:MDGL) upgraded to Buy with a $127 (47% upside) price target at UBS. Shares up 2% premarket.
Patterson Companies (NASDAQ:PDCO) upgraded to Neutral at Bank of America. Shares up 1% premarket.
Fate Therapeutics (NASDAQ:FATE) downgraded to Market Perform at BMO. Shares down 3% premarket.
Henry Schein (NASDAQ:HSIC) downgraded to Underperform at BofA. Shares down 1% premarket.
OrganiGram (OGI CN) downgraded to Market Perform at Raymond James. Shares (NASDAQ:OGI) down 1% premarket in U.S.
Teladoc (NYSE:TDOC) downgraded to Neutral with a $90 (4% upside) price target at BofA. Shares down 1% premarket.
Posted by at No comments:

ADMA Bio up on 2020 strategic outlook

ADMA Biologics (NASDAQ:ADMA) is up 10% premarket on announcing preliminary Q4 and FY 2019 revenues, providing updates on the commercial launches of BIVIGAM and ASCENIV, as well as introducing 2020 strategic outlook.
Q4 and FY 2019 total revenues of $11.9M and $29.2M, respectively.
Commercial launches for BIVIGAM and ASCENIV progressing in line with expectations. The Company continues to ramp up production of these two products and build inventory to support continued growth and market supply.
ADMA is focused on the following key strategic priorities in 2020: Continue to expand the commercial traction of BIVIGAM and ASCENIV.
Evaluate and implement strategies for manufacturing capacity expansion as well as strengthening the supply chain capabilities.
Secure new supply contracts for potential CMO opportunities as well as explore business development opportunities.
ADMA plans to host a conference call and webcast to discuss its Q4 full year 2019 financial results during Q1 2020.
Posted by at No comments:

AMAG Pharma provides strategic and financial update

AMAG Pharmaceuticals (NASDAQ:AMAG) announces 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.
Posted by at No comments:

Medtronic deep brain stimulation system CE Mark’d

Medtronic (NYSE:MDT) announces 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.
Posted by at No comments:

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.
Posted by at No comments:

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
https://seekingalpha.com/news/3530671-enanta-to-provide-r-and-d-and-business-update-for-2020-during-annual-jpm-conference
Posted by at No comments:

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.
Posted by at No comments:
Subscribe to: Posts (Atom)