Market Overview

Analyst: AcelRx Will Address FDA Concerns, Secure Approval This Year

Share:
Analyst: AcelRx Will Address FDA Concerns, Secure Approval This Year
Related ACRX
85 Biggest Movers From Friday
68 Stocks Moving In Friday's Mid-Day Session

AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) has been slowly recovering from a mid-October plunge following the FDA's issuance of a Complete Response Letter.

Cantor Fitzgerald forecast an additional 160 percent in upside for the stock. 

The Rating

Analyst Brandon Folkes initiated coverage of AcelRx with an Overweight rating and $6 price target.

The Thesis

The firm’s Dsuvia is expected to receive regulatory approval in November with a Risk Evaluation and Mitigation Strategy, Folkes said in the initiation note. 

“Since ACRX obtained a CRL in 2017, the company has addressed the FDA's concerns, and reduced the maximum daily dosage of Dsuvia to 12 doses from 24,” the analyst said. “This aligns with the FDA's goal of reducing opioid usage, and we believe the agency will have an Adcom for Dsuvia where it can discuss any remaining concerns.”

Cantor Fitzgerald anticipates that AcelRx will address enduring safety concerns and REMS questions in the third quarter.

AcelRX's Zalviso could be approved in 2019 after a late 2018 resubmission of the New Drug Application, Folkes said; the analyst expects a 2020 launch. 

“Both Dsuvia and Zalviso offer advantages to the patient, physician/nurse and the treatment facility, that if priced accordingly, we believe will drive uptake of both products beyond the Street's current estimates which should drive the stock higher."

Price Action

At the time of publication, AcelRX shares were trading up 3.42 percent at a rate of $3.78.

Related Links:

Marinus Pharmaceuticals Has 3 Major Catalysts In 2018, Ladenburg Thalmann Says In Bullish Initiation

Analyst: Sage Therapeutics Holds A Breakthrough In Depression Treatment

Latest Ratings for ACRX

DateFirmActionFromTo
Oct 2018B. Riley FBRInitiates Coverage OnBuy
Oct 2018JefferiesUpgradesHoldBuy
Oct 2018Ladenburg ThalmannReiteratesBuyBuy

View More Analyst Ratings for ACRX
View the Latest Analyst Ratings

Posted-In: Brandon Folkes Cantor FitzgeraldAnalyst Color Health Care Price Target Initiation Analyst Ratings General Best of Benzinga

 

Related Articles (ACRX)

View Comments and Join the Discussion!

Latest Ratings

StockFirmActionPT
LXFTKeyBancDowngrades0.0
CPAImperial CapitalDowngrades68.0
PRMWImperial CapitalInitiates Coverage On18.0
TGTKeyBancInitiates Coverage On110.0
QCOMMorgan StanleyUpgrades0.0
View the Latest Analytics Ratings
Don't Miss Out!
Join Our Newsletter
Subscribe to:
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Daily Analyst Rating
A summary of each day’s top rating changes from sell-side analysts on the street.
Fintech Focus
Your weekly roundup of hot topics in the exciting world of fintech.
Thank You
for registering for Benzinga’s newsletters and alerts.
• The Daily Analysts Ratings email will be received daily between 7am and 10am.
• The Market in 5 Minutes email will be received daily between 7am and 8am.
• The Fintech Focus email will be received every Friday between 2pm and 5pm.

41 Stocks Moving In Tuesday's Mid-Day Session

Adient's Turnaround Will Take Years, Baird Says In Bearish Turn