Market Overview

Adcom Outcome For Lipcocine's Testosterone Drug Punctures Stock; Canaccord Downgrades

Adcom Outcome For Lipcocine's Testosterone Drug Punctures Stock; Canaccord Downgrades

Lipocine Inc (NASDAQ: LPCN), a pharma company focusing on men's and women's health, announced Wednesday the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee, voted against the benefit/risk profile of TLANDO, its oral testosterone product candidate for testosterone replacement therapy in adult males.

The PDUFA goal date for the candidate is set for May 8.

The Analyst

Canaccord Genuity analyst Dewey Steadman downgraded Lipocine from Buy to Hold and lowered his price target from $11 to $2.

The Thesis

The FDA panel was largely worried about the completeness and consistency of the data presented, Steadman said in a Thursday note. Panel members didn't back the drug up due to CV safety, unreliable serum readings and insufficient stopping criteria, Steadman added.

The analyst said that panel members who backed the drug had same concerns, but felt the benefits outweigh risks for hypogonadal patients.

Despite the thumbs down from the FDA panel, the drug could ultimately be approvable if appropriate blood pressure data and other items are presented to the FDA.

"However, the timing and scope of such submissions are yet to be determined and we think LPCN shares will be rangebound at current levels until a clear path to approval is forged," Canaccord Genuity said.

Price Action

Shares of Lipocine gained about 1.5 percent over the past year. The stock Thursday plunged 45 percent to $1.90.

Related Links:

Attention Biotech Investors: Brace For These January PDUFA Events

Morgan Stanley: Epizyme Has 'Blockbuster' Cancer Drug In The Making

Latest Ratings for LPCN

Mar 2018Initiates Coverage OnBuy
Feb 2018UpgradesHoldBuy
Jan 2018DowngradesBuyHold

View More Analyst Ratings for LPCN
View the Latest Analyst Ratings

Posted-In: Canaccord GenuityAnalyst Color Downgrades Health Care Price Target Top Stories Analyst Ratings General Best of Benzinga


Related Articles (LPCN)

View Comments and Join the Discussion!

Latest Ratings

IBMWells FargoMaintains140.0
PNCWells FargoMaintains147.0
TWOUDA DavidsonMaintains17.0
IDYAOppenheimerInitiates Coverage On17.0
View the Latest Analytics Ratings
Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Trading Daily
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
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.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at

Delek Vs. PBF Energy: A New Pair Trade From Morgan Stanley

High-Yield Dividend ETFs: 2018 Could Be Better