The Life Sciences Report Examines How Analysts Keep Focus

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
The Life Sciences Report Examines How Analysts Keep Focus on DURECT's DUR-928

SAN FRANCISCO, CA --(Marketwired - October 07, 2016) - The FDA's recent Complete Response Letter for Remoxy, which is licensed by DURECT Corp. ( NASDAQ : DRRX ) to Pain Therapeutics, has not changed the view of several analysts who follow DURECT. They are focused on DUR-928 for NASH and impaired kidney function, indications that are of great interest to Big Pharma.

Included in this article is: DURECT Corp.

On Sept. 26, DURECT Corp. announced that Pain Therapeutics received a "Complete Response Letter (CRL) from the FDA for Pain Therapeutics' New Drug Application (NDA) for REMOXY ER (oxycodone) extended-release capsules CII. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval." DURECT would receive royalties of 6.0% to 11.5% of net sales from Pain Therapeutics.

Pain Therapeutics notes that the "CRL specifies additional actions that are needed in order to obtain approval of REMOXY ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting). These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants."

Analyst Jim Molloy of Laidlaw & Company, in a Sept. 30 research report, states that the FDA's action pushes back approval of Remoxy until 2019 at the earliest, and he maintains a Buy on DURECT. He notes DURECT's other programs remain on track: "DUR-928 is still expected to read out Phase 1 data in 4Q16 for both liver (NASH) and kidney, and Posimir remains on track for 4Q17 Phase 3 data on post-surgical pain relief." He places a target price of $3.00 on DURECT, explaining, "Our price target is based on a sum-of-the-parts analysis with the Remoxy royalty at $0.50/share, the Posimir royalty at $1.00/share, DUR-928 at $1.00/share, and net cash (end-2017) tech & legacy polymer business valued at $0.50/share."

Continue reading this article: Analysts Keep Focus on DURECT's DUR-928

About Streetwise Reports - The Life Sciences Report

Investors rely on The Life Sciences Report to share investment ideas for the biotech, pharmaceutical, medical device, and diagnostics industries. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

DISCLOSURE:

The following companies mentioned in this article are sponsors of Streetwise Reports: DURECT Corp. The companies mentioned in this article were not involved in any aspect of the article preparation. Streetwise Reports does not accept stock in exchange for its services. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

Please see the end of the article for the complete disclosure: Analysts Keep Focus on DURECT's DUR-928

Carrie Beal Amaro Associate Publisher Email contact

Scroll down for more posts ▼

Top 10 Most Recent News Articles

EZ MOUSE Revolutionizes Multi-Device Computing Control

Updated Category News Views 74

A New Dawn for Multi-Device Users Sometimes, the best ideas are born from sheer frustration. Take this EZ MOUSE invention, for example. Some creative soul from Sun Prairie, Wisc. had enough of juggling multiple computer mice for their array of desktops and laptops. In response, they hatched the idea for a patent-pending gadget that aims to streamline operations across...

Continue Reading
LASEROPTEK Embraces CPT Clarity: Impacts on Dermatology

Updated Category News Views 47

CPT Changes: A New Era for Dermatology? Get this: the American Medical Association's revisions to the CPT codes could be just the spark LASEROPTEK's been waiting for. Landing on the desk is the 2027 Current Procedural Terminology (CPT) code set which clarifies how docs report targeted UVB laser treatments. We're talking about codes 96920–96922, now clear as crystal,...

Continue Reading
Ford Foundation's New Funding Boosts Global Flexibility

Updated Category News Views 60

A Bold New Chapter for Ford Foundation Forget your typical, rigid funding structures; the Ford Foundation is shaking things up. This ain't about just doling out cash and controlling the reigns anymore. Nope, they've pulled the curtain aside to reveal plans for a more agile, empowering approach to sustaining nonprofit partners globally. On the table is a guaranteed 50%...

Continue Reading
Autoliv Welcomes Rosenberg: Strategy Shift or Status Quo?

Updated Category News Views 60

Big Moves in the Boardroom Autoliv's latest announcement has stirred up the automotive safety world—a development that might feel like just another board shuffle, but there's more here than meets the eye. On November 10, 2026, Autoliv decided to toss Joachim Rosenberg into the mix as an independent director, bumping its board headcount from nine to ten. Who's This...

Continue Reading
Global Museum of Illusions Comes to San Francisco

Updated Category News Views 176

Illusions on Market Street The Global Museum of Illusions, the fast-growing sensation in private museums, is setting its sights on San Francisco with a new location opening on Market Street this November 13. They're dangling a juicy 50% off presale ticket offer for the early birds. A Mind-Bending Experience This museum isn't your run-of-the-mill art gallery or historical...

Continue Reading
Schools Embrace Patelco's Financial Literacy Initiative

Updated Category News Views 31

Driving Financial Literacy Forward When local schools start scrambling to meet new curriculum requirements, you know an initiative has found its stride. Patelco Credit Union's high school financial education program is making waves in the Bay Area as more schools jump on the bandwagon. With California’s looming finance education requirements, Patelco offers just the...

Continue Reading
AssureTrace Brings Graham Clark on Board for Growth

Updated Category News Views 0

Serialization's Fresh Outlook So, here we are—with one sharp mover joining the pack. Graham Clark is stepping into AssureTrace as the Chief Revenue Officer and Business Director. Another suit hopping on yet another board, but this time, it's got some seasoning we're looking at. Clark's packing over 23 years of serialization hustle, and that's not small change in the...

Continue Reading
Dutch Consumers Open to Recycling, Trust Lags Behind

Updated Category News Views 41

Dutch Consumers: Committed But Skeptical You think positive outlooks on clothing recycling mean business is booming, but scratch beneath the surface, and you'll find over 80% of Dutch consumers keen on recycling—but half of them think their efforts might be going to waste. Reju, a trailblazer in textile regeneration, gathered insights from more than a thousand Dutch...

Continue Reading
Summit Midstream's Q3 Financial Results Signal Growth

Updated Category News Views 47

Summit Midstream Delivers Strong Q3 Results Good grief, you'd think the grease is sliding off the griddle with these numbers. Summit Midstream Corporation (NYSE:SMC) is putting up figures that ought to make even the most poker-faced of traders crack a smile. We've got a net income sitting pretty at $15.9 million, and an Adjusted EBITDA that's climbed up to $70.7 million....

Continue Reading
Elong Kicks Off Central Asia Strategy with Almaty Launch

Updated Category News Views 17

Elong's Strategic Move into Central Asia When a company like Elong Hotel Technology decides to plant its flag in Central Asia, it’s more than just another overseas venture. This brand launch in Almaty is a bold statement—a signal that they're here to shake things up in a region ripe for development but lacking in hotel chains. With only about 20% penetration for local...

Continue Reading

Top 5 Most Recently Viewed Articles

Arizona Sonoran Copper Company Pursues C$30 Million Financing

Updated Category News Views 164

Arizona Sonoran Copper Company Inc. (TSX:ASCU | OTCQX:ASCUF) made headlines with its recent move to file a preliminary short-form prospectus for a bought deal offering. Traders watched closely as the company aimed to issue around 20,700,000 common shares at C$1.45 per share, targeting gross proceeds of approximately C$30,015,000. This isn't just any funding round; it...

Continue Reading
Telehealth Market Set for Remarkable Growth Towards 2031

Updated Category News Views 127

Telehealth Market Overview and Expected Growth The Global Telehealth Market has been experiencing a significant rise, with its value climbing from USD 102.44 Billion in 2023 to an impressive USD 364.68 Billion by 2031. This growth trajectory reflects a robust compound annual growth rate (CAGR) of 17.2% projected for the period from 2024 to 2031. The surge in telehealth...

Continue Reading
Potential East Coast Port Strike Could Disrupt Economy Soon

Updated Category News Views 70

U.S. East Coast and Gulf Coast port workers were gearing up for a potential strike back in late 2024, raising alarms across the board. The International Longshoremen's Association (ILA), representing about 45,000 workers, found themselves at a standoff with the United States Maritime Alliance (USMX) as their labor contract was set to expire without any negotiations lined...

Continue Reading
Huawei Revolutionizes Running with Eliud Kipchoge Partnership

Updated Category News Views 163

Unlocking New Possibilities in Running Huawei, a trailblazer in technology, has embarked on an exciting new journey by partnering with the dsm-firmenich Running Team, which features the iconic marathoner Eliud Kipchoge. This collaboration aims to elevate the running culture globally and motivate countless individuals to take up the sport. As the official technology...

Continue Reading
Assertio Expands Leadership with Mark Reisenauer Appointment

Updated Category News Views 126

Assertio Holdings, Inc. Welcomes Mark Reisenauer to Its Board Assertio Holdings, Inc. (Nasdaq: ASRT), a notable player in the pharmaceutical industry known for its innovative products, has announced the appointment of Mark Reisenauer to its Board of Directors. Mr. Reisenauer joins the board as an independent director and will be actively involved in the Compensation...

Continue Reading