|Bid||1.9000 x 800|
|Ask||0.0000 x 4000|
|Day's Range||1.9700 - 2.1200|
|52 Week Range||0.5000 - 3.9500|
|Beta (5Y Monthly)||1.91|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 03, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||4.65|
Biopharmaceutical company Durect Corp.'s shares slid 12% in premarket trade Friday, after a U.S. Food and Drug Administration committee ended a meeting to review the company's Posimir treatment for post-surgical pain with a split vote, as six members voted to recommend the treatment and six voted against. The stock was halted all day Thursday, ahead of the meeting. "We are encouraged by the support from a number of the Committee members," Chief Executive James Brown said in a statement. "We continue to believe the data meets all of the regulatory requirements and that the weight of the evidence supports approval. We look forward to working with the agency as it completes its review of the POSIMIR application." The FDA is not obliged to take the recommendation of the committee, called the Anesthetic and Analgesic Drug Products Advisory Committee, although it often does. Durect shares have gained 322% in the last 12 months, while the S&P 500 has gained 26%.
The following is a roundup of top developments in the biotech space over the last 24 hours: Scaling The Peaks (Biotech stocks that hit 52-week highs on Jan. 16.) Acceleron Pharma Inc (NASDAQ: XLRN ) Aimmune ...
DURECT Corporation (Nasdaq: DRRX) today announced that the U.S. Food and Drug Administration's (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) met yesterday to discuss the Class 2 New Drug Application (NDA) resubmission for POSIMIR® (bupivacaine extended-release solution). In a split vote on the key question, six advisory committee members voted to recommend that the efficacy, safety, and overall risk-benefit profile of POSIMIR support approval, while six did not support approval based on the information presented.
Shares of biopharmaceutical company Durect Corp. were halted Thursday, ahead of a U.S. Food and Drug Administration committee meeting to review Posimir, a treatment for post-surgical pain. The meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) will start at 8 a.m. Eastern and is expected to end at 5. p.m. Posimir is designed to be injected into the surgical site and to deliver bupivacanine for up to three days after surgery. The FDA is not obliged to follow the recommendation of the committee but often does so. Durect shares have gained 305% in the last 12 months, while the S&P 500 has gained 26%.
DURECT Corporation (Nasdaq: DRRX) today announced that NASDAQ has halted trading of the Company's common stock today.
The pharmaceutical business is part of the larger healthcare sector. Pharmaceutical products may be generic, such as those used for common ailments like the flu and colds, or branded, patented drugs used for treating rare diseases including certain types of cancers. Among the best-known pharmaceutical companies are Eli Lilly & Co. (LLY) and Merck & Co. (MRK).
Shares of drug developer Durect Corp. shed nearly a third of their value Thursday after the Cupertino company said its headline drug failed a mid-stage clinical trial aimed at people with itchy, scaly psoriasis. Durect's drug, called DUR-928, has been closely watched not only because of of the psoriasis study but because it also is being tested as a treatment for alcoholic hepatitis and nonalcoholic steatohepatitis, or NASH — a fatty liver disease that is one of the hottest potential commercial opportunities for drug developers. Then Durect disclosed the topline data from the psoriasis trial, and the stock opened at $2.50 and sunk as low as $2.05.
Shares of Durect Corp. tumbled 34% on Thursday morning after the biopharmaceutical company said it would stop development of DUR-928 as a treatment for psoriasis. Durect said that a mid-stage clinical trial for patients with mild to moderate plaque psoriasis found that the investigational therapy did not benefit patients more than the placebo. The company plans to continue developing DUR-928 as a treatment for alcoholic hepatitis and nonalcoholic steatohepatitis, which is commonly referred to as NASH. Durect's stock has gained 111% over the last three months, while the S&P 500 is up 8% over the last quarter.
DURECT Corporation (Nasdaq: DRRX) today announced the results from its Phase 2a clinical trial of DUR-928 in patients with mild to moderate plaque psoriasis. Twenty-two patients completed the study, applying DUR-928 topically to the plaque on one arm and the vehicle (placebo) to a similar plaque on the other arm daily for 28 days.
In the stock market, sometimes all it takes is a single catalyst to propel shares to sky-high levels. This is especially common with healthcare stocks. While they carry significant risk, these names rely on only a few key milestones such as favorable trial data or attaining FDA approval, so a single dose of good news can have a big impact on share prices.The latter is particularly important as drug or medical device approval from the regulatory agency can lead to sustainable revenues for a company. No wonder, then, that investor focus locks in on healthcare companies ahead of decisions from the FDA.Bearing this in mind, we took a closer look at 3 healthcare stocks awaiting huge decisions from the FDA in January. TipRanks, a company that measures and tracks the performance of analysts, revealed that Wall Street sees each of these names as solid Buys. Here’s what we uncovered.Durect Corporation (DRRX) Recognized for its expertise in both formulation and drug delivery, Durect focuses on developing novel treatments for chronic kidney disease as well as acute organ injury. Its lead candidate, DUR-928, is an orally bioavailable small molecule that’s part of the company’s Epigenetic Regulator program. Representing a new class of therapeutics, it could play a key role in cellular functions like lipid homeostasis, inflammation and cell survival.That being said, the attention directed at DRRX is related to its POSIMIR candidate, designed to provide non-opioid pain relief after surgery. While still commonly used, opioids often have undesirable side effects and can be highly addictive. With 72 million surgical procedures performed each year in the U.S., there is a large unmet need for alternative forms of pain management.On January 16, an AdCom meeting will take place to determine if the FDA will recommend POSIMIR approval for the post-surgical analgesia indication.H.C. Wainwright analyst Ed Arce notes that his bullish thesis remains very much intact. He argues that the company’s submission of new data and re-analysis of the integrated summary of safety bode well for FDA approval.“PERSIST was designed based on extensive consultation and feedback from the FDA, and DURECT has successfully compiled a safety database with over 260 patients in the study to sufficiently address the issues raised in the CRL…We believe POSIMIR's data portfolio that was built upon efficacy data from two completed trials and safety data of all 16 completed trials, assembled under Dr. Simon's guidance, is sufficient to support POSIMIR's approval,” the analyst explained.Based on this conclusion, the five-star analyst told investors that he is staying with the bulls, reiterating the Buy rating. At his $4 price target, shares could surge 23% in the coming twelve months. (To watch Arce’s track record, click here)Cantor's Eliana Merle set a more aggressive price target along with her Buy rating based on not only POSIMIR but also DUR-928’s potential as a treatment for Alcoholic hepatitis (AH), for which there is a huge opportunity. Should the $5 target be met, investors could see 53% upside. (To watch Merle’s track record, click here)Judging from the consensus breakdown, it has been relatively quiet when it comes to other analyst activity. Over the last three months, only 2 analysts have reviewed the biopharma. Both of which, however, were bullish, making the consensus a Moderate Buy. On top of this, the $4.50 average price target puts the upside potential at 38%. (See Durect stock analysis on TipRanks)Aimmune Therapeutics (AIMT)Switching gears now, Aimmune takes aim at food allergies. The biopharma develops new treatments for people with potentially life-threatening food allergies. While shares are up 37% in 2019, investors want to know if AIMT has more fuel in the tank as it approaches the FDA decision for its lead candidate.PALFORZIA (AR101), its oral immunotherapy (OIT) treatment of peanut allergy, could see an approval decision come in late January 2020 for its use in the U.S., with the EU approval outcome expected in the second half of the year. Back in September, the company got a piece of good news as the FDA’s Allergenic Products Advisory Committee (APAC) voted in favor of approval for the therapy’s use in pediatric patients with peanut allergies.In addition to the vote of confidence from the panel, Wedbush’s Liana Moussatos sees a clear path to approval based on “robust efficacy and safety data to date.” Despite different regions of study, entry criteria, dosing periods and primary endpoints, both of the Phase 3 studies indicated consistent results. If that wasn’t promising enough, the analyst forecasts more than $1.5 billion in annual sales worldwide starting in 2023 if PALFORZIA is in fact approved. To this end, Moussatos left the Outperform rating and $79 price target unchanged. This conveys her confidence in AIMT’s ability to skyrocket 142% in the year ahead. (To watch Moussatos’ track record, click here)Meanwhile, Christopher Raymond of Piper Jaffray cites a recent meeting with management as reason for his bullish approach. He came away with a much more optimistic take on PALFORZIA’s launch. “We are much more confident that Palforzia’s launch can meaningfully outperform expectations, both near- and long-term. Coupling this with the stock’s 30% short interest, we like the opportunity for meaningful upside into this drug’s late January expected approval and launch,” the five-star analyst noted. As a result, Raymond maintained both the bullish call and $60 price target. (To watch Raymond’s track record, click here)Is the rest of the Street in agreement? As it turns out, the analyst consensus is more of a mixed bag. Split almost right down in the middle, 3 Buy ratings and 4 Holds were assigned in the last three months, giving AIMT Moderate Buy status. With a $44.14 average price target, the potential twelve-month gain comes in at 35%. (See Aimmune stock analysis on TipRanks)Epizyme (EPZM) Through the use of targeted epigenetic medicines, Epizyme is developing treatments for cancer and other serious diseases. Ahead of the January 23 PDUFA date for its primary product candidate, tazemetostat, all eyes are on the company.Looking at the results of the AdCom that took place earlier this month, it’s clear why investors have been getting excited. The panel voted unanimously to support the approval of tazemetostat for use in epithelioid sarcoma. Even though there was some concern about an open-label single-arm study, the panelists were impressed by the duration of response for a small indication with high unmet need, its safety and tolerability profile, its efficacy in a second-line (2L) setting and the limited amount of available treatment options.While the outcome doesn’t mean that final FDA approval is a sure thing, the Street is certainly buzzing. Since the AdCom vote, shares have climbed 24% higher, pushing EPZM’s 2019 rise to a whopping 267%.Jeffries analyst Michael Yee believes the AdCom should ease concerns about a possible FDA rejection. “Bottom line: we think the outcome today partially de-risks EPZM's follicular lymphoma program (NDA filing by YE:19) and should enable the company to transition to a commercial stage company by 2020,” he commented. With this in mind, Yee left the Buy rating and $21 price target as is. (To watch Yee’s track record, click here)Like Yee, Morgan Stanley’s David Lebovitz has high hopes for EPZM, pointing out that the FDA usually adheres to the recommendations of its AdCom panels. This prompted the analyst to keep the Overweight rating and $24 price target, suggesting 11% upside potential. (To watch Lebovitz’s track record, click here)Turning now to the rest of the Street, other analysts are on the same page. Based on the 6 Buy ratings vs no Holds or Sells, the Strong Buy consensus comes in just like the AdCom vote, unanimously. Given the recent uptick to the share price, the $20.33 average price target implies 10% downside. (See Epizyme stock analysis on TipRanks)
Biotech stocks advanced in the penultimate week of the year, and the iShares NASDAQ Biotechnology Index (NASDAQ: IBB ) is on track to end the year with gains in excess of 25%. The previous week saw FDA ...
Looking for stocks with high upside potential? Just follow the big players within the hedge fund industry. Why should you do so? Let’s take a brief look at what statistics have to say about hedge funds’ stock picking abilities to illustrate. The Standard and Poor’s 500 Index returned approximately 26% in 2019 (through November 22nd). Conversely, hedge […]
CUPERTINO, Calif., Nov. 15, 2019 /PRNewswire/ -- DURECT Corporation (DRRX) announced today that James E. Brown, President and CEO, will be presenting at the Stifel 2019 Health Care Conference, at the Lotte New York Palace Hotel on Tuesday, November 19, 2019 at 3:35 p.m. EST. Institutional investors and analysts that are attending the conference may request a one-on-one meeting through the conference coordinators. The live audio webcast of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on the "Investors" tab.
CUPERTINO, Calif., Nov. 12, 2019 /PRNewswire/ -- DURECT Corporation (DRRX) today announced the results from its Phase 2a clinical trial of DUR-928 in alcoholic hepatitis (AH), presented as a late-breaking oral presentation at The Liver Meeting®. The study results were also selected for inclusion in the 'Best of The Liver Meeting' summary slide presentation in the alcohol-related liver disease category. Today at Noon Eastern Time, DURECT will host a Key Opinion Leader (KOL) webcast featuring a presentation of the results delivered by one of the principal investigators of the trial, Tarek Hassanein, M.D. Dr. Hassanein will be available for a question and answer session following the presentation.
CUPERTINO, Calif., Nov. 6, 2019 /PRNewswire/ -- DURECT Corporation (DRRX) announced today that it will host a key opinion leader (KOL) conference call and live webcast to discuss the results of its recently completed Phase 2a clinical trial of DUR-928 in patients with alcoholic hepatitis (AH) on Tuesday, November 12 at 12:00 noon EST. The call will feature a review of the late-breaking oral presentation that Tarek I. Hassanein, M.D. will deliver at The Liver Meeting® 2019 at 8:30 a.m. EST on Tuesday, November 12. A replay of the webcast and data slide presentation will be available on the Investor section of the DURECT website at https://investors.durect.com/ after the call.
Live Webcast of Earnings Call Today at 4:30 p.m. Eastern Time CUPERTINO, Calif. , Nov. 4, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended ...
CUPERTINO, Calif. , Oct. 30, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that it will report third quarter and nine months ended September 30, 2019 financial results and host ...
Study Results Were Selected for Inclusion in the "Best of The Liver Meeting" Summary Slide Presentation Poster Comparing DUR-928 Data to Historical Control Will Also be Presented CUPERTINO, Calif. ...
While initial public offerings get most of the splash, public companies also are raking in cash with follow-on offerings. How long will the Wall Street spigot stay open?
CUPERTINO, Calif. , Oct. 17, 2019 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that it will be presenting at two upcoming investor conferences focused on non-alcoholic steatohepatitis ...
CUPERTINO, Calif., Oct. 7, 2019 /PRNewswire/ -- DURECT Corporation (DRRX) today announced that it has completed enrollment in its Phase 2a clinical trial of topical DUR-928 in patients with mild to moderate plaque psoriasis. The company also announced that it has now enrolled 30 of the planned 60 patients in its ongoing Phase 1b trial with oral DUR-928 in patients with non-alcoholic steatohepatitis (NASH). "We are pleased that on the heels of completing the alcoholic hepatitis trial on schedule and announcing positive results, we have also achieved important enrollment milestones in our ongoing psoriasis and NASH trials," said James E. Brown, President and CEO of DURECT.
CUPERTINO, Calif., Oct. 2, 2019 /PRNewswire/ -- DURECT Corporation (DRRX) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that its Class 2 NDA resubmission for POSIMIR® (bupivacaine extended-release solution) will be discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). DURECT commissioned the advisory services of Dr. Lee S. Simon to lead the Company's preparation efforts to prepare for the advisory committee meeting.
CUPERTINO, Calif., Sept. 26, 2019 /PRNewswire/ -- DURECT Corporation (DRRX) announced today that James E. Brown, Chief Executive Officer will be presenting at the Cantor Fitzgerald Global Health Care Conference, at the InterContinental New York Barclay Hotel on Friday, October 4, 2019 at 10:40 a.m. EDT. Institutional investors and analysts that are attending the conference may request a one-on-one meeting through the conference coordinators. The live audio webcast of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on the "Investors" tab. If you are unable to participate during the live webcast, the call will be archived on DURECT's website in the "Event Calendar" of the "Investors" section.