Durect Corporation (DRRX) 1.27 $DRRX
DURECT Provides REMOXY® Update
PR Newswire - Fri Jul 01, 8:05AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has announced that the U.S. Food and Drug Administration (FDA) has determined that an Advisory Committee meeting for REMOXY®, which had been tentatively scheduled for August 5, 2016, is unnecessary and will not be held. REMOXY was previously the subject of an Advisory Committee meeting in 2008. Pain Therapeutics also stated that the FDA advised them that the regulatory review of the REMOXY New Drug Application (NDA) remains active and on-going. The Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA of September 25, 2016 is unchanged.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
DURECT to Present at the Cantor Fitzgerald Healthcare Conference
PR Newswire - Tue Jun 28, 3:30PM CDT
DURECT Corporation (Nasdaq: DRRX) announced today that James E. Brown, President and CEO, will be presenting at the Cantor Fitzgerald Healthcare Conference on Tuesday, July 12 at 8:00 a.m. Eastern Time. The conference is being held at Le Parker Meridien Hotel in New York City. Investors and analysts that are attending the conference may request a one-on-one meeting through the conference organizers at http://www.meetmax.com/sched/event_37633/inve...d=INVESTOR.
DRRX: 1.27 (+0.07)
DURECT to Present at the Jefferies Healthcare Conference
PR Newswire - Tue May 31, 7:30AM CDT
DURECT Corporation (Nasdaq: DRRX) announced today that Jim Brown, President and Chief Executive Officer, will be presenting at the Jefferies Healthcare Conference on Friday, June 10 at 1:30 pm Eastern Time. The conference is being held at the Grand Hyatt Hotel in New York. Management will also be available for one-on-one meetings at this conference; interested institutional investors should request a one-on-one meeting through the conference coordinators.
DRRX: 1.27 (+0.07)
DURECT Announces FDA Advisory Committee Meeting for REMOXY®
PR Newswire - Thu May 19, 8:05AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has announced that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY® New Drug Application (NDA), in a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee tentatively scheduled for August 5, 2016. Pain Therapeutics also stated that the FDA advised them that the Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA of September 25, 2016 is unchanged.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
DURECT Announces New REMOXY® Data being Presented at American Pain Society Meeting
PR Newswire - Wed May 11, 8:05AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced researchers will present new data around REMOXY's abuse-deterrent properties at the 35th Annual Scientific Meeting of the American Pain Society (APS) meeting. The scientific poster is titled "REMOXY: Human Abuse Potential Study of an Extended-Release Oxycodone Formulation." Co-authors Lynn Webster and Nadav Friedmann are scheduled to present the data at APS on Thursday, May 12, 2016, from 3:45 to 5:15 pm Central Time. This scientific poster will be available for review by the general public on DURECT's website at www.durect.com.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
Durect reports 1Q loss
Automated Insights - Thu May 05, 5:12PM CDT
CUPERTINO, Calif. (AP) _ Durect Corp. (DRRX) on Thursday reported a loss of $7.9 million in its first quarter.
DRRX: 1.27 (+0.07)
DURECT Corporation Announces First Quarter 2016 Financial Results and Update of Programs
PR Newswire - Thu May 05, 3:05PM CDT
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the first quarter of 2016. Total revenues were $3.6 million and net loss was $7.9 million for the three months ended March 31, 2016 as compared to total revenues of $4.8 million and net loss of $4.9 million for the three months ended March 31, 2015.
DRRX: 1.27 (+0.07)
DURECT Announces Closing of Public Offering of Common Stock
PR Newswire - Fri Apr 29, 11:15AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced the closing of an underwritten public offering of 13,800,000 shares of its common stock, offered at a price of $1.25 per share to the public, including 1,800,000 shares purchased by the underwriters pursuant to their option. All of the shares in the offering were sold by DURECT. The gross proceeds to DURECT from this offering were approximately $17.3 million, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by DURECT.
DRRX: 1.27 (+0.07)
DURECT Corporation Invites You to Join its First Quarter 2016 Earnings Conference Call
PR Newswire - Thu Apr 28, 3:30PM CDT
In conjunction with DURECT Corporation's (Nasdaq: DRRX) first quarter 2016 financial results press release, you are invited to listen to the conference call that will be broadcast live over the internet on Thursday, May 5, 2016 at 4:30 pm Eastern Time (1:30 pm Pacific Time).
DRRX: 1.27 (+0.07)
DURECT Announces Pricing of Public Offering of Common Stock
PR Newswire - Tue Apr 26, 8:00AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced the pricing of an underwritten public offering of 12,000,000 shares of its common stock, offered at a price of $1.25 per share to the public. The gross proceeds to DURECT from this offering are expected to be $15 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by DURECT. All of the shares in the offering are to be sold by DURECT. The offering is expected to close on or about April 29, 2016, subject to the satisfaction of customary closing conditions. DURECT has granted the underwriters a 30-day option to purchase up to an aggregate of 1,800,000 additional shares.
DRRX: 1.27 (+0.07)
DURECT Announces Proposed Public Offering of Common Stock
PR Newswire - Mon Apr 25, 3:01PM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that it is offering, subject to market conditions, shares of its common stock in an underwritten public offering. DURECT anticipates using the net proceeds from this offering for general corporate purposes, which may include clinical trials, research and development activities, capital expenditures, selling, general and administrative costs and to meet working capital needs. All of the shares in the offering are to be sold by DURECT.
DRRX: 1.27 (+0.07)
JonesTrading's George Zavoico Interviewed by The Life Sciences Report
Marketwired - Thu Apr 14, 8:02AM CDT
While the vagaries of the 2016 political season create uncertainty in the biotech and pharmaceutical sectors, companies are moving ahead with innovative cell therapies, gene therapies and new, safer ways to deliver addictive drugs, and investors find themselves in a position to play the development ideas with varying degrees of risk. In this interview with The Life Sciences Report, George Zavoico of Jones Trading Institutional Services explores how the presidential race could affect the biotech industry, and explains the growth prospects of three biotech names that could strike gold.
DRRX: 1.27 (+0.07)
DURECT Announces POSIMIR® Program Update
PR Newswire - Thu Apr 07, 4:00PM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that after the PERSIST Phase 3 trial for POSIMIR® was underway and enrolling patients at multiple sites, the Company received a letter from FDA advising the Company to make a number of amendments to the PERSIST trial. One of the recommendations was to incorporate standard bupivacaine HCl as an active control. The Company had a follow-up call with the FDA this week to discuss the advice letter, as a result of which the Company has decided to implement the FDA's recommendations. This change will add to the time and cost to complete the PERSIST trial, but the Company believes that a positive outcome from this trial design would result in a stronger NDA filing and potentially provide commercial advantages. The Company will provide an update on the impact to PERSIST once it has worked through the logistics of making this change. In the interim, the Company will continue enrollment under the existing protocol. As a point of reference, the Company notes that in cohort 2 of the BESST trial, which like PERSIST was in laparoscopic cholecystectomy patients, the control arm was also standard bupivacaine HCl and POSIMIR achieved a statistically significant pain reduction over 72 hours compared to the control when using the same statistical method being used in PERSIST.
DRRX: 1.27 (+0.07)
DURECT Announces Resubmission of REMOXY® New Drug Application to the U.S. Food and Drug Administration
PR Newswire - Tue Mar 29, 10:15AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced its licensee, Pain Therapeutics (Nasdaq: PTIE), has resubmitted the New Drug Application (NDA) for REMOXY® (oxycodone capsules CII) to the U.S. Food and Drug Administration (FDA). Pain Therapeutics has stated that they expect to be notified by the FDA of a Prescription Drug User Fee Act (PDUFA) action date within 30 days. The original REMOXY NDA has a Priority Review Designation.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
Biotech Sector Report Analyst Coverage Focusing on Upcoming FDA Decisions
ACCESSWIRE - Mon Mar 28, 7:01AM CDT
NEW YORK, NY / ACCESSWIRE / March 28, 2016 / DURECT Corporation (NASDAQ: DRRX), Genocea Biosciences Inc. (NASDAQ: GNCA), Flamel Technologies SA (NASDAQ: FLML), and Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) are four tickers in the biotech space currently suffering due to the overall poor market sentiment towards the space. The biotech sector has had a cruel start to the year. The Nasdaq Biotechnology Index is down 18% so far in 2016, and is now off about 30% since its July peak. This fall in market value has led to potential opportunities for big players in the space to pick up valuable assets are very low prices. While large drugmakers have hardly been exempt from the pain, the selloff should present a chance for them to find some cheap deals. Additionally, the four companies described here are expecting results from the FDA which may lead to even more upside for the junior biotech sector.
FLML: 11.36 (+0.22), VNDA: 11.47 (+0.02), GNCA: 4.45 (+0.11), DRRX: 1.27 (+0.07)
Laidlaw & Co. Analyst Jim Molloy Interviewed by The Life Sciences Report
Marketwired - Thu Mar 17, 8:01AM CDT
After a devastating start to 2016, biotech stocks have snapped back. Laidlaw & Co. analyst Jim Molloy likes the resurgence he's seeing in biotechnology share prices, but cautions that confirmation of a recovery will require cash-laden drug developers to begin acquiring smaller biotechs trading at depressed market valuations. In the meantime, Molloy says, individual and small institutional investors can still buy growth stories at bargain prices. In this interview with The Life Sciences Report, Molloy mentions three names with near-term catalysts that, with good data, can bring a needed lift to biotech portfolios.
CERC: 2.53 (-0.04), DRRX: 1.27 (+0.07)
DURECT Corp.'s CEO James E. Brown Interviewed by The Life Sciences Report
Marketwired - Tue Feb 02, 8:03AM CST
Alza Corp. was a pioneer in the field of drug delivery, and that illustrious heritage continues in its spinout, DURECT Corp. (NASDAQ: DRRX), which has leveraged the technology to enable highly innovative, value-added products that may soon be on the market. In this interview with The Life Sciences Report, DURECT cofounder and CEO James E. Brown discusses his company's pipeline, and how DURECT is evolving into a high-margin, blockbuster biotech.
JNJ: 122.85 (+0.34), DRRX: 1.27 (+0.07)
DURECT to Present at the BIO CEO & Investor Conference
PR Newswire - Thu Jan 28, 4:00PM CST
DURECT Corporation (Nasdaq: DRRX) announced today that Matt Hogan (Chief Financial Officer) will be presenting at the BIO CEO & Investor Conference on Monday, February 8 at 4:00 p.m. Eastern Time. The conference is being held at the Waldorf-Astoria Hotel in New York City. Investors and analysts that are attending the conference may request a one-on-one meeting through the conference organizers at https://www.bio.org/events/conferences/bio-ce...rce-center.
DRRX: 1.27 (+0.07)
Attention Deficit Hyperactivity Disorder (ADHD) - Pipeline Review, H2 2015
M2 - Thu Jan 28, 5:23AM CST
Research and Markets (http://www.researchandmarkets.com/research/jxcczv/attention_deficit) has announced the addition of the "Attention Deficit Hyperactivity Disorder (ADHD) - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Attention Deficit Hyperactivity Disorder (ADHD), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Attention Deficit Hyperactivity Disorder (ADHD) and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - Attention Deficit Hyperactivity Disorder (ADHD) Overview - Therapeutics Development - Pipeline Products for Attention Deficit Hyperactivity Disorder (ADHD) - Overview - Pipeline Products for Attention Deficit Hyperactivity Disorder (ADHD) - Comparative Analysis - Attention Deficit Hyperactivity Disorder (ADHD) - Therapeutics under Development by Companies - Attention Deficit Hyperactivity Disorder (ADHD) - Therapeutics under Investigation by Universities/Institutes - Attention Deficit Hyperactivity Disorder (ADHD) - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Attention Deficit Hyperactivity Disorder (ADHD) - Products under Development by Companies - Attention Deficit Hyperactivity Disorder (ADHD) - Products under Investigation by Universities/Institutes - Attention Deficit Hyperactivity Disorder (ADHD) - Companies Involved in Therapeutics Development - Alcobra Ltd - Amarantus Bioscience Holdings, Inc. - APeT Holding BV - Arbor Pharmaceuticals, LLC. - BCWorld Pharm Co. Ltd. - Collegium Pharmaceutical, Inc. - Curemark, LLC - Domain Therapeutics SA - DURECT Corporation - H. Lundbeck A/S - Heptares Therapeutics Limited - Highland Therapeutics, Inc. - Hisamitsu Pharmaceutical Co., Inc. - Integrative Research Laboratories Sweden AB - Intra-Cellular Therapies, Inc. - KemPharm, Inc. - Luc Therapeutics, Inc. - Medgenics Inc. - Merck & Co., Inc. - Neos Therapeutics, Inc. - NeuroDerm Ltd. - Neurovance, Inc. - P2D Bioscience - Polleo Pharma Limited - Reviva Pharmaceuticals Inc. - Samyang Biopharmaceuticals Corporation - Shire Plc - Signature Therapeutics, Inc - Sunovion Pharmaceuticals Inc. - Supernus Pharmaceuticals, Inc. - Taisho Pharmaceutical Holdings Co., Ltd. - Tris Pharma, Inc. - Vernalis Plc For more information visit http://www.researchandmarkets.com/research/jx...on_deficit
KMPH: 4.29 (+0.16), MDGN: 5.98 (+0.18), ADHD: 4.86 (+0.24), SUPN: 21.11 (+0.51), COLL: 12.74 (+0.24), DRRX: 1.27 (+0.07), NEOS: 9.37 (+0.25), NDRM: 16.82 (+0.56), MRK: 59.35 (+0.57), SHPG: 188.21 (-1.31), ITCI: 40.64 (+0.97)
DURECT Announces Initiation of DUR-928 Dosing in Patients
PR Newswire - Mon Jan 11, 7:00AM CST
DURECT Corporation (Nasdaq: DRRX) today announced it has initiated a single-ascending-dose Phase 1b clinical trial with DUR-928 in patients with nonalcoholic steatohepatitis (NASH). DUR-928 is an endogenous, small-molecule, new chemical entity (NCE), which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and NASH, and in acute organ injuries such as acute kidney injury (AKI).
DRRX: 1.27 (+0.07)
DURECT Provides REMOXY® Update
PR Newswire - Fri Jul 01, 8:05AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has announced that the U.S. Food and Drug Administration (FDA) has determined that an Advisory Committee meeting for REMOXY®, which had been tentatively scheduled for August 5, 2016, is unnecessary and will not be held. REMOXY was previously the subject of an Advisory Committee meeting in 2008. Pain Therapeutics also stated that the FDA advised them that the regulatory review of the REMOXY New Drug Application (NDA) remains active and on-going. The Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA of September 25, 2016 is unchanged.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
DURECT to Present at the Cantor Fitzgerald Healthcare Conference
PR Newswire - Tue Jun 28, 3:30PM CDT
DURECT Corporation (Nasdaq: DRRX) announced today that James E. Brown, President and CEO, will be presenting at the Cantor Fitzgerald Healthcare Conference on Tuesday, July 12 at 8:00 a.m. Eastern Time. The conference is being held at Le Parker Meridien Hotel in New York City. Investors and analysts that are attending the conference may request a one-on-one meeting through the conference organizers at http://www.meetmax.com/sched/event_37633/inve...d=INVESTOR.
DRRX: 1.27 (+0.07)
DURECT to Present at the Jefferies Healthcare Conference
PR Newswire - Tue May 31, 7:30AM CDT
DURECT Corporation (Nasdaq: DRRX) announced today that Jim Brown, President and Chief Executive Officer, will be presenting at the Jefferies Healthcare Conference on Friday, June 10 at 1:30 pm Eastern Time. The conference is being held at the Grand Hyatt Hotel in New York. Management will also be available for one-on-one meetings at this conference; interested institutional investors should request a one-on-one meeting through the conference coordinators.
DRRX: 1.27 (+0.07)
DURECT Announces FDA Advisory Committee Meeting for REMOXY®
PR Newswire - Thu May 19, 8:05AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has announced that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY® New Drug Application (NDA), in a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee tentatively scheduled for August 5, 2016. Pain Therapeutics also stated that the FDA advised them that the Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA of September 25, 2016 is unchanged.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
DURECT Announces New REMOXY® Data being Presented at American Pain Society Meeting
PR Newswire - Wed May 11, 8:05AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced researchers will present new data around REMOXY's abuse-deterrent properties at the 35th Annual Scientific Meeting of the American Pain Society (APS) meeting. The scientific poster is titled "REMOXY: Human Abuse Potential Study of an Extended-Release Oxycodone Formulation." Co-authors Lynn Webster and Nadav Friedmann are scheduled to present the data at APS on Thursday, May 12, 2016, from 3:45 to 5:15 pm Central Time. This scientific poster will be available for review by the general public on DURECT's website at www.durect.com.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
Durect reports 1Q loss
Automated Insights - Thu May 05, 5:12PM CDT
CUPERTINO, Calif. (AP) _ Durect Corp. (DRRX) on Thursday reported a loss of $7.9 million in its first quarter.
DRRX: 1.27 (+0.07)
DURECT Corporation Announces First Quarter 2016 Financial Results and Update of Programs
PR Newswire - Thu May 05, 3:05PM CDT
DURECT Corporation (Nasdaq: DRRX) announced today financial results for the first quarter of 2016. Total revenues were $3.6 million and net loss was $7.9 million for the three months ended March 31, 2016 as compared to total revenues of $4.8 million and net loss of $4.9 million for the three months ended March 31, 2015.
DRRX: 1.27 (+0.07)
DURECT Announces Closing of Public Offering of Common Stock
PR Newswire - Fri Apr 29, 11:15AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced the closing of an underwritten public offering of 13,800,000 shares of its common stock, offered at a price of $1.25 per share to the public, including 1,800,000 shares purchased by the underwriters pursuant to their option. All of the shares in the offering were sold by DURECT. The gross proceeds to DURECT from this offering were approximately $17.3 million, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by DURECT.
DRRX: 1.27 (+0.07)
DURECT Corporation Invites You to Join its First Quarter 2016 Earnings Conference Call
PR Newswire - Thu Apr 28, 3:30PM CDT
In conjunction with DURECT Corporation's (Nasdaq: DRRX) first quarter 2016 financial results press release, you are invited to listen to the conference call that will be broadcast live over the internet on Thursday, May 5, 2016 at 4:30 pm Eastern Time (1:30 pm Pacific Time).
DRRX: 1.27 (+0.07)
DURECT Announces Pricing of Public Offering of Common Stock
PR Newswire - Tue Apr 26, 8:00AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced the pricing of an underwritten public offering of 12,000,000 shares of its common stock, offered at a price of $1.25 per share to the public. The gross proceeds to DURECT from this offering are expected to be $15 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by DURECT. All of the shares in the offering are to be sold by DURECT. The offering is expected to close on or about April 29, 2016, subject to the satisfaction of customary closing conditions. DURECT has granted the underwriters a 30-day option to purchase up to an aggregate of 1,800,000 additional shares.
DRRX: 1.27 (+0.07)
DURECT Announces Proposed Public Offering of Common Stock
PR Newswire - Mon Apr 25, 3:01PM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that it is offering, subject to market conditions, shares of its common stock in an underwritten public offering. DURECT anticipates using the net proceeds from this offering for general corporate purposes, which may include clinical trials, research and development activities, capital expenditures, selling, general and administrative costs and to meet working capital needs. All of the shares in the offering are to be sold by DURECT.
DRRX: 1.27 (+0.07)
JonesTrading's George Zavoico Interviewed by The Life Sciences Report
Marketwired - Thu Apr 14, 8:02AM CDT
While the vagaries of the 2016 political season create uncertainty in the biotech and pharmaceutical sectors, companies are moving ahead with innovative cell therapies, gene therapies and new, safer ways to deliver addictive drugs, and investors find themselves in a position to play the development ideas with varying degrees of risk. In this interview with The Life Sciences Report, George Zavoico of Jones Trading Institutional Services explores how the presidential race could affect the biotech industry, and explains the growth prospects of three biotech names that could strike gold.
DRRX: 1.27 (+0.07)
DURECT Announces POSIMIR® Program Update
PR Newswire - Thu Apr 07, 4:00PM CDT
DURECT Corporation (Nasdaq: DRRX) today announced that after the PERSIST Phase 3 trial for POSIMIR® was underway and enrolling patients at multiple sites, the Company received a letter from FDA advising the Company to make a number of amendments to the PERSIST trial. One of the recommendations was to incorporate standard bupivacaine HCl as an active control. The Company had a follow-up call with the FDA this week to discuss the advice letter, as a result of which the Company has decided to implement the FDA's recommendations. This change will add to the time and cost to complete the PERSIST trial, but the Company believes that a positive outcome from this trial design would result in a stronger NDA filing and potentially provide commercial advantages. The Company will provide an update on the impact to PERSIST once it has worked through the logistics of making this change. In the interim, the Company will continue enrollment under the existing protocol. As a point of reference, the Company notes that in cohort 2 of the BESST trial, which like PERSIST was in laparoscopic cholecystectomy patients, the control arm was also standard bupivacaine HCl and POSIMIR achieved a statistically significant pain reduction over 72 hours compared to the control when using the same statistical method being used in PERSIST.
DRRX: 1.27 (+0.07)
DURECT Announces Resubmission of REMOXY® New Drug Application to the U.S. Food and Drug Administration
PR Newswire - Tue Mar 29, 10:15AM CDT
DURECT Corporation (Nasdaq: DRRX) today announced its licensee, Pain Therapeutics (Nasdaq: PTIE), has resubmitted the New Drug Application (NDA) for REMOXY® (oxycodone capsules CII) to the U.S. Food and Drug Administration (FDA). Pain Therapeutics has stated that they expect to be notified by the FDA of a Prescription Drug User Fee Act (PDUFA) action date within 30 days. The original REMOXY NDA has a Priority Review Designation.
DRRX: 1.27 (+0.07), PTIE: 2.24 (+0.03)
Biotech Sector Report Analyst Coverage Focusing on Upcoming FDA Decisions
ACCESSWIRE - Mon Mar 28, 7:01AM CDT
NEW YORK, NY / ACCESSWIRE / March 28, 2016 / DURECT Corporation (NASDAQ: DRRX), Genocea Biosciences Inc. (NASDAQ: GNCA), Flamel Technologies SA (NASDAQ: FLML), and Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) are four tickers in the biotech space currently suffering due to the overall poor market sentiment towards the space. The biotech sector has had a cruel start to the year. The Nasdaq Biotechnology Index is down 18% so far in 2016, and is now off about 30% since its July peak. This fall in market value has led to potential opportunities for big players in the space to pick up valuable assets are very low prices. While large drugmakers have hardly been exempt from the pain, the selloff should present a chance for them to find some cheap deals. Additionally, the four companies described here are expecting results from the FDA which may lead to even more upside for the junior biotech sector.
FLML: 11.36 (+0.22), VNDA: 11.47 (+0.02), GNCA: 4.45 (+0.11), DRRX: 1.27 (+0.07)
Laidlaw & Co. Analyst Jim Molloy Interviewed by The Life Sciences Report
Marketwired - Thu Mar 17, 8:01AM CDT
After a devastating start to 2016, biotech stocks have snapped back. Laidlaw & Co. analyst Jim Molloy likes the resurgence he's seeing in biotechnology share prices, but cautions that confirmation of a recovery will require cash-laden drug developers to begin acquiring smaller biotechs trading at depressed market valuations. In the meantime, Molloy says, individual and small institutional investors can still buy growth stories at bargain prices. In this interview with The Life Sciences Report, Molloy mentions three names with near-term catalysts that, with good data, can bring a needed lift to biotech portfolios.
CERC: 2.53 (-0.04), DRRX: 1.27 (+0.07)
DURECT Corp.'s CEO James E. Brown Interviewed by The Life Sciences Report
Marketwired - Tue Feb 02, 8:03AM CST
Alza Corp. was a pioneer in the field of drug delivery, and that illustrious heritage continues in its spinout, DURECT Corp. (NASDAQ: DRRX), which has leveraged the technology to enable highly innovative, value-added products that may soon be on the market. In this interview with The Life Sciences Report, DURECT cofounder and CEO James E. Brown discusses his company's pipeline, and how DURECT is evolving into a high-margin, blockbuster biotech.
JNJ: 122.85 (+0.34), DRRX: 1.27 (+0.07)
DURECT to Present at the BIO CEO & Investor Conference
PR Newswire - Thu Jan 28, 4:00PM CST
DURECT Corporation (Nasdaq: DRRX) announced today that Matt Hogan (Chief Financial Officer) will be presenting at the BIO CEO & Investor Conference on Monday, February 8 at 4:00 p.m. Eastern Time. The conference is being held at the Waldorf-Astoria Hotel in New York City. Investors and analysts that are attending the conference may request a one-on-one meeting through the conference organizers at https://www.bio.org/events/conferences/bio-ce...rce-center.
DRRX: 1.27 (+0.07)
Attention Deficit Hyperactivity Disorder (ADHD) - Pipeline Review, H2 2015
M2 - Thu Jan 28, 5:23AM CST
Research and Markets (http://www.researchandmarkets.com/research/jxcczv/attention_deficit) has announced the addition of the "Attention Deficit Hyperactivity Disorder (ADHD) - Pipeline Review, H2 2015" report to their offering. This report provides comprehensive information on the therapeutic development for Attention Deficit Hyperactivity Disorder (ADHD), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Attention Deficit Hyperactivity Disorder (ADHD) and special features on late-stage and discontinued projects. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Key Topics Covered: - Introduction - Attention Deficit Hyperactivity Disorder (ADHD) Overview - Therapeutics Development - Pipeline Products for Attention Deficit Hyperactivity Disorder (ADHD) - Overview - Pipeline Products for Attention Deficit Hyperactivity Disorder (ADHD) - Comparative Analysis - Attention Deficit Hyperactivity Disorder (ADHD) - Therapeutics under Development by Companies - Attention Deficit Hyperactivity Disorder (ADHD) - Therapeutics under Investigation by Universities/Institutes - Attention Deficit Hyperactivity Disorder (ADHD) - Pipeline Products Glance - Late Stage Products - Clinical Stage Products - Early Stage Products - Attention Deficit Hyperactivity Disorder (ADHD) - Products under Development by Companies - Attention Deficit Hyperactivity Disorder (ADHD) - Products under Investigation by Universities/Institutes - Attention Deficit Hyperactivity Disorder (ADHD) - Companies Involved in Therapeutics Development - Alcobra Ltd - Amarantus Bioscience Holdings, Inc. - APeT Holding BV - Arbor Pharmaceuticals, LLC. - BCWorld Pharm Co. Ltd. - Collegium Pharmaceutical, Inc. - Curemark, LLC - Domain Therapeutics SA - DURECT Corporation - H. Lundbeck A/S - Heptares Therapeutics Limited - Highland Therapeutics, Inc. - Hisamitsu Pharmaceutical Co., Inc. - Integrative Research Laboratories Sweden AB - Intra-Cellular Therapies, Inc. - KemPharm, Inc. - Luc Therapeutics, Inc. - Medgenics Inc. - Merck & Co., Inc. - Neos Therapeutics, Inc. - NeuroDerm Ltd. - Neurovance, Inc. - P2D Bioscience - Polleo Pharma Limited - Reviva Pharmaceuticals Inc. - Samyang Biopharmaceuticals Corporation - Shire Plc - Signature Therapeutics, Inc - Sunovion Pharmaceuticals Inc. - Supernus Pharmaceuticals, Inc. - Taisho Pharmaceutical Holdings Co., Ltd. - Tris Pharma, Inc. - Vernalis Plc For more information visit http://www.researchandmarkets.com/research/jx...on_deficit
KMPH: 4.29 (+0.16), MDGN: 5.98 (+0.18), ADHD: 4.86 (+0.24), SUPN: 21.11 (+0.51), COLL: 12.74 (+0.24), DRRX: 1.27 (+0.07), NEOS: 9.37 (+0.25), NDRM: 16.82 (+0.56), MRK: 59.35 (+0.57), SHPG: 188.21 (-1.31), ITCI: 40.64 (+0.97)
DURECT Announces Initiation of DUR-928 Dosing in Patients
PR Newswire - Mon Jan 11, 7:00AM CST
DURECT Corporation (Nasdaq: DRRX) today announced it has initiated a single-ascending-dose Phase 1b clinical trial with DUR-928 in patients with nonalcoholic steatohepatitis (NASH). DUR-928 is an endogenous, small-molecule, new chemical entity (NCE), which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and NASH, and in acute organ injuries such as acute kidney injury (AKI).
DRRX: 1.27 (+0.07)
