DRRX - DURECT Corporation
| Previous Close | 2.0800 |
| Open | 2.0700 |
| Bid | 2.1400 x 2900 |
| Ask | 2.2300 x 800 |
| Day's Range | 2.0500 - 2.2500 |
| 52 Week Range | 0.5000 - 3.9500 |
| Volume | 978,195 |
| Avg. Volume | 1,599,013 |
| Market Cap | 417.426M |
| Beta (5Y Monthly) | 2.13 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -0.1390 |
| Earnings Date | Nov 03, 2019 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 4.72 |
- TipRanks
3 “Strong Buy” Healthcare Stocks With Triple-Digit Upside
To buy or not to buy, that’s the question. For even the most seasoned Wall Street observers, determining the ideal time to pull the trigger on a particular stock can be a challenge. These decisions involve considering what type of gains are expected, more consistent growth achieved over the long haul or rapid upward climbs.More risk-tolerant investors are often drawn to the latter, enticed by the possibly of sky-high returns delivered at the drop of a hat. So, where can these stocks with huge upside potential be found? The healthcare sector. Its nature positions many companies to see their share prices multiply as a single update can either send shares through the roof or down the drain.With this in mind, we set out on our own search to find compelling plays in this volatile industry. Given the sheer size of the market, we used TipRanks’ Stock Screener tool to uncover 3 healthcare stocks that the analysts believe can double in the next year. In fact, each has attracted enough support from Wall Street to earn a “Strong Buy” consensus rating.Rockwell Medical (RMTI)Focusing on end-stage renal disease (ESRD) and chronic kidney disease (CKD), Rockwell Medical develops innovative therapies to help improve the lives of patients. Even with its leading iron maintenance therapy, Triferic, already receiving FDA approval for use in dialysis patients, analysts believe that its growth story is just getting started.The company announced on January 14 that it had finalized a license and supply agreement with Sun Pharma, a subsidiary of Sun Pharmaceutical Industries Ltd., for the rights to commercialize Triferic. Based on the terms of the agreement, RMTI will receive an undisclosed upfront sum to provide the therapy to Sun Pharma, who will be its exclusive development and commercialization partner in India. The company is also entitled to royalties on net sales and milestone payments.As Sun Pharma is the largest pharmaceutical company in India, boasting over $4 billion in annual sales, and there are about 120,000 patients receiving hemodialysis in the country, it’s no wonder the Street is excited. Citing Sun Pharma’s standing in the Indian pharmaceutical market, H.C. Wainwright analyst Raghuram Selvaraju sees the agreement as boding well for the company. “We note Sun Pharma's acquisitive business strategy and believe that Sun may eventually have interest in acquiring the Triferic franchise if it demonstrates rapid growth,” he explained.Furthermore, the company's IV Triferic is approaching its March PDUFA date, and Selvaraju points out that the drug is capable of reaching peak sales.As a result, the five-star analyst left his Buy rating and $11 price target unchanged. Should the target be met, a 402% twelve-month gain could be in the cards. (To watch Selvaraju’s track record, click here)Brandon Folkes of Cantor Fitzgerald added, "Beyond the India opportunity, we expect meaningful news flow from RMTI this year. A U.S. approval of IV Triferic is expected in 2020, as well as a submission of the IV formulation in Canada, potential approval of Triferic in Chile, and updates on the China and EU opportunities. All of which have the potential to drive positive inflections for the stock this year [...] We believe Triferic is an innovative product that will drive significant value for RMTI shareholders. We expect product approvals and upward earnings revisions in our DCF model to drive RMTI's stock higher."Bearing this in mind, he stayed with the bulls, reiterating his Overweight call. At $11, his price target matches Selvaraju’s. (To watch Folkes’ track record, click here)With 100% Street support, the message is clear: Rockwell Medical is a Strong Buy. Adding to the good news, the average price target of $9.33 puts the upside potential at 326%. (See Rockwell Medical price targets and analyst ratings on TipRanks)Durect Corporation (DRRX)Biopharma company Durect has definitely had a rough going recently. Following an AdCom’s split vote after reviewing its Posimir treatment for post-surgical pain, shares dipped 12% premarket. That being said, two members of the Street just told investors that they are still optimistic enough to get on board.One of the analysts singing DRRX’s praises is B.Riley FBR’s Mayank Mamtani, highlighting its “first and only-of-its kind treatment, DUR-928, for multiple liver diseases, notably alcoholic hepatitis (AH).” He noted, “We believe that the strong efficacy and excellent safety observed with DUR-928 therapy in the Phase 2a trial has paved the path for late-stage development and primarily contributed to the 600%-plus stock move in 2019. We also believe that DUR-928 has the potential to become a part of combination treatment regimens for nonalcoholic steatohepatitis (NASH).”Additionally, Mamtani points to its transition away from legacy operations associated with drug delivery platforms and its potential to be a partner for a larger biopharma name as making it a standout. In line with his bullish take, the five-star analyst started coverage with a Buy rating and $5 price target. (To watch Mamtani’s track record, click here)Like Mamtani, Craig-Hallum’s Francois Brisebois sees huge potential based on DUR-928. “We believe shares are undervalued today given the opportunity for DUR-928 in AH alone, to which we have ascribed the vast majority of our valuation,” he commented. The analyst adds, “It’s hard to overstate DUR-928’s market potential in AH. We derive a TAM of $3 billion based upon the 117,000 annual hospitalizations and what we see as a fairly conservative $25,000 one-time cost of therapy given that hospitalizations cost are over $50,000 per patient in the first year.”It comes as no surprise, then, that Brisebois initiated coverage by publishing a bullish call. At the $6 price target, shares could soar 277% over the next twelve months. (To watch Brisebois’ track record, click here)In general, the rest of the Street is on the same page. 4 Buys and 1 Hold assigned in the last three months coalesce into a Strong Buy analyst consensus. Not to mention the $4.72 average price target implies 197% upside potential. (See Durect stock analysis on TipRanks)Zynerba Pharmaceuticals (ZYNE)Specializing in transdermal cannabinoid therapies, Zynerba wants to help patients suffering from Fragile X syndrome (FXS), a condition that can cause anxiety, social withdrawal and violent outbursts. On the heels of its announcement that it successfully achieved its patient screening target in its pivotal CONNECT-FX trial, which is evaluating its topical cannabinoid Zygel in children and adolescents with FXS, some believe that huge gains are in store.With pivotal results expected in June, Ladenburg Thalmann & Co. analyst Michael Higgins thinks the development team’s experience, Phase 2 results, CBD’s anxiolytic activity and the recruitment make a strong data readout very likely. On top of this, he believes management’s strategy of enrolling patients with more severe FXS will pay off. “We agree with management that along with the increased dosing the enrollment criteria should ensure Zygel’s efficacy in treating problematic FXS behaviors will be most appropriately demonstrated,” he explained.Even though Zynerba is a single-product company, Higgins points out that it has at least three events coming up in its second quarter and other regulatory, clinical and marketing-based events in 2020 that could prove to be major catalysts. These include Phase 3 CONNECT-FX data, which if positive could result in Fast Track designation, as well as data from the Phase 2 BRIGHT, Phase 2 INSPIRE and from Phase 2 DEE trials. In addition, Zygel could meet the needs of patients with autism spectrum disorder, 22q11.2 deletion syndrome and rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies, three other large market indications.To this end, Higgins kept his Buy rating and $26 price target as is. This conveys his confidence in ZYNE’s ability to skyrocket 417% in the next twelve months. (To watch Higgins’ track record, click here)Looking at the consensus breakdown, it has been relatively quiet when it comes to analyst activity as only two other reviews have been issued recently. However, both were bullish, making the consensus rating a Strong Buy. It also doesn’t hurt that the $18.67 average price target brings the potential twelve-month gain to 271%. (See Zynerba stock analysis on TipRanks)
- InvestorPlace
5 Stocks Under $5 With Colossal Growth Prospects
Investors want to see a return on investment, it's as simple as that. Regardless of the size of the investment, the end goal remains the same. Sure, there are several ways to go about achieving this objective, yet time after time Wall Street observers circle back to a single tried and true strategy.Growth investing involves identifying the stocks with long-term growth prospects that go above and beyond those of their peers.It should be noted, though, that plays in the growth-stock arena can sometimes come with a price tag to match their huge potential for gains. However, there are compelling names out there that don't cost a fortune.InvestorPlace - Stock Market News, Stock Advice & Trading TipsWhile some naysayers might argue that you get what you pay for, others will point out that stocks trading at low levels can represent some of the most compelling names on the Street, with entry points that make them even more attractive. * 7 Stocks to Buy for February Contrarians With this in mind, I used TipRanks' Stock Screener tool during my own search for affordable growth names. After sorting the results by current share price, analyst consensus and price target, the tool revealed three stocks that have received a wealth of support from Wall Street analysts, all under $5 per share. To top it all off, each boasts massive upside potential from current levels. Matinas BioPharma (MTNB)Source: Shutterstock Like the name suggests, Matinas BioPharma Holdings (NYSE MKT:MTNB) is a biopharma focused on the development of lead candidate, MAT9001, its prescription-only omega-3 fatty acid drug for cardiovascular and metabolic conditions. After the FDA approved the label expansion of Amarin's Vascepa drug to include cardiovascular disease patients with high triglycerides of greater than 150 mg/dL, some analysts believe that MTNB's $1.44 share price is a bargain.Piper Sandler analyst Edward Tenthoff tells investors that his bullish thesis is primarily driven by earlier data published by MTNB. Back in 2015, the company reported that during a Phase 1 study, MAT9001 was found to have produced a greater reduction of triglycerides, with the figure coming in at 33% compare to Vascapa's 11%.The drug is currently being evaluated in the Phase 2 ENHANCE-IT study versus Vascepa. With data slated for release in the fourth quarter of this year, big things could be on the way. Tenthoff argues MTNB could start a single Phase 3 severe hypertriglyceridemia trial in 2021 and see potential approval in 2023. In addition, he thinks that the importance of omega-3-based medicines is expanding.All of the above factors prompted the analyst to start his MTNB coverage by publishing an "overweight" rating and setting a $3 price target. Should the target be met, shares could be in for a 108% gain over the next twelve months.Similarly, the rest of the Street takes a bullish approach when it comes to MTNB. Out of four analysts tracking the name over the last three months, 100% see the stock as a "buy," making the consensus rating a "strong buy." Given the $3.25 average price target, the upside potential of 126% surpasses Tenthoff's estimate. See the MTNB stock analysis. Northern Oil And Gas (NOG)Source: Shutterstock Northern Oil and Gas (NYSE MKT:NOG) is one of the primary non-operator franchises in the Bakken and Three Forks plays in the Williston Basin of North Dakota and Montana. Its total footprint, which lands at about 165,000 acres, as well as its proved reserves of 65.3 million barrels of oil equivalent at year-end 2015, has helped cement its status as one of the leading players in the space. Its $1.69 price tag seems almost too good to be true.Back in December, the company gave investors a reason to get excited after it announced that it would start paying out a quarterly dividend. The first dividend will come in at two cents per share, payable in April 2020. In addition, the forward yield lands at 3.14%.This news prompted Imperial Capital analyst Jason Wangler to boost his rating from "in-line" to "outperform." He argues that while the dividend is modest, it demonstrates that NOG has taken steps in the right direction in terms of its balance sheet over the last two years. On top of this, it also means that the name can be thought of as a yield vehicle.It makes sense, then, that in addition to the upgrade, Wangler bumped up the price target from $2 to $2.50. At this new target, the upside potential comes in at 48%. * 7 Under-the-Radar European Stocks to Buy for 2020 When it comes to other analyst activity, it has been relatively quiet on Wall Street. That being said, the two other analysts that published a review in the last three months rated NOG as a "buy," making the Street consensus a "strong buy." Not to mention the $3.25 average price target brings the upside potential to 92%. See the NOG stock analysis. Durect Corporation (DRRX) Source: Shutterstock Durect Corporation (NASDAQ:DRRX) has a simple objective: to transform medicine. It wants to develop drugs that can provide meaningful advances in patient health and wellbeing. At the bargain price of $2.12 per share, analysts warn investors that if they wait too long, they could miss out on the opportunity.While investor concern has definitely emerged, Craig-Hallum analyst Francois Brisebois is still very much on board. Fears among investors have been driven by the company's announcement that the AdCom vote for its Posimir drug's Class 2 New Drug Application (NDA) resubmission was split right down the middle.As a result, Brisebois doesn't assign any value to the drug in the model. Rather, he highlights its DUR-928 candidate for primary alcoholic hepatitis as DRRX's primary value driver, calling early efficacy and safety data incredibly encouraging. On top of this, the analyst argues that the combination of the current poor standard of care and the $3 billion total addressable market played into his conclusion that investors should buy on any weakness.With this in mind, Brisebois kicked off his DRRX coverage by issuing a "buy" rating. In addition, he set a Street high price target of $6, implying a staggering 183% upside potential.Meanwhile, the rest of the Street also likes what it's seeing. A "strong buy" consensus rating breaks down into three "buys" and a single "hold." While less aggressive than that of Brisebois, the $4.65 average price target still puts the potential twelve month gain at 119%. See the DRRX stock analysis. Carrols Restaurant Group (TAST)Source: Shutterstock While the name Carrols Restaurant Group (NASDAQ:TAST) might not ring any bells, but you've probably heard of its restaurants Burger King and Popeyes. It is true that shares took a pretty substantial hit following its preliminary fourth quarter results. Now at just $4.80 apiece, Deutsche Bank's Brian Mullan is still in the restaurant company's corner.The negative reaction came largely as a result of Burger King's same store sales (SSS) results. At 2%, the figure falls well below the implied guidance's range of 4% to 5% range and reflects a deceleration in November and December.However, Mullan tells investors that there's a silver lining. Management noted that the focus will shift towards managing both net leverage levels and free cash flow. "While management wasn't explicit with its plans, reading the tea leaves our sense is that these comments could pertain to either: 1) a reduced pace of acquisitions for the foreseeable future, 2) a potential slowdown in new unit development, or 3) all of the above," he explained.This combined with the new CFO appointment implies that the plans for the above are "… fluid and evolving. We think the key takeaway here is that management is mindful of the market's perception of TAST's net leverage levels, and that it has several options at its disposal to address this, should it see fit," Mullan added.Taking all of this into consideration, the analyst left his "buy" rating and $8 price target as is. This means that shares could potentially surge 67% in the next twelve months. * 7 Biometrics Stocks That Will Help Shape the Next Decade Judging by the consensus breakdown, the rest of the Street is in agreement. With only "buy" ratings assigned in the last three months, the message is clear: TAST is a "strong buy." It also doesn't hurt that the $8.83 average price target suggests 84% upside potential. See the TAST stock analysis. VBI Vaccines (VBIV)Source: Shutterstock VBI Vaccines' (NASDAQ:VBIV) claim to fame is its Sci-B-Vac product, which was the first vaccine to be commercially-approved for hepatitis B. The vaccine is currently available in Israel and ten other countries. It recently completed its Phase 3 program in the U.S., Europe and Canada. After new data was released earlier this month, analysts have been impressed, to say the least.On Jan. 9, the company, which goes for $1.46 a share, announced that Sci-B-Vac had met both its primary and secondary endpoints in the second Pivotal Phase 3 CONSTANT study. Both management and investors were excited by the results as they demonstrate that the candidate is both safe and highly-potent.While this outcome is encouraging, VBIV's potential extends beyond Sci-B-Vac. BMO Capital analyst Do Kim highlights its VBI-1901 and VBI-2601 candidates as potentially driving significant upside. According to the analyst, updated Phase 1/2a tumor response and survival data for VBI-1901's use in glioblastoma multiforme (GMB) is slated for release some time in the first half of 2020. Should the results be favorable, VBIV could develop a modified version to target other EBV+ cancers. On top of this, VBI-2601 proof-of-concept for use in chronic hepatitis B infection (HBV) is expected in the second half of the year."We believe the initial data could be meaningful for VBI's vaccine approach for a functional HBV cure, with the potential for combining beyond antivirals, including Brii's VIR-2218 and other HBsA RNAi. With an estimated 257 million chronically infected patients worldwide, we believe HBV represents a significant market opportunity for a functional cure," Kim commented.Based on everything the healthcare name has going for it, Kim reiterated his "outperform" rating and $5 price target, indicating 242% upside potential.Out of three total analysts that have thrown their hat in with a review, 100% sided with the bulls, making the consensus rating a "strong buy." See the VBIV stock analysis.TipRanks offers investors the latest insight into eight different sectors by tracking the activity of over 5,000 Wall Street analysts. As of this writing, Maya Sasson did not hold a position in any of the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 Stocks to Buy for February Contrarians * 10 of the Top Franchise Stocks to Buy Now * 5 High-Yield Stocks With High Free Cash Flow Yields The post 5 Stocks Under $5 With Colossal Growth Prospects appeared first on InvestorPlace.
- MarketWatch
UPDATE: Durect stock slides after FDA committee ends meeting with split vote on post-surgical pain treatment
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%.
- Benzinga
The Daily Biotech Pulse: Novo Nordisk's Ozempic Receives Label Expansion For Cardiovascular Events, Adcom Disappointment Inflicts Pain On Durect Shares
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 ...
- PR Newswire
DURECT Corporation Announces Outcome of FDA Advisory Committee Meeting for POSIMIR®
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.
- MarketWatch
Biopharma Durect shares halted ahead of FDA committee meeting on post-surgical pain treatment
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%.
- PR Newswire
DURECT Corporation Trading Halted Today; FDA Advisory Committee to Discuss POSIMIR® (bupivacaine extended-release solution) for Post-Surgical Analgesia
DURECT Corporation (Nasdaq: DRRX) today announced that NASDAQ has halted trading of the Company's common stock today.
- Investopedia
Top Pharmaceutical Stocks for Q1 2020
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).
- American City Business Journals
Drug developer dips on failed psoriasis trial
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.
- MarketWatch
Durect's stock tumbles after failed psoriasis trial
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.
- PR Newswire
DURECT Corporation Announces Top-Line Results from Phase 2a Clinical Trial in Patients with Psoriasis
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.
- TipRanks
3 Healthcare Stocks With Huge FDA Decisions in January
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)
- Benzinga
Week Ahead In Biotech: PDUFA Date Ahead For Astra Zeneca, Merck's Lynparza, Pending Clinical Readouts In Focus
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 ...
- Insider Monkey
Hedge Funds Had Impeccable Timing Buying DURECT Corporation (DRRX)
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 […]
- Thomson Reuters StreetEvents
Edited Transcript of DRRX earnings conference call or presentation 4-Nov-19 9:30pm GMT
Q3 2019 DURECT Corp Earnings Call
- PR Newswire
DURECT to Present at the Stifel 2019 Health Care Conference
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.
- PR Newswire
DURECT Corporation Announces Positive Results from the Phase 2a Clinical Trial of DUR-928 in Alcoholic Hepatitis Patients in a Late-Breaking Presentation at The Liver Meeting®
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.
- PR Newswire
DURECT to Host Key Opinion Leader Call on DUR-928 Phase 2a Alcoholic Hepatitis Study Results
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.
- PR Newswire
DURECT Corporation Announces Third Quarter 2019 Financial Results and Update of Programs
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 ...
- PR Newswire
DURECT Corporation to Announce Third Quarter 2019 Financial Results and Provide Business Update on November 4
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 ...
- PR Newswire
DURECT Announces DUR-928 Phase 2a Alcoholic Hepatitis Study Results Selected for Late-Breaking Oral Presentation at The Liver Meeting® 2019
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. ...
- American City Business Journals
These 24 Bay Area drug and diagnostics companies quietly raised nearly $3B this year
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?
- PR Newswire
DURECT to Present at Two Upcoming NASH Investor Conferences
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 ...
- PR Newswire
DURECT Announces Completion of Enrollment in its Phase 2a Clinical Trial of DUR-928 in Psoriasis and 50% Enrollment in its Phase 1b DUR-928 Clinical Trial in NASH
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.
