Commodity Channel Index
|Bid||15.50 x 900|
|Ask||15.51 x 900|
|Day's Range||15.31 - 16.00|
|52 Week Range||3.52 - 21.93|
|Beta (5Y Monthly)||1.28|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||11.92|
Shares in Aurinia Pharmaceuticals, Inc (AUPH) advanced in pre-market trading as the biotech company announced the submission of the New Drug Application (NDA) for its experimental voclosporin drug for the treatment kidney inflammation.The stock rose 3.1% to $16.75 in pre-market U.S. trading. Aurinia said that the NDA submitted to the U.S. Food and Drug Administration (FDA) is backed by a global clinical program including the pivotal Phase 3 Aurora study and the pivotal Phase 2 Aura LV study.There are currently no FDA-approved treatments for serious kidney inflammation, also known as lupus nephritis (LN). Voclosporin is a potentially best-in-class calcineurin inhibitor (CNI) and an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney.“LN is a severe and debilitating consequence of lupus, which can severely impact the quality of life of individuals struggling with this disease,” said Peter Greenleaf, President and CEO of Aurinia. “We are rapidly advancing our U.S. commercial strategy and infrastructure to support a potential launch early next year.”The Canada-based biotech company added that the NDA submission also includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months.Shares in Aurinia have dropped 24% so far this year. Five-star analyst Ed Arce at H.C. Wainwright this month reaffirmed his Buy rating on the stock with a bullish $32 price target (97% upside potential).“With several key appointments to its Board and its senior management team highlighting the ongoing commercial preparations, we expect Aurinia to rapidly take a leading position in the LN market with voclosporin,” Arce wrote in a note to investors. “We estimate an 87.5% probability of approval for voclosporin, with a launch in early 2021 assuming a rather modest 19.6% peak penetration in diagnosed active LN patients.”Overall, TipRanks data shows that the biotech player is drawing an unanimous bullish outlook from Wall Street. The score of 6 Buy ratings from analysts in the past three months is making the consensus a Strong Buy. The 12-month average price target stands at $25.40, reflecting a 56% upside potential from where the stock is currently trading. (See AUPH stock analysis on TipRanks).Related News: Regeneron and Sanofi’s Dupixent Shows ‘Positive’ Trial Data, Meets Co-Primary Endpoints Regeneron To Repurchase $5 Billion Stake From Sanofi Chi-Med, BeiGene Join Forces For Solid Cancer Tumor Treatment More recent articles from Smarter Analyst: * AutoZone Surprises with Business as Usual Quarter * 3 "Strong Buy" Penny Stocks That Offer Massive Potential Gains * Logitech Shares Lifted In Pre-Market On Share Buyback Plan, 10% Dividend Boost * Billionaire Ackman Exits Berkshire Hathaway, Blackstone To Fund Opportunities
Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced the completion of the rolling submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for voclosporin as a potential treatment for lupus nephritis ("LN"), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus ("SLE"). There are currently no FDA-approved treatments for LN. The NDA submission includes a request for Priority Review, which, if granted, would shorten the FDA’s review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months.
Despite COVID-19's devastating impact, one legendary stock picker might have just cracked the market code. While the broader market tumbled, investing firm Renaissance Technologies and its founder Jim Simons could mark 2020 as a year of record-smashing growth. Since the start of this year through April 14, the firm’s core Medalian hedge fund notched a 24% gain.So, how has Simons managed to do it? When the professor and mathematician left the world of academia and launched Renaissance in 1982, he fundamentally changed the investing process, pioneering a new quantitative approach that relies on algorithms to uncover patterns in the market. Using this strategy, the firm has become one of the best-performing quant shops on the Street.Traditional methods like relying on intuition, speaking with companies and analyzing balance sheets didn’t stand a chance against Simons and his computer models. Medallion has returned 66% per year, or 39% after fees, since 1998, leaving other gurus like Warren Buffet and Ray Dalio in the dust. While Simons, who is now worth an estimated $23 billion, remains active at the firm but doesn’t directly oversee the fund anymore, he is in a league of his own, and is considered one of the all-time investing greats.Looking at Renaissance’s recent activity as a starting point, we poured through its latest 13F filing in an attempt to find compelling opportunities among its purchases. Narrowing in on three healthcare stocks, TipRanks’ database revealed that each is also admired by the analyst community, enough so to earn a “Strong Buy” consensus rating. It doesn’t hurt that all three sport some serious upside potential as well. Durect Corporation (DRRX)Using its endogenous epigenetic regulator program, Durect develops innovative treatments for acute organ injuries and chronic liver diseases. While it has experienced a pullback recently, some believe the weakness presents a buying opportunity. Among the bulls is Simons’ firm. In the last quarter, Renaissance gave its DRRX holding a boost when it added 989,000 shares. Its new position, which now lands at 5,208,212 shares, is valued at $8,073,000.Turning now to the Wall Street analysts, several take an optimistic approach when it comes to DRRX, including B.Riley FBR’s Mayank Mamtani. To back up his bullish thesis, the five-star analyst cites management’s update on the progress of lead development candidate, DUR-928, an epigenetic modulator. According to the company’s announcement, it’s collaborating with the FDA to study DUR-928 in a Phase 2 clinical trial involving COVID-19 patients in the hospital with acute organ injury.In preclinical studies, DUR-928 has already been able to stabilize mitochondria, modulate inflammatory responses and promote cell survival and tissue regeneration. Additionally, Mamtani points out that the candidate “may play an important role for up to half of hospitalized patients with COVID-19 reported to have had elevated liver enzyme levels, indicative of liver injury and more than a third of hospitalized patients reported to have kidney damage.” He added, “We are encouraged by DRRX's commitment to leverage DUR-928's unique mechanism to help combat the public health crisis, with an incremental cost of ~$3 million that has relatively limited impact on cash runway.” That being said, DUR-928's potential extends beyond COVID-19. Enrollment for the Phase 1b open label NASH program has been completed, with top-line data slated for release in Q2. The company has also been ramping up preparations to initiate a Phase 2b program for IV-administered DUR-928 in severe alcoholic hepatitis (AH) patients. These preparations include reaching an agreement on trial design and key study endpoints with the FDA. It should be noted that enrollment is now expected to begin in the second half of 2020 thanks to COVID-19-related impacts.As for its other candidate, POSIMIR, the company is currently managing information requests (IRs) regarding the NDA review. Mamtani thinks this “suggests an active engagement of agency in the review process.”Taking into account everything DRRX has to offer, Mamtani stated, “Given the recent pullback, we find both an undervalued AH opportunity and NT catalysts in top-line Phase 1b NASH results and the POSIMIR decision to offer an additional attractive entry point for DRRX shares.”To this end, Mamtani left a Buy rating and $5 price target on the stock. Should this target be met, a twelve-month gain of 100% could be in store. (To watch Mamtani’s track record, click here)Do other analysts agree with Mamtani? It turns out that they do. With 100% Street support, or 3 Buy ratings to be exact, the message is clear: DRRX is a Strong Buy. At $5.25, the average price target implies 110% upside potential. (See Durect stock analysis on TipRanks)Heron Therapeutics (HRTX)By applying innovative science and technologies with well-known pharmacology, Heron hopes to develop patient-focused solutions that address unmet medical needs. While HRTX did receive a CRL regarding its HTX-011 product, some believe it has the potential to be a best-in-class drug for post-operative pain.One of its fans is Renaissance. The billionaire’s fund snapped up 870,892 shares, increasing its HRTX holding by a whopping 482%. As for the new value of Renaissance’s position, it comes in at over $12.3 million.Wall Street analysts also have good things to say about HRTX. Representing Leerink, analyst Ami Fadia notes that HTX-011 review is on track for the June 26 PDUFA date, based on HRTX’s recent conversation with the FDA. Management also stated that the FDA communications suggest things are progressing well, with label discussions not expected to kick off before early June. With respect to HTX-011's CE marking in the EU, there will be a delay as a result of COVID-19, but management thinks the decision could come in the second half of 2020 and that the device shouldn’t encounter any review issues.Calling the HTX-011 growth opportunity underappreciated, Fadia argues “HTX-011's potential is supported by the strong pain reduction, safety, and opioid-sparing data from the Phase 3, and the total knee arthroplasty (TKA) and breast augmentation nerve block Phase 2b data.” She added, “We believe management has taken the appropriate steps to resolve the issues in the CRL, the additional three-month delay is not reflective of additional issues specific to HTX-011, and management can get approval by the June 26, 2020, PDUFA date.”On top of this, COVID-19 has had a relatively limited impact on Cinvanti sales, and the asset has held up well as arbitrage progresses. “Management remains confident in growth back in the franchise starting 2021, recapturing not only the clinic share lost during the arbitrage period but also continuing to gain share among those clinics that have been waiting until post arbitrage before adopting Cinvanti,” Fadia said.Bearing this in mind, Fadia stayed with the bulls. Along with an Outperform call, she reiterated the $26 price target. This target conveys her confidence in HRTX’s ability to climb 64% higher in the next year. (To watch Fadia’s track record, click here)With only Buy ratings assigned in the last three months, 6 to be exact, the consensus is unanimous: HRTX is a Strong Buy. In addition, the $38 average price target is more aggressive than Fadia’s and implies 136% upside potential. (See Heron stock analysis on TipRanks)Aurinia Pharmaceuticals (AUPH)Last up to bat, we have Aurinia, which wants to transform the way autoimmune diseases are treated. As its Voclosporin therapy represents a huge opportunity, Wall Street is getting behind this healthcare company.Simons’ firm didn’t miss out on an opportunity to tack on more shares to its AUPH holding. Renaissance bought up 860,266 shares, bringing its total stake in the company to 1,438,800 shares. After the position was bumped up by 149%, the new value is $20.9 million.Meanwhile, Cowen analyst Ken Cacciatore also likes what he’s seeing. He points out that the rolling NDA submission for Voclosporin, a next-generation calcineurin inhibitor that blocks IL-2 expression and T-cell mediated immune responses, in lupus nephritis (LN) is moving right on track, and should be completed by the end of Q2. This means that an approval could potentially come in the first half of 2021. “Our conviction in this management team and opportunity remains unchanged. This asset is still materially discounted at this valuation level, in our view,” he commented.According to Cacciatore, the robust results from the Phase 3 AURORA study “confirmed Voclosporin’s safety profile, clarifying the prior imbalance in deaths from the low-dose Voclosporin arm in Phase 2.” The analyst added, “Based on these results, and given the unmet need and significant market opportunity in LN, we believe Voclosporin could easily reach $1 billion-plus in this indication alone.”When it comes to AUPH’s intellectual property, Cacciatore thinks it is strong enough to enable more durability than others might expect. Expounding on this, he said, “Specifically, our legal consultants believe the patent claim of dose adjustments based on eGFR – and the unexpected findings of potentially improved efficacy at those lowered optimized doses – appears solid and defendable (after a full review of the prosecution history). And we believe the Voclosporin label will include language describing these findings/instructions, meaning generics would infringe.”Based on the clear pathway to approval for Voclosporin, most likely via a priority review, and the strength of its intellectual property, the deal is sealed for Cacciatore. As a result, he maintained an Outperform rating and $30 price target. Given this target, shares could rise 77% in the next twelve months. (To watch Cacciatore’s track record, click here)As for other analysts, it turns out that they have also been impressed. 6 Buys and no Holds or Sells have been received in the last three months, making the consensus rating a Strong Buy. A twelve-month gain of 52% could be in the cards if the $25.80 average price target is met. (See Aurinia stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
AUPH earnings call for the period ending March 31, 2020.
Shareholders might have noticed that Aurinia Pharmaceuticals Inc. (TSE:AUP) filed its first-quarter result this time...
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") today announced that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat during the 2020 RBC Capital Markets’ Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 10:20 a.m. E.D.T.
Aurinia (AUPH) delivered earnings and revenue surprises of 25.00% and -50.00%, respectively, for the quarter ended March 2020. Do the numbers hold clues to what lies ahead for the stock?
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) ("Aurinia" or the "Company") today reported financial results for the first quarter ended March 31, 2020 and provided an update on recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars.
Aurinia (AUPH) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Anyone researching Aurinia Pharmaceuticals Inc. (TSE:AUP) might want to consider the historical volatility of the...
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the appointment of Timothy P. Walbert, chairman, president and chief executive officer (CEO) of Horizon Therapeutics plc, to the Company’s Board of Directors.
We hate to say this but, we told you so. On February 27th we published an article with the title Recession is Imminent: We Need A Travel Ban NOW and predicted a US recession when the S&P 500 Index was trading at the 3150 level. We also told you to short the market and buy […]
NKF 2020 Spring Clinical Meetings Late-Breaking Presentation Announcement
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, announced today that the Company has initiated a Rolling Submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis ("LN"). The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the Nonclinical Module and expects to complete the submission of all Modules by the end of the second quarter of 2020.
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH / TSX:AUP) ("Aurinia" or the "Company") , a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced new initiatives to support the lupus nephritis (LN) community and raise disease awareness on World Kidney Day, during National Kidney Month and beyond. These initiatives and resources include:
AURINIA REPORTS FOURTH QUARTER AND FULL YEAR 2019 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
NEW YORK, NY / ACCESSWIRE / March 5, 2020 / Aurinia Pharmaceuticals, Inc. (AUPH) will be discussing their earnings results in their 2019 Fourth Quarter Earnings call to be held on March 5, 2020 at 4:30 ...
Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX: AUP) (the "Company") today announced that it will release its fourth quarter and full year 2019 financial results on Thursday, March 5, 2020, after the markets close. Aurinia’s management team will host a conference call to discuss the Company’s financial results and to provide a general business update.
Finding a stock which will deliver enormous returns is the Street’s holy grail. Upon first glance, this task may seem rather simple. Step 1 is to pinpoint a company with a small market cap and low valuation, preferably one that remains a relatively well-kept secret. Step 2: invest in said undiscovered gem, and then sit back and watch in gleeful awe as the initial investment multiplies itself repeatedly.While these thoughts are fanciful, they are not entirely unrealistic. Just ask anyone who invested in Netflix a decade ago, or in Amazon a decade before. It is possible to find other small-cap names poised to hand over similar returns these giants provided early investors, although admittedly, they are relatively rare and hard to come by. After all, if this was so easily achievable, we would all be filthy rich.With this in mind, we went on our own intrepid search for small-cap stocks, specifically ones which the Street thinks have enormous growth potential. Using TipRanks’ Stock Screener, we were able to get the scoop on three promising tickers. It appears that apart from the upside potential, all three also currently boast a “Strong Buy” consensus rating from Wall Street analysts. Here are the details.Aurinia Pharmaceuticals (AUPH)As biotechs tend to do, Aurinia’s share price soared majestically in early December. The surge followed the news that positive efficacy and safety results were achieved in a Phase 3 trial using voclosporin, the company’s candidate for the treatment of lupus nephritis. By the end of the month, Aurinia stock was trading 141% higher than it was before the news broke. If the orphan disease-focused biopharma continues in the same vein, it won’t be long before it outstrips its $2.1 billion market cap.Lupus (System Lupus Erythematosus – SLE) is a chronic condition which affects more than half a million people in the US, the majority of which are women. The disease can affect the heart, lungs and kidneys, amongst other parts of the body. Lupus nephritis (LN) is an inflammation of the kidney that represents a serious progression of SLE.Aurinia is expected to file an NDA for voclosporin’s use in treating patients with LN sometime in the first half of 2020, with potential approval by 2021. The drug is currently in trials for other indications, with results from a Phase 2/3 study using ophthalmic voclosporin to treat dry eye syndrome expected in 2H20.For Jefferies’ Maury Raycroft, the results were reason enough to take a bullish stance on Aurinia. The 4-star analyst said, "AUPH recently reported positive Phase 3 data that showed lead asset voclosporin (VCS) was effective and safe in lupus nephritis (LN) -- removal of the safety overhang was critical. Given clear need for approved LN agents and VCS' differentiated profile, we believe AUPH has an appealing opportunity ahead. After the LN Phase 3, we also believe VCS potential in FSGS and dry eye syndrome (DES) is more de-risked."Raycroft, therefore, initiated coverage on Aurinia with a Buy rating and set a price target of $27. The figure conveys the analyst’s belief that Aurinia has potential upside of 44% left in the tank. (To watch Raycroft’s track record, click here)The biopharma gets total support from the Street as of now; 5 Buys add up to a unanimous Strong Buy consensus rating. At $25, the average price target suggests 32% will be added to Aurinia’s share price over the next 12 months. (See Aurinia stock analysis on TipRanks) TTEC Holdings (TTEC)Hovering around roughly the same market cap as Aurinia, we come across TTEC Holdings. The $1.9 billion company, though, is an entirely different beast.TTEC deals in customer experience technology and services, with its digital offerings including AI enabled cloud platforms and CX (customer experience) consulting solutions. 2019 was a good one for TTEC, as its share price grew by 41% along the way. According to some fans on the Street, 2020 is shaping up to be much of the same.The company has several partnerships with household names in place. On January 22, TTEC announced a new contract with Volkswagen Group UK to oversee its digital transformation and provide customer experience solutions. The contract comes hot on the heels of new strategic alliances with LivePerson and Cisco Contact Center. Additionally, in October, TTEC acquired FCR, a customer experience provider for a multitude of industries that include high tech, e-commerce and gaming, amongst others.Northland’s Michael Latimore is a believer in the TTEC story. According to the 4-star analyst, the company’s expanded cloud contact center and AI partnerships are set to increase its growth opportunities. Latimore also notes that TTEC provides the highest-rated agent services to global 1,000 companies. This prompted the analyst to initiate coverage on the global tech services provider. The newly bestowed Outperform rating comes alongside a price target of $60. Bottom line? Latimore expects an 46% to be added to TTEC’s share price over the next year. (To watch Latimore’s track record, click here)Merrill Lynch’s Jason Kupferberg is another analyst siding with the bulls. The 5-star analyst believes TTEC’s competitive positioning, key partnerships and market leading position in customer experience technology and services are good enough reasons to initiate coverage with a Buy rating and $48 price target. (To watch Kupferberg’s track record, click here)And what about the rest of the Street? All good news, it appears. 4 Buy ratings coalesce into a Strong Buy consensus rating. The average price target comes in at $55, and implies further room for upside in the shape of 34%. (See TTEC stock analysis on TipRanks) Skyline Champion Corporation (SKY)SKY is in fact a relatively new company, created in June 2018 following a merger between Skyline and Champion Enterprises. Now, the company is one of the largest publicly traded factory-built-housing names in the US. With a market cap of $1.6 billion, it is the smallest company on our list. Don’t be fooled, though, by the relatively small figure, as this builder of manufactured and modular homes had a stellar 2019.The rally, though, came to an end last week with the release of the company’s latest earnings report, following which, the share price has dropped by over 20%. Despite the fact that EPS of $0.30 beat the estimate, revenue came in below expectations, down by 3.5% year-over-year to $342.2 million.So, following the earnings disappointment, should you stay away from the home builder? On the contrary, thinks SunTrust Robinson’s Rohit Seth. The 4-star analyst highlights Skyline’s M&A flexibility, superior positioning to cyclical and secular tailwinds, as well as its continued self-help opportunities as reasons for the company’s "significant estimate upside potential."As a result, the 4-star analyst kept his Buy rating on Sky and liked the company’s builder developer strategy enough to bump up his price target. The new target was raised from $40 to $45, and implies upside potential of 56% over the coming months. (To watch Seth’s track record, click here)Skyline’s Strong Buy consensus rating breaks down into 3 Buys and 1 Hold. Analysts, on average, expect the share price to reach $38.25 over the next 12 months, a figure which could provide gains of 32%. (See Skyline stock analysis on TipRanks)
Investors need to pay close attention to Aurinia Pharmaceuticals (AUPH) stock based on the movements in the options market lately.