|Bid||238.98 x 800|
|Ask||239.95 x 1100|
|Day's Range||231.93 - 241.06|
|52 Week Range||103.75 - 272.74|
|Beta (5Y Monthly)||1.08|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||244.68|
* Biologics License Application for efgartigimod in generalized myasthenia gravis on track to be submitted to U.S. Food and Drug Administration by end of year * Full data from ADAPT trial to be presented at upcoming medical meeting in 2020 * Cusatuzumab development strategy aligned with evolving AML treatment landscape to focus on combination with venetoclax and azacitidine * €1.9 billion in cash and cash equivalents and current financial assets strongly support commercial launch preparation of efgartigimod * Management to host conference call today at 2:30 pm CEST (8:30 am ET) July 30, 2020 Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced its half year 2020 financial results and provided a second quarter business update and outlook for the remainder of the year.“We are proud of the progress we have made during the first half of 2020 to advance our immunology pipeline and validate our first-in-class FcRn antagonist, efgartigimod. We announced positive topline results from the Phase 3 ADAPT trial, furthering our conviction that efgartigimod has the potential to significantly improve the standard of care for people with gMG as well as several other autoantibody-driven diseases. We are focused on our planned 2021 U.S. commercial launch of efgartigimod to bring this therapy to patients as quickly as possible and to advance on our ‘argenx 2021’ vision,” said Tim Van Hauwermeiren, CEO of argenx."We also remain committed to advancing our robust pipeline, including our late-stage efgartigimod trials in additional autoimmune indications and our early-stage candidates from our Immunology Innovation Program. Regarding cusatuzumab, which we are currently developing in a global collaboration with Janssen, as clinical trial sites re-open, we are taking the opportunity to evaluate the most appropriate development strategy given the rapidly evolving treatment landscape, ” continued Mr. Van Hauwermeiren. SECOND QUARTER 2020 AND RECENT BUSINESS UPDATEargenx continues to execute on its “argenx 2021” vision to become a fully integrated, global immunology company. The company continues to implement measures across the organization and in the operations of globally run clinical trials to minimize the impact of COVID-19 on employees, patients and their communities, physicians and ongoing business priorities. Commercial preparations underway to support potential approval and launch of argenx’s first-in-class FcRn antagonist, efgartigimod, in its first indication, generalized myasthenia gravis (gMG). * Biologics License Application (BLA) on track to be filed with the U.S. Food and Drug Administration (FDA) by the end of 2020 with an expected U.S. commercial launch in 2021 * Japanese Marketing Authorization Application (J-MAA) expected to be filed with the Pharmaceuticals and Medical Devices Agency (PMDA) in the first half of 2021 with an expected efgartigimod launch in gMG in Japan following the U.S. commercial launch * Commercial infrastructure readiness activities, including with global supply chain, are on track for launch timeline in the U.S. and Japan In May, argenx reported positive topline data from the Phase 3 ADAPT trial showing efgartigimod was well-tolerated and able to drive responses that support plans to offer individualized dosing to gMG patients. * ADAPT met its primary endpoint showing 67.7% of acetylcholine receptor-antibody positive (AChR-Ab+) gMG patients were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared with 29.7% on placebo (p<0.0001) * 63.1% of AChR-Ab+ gMG patients responded to efgartigimod compared with 14.1% on placebo on the Quantitative Myasthenia Gravis (QMG) score (p<0.0001) * 40.0% of efgartigimod-treated AChR-Ab+ patients achieved minimal symptom expression defined as MG-ADL scores of 0 (symptom free) or 1, compared to 11.1% treated with placebo * In AChR-Ab+ patients who met the primary endpoint, the majority showed a sustained response, including 88.6% who achieved a response for at least six weeks, 56.8% for at least eight weeks and 34.1% for at least 12 weeks * Safety profile of efgartigimod was comparable to placebo * Detailed data set to be presented at upcoming medical meeting in 2020 * argenx plans to meet with FDA in fourth quarter of 2020 to discuss bridging strategy for subcutaneous (SC) efgartigimod Positive ADAPT data support continued progress of efgartigimod in additional severe autoimmune indications within key commercial franchises. * Primary immune thrombocytopenia (ITP) registrational program includes ongoing ADVANCE trial evaluating 10mg/kg IV efgartigimod in up to 156 patients * Enrollment delays in the program have been observed due to COVID-19 * Discussions ongoing with FDA on how to bring forward SC components of program to meet COVID-19 enrollment challenges * Chronic inflammatory demyelinating polyneuropathy (CIDP) Phase 2 ADHERE trial ongoing evaluating SC efgartigimod * Due to COVID-19 enrollment delays, potential decision to expand trial up to 130 patients now expected in 2021 * Pemphigus vulgaris (PV) registrational trial to start in second half of 2020 following proof-of-concept data from adaptive Phase 2 trial that showed fast onset of disease control and deep responses with potential for steroid sparing * Fifth indication to be announced by end of 2020 Cusatuzumab development strategy aligned with evolving treatment landscape and anticipated global adoption of venetoclax in acute myeloid leukemia (AML) clinical practice. * Development plan, in collaboration with Cilag GmbH International, an affiliate of the Janssen Pharmaceutical Companies of Johnson & Johnson, to now focus on cusatuzumab in combination with venetoclax, including in the Phase 1b ELEVATE combination trial of cusatuzumab with venetoclax and azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy * Trial enrolling again after pause due to COVID-19 * Maturing data from Phase 2 CULMINATE trial of cusatuzumab in combination with azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy suggest that complete response rates are not likely to exceed those from the VIALE-A trial of venetoclax in combination with azacitidine presented at the European Hematology Association (EHA) Annual Congress in June 2020 * Based on enrollment to date, dose selected to be 20mg/kg * CULMINATE trial will continue to evaluate responses and durability for existing patients but will not enroll new patients * Topline data to be reported in early 2021 * Registration strategy to be determined following evaluation of maturing data across cusatuzumab program and AML treatment landscape * Phase 1 trial of cusatuzumab in combination with azacitidine trial in Japan evaluating newly diagnosed, elderly AML patients who are ineligible for intensive chemotherapy remains ongoing * Phase 2 BEACON trial of cusatuzumab in combination with azacitidine versus azacitidine alone in higher-risk patients with myelodysplastic syndromes (MDS) who are ineligible for intensive chemotherapy remains paused for enrollment * Part 1 dose escalation of Phase 1 study of cusatuzumab in combination with azacitidine in newly diagnosed, elderly patients with AML who are ineligible for intensive chemotherapy, published in Nature Medicine argenx continues to advance its early-stage pipeline of first-in-class antibodies against immunologic targets. * ARGX-117 targeting complement C2 to be evaluated in Phase 1 healthy volunteer trial starting in third quarter of 2020 * Following analysis of Phase 1 data, argenx plans to launch Phase 2 proof-of-concept trials in severe autoimmune diseases, including multifocal motor neuropathy (MMN) * Single-center Phase 1 trial remains open for enrollment to evaluate ARGX-117 as a potential treatment for acute respiratory distress syndrome (ARDS), a frequent and serious complication associated with COVID-19 * ARGX-118 targeting Galectin-10 is undergoing lead optimization work as a potential treatment for airway inflammation * ARGX-119 on track to be announced in 2020 Partnered antibody candidates that emerged from argenx’s Immunology Innovation Program continue to have the potential to bring non-dilutive capital in the form of milestone payments and future royalties * AbbVie’s ongoing Phase 1 trial of ABBV-151 (formerly ARGX-115) in solid tumors remains open for enrollment * LEO Pharma plans to reopen sites in late August for enrollment in ongoing Phase 1 trial of LP0145 (formerly ARGX-112) for the treatment of atopic dermatitis * Staten initiated dosing in first-in-human clinical trial of STT-5058 (formerly ARGX-116) targeting apoC3 for the potential treatment of dyslipidemia HALF YEAR 2020 FINANCIAL RESULTS (CONSOLIDATED) Six Months Ended June 30, (in thousands of € except for shares and EPS) 2020 2019 Variance Revenue € 22,388 € 43,532 € (21,143) Other operating income 8,729 7,767 961 Total operating income 31,117 51,299 (20,182) Research and development expenses (171,718) (78,304) (93,414) Selling, general and administrative expenses (61,644) (27,462) (34,181) Total operating expenses (233,362) (105,767) (127,595) Change in fair value on non-current financial assets 848 — 848 Operating loss € (201,397) € (54,467) € (146,929) Financial income/(expense) (2,178) 7,210 (9,388) Exchange gains/(losses) 199 2,486 (2,287) Loss before taxes € (203,376) € (44,771) € (158,605) Income tax (expense)/benefit € (2,261) € (350) € (1,911) Loss for the year and total comprehensive loss € (205,637) € (45,121) € (160,516) Net increase/(decrease) in cash, cash equivalents and current financial assets compared to year-end 2019 and 2018 596,977 1,368,229 Cash, cash equivalents and current financial assets at the end of the period 1,932,798 944,283 DETAILS OF THE FINANCIAL RESULTS On June 30, 2020, cash and cash equivalents and current financial assets totaled €1,932.8 million, compared to €1,335.8 million on December 31, 2019. The increase in cash and cash equivalents and current financial assets resulted primarily from the closing of a global offering, including a U.S. offering and a European private placement, which resulted in the receipt of €730.7 million net proceeds in June 2020.Total operating income decreased by €20.2 million for the six months ended June 30, 2020 to €31.1 million, compared to €51.3 million for the six months ended June 30, 2019. This decrease is primarily related to the milestone payments following the first-in-human clinical trial with ABBV-151 under the AbbVie collaboration which was achieved in the first six months of 2019, partly offset by the revenue recognition of the transaction price related to the Janssen collaboration and the increase in other income mainly driven by higher payroll tax rebates for employing certain research and development personnel.Research and development expenses in the first six months of 2020 amounted to €171.7 million, compared to €78.3 million for the first six months of 2019. The increase resulted primarily from higher external research and development expenses primarily related to the efgartigimod program in various indications, the cusatuzumab program and other clinical and preclinical programs. Furthermore, the personnel expenses increased due to the planned increase in headcount.Selling, general and administrative expenses totaled €61.6 million in the first six months of 2020, compared to €27.5 million for the first six months of 2019. This increase primarily resulted from higher personnel expenses and consulting fees related to the preparation of a possible future commercialization of argenx’s lead product candidate, efgartigimod.For the six months ended June 30, 2020, financial expenses, which primarily relate to interest received and changes in fair value of current financial assets, amounted to €2.2 million compared to a financial income of €7.2 million for the six months ended June 30, 2019. Financial expenses corresponded mainly to a decrease in net asset value on its current financial assets following the impact of the COVID-19 outbreak on the financial markets.Exchange gains totaled €0.2 million for the six months ended June 30, 2020, compared to €2.5 million for the six months ended June 30, 2019 and were mainly attributable to unrealized exchange rate gains on cash, cash equivalents and current financial assets.A net loss of €205.6 million and an operating loss of €201.4 million were realized for the six months ended June 30, 2020, compared to a net loss of €45.1 and operating loss of €54.5 million for the six months ended June 30, 2019.EXPECTED 2020 FINANCIAL CALENDAR: ·October 22, 2020: Q3 financial results & business update CONFERENCE CALL DETAILS The half year 2020 results and second quarter business update will be discussed during a conference call and webcast presentation today at 2:30 pm CET/8:30 am ET. To participate in the conference call, please select your phone number below and use the confirmation code 7470386. The webcast may be accessed on the Investors section of the argenx website at argenx.com/investors.Dial-in numbers: Please dial in 5–10 minutes prior to 2:30 p.m. CET/ 8:30 a.m. ET using the number and conference ID below.Confirmation Code: 7470386 Belgium +32 (0)2 793 3847 Belgium 0800 484 71 France +33 (0)1 7070 0781 France 0805 101 465 Netherlands +31 (0)20 0795 6614 Netherlands 0800 023 5015 United Kingdom +44 (0) 844 481 9752 United Kingdom 0800 279 6619 United States +1 (646) 741 3167 United States +1 (877) 870 9135About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx is translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx is evaluating efgartigimod in multiple serious autoimmune diseases, and cusatuzumab in hematological cancers in collaboration with Janssen. argenx is also advancing several earlier stage experimental medicines within its therapeutic franchises. argenx has offices in Belgium, the United States and Japan. For more information, visit www.argenx.com and follow us on LinkedIn at https://www.linkedin.com/company/argenx/.For further information, please contact: Beth DelGiacco, Vice President, Investor Relations (US) +1 518 424 4980 firstname.lastname@example.orgJoke Comijn, Director Corporate Communications & Investor Relations (EU) +32 (0)477 77 29 44 +32 (0)9 310 34 19 email@example.comForward-looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should” and include statements argenx makes concerning its 2020 business and financial outlook and related plans; the therapeutic potential of its product candidates; the intended results of its strategy and argenx’s, and its collaboration partners’, advancement of, and anticipated clinical development, data readouts and regulatory milestones and plans, including the timing of planned clinical trials and expected data readouts; the design of future clinical trials and the timing of regulatory filings and regulatory approvals. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.
On Thursday, July 30, argenx (NASDAQ: ARGX) will release its latest earnings report. Benzinga's outlook for argenx is included in the following report.Earnings and Revenue argenx EPS will likely be near $-2.7 while revenue will be around $22.22 million, according to analysts. argenx's loss in the same period a year ago was $-1.120 per share. Quarterly sales came in at $7.83 million. If the company were to match the consensus estimate, earnings would be down 141.07%. Revenue would be up 29.94% from the year-ago period. In comparison to analyst estimates in the past, here's how the company's reported EPS stacks up:Quarter Q1 2020 Q4 2020 Q3 2019 Q2 2019 EPS Estimate -1.56 -1.10 -1.34 -0.91 EPS Actual -2.06 -2.63 -0.72 -1.12 Revenue Estimate 17.10 M 21.84 M 17.30 M 17.47 M Revenue Actual 21.15 M 19.45 M 9.52 M 7.83 M Stock Performance Shares of argenx were trading at $253.23 as of July 29. Over the last 52-week period, shares are up 75.8%. Given that these returns are generally positive, long-term shareholders should be content going into this earnings release.View more earnings on ARGXDon't be surprised to see the stock move on comments made during its conference call. argenx is scheduled to hold the call at 09:00:00 ET and can be accessed here: https://edge.media-server.com/mmc/p/wc62shzrSee more from Benzinga * Benzinga's Top Upgrades, Downgrades For July 29, 2020 * Stocks That Hit 52-Week Highs On Friday * Stocks That Hit 52-Week Highs On Thursday(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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Breda, the Netherlands / Ghent, Belgium — argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today the closing of its previously announced global offering of an aggregate of 4,207,292 ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)), which includes the full exercise of the underwriters’ option to purchase 548,777 additional ADSs. Stifel, JMP Securities, Wedbush PacGrow, Nomura and Kempen & Co acted as co-managers for the offering. The securities were offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC).
Breda, the Netherlands / Ghent, Belgium — argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today that the underwriters of its previously announced global offering of ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)) have exercised their option to purchase 548,777 additional ADSs in full on the same terms and conditions as the global offering. This option exercise brings the anticipated total gross proceeds from the global offering to approximately $862.5 million (approximately €784.7 million) from the sale of an aggregate of 4,207,292 ordinary shares (including ordinary shares represented by ADSs).
Breda, the Netherlands / Ghent, Belgium — argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today the pricing of a global offering of ordinary shares represented by American Depository Shares (ADSs) in the United States and certain other countries outside of European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area. The Company anticipates total gross proceeds of approximately $750.0 million (approximately €682.4 million) from the sale of 2,584,138 ADSs at a price of $205.00 per ADS and the sale of 1,074,377 ordinary shares at a price of €186.52 per ordinary share.
argenx's (ARGX) lead pipeline candidate, efgartigimod, meets primary endpoint in a pivotal study evaluating it in myasthenia gravis. A BLA is likely to be filed by the end of 2020.
Breda, the Netherlands / Ghent, Belgium — argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, announced today that it has commenced a global offering of $500 million (approximately €458.3 million) of ordinary shares, which may be represented by American Depository Shares (“ADSs”). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area.
Shares of argenx (NASDAQ: ARGX), a clinical-stage biotechnology company, are on the move following positive results from the Adapt trial of efgartigimod. An impressive 67.7% of those treated with efgartigimod achieved improvements on their myasthenia gravis activities of daily living (MG-ADL) scores of at least two points. Myasthenia gravis is a relatively rare immune disorder that weakens patients by jamming up the transmission of signals between their brains and their muscle fibers.
Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced positive topline data from the pivotal ADAPT trial of efgartigimod. ADAPT met its primary endpoint defined as percentage of responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score among acetylcholine receptor-antibody positive (AChR-Ab+) generalized myasthenia gravis (gMG) patients.
A press release with our first quarter 2020 business update and financial results was issued earlier today and can be found on our website along with the presentation for today's webcast. Thank you, Beth and welcome everyone.
- Topline data readout from Phase 3 ADAPT trial of efgartigimod in generalized myasthenia gravis on track for mid-2020 and Biologics License Application filing.
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As the month of May kicked off, stocks got off to a rocky start. The market slumped in response to a first quarter profit miss from eCommerce giant Amazon (NASDAQ:AMZN) and its plan to put all second-quarter earnings towards its COVID-19 response, with all three of the major U.S. indexes landing in the red on the week's final day of trading. Aside from healthcare stocks, many also came under pressure as tensions between the U.S. and China flared after the Trump administration stated that China will be held accountable for COVID-19. May 1's disappointing trading session came on the heels of the largest monthly surge for Wall Street in more than three decades. However, that's not to say investors should hold off on all new additions to their portfolios. The investing pros note that it's still possible to unmask the names poised to take off on an upward trajectory, you just have to know what to look for. This is especially true of the healthcare space, which has managed to hold up significantly better than other industries. Advising careful due diligence, they recommend focusing on healthcare stocks the analyst community as a whole believes have healthy long-term growth prospects. InvestorPlace - Stock Market News, Stock Advice & Trading TipsOnce we knew what to watch out for, we used TipRanks' database to pinpoint seven compelling healthcare stocks: * Ascendis Pharma A/S (NASDAQ:ASND) * Argenx SE (NASDAQ:ARGX) * Amicus Therapeutics, Inc. (NASDAQ:FOLD) * Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) * Natera, Inc. (NASDAQ:NTRA) * United Therapeutics Corporation (NASDAQ:UTHR) * Axsome Therapeutics Inc. (NASDAQ:AXSM) * 10 Key Stocks to Watch Over the Next Few Months Each of these healthcare stocks is backed by several analysts, enough to earn a "strong buy" consensus rating. Not to mention some pretty impressive upside potential is on the table. Let's dive right in. Ascendis Pharma (ASND) Source: Shutterstock The first of our healthcare stocks to buy is Ascendis Pharma. Using its cutting-edge TransCon technology, Ascendis optimizes the dosing capabilities of products that are already on the market. Following a recent Phase 2 data readout, several members of the Street are even more excited about this stock's long-term growth prospects. Writing for Oppenheimer, analyst Leland Gershell argues that the results clearly demonstrate TransCon PTH has the potential to be a "true replacement therapy in patients with hypoparathyroidism." In the 21µg/day arm, which was the highest dose, nine out of 15 patients met each of the primary and secondary composite endpoints. All patients were able to eliminate the standard of care (SOC). Adding to the good news, there was a positive effect on renal calcium resorption. Gershell added, "No severe or serious adverse events were recorded, nor was any hypocalcemia during titration off SOC. Hypercalcemia was observed in 2/15 (13%) in 21µg/day cohort w/o clinical sequelae. We would expect dose tailoring on an individual basis, as would occur in practice vs. trial's fixed dosing, to be supportive to safety." Looking forward to the initiation of Phase 3 in the fourth quarter, Gershell sees a large market opportunity, with the worldwide target market coming in at 200,000 and at 70,000-112,000 for the U.S. Taking all of this into consideration, Gershell decided to stay on the bulls' side. Along with his "outperform" call, he also bumped up the price target to $219, implying 71% upside potential. Out of nine total ratings, 100% were bullish, making ASND's Street consensus a "strong buy." See the ASND stock analysis. Argenx SE (ARGX) Source: Shutterstock When it comes to Argenx, there is certainly some overhang. Cowen analyst Yaron Werber points out that full year 2019 was solid for ARGX, but there's more to the story. Several competing FcRn-targeting drugs in the MG space, including Immunovant's IMVT-1401 and Momenta's M281, have upcoming data readouts. These candidates appear to be well-tolerated and have previously shown upwards of 70-80%+ knockdown of IgG. However, the Cowen analyst believes ARGX's lead candidate, efgartigimod, can go head-to-head with these other therapies. "We believe that ARGX's efgartigimod has a potentially best-in-class profile with a first mover advantage across several indications (MG, ITP, PV and CIDP) while offering both IV and SQ formulations. Efgartigimod is eying lucrative multi-billion dollar markets. Our peak $2.3 billion in sales is based on a peak 30% share in MG and ITP with a 75% probability of success. Approval in both segments offers attractive upside before even considering the potential in other indications," Werber commented. As autoimmune disorders like MG, ITP, PV and CIDP still have unmet needs because the current available options like steroids and immunosuppressants have poor tolerability and IVIg is expensive, inconvenient, and faces capacity constraints, favorable Phase 3 MG data in mid-2020 and the BLA filing in MG in Q4 2020 could drive substantial upside in 2020. To this end, Werber left an "outperform" rating and $191 price target on the stock. Should this target be met, a twelve-month gain of 31% could be in store. * 7 A-Rated REITs to Buy Now Does the rest of the Street think ARGX can outperform in the long run? As it turns out, other analysts say yes. Six "buys" compared to no "holds" or "sells" assigned in the last three months add up to a "strong buy" consensus rating. At $194.36, the average price target puts the upside potential at 34%. See the ARGX stock analysis. Amicus Therapeutics (FOLD) Source: Shutterstock Amicus Therapeutics specializes in developing better therapies to help patients suffering from ultra-orphan diseases, including lysosomal storage disorders (LSDs). As one of its lead programs has already been well received post-launch, one analyst believes the healthcare company's future is only getting brighter. Its oral pharmaco-chaperone drug, Galafold, for Fabry, generated hefty sales of $55.3 million in Q4 2019. Not only did this top-line number beat the Street's $49.7 million call, but it also surpassed Cowen analyst Ritu Baral's $50.5 million estimate. Not to mention this result represents 13% quarter-over-quarter growth. Even though FOLD had a net loss of $91 million during the quarter and SG&A expense gained 9% quarter-over-quarter, it should be noted that this was in part caused by the expanded geographic scope of the launch of Galafold into Japan and the U.S. Baral added, "FOLD projects YE20 Galafold sales of $250-$260 million that would represent 37-43% year-over-year growth. Projected growth assumes maturing uptake in the EU top 5 countries (market share changing from ERT-switch to ERT-naive) and continued rapid uptake in US and non-top 5 EU countries. FOLD expects to see commercial sales from Latin American countries in 2021 to further drive topline growth." To top it all off, GTx pipeline development is continuing. CLN6 follow-up and initial CLN3 data are both slated for the second half of 2020. It should come as no surprise, then, that Baral kept an "outperform" call and $31 price target on the stock. This conveys her confidence in FOLD's ability to soar 174% in the next year. As for the rest of the Street, other analysts are in agreement. With three "buys" and one "hold," the word on the Street is that the healthcare name is a "strong buy." Based on the $21.17 average price target, shares could climb 87% higher in the next twelve months. See the FOLD stock analysis. Iovance Biotherapeutics (IOVA) Source: Shutterstock Next up on this list of healthcare stocks to buy is Iovance Biotheraputics. With the goal of stomping out cancer, Iovance develops transformative immuno-oncology tumor-infiltrating lymphocytes (TIL) therapies that use the power of a patient's own immune system. After its collaborator, Moffitt Cancer Center, provided an update on the Phase 1 testing of TILs plus nivolumab in CKI-naive metastatic non-small-cell lung carcinoma (NSCLC) patients, the stock is on Wall Street's radar. In order to be eligible, patients needed to be anti-PD-1 naive and at least one safely accessible metastasis from where TILs were isolated had to be present. Looking at the data, the therapy was effective in 25% of patients, with two complete responses recorded. On top of this, the key analysis indicates that in order to spur a clinical response, TILs need to survive and circulate systematically. Further explaining this, H.C. Wainwright's Joseph Pantginis noted, "Importantly, the authors also demonstrated that neoantigen positive T cells represented 21% of total TIL clonotypes. Although TIL clonotype persistence declines with time in the blood of these patients, persistent and stable levels of infused T cells associated with higher tumor killing and response. Thus, we believe that methods to enrich for these TIL populations, such as Iovance's next generation TILs could be critical to drive better clinical responses." As NSCLC is a notoriously difficult indication to address, Pantginis argues that the results should be interpreted as a major positive. With this in mind, he left a "buy" rating on IOVA. Along with his bullish call, the analyst lifted the price target from $36 to $48. This brings the upside potential to 50%. * 10 Healthcare Stocks to Buy Despite the Headlines With 100% Street support, or nine "buy" ratings set in recent months, the consensus is unanimous: IOVA is a "strong buy." See the IOVA stock analysis. Natera (NTRA) Source: Shutterstock At the core of Natera's mission, it hopes its innovative technology will deliver highly accurate solutions for noninvasive prenatal testing (NIPT), genetic-carrier screening, (PGD/PGS) as well as miscarriage testing. With it handing out a preliminary Q1 beat, several analysts believe the sky's the limit when it comes to this name among healthcare stocks. According to the company's management, Q1 revenue is expected to come in around $89-91 million, which would reflect 33-36% year-over-year growth. Additionally, even though investors have expressed concern regarding rising levels of competition, uptake for its mobile phlebotomy service, which allows patients to provide blood samples from the safety of their own home, has been solid. Weighing in for Canaccord Genuity, analyst Max Masucci points out that during the COVID-19 pandemic, NTRA has actually been gaining market share. "NTRA's core reproductive health business provides an essential service to pregnant women, and we continue to expect pregnancy-related doc visits to decline less than routine primary care visits over the coming months …We were positively surprised to see a major commercial payor grant temporary coverage to an incremental 20 million average risk pregnancies (for NIPT), which we view as an important step in the right direction," he stated. It also doesn't hurt that the company has a pro-forma cash balance of about $650 million-plus thanks to its $250 million-plus convertible raise. All of the above prompted Masucci to keep his "buy" rating and $46 price target as is. Given this target, the upside potential lands at 31%. NTRA has received support from other Wall Street analysts as well. The stock has only "buy" ratings attached to it, three to be exact, and thus the analyst consensus is a "strong buy." At $46.33, the average price target is slightly more aggressive than Masucci's and implies 32% upside potential. See the NTRA stock analysis. United Therapeutics (UTHR) Source: Freestocks Via UnsplashPharmaceutical company United Therapeutics already has multiple therapies approved for the treatment of pulmonary arterial hypertension (PAH) and pediatric neuroblastoma. However, after a strong showing in its first quarter, the gains could still keep on coming for UTHR, making it another great option for healthcare stocks to buy. During the most recent quarter, net revenue came in at $356.3 million, surpassing the $344.3 million consensus estimate. GAAP EPS also exceeded expectations, with the figure landing at $3.12 compared to the Street's $2.74 call. The top and bottom-line beats were primarily driven by Remodulin's resilience to generic versions of treprostinil, with the drug contributing $145.3 million in Q1 sales. Not to mention Orenitram saw 18% year-over-year revenue growth. Looking specifically at its cash position, UTHR rounded out the quarter with a healthy balance of $2.41 billion. While some investors have sounded the alarm bells regarding COVID-19's effect on sales, Wedbush analyst Liana Moussatos argues that the impact might not actually be so profound. "Management commented that Q1 sales were not impacted by the COVID-19 pandemic, but observed a decrease in new prescriptions and new patient starts for treprostinil-based therapies (Remodulin, Tyvaso and Orenitram) in April 2020 primarily due to the inability of patients to visit the doctor's office physically. Due to our view that COVID-19 is likely only to have a transient decrease in Q2 revenues, we remain comfortable with our revenue projections for 2020," Moussatos explained. On top of this, multiple near-term catalysts are fast-approaching, including the submission of an sNDA to expand Tyvaso labeling, a discussion with the FDA about potential indication expansion for Unituxin in relapsed/refractory neuroblastoma, and the launch of the pharmacy-filled version of Remodulin's RemUnity system. Based on all of the above, it's no wonder Moussatos reiterated an "outperform" rating and $243 price target, which indicates 123% upside potential. * 7 Stocks to Buy Benefiting From Millennial Money In general, other Wall Street analysts take a similar approach when it comes to UTHR and other healthcare stocks. Out of seven total analysts that have thrown an opinion into the mix recently, six were bullish, making the consensus rating a "strong buy." See the UTHR stock analysis. Axsome Therapeutics (AXSM) Source: Shutterstock And just like that, Axsome Therapeutics has another blockbuster opportunity, making it a great option out of the healthcare stocks out there. The company, which develops therapies for patients suffering from central nervous system (CNS) disorders, announced on April 27 that AXS-05 had met the primary and secondary endpoints in the Phase 2b/3 ADVANCE-1 trial testing the drug in patients experiencing agitation related to Alzheimer's disease (AD), the most common form of dementia. Compared to the placebo, AXS-05 was able to rapidly, substantially, and significantly improve agitation. Commenting on the results, H.C. Wainwright analyst Raghuram Selvaraju noted, "We believe that regulators in multiple territories ought to view these data favorably, particularly in light of the rapid onset of action and robust treatment effect. Furthermore, we expect that any confirmatory trial in this indication would not need to include an active comparator arm." It should be noted that currently, no FDA-approved treatments are available for AD agitation. In addition, agitation is seen in up to 70% of AD sufferers and is associated with accelerated cognitive decline, earlier nursing home placement and increased mortality risk. Given the high unmet medical need, the candidate has been granted FDA Fast Track designation. Thanks to this huge market opportunity, Selvaraju believes AXSM is well positioned for hefty gains. Along with his bullish call, he increased the price target to $210. This brings the upside potential to 133%. The rest of the Street doesn't beg to differ. With six "buys" compared to zero "holds" or "sells," the consensus is unanimous: AXSM is a "strong buy." While less aggressive than Selvaraju's, the $142.80 average price target still leaves room for 58% upside potential. See the AXSM 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 * America's 1 Stock Picker Reveals Next 1,000% Winner * 25 Stocks You Should Sell Immediately * 1 Under-the-Radar 5G Stock to Buy Now * The 1 Stock All Retirees Must Own The post 7 "Strong Buy" Healthcare Stocks to Buy Now appeared first on InvestorPlace.
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Topline data from Phase 3 ADAPT trial of efgartigimod in gMG expected in mid-2020Continued progress across broadest FcRn antagonist pipeline with up to five.
The calendar might have flipped to 2020, but that doesn’t mean everything has changed. Investors are still scouring the Street in search of the most compelling investment opportunities, the names that could see 2020 be their year.These aren’t just any run of the mill stocks. We’re talking about tickers that are set to outperform the broader market and can hand over substantial returns in the year ahead. Having said that, tackling this job isn’t always easy. With so many options out there, it can seem overwhelming. Luckily, Wall Street analysts are here to lend a hand.Often experts in the industries that they cover, a nod of approval from the Street’s seasoned pros can signal that a certain stock should be on investors’ radar. Bearing this in mind, we turned to the analysts at investing firm Cowen for some inspiration as we started our own search. Using TipRanks, which assembles a comprehensive database of stock performance information, we were able to take a closer look at 3 of the firm’s top picks for 2020. To top it off, each has the support of the rest of the Street as well, boasting a “Strong Buy” consensus rating.Alexion Pharmaceuticals (ALXN)Alexion is best known for developing innovative therapies to improve the lives of patients battling rare diseases. While the company stumbled a bit in 2019 as a result of concerns about competition from biosimilars, Cowen thinks that 2020 could see a major turnaround for the company.Analyst Phil Nadeau tells investors that the market has been “overly harsh” about ALXN’s potential, noting that the shift from its Soliris drug to Ultomiris should bode well for the company. “Our DCF analysis suggests that the current stock price assumes that worldwide sales of ALXN’s C5 franchise in atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH) in 2024 and after are 75% below our current projections. We think that this is an overly pessimistic view of its sustainability. Based on Ultomiris' benefits over Soliris we think that ALXN's franchise is far more defensible than most investors give it credit,” he explained.According to Nadeau, the fact that ALXN has made significant progress in terms of rebuilding its pipeline and transferring the C5 franchise to Ultomiris could drive a re-rating for the healthcare name. Not only does Ultomiris offer improved potency and convenience, but it also has a lower annual price. Additionally, the maturation of its pipeline could contribute to gains in 2020.As a result, the five-star analyst left the Outperform rating and $165 price target as is. At this target, shares could climb 55% in the twelve months ahead. (To watch Nadeau’s track record, click here)What does the rest of the Street have to say? As it turns out, Wall Street is also in favor of ALXN. 12 Buy ratings and 3 Holds received in the last three months make it a Strong Buy. While lower than Nadeau’s estimate, the $145.67 average price target puts the upside potential at a respectable 37%. (See Alexion stock analysis on TipRanks)Alnylam Pharmaceuticals (ALNY)Using RNA interference (RNAi), Alnylam is changing the way debilitating diseases are treated. Based on the Nobel Prize-winning science, the company offers five late-stage programs that could address the large unmet need. Even with shares up 58% in the last year, Cowen’s Ritu Baral believes even more gains are in store.The analyst cites ALNY’s patented GalNAc construct science as well as its clinical strategy as helping it become a “dominant” player in the space. Its ONPATTRO (patisiran) drug for hATTR familial amyloid polyneuropathy (FAP) has already impressed with its performance and has seen consistent growth since its initial launch. In its third quarter, sales came in at $46.1 million, up 21% quarter-over-quarter with 600 patients currently using the therapy. Part of this success is thanks to its partnerships with 23andMe and genetic testing through the Alnylam Act Program, which has increased physician education, disease awareness and helped improve diagnostic methodology.The good news doesn’t stop there in Baral’s opinion. “The company is further de-risked by its late-stage compounds including just-launched GIVLAARI, inclisiran, and lumasiran that should significantly increase recurrent revenues within the next 24-months and drive top-line growth. This is coupled with multiple early stage programs (most wholly owned, some partnered) in both orphan disorders and more prevalent diseases which should yield multiple catalysts in the same time frame,” the five-star analyst commented.Baral argues that the company is transitioning to a “self-sustainable large cap biotechnology”, with this potentially attracting a broader group of investors. It’s no wonder, then, that the analyst boosted the price target from $120 to $154 in addition to maintaining the Outperform rating. This conveys her confidence in ALNY’s ability to surge 33% in the next twelve months. (To watch Baral’s track record, click here)Similarly, the rest of the Street takes a bullish approach when it comes to ALNY. A Strong Buy consensus rating is broken down into 13 Buys, 1 Hold and 1 Sell. Based on the average price target of $136.47, the upside potential lands at 18%. (See Alnylam stock analysis on TipRanks)Argenx SE (ARGX)With a novel approach that combines the diversity of the llama immune system and antibody engineering, Argenx develops treatments for cancer and severe autoimmune diseases. On the heels of a stellar 2019, Cowen is expecting a similar performance to be slated for 2020.Analyst Yaron Werber highlights the company’s lead candidate efgartigimod (anti-FcRn antibody fragment) as having a “potentially best-in-class profile with a first mover advantage across several indications.” The drug is targeting lucrative multi-billion dollar markets, with his estimate putting peak sales at $2.3 billion.While there are treatment options currently available for autoimmune disorders like Myasthenia Gravis (MG), pemphigus vulgaris (PV), idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) such as steroids and immunosuppressants, they aren’t always tolerated well and IVIg is expensive, inconvenient and faces capacity constraints. “Efgartigimod is the most advanced FcRn antagonist in development and we anticipate that positive data in PV (POC Ph2: H1:20) and MG (Ph3: H2:20) should drive stock appreciation,” Werber noted.In addition, the company has partnered with Johnson & Johnson, which could speed up the development of cusatuzumab, its anti-CD70 antibody currently in Phase 2.Werber added, “With a deep pipeline, multiple catalysts in FY20 and clear path for near- and longer-term value creation, the stock has ample room for appreciation based on data readouts, derisking clinical milestones, and boosting confidence in new indications.” To this end, Werber reiterated the Outperform rating while also attaching a new $191 price target. Should the five-star analyst’s target be met, shares are looking at a twelve-month gain of 20%. (To watch Werber’s track record, click here)In general, other Wall Street analysts are on the same page. With 10 Buys compared to a single Hold, the word on the Street is that ARGX is a Strong Buy. Given the $180.90 average price target, the upside potential amounts to 14%. (See Argenx stock analysis on TipRanks)
Biotech stocks advanced in the penultimate week of the year, and the iShares NASDAQ Biotechnology Index (NASDAQ: IBB ) is on track to end the year with gains in excess of 25%. The previous week saw FDA ...
Like everyone else, elite investors make mistakes. Some of their top consensus picks, such as Amazon, Facebook and Alibaba, have not done well in Q4 of 2018 due to various reasons. Nevertheless, the data show elite investors' consensus picks have done well on average over the long-term. The top 20 stocks among hedge funds beat […]
Are you prone to sudden surges of joy, abruptly followed by sinking bouts of misery? Do you react disproportionately to good or bad news? Well then, you might just be a biotech stock.Known for extreme volatility, biotech stocks can be great news for the risk tolerant investor, but of course, the flipside means they can be bad news, too. So, in this tricky sector, it is hard to know how to choose the right stock to invest in.At Stifel’s recent Healthcare Conference in New York, the investment banking firm took a deep look at some of the biotechs' latest developments. Following the conference’s close, we decided to get the magnifying glass out, and with the help of TipRanks’ Stock Screener home in on the biotech stocks Stifel singled out, but in particular, ones with a Strong Buy consensus rating. Let's dive in.CymaBay Therapeutics (CBAY)First up is CymaBay Therapeutics, a company on a mission to improve the lives of patients with liver and other chronic diseases. The biopharma focuses on developing innovative therapies for patients with rare conditions in which the lack of a market doesn’t cater to their medical needs. These are known as orphan diseases.The company’s main drug is Seladelpar, currently in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).As if to prove our introduction regarding biotechs’ volatility, CymaBay lost over 50% in one day in June, following mixed results from the company’s Phase 2b study in NASH, which exhibited minimal reductions in liver fat compared to placebo. Since then the stock has yet to regain a foothold on the market ladder.Stifel’s analyst Derek Archila sat down with CymaBay management, and got the lowdown from the team regarding the Seladelpar trials. The analyst noted, “On the commercial front, management highlighted the potential of seladelpar as part of a combo therapy, with already approved therapies such as the GLP-1R agonists of SGLT2s, given NASH is a multi-factorial disease. We agree with this and see combination therapies playing a key role in treating NASH patients.” Archila further added, “Although NASH is important to the CBAY story, management indicated they view the company as an orphan disease company given seldelpar development is furthest along in PBC, with the Phase 3 ENHANCE study recently completing enrollment. We believe seladelpar has demonstrated sufficient proof-of-concept in this indication.” CymaBay remains on track to report topline data from ENHANCE 52-week study in early 2021.Reassured by the meeting, Archila reiterated his Buy rating on CBAY along with a price target of $14. With CBAY currently trading at $5.61, this indicates substantial upside potential of 150%. (To watch Archila’s track record, click here)It seems like the Street is with Archila on this one. With 3 Buys and 1 Hold the biotech stock has Strong Buy pasted across its label. Importantly, CBAY has an average price target of $14.25, an even slightly more bullish outcome than Archila’s target. (See CymaBay stock analysis on TipRanks)Heron Therapeutics (HRTX)Next up is Heron Therapeutics, a biotech developing treatments for patients suffering from cancer or postoperative pain.The company experienced what we shall call a “biotech classic” in May, when it lost roughly 30% of its value following an FDA rejection of its experimental post-operative pain medication, HTX-011. The rejection centered around the lack of Chemistry, Manufacturing and Controls (CMC) data and was not based on clinical or safety issues.Things are looking up though. In October the FDA accepted Heron’s NDA resubmission for HTX-011 with a PDUFA date set for March 26, 2020. The company is expecting approval and is gearing up to launch HTX-011 shortly thereafter.Stifel’s Derek Archila recently met up with Heron’s CEO Barry Quart, who told Archila: "2020 will be a big year for the company."The analyst noted, “The key point the CEO emphasized is that HRTX's chemo-induced nausea and vomiting (CINV) franchise (Cinvanti and Sustol) is an excellent platform to leverage for the launch of HTX-011 because the target hospitals are very similar. The strategy and tailwinds behind the launch of Cinvanti, such as improved product profile and favorable reimbursement, have produced 42% market share in a market that was 100% controlled by MRK's Emend. Similarly, management believes HTX-011 has an improved profile compared to both generic bupivacaine and PCRX's Exparel both in terms of efficacy and usability.”To this end, Archila reiterated a Buy rating on HRTX stock alongside a $36 price target, indicating an increase of 45% from the recent share price.There’s further good news for HRTX, as currently TipRanks gives Heron a Strong Buy consensus rating. This breaks down into a unanimous 7 "buy" ratings. With an average stock-price forecast of $45.86, the street is in even more of a bullish mood than Archila, providing ample upside of 86% from current levels. (See Heron stock analysis on TipRanks)Argenx (ARGX)Completing our trio of biotechs is the Netherlands’ based Argenx. In a similar vein to both our previous choices, the biopharma focuses on patients with unmet medical needs. Its modus operandi is the development of antibody-based therapies for the treatment of severe auto-immune diseases and cancer.Argenx’s lead drug candidate is efgartigimod, a treatment for patients with severe autoimmune disorders associated with high levels of pathogenic immunoglobulin G, or IgG. Argenx has high hopes for the drug and believes it can have a wide therapeutic impact. It is currently being investigated in MG (myasthenia gravis - a neuro muscular disease), immune thrombocytopenia (a shortage of blood cell fragments needed for normal blood clotting) and skin blistering diseases.At Stifel’s recent Healthcare Conference, Derek Archila sat down with Argenx CEO Tim Van Hauwermeiren for a fire side chat regarding efgartigimod’s progress. The analyst noted, "The first indication it will likely be approved for is MG, for which ARGX expects Phase 3 ADAPT data in 2H20. Management has guided to a potential launch in 2021 for MG. Briefly on the launch, management expects efgartigimod to be used early in the treatment algorithm, after corticosteroids. Efgartigimod will be launched as an IV infusion but has plans to bring a SC form to market in MG.”As a result, Archila reiterated a Buy rating on ARGX along with a price target of $154, implying about 10% upside for the stock.All in all, the rest of the Street has an optimistic view of ARGX. The stock’s Strong Buy status comes from the 7 "buy" and 2 "hold" ratings issued over the previous three months. The upside potential lands at 11%, slightly above Archila's forecast. (See Argenx stock analysis on TipRanks)