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Ascendis Pharma A/S (ASND)
Chart Events
Performance Outlook
| Previous Close | 125.61 |
| Open | 125.82 |
| Bid | 120.00 x 1000 |
| Ask | 172.50 x 800 |
| Day's Range | 122.48 - 125.82 |
| 52 Week Range | 120.02 - 183.98 |
| Volume | 459,669 |
| Avg. Volume | 214,860 |
| Market Cap | 6.631B |
| Beta (5Y Monthly) | 0.74 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -9.85 |
| Earnings Date | Mar 10, 2021 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 194.55 |
Fair Value
Related Research
- TipRanks
Analysts Say These 3 Stocks Are Their Top Picks for 2021
Remember back in February, when we were worried about a market correction? Back when the NASDAQ dipped 10% from its peak… Yeah, well, never mind about that. Markets are up, up, up lately. A strong jobs report last Friday has helped, showing 916,000 new positions in March, the best print since last August, and almost a quarter-million higher than expectations. Rising markets make it a good time to look at the ‘top picks’ from Wall Street’s stock analysts. The three stocks we’re looking at are an interesting lot, and they have certain commonalities: a Strong Buy consensus rating, tangible upside potential for investors, and a ‘Top Pick’ review. Using the TipRanks database, we’ve pulled the details on those stocks to find out what makes them so compelling. Here are the results. Ascendis Pharma (ASND) First up, Ascendis Pharma, is an ‘emerging’ biotechnology company with a primary focus on rare diseases in endocrinology. The company has an active pipeline, with three drug candidates in clinical trials for endocrine diseases, including pediatric and adult growth hormone deficiency, adult hypoparathyroidism, and achondroplasia. The company develops its medications using its TransCon technology, which allows the direct application of proteins, peptides, and small molecules to target areas of the body through a carrier drug with known biological action. In addition to its primary pipeline, Ascendis also has two oncology drug candidates in preclinical development. The company's pediatric growth hormone deficiency (GHD) drug, TransCon HGH (lonapegsomatropin), has completed a Phase 3 trial and the company is preparing for the PDUFA date at the end of June – with expectation of launching the drug commercially on the US market in 3Q21. Ascendis anticipates a European Commission decision on use of lonapegsomatropin during 4Q21. There is an ongoing global Phase 3 trial for adults with GHD, with complete enrollment expected by early next year, and Ascendis has submitted its clinical trial notification to begin a Phase 3 trial for pediatric patients in Japan. Furthermore, the company is preparing for Phase 3 clinical trials for TransCon PTH, a treatment for adult hypoparathyroidism. The company anticipates topline results in 4Q21. As above, the company is also proceeding with clinical trial notification in Japan, for 2Q21. With all of that in the background, Wedbush analyst Liana Moussatos listed ASND as one of her top picks for 2021 “In 2021, we look forward to 1) TC-hGH/pediatric growth hormone deficiency (GHD; lonapegsomatropin) June 25, 2021, PDUFA date; 2) potential TC-hGH/GHD MAA approval in Q4:21; and 3) topline results from the pivotal Phase 3 PaTHway for TCPTH in adult hypoparathyroidism (HP) in Q4:21. We see these events as potential inflection points for the stock. We expect 2021 to be a transformative year for Ascendis in front of several potential value creation events,” Moussatos noted. In line with these comments, Moussatos rates ASND shares an Outperform (i.e. Buy), and sets a $209 price target indicating a 60% one-year upside potential. (To watch Moussatos’ track record, click here) Moussatos is no outlier on Ascendis; this stock has 6 recent reviews, with 5 to Buy and 1 to Hold. The shares are priced at $130.63 and their $191.25 average price target suggests 46% growth in the next 12 months. (See ASND stock analysis on TipRanks) AlloVir (ALVR) The next company on our list, AlloVir, is another cutting-edge biotech firm. AlloVir’s focus is the development of allogenic, off-the-shelf virus-specific T-cell candidates. These are drugs specifically designed to prevent or treat viral infections in immunocompromised patients with T-cell deficiencies – and limited treatment options. The company’s pipeline features five candidate agents for the treatment of twelve ‘devastating’ viruses, including HHV-6, EBV, PIV, HBV, and even COVID-19. The most advanced drug candidate in the pipeline, ALVR105, also called Viralym-M, is undergoing trials for a range of applications, including the treatment of virus-associated hemorrhagic-cystitis, cytomegalovirus (CMV), and adenovirus (AdV). In addition, there are clinical studies of the drug candidate as a preventative for BKV, CMV, AdV, EBV, HHV-6 and others viral diseases. The clinical trials range from Phase 1b/2 to Phase 3. The company’s lead candidate, Viralym-M, is in an ongoing Phase 3 trial for the treatment of virus-associated hemorrhagic-cystitis. The company also tests Viralym-M in two proof-of-concept Phase 2 trials. These include a clinical study of the drug candidate as a first of its kind, multi-virus preventative for HSCT recipients and a study of the drug in the treatment of BK viremia in kidney transplant patients. These trials are ongoing, and actively recruiting patients. In addition to ALVR105/Viralym-M, the company next two most advanced programs are ALVR 109 and ALVR106. ALVR109 has entered Phase 1 proof-of-concept clinical trial as a treatment for COVID-19. Preclinical data released in December demonstrated disease specific antiviral activity. ALVR 106 has had its investigation new drug (IND) application approved, and is cleared to initiate clinical trials in the treatment of influence, PIV, and respiratory syncytial virus. In his coverage of this stock for Piper Sandler, 5-star analyst Christopher Raymond writes, “[All] important timelines remain essentially on track. To us, the most critical of those are Phase 2 POC data for Viralym-M in the prevention setting for HSCT patients and for Phase 2 POC data for Viralym-M in the treatment of BK virus in kidney transplant recipients. Those two events remain on track for 2H21. While we do not model contribution form ALVR109 (in high-risk patients with COVID-19), we note that POC data from that program is also anticipated 2H21.” At the bottom line, Raymond says, “[We] continue to view ALVR as an emerging leader in virus specific cell therapies… it remains a top 2021 pick.” To this end, Raymond gives ALVR an Overweight (i.e. Buy) rating, and his $55 price target implies a robust upside of ~132% for the year ahead. (To watch Raymond’s track record, click here) Like the Piper Sandler analyst, the rest of the Street is bullish on ALVR. 3 Buy ratings compared to no Holds or Sells add up to a Strong Buy consensus rating. At $49.33, the average price target implies upside potential of ~108%. (See ALVR stock analysis on TipRanks) Western Digital (WDC) From biotech to high-tech, we’ll change gears and look at Western Digital. The company produces hard disks and other data storage, including SSDs and flash memory. Western Digital's products are used in the data center and cloud storage industries; Western Digital includes well-known brands like WD and SanDisk. As can be imagined, Western Digital has seen steady business in the last 18 months, despite the COVID pandemic. The move toward remote work and virtual offices put a premium on computer chips of all sorts, including memory and cloud storage. WDC’s revenues have held steady through that period, near $4 billion quarterly. For the past two years, the company has reported quarterly revenues in the range between $3.67 billion and $4.29 billion; the most recent quarter, 2Q fiscal 21, showed $3.94 billion at the top line, with non-GAAP EPS of 69 cents per share and free cash flow of $149 million. The company presented forward guidance for fiscal Q3, projecting the top line between $3.85 billion and $4.05 billion and non-GAAP EPS between 55 and 75 cents. Investors like predictability, and Western Digital’s performance has been just that. The company’s stock has benefited, and the shares are up 87% over the past 12 months. This is a modest outperformance compared to the NASDAQ index, which is up 73% over the same period. C J Muse, 5-star analyst with Evercore ISI, digs deep under the hood of Western Digital, and summing up writes, “While WDC shares are up 25% YTD, we see at least another 30% upside fueled by meaningful positive revisions to forward EPS estimates…. consensus estimates are moving materially higher with potential CY21 exit run rate of ~$10+ (cons $7.60) and additional upside into CY22 (we see stretch goal of $15.00 vs. current cons $7.44)…. With vision to at least 30% upside as the NAND industry emerges from a cyclical trough, WDC remains a Top Pick.” Muse puts a $100 price target on WDC, for a 38% one-year upside potential. (To watch Muse’s track record, click here) Tech companies typically garner a lot of analyst attention, and Western Digital has 21 recent stock reviews. These break down to 17 Buys against just 4 Holds, giving the stock its Strong Buy consensus rating. Shares are priced at $72.22, and the $80.26 average target implies an 11% upside from that level. (See WDC stock analysis on TipRanks) To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
- GlobeNewswire
Ascendis Pharma A/S Announces Participation at the J.P. Morgan 10th Annual Napa Valley Biotech Forum
COPENHAGEN, Denmark, March 30, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, today announced that the company will participate at the J.P. Morgan 10th Annual Napa Valley Biotech Forum. Company executives will provide a business overview and an update on the Company’s pipeline programs. Details Event J.P. Morgan 10th Annual Napa Valley Biotech Forum Location Virtual Date Tuesday, March 30, 2021 Time 4:00 p.m. Eastern Time A live audio webcast of the presentation will be available on the Investors and News section of the Company’s website at www.ascendispharma.com. A webcast replay will also be available on the Company’s website shortly after conclusion of the event for 30 days. About Ascendis Pharma A/S Ascendis Pharma is applying its innovative TransCon technologies to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, Palo Alto and Redwood City, California, and Princeton, New Jersey. Please visit www.ascendispharma.com (for global information) or www.ascendispharma.us (for U.S. information.) Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Ascendis’ ability to apply its platform technology to build a leading, fully integrated biopharmaceutical company, (ii) Ascendis’ product pipeline and expansion into additional therapeutic areas and (iii) Ascendis’ expectations regarding its ability to utilize its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis’ ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 10, 2021 and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma Group. © March 2021 Ascendis Pharma A/S. Investor contacts: Media contact:Tim Lee Ami KnoeflerAscendis Pharma Ascendis Pharma(650) 374-6343 (650) 739-9952tle@ascendispharma.com ack@ascendispharma.com Patti Bank Westwicke Partners (415) 513-1284 patti.bank@westwicke.com ir@ascendispharma.com
- GlobeNewswire
Ascendis Pharma A/S Presents 6-Month Open-Label Extension Data from Phase 2 PaTH Forward Trial of TransCon PTH in Adult Hypoparathyroidism at ENDO 2021
Clinical data demonstrate the potential of TransCon PTH as a hormone replacement therapy for adults with hypoparathyroidismCOPENHAGEN, Denmark, March 23, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon™ technologies to create product candidates that address unmet medical needs, today presented the safety and efficacy results of TransCon PTH after six-months of treatment in patients with hypoparathyroidism enrolled in the open-label extension period (OLE) of the phase 2 PaTH Forward Trial, at the Endocrine Society’s annual meeting, taking place virtually from March 20-23, 2021. “The study demonstrated that a majority of subjects were able to achieve independence from conventional therapeutic supplements, while maintaining serum calcium in the normal range and having clinically meaningful improvements in urine calcium levels, bone turnover markers and bone mineral density and quality of life,” said Mishaela Rubin, M.D. M.S., Associate Professor of Medicine in the Metabolic Bone Disease Unit at the Vagelos College of Physicians & Surgeons at Columbia University Irving Medical Center in New York City. “Importantly, we are presenting the first data on the treatment effect of TransCon PTH on the Hypoparathyroidism Patient Experience Scale (HPES). In this study, HPES scores all decreased from baseline to Week 26, indicating fewer and less impact of disease-specific symptoms. These data are promising and TransCon PTH may offer a new potential treatment option for patients with hypoparathyroidism, many of whom have their daily lives disrupted by the disorder.” Presentation Details and Data Highlights1Presentation title: TransCon PTH as a Hormone Replacement Therapy for Patients with Hypoparathyroidism: 6-Month Update from the PaTH Forward Open-Label Extension in 58 subjects.Oral session: Novel Treatments for Metabolic Bone Diseases; March 23, 2021 at 2:15 to 2:25 p.m. EDT. Presenter: Mishaela Rubin, M.D. M.S.Summary of findings: Six-month results from the PaTH Forward OLE demonstrated: Over 90 percent of subjects demonstrated independence from standard-of-care (calcium ≤ 500 mg/day and active vitamin D = 0 µg/day) and 76 percent of subjects eliminated all supplements while: Maintaining mean serum calcium in the normal rangeReducing mean 24-hour urine calcium to within the normal rangeAchieving sustained reductions in mean serum phosphate and calcium x phosphate productDemonstrating enhanced quality of life on both SF-36 Functional Health Survey and HPESTrending towards normalization of skeletal remodeling. TransCon PTH continues to be well-tolerated: No adverse events of hypocalcemia or hypercalcemia requiring visit to hospital, emergency room or urgent care. “All 58 subjects in the open-label extension have now completed 12 months of treatment on TransCon PTH without any additional dropouts, which is a reflection of patient comfort with this once-daily injection as a chronic therapy for hypoparathyroidism,” said Mark Bach, M.D., Ph.D., Senior Vice President of Endocrine Medical Sciences at Ascendis Pharma. “TransCon PTH is a potential hormone replacement therapy that was designed to restore calcium metabolism and improve quality of life for people with hypoparathyroidism, and we plan to present the 12-month results at an upcoming scientific meeting.” In addition, to PaTH Forward, Ascendis Pharma is conducting the PaTHway Trial, a phase 3 clinical study evaluating the safety, tolerability and efficacy of TransCon PTH in adults with HP. Topline results are expected from PaTHway in the fourth quarter of 2021. About the PaTH Forward Trial1 PaTH Forward is a global, phase 2, randomized, double-blind, placebo-controlled group trial evaluating the safety and efficacy of three fixed doses of TransCon PTH (15, 18 or 21 µg/day or placebo). The trial enrolled 59 adult subjects with chronic HP who received standard of care or were previously treated with PTH therapies. The goal of PaTH Forward is to evaluate TransCon PTH control of serum and urinary calcium and identify a titration regimen for complete withdrawal of standard of care (i.e., active vitamin D and calcium supplements). PaTH Forward has introduced a ready-to-use pre-filled pen injector and assesses disease-specific patient-reported outcomes. After four weeks of fixed dosing, all subjects were eligible to enter an open-label extension period with the opportunity to receive a customized maintenance dose of TransCon PTH to evaluate long-term safety and efficacy. About TransCon PTH2 TransCon PTH is an investigational once-daily long-acting prodrug of parathyroid hormone (PTH[1-34]) in development as a treatment for adult hypoparathyroidism (HP) designed to restore PTH at physiologic levels for 24 hours each day to address both the short-term symptoms and long-term complications of the disease. TransCon PTH was granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) in June 2018, and in October 2020 was granted Orphan Designation by the European Commission for the treatment of hypoparathyroidism. About Hypoparathyroidism (HP) 3,4,5,6,7,8 Hypoparathyroidism (HP) is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone (PTH), resulting in low calcium and elevated phosphate levels in the blood. HP affects approximately 200,000 patients in the United States, Europe, Japan and South Korea, the majority of whom develop the condition following damage or accidental removal of the parathyroid glands during thyroid surgery. Patients often experience decreased quality of life. In the short term, symptoms include weakness, severe muscle cramps (tetany), abnormal sensations such as tingling, burning and numbness (paresthesia), memory loss, impaired judgment and headache. Over the long term, this complex disorder can increase risk of major complications, such as extraskeletal calcium depositions occurring within the brain, lens of the eye, and kidneys, which can lead to impaired renal function. HP remains among the few hormonal insufficiency states without a replacement therapy that restores the missing hormone at physiologic levels. Standard of care with active vitamin D analogs and calcium supplementation do not fully control the disease and may contribute to risk of renal disease. As a result, patients with HP have an estimated 4-fold to 8-fold greater risk of renal disease compared to healthy controls. About TransCon™ Technology TransCon refers to “transient conjugation.” The proprietary TransCon platform is an innovative technology to create new therapies that are designed to potentially optimize therapeutic effect, including efficacy, safety and dosing frequency. TransCon molecules have three components: an unmodified parent drug, an inert carrier that protects it, and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent drug from clearance. When injected into the body, physiologic conditions (e.g., pH and temperature) initiate the release of the active, unmodified parent drug in a predictable manner. Because the parent drug is unmodified, its original mode of action is expected to be maintained. TransCon technology can be applied broadly to a protein, peptide or small molecule in multiple therapeutic areas, and can be used systemically or locally. About Ascendis Pharma A/S Ascendis Pharma is applying its innovative TransCon technologies to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, Palo Alto and Redwood City, California, and Princeton, New Jersey. Please visit www.ascendispharma.com (for global information) or www.ascendispharma.us (for U.S. information.) Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Ascendis’ future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) Topline results expected from PaTHway in the fourth quarter of 2021; (ii) Ascendis’ ability to apply its platform technology to build a leading, fully integrated biopharmaceutical company, (iii) Ascendis’ product pipeline and expansion into additional therapeutic areas and (iv) Ascendis’ expectations regarding its ability to utilize its TransCon technologies to create new and potentially best-in-class therapies. Ascendis may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Ascendis makes, including the following: unforeseen safety or efficacy results in its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development and potential commercialization of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs, selling, general and administrative expenses, other research and development expenses and Ascendis’ business generally; delays in the development of its oncology programs, TransCon hGH, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; Ascendis’ ability to obtain additional funding, if needed, to support its business activities and the effects on its business from the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ascendis’ business in general, see Ascendis’ Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 10, 2021 and Ascendis’ other future reports filed with, or submitted to, the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments that Ascendis may enter into or make. Ascendis does not assume any obligation to update any forward-looking statements, except as required by law. Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo and TransCon are trademarks owned by the Ascendis Pharma Group. © March 2021 Ascendis Pharma A/S. Investor contacts:Media contact:Tim LeeAmi KnoeflerAscendis PharmaAscendis Pharma(650) 374-6343(650) 739-9952tle@ascendispharma.comack@ascendispharma.com Patti Bank Westwicke Partners (415) 513-1284 patti.bank@westwicke.com ir@ascendispharma.com 1 Rubin M, et al. Oral presentation at ENDO 2021.2 Karpf DB, et al. J Bone Miner Res. 2020; x:1-11. 3 Mannstadt M, et al. Nature Reviews 2017, 3: 17055 4 Ascendis Pharma HP Patient Experience Research.5 Hadker N, et al. Endo Pract. 2014, 20(7);671-679. 6 Powers J, et al. J Bone Miner Res 2013, 28: 2570-2576.7 Mitchell DM, et al. J Clin Endocrinol Metab 2012, 97(12): 4507-45148 Underbjerg L, et al. J Bone Miner Res 2013, 28: 2277-2285
