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Strongbridge Biopharma plc (SBBP)

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2.7100-0.0600 (-2.17%)
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2.7000 -0.01 (-0.37%)
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Neutralpattern detected
Previous Close2.7700
Open2.8600
Bid0.0000 x 2200
Ask3.2500 x 1800
Day's Range2.6700 - 2.9500
52 Week Range1.5000 - 4.6300
Volume647,453
Avg. Volume621,071
Market Cap182.231M
Beta (5Y Monthly)1.71
PE Ratio (TTM)N/A
EPS (TTM)-0.7900
Earnings DateOct 29, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est7.80
  • Strongbridge Biopharma plc Announces Publication of Secondary Endpoints Data from Phase 3 SONICS Study of RECORLEV™ (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome in the Journal, Pituitary
    GlobeNewswire

    Strongbridge Biopharma plc Announces Publication of Secondary Endpoints Data from Phase 3 SONICS Study of RECORLEV™ (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome in the Journal, Pituitary

    ~ RECORLEV™ (levoketoconazole) Treatment Resulted in Significantly Improved Clinician-Assessed Signs and Symptoms and Patient-Reported Outcomes of Cushing’s Syndrome ~DUBLIN, Ireland and TREVOSE, Pa., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that secondary endpoint results from the Phase 3 SONICS study of RECORLEV™ (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome were published online in advance of print publication in the peer-reviewed journal, Pituitary, the official publication of the Pituitary Society and the Growth Hormone Research Society. “People with Cushing’s syndrome often experience a variety of problematic signs, symptoms, and comorbidities related to excess cortisol, testosterone or both,” said Fredric Cohen, M.D., chief medical officer of Strongbridge Biopharma. “The SONICS study provided important evidence that RECORLEV treatment was associated with durable improvements in several of the more common and bothersome signs and symptoms of the syndrome, including those that most commonly affect women, such as hirsutism and acne, which are related to increases in testosterone produced by the adrenal glands.”The manuscript, entitled “Levoketoconazole improves clinical signs and symptoms and patient-reported outcomes in patients with Cushing’s syndrome,” includes analyses demonstrating that treatment with RECORLEV led to significant improvements in Cushing’s syndrome signs and symptoms, patient-reported quality of life (QoL) outcomes, depression symptoms, and testosterone levels. * Significant mean improvements from baseline were noted at end of the Maintenance phase (Month 6) for acne, hirsutism (females only), and peripheral edema. * These improvements were observed as early as Day 1 of Maintenance for hirsutism, the end of Month 1 of Maintenance for acne, and Month 4 of Maintenance for peripheral edema. * By Month 3 of Maintenance, significant mean improvements in patient-reported QoL outcomes were observed and by Month 6, symptoms of depression had improved. * A reduction in mean free-testosterone in women, consistent with improvements in clinical signs of hyperandrogenism was observed, and a modest increase in mean free-testosterone in men was observed. * RECORLEV was generally well-tolerated; the most commonly reported adverse events during the dose-titration and maintenance phases were nausea (32%) and headache (28%). The full manuscript can be accessed online at: https://www.strongbridgebio.com/therapeutic-focus/key-publications-posters/related-investigational-agent-recorlev/heading_4About Cushing’s Syndrome Endogenous Cushing’s syndrome is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure - often the result of a benign tumor of the pituitary gland. This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, and this often results in undesirable physical changes. The disease is most common among adults between the ages of 30 to 50, and it affects women three times more often than men. Women with Cushing's syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne. Additionally, the internal manifestations of the disease are potentially life threatening. These include metabolic changes such as high blood sugar, or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle and bone, and psychologic disturbances such as depression, anxiety and insomnia. Untreated, the five-year survival rate is only approximately 50 percent.About the SONICS Study SONICS is an open-label, Phase 3 study of RECORLEV as a treatment for endogenous Cushing’s syndrome that enrolled 94 patients at centers in North America, Europe and the Middle East. Following a screening phase, SONICS has three treatment phases:(1) Dose Titration Phase: Patients started RECORLEV at 150 mg twice daily (300 mg total daily dose) and titrated in 150 mg increments with the goal of achieving a therapeutic dose – a dose resulting in mUFC normalization – at which point titration was stopped; (2) Maintenance Phase: The dose was fixed and should not have been changed other than for safety reasons or loss of efficacy. At the end of the six-month maintenance phase, the mUFC response rate was measured; and (3) Extended Evaluation Phase: Patients continued on RECORLEV for another six months to evaluate long-term safety and tolerability and explore efficacy durability.About RECORLEV RECORLEV® (levoketoconazole) is an investigational cortisol synthesis inhibitor in development for the treatment of patients with endogenous Cushing’s syndrome, a rare but serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure. RECORLEV is the pure 2S,4R enantiomer of ketoconazole, a steroidogenesis inhibitor. RECORLEV has demonstrated in two successful Phase 3 studies to significantly suppress serum cortisol and has the potential to be a next-generation cortisol inhibitor. The Phase 3 program for RECORLEV includes SONICS and LOGICS: two multinational studies designed to evaluate the safety and efficacy of RECORLEV when used to treat endogenous Cushing’s syndrome. The SONICS study met its primary and secondary endpoints, demonstrating a statistically significant normalization rate of urinary free cortisol at six months. The LOGICS study, which met its primary endpoint, is a double-blind, placebo-controlled randomized-withdrawal study of RECORLEV that is designed to supplement the long-term efficacy and safety information supplied by SONICS. The ongoing long-term open label OPTICS study will gather further useful information related to the long-term use of RECORLEV.RECORLEV has received orphan drug designation from the FDA and the European Medicines Agency for the treatment of endogenous Cushing's syndrome.About Strongbridge Biopharma Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s rare endocrine franchise includes RECORLEV® (levoketoconazole), a cortisol synthesis inhibitor currently being studied in Phase 3 clinical studies for the treatment of endogenous Cushing’s syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency. The Company’s rare neuromuscular franchise includes KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws. The words “anticipate,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements, including statements related to the secondary endpoint data from the SONICS study, the potential advantages of RECORLEV,  Strongbridge’s strategy, plans, outcomes of product development efforts and objectives of management for future operations. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed in such statement, including risks and uncertainties associated with clinical development and the regulatory approval process, the reproducibility of any reported results showing the benefits of RECORLEV, the adoption of RECORLEV by physicians, if approved, as treatment for any disease and the emergence of unexpected adverse events following regulatory approval and use of the product by patients.  Additional risks and uncertainties relating to Strongbridge and its business can be found under the heading “Risk Factors” in Strongbridge’s Annual Report on Form 10-K for the year ended December 31, 2019 and its subsequent Quarterly Reports on Form 10-Q, as well as its other filings with the SEC. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.Contacts:Corporate and Media Relations Elixir Health Public Relations Lindsay Rocco +1 862-596-1304 lrocco@elixirhealthpr.comInvestor Relations Solebury Trout Mike Biega +1 617-221-9660 mbiega@soleburytrout.com

  • Strongbridge Biopharma plc Announces Participation in Two Upcoming Investor Conferences
    GlobeNewswire

    Strongbridge Biopharma plc Announces Participation in Two Upcoming Investor Conferences

    DUBLIN, Ireland and TREVOSE, Pa., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that management will participate in fireside chats at the Stifel and Jefferies 2020 Virtual Healthcare Conferences. Details for the presentations are as follows: * The Stifel 2020 Virtual Healthcare Conference on Monday, November 16, 2020, from 10:40 – 11:10 a.m. ET. Following is a link to access the webcast: https://wsw.com/webcast/stifel27/sbbp/2079792   * The Jefferies Virtual Healthcare Conference on Thursday, November 19, 2020, from 7:55 – 8:25 p.m. GMT. Following is a link to access the webcast: https://wsw.com/webcast/jeff141/sbbp/1833975 The Company’s presentations will be webcast live and archived on the “Events & Presentations” page in the Investor section of the Company’s website at www.strongbridgebio.com.About Strongbridge Biopharma Strongbridge Biopharma is a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Strongbridge’s rare endocrine franchise includes RECORLEV® (levoketoconazole), a cortisol synthesis inhibitor currently being studied in Phase 3 clinical studies for the treatment of endogenous Cushing’s syndrome, and veldoreotide extended release, a pre-clinical next-generation somatostatin analog being investigated for the treatment of acromegaly and potential additional applications in other conditions amenable to somatostatin receptor activation. Both RECORLEV and veldoreotide have received orphan drug designation from the FDA and the European Medicines Agency. The Company’s rare neuromuscular franchise includes KEVEYIS® (dichlorphenamide), the first and only FDA-approved treatment for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis. KEVEYIS has orphan drug exclusivity in the United States.Contacts:Investor Relations Solebury Trout Mike Biega +1 617-221-9660 mbiega@soleburytrout.comCorporate & Media Relations Elixir Health Public Relations Lindsay Rocco +1 862-596-1304 lrocco@elixirhealthpr.com

  • Oppenheimer Sees These 3 Stocks Skyrocketing Over 100%
    TipRanks

    Oppenheimer Sees These 3 Stocks Skyrocketing Over 100%

    The U.S. presidential election has come to a close, and Wall Street isn’t opposed to the administration change. Last week saw the S&P 500 notch its second-best performance during an election week on record, even as Trump’s chances of getting re-elected became slimer and slimer.Weighing in for Oppenheimer, Chief Investment Strategist John Stoltzfus noted, “What appears clear so far is that the equity markets are not averse to a change of administration stateside at least so long as the Republicans maintain control over the Senate. Checks and balances ‘on the Hill’ have been known to be important to investors over the course of history. The present in our view is no exception.”There is, however, some uncertainty surrounding the Senate, with the two runoff elections for seats in Georgia scheduled for January 5, only 15 days before Inauguration Day. That said, Stoltzfus points out that continued better-than-expected Q3 results from S&P 500-listed companies, economic data tied to job gains and a sharp decline in the unemployment rate have also been helping to prop stocks up.Taking Stoltzfus’ outlook into consideration, we wanted to take a closer look at three stocks earning a round of applause from Oppenheimer, with the firm’s analysts forecasting over 100% upside potential for each. Using TipRanks’ database, we learned that the rest of the Street is in agreement, as all three boast a “Strong Buy” analyst consensus. Strongbridge Biopharma (SBBP)First up we have Strongbridge Biopharma, which is focused on developing therapies for rare diseases with significant unmet needs. Ahead of a key regulatory filing, Oppenheimer believes that SBBP's $2.12 share price reflects an attractive entry point.Representing the firm, analyst Hartaj Singh points out that investor focus has landed squarely on Recorlev, the company's investigational cortisol synthesis inhibitor, in Cushing's syndrome. The company is gearing up to file an NDA for the therapy in Q1 2021, and the analyst is optimistic about its potential approval.In the LOGICS study, the therapy met its primary endpoint, with SBBP reporting the number of cases of a loss of mean urinary free cortisol (mUFC) response was 54.5% higher among patients who withdrew to placebo versus those who remained on Recorlev. Additionally, there was a rapid reversibility of the Recorlev treatment benefits on cholesterol following the switch to placebo given the 8-week time frame.Meanwhile, in the SONICS study, a significant benefit on mUFC normalization was observed in 30% of the patients and several cardiovascular secondary measures. It should also be noted that none of the 44 patients who were randomized discontinued due to adverse events.“Post-LOGICS, we continue to view Recorlev as a differentiated treatment for Cushing's, both compared to off-label ketoconazole and the branded treatment landscape. Management reiterated its confidence in the drug's positioning, based on market research with payors and physicians. Given LOGICS reaffirming the clinical benefit profile observed in SONICS, we are encouraged by its potential to become a mainstay treatment for the disease,” Singh explained.What’s more, management is not anticipating an AdComm meeting, and Singh thinks speculation on labeling both from a safety and efficacy perspective may increase prior to the potential PDUFA decision. To this end, he expects more visibility as the NDA filing and acceptance gets closer.Adding to the good news, the launch of Keveyis, the company's FDA-approved treatment for hyperkalemic, hypokalemic and related variants of Primary Periodic Paralysis (an ultra-rare neuromuscular disorder), is progressing well despite the COVID-19 pandemic, according to Singh.“With quarterly sales of ~$8.0 million, above our estimate of ~$7.8 million, the growing trajectory of the launch has been encouraging, with additional room for long-term growth highlighted by management. We anticipate more credit could be ascribed to these efforts, following additional updates from life-cycle management strategies,” the analyst commented.To this end, Singh rates SBBP shares an Outperform (i.e. Buy) along with a $7 price target. What's in it for investors? Upside potential of 233%. (To watch Singh’s track record, click here)All in all, other analysts echo Singh’s sentiment. 3 Buys and no Holds or Sells add up to a Strong Buy consensus rating. With an average price target of $8, the upside potential comes in at 272%. (See SBBP stock analysis on TipRanks)Molecular Templates (MTEM)Molecular Templates works to bring the next generation of immunotoxins called engineered toxin bodies (ETBs), which are a novel class of therapeutics with unique biology and a differentiated mechanism of action, to market. Although one of its trials was put on a partial clinical hold, Oppenheimer still believes its long-term growth narrative is strong.The Phase 2 monotherapy trial evaluating lead candidate MT-3724, an ETB that targets CD20 (a B-cell marker that is expressed in 90 percent of B-cell non-Hodgkin’s lymphoma (NHL)), was placed on partial clinical hold on November 4 following a treatment-related fatality. Management pointed to capillary leak syndrome (CLS) as the cause of the patient death. MT-3724 is being evaluated in three ongoing Phase 2 trials, one monotherapy and two combination.It should be noted that six patients (fatality patient and five treated in DLBCL monotherapy study) received the drug from the same batch, and the first five completed the study without evidence of CLS. Later PK analysis found peak drug exposure (Cmax) 3-4x expected levels in five out of six patients receiving the therapy from the lot. Management plans to investigate what caused the higher Cmax levels.Oppenheimer’s Kevin DeGeeter told clients, “We would look to accumulate MTEM shares into any weakness based on expectation: 1) manufacturing batch inconsistency may have resulted in excess Cmax in limited number of patients providing clear path to remedy the problem, 2) limited read through on immunogenicity from MT-3724 (only product on first-gen ETB backbone) to other pipeline programs, and 3) guarded expectation for commercial opportunity of MT-3724 prior to clinical hold with market opportunity focused primarily on salvage patients.”Even if the CLS is determined to be dose-related, the five-star analyst argues there may still be a path forward for MT-3724, as the monotherapy study is evaluating a dose of 50 µg/kg while combination studies are assessing a 10-25 µg/kg dose.Reflecting another positive, the hold doesn’t impact studies for products on the second-generation ETB backbone, including MT-5111, TAK-169 and MT-6402. In addition, the company is set to provide a clinical update on CTX001, a potential treatment for sickle cell disease (SCD).DeGeeter opined, “Our investment thesis is based, at least in part, on continued partnering of ETB platform to large biotechs for targets outside of MTEM's core oncology focus. Despite the clinical hold on MT-3724, MTEM remains in active discussions with potential partners. We'd view additional partnering deals as validation of the platform's overall safety profile.”In line with his optimistic approach, DeGeeter rates MTEM an Outperform (i.e. Buy) along with a $20 price target. This figure indicates 123% upside potential from current levels. (To watch DeGeeter’s track record, click here)Are other analysts in agreement? They are. Only Buy ratings, 3 to be exact, have been issued in the last three months. Therefore, the message is clear: MTEM is a Strong Buy. Given the $18.33 average price target, shares could soar 108% in the next year. (See MTEM stock analysis on TipRanks)Provention Bio (PRVB)At the forefront of the autoimmune disease space, Provention Bio is working to improve the lives of patients from all over the world. With the company making significant headway in its efforts to gain approval for one of its therapies, Oppenheimer thinks that now is the time to snap up shares.On November 2, Provention Bio announced that the rolling submission of a BLA to the FDA for regulatory approval of teplizumab for the delay or prevention of clinical type 1 diabetes (T1D) in at-risk individuals had been completed. The submission included chemistry, manufacturing and controls (CMC) and administrative information modules. Now, the FDA has 60 days to review the final submission to determine if the BLA is complete, and then, a PDUFA date will be set.Writing for Oppenheimer, analyst Justin Kim points out that the BLA acceptance will be a key milestone for PRVB. “We believe the external validation and review of the application would reflect favorably on the significant efforts Provention has made towards completion of this filing, namely manufacturing scale-up. As a potential advisory committee meeting and regulatory decision offer subsequently greater validation, we have confidence into these events based on teplizumab's established clinical profile.”Going forward, Kim believes the therapy’s commercialization will become a central theme in 2021. Based on teplizumab's 14-day infusion cycle, logistics and physician/patient reception of the modality, especially during the COVID-19 pandemic, are attracting major attention, according to the analyst.Should the candidate ultimately be granted approval, screening and awareness work could reflect a significant tailwind, in Kim’s opinion. With it already having established meaningful relationships across key T1D advocacy groups and foundations, “Provention is well-positioned and connected to build momentum for screening and identification initiatives.” The analyst added, “While the hurdle to execute successfully is high, reward, in our view, would be commensurate.”When it comes to the long-term opportunity, “the TN-10 population criteria” remains a key area of focus for Kim, as “these opportunities may not only expand the market opportunity for teplizumab but also significantly solidify its positioning the treatment paradigm.” He also mentions that re-dosing paradigms and adjunctive use post-transplant for teplizumab are other points of strength.Summing it all up, Kim stated, “PRVB remains underappreciated in our universe, potentially given macro themes around COVID-19 and intensified focus on momentum names. However, as continued execution carries PRVB through successful regulatory, pre-commercial, and commercial milestones, we believe the shares could enter a period of significant re-rating.”Everything that PRVB has going for it prompted Kim to leave his Outperform (i.e. Buy) rating as is. Along with the call, he keeps the price target at $29, suggesting 106% upside potential. (To watch Kim’s track record, click here)Turning to the rest of the Street, the bulls have it on this one. With 4 Buys and no Holds or Sells assigned in the last three months, the word on the Street is that PRVB is a Strong Buy. At $28.75, the average price target implies 104% upside potential. (See PRVB 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.