|Bid||0.8510 x 1400|
|Ask||0.8560 x 800|
|Day's Range||0.6010 - 0.6794|
|52 Week Range||0.4510 - 7.1900|
|Beta (5Y Monthly)||0.90|
|PE Ratio (TTM)||N/A|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||N/A|
It has been a roller coaster 2020 so far for nano-cap biotech Iterum Therapeutics (ITRM).Over the past two trading sessions, ITRM shares surged nearly 85% after a regulatory path was outlined for the company’s oral tablet sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone-resistant pathogen. However, Iterum’s 2020 has been a hard slog so far, as even after the week's outsized gains, the stock is still down by 73% year-to-date.Iterum announced it will submit the NDA (new drug application) for sulopenem after the FDA provided management with the requirements and the areas of focus for the treatment in a pre-NDA meeting.So, with the latest good news, is the scene set for more upside? H.C. Wainwright analyst Ed Arce is not sure.In June, the company announced topline results from its Phase 3 trial of sulopenem for the treatment of uncomplicated urinary tract infections (uUTI) that achieved one primary endpoint but missed on another. As a result, Iterum then decided to pursue sulopenem's approval for a narrower uUTI patient sub-population with a quinolone-resistant pathogen.Arce points out the problem the narrower indication represents: “Although sulopenem's confirmed regulatory pathway for uUTI represents a significant achievement, we note that its market potential is now reduced to a subset of uUTI patients (we estimate 40-50% of cases are quinolone-resistant) and does not include any complicated UTI (cUTI) or complicated intraabdominal infections (cIAI) indications.”What’s more, Arce believes Iterum “continues to face a significant financial hurdle.” Management estimates it has enough cash to fund operations into 4Q20, which is “at most 3 months from now.”Arce also believes the company needs to work with a bigger marketing partner “to meaningfully penetrate the community setting and serve as an important validation of sulopenem's market potential.”Therefore, “while Iterum works to extend its cash runway while seeking to secure a partnership for sulopenem,” Arce remains on the sidelines with a Neutral (i.e. Hold) rating without suggesting a price target. (To watch Arce’s track record, click here)Over the past 3 months, two other analysts have posted a review of Iterum’s prospects, also suggesting a Hold. However, the Hold consensus rating might as well be a Buy, as given the average price target clocks in at $2, the potential is for 46% upside over the coming months. (See ITRM stock analysis on TipRanks)To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.
Here's a roundup of top developments in the biotech space over the last 24 hours.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Sept. 29) * Acceleron Pharma Inc (NASDAQ: XLRN) (announced Health Canada approval of luspatercept for RBC transfusion-dependent anemia associated with beta-thalassemia) * Adaptive Biotechnologies Corp (NASDAQ: ADPT) * Adial Pharmaceuticals Inc (NASDAQ: ADIL)(announced EUA for antibody test for COVID-19) * Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) * Axonics Modulation Technologies Inc (NASDAQ: AXNX) * Beigene Ltd (NASDAQ: BGNE) * BioLife Solutions Inc (NASDAQ: BLFS) * Blueprint Medicines Corp (NASDAQ: BPMC) * Cardiff Oncology Inc (NASDAQ: CRDF) * Celldex Therapeutics, Inc. (NASDAQ: CLDX) * CymaBay Therapeutics Inc (NASDAQ: CBAY) * Fate Therapeutics Inc (NASDAQ: FATE) * Guardant Health Inc (NASDAQ: GH) * Inspire Medical Systems Inc (NYSE: INSP) * Insulet Corporation (NASDAQ: PODD) * Kaleido Biosciences Inc (NASDAQ: KLDO)(announced dosing of first patient in ulcerative colitis study) * Kura Oncology Inc (NASDAQ: KURA) * Lantern Pharma Inc. (NASDAQ: LTRN) * Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) * Natera Inc (NASDAQ: NTRA) * Novo Nordisk A/S (NYSE: NVO) * Pacific Biosciences of California Inc (NASDAQ: PACB) * Seattle Genetics, Inc. (NASDAQ: SGEN) * Shockwave Medical Inc (NASDAQ: SWAV) * Twist Bioscience Corp (NASDAQ: TWST)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Sept. 29) * Alector Inc (NASDAQ: ALEC) * Dyne Therapeutics Inc (NASDAQ: DYN) * Greenwich Lifesciences Inc (NASDAQ: GLSI)(debuted on Nasdaq Friday) * Happiness Biotech Group Ltd (NASDAQ: HAPP) * Neos Therapeutics Inc (NASDAQ: NEOS) * Orchard Therapeutics PLC - ADR (NASDAQ: ORTX) * Outset Medical Inc (NASDAQ: OM) * PainReform Ltd (NASDAQ: PRFX) (commenced preparations of pivotal Phase 3 study of PRF-110 for the treatment of post-operative pain) * Renalytix AI PLC (NASDAQ: RNLX) * Satsuma Pharmaceuticals Inc (NASDAQ: STSA) * Teligent Inc (NEW JERSEY) (NASDAQ: TLGT) * Theravance Biopharma Inc (NASDAQ: TBPH) * Tricida Inc (NASDAQ: TCDA) * Uniqure NV (NASDAQ: QURE) * Vaccinex Inc (NASDAQ: VCNX)Stocks In Focus Moderna's Coronavirus Vaccine Found Equally Effective Against At-Risk Older Population Moderna Inc (NASDAQ: MRNA) announced publication in the New England Journal of Medicine second interim results from the Phase 1 study of mRNA-1273 in older age cohorts, showing the investigational vaccine-induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the 56-70 and 71+ age cohorts. It also elicited Th1-biased CD4 T cell responses in these age cohorts."Neutralizing antibody titers and T cell responses in the 56-70 and 71+ age cohorts were consistent with those reported in younger adults," the company said. The vaccine candidate was also well tolerated in all age cohorts."Given the increased morbidity and mortality of COVID-19 in older and elderly adults, these data give us optimism in demonstrating mRNA-1273's protection in this population, which is being evaluated in the Phase 3 COVE study," Moderna said.Separately, Moderna's CDMO partner Lonza said new production lines at its Portsmouth, New Hampshire facility should start making vaccine ingredients in November, and three lines at its Swiss Alps facility will likely begin delivering by December, Reuters reported, citing company executives.The stock rose 4.93% to $74 in after-hours trading.CureVac Initiates Mid-stage Study of COVID-19 Vaccine CureVac BV (NASDAQ: CVAC) announced the dosing of the first participant in a Phase 2a clinical trial of its COVID-19 vaccine candidate, CVnCoV. The dose-confirmation study is being conducted in Peru and Panama and targets enrolling a total of 690 healthy participants in two distinct groups - older adults ages 61 and above, and younger participants 18 to 60 years old, the company said.The company said it expects to report first comprehensive data from the Phase 2a study in older adults in the fourth quarter 2020.In after-hours trading, the stock was up 8.12% to $49.39.Eton's Hormone Replacement Therapy For Adrenocortical Insufficiency In Children Clears FDA Hurdle Eton Pharmaceuticals Inc (NASDAQ: ETON) said the FDA approved Alkindi Sprinkle, or hydrocortisone, oral granules as replacement therapy for adrenocortical insufficiency in children under 17 years of age.Alkindi Sprinkle is the first and only FDA-approved granular hydrocortisone formulation for the treatment of adrenocortical insufficiency specifically designed for use in children, Eton said.The company expects the drug to be commercially available in the fourth quarter of 2020.The stock rallied 18.29% to $9.25 in after-hours trading.CTI BioPharma To Begin Rolling NDA Submission For Drug to Treat Bone Marrow Cancer CTI BioPharma Corp (NASDAQ: CTIC) said it has reached an agreement with the FDA to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia. This follows the company's recent pre-NDA meeting with the agency.The FDA has agreed to a rolling NDA submission which is expected to commence within a few weeks, with completion of the NDA submission anticipated in the first quarter of 2021, the company said.The stock jumped 208.57% to $3.24 in after-hours trading.Tonix's Fibromyalgia Study Extended to Include Additional Participants Following IDMC Review Following a pre-planned interim analysis of a Phase 3 study of TNX-102 SL, 5.6 mg, for the management of fibromyalgia, Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) said the independent data monitoring committee made the non-binding recommendation that the trial continue to completion with the addition of 210 participants to the original sample size of 470 participants. This is the maximum number of participants that could be added under the interim statistical analysis plan, Tonix said.The company now expects to report top-line results from the study in the fourth quarter.The stock fell 6.67% to 84 cents in after-hours trading.Pfizer Forges Oncology Partnership to Market Cancer Drug In Mainland China Pfizer Inc. (NYSE: PFE) and Hong Kong-based CStone Pharma announced the formation of a strategic collaboration for the development and commercialization of CStone's PD-L1 antibody sugemalimab, a cancer drug, in mainland China. The collaboration also envisages bringing additional oncology assets to the Greater China market. As part of the collaboration, Pfizer through its Hong Kong unit will make a $200 million equity investment in CStone.CStone is also entitled to receive up to $280 million in milestone payments for sugemalimab and additional tiered royalties. While Pfizer obtains exclusive commercialization rights in mainland China, CStone has the development and commercialization rights outside mainland China.Catalyst Pharma To Appeal District Court Ruling In Lawsuit On LEMS Drug Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) said following the federal judge upholding the verdict of the Magistrate Judge, granting summary judgment in favor of the FDA and Jacobus, and dismissing Catalyst's case, it intends to appeal the result to the Eleventh Circuit Court of Appeals.The lawsuit filed by Catalyst challenged FDA decision to approve Jacobus' Ruzurgi for the treatment of Lambert-Eaton myasthenic syndrome, or LEMS, in patients 6 years to less than 17 years of age.Catalyst's Firdapse was approved in 2018 for LEMS in adults.The stock was down 2.49% to $3.13 in after-hours trading.Iterum Plans to File NDA For Antibotic To Treat Uncomplicated Urinary Tract Infections Iterum Therapeutics PLC (NASDAQ: ITRM) said, based on discussions at a pre-NDA meeting with the FDA, it plans to proceed with an NDA submission for sulopenem etzadroxil/probenecid, a bilayer tablet, for the treatment of uncomplicated urinary tract infections in patients with a quinolone-resistant pathogen.In premarket trading Wednesday, the stock was soaring 72.25% to $1.11.Offerings Aptorum Group Ltd (NASDAQ: APM), which rallied Tuesday on the setting up of a liquid biopsy diagnostics subsidiary, priced its offering of 2.769 million Class A ordinary shares and warrants to purchase up to another 2.769 million Class A Ordinary Shares, at a combined public offering price of $3.25 per share and related warrant.The warrants have an exercise price of $3.25 per share are exercisable immediately upon issuance and expire on the five-year anniversary of the date of issuance, the company said.Aptorum expects to raise gross proceeds of $9 million from the offering.The stock was down 4.41% to $4.55 in after-hours trading.Cardiff Oncology priced its previously announced underwritten public offering of 6.5 million shares of its common stock at $13.5 apiece. The gross proceeds from the offering are expected at $88 million.The stock rose 6.42% to $14.91 in after-hours trading.Arcutis Biotherapeutics Inc (NASDAQ: ARQT) announced the commencement of an underwritten public offering of 4 million shares of its common stock. Concurrent with the public offering, the company said it plans to sell to OrbiMed Advisors, an affiliate of one of its directors, $35 million worth of shares in a private placement.In after-hours trading, the stock slid 1.74% to $30.50.PDUFA Date Mesoblast limited (NASDAQ: MESO) awaits FDA decision on its BLA for remestemcel-L (MSC-100-IV) in steroid-refractory acute graft versus host disease in children.See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * The Daily Biotech Pulse: FDA Nod For Pfizer, Sorrento's COVID-19 Antibody Animal Data, Orphazyme's Wall Street Debut * The Week Ahead In Biotech: FDA Decisions For Mesoblast And Eton, Coronavirus Vaccine Updates(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
DUBLIN, Ireland and CHICAGO, July 13, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral antibiotics to treat infections caused by multi-drug resistant pathogens in community settings, today announced the record date for the Company’s planned rights offering. As previously disclosed, the Company had agreed to undertake a rights offering of subscription rights to purchase additional units in connection with the Company’s January 2020 private placement of units consisting of 6.500% Exchangeable Senior Subordinated Notes due 2025 and Limited Recourse Royalty-Linked Subordinated Notes. The planned rights offering will be made only by means of a prospectus, and this announcement does not constitute an offer to sell, or a solicitation of an offer to buy, any securities. Under the planned rights offering, the Company and Iterum Bermuda Therapeutics Limited, the Company’s wholly-owned subsidiary (“Iterum Bermuda”), will distribute to the Company’s eligible holders of ordinary shares and eligible warrant holders one non-transferable subscription right for each ordinary share owned (or deemed owned in the case of eligible warrant holders) as of the close of business (5pm Eastern Time) on the record date, August 5, 2020. Each right will entitle the holder to purchase, at the holder’s election and subject to availability, at a subscription price of $1,000 per unit, one unit consisting of (i) a 6.500% Exchangeable Senior Subordinated Note due 2025 (the “Exchangeable Notes”), to be issued by Iterum Bermuda in the original principal amount of $1,000.00, fully and unconditionally guaranteed on an unsecured senior subordinated basis by the Company, Iterum Therapeutics International Limited, Iterum Therapeutics US Limited and Iterum Therapeutics US Holding Limited (collectively, the “Guarantors”), and (ii) 50 Limited Recourse Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”), to be issued by Iterum Bermuda, fully and unconditionally guaranteed on an unsecured senior subordinated basis by the Guarantors.The Company will only accept subscription rights for up to 8,400 units for a total purchase price of $8.4 million, which amount is approximately equal to the maximum aggregate principal amount of additional notes that may be issued under the indentures pursuant to which the Exchangeable Notes and Royalty-Linked Notes will be issued. Accordingly, sufficient units may not be available to honor all subscriptions in full or at all. If exercises of subscription rights exceed the number of units available in the planned rights offering, the Company will allocate the available units pro rata among the record holders exercising the subscription rights in proportion to the number of ordinary shares each of those record holders owned or were deemed to own on the record date, relative to the number of shares owned or deemed to be owned on the record date by all record holders exercising the subscription right.The subscription rights will be non-transferable and will only be exercisable during the applicable subscription period. The Company anticipates that the subscription period will begin on or about August 11, 2020, or as soon as practicable thereafter, and continue for a period of at least 20 calendar days. The Company expects to announce additional details about the planned rights offering in the near future.A registration statement relating to the planned rights offering has been filed with the Securities and Exchange Commission (the “SEC”) but has not yet become effective. The planned rights offering will be made pursuant to such registration statement and a prospectus to be filed with the SEC prior to the commencement of the planned rights offering. The securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective.The information herein, including the expected timing and terms of the planned rights offering, is not complete and is subject to change. The Company reserves the right to cancel or terminate the planned rights offering at any time. This press release does not constitute an offer to sell or the solicitation of an offer to buy any subscription rights, units or any other securities, nor will there be any sale of subscription rights, units or any other securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.About Iterum Therapeutics plcIterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.Forward-Looking Statements This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing, terms and completion of the planned rights offering and the Company’s plans, strategies and prospects for its business. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company’s control, including whether the conditions for the closing of the offering will be satisfied, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the Company’s ability to apply for regulatory approval, changes in public policy or legislation, commercialization plans and timelines, if sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company’s expectations regarding how far into the future the Company’s cash on hand will fund the Company’s ongoing operations, the sufficiency of the Company’s cash resources and the Company’s ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, risks and uncertainties concerning the outcome, impact, effects and results of the Company’s evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company’s ability to complete one at all, the price of the Company’s securities, the expected use of proceeds from the planned rights offering and other factors discussed under the caption “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.Investor Contact: Judy Matthews Chief Financial Officer 312-778-6073 IR@iterumtx.comSource: Iterum Therapeutics plc