|Bid||3.3000 x 1000|
|Ask||3.3200 x 1800|
|Day's Range||3.2000 - 3.3500|
|52 Week Range||0.6200 - 3.6800|
|Beta (5Y Monthly)||0.98|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 06, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||6.00|
CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has commenced a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration ("FDA" or "the Agency") seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L). CTI has previously announced the results of a recent Pre-NDA meeting with FDA where agreement was reached on an NDA submission package based upon available data from the completed Phase 3 PERSIST-1 and PERSIST-2, and the Phase 2 PAC203 trials.
Until yesterday, shares of CTI BioPharma (CTIC) had been firmly planted in the red in 2020. But sentiment can turn fast in the biotech world and the cancer drug maker provided investors with a dreamy week. The stock surged 135% over the past two trading sessions, after the FDA cleared the way for one of its treatment’s quick approval.Specifically, the company announced that after a pre-NDA meeting with the FDA, the agency has granted the biotech a rolling NDA submission for possible accelerated approval of pacritinib in thrombocytopenic myelofibrosis patients. The NDA submission should be completed by 1Q21.CTI managed to persuade the regulators that based on the existing data, the risk mitigation measures have shifted the risk/benefit profile enough to allow for a review. Results from the Phase III PERSIST-1 and 2 and the dose-finding PAC203 study have been deemed strong enough for NDA submission.Needham analyst Chad Messer believes “the surprising development highlights the lack of therapeutic options in this group of patients.” The analyst expects pacritinib to make its market entrance a lot earlier than initially expected. “If pacritinib is accepted for priority review, which we believe likely, it will be subject to a ~6 month review period,” the analyst said. “As a reminder, in July 2018 following the 1st interim analysis of PAC203, CTI had a Type B meeting with the FDA, in which the FDA indicated an additional Phase III trial would be necessary for filing. This recent development accelerates timelines for pacritinib which may now be on the market late 2021.”CTI saw out the second quarter with approximately $70 million in cash, which should be enough to fund operations into 4Q21 and pass the potential approval, according to Messer.As a result, the Needham analyst reiterates a Buy rating on CTIC shares, while boosting the price target from $3.5 to $6. Investors could be pocketing gains of nearly 140%, should the target be met over the next 12 months. (To watch Messer’s track record, click here)Overall, there is little action on the Street heading CTIC's way right now, with only one other analyst chiming in with a bullish view on the company's prospects. An additional Buy rating means the stock qualifies as a Moderate Buy. The average price target, though, is $5, and implies nearly 100% upside potential. (See CTIC 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.