Price Crosses Moving Average
|Bid||53.08 x 800|
|Ask||52.98 x 900|
|Day's Range||51.16 - 53.37|
|52 Week Range||30.79 - 59.89|
|Beta (5Y Monthly)||1.40|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 04, 2020 - Aug 10, 2020|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||59.20|
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended by a majority of votes to remove the statement "efficacy has not been demonstrated in non-ambulatory patients" from the SmPC for Translarna™ (ataluren). This label change enables healthcare professionals to use their clinical judgement to make treatment decisions for their patients on Translarna who have lost ambulation.1 The change also should support reimbursement agencies granting continued access to Translarna for patients who become non-ambulatory during the course of their treatment. The CHMP's positive opinion is subject to final approval by the European Commission, which is normally granted in a two-month time frame.
PTC Therapeutics (PTCT) gets an FDA sanction to begin a phase II/III study on its DHODH inhibitor PTC299 as a potential treatment of COVID-19. The study will start in the United States shortly.
PTC (PTCT) commences a phase II/III study to evaluate PTC299, a dihydroorotate dehydrogenase (DHODH) inhibitor, as a potential treatment for COVID-19.
Here's a roundup of top developments in the biotech space over the last 24 hour.Scaling The Peaks (Biotech Stocks Hitting 52-week Highs June 16) * ADC Therapeutics SA (NYSE: ADCT) * Adverum Biotechnologies Inc (NASDAQ: ADVM) (named a new CEO) * Amicus Therapeutics, Inc. (NASDAQ: FOLD) * Applied Molecular Transport Inc (NASDAQ: AMTI) (IPOed June 5) * Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) * Eli Lilly And Co (NYSE: LLY) (announced FDA approval for its rapidly-acting insulin injection, and positive results for its breast cancer study) * Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI) * Celldex Therapeutics, Inc. (NASDAQ: CLDX) * Celsion Corporation (NASDAQ: CLSN) * Cerus Corporation (NASDAQ: CERS) * Evoke Pharma Inc (NASDAQ: EVOK) * Fennec Pharmaceuticals Inc (NASDAQ: FENC) * Ideaya Biosciences Inc (NASDAQ: IDYA)( announced an oncology partnership with GlaxoSmithKline plc (NYSE: GSK)) * Immunovant Inc (NASDAQ: IMVT) * ITAMAR MED LTD/S ADR (NASDAQ: ITMR) * Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) * Nemaura Medical Inc (NASDAQ: NMRD)(presented sugarBEAT continuous glucose monitor for patients with Type 2 diabetes at the virtual ADA conference) * Neubase Therapeutics Inc (NASDAQ: NBSE) * Nymox Pharmaceutical Corp (NASDAQ: NYMX) * Ocular Therapeutix Inc (NASDAQ: OCUL) * Odonate Therapeutics Inc (NASDAQ: ODT) * Passage Bio Inc (NASDAQ: PASG) * Pliant Therapeutics Inc (NASDAQ: PLRX) * Sarepta Therapeutics Inc (NASDAQ: SRPT) * SpringWorks Therapeutics Inc (NASDAQ: SWTX) * TELA Bio Inc (NASDAQ: TELA) * Trillium Therapeutics Inc (NASDAQ: TRIL) * Vaxcyte Inc (NASDAQ: PCVX)(IPOed Friday) * Zynex Inc. (NASDAQ: ZYXI)Down In The Dumps (Biotech Stocks Hitting 52-week Lows June 16) * Generation Bio Co (NASDAQ: GBIO) (IPOed Friday) * Lantern Pharma Inc (NASDAQ: LTRN) (IPOed Thursday)Related Link: Sinovac Makes Headway In Coronavirus Vaccine Race With Positive Preliminary Phase 1/2 ResultsStocks In Focus Fulgent's At-home COVID Testing Solution Gets FDA's EUA Fulgent Genetics Inc (NASDAQ: FLGT) said it has received FDA's Emergency Use Authorization, or EUA, for its at-home testing solution for COVID-19. The company added it has launched the testing solution and that its testing service will be made available through Picture Genetics, its consumer-initiated genetic testing platform, beginning next week.The stock soared 18.18% to $19.50 in the after-hours trading.Amarin, Apotex Settle Patent Litigation Regarding Generic Vascepa Amarin Corporation plc (NASDAQ: AMRN) announced a settlement agreement with Apotex to resolve patent litigation regarding an ANDA filed by the latter for a generic form of the former's Vascepa.As part of the settlement agreement, Apotex is precluded from selling a generic version in the U.S. until Aug. 9, 2029, or earlier under certain customary circumstances such as Amarin not prevailing in the pending appeal of the March 2020 Nevada district court decision.The stock added 5.37% to $7.26 in after-hours trading.Merck Gets Another FDA Approval For Keytruda, Prices $4.5B Debt Offering Merck & Co., Inc. (NYSE: MRK) announced FDA approval for its Keytruda anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test.Separately, the company said it has priced $4.5 billion public offering of four series of senior unsecured notes.Novartis Cosentyx Gets FDA Approval For Additional Indication Novartis AG (NYSE: NVS) said the FDA approved its Cosentyx for the treatment of active non-radiographic axial spondyloarthritis, confirming its efficacy in addressing the axial spondyloarthritis disease spectrum.EUA For Chembio's Coronavirus Antibody Test Revoked The FDA said it has revoked its EUA for Chembio Diagnostics Inc's (NASDAQ: CEMI) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, citing performance concerns with the accuracy of the test.The stock slumped 31.02% to $6.85 in after-hours trading.Zomedica Appoints Medical Device Industry Veteran Robert Cohen as Interim CFO Zomedica Pharmaceuticals Corp (NYSE: ZOM) announced the appointment of medical devices industry veteran Robert Cohen as its Interim CEO, effective immediately, even as it gears to launch its Truforma point-of-care diagnostic platform. Shameze Rampertab, who was serving as interim CEO, will continue in his role as CFO, the company added.The stock advanced 14.21% to 22 cents in after-hours trading.PTC Gets FDA Nod To Initiate Phase 2/3 Study For Potential COVID-19 Treatment PTC Therapeutics, Inc. (NASDAQ: PTCT) said the FDA has authorized the initiation of a Phase 2/3 trial to investigate PTC299, a dihydroorotate dehydrogenase inhibitor, as a potential treatment for COVID-19.The company said the investigational asset has the potential to address the two critical elements of COVID-19 - high viral replication and uncontrolled inflammatory response that ensues after infection. The company also said it plans to initiate an integrated Phase 2/3 study in the U.S. in the coming days with additional sites planned globallyInspire's Therapy To Be Covered By Cigna Inspire Medical Systems Inc (NYSE: INSP) said Cigna Corp (NYSE: CI) will provide coverage for its Inspire therapy, effective June 15, 2020."With the addition of Cigna, we now have 54 coverage policies, representing over 180 million members, that cover Inspire therapy, compared to 83 million members just one year ago," Inspire said.Progenics Shareholders Approve Merger With Lantheus Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) said its shareholders approved its previously-announced merger with Lantheus Holdings Inc (NASDAQ: LNTH). The merger is now subject to customary closing conditions and is expected to close on or about June 19.Ipsen Gets Fast Track Designation For Pancreatic Cancer Drug IPSEN S A/S ADR (OTC: IPSEY) said the FDA granted the Fast Track designation for the investigational use of liposomal irinotecan in combination with 5- fluorouracil/leucovorin and oxaliplatin, for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma.Offerings Provention Bio Inc (NASDAQ: PRVB) said it has commenced an underwritten public offering of 5.5 million shares of its common stock. All of the shares to be sold in the offering are to be sold by the company.The stock slipped 5.54% to $15.52 in after-hours trading.AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) said it has priced its previously announced underwritten public offering of 8.5 million shares of its common stock at $5.25 per share, for raising gross proceeds of $44.6 million. The offering is expected to close on or about June 19.The stock fell 4% to $6 in after-hours trading.Actinium Pharmaceuticals Inc (NYSE: ATNM) priced its secondary offering of 76.923 million shares at 32.5 cents per share for raising gross proceeds of $25 million. The offering is expected to close on or about June 19.The stock plunged 17.98% to 36 cents after-hours trading.Shockwave Medical Inc (NASDAQ: SWAV) priced its public offering of 1.7 million shares at $45.75 per share, The offering is expected to raise gross proceeds of $77.8 million and close on or about June 19.On The Radar Adcom Meetings FDA's Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee will consider through teleconferencing SP 2577 presentation by Salarius Pharmaceuticals Inc (NASDAQ: SLRX) and marizomib, presentation by Celgene, a subsidiary of Bristol-Myers Squibb Co (NYSE: BMY). SP 2577 is being evaluated for the treatment of relapsed/refractory patients with Ewing sarcoma and marizomib for multiple myeloma.The FDA said the subcommittee will consider and discuss issues relating to the development of each product for pediatric use and provide guidance to facilitate the formulation of written requests for pediatric studies, if appropriate.See more from Benzinga * The Week Ahead In Biotech: FDA Decisions In The Cards For Merck, Epizyme, Evoke And Ultragenyx * The Daily Biotech Pulse: FDA Nod For Viela, 3 IPOs And Hematology Congress Presentations(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
PTC Therapeutics, Inc. (NASDAQ: PTCT), today announced that the U.S. Food and Drug Administration has authorized the initiation of a Phase 2/3 trial to investigate PTC299, a dihydroorotate dehydrogenase (DHODH) inhibitor, as a potential treatment for COVID-19. PTC299 is an oral investigational drug with a novel dual-mechanism of action that has the potential to address the two critical elements of COVID-19: 1) the high viral replication and 2) the uncontrolled inflammatory response that ensues after infection. PTC will initiate an integrated Phase 2/3 study in the U.S. in the coming days with additional sites planned globally.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on June 10, 2020 it approved non-statutory stock options to purchase an aggregate of 54,675 shares of its common stock and 3,940 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to five new employees. The awards were made pursuant to the NASDAQ inducement grant exception as a component of the new hires' employment compensation.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced two-year data from Part 1 of the SUNFISH trial in children and adults with type 2 or 3 spinal muscular atrophy (SMA) and new preliminary 12-month data from JEWELFISH. The results of an exploratory efficacy analysis from SUNFISH showed risdiplam significantly improved motor function after 24 months of treatment compared to natural history data (Motor Function Measure Scale (MFM) 3.99 point difference; p< 0.0001). In addition, preliminary 12-month data from the JEWELFISH trial in people with SMA aged 6 months to 60 years, previously treated with other SMA therapies, showed that treatment with risdiplam led to rapid and sustained increases in SMN protein levels. No new safety signals were observed and the overall adverse event profile was consistent with that of treatment-naive patients.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the launch of the Talent Pipeline Program (TPP), a one-year global internship program aimed at providing recent graduates real-world experience in the biopharmaceutical industry and related professions, including research, finance, commercial, compliance, quality, legal, information technology, and communications. Throughout the immersive internship program, participants will be provided mentorship, job coaching, career counseling, and leadership training.
In this article we will take a look at whether hedge funds think PTC Therapeutics, Inc. (NASDAQ:PTCT) is a good investment right now. We check hedge fund and billionaire investor sentiment before delving into hours of research. Hedge funds spend millions of dollars on Ivy League graduates, unconventional data sources, expert networks, and get tips […]
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it has successfully completed the acquisition of Censa Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of CNSA-001 (sepiapterin), a clinical-stage investigational therapy for orphan metabolic diseases, including phenylketonuria (PKU) and other diseases associated with defects in the tetrahydrobiopterin (BH4) biochemical pathways diagnosed at birth.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it will hold a series of virtual deep dive webinars discussing its therapeutic platforms and programs. The first webinar in the series will discuss its Bio-e platform on Friday, June 5 at 10:00 a.m. ET.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, and to support the health and well-being of its stockholders, employees and communities, its 2020 Annual Meeting of Stockholders, has been changed to a virtual meeting to be held on Wednesday, June 10, 2020 at 2:00 p.m. Eastern Time. Stockholders will be able to participate in this year's Annual Meeting only via the virtual meeting.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that management will present a company overview at the Jefferies Virtual Healthcare Conference on Tuesday, June 2nd at 1:00 p.m. ET.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it has entered into an agreement to acquire Censa Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of CNSA-001 (sepiapterin), a clinical-stage investigational therapy for orphan metabolic diseases, including phenylketonuria (PKU) and other diseases associated with defects in the tetrahydrobiopterin (BH4) biochemical pathways diagnosed at birth. The transaction was approved by the Boards of both companies.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that management will present in a virtual format at the following conferences:
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced positive results from part 2 of the pivotal FIREFISH study evaluating risdiplam in infants with type 1 spinal muscular atrophy (SMA). The global study met its primary endpoint of infants sitting without support for five seconds by month 12, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Type 1 SMA babies do not achieve this milestone without therapy. Substantial results were demonstrated across multiple secondary and exploratory endpoints, as infants in the study achieved milestones not seen in natural history. In addition to being able to sit without support, infants were able to maintain upright head control, roll to the side, and stand without support after 12 months of treatment. At 12 months, 95% infants maintained the ability to swallow and 89% were able to feed orally. No new safety signals were identified in part 2 of the study. These data will be reviewed during a conference call today at 11:30 am ET by our development partner, Roche.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the appointments of Matthew Klein, M.D., to Chief Development Officer and Eric Pauwels to Chief Business Officer. Dr. Klein will be responsible for the development of our clinical stage programs. As the Chief Business Officer, Mr. Pauwels will be responsible for our customer facing activities with health care providers, patients and payers ensuring that our therapies are available and accessible to rare disease patients and their families worldwide.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Company will host a webcast conference call to report its first quarter 2020 financial results and provide an update on the company's business and outlook on Thursday, April 30, 2020 at 4:30 p.m. (ET) after the closing of the market.
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of risdiplam to August 24, 2020. Roche recently submitted additional data including comprehensive data from SUNFISH part 2 to help provide access to risdiplam for a broad range of people living with spinal muscular atrophy (SMA), triggering this extension. The FDA has informed Roche that the review team is working expeditiously to complete their review of the application as quickly as possible. The FDA has also indicated to Roche that no substantive review issues have been identified to date.
Intercept Pharmaceuticals hoping for approval on medication to compete in large and fast-growing market for NASH treatments Continue reading...
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