PTC Therapeutics, Inc., a biopharmaceutical company, focuses on the discovery, development, and commercialization of medicines to patients with rare disorders. Its portfolio pipeline includes commercial products and product candidates in various stages of development, including clinical, pre-clinical and research and discovery stages, focuses on the development of treatments for multiple therapeutic areas, including rare diseases and oncology. The company offers Translarna and Emflaza for the treatment of Duchenne muscular dystrophy in the European Economic Area and the United States; commercializes Tegsedi and Waylivra for the treatment of rare diseases in Latin America and the Caribbean; and markets Evrysdi for the treatment of SMA in adults and children two months and older in Brazil. The company's splicing platform includes PTC518, which is being developed for the treatment of Huntington's disease. PTC Therapeutics, Inc. has collaborations with F. Hoffman-La Roche Ltd and Hoffman-La Roche Inc., as well as the Spinal Muscular Atrophy Foundation to advance drug discovery and development research in regenerative medicine; research collaboration with Massachusetts General Hospital for the treatment of rare genetic disorders resulting from pre-mRNA; and Akcea Therapeutics, Inc. to commercialize Tegsedi and Waylivra for the treatment of rare diseases in Latin America and the Caribbean. PTC Therapeutics, Inc. was founded in 1998 and is headquartered in South Plainfield, New Jersey.
IPO Year: 2013
Exchange: NASDAQ
Website: ptcbio.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 10/10/2024 | Mkt Perform | Raymond James | |
| 9/4/2024 | $44.00 | Outperform | Robert W. Baird |
| 8/26/2024 | $47.00 | Buy | UBS |
| 5/20/2024 | Underperform → Mkt Perform | Raymond James | |
| 12/19/2023 | $28.00 | Equal-Weight → Underweight | Morgan Stanley |
| 12/8/2023 | $37.00 | Overweight | Wells Fargo |
| 10/30/2023 | $165.00 | Perform → Outperform | Oppenheimer |
| 10/27/2023 | $29.00 → $17.00 | Neutral → Sell | Citigroup |
| 10/6/2023 | $45.00 → $25.00 | Buy → Hold | Truist |
| 9/18/2023 | $55.00 → $28.00 | Buy → Neutral | Citigroup |
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- First-ever FDA approval for gene therapy directly administered to the brain - - Priority review voucher granted - - Broad label including children and adults - - PTC pioneers new approach for CNS drug delivery - WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved in the United States that is directly administered to the brain. "PTC has once again pioneered a new approach to treating highly morbid neurologic diseases," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics
– Strong revenue performance, supporting increase in full-year revenue guidance to $750-800 million – – Regulatory filings for sepiapterin, Translarna™ and AADC gene therapy under review by FDA – – On track to achieve remaining 2024 clinical and regulatory milestones, including NDA submission for vatiquinone – WARREN, N.J., Nov. 7, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ:PTCT) today announced a corporate update and financial results for the third quarter ending September 30, 2024. "I am proud of our team's strong execution," said Matthew Klein, M.D., Chief Executive Officer. "We continue to achieve excellent revenue performance allowing us to raise full-year revenue guidance.
WARREN, N.J., Nov. 4, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced that the company will present a company overview at the following conferences: UBS Global Healthcare ConferenceWednesday, Nov. 13 at 2:45 p.m. PST / 5:45 p.m. EST Jefferies London Healthcare ConferenceTuesday, Nov. 19 at 11:30 a.m. GMT / 6:30 a.m. EST Citi's 2024 Global Healthcare ConferenceTuesday, Dec. 3 at 2:30 p.m. EST The presentations will be webcast live on the Events and Presentations page under the Investor section of PTC Therapeutics' website at https://ir.ptcbio.com/events-presentations and will be archived for 30 days following the presentation. It is recommended that users connect to
WARREN, N.J., Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). "The NDA acceptance for review is a significant milestone that brings us one step closer to providing this important treatment to boys and young men living with nonsense mutation Duchenne muscular dystrophy in the United States," said Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics. "The totality of evidence clearly supports the favorable safety profile and sh
WARREN, N.J., Oct. 25, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced that on Oct. 23, 2024, the company approved non-statutory stock options to purchase an aggregate of 13,690 shares of its common stock and 20,250 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to nineteen new employees. The awards were made pursuant to the Nasdaq inducement grant exception as a component of the new hires' employment compensation. The inducement grants were approved by PTC's Compensation Committee on Oct. 23, 2024, and are being made as an inducement material to each employee's acceptance of employment with the c
WARREN, N.J., Oct. 24, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced that the company will host a webcast conference call to report its third quarter 2024 financial results and provide an update on the company's business and outlook on Thursday, Nov. 7, at 4:30 p.m. EST. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations. A replay of the call will be available app
- Opinion to be reviewed by European Commission - WARREN, N.J., Oct. 18, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has maintained its negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne Muscular Dystrophy (nmDMD) following re-examination. The opinion will now be reviewed by the European Commission (EC) which is expected to decide on opinion adoption in approximately 67 days. "CHMP again based its decision on the results of the primary analysis subpopulation of Study 041
WARREN, N.J., Oct. 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) announced today that the FDA has set a target regulatory action date of July 29, 2025, for the review of the New Drug Application (NDA) for sepiapterin, consistent with a standard review timeline. The NDA was submitted with an indication for the treatment of pediatric and adult patients with phenylketonuria (PKU), including all age groups and the full spectrum of disease subtypes. In addition, PTC announced that the results of the Phase 3 APHENITY trial were recently published in The Lancet, one of the most prestigious peer-reviewed medical journals. "The Lancet publication reflects the promising and transforma
- Statistically significant results on primary endpoint of long-term study analyses - - Following FDA pre-NDA feedback, submission on track for December 2024 - WARREN, N.J., Oct. 8, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) provided today several positive updates on the vatiquinone Friedreich ataxia (FA) program. The pre-specified endpoint for two different FA long-term extension studies was met, with highly statistically significant evidence of durable treatment benefit on disease progression. In addition, PTC recently aligned with FDA on key aspects of the planned NDA submission for vatiquinone. "The results of the extension studies provide further evidence of the potentia
WARREN, N.J., Oct. 1, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of pediatric and adult patients living with phenylketonuria (PKU). A Prescription Drug User Fee Act (PDUFA) target action date is expected to be provided in the Day 74 Letter. "The FDA filing acceptance for sepiapterin is a critical milestone toward bringing this potential important therapy to children and adults living with PKU in the United States," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "The clinical trial data, including the evidence of enabling diet liberalizatio
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Raymond James resumed coverage of PTC Therapeutics with a rating of Mkt Perform
Robert W. Baird initiated coverage of PTC Therapeutics with a rating of Outperform and set a new price target of $44.00
UBS resumed coverage of PTC Therapeutics with a rating of Buy and set a new price target of $47.00
Raymond James upgraded PTC Therapeutics from Underperform to Mkt Perform
Morgan Stanley downgraded PTC Therapeutics from Equal-Weight to Underweight and set a new price target of $28.00
Wells Fargo initiated coverage of PTC Therapeutics with a rating of Overweight and set a new price target of $37.00
Oppenheimer upgraded PTC Therapeutics from Perform to Outperform and set a new price target of $165.00
Citigroup downgraded PTC Therapeutics from Neutral to Sell and set a new price target of $17.00 from $29.00 previously
Truist downgraded PTC Therapeutics from Buy to Hold and set a new price target of $25.00 from $45.00 previously
Citigroup downgraded PTC Therapeutics from Buy to Neutral and set a new price target of $28.00 from $55.00 previously
For Immediate Release: November 14, 2024 The U.S. Food and Drug Administration approved Kebilidi (eladocagene exuparvovec-tneq), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. Kebilidi is the first FDA-approved gene therapy for treatment of AADC deficiency. “Clinical advancements in the f
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BOSTON, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Sensorium Therapeutics (Sensorium), a biotechnology company translating insights from nature and human experience to deliver transformational therapeutics, today announced the appointment of veteran life sciences executive David Southwell to its Board of Directors. "We are excited to welcome David to our Board," said Dick Simon, Chief Executive Officer of Sensorium. "He is a seasoned life sciences executive with a track record of success that spans multiple therapeutic areas and development stages. David's depth of experience will be a key asset as we advance our lead program, SENS-01, towards the clinic and expand our drug pipeline into addition
SOUTH PLAINFIELD, N.J., July 17, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced the appointment of Pierre Gravier to the role of Chief Financial Officer (CFO). Mr. Gravier brings more than 17 years of experience as an investment banker, venture capitalist and scientist to PTC. Most recently, Pierre was a managing director in the healthcare group of Perella Weinberg Partners, a leading independent global advisory firm. At Perella Weinberg, he focused on advising companies in the biopharmaceutical and pharmaceutical sectors on finance strategy and corporate development. "We are incredibly excited to have Pierre as part of PTC's leadership team," said Matthew B. Klein
Cantor Fitzgerald analyst Kristen Kluska reiterates PTC Therapeutics (NASDAQ:PTCT) with a Overweight and maintains $62 price target.
Morgan Stanley analyst Jeffrey Hung maintains PTC Therapeutics (NASDAQ:PTCT) with a Equal-Weight and raises the price target from $30 to $32.
- Reuters
Cantor Fitzgerald analyst Kristen Kluska maintains PTC Therapeutics (NASDAQ:PTCT) with a Overweight and raises the price target from $52 to $62.
U.S. stock futures were higher this morning, with the Nasdaq futures gaining around 0.2% on Friday. Shares of NIKE, Inc. (NYSE:NKE) fell sharply in today's pre-market trading following fourth-quarter earnings and soft FY25 guidance. Analysts at Stifel and Morgan Stanley downgraded the stock following the report. NIKE shares dipped 15.6% to $79.42 in pre-market trading. Here are some big stocks recording losses in today's pre-market trading session. Accolade, Inc. (NASDAQ:ACCD) shares tumbled 32.1% to $4.34 in pre-market trading after the company reported first-quarter financial results and issued worse-than-expected FY25 revenue guidance. Also, Needham maintained a Buy rating
U.S. stocks were mixed, with the Dow Jones index gaining around 50 points on Friday. Shares of Asana, Inc. (NYSE:ASAN) rose sharply during Friday's session after the company announced a $150 million share repurchase program and reaffirmed its forward guidance. Asana said its board of directors approved a stock repurchase program authorizing the company to repurchase up to $150 million of its Class A common stock through June 30, 2025. Asana shares jumped 13.4% to $12.90 on Friday. Here are some other big stocks recording gains in today’s session. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shares jumped 39.2% to $171.89 after the company announced FDA approval of an expansion to
B of A Securities analyst Tazeen Ahmad maintains PTC Therapeutics (NASDAQ:PTCT) with a Underperform and raises the price target from $25 to $32.
– Strong revenue performance, supporting increase in full-year revenue guidance to $750-800 million – – Regulatory filings for sepiapterin, Translarna™ and AADC gene therapy under review by FDA – – On track to achieve remaining 2024 clinical and regulatory milestones, including NDA submission for vatiquinone – WARREN, N.J., Nov. 7, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ:PTCT) today announced a corporate update and financial results for the third quarter ending September 30, 2024. "I am proud of our team's strong execution," said Matthew Klein, M.D., Chief Executive Officer. "We continue to achieve excellent revenue performance allowing us to raise full-year revenue guidance.
WARREN, N.J., Oct. 24, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced that the company will host a webcast conference call to report its third quarter 2024 financial results and provide an update on the company's business and outlook on Thursday, Nov. 7, at 4:30 p.m. EST. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations. A replay of the call will be available app
– Continued strong revenue performance – – NDAs for sepiapterin and Translarna™ submitted to FDA – – Positive interim data readout from PTC518 PIVOT-HD study – – On track to achieve remaining 2024 clinical and regulatory milestones – WARREN, N.J., Aug. 8, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ:PTCT) today announced a corporate update and financial results for the second quarter ending June 30, 2024. "I am proud of our team's continued outstanding execution as we have accomplished all our objectives so far this year," said Matthew Klein, M.D., Chief Executive Officer. "We are in a strong cash position, submitted three drug approval applications to the FDA and remain on schedul
WARREN, N.J., July 25, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced that the company will host a webcast conference call to report its second quarter 2024 financial results and provide an update on the company's business and outlook on Thursday, Aug. 8, at 4:30 p.m. EDT. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations. A replay of the call will be available
- FDA lifts PTC518 partial clinical hold based on PIVOT-HD data - - Conference call and webcast to be held June 20th at 8:00 am EDT - WARREN, N.J., June 20, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today shared interim results from the Phase 2 PIVOT-HD study of PTC518 in Huntington's disease (HD) patients. At Month 12, PTC518 treatment resulted in dose-dependent lowering of mutant huntingtin (mHTT) protein in the blood and cerebrospinal fluid (CSF) in the interim cohort of patients. In addition, favorable trends were demonstrated on several relevant HD clinical assessments including Total Motor Score (TMS) and Composite Unified Huntington's Disease Rating Scale (cUHDRS). Fu
– Strong revenue performance across product portfolio – – Submitted MAA for sepiapterin and BLA for Upstaza – – On target to achieve remaining 2024 clinical and regulatory milestones, including global submissions for sepiapterin – WARREN, N.J., April 25, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ:PTCT) today announced a corporate update and financial results for the first quarter ending March 31, 2024. "We are off to a strong start in 2024, with outstanding commercial performance and achievement of all planned clinical and regulatory milestones for the first quarter," said Matthew Klein, M.D., Chief Executive Officer, PTC Therapeutics, Inc. "We remain on track to achieve the ma
SOUTH PLAINFIELD, N.J., April 11, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced that the company will host a webcast conference call to report its first quarter 2024 financial results and provide an update on the company's business and outlook on Thursday, April 25, at 4:30 p.m. ET. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations. A replay of the call will be
– 34% year-over-year growth in 2023 total revenue – – Global filings of sepiapterin remain on track with first submission of the EU MAA expected in March – – Potential NDA submission for vatiquinone for Friedreich ataxia expected in late 2024 – SOUTH PLAINFIELD, N.J., Feb. 29, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ:PTCT) today announced a corporate update and financial results for the fourth quarter and full year ending December 31, 2023. "We closed out 2023 with strong revenue performance in the fourth quarter," said Matthew Klein, M.D., Chief Executive Officer, PTC Therapeutics, Inc. "We are well-positioned for a successful 2024 with several potential exciting clinical a
SOUTH PLAINFIELD, N.J., Feb. 15, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) today announced that the company will host a webcast conference call to report its fourth quarter and full year 2023 financial results and provide an update on the company's business and outlook on Thursday, Feb. 29, at 4:30 p.m. EST. To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations. A replay of th
- Conference call to be held at 8:45 am EDT - SOUTH PLAINFIELD, N.J., Sept. 15, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ:PTCT) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna™ (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). The negative opinion also applies to the renewal of the existing conditional authorization. PTC plans to submit a request for re-examination per EMA guidelines. Translarna will remain on the market and available to patie