PTC Therapeutics

PTC Therapeutics, Inc. is a biopharmaceutical company, which engages in the discovery and commercialization of clinically differentiated medicines. It focuses on the development of new treatments for multiple therapeutic areas, including rare diseases and oncology. The firm's portfolio includes Translarna, Emflaza, Tegsedi, Waylivra, and Evrysdi. The company was founded by Allan Steven Jacobson and Stuart W. Peltz on March 31, 1998 and is headquartered in South Plainfield, NJ.

Earnings data Q1 2021

Earnings data Q2 2021

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Earnings data Q1 2022

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Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

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Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

PTC Therapeutics reports robust earnings, faces data release delays

PTC Therapeutics demonstrated strong financial performance and revenue growth in Q4 2022, setting a positive trajectory for 2023.
While facing challenges such as data release delays and regulatory engagements, the company's innovative pipeline and commercial successes position it well for future opportunities.
With upcoming data readouts, regulatory discussions, and market expansion initiatives, PTC is poised to navigate challenges and leverage opportunities for continued growth and impact.

PTC Therapeutics achieves record revenue, faces regulatory challenges and growth opportunities

PTC Therapeutics reported strong financial performance in Q1 2023, with a clear path towards achieving revenue targets. While facing challenges such as regulatory interactions and data expectations, the company is leveraging opportunities in upcoming study results and strategic initiatives to drive growth and market differentiation.

PTC Therapeutics reports strong Q2 revenue and advances pipeline

PTC Therapeutics showcased robust financial performance, positive trial outcomes, and strategic cost-saving measures in Q2 2023.
The company's strong revenue growth, global expansion plans, and pipeline advancements position it for sustained success.
Challenges include addressing analyst inquiries, navigating regulatory pathways, and ensuring market access post-2024.
Opportunities in product launches, regulatory activities, and strategic partnerships offer avenues for continued growth and innovation.

PTC Therapeutics reports robust Q3 earnings and strategic growth plans

PTC Therapeutics demonstrated strong financial performance and strategic partnerships in Q3 2023 earnings call.
The company's focus on pipeline advancement, commercial growth, and regulatory strategies positions it for future success.
While facing challenges in regulatory compliance and product comparability, PTC Therapeutics is leveraging opportunities for revenue growth and market expansion.

PTC Therapeutics posts robust Q4 earnings amidst regulatory challenges

PTC Therapeutics delivered strong financial performance in Q4 2023, driven by revenue growth and transformative gene therapy results, despite challenges from the CHMP opinion.
The company's strengths lie in its solid balance sheet, positive community feedback, and FDA alignment on registration programs, positioning it for future growth and approvals.
Opportunities abound in the launch of sepiapterin, accelerated approval discussions with the FDA, and promising programs for FA and ALS, signaling a positive outlook for PTC.

PTC Therapeutics reports robust Q1 performance amidst regulatory milestones

PTC Therapeutics demonstrated strong financial and operational performance in Q1 2024, driven by revenue growth and regulatory progress.
While facing challenges such as delays in European market access and regulatory complexities, the company remains focused on key therapeutic advancements.
Opportunities lie in upcoming clinical results, potential market expansions, and strategic regulatory pathways for accelerated product approvals.

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PTC Therapeutics, Inc. is a biopharmaceutical company, which focuses on the discovery, development, and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. The company was founded by Allan Steven Jacobson and Stuart Walter Peltz on March 31, 1998 and is headquartered in Warren, NJ.

WARREN, N.J. , Dec. 23, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that CEO Matthew B.

PTC Therapeutics to Present at the 43rd Annual J.P. Morgan Healthcare Conference

- If approved, vatiquinone would be the first and only authorized therapy for children with FA - - PTC's fourth approval application submitted to FDA in 2024 - WARREN, N.J. , Dec. 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the submission of the vatiquinone New Drug Application (NDA) for the treatment of children and adults living with Friedreich ataxia (FA) to the U.S. Food and Drug Administration (FDA).

PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich Ataxia

WARREN, N.J. , Dec. 17, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that on Dec. 13, 2024, the company approved non-statutory stock options to purchase an aggregate of 1,725 shares of its common stock and 5,060 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to eight new employees.

PTC Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Per the terms, PTC will receive $1 billion in upfront payment from Novartis upon the deal's closure. It is also eligible for milestone payments of up to $1.9 billion.

PTCT Stock Soars on Licensing Deal With NVS for Huntington's Therapy

Shares of PTC Therapeutics (PTCT) soared 16% Monday when the pharmaceutical firm announced it struck a nearly $2 billion license and collaboration deal with Novartis (NVS).

PTC Therapeutics Stock Soars on Novartis Licensing Agreement

Novartis

On Monday, PTC Therapeutics, Inc.  PTCT signed an exclusive global license and collaboration agreement with Novartis AG NVS for its PTC518 Huntington's disease program, which includes related molecules.

PTC Therapeutics Inks Licensing Pact With Novartis Worth Up To ~$3 Billion For Huntington's Program

Novartis will pay PTC Therapeutics up to $2.9 billion in a licensing deal for its Huntington's treatment. PTC Therapeutics stock surged.

PTC Therapeutics Scores A $2.9 Billion Novartis Deal And Hits Profit-Taking Zone

PTC Therapeutics has entered into a licensing deal with a unit of Novartis AG for up to $1.9 billion, the company said on Monday, for its experimental drug being developed for a rare neurological disorder.

PTC Therapeutics signs up to $1.9 billion licensing deal with Novartis

- PTC to receive $1.0B in cash at closing - - PTC is eligible to receive up to $1.9B in development, regulatory and sales milestones - - PTC to share profits in the U.S. and tiered double-digit royalties on ex-U.S. net sales - - Novartis will assume global development, manufacturing and commercial responsibilities following completion of placebo-controlled portion of ongoing PIVOT-HD study - - PTC will host a conference call on Dec. 2, 2024, at 8:30 am EST- WARREN, N.J. , Dec. 2, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the signing of an exclusive global license and collaboration agreement with Novartis Pharmaceuticals Corporation, a subsidiary of Novartis AG (NYSE: NVS), for its PTC518 Huntington's disease program, which includes related molecules.

PTC Therapeutics Enters into a Global License and Collaboration Agreement with Novartis for PTC518 Huntington's Disease Program

On Tuesday, PTC Therapeutics Inc PTCT revealed data from the global Phase 2 placebo-controlled CardinALS study of Utreloxastat in amyotrophic lateral sclerosis patients.

PTC Therapeutics Ends Utreloxastat Development After Rare Neurodegenerative Disease Trial Misses Goal, Analyst Maintains Outperform With Focus On Sepiapterin, Huntington's Programs

WARREN, N.J. , Nov. 27, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction.

PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million

PTC Therapeutics said on Tuesday it is discontinuing the development of its drug for a type of fatal neurodegenerative disease, as it did not meet the main goal in a mid-stage trial.

PTC Therapeutics discontinues development of ALS drug after trial failure

- Study failed to meet primary and secondary efficacy endpoints - WARREN, N.J. , Nov. 26, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the global Phase 2 placebo-controlled CardinALS study did not meet its primary endpoint of slowing disease progression on the composite ALSFRS-R and mortality analysis.

PTC Therapeutics Announces Topline Results of CardinALS Trial of Utreloxastat in ALS Patients

The U.S. Food and Drug Administration approved PTC Therapeutics' gene therapy that is administered directly in the brain to treat a potential fatal enzyme deficiency disorder, the company said on Wednesday.

US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder

- 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 Therapeutics Announces FDA Approval of AADC Deficiency Gene Therapy

PTC Therapeutics, Inc. (NASDAQ:PTCT ) Q3 2024 Earnings Conference Call November 7, 2024 4:30 PM ET Company Participants Jane Hanlon - Associate Director, Investor Relations Matthew Klein - Chief Executive Officer Eric Pauwels - Chief Business Officer Pierre Gravier - Chief Financial Officer Conference Call Participants Rick Bienkowski - Cantor Fitzgerald Eric Joseph - JPMorgan Kelly Shi - Jefferies Michael Riad - Morgan Stanley Brian Abraham - RBC Capital Markets Ellie Merle - UBS Joel Beatty - Baird Sami Corwin - William Blair Peyton Bohnsack - TD Cowen Paul Choi - Goldman Sachs Gena Wang - Barclays Danielle Brill - Raymond James Joseph Schwartz - Leerink Partners Operator Welcome to the PTC Third Quarter 2024 Financial Results Conference Call. At this time all participants are in a listen-only mode.

PTC Therapeutics, Inc. (PTCT) Q3 2024 Earnings Call Transcript

The headline numbers for PTC Therapeutics (PTCT) give insight into how the company performed in the quarter ended September 2024, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.

PTC Therapeutics (PTCT) Q3 Earnings: Taking a Look at Key Metrics Versus Estimates

PTC Therapeutics (PTCT) came out with a quarterly loss of $1.39 per share versus the Zacks Consensus Estimate of a loss of $1.54. This compares to loss of $1.76 per share a year ago.

PTC Therapeutics (PTCT) Reports Q3 Loss, Tops Revenue Estimates

– 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.

PTC Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results

Besides Wall Street's top -and-bottom-line estimates for PTC Therapeutics (PTCT), review projections for some of its key metrics to gain a deeper understanding of how the company might have fared during the quarter ended September 2024.

Unlocking Q3 Potential of PTC Therapeutics (PTCT): Exploring Wall Street Estimates for Key Metrics

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 Conference Wednesday, Nov. 13 at 2:45 p.m.

PTC Therapeutics to Participate at Upcoming Investor Conferences

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).

PTC Therapeutics Announces FDA Acceptance of Translarna™ NDA Resubmission

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.

PTC Therapeutics to Host Conference Call to Discuss Third Quarter 2024 Financial Results

- 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.

CHMP Maintains Negative Opinion on Translarna™ Reexamination

PTC Therapeutics (PTCT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

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