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.

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Earnings data Q3 2023

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Earnings data Q1 2024

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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.

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. 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.

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

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.

Will PTC Therapeutics (PTCT) Report Negative Q3 Earnings? What You Should Know

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.

PTC Therapeutics Announces FDA Target Regulatory Action Date for Sepiapterin and Lancet Publication of Phase 3 Trial Results

PTC Therapeutics (PTCT) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

PTC Therapeutics (PTCT) Surges 16.5%: Is This an Indication of Further Gains?

PTC Therapeutics announces positive results from long-term treatment studies on vatiquinone for the treatment of Friedreich ataxia.

PTCT Stock Rises on Positive Updates on Friedreich Ataxia Program

- 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.

PTC Therapeutics Announces Positive Results from Long-Term Treatment Studies and Updates on Regulatory Progress for Vatiquinone Friedreich Ataxia Program

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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).

PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients

WARREN, N.J. , Sept. 26, 2024 /PRNewswire/ -- PTC Therapeutics (NASDAQ: PTCT) announced today that the FDA has granted Fast Track designation to the PTC518 program for the treatment of Huntington's disease.

FDA Grants Fast Track Designation to PTC518 Huntington's Disease Program

PTC Therapeutics, Inc. achieved dose-dependent lowering of mutant Huntingtin protein in both the blood and CSF of HD patients, using 5 mg and 10 mg of PTC518. The global Huntington's Disease treatment market is expected to reach $3.06 billion by 2033. NDA of sepiapterin for the treatment of patients with phenylketonuria submitted July 2024.

PTC Therapeutics: Positive HD Data Along With NDA Submission Brings Further Value

NEW YORK, NY / ACCESSWIRE / August 11, 2024 / Pomerantz LLP is investigating claims on behalf of investors of PTC Therapeutics, Inc. ("PTC" or the "Company") (NASDAQ:PTCT). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of PTC Therapeutics, Inc. - PTCT

PTC Therapeutics, Inc. (NASDAQ:PTCT ) Q2 2024 Earnings Conference Call August 8, 2024 4:30 PM ET Company Participants Ron Aldridge – Senior Director of Investor Relations Matthew Klein - Chief Executive Officer Eric Pauwels - Chief Business Officer Kylie O'Keefe - Chief Commercial Officer Pierre Gravier - Chief Financial Officer Conference Call Participants Kristen Kluska - Cantor Fitzgerald Eric Joseph – J.P. Morgan Kelly Shi – Jefferies Samantha Corwin - William Blair Brian Abraham - RBC Capital Markets Joseph Thome - TD Cowen Jeff Hung - Morgan Stanley Gena Wang – Barclays David Lebowitz – Citi Joseph Schwartz - Leerink Partners Operator Good day and thank you for standing by.

PTC Therapeutics, Inc. (PTCT) Q2 2024 Earnings Call Transcript

PTC Therapeutics (PTCT) came out with a quarterly loss of $1.16 per share versus the Zacks Consensus Estimate of a loss of $1. This compares to loss of $2.66 per share a year ago.

PTC Therapeutics (PTCT) Reports Q2 Loss, Misses Revenue Estimates

– 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.

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