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

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Earnings data Q1 2023

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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.

The Brazilian Health Regulatory Agency has approved PTC Therapeutics Inc's (NASDAQ: PTCT) Waylivra (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS).  The approval is based on the Phase 3 APPROACH study results and the APPROACH Open-Label Extension study and is supported by results from the Phase 3 COMPASS study.

PTC Therapeutics' Waylivra Scores Approval In Brazil For Genetic Disorder

SOUTH PLAINFIELD, N.J., Aug. 23, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved Waylivra™ (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS) in Brazil.

PTC Therapeutics Announces Waylivra™ Approval in Brazil as First Treatment for Familial Chylomicronemia Syndrome

SOUTH PLAINFIELD, N.J., Aug. 23, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the publication of a manuscript, "Gene Therapy in the Putamen for Curing AADC Deficiency and Parkinson's Disease," in the European Molecular Biology Organization Journal.

Targeting the Putamen with Gene Therapy Leads to Sustained Improvements in Motor and Non-Motor Functions in Children with AADC Deficiency

PTC Therapeutics, Inc. (PTCT) CEO Stuart Peltz on Q2 2021 Results - Earnings Call Transcript

Shares of PTC Therapeutics (NASDAQ:PTCT) decreased in after-market trading after the company reported Q2 results. Quarterly Results Earnings per share increased 35.88% year over year to ($1.68), which beat the estimate of ($1.82).

Recap: PTC Therapeutics Q2 Earnings

SOUTH PLAINFIELD, N.J., July 29, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and financial results for the second quarter ending June 30, 2021.

PTC Therapeutics Provides a Corporate Update and Reports Second Quarter 2021 Financial Results

SOUTH PLAINFIELD, N.J., July 28, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that results from Part 2 of the FIREFISH pivotal study were published in the New England Journal of Medicine.

Significant Improvements in Survival and Developmental Milestones Demonstrated in Type 1 SMA Patients Treated with Evrysdi™

SOUTH PLAINFIELD, N.J., July 15, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Company will host a webcast conference call to report its second quarter 2021 financial results and provide an update on the company's business and outlook on Thursday, July 29, 2021, at 4:30 p.m.

PTC Therapeutics to Host Conference Call to Discuss Second Quarter 2021 Financial Results

SOUTH PLAINFIELD, N.J., June 24, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today presented pooled placebo data from multiple studies in which the results confirmed the clinical benefit of EMFLAZA® (deflazacort) over prednisone for the treatment of Duchenne muscular dystrophy (DMD).

Results Add to Body of Evidence Confirming EMFLAZA®'s Benefit Over Prednisone

SOUTH PLAINFIELD, N.J., June 23, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Evrysdi™ (risdiplam) was approved in Japan by the Japanese Ministry of Health, Labor and Welfare for the treatment of spinal muscular atrophy (SMA).

Evrysdi™ Approved in Japan for the Treatment of Spinal Muscular Atrophy

SOUTH PLAINFIELD, N.J., June 11, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced positive interim results from the ongoing RAINBOWFISH trial that demonstrated pre-symptomatic infants with spinal muscular atrophy (SMA) treated with Evrysdi were able to reach motor milestones such as sitting without support, rolling, crawling, standing unaided and walking independently.

Pre-symptomatic Infants with Spinal Muscular Atrophy Achieved Same Motor Milestones as Healthy Children After Treatment with Evrysdi™ in RAINBOWFISH

SOUTH PLAINFIELD, N.J., June 9, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the election of Mary L.

Health and Human Services Expert Mary L. Smith Joins PTC Therapeutics' Board of Directors

The FDA and the European Commission bestow Orphan Drug status to PTC Therapeutics' (PTCT) PTC923 for the treatment of hyperphenylalaninemia.

PTC Therapeutics' (PTCT) PTC923 Gets Orphan Drug Tag in US & EU

SOUTH PLAINFIELD, N.J., May 26, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that both the United States Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation (ODD) for PTC923 for the treatment of patients with hyperphenylalaninemia.

PTC Therapeutics Announces Orphan Drug Designations of PTC923 for the Treatment of Hyperphenylalaninemia

SOUTH PLAINFIELD, N.J., May 17, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced data from the first study on the impact of caring for a child with the ultra-rare genetic disorder, aromatic L-Amino acid decarboxylase deficiency (AADC-d).

New Data Shows Devastating Impact of AADC Deficiency on Caregivers

PTC Therapeutics, Inc. (PTCT) CEO Stuart Peltz on Q1 2021 Results - Earnings Call Transcript

Shares of PTC Therapeutics (NASDAQ:PTCT) were flat after the company reported Q1 results. Quarterly Results Earnings per share were down 1.10% over the past year to ($1.83), which missed the estimate of ($1.51).

PTC Therapeutics: Q1 Earnings Insights

SOUTH PLAINFIELD, N.J., May 4, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and financial results for the first quarter ending March 31, 2021.

PTC Therapeutics Provides a Corporate Update and Reports First Quarter 2021 Financial Results

PTC Therapeutics (PTCT) has been on a bit of a cold streak lately, but there might be light at the end of the tunnel for this overlooked stock

PTC Therapeutics (PTCT) Enters Oversold Territory

SOUTH PLAINFIELD, N.J., April 20, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Company will host a webcast conference call to report its first quarter 2021 financial results and provide an update on the company's business and outlook on Tuesday, May 4, 2021 at 4:30 p.m.

PTC Therapeutics to Host Conference Call to Discuss First Quarter 2021 Financial Results

SOUTH PLAINFIELD, N.J., April 15, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that results from Part 2 of the pivotal FIREFISH trial demonstrated that infants with type 1 spinal muscular atrophy (SMA) treated with Evrysdi™ (risdiplam) obtained increases in survival and sustained improvements in achieving key motor milestones, including head control, sitting, rolling over, and further developing towards acquiring the ability to stand, and walk.

Continued Improvements in Motor Milestones in Infants with Type 1 Spinal Muscular Atrophy After Two Years of Treatment with Evrysdi™

SOUTH PLAINFIELD, N.J., April 14, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today introduced a new no-charge, patient-initiated testing program in the United States for individuals who have symptoms consistent with, or a diagnosis of, cerebral palsy (CP) with no evidence of brain injury.

PTC Therapeutics Launches the PTC Pinpoint Direct™ Program for Patient-Initiated Genetic Testing

SOUTH PLAINFIELD, N.J., April 7, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that it has been named a winner of the 2021 "Don Clifton Strengths-Based Culture Award" from Gallup.

PTC Therapeutics Received Gallup's "Don Clifton Strengths-Based Culture" Award

SOUTH PLAINFIELD, N.J., April 7, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) will host a webinar in its deep dive series discussing the PTC518 Huntington disease (HD) program on Thursday, April 15 at 9 a.m.

PTC Therapeutics to Host PTC518 Huntington Disease Deep Dive Webinar

SOUTH PLAINFIELD, N.J., April 1, 2021 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that a $20 million milestone payment was triggered by the first commercial sale of Evrysdi™ (risdiplam) in the European Union under its License and Collaboration Agreement with Roche.

News for PTC Therapeutics Stock (PTCT)