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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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.

European regulators voted against fully approving a muscular dystrophy treatment from PTC Therapeutics, and PTC stock crashed Friday.

PTC Therapeutics Crashes 29% After European Regulators Reject Its Muscular Dystrophy Drug

PTC Therapeutics (NASDAQ:PTCT) stock sank in Friday premarket trading after the European Medicines Agency (EMA) turned down full market authorization for Translarna, its key treatment for Duchenne muscular dystrophy. Ahead of the opening bell, the company's shares were down 29% at $26.56.

PTC Therapeutics slumps on EU snub for DMD drug

- 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).

CHMP Delivers Opinion on Translarna™ for Conversion to Full Authorization

- 2023 recipients include patient advocacy organizations in Australia and Brazil - SOUTH PLAINFIELD, N.J. , Sept. 7, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the two recipients of its 2023 STRIVE Awards for Duchenne Muscular Dystrophy.

PTC Therapeutics' 2023 STRIVE Awards Program Funds Initiatives Supporting the Duchenne Patient Community

- Results from the APHENITY trial in PKU and long-term extension study including Phe tolerance to be highlighted - SOUTH PLAINFIELD, N.J. , Aug. 28, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that results from the APHENITY clinical trial and long-term extension study will be presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium 2023 which is being held from Aug. 29 to Sept.

PTC Therapeutics to Present Recent Data for Sepiapterin at the Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual Symposium

AstraZeneca

Sangamo Therapeutics

Rare disease stocks have a difficult task. The rarer a disease is, the less public research goes into studying it.

Untapped Potential: 3 Stocks Tackling the Toughest Rare Diseases

PTC Therapeutics, Inc. lacks solid margins and revenue streams, increasing investment risks. The company focuses on developing medicines for rare disorders, but a failed drug test caused stock price to tumble. The company's profitability is low, and there are uncertainties surrounding license renewals and regulatory requirements in Europe.

PTC Therapeutics: Struggling Still But Potential Remains

PTC Therapeutics, Inc. (NASDAQ:PTCT ) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET Company Participants Ron Aldridge - Senior Director, 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 Kelly Shi - Jefferies Sami Corwin - William and Blair Kristen Kluska - Cantor Fitzgerald David Lebowitz - Citi Michael Riad - Morgan Stanley Yihan Li - UBS Joseph Thome - TD Cowen Tazeen Ahmad - Bank of America Paul Choi - Goldman Sachs Operator Good day, and thank you for standing by and welcome to the PTC Second Quarter 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode.

PTC Therapeutics, Inc. (PTCT) Q2 2023 Earnings Call Transcript

While the top- and bottom-line numbers for PTC Therapeutics (PTCT) give a sense of how the business performed in the quarter ended June 2023, it could be worth looking at how some of its key metrics compare to Wall Street estimates and year-ago values.

PTC Therapeutics (PTCT) Q2 Earnings: How Key Metrics Compare to Wall Street Estimates

– Second-quarter 2023 total revenue of $214 million, representing 29% year-over-year growth – – Positive APHENITY and PIVOT-HD data readouts in the second quarter – – Numerous regulatory milestones planned for the second half of 2023 –  SOUTH PLAINFIELD, N.J., Aug. 3, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and financial results for the second quarter ending June 30, 2023.

PTC Therapeutics Provides Corporate Update and Reports Second Quarter Financial Results

LOS ANGELES, CA / ACCESSWIRE / August 3, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ:PTCT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against PTC Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

- Following ratification by the European Commission, Evrysdi will be available to treat all spinal muscular atrophy patients, including babies from birth - SOUTH PLAINFIELD, N.J. , July 21, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Evrysdi® (risdiplam) marketing authorization to include infants under two months of age in the European Union (EU).

CHMP Recommends Evrysdi® for Babies Under Two Months Old with Spinal Muscular Atrophy

SOUTH PLAINFIELD, N.J. , July 20, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will host a webcast conference call to report its second quarter 2023 financial results and provide an update on the company's business and outlook on Thursday, Aug. 3, at 4:30 p.m.

PTC Therapeutics to Host Conference Call to Discuss Second Quarter 2023 Financial Results

LOS ANGELES, CA / ACCESSWIRE / July 19, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ:PTCT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against PTC Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

-- Dr. Jacobson recognized for his pioneering work in nonsense-mediated mRNA decay -- SOUTH PLAINFIELD, N.J. , July 19, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Allan Jacobson, Ph.D.

PTC Therapeutics Co-Founder Allan Jacobson, Ph.D., Awarded 2023 Gruber Genetics Prize

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).

PTC Therapeutics Appoints Experienced Healthcare Finance Strategist Pierre Gravier as Chief Financial Officer

LOS ANGELES, CA / ACCESSWIRE / July 13, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ:PTCT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against PTC Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

SOUTH PLAINFIELD, N.J., July 11, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT), announced today that the company will provide a virtual presentation on PKU including discussion of the current therapeutic and commercial landscape with an expert key opinion leader.

PTC Therapeutics Announces Virtual Presentation on Phenylketonuria (PKU) and Sepiapterin

LOS ANGELES, CA / ACCESSWIRE / July 11, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ:PTCT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against PTC Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / July 8, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ: PTCT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

SHAREHOLDER ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against PTC Therapeutics, Inc. and Encourages Investors with Losses In Excess of $100,000 to Contact the Firm

SOUTH PLAINFIELD, N.J., June 29, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the MIT-E trial of vatiquinone for the treatment of mitochondrial disease associated seizures (MDAS) failed to achieve its primary endpoint of reduction in observable motor seizures.

PTC Therapeutics Announces Results from MIT-E Clinical Trial of Vatiquinone for the Treatment of Mitochondrial Disease Associated Seizures

PTC Therapeutics Inc said on Wednesday its experimental Huntington's disease drug lowered mutated protein levels that cause the disease, citing interim data from a mid-stage study.

PTC Therapeutics Huntington's disease drug shows promise in mid-stage trial

- D ose-dependent lowering of blood Huntingtin (HTT) protein levels at 12 weeks - - Favorable tolerability profile with no treatment-related serious adverse events or NfL spikes -  - Conference call and webcast to be held June 21 st at 8:00 am EDT -  SOUTH PLAINFIELD, N.J. , June 21, 2023 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today shared interim data from the 12-week portion of the PIVOT-HD Phase 2 study of PTC518 in Huntington's disease (HD) patients.

PTC Therapeutics Shares Positive Interim Data from PIVOT-HD Clinical Trial in Huntington's Disease Patients

LOS ANGELES, CA / ACCESSWIRE / June 4, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ: PTCT) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

ONGOING INVESTIGATION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against PTC Therapeutics, Inc. and Encourages Investors with Losses to Contact the Firm

PTC Therapeutics' (PTCT) vatiquinone did not achieve its primary endpoint in a late-stage study in treating Friedreich Ataxia patients. Shares decline 21% post the news.

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