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 Q3 2023

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Earnings data Q1 2024

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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.

NEW YORK CITY, NY / ACCESSWIRE / July 10, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of PTC Therapeutics, Inc. ("PTC" or "the Company") (NASDAQ:PTCT). Investors who purchased PTC securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/PTCT.

Bronstein, Gewirtz and Grossman, LLC sends a Class Action Lawsuit reminder to shareholder investors for PTC Therapeutics, Inc to Lead the Class Action Lawsuit!

PTC Therapeutics (PTCT) falls as the EC's advisory committee adopts a negative opinion regarding the renewal of the conditional marketing approval of Translarna to treat nmDMD in the EU.

PTC Therapeutics (PTCT) Down on Negative CHMP Opinion on DMD Drug

- PTC to submit a request for re-examination - WARREN, N.J. , June 28, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the CHMP has issued a negative opinion on the renewal of the conditional marketing authorization of Translarna™ (ataluren) for the treatment of nmDMD.

CHMP Issues Negative Opinion on Translarna™ Following European Commission Request for Review

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 suggests that there could be more strength down the road.

PTC Therapeutics (PTCT) Soars 9.7%: Is Further Upside Left in the Stock?

- FDA lifts PTC518 partial clinical hold based on PIVOT-HD data - - Conference call and webcast to be held June 20 th 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.

Interim PIVOT-HD Results Demonstrate Evidence of Favorable CNS Biomarker and Clinical Effects at Month 12 in Huntington's Disease Patients

WARREN, N.J. , May 29, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company will present a company overview at the following conference: William Blair's 44th Annual Growth Stock Conference Tuesday, June 4, at 9:00 am ET / 8:00 am CT The presentation 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.

PTC Therapeutics to Participate at Upcoming Investor Conference

- Review of European marketing application for PKU now initiated - WARREN, N.J. , May 28, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the sepiapterin MAA for PKU has been validated and accepted for review by the EMA.

PTC Therapeutics Announces Validation of Sepiapterin European MAA

PTC Therapeutics (PTCT) gains 21% on May 20 after the EC decided against adopting the negative CHMP opinion of January 2024 on the annual renewal of the conditional approval of Translarna.

PTC Therapeutics (PTCT) Up as EC Returns CHMP Opinion on DMD Drug

PTC stock is poised to open at a nine-month high Monday after the EC decided against pulling its drug, Translarna, from the market.

PTC Therapeutics Stock Soars As Its Biggest Drug 'Lives To Fight Another Day'

- European Commission decides against adoption of negative opinion - - Translarna authorization remains active in Europe - - 2024 revenue guidance paused - WARREN, N.J. , May 20, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the European Commission (EC) has decided not to adopt the CHMP's negative opinion of January 24, 2024 on the annual renewal of the conditional marketing authorization of Translarna™ (ataluren) and has returned the opinion to the CHMP for re-evaluation.

PTC Therapeutics Announces European Commission Returns Translarna™ Opinion to CHMP For Re-evaluation

PTC Therapeutics, Inc. has submitted a New Drug Application for Upstaza for AADC Deficiency, with a PDUFA date set for November 13th, 2024. The company has several other regulatory milestones expected in 2024, including the resubmission of Translarna for DMD and the submission of vatiquinone for Friedreich's Ataxia. PTC Therapeutics also has two data readouts expected this year for PTC518 and utreloxastat, which could provide additional investment opportunities.

PTC Therapeutics: Multiple Regulatory Submissions Along With Data Cuts

- PDUFA target action date of November 13, 2024 - WARREN, N.J. , May 14, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the FDA has accepted for filing the Biologics License Application (BLA) for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of AADC deficiency.

PTC Therapeutics Announces FDA Acceptance and Priority Review of the BLA for Upstaza™

PTC Therapeutics, Inc. (NASDAQ:PTCT ) Q1 2024 Earnings Conference Call April 25, 2024 4:30 PM ET Company Participants Jane Hanlon - Associate 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 - JPMorgan Kelly Shi - Jefferies Samantha Corwin - William Blair Joseph Thome - TD Cowen Gena Wang - Barclays Jeff Hung - Morgan Stanley David Lebowitz - Citi Danielle Brill - Raymond James Tazeen Ahmad - Bank of America Paul Choi - Goldman Sachs Operator Good day and thank you for standing by. Welcome to PTC First Quarter 2024 Financial Results Conference Call.

PTC Therapeutics, Inc. (PTCT) Q1 2024 Earnings Call Transcript

Although the revenue and EPS for PTC Therapeutics (PTCT) give a sense of how its business performed in the quarter ended March 2024, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

Compared to Estimates, PTC Therapeutics (PTCT) Q1 Earnings: A Look at Key Metrics

– 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.

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

PTC Therapeutics (PTCT) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

PTC Therapeutics (PTCT) Expected to Beat Earnings Estimates: Can the Stock Move Higher?

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.

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

- First marketing authorization submission for sepiapterin with additional global submissions to follow in 2024 - SOUTH PLAINFIELD, N.J. , March 28, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the submission of the sepiapterin MAA to the European Medicines Agency.

PTC Announces Submission of Sepiapterin MAA for Treatment of PKU to EMA

NEW YORK, NY / ACCESSWIRE / March 26, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of PTC Therapeutics, Inc. ("PTC") (NASDAQ:PTCT) concerning possible violations of federal securities laws. On September 15, 2023, PTC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion of its drug Translarna, for the treatment of nonsense mutation Duchenne muscular dystrophy.

PTC Therapeutics, Inc. Investigated Regarding Potential Securities Law Violations - Contact Levi & Korsinsky for Details- PTCT

NEW YORK, NY / ACCESSWIRE / March 25, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of PTC Therapeutics, Inc. ("PTC") (NASDAQ:PTCT) concerning possible violations of federal securities laws. On September 15, 2023, PTC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion of its drug Translarna, for the treatment of nonsense mutation Duchenne muscular dystrophy.

PTC Therapeutics, Inc. (PTCT) Shareholders May Have Been Affected by Fraud- Levi & Korsinsky Investigates

NEW YORK, NY / ACCESSWIRE / March 22, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of PTC Therapeutics, Inc. ("PTC") (NASDAQ:PTCT) concerning possible violations of federal securities laws. On September 15, 2023, PTC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion of its drug Translarna, for the treatment of nonsense mutation Duchenne muscular dystrophy.

PTCT ACTIVE INVESTIGATION: Contact Levi & Korsinsky if you lost money on your PTC Therapeutics, Inc. investment

NEW YORK, NY / ACCESSWIRE / March 20, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of PTC Therapeutics, Inc. ("PTC") (NASDAQ:PTCT) concerning possible violations of federal securities laws. On September 15, 2023, PTC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion of its drug Translarna, for the treatment of nonsense mutation Duchenne muscular dystrophy.

ATTENTION PTCT SHAREHOLDERS: Investors who lost money on PTC Therapeutics, Inc. are urged to contact Levi & Korsinsky about an ongoing investigation

PTC Therapeutics (PTCT) submits BLA for gene therapy Upstaza to the FDA and announces plans to resubmit its application for Translarna to the regulatory body. Its shares rise on these updates.

PTC Therapeutics (PTCT) Up on Positive Regulatory Updates

- BLA submitted to FDA for Upstaza™ for the treatment of AADC deficiency - - NDA to be submitted mid-year for Translarna™ based on FDA feedback - SOUTH PLAINFIELD, N.J., March 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the submission of a BLA to the U.S. FDA for Upstaza™ (eladocagene exuparvovec), a gene therapy for the treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.

PTC Therapeutics Provides Key Regulatory Updates

NEW YORK, NY / ACCESSWIRE / March 14, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of PTC Therapeutics, Inc. ("PTC") (NASDAQ:PTCT) concerning possible violations of federal securities laws. On September 15, 2023, PTC announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a negative opinion of its drug Translarna, for the treatment of nonsense mutation Duchenne muscular dystrophy.

News for PTC Therapeutics Stock (PTCT)