PTC Therapeutics, Inc. ( PTCT Quick Quote PTCT - Free Report) announced additional strategic prioritization following the continued review of its portfolio that it commenced in May 2023.
This portfolio prioritization was initiated by the company to focus its resources on its differentiated, high-potential R&D programs and the support of its robust global commercial infrastructure.
As a part of the prioritization, PTC Therapeutics stated that it will reduce its workforce by 25%. Employees working on early-stage research programs, employees at the gene therapy manufacturing facility located in Hopewell, NJ and associated selling, general and administrative functions will be greatly impacted by this reduction.
The company expects to complete the workforce reduction by Jan 15, 2024.
Management expects that these cost-saving measures will result in an approximate 20% reduction in annualized operating expenses compared with the annual guidance provided by the company.
Concurrently, the company confirmed its plans to submit the re-examination request for the Committee for Medicinal Products for Human Use (CHMP) opinion on Translarna (ataluren).
Shares are trading down in the pre-market trading hours.
Shares of PTC Therapeutics have plunged 40.6% year to date against the
industry’s 8.0% decline. Image Source: Zacks Investment Research
Earlier in the month, the CHMP of the European Medicines Agency gave a negative opinion on the conversion of conditional marketing authorization to full marketing authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).
While Translarna will remain on the market and available to patients with nmDMD until the re-examination process is completed, the negative opinion applies to the renewal of the existing conditional authorization.
Management believes the totality of evidence collected in three placebo-controlled trials and the STRIDE registry provides clear evidence of Translarna’s benefit.
Translarna was given conditional marketing authorization in Europe in 2014, based on the results of Study 007 and the conditional authorization was renewed in 2017 after PTCT agreed to a specific obligation to conduct a third placebo-controlled trial, Study 041. The results of this study included nominally statistically significant results on several key endpoints in the overall enrolled Intent-to-Treat population of 359 boys, even though it did not meet statistical significance in the primary analysis subgroup.
The company also has Emflaza (deflazacort) for the treatment of Duchenne muscular dystrophy in its portfolio.
PTCT has also developed Evrysdi (risdiplam) in collaboration with Swiss pharma giant
Roche ( RHHBY Quick Quote RHHBY - Free Report) for the treatment of spinal muscular atrophy (SMA).
Roche acquired an exclusive worldwide license to the company’s SMA program in 2011 in return for milestone and royalty payments.
Zacks Rank & Stocks to Consider
PTCT currently carries a Zacks Rank #3 (Hold).
Some well-placed stocks in the industry are
Eton Pharmaceuticals ( ETON Quick Quote ETON - Free Report) and Dynavax Technologies ( DVAX Quick Quote DVAX - Free Report) . Eton currently sports a Zacks Rank #1 (Strong Buy) and Dynavax carries a Rank #2 (Buy).
You can see
. the complete list of today’s Zacks #1 Rank stocks here
Los estimates for Eton for 2023 have narrowed to 10 cents from 31 cents in the past 60 days, while earnings estimates for 2024 are pegged at 26 cents per share.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.