Dernières nouvelles pour PTC Therapeutics (NASDAQ:PTCT) Stock

PTC Therapeutics

PTC Therapeutics Inc is a biopharmaceutical company focused on the discovery, development, and commercialization of orally administered, small-molecule therapeutics. Its target area is RNA biology post-transcriptional control processes of the events occurring in a cell when an RNA messenger is copied from DNA during the transcription process. The discovered products address multiple therapeutic areas, including rare disorders, such as nonsense mutations in Duchenne muscular dystrophy and oncology.

PTC Therapeutics Inc

On Thursday, the FDA granted accelerated approval to PTC Therapeutics, Inc.&#8217;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) gene therapy for AADC deficiency, the first-ever gene therapy approved in&nbsp;the U.S. that is directly <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/n41958648/ptc-therapeutics-announces-fda-approval-of-aadc-deficiency-gene-therapy" rel="noreferrer noopener">administered to the brain</a>.
The gene therapy, which will be marketed in&nbsp;the United States&nbsp;with the brand name Kebilidi (eladocagene exuparvovec-tneq), is indicated for the treatment of children and adults with aromatic L-amino acid decarboxylase (AADC) deficiency, including the full spectrum of disease severity.
Launch preparations are well underway, with centers already identified and surgeons trained in the procedure to deliver the gene therapy.&nbsp;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39413593/ptc-therapeutics-says-fda-lifts-clinical-hold-on-investigational-study-in-patients-with-rare-weak" rel="noreferrer noopener">PTC Therapeutics Says FDA Lifts Clinical Hold On Investigational Study In Patients With Rare Weak Nerve Cell Disorder</a>
AADC deficiency is a rare genetic disorder that results in the inability to synthesize dopamine, a neurotransmitter essential for motor function.
Affected individuals may experience symptoms such as delays in gross motor function (head control, sitting, standing, and walking), hypotonia (weak muscle tone), and developmental and cognitive delays.&nbsp;
Kebilidi is a gene replacement therapy that is directly administered to the putamen of the brain through a stereotactic neurosurgical procedure.
Kebilidi is administered via four infusions in one surgical session into a large structure in the brain involved in motor control.
Clinical trial results demonstrate that following gene therapy,&nbsp;de novo synthesis of dopamine occurs, followed by the progressive acquisition of motor development milestones.&nbsp;
The safety and effectiveness of Kebilidi were <a target="_blank" href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treatment-aromatic-l-amino-acid-decarboxylase-deficiency?utm_medium=email&amp;utm_source=govdelivery" rel="noreferrer noopener">demonstrated</a> in an open-label, single-arm clinical study in 13 pediatric patients.
The efficacy of Kebilidi was demonstrated based on gross motor function improvement in 8 of 12 treated patients, which has not been reported in untreated patients with the severe presentation of AADC deficiency.&nbsp;
Kebilidi&nbsp;received accelerated approval based on the safety and clinical efficacy findings in the ongoing global gene therapy clinical trial (PTC-AADC-GT-002).&nbsp;
Confirmatory evidence will be provided from the long-term follow-up of patients already treated in the study.
Along with the approval, a rare disease priority review voucher was granted. The company plans to&nbsp;monetize the voucher.
Barclays maintains PTC Therapeutics with an Equal-Weight rating, raising the price target from $43 to $45.
Price Action: PTCT stock is down 2.41% at $42.97 at last check Thursday.
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PTCT

FDA Grants Conditional Approval For PTC Therapeutics' Gene Therapy As First Ever With Direct Administration In Brain

Barclays analyst Gena Wang maintains PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) with a Equal-Weight and raises the price target from $43 to $45.

Price Target

Analyst Ratings

Barclays Maintains Equal-Weight on PTC Therapeutics, Raises Price Target to $45

<ul>
<li>- First-ever FDA approval for gene therapy directly administered to the brain -</li>
<li>- Priority review voucher granted -</li>
<li>- Broad label including children and adults -</li>
<li>- PTC pioneers new approach for CNS drug delivery -</li>
</ul>

Reported Earlier, PTC Therapeutics Secures FDA Approval For Brain-Administered Gene Therapy For AADC Deficiency

Barclays analyst Gena Wang maintains PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) with a Equal-Weight and raises the price target from $31 to $43.

Barclays Maintains Equal-Weight on PTC Therapeutics, Raises Price Target to $43

WIIM

PTC Therapeutics shares are trading higher after Baird raised its price target on the stock from $44 to $48.

Baird analyst Joel Beatty maintains PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) with a Outperform and raises the price target from $44 to $48.

Baird Maintains Outperform on PTC Therapeutics, Raises Price Target to $48

Guidance

PTC Therapeutics Sees FY24 Revenue $750M-$800M Vs $734.433M Est.

PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) reported quarterly losses of $(1.39) per share which beat the analyst consensus estimate of $(1.47) by 5.44 percent. The company reported quarterly sales of $196.800 million which beat the analyst consensus estimate of $172.655 million by 13.98 percent. This is a 0.11 percent increase over sales of $196.576 million the same period last year.

Earnings

Earnings Beats

PTC Therapeutics Q3 2024 GAAP EPS $(1.39) Beats $(1.47) Estimate, Sales $196.800M Beat $172.655M Estimate

PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) is preparing to release its quarterly earnings on Thursday, 2024-11-07. Here's a brief overview of what investors should keep in mind before the announcement.
Analysts expect PTC Therapeutics to report an earnings per share (EPS) of $-1.44.
PTC Therapeutics bulls will hope to hear the company announce they've not only beaten that estimate, but also to provide positive guidance, or forecasted growth, for the next quarter.
New investors should note that it is sometimes not an earnings beat or miss that most affects the price of a stock, but the guidance (or forecast).
<h3>Overview of Past Earnings</h3>
The company's EPS missed by $0.24 in the last quarter, leading to a 3.57% drop in the share price on the following day.
Here's a look at PTC Therapeutics's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-1.05</td>
<td>-1.24</td>
<td>0.50</td>
<td>-1.17</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-1.29</td>
<td>-1.20</td>
<td>-0.24</td>
<td>-1.76</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-4.0%</td>
<td>12.0%</td>
<td>13.0%</td>
<td>-23.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1730916127_0_0.png" alt="eps graph" />
<h3>Tracking PTC Therapeutics's Stock Performance</h3>
Shares of PTC Therapeutics were trading at $40.87 as of November 05. Over the last 52-week period, shares are up 127.22%. Given that these returns are generally positive, long-term shareholders are likely bullish going into this earnings release. 
<a href="https://www.benzinga.com/quote/PTCT/earnings">To track all earnings releases for PTC Therapeutics visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Earnings Preview For PTC Therapeutics

PTC Therapeutics Announced That The U.S. Food And Drug Administration Has Accepted For Review The Resubmission Of The New Drug Application For Translarna For The Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy

The opinion will now be reviewed by the European Commission (EC) which is expected to decide on opinion adoption in approximately 67 days.
&quot;CHMP again based its decision on the results of the primary analysis subpopulation of Study 041 instead of the totality of evidence for Translarna. That evidence includes data across three placebo-controlled trials and our STRIDE registry that demonstrates consistent short and long-term efficacy as well as safety supportive of continued authorization. In addition, the CHMP opinion is clearly against the expressed wishes of physicians, patients and families throughout&nbsp;Europe,&quot; said&nbsp;Matthew B. Klein, M.D., Chief Executive Officer, PTC Therapeutics, Inc.

PTC Therapeutics Says CHMP Of European Medicines Agency Maintained Its Negative Opinion On Renewal Of Conditional Marketing Authorization Of Translarna For Treatment Of Nonsense Mutation Duchenne Muscular Dystrophy

PTC Therapeutics Reports FDA Sets Target Regulatory Action Date For Sepiapterin and Lancet Publication Of Phase 3 Trial Results

Morgan Stanley analyst Jeffrey Hung maintains PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) with a Equal-Weight and raises the price target from $32 to $45.

Morgan Stanley Maintains Equal-Weight on PTC Therapeutics, Raises Price Target to $45

Baird analyst Joel Beatty reiterates PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) with a Outperform and maintains $44 price target.

Reiteration

Baird Reiterates Outperform on PTC Therapeutics, Maintains $44 Price Target

PTC Therapeutics shares are trading higher after the company announced its Vatiquinone Friedreich Ataxia program met its endpoint for two FA long-term extension studies. Also, PTC has recently aligned with the FDA on key aspects of the planned NDA submission.

PTC Therapeutics Announces Updates On Vatiquinone Friedreich Ataxia Program; Says Pre-Specified Endpoint For Two FA Long-Term Extension Studies Was Met, Says Co. Recently Aligned With FDA On Key Aspects On Planned NDA Submission

RBC Capital analyst Brian Abrahams maintains PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) with a Sector Perform and raises the price target from $32 to $34.

RBC Capital Maintains Sector Perform on PTC Therapeutics, Raises Price Target to $34

PTC Therapeutics Announces FDA Acceptance For Filing Of NDA For Sepiapterin For Pediatric And Adult Phenylketonuria Patients

FDA Grants Fast Track Designation To PTC Therapeutics' PTC518 Program For Huntington's Disease, Highlighting Its Potential As A Disease-Modifying Therapy

Cantor Fitzgerald analyst Kristen Kluska reiterates PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) with a Overweight and maintains $64 price target.

Cantor Fitzgerald Reiterates Overweight on PTC Therapeutics, Maintains $64 Price Target

JFrog slips as earnings season hops along while pair of semis rebound

In a report released on November 8, Gena Wang from Barclays maintained a Hold rating on PTC Therapeutics (PTCT – Research Report), with a price tar...

PTC Therapeutics (PTCT) Receives a Hold from Barclays

Barclays raised the firm's price target on PTC Therapeutics (PTCT) to $43 from $31 and keeps an Equal Weight rating on the shares. The company repo...

PTC Therapeutics price target raised to $43 from $31 at Barclays

Joseph Schwartz, an analyst from Leerink Partners, reiterated the Hold rating on PTC Therapeutics (PTCT – Research Report). The associated price ta...

Balancing Growth Prospects and Regulatory Challenges: A Hold Rating on PTC Therapeutics

PTC Therapeutics (PTCT) announced that the FDA accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene t...

PTC Therapeutics' AADC deficiency gene therapy granted FDA approval

William Blair analyst Sami Corwin has maintained their bullish stance on PTCT stock, giving a Buy rating on November 7. Sami Corwin has given his B...

PTC Therapeutics Gains Buy Rating Following FDA Approval of Groundbreaking Gene Therapy Kebilidi

Analysts have been eager to weigh in on the Healthcare sector with new ratings on PTC Therapeutics (PTCT – Research Report), Medtronic (MDT – Resea...

Analysts Have Conflicting Sentiments on These Healthcare Companies: PTC Therapeutics (PTCT), Medtronic (MDT) and OptimizeRx (OPRX)

In a report released today, Gena Wang from Barclays maintained a Hold rating on PTC Therapeutics (PTCT – Research Report), with a price target of $...

Barclays Remains a Hold on PTC Therapeutics (PTCT)

Barclays raised the firm's price target on PTC Therapeutics (PTCT) to $45 from $43 and keeps an Equal Weight rating on the shares. After approvals ...

PTC Therapeutics price target raised to $45 from $43 at Barclays

PTC Therapeutics wins FDA nod for gene therapy

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Press Releases

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

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

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