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IPSEN S.A. ADR

Ipsen is a global biotechnology company headquartered in France that develops and commercializes medicines across three therapeutic areas: oncology, neuroscience, and rare diseases. Ipsen was founded in 1929 as a consumer healthcare company focused on prescription-based products for digestive disorders and neurological disorders. Over the past nearly 100 years, Ipsen has shifted its focus to specialty care, which comprises the vast majority of its total revenue. In February 2022, Ipsen announced the divestment of its consumer healthcare business, which accounted for 8% of 2021 revenue. Ipsen has a large global footprint and sells more than 25 drugs in 115 countries.

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The U.S. FDA has granted accelerated approval for Iqirvo, a novel drug from Ipsen SA and Genfit SA, designed for treating primary biliary cholangitis (PBC). This approval, based on the drug&#39;s ability to reduce alkaline phosphatase levels, marks a significant advancement in therapies available for PBC.

FDA Fast-Tracks Ipsen And Genfit&#39;s New Liver Disease Treatment, Iqirvo

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Roche Holdings AG (OTC: RHHBY), Exelixis Inc (NASDAQ: EXEL), and Ipsen&amp;nbs

Third Time Lucky: Exelixis&#39; Cabozantinib Combo Therapy Aces Pivotal Study In Prostate Cancer Patients

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Friday, CymaBay Therapeutics Inc&#39;s (NASDAQ: CBAY) competitors Genfit SA (NASDAQ: GNFT) and Ipsen SA (OTC: 

Genfit&#39;s Miss Is CymaBay Therapeutics&#39; Gain: Analyst Says Rival Data Leaves Room for Seladelpar To Emerge As Best-In-Class

Ipsen SA

Increlex is a biologic product used to treat children and adolescents from 2- to 18-years-old who suffer from severe primary insulin-like growth factor 1 deficiency (SPIGFD) because their bodies do not make enough insulin-like growth factor 1 (IGF-1).
The medicine is approved in 40 territories, including the United States (U.S.) and the European Union (EU). It is estimated that approximately 200 patients in the United States and 900-1,000 patients in Europe live with SPIGFD. Increlex is the only treatment approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) for SPIGFD.
Ipsen reported global sales for Increlex of &euro;17.3 million in 2023.

ETON

Eton Pharmaceuticals Enters Asset Purchase Agreement To Acquire Increlex (Mecasermin Injection) From Ipsen; No Terms Disclosed

Ipsen ((Euronext: IPN, OTC:<a class="ticker" href="https://www.benzinga.com/stock/IPSEY#OTC">IPSEY</a>) and Day One Biopharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DAWN#NASDAQ">DAWN</a>) (Day One), announced today a new global partnership outside the U.S. for tovorafenib, an oral, once-weekly, type II RAF inhibitor for pediatric low grade glioma (pLGG), the most common form of childhood brain cancer, i and any future indications developed by Day One.
Under the terms of the agreement, Ipsen will be responsible for the regulatory and commercial activities for tovorafenib in all territories outside of the U.S. Day One will receive an upfront payment of approximately $111 million, which includes approximately $71 million in cash as well as a $40 million equity investment at a premium and up to approximately $350 million in additional launch and sales milestone payments. Day One will receive tiered double-digit royalties starting at mid-teens percentage on sales.

DAWN

Ipsen And Day One Earlier Announced Exclusive Ex U.S. Licensing Agreement To Commercialize Tovorafenib For The Most Common Childhood Brain Tumor

<ul>
<li>Ipsen secures ex-U.S. regulatory and commercial rights to tovorafenib for most common childhood brain tumor, pediatric low-grade glioma (pLGG), and any future indications</li>
<li>OJEMDA&trade; (tovorafenib) is the first FDA-approved treatment for relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or V600 mutation, following the pivotal Phase II trial, FIREFLY-1</li>
<li>Day One receives approximately&nbsp;$111 million&nbsp;upfront in cash and equity investment with up to approximately&nbsp;$350 million&nbsp;in milestone payments and double-digit tiered royalties</li>
<li>Ongoing Phase III trial, FIREFLY-2, is evaluating tovorafenib as a monotherapy for newly diagnosed children and young adults with RAF-altered low-grade glioma requiring first-line systemic therapy</li>
</ul>

Ipsen And Day One Enter Ex-U.S. Licensing Deal For Pediatric Brain Cancer Drug Tovorafenib

Ipsen SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/IPSEF#OTC">IPSEF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/IPSEY#OTC">IPSEY</a>) announced Monday that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets <a target="_blank" href="https://www.benzinga.com//node/39259958" rel="noreferrer noopener">to treat primary biliary cholangitis (PBC).</a>
PBC is a rare, autoimmune, cholestatic liver disease where a build-up of bile and toxins and chronic inflammation causes irreversible fibrosis of the liver and destruction of the bile ducts.
This drug is approved for use with ursodeoxycholic acid (UDCA) or as a standalone treatment in cases where UDCA is not tolerated.
Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed from GENFIT S.A. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GNFT#NASDAQ">GNFT</a>) in 2021.
The expedited approval is based on the medication&#8217;s ability to reduce levels of alkaline phosphatase (ALP), an indicator of liver health.
Continued approval will depend on further verification in confirmatory trials. The approval of Iqirvo follows promising results from the Phase III ELATIVE trial, which was published in the New England Journal of Medicine.
The study found that patients treated with Iqirvo, in addition to UDCA, were 13 times more likely to achieve a primary biochemical response compared to those receiving a placebo.
Iqirvo, developed by Genfit and commercialized by Ipsen, is now available for prescription in the U.S., <a target="_blank" href="https://www.benzinga.com//node/39260587" rel="noreferrer noopener">offering a new therapeutic option for treating PBC.</a>
In 2024, GENFIT anticipates substantial milestone payments from Ipsen totaling approximately €89 million, which include €48.7 million expected from the initial U.S. sales of Iqirvo.
PBC impacts approximately 100,000 people in the U.S. and is growing globally. If inadequately treated, it can cause liver failure.
Christelle Huguet, Executive Vice President, Head of Research and Development at Ipsen, said, &#8220;Iqirvo demonstrated statistically significant improvements in biochemical response compared to UDCA alone. Iqirvo is therefore a much-needed treatment option and the first new medicine for PBC in nearly a decade.&#8221;
Iqirvo is priced at approximately $11,500 for a monthly supply, Reuters reported.
Price Action: GNFT shares are trading lower by 1.45% at $5.50 in premarket at the last check Tuesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo via Shutterstock

FDA Fast-Tracks Ipsen And Genfit's New Liver Disease Treatment, Iqirvo

GENFIT is eligible to receive a &euro;48.7 million milestone payment from Ipsen upon the first commercial sale of Iqirvo in the U.S., as well as tiered double-digit royalties of up to&nbsp;20%.
<div>Ipsen&#39;s Iqirvo&nbsp;(elafibranor) 80 mg tablets received U.S. FDA accelerated approval as a first-in-class treatment for Primary Biliary Cholangitis (PBC).</div>

GENFIT Says Iqirvo Is First-ever Drug Developed In-house By Company To Achieve FDA Approval; Expects To Receive Milestone Payments From Ipsen

Iqirvo is a first-in-class oral, once-daily peroxisome proliferator-activated receptor (PPAR) agonist. Iqirvo was in-licensed from GENFIT in 2021.
Iqirvo was discovered and developed by GENFIT and Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021.

Ipsen Says Iqirvo Secured FDA Accelerated Approval As First-In-Class PPAR Treatment For Primary Biliary Cholangitis; Iqirvo Was In-licensed From GENFIT In 2021

Ipsen And Skyhawk Therapeutics Partner To Pioneer RNA-Based Treatments For Rare Neurological Conditions

<ul>
<li>Ipsen secures exclusive global rights for development and commercialization of STRO-003, an antibody-drug conjugate, completing the final stages of pre-clinical development</li>
<li>STRO-003 targets ROR1, a clinically validated antibody drug conjugate (ADC) target</li>
<li>STRO-003 has shown robust monotherapy efficacy and potential for a differentiated safety profile in preclinical development in solid tumors and hematological malignancies1</li>
</ul>

STRO

Ipsen And Sutro Biopharma Enter Exclusive Global Licensing Agreement For An ADC Targeting Solid Tumors

The company has&nbsp;received a&nbsp;$225 million&nbsp;payment which was due from Ipsen, S.A. as a result of its receipt of approval from the U.S. Food and Drug Administration, or FDA, to market ONIVYDE as a first-line treatment of metastatic adenocarcinoma on the pancreas.&nbsp;Merrimack&#39;s Board of Directors has evaluated the likelihood of receiving additional milestone payments under the Ipsen Agreement and from the 2019 Agreement with Elevation Oncology and has concluded that it is unlikely that any additional milestone payments from either agreement will become payable. The company announced a special meeting of stockholders on May 10, 2024 to approve a Plan of Dissolution which includes plans for a liquidating dividend payable to stockholders.

MACK

Merrimack Secures $225M Milestone Payment From Ipsen; Says It Is Unlikely That Any Additional Milestone Payments Will Become Payable

<ul>
<li>Approval based on Phase III NAPOLI 3 clinical trial in which Onivyde&#xAE; regimen (NALIRIFOX) demonstrated statistically significant superiority and clinically meaningful improvements in overall survival and progression-free survival versus nab-paclitaxel and gemcitabine 1 &nbsp;</li>
<li>NAPOLI 3 represents the first positive Phase III trial in first-line metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate superior overall survival versus the currently approved regimen of nab-paclitaxel and gemcitabine1 &nbsp;</li>
<li>Onivyde is the only FDA-approved treatment regimen to demonstrate efficacy in two Phase III trials across lines of therapy in mPDAC1,2 &nbsp;</li>
</ul>
PARIS, FRANCE, 13 February 2024 - Ipsen ((Euronext: IPN, OTC:<a href="https://www.benzinga.com/stock/IPSEY#OTC">IPSEY</a>) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application for Onivyde&#xAE; (irinotecan liposome injection) plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA's approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy.
"The results from the Phase III NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen," said Christelle Huguet, EVP and Head of Research and Development, Ipsen. "With today's approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the U.S."
Pancreatic adenocarcinoma (PDAC) is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally.3,4 Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV).5 Characterized as a complex cancer due to rapid tumor progression, limited genetic targets and multiple resistance mechanisms,6 mPDAC has a poor prognosis with fewer than 20% of people surviving longer than one year.4,5 Overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.4,5
"Metastatic pancreatic adenocarcinoma is a difficult disease to manage with very few available treatment options. Given the reality of this aggressive form of cancer and the complexity of the disease, every advance in the treatment landscape represents a meaningful improvement in patient outcomes." said Dr. Zev Wainberg, Professor of Medicine and Co-Director of the UCLA GI Oncology Program. "The approval of this Onivyde regimen is an important milestone for people living with mPDAC, their families and healthcare providers, with the NAPOLI 3 trial having demonstrated survival benefits versus a current standard of care treatment option."
"We are pleased that the U.S. Food and Drug Administration has issued this new approval of the NALIRIFOX regimen. With each new approved treatment, there is more hope for those who will be diagnosed in the future and people currently living with pancreatic cancer may have more time with their loved ones," said Julie Fleshman, JD, MBA, President and CEO of Pancreatic Cancer Action Network (PanCAN), a patient advocacy organization committed to providing evidence-based information and resources to patients and caregivers, along with advancing research to improve patient outcomes. "We are thankful to the patients who participated in this clinical trial as they play a crucial role in advancing treatments for pancreatic cancer."
NAPOLI 3 data
The FDA approval was based on efficacy and safety data from NAPOLI 3, a randomized, open-label, Phase III pivotal trial that enrolled 770 people living with mPDAC between the ages of 20 and 85 without prior treatment across 187 trial site locations in 18 countries. The study, which met the primary and secondary endpoints, was presented as a late-breaking presentation at the ASCO Gastrointestinal conference 2023 and subsequently published in The Lancet.1,7Additionally, NALIRIFOX was recognized by the National Comprehensive Cancer Network&#xAE; (NCCN) guidelines&#x2A; and recommended as a preferred, Category 1 treatment option in first-line metastatic disease and as a preferred option in first-line locally advanced disease.8
<ul>
<li>The study demonstrated NALIRIFOX (n=383) provided a statistically significant improvement in median overall survival (mOS) of 11.1 months (95% confidence interval (CI) (10.0, 12.1)) compared to 9.2 months (95% CI (8.3, 10.6)) in nab-paclitaxel and gemcitabine treated patients (n=387); (hazard ratio (HR) 0.84 [95% CI 0.71–0.99]; p=0.0403).9</li>
<li>NALIRIFOX regimen also demonstrated a statistically significant improvement in median progression-free survival (mPFS) of 7.4 months (95% CI (6.0, 7.7)) versus 5.6 months (95% CI (5.3, 5.8)) for nab-paclitaxel and gemcitabine treated patients (HR 0.70 [95% CI 0.59–0.85]; p=0.0001).9</li>
<li>The objective response rate was 41.8% (36.8%-46.9%; 95% CI) for patients treated with the NALIRIFOX regimen versus 36.2% (31.4%-41.2%; 95% CI) for patients treated with nab-paclitaxel and gemcitabine.9</li>
<li>The safety profile of the Onivyde regimen was manageable and consistent with the profiles of the treatment components, with the potential of serious adverse events of fatal neutropenic fever and severe diarrhea. The most common Grade 3/4 treatment-emergent adverse events were diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation and decreased weight.9 In NAPOLI 3, Grade 3 and 4 diarrhea (early and late-onset) occurred in 20% receiving NALIRIFOX. In the clinical trial, diarrhea was managed following institutional guidelines and appropriate antidiarrheal medications.9</li>
</ul>
&#x2A;NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
ENDS
About Onivyde&nbsp;(irinotecan liposome injection)
Onivyde is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In Onivyde, irinotecan is enclosed in tiny fat particles called ‘liposomes', which accumulate in the tumor and release slowly over time. Onivyde is administered via intravenous infusion over 90 minutes every two weeks, with recommendations on dosing modifications. Onivyde may be prescribed immediately in the U.S. for eligible people living with mPDAC who are treatment naïve or following gemcitabine-based therapy.
To support access to Onivyde for eligible individuals in the U.S., Ipsen Cares patient support program is available as a resource to people living with mPDAC and their caregivers to provide educational support and address coverage, access and reimbursement questions (1-866-435-5677).
Onivyde is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil (FU) and leucovorin (LV) for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. Onivyde is not indicated as a single agent for the treatment of adult patients with metastatic pancreatic adenocarcinoma.
In 2020, the FDA granted Ipsen Fast Track designation for Onivyde as a first-line combination treatment for mPDAC. The FDA's Fast Track program facilitates the development and expedites the review of medicines that treat serious conditions and have the potential to address an unmet medical need.
Ipsen has exclusive commercialization rights for the current and potential future indications for Onivyde in the U.S. Servier, an independent international pharmaceutical company with an international presence in 150 countries, is responsible for the commercialization of Onivyde outside of the U.S. and Taiwan. PharmaEngine is a commercial stage oncology company headquartered in Taipei and is responsible for the commercialization of Onivyde in Taiwan.
About PDAC
PDAC is the most common type of cancer that forms in the pancreas, with more than 60,000 people diagnosed in the U.S. each year and nearly 500,000 people globally.3,4 Since there are no specific symptoms in the early stages, PDAC is often detected late and after the disease has spread to other parts of the body (metastatic or stage IV).5 Weight loss, abdominal pain and jaundice are the most common symptoms, making PDAC difficult to detect.10 Despite significant advances in cancer treatments since the 1970s, no treatment options for PDAC significantly extend life.5 Currently, fewer than 20% of people diagnosed with PDAC survive longer than one year and, overall, pancreatic cancer has the lowest five-year survival rate of all cancer types globally and in the U.S.3,4
About the NAPOLI 3 trial1
NAPOLI 3 is a randomized, open-label Phase III trial of an investigational Onivyde treatment regimen (NALIRIFOX) in patients who have not previously received chemotherapy for mPDAC. NAPOLI 3 enrolled 770 patients across 187 trial site locations in 18 countries across Europe, North America, South America, Asia, and Australia. Patients were randomized to receive Onivyde plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle) compared to an injection of nab-paclitaxel and gemcitabine (n=387) administered three times a month (days 1, 8, 15 of a 28-day cycle).

Ipsen's Onivyde Regimen, A Potential New Standard-Of-Care First-Line Therapy In Metastatic Pancreatic Adenocarcinoma, Approved By FDA

Contracts

Asset Sales

BZ NOTE: Merrimack Pharmaceuticals, As Part Of Its Agreement With Ipsen For The Sale Of Its Oncology Assets Including ONIVYDE, Is Eligible To Receive Additional Payments With The Possibility Of Up To $450M Contingent Upon The Approval Of Potential New Indications For ONIVYDE In The U.S.

<a href="https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma">https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-irinotecan-liposome-first-line-treatment-metastatic-pancreatic-adenocarcinoma</a>
On February 13, 2024, the Food and Drug Administration approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma.
Full prescribing information for Onivyde will be posted <a href="https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm">here</a>.
Efficacy was evaluated in NAPOLI 3 (NCT04083235), a randomized, multicenter, open-label, active-controlled trial in 770 patients with metastatic pancreatic adenocarcinoma who had not previously received chemotherapy in the metastatic setting. Randomization was stratified by region, liver metastases, and ECOG performance status. Patients were randomized (1:1) to receive one of the following treatments:
<ul>
<li>NALIRIFOX: irinotecan liposome 50 mg/m2 as an intravenous infusion over 90 minutes, followed by oxaliplatin 60 mg/m2 as an intravenous infusion over 120 minutes, followed by leucovorin 400 mg/m2 intravenously over 30 minutes, followed by fluorouracil 2400 mg/m2 intravenously over 46 hours, every 2 weeks.</li>
<li>Gem+NabP: Nab-paclitaxel 125 mg/m2 as an intravenous infusion over 35 minutes, followed by gemcitabine 1000 mg/m2 intravenously over 30 minutes on days 1, 8, and 15 of each 28-day cycle.</li>
</ul>
The main efficacy outcome measure was overall survival (OS). Additional efficacy measures were investigator-assessed progression-free survival (PFS) and objective response rate (ORR). NAPOLI 3 demonstrated a statistically significant improvement in OS and PFS for the NALIRIFOX arm over the Gem+NabP arm. Median OS was 11.1 months (95% CI: 10.0, 12.1) in the NALIRIFOX arm and 9.2 months (95% CI: 8.3, 10.6) in the Gem+NabP arm (Hazard Ratio [HR] 0.84 [95% CI: 0.71, 0.99]; p-value 0.0403). Median PFS was 7.4 months (95% CI: 6.0, 7.7) in the NALIRIFOX arm and 5.6 months (95% CI: 5.3, 5.8) in the Gem+NabP arm (HR 0.70 [95% CI: 0.59, 0.85]; p-value 0.0001). ORR was 41.8% (95% CI: 36.8, 46.9) in the NALIRIFOX arm and 36.2% (95% CI: 31.4, 41.2) in the Gem+NabP arm.
The most common adverse reactions of NALIRIFOX (≥20% with a difference between arms of ≥5% for all grades or ≥2% for Grades 3 or 4 compared to Gem+NabP) were diarrhea, fatigue, nausea, vomiting, decreased appetite, abdominal pain, mucosal inflammation, constipation, and decreased weight. The most common laboratory abnormalities (≥10% Grade 3 or 4) were decreased neutrophils, decreased potassium, decreased lymphocyte, and decreased hemoglobin.
The recommended irinotecan liposome dose is 50 mg/m2 administered by intravenous infusion over 90 minutes every 2 weeks. Administer irinotecan liposome before oxaliplatin, fluorouracil, and leucovorin. There is no recommended dosage of irinotecan liposome for patients with serum bilirubin above the upper limit of normal.
This application was granted orphan drug designation.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's&nbsp;<a href="https://www.accessdata.fda.gov/scripts/medwatch/index.cfm">MedWatch Reporting System</a> or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE's <a href="https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate">Project Facilitate</a> at 240-402-0004 or email <a href="mailto:OncProjectFacilitate@fda.hhs.gov">OncProjectFacilitate@fda.hhs.gov</a>.

FDA Approves Irinotecan Liposome For First-line Treatment Of Metastatic Pancreatic Adenocarcinoma

Ipsen ((Euronext: IPN, OTC:<a class="ticker" href="https://www.benzinga.com/stock/IPSEY#OTC">IPSEY</a>) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational elafibranor. An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR &alpha;,&delta;) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade. The target FDA PDUFA date under priority review is June 10, 2024.

Ipsen Confirms FDA Grants Priority Review For New Drug Application For Elafibranor For The Treatment Of Rare Cholestatic Liver Disease, PBC

<ul>
<li>New Drug Application granted priority review with PDUFA date set for June 10, 2024</li>
<li>European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor</li>
<li>Investigational elafibranor is the first novel second-line treatment for primary biliary cholangitis (PBC) to be filed in E.U. and U.S. in nearly a decade</li>
</ul>

U.S. FDA Grants Priority Review For Ipsen's New Drug Application For Elafibranor For The Treatment Of Rare Cholestatic Liver Disease, PBC

Roche Holdings AG&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>),&nbsp;Exelixis Inc&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/exel#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">EXEL</a>), and&nbsp;Ipsen&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ipsey#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">IPSEY</a>) say Phase 3 CONTACT-02 pivotal trial evaluating Cabometyx (cabozantinib) in combination with Tecentriq (atezolizumab) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/08/b33956093/exelixis-and-ipsen-announce-positive-results-from-phase-3-contact-02-pivotal-trial-evaluating-cabo" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">met one of the primary endpoints</a>.
The study demonstrated a statistically significant improvement in progression-free survival (PFS) at the primary analysis.&nbsp;
CONTACT-02 is evaluating cabozantinib combined with atezolizumab compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable soft tissue disease previously treated with one novel hormonal therapy.
Tecentriq plus Cabometyx failed two, namely CONTACT-01 in non-small cell lung cancer and CONTACT-03 in renal cell carcinoma.
In the CONTACT-03 study, Tecentriq plus Cabometyx failed to meet its primary endpoint of overall survival at the final analysis&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/03/31193407/roche-exelixis-report-second-flop-out-of-three-trials-evaluating-cabozantinibatezolizumab-combo" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">compared to chemotherapy</a>.&nbsp;
The CONTACT-01 study did not meet its primary endpoint of overall&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/12/30021617/exelixis-cabometyxtecentriq-combo-misses-overall-survival-goal-in-lung-cancer-setting" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">survival at the final analysis</a>.&nbsp;
The companies say they will present the results at a later medical meeting and discuss them with regulatory authorities.
William Blair&nbsp;analysts&nbsp;Andy Hsieh&nbsp;and Alexandra Ramsey say they cautiously approached the top-line results given the challenges associated with treating mCRPC and multiple setbacks involving checkpoint inhibitor combinations.&nbsp;
However, the results have pleasantly exceeded our expectations and the broader market&#39;s expectations.
Assuming a treatment duration of 5 months, the estimated total U.S. market value is approximately $1.9 billion, based on a net monthly cost of $17,000. They say that unless there&#39;s a considerable and meaningful reduction in disease progression or mortality, the FDA will likely demand a statistically significant survival benefit before approving, with a hazard ratio between 0.50 and 0.60.
The analysts maintain the&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/EXEL/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Outperform rating on the stock</a>.
Price Action:&nbsp;EXEL shares are up 1.23% at $21.36 on the last check Monday.

Third Time Lucky: Exelixis' Cabozantinib Combo Therapy Aces Pivotal Study In Prostate Cancer Patients

Exelixis And Ipsen Announce Results From Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib In Combination With Atezolizumab In Metastatic Castration-Resistant Prostate Cancer

Friday,&nbsp;CymaBay Therapeutics Inc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cbay#NASDAQ">CBAY</a>) competitors&nbsp;Genfit SA&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gnft#NASDAQ">GNFT</a>) and&nbsp;Ipsen SA&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/ipsey#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">IPSEY</a>) announced topline results from the Phase III ELATIVE trial of&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/06/33078339/ipsen-genfits-elafibranor-shows-promise-in-primary-biliary-cholangitis-patients" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">elafibranorin primary biliary cholangitis (PBC)</a>.
The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg exhibiting a cholestasis response compared to 4% on placebo.
A significant improvement in the normalization of ALP at Week 52 was observed as the first secondary endpoint, indicating the efficacy of elafibranor.
While a trend towards pruritus (itching) improvement was observed, it did not reach statistical significance.
CymaBay&#39;s ongoing Phase 3 RESPONSE study is on track to release topline results in Q3. Management previously indicated that the study has sufficient power to capture the effect of pruritis reduction for those treated with seladelpar.
William Blair&nbsp;analyst is optimistic that seladelpar could show a statistically significant reduction in itch.&nbsp;
In the previous ENHANCE study, treatment with seladelpar led to a 1.59-point improvement (p=0.0165) for the 10 mg dose and a 0.46-point reduction for the 5 mg dose among those with moderate to severe itch at baseline.&nbsp;
At the European Association for the study of the Liver annual congress, CymaBay presented a poster that suggested treatment with seladelpar led to a dose-dependent reduction in interleukin-31, a validated &quot;itch cytokine.&quot;&nbsp;
It notes that while the final arbiter will be the RESPONSE study results of seladelpar, a competitive overhang on the stock has been removed for Cymabay.
The analyst keeps an&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/CBAY/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Outperform rating on CBAY stock</a>.
Price Action:&nbsp;CBAY shares are up 41.6% at $11.10 on the last check Friday.

Genfit's Miss Is CymaBay Therapeutics' Gain: Analyst Says Rival Data Leaves Room for Seladelpar To Emerge As Best-In-Class

Ipsen SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) and&nbsp;Genfit SA&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gnft#NASDAQ">GNFT</a>)&nbsp;<a class="editor-rtfLink" href="https://www.globenewswire.com/news-release/2023/06/30/2697512/0/en/Ipsen-and-GENFIT-Announce-Positive-Results-from-Phase-III-ELATIVE-trial-of-elafibranor-in-patients-with-primary-biliary-cholangitis-a-rare-cholestatic-liver-disease.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">announced</a>&nbsp;topline data from the Phase 3 ELATIVE trial evaluating the efficacy and safety of elafibranor for primary biliary cholangitis (PBC) who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard therapy.
PBC is a chronic disease in which the bile ducts in the liver are slowly destroyed.
The trial met its primary composite endpoint, with 51% of patients on elafibranor 80mg exhibiting a cholestasis response compared to 4% on placebo.
Cholestasis occurs when the flow of bile from the liver is reduced or blocked. Bile is fluid produced by the liver that aids in the digestion of food, especially fats.
Cholestasis response is characterized by a specific level and decrease of alkaline phosphatase (ALP) and total bilirubin (TB) &le; ULN at 52 weeks.
A significant improvement in the normalization of ALP at Week 52 was observed as the first secondary endpoint, indicating the efficacy of elafibranor.
While a trend towards pruritus (itching) improvement was observed, it did not reach statistical significance.
The study revealed that elafibranor was generally well-tolerated with a consistent safety profile as in previous studies.
Ipsen plans to discuss these results with regulatory bodies and aims to move forward with regulatory submissions to the FDA and the European Medicines Agency.
In September last year,&nbsp;Genfit&nbsp;acquired the Swiss startup Versantis for CHF40 million upfront in a small-time buyout to expand its&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/09/28917527/genfit-to-this-swiss-firm-expanding-its-portfolio-in-liver-diseases" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">portfolio in liver diseases</a>.
Price Action:&nbsp;GNFT shares are down 14.30% at $3.47 on the last check Friday.

Ipsen, Genfit's Elafibranor Shows Promise In Primary Biliary Cholangitis Patients

Ipsen And Genfit Announced Topline Data From The Pivotal ELATIVE Phase 3 Trial, Of Elafibrano For Primary Biliary Cholangitis; The Trial Met Its Primary Composite Endpoint, With 51% Of Patients Achieving Cholestasis Response Compared With 4% On Placebo

On Friday, FDA&#39;s Gastrointestinal Drugs Advisory Committee voted 12 to 2&mdash;with two abstentions&mdash;that the benefits of&nbsp;Intercept Pharmaceutical Inc&#39;s&nbsp;ICPT Ocaliva 25 mg, also known as Obeticholic acid (OCA), don&#39;t outweigh the risks in nonalcoholic steatohepatitis (NASH)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/05/32504880/intercept-pharma-stock-tumbles-fda-panel-votes-against-intercepts-fatty-liver-drug-dashing-its-dr" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">patients with stage 2 or 3 fibrosis</a>.
HC Wainwright&nbsp;has downgraded the&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/ICPT/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">stock to Sell from Neutral</a>&nbsp;based on: OCA is either never approved for NASH or is approved in ~ four years on (still) marginal benefit-risk and is a commercial failure;
The management decides soon after the CRL to abandon the program altogether, terminate the LT outcomes study and all ancillary R&amp;D work on OCA in NASH, and concurrently announce a cost-cutting reorganization;
Sales of Ocaliva for PBC continue to grow in the low-to-mid teens % this year and in 2024 (peak year) before it LOE in September 2031 or it faces competition from&nbsp;CymaBay Therapeutics Inc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/cbay#NASDAQ">CBAY</a>) seladelpar,&nbsp;Ipsen SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsef#OTC">IPSEF</a>)/&nbsp;Genfit SA&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gnft#NASDAQ">GNFT</a>) elafibranor&mdash;enter the market by 1Q25.
Even if approved, the analyst says it is unlikely to be commercially successful, especially considering a potentially far superior option, DURECT Corp&#39;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/drrx#NASDAQ">DRRX</a>) larsucosterol.
Price Action:&nbsp;ICPT shares closed down by 29.7% at $9.53 on Monday.

Termination

DRRX

ICPT

What Now After FDA AdComm Rebuke for Intercept Pharmaceutical? Analyst Says Approval Of Intercept's 'OCA In NASH May Never Occur

In other news, Sichuan Biokin Pharma has filed for an IPO on the Hong Kong Exchange; more on the Biosecure Act being pushed by US Speaker of the House Johnson.

Week In Review: Foreseen Sells ADC Rights To France's Ipsen In $1 Billion Deal

Ipsen S.A. Non-GAAP EPS of €4.78, revenue of €1.66B; raises FY24 outlook

Ipsen liver disease drugs endorsed in EU

With the steady growth in the global economy and other supportive aspects like easing inflation and the possibility of interest rate cuts, mid-cap stocks present great opportunities. Thus, fundamentally sound mid-cap stocks Pilgrim's Pride (PPC), Ipsen (IPSEY), and Isuzu Motors (ISUZY) could be ideal buys. Keep reading... Mid-cap stocks can offer balanced diversification in the portfolio, create long-term gains, and capital appreciation, making them ideal as long-term investments.
Therefore, investors could consider investing in quality mid-cap stocks Pilgrim's Pride Corporation (<a href="https://stocknews.com/stock/PPC/">PPC</a>), Ipsen S.A. (<a href="https://stocknews.com/stock/IPSEY/">IPSEY</a>), and Isuzu Motors Limited (<a href="https://stocknews.com/stock/ISUZY/">ISUZY</a>) for gains.
Despite headwinds like elevated debt burdens, higher interest rates and various geopolitical uncertainties, the global economy is growing at a decent pace, supported by an easing inﬂation, more accommodative ﬁnancial conditions and rise in global trade. In the July's update, <a href="https://www.spglobal.com/marketintelligence/en/mi/research-analysis/global-economic-outlook-july-2024.html">S&amp;P Global Market Intelligence analysts'</a> forecast maintained global real GDP growth at 2.7% in 2024.
According to a world bank report, the global economy is expected to <a href="https://www.worldbank.org/en/news/press-release/2024/06/11/global-economic-prospects-june-2024-press-release">grow by 2.6% in 2024</a> and is anticipated to grow to a 2.7% in 2025-26. Also, developing economies are grow to grow 4% on average during 2024-25.
Amid this, <a href="https://www.jpmorgan.com/insights/investing/investment-trends/are-overlooked-small--and-mid-cap-stocks-about-to-surge">mid-cap stocks prospects</a> appear promising. With durable earnings growth and near-record valuation, they present great potential for entry in the segment. Various stocks in the category focus on profitability and, growing competitive advantage and potential of becoming large-cap stocks over the time.
Further, mid-cap stocks offer capital appreciation, effective portfolio diversification, and great long term gains, making them suitable investment choices.
Considering the economy's outlook, it could be wise to invest in robust mid-cap stocks such as PPC, IPSEY, and ISUZY having big cap potential.
Pilgrim's Pride Corporation (<a href="https://stocknews.com/stock/PPC/">PPC</a>)
PPC produces, processes, markets, and distributes fresh, frozen, and value-added chicken and pork products to retailers, distributors, and foodservice operators. The company offers fresh products, like refrigerated whole or cut-up chicken, selected chicken parts, primary pork cuts, added value pork, and pork ribs. It has a $10.45 billion market capitalization.
In terms of forward non-GAAP P/E, PPC is trading at 10.77 x, 36.9% lower than the industry average of 17.07x. Likewise, the stock's forward Price/Sales multiple of 0.58 is 54.5% lower than the industry average of 1.28. Also, its forward EV/EBITDA of 6.97x is 34.2% lower than the industry average of 10.60x.
For the second quarter that ended June 30, 2024, PPC's <a href="https://www.investopedia.com/terms/n/netsales.asp">net sales</a> increased 5.8% year-over-year to $4.56 billion. The company's operating income rose 339.5% from the year-ago value to $440.79 million. Adjusted net income attributable to Pilgrim's of $397.96 million and $1.67 per common share, indicate growths of 278.1% and 279.5% from the prior year's quarter, respectively.
Also, the company's adjusted EBITDA increased 163.7% from the year-ago quarter to $655.94 million. Its cash and cash equivalents stood at $1.32 billion as of June 30, 2024, compared to $697.75 million as of December 31, 2023.
Analysts expect PPC's revenue for the third quarter (ending September 2024) to increase 3.6% year-over-year to $4.52 billion and its EPS for the ongoing quarter is expected to grow 126.3% year-over-year to $1.31. Furthermore, the company has topped the consensus EPS estimates in each of the trailing four quarters.
Shares of PPC have gained 62.3% over the past six months and 75.4% over the past year to close the last trading session at $44.05.
PPC's bright prospects are reflected in its <a href="https://stocknews.com/powr-ratings/">POWR Ratings</a>. The stock has an overall rating of A, which translates to a Strong Buy in our proprietary rating system. The POWR Ratings are calculated by considering 118 different factors, each weighted to an optimal degree.
PPC has an A grade for Growth and Stability. It also has a B grade for Sentiment and Quality. The stock has topped among the 76 stocks in the B-rated <a href="https://stocknews.com/category/food-makers/">Food Makers</a> industry.
To check other POWR Ratings of PPC for Value and Momentum, <a href="https://stocknews.com/stock/PPC/">click here</a>.
Ipsen S.A. (<a href="https://stocknews.com/stock/IPSEY/">IPSEY</a>)
Headquartered in Boulogne-Billancourt, France, IPSEY operates as a biopharmaceutical company globally. It provides drugs in the oncology, neuroscience, and rare diseases areas. The company provides Somatuline, Dysport, Decapeptyl, Cabometyx, Onivyde, and Tazverik. It also offers NutropinAq for growth failure in children. IPSEY is valued at $9.25 billion by market cap.
On July 26, IPSEY received CHMP positive opinions for Iqirvo&#xAE; (elafibranor) recommended for treating primary biliary cholangitis and Kayfanda&#xAE; (odevixibat) recommended for cholestatic pruritus in patients with Alagille syndrome, two rare cholestatic liver diseases.
The CHMP positive opinions received for two potential new medicines in rare cholestatic liver diseases, on the same day marked a rare achievement for IPSEY. It demonstrates the company's commitment to address the unmet medical needs in such diseases.
On July 25, IPSEY and Day One Biopharmaceuticals (DAWN) entered into a new global partnership outside the U.S. through an exclusive licensing agreement to commercialize tovorafenib for pediatric low grade glioma (pLGG), the most common childhood brain tumor.
During the first half that ended June 30, 2024, IPSEY's total sales increased 8% year-over-year to €1.66 billion ($1.81 billion). Its core operating income grew 2.8% from the year-ago value to €538 million ($588.10 million). The company's consolidated net profit came in at €232.30 million ($253.93 million) or €2.78 per share, up 19.1% and 18.4% year-over-year, respectively.
In addition, the company's free cash flow rose 5.9% from the year-ago value to €393.50 million ($430.14 million).
As per the full-year 2024 guidance, IPSEY expects total-sales growth of more than 7%, at constant currency, updated from the prior guidance of 6.0%.
Analysts expect IPSEY's revenue for the fiscal year (ending December 2024) to grow 12.3% year-over-year to $3.79 billion. Over the past six months, the stock has plunged 4.1% to close the last trading session at $28.08.
IPSEY's POWR Ratings reflect its robust outlook. The stock has an overall rating of A, translating to a Strong Buy in our proprietary rating system.
IPSEY has an A grade for Value and Stability and a B grade for Quality. It is ranked #15 among 152 stocks within the <a href="https://stocknews.com/category/pharmaceuticals/">Medical - Pharmaceuticals</a> industry.
To see the other ratings of IPSEY for Growth, Sentiment, and Momentum, <a href="https://stocknews.com/stock/IPSEY/">click here</a>.
Isuzu Motors Limited (<a href="https://stocknews.com/stock/ISUZY/">ISUZY</a>)
Based in Yokohama-shi, Japan, ISUZY manufactures and sells commercial vehicles, light commercial vehicles, and diesel engines and components globally. Its products comprise of heavy and medium-duty trucks and buses, and light-duty trucks, passenger pickup vehicles, pickup trucks, and SUVs, and marine and industrial engines.
On July 31, ISUZY initiated the global launch of connected services for BEV trucks – beginning with light-duty BEV trucks for North America in the present year and will gradually expand the services to other markets around the world in conjunction with the introduction of BEV trucks.
On July 29, ISUZY started production of new heavy-duty S&amp;E Series for international markets at the Thai production base of UD Trucks Corporation, an Isuzu Group company. It will be introduced mainly to markets across ASEAN (Association of Southeast Asian Nations), the Middle East, and Latin America.
Isuzu and UD Trucks are continuously expanding their product collaboration since last year and will continue to accelerate synergies.
For the first quarter that ended June 30, 2024, ISUZY reported net sales of ¥747.95 billion ($5.16 billion). Its operating income grew 12.1% from the year-ago value to ¥76.91 billion ($530.28 million). Net income attributable to owners of parent came in at ¥46.91 billion ($323.44 million) and ¥62.66 per share, up 3.3% and 7.8% from the prior year's quarter, respectively.
Analysts expect ISUZY's revenue for the second quarter (ending September 2026) to grow marginally year-over-year to $5.70 billion. For the fiscal year 2024, the company's revenue is expected to grow 173.7% year-over-year to $23.05 billion. Moreover, the company surpassed the consensus revenue estimates in three of the four trailing quarters.
Over the past year, the stock has surged 2% to close the last trading session at $13.05.
ISUZY's sound fundamentals are reflected in its POWR Ratings. The stock has an overall grade of B, translating to a Buy in our proprietary rating system.
ISUZY has an A grade for Value and a B for Stability and Quality. It is ranked #9 among the 52 stocks within the <a href="https://stocknews.com/category/auto-vehicle-makers/">Auto &amp; Vehicle Manufacturers</a> industry.
To see the other ratings of ISUZY for Growth, Momentum, and Sentiment, <a href="https://stocknews.com/stock/ISUZY/">click here</a>.
Top of Form
What To Do Next?
43 year investment veteran, Steve Reitmeister, has just released his 2024 market outlook along with trading plan and top 11 picks for the year ahead.
<a href="https://report.stocknews.com/sign-up/stock-market-outlook-2024/?formplacement=artbotad_smo24_rep">2024 Stock Market Outlook &gt;</a>

<hr />
PPC shares were trading at $44.76 per share on Thursday afternoon, up $0.71 (+1.61%). Year-to-date, PPC has gained 61.82%, versus a 12.09% rise in the benchmark S&amp;P 500 index during the same period.
<hr><div style="clear:both;"></div> <h2>About the Author: Rjkumari Saxena</h2> <img src='https:/wp-content/uploads/2024/04/Rajkumari-Saxena_Image-1.jpeg' style="float:left; padding:5px;width:125px;">Rajkumari started her career as a writer but gradually shifted her focus to financial journalism, leveraging her educational background in Commerce. Fascinated by the interplay of business and economic shifts in equities, she aspires to evolve as an analyst. With a knack for simplifying complex financial concepts, her mission is to empower investors with insights that lead to profitable decisions.<a href="https://stocknews.com/authors/?author=rajkumari-saxena">More...</a>The post <a href=https://stocknews.com/news/ppc-ipsey-isuzy-3-mid-cap-stocks-with-big-cap-potential/>3 Mid-Cap Stocks With Big Cap Potential</a> appeared first on <a href=https://stocknews.com/>StockNews.com</a>

3 Mid-Cap Stocks With Big Cap Potential

Gilead exits J&J royalty deal for liver drug ahead of potential FDA nod

Gilead wins FDA nod for liver disease drug

Eton Pharmaceuticals to buy Increlex product from Ipsen

Ipsen S.A. reports Q3 results; raises FY24 guidance

The specialty pharma sector is leading the charge in developing life-changing solutions for rare and chronic conditions. Amid this backdrop, investors might consider adding three fundamentally solid specialty pharma stocks, namely, Ipsen S.A. (IPSEY), ACADIA Pharmaceuticals (ACAD), and Neurocrine Biosciences (NBIX) in their portfolios. Read on… The specialty pharmaceutical sector is transforming healthcare innovation, addressing conditions that often go untreated due to the lack of effective therapies. The companies in this sector focus on developing drugs for rare diseases, and other unmet medical needs, providing hope to patients while creating lucrative opportunities for investors.
As the quest for innovation and cures continues, it might be wise to consider investing in robust specialty pharma stocks Ipsen S.A. (<a href="https://stocknews.com/stock/IPSEY/">IPSEY</a>), ACADIA Pharmaceuticals Inc. (<a href="https://stocknews.com/stock/ACAD/">ACAD</a>), and Neurocrine Biosciences, Inc. (<a href="https://stocknews.com/stock/NBIX/">NBIX</a>), poised for potential gain.
The key growth factor in this sector is the increasing prevalence of chronic diseases, coupled with <a href="https://www.globenewswire.com/news-release/2024/11/20/2984644/28124/en/Specialty-Pharmaceuticals-Research-Report-Increased-Reimbursement-Through-Medical-and-Pharmacy-Benefits-Driving-the-Market-Reaching-965-Billion-by-2030.html">advancements in biotechnology, genetic research, and personalized medicine</a>. These innovations have enabled specialty pharma companies to develop targeted therapies, ensuring higher efficacy and fewer side effects than traditional treatments. The market is highly dynamic, with rapid advances in technology and medicine requiring continuous adaptation to the evolving scientific landscape.
Further, supportive regulatory policies have also played a pivotal role in the sector's expansion. By mid-2024, the U.S. Food and Drug Administration (FDA) had approved 23 novel drug therapies, <a href="https://www.pharmacytimes.com/view/navigating-the-rapid-growth-of-specialty-drugs-opportunities-challenges-and-the-path-ahead">with specialty drugs representing about 75%</a>. The rise in approvals shows the increasing demand for patients with complex and chronic conditions or rare diseases.
Moreover, the specialty pharmaceutical market is anticipated to <a href="https://www.mordorintelligence.com/industry-reports/specialty-pharmaceuticals-market">reach $55.61 billion by 2029</a>, exhibiting a CAGR of 36.5%. Also, strategic partnerships with larger pharma firms bolster specialty pharma companies' market presence.
With that in mind, let's delve into the fundamentals of the three <a href="https://stocknews.com/category/pharmaceuticals/">Medical - Pharmaceuticals</a> stock picks, starting with the third choice.
Stock #3: Ipsen S.A. (<a href="https://stocknews.com/stock/IPSEY/">IPSEY</a>)
Headquartered in Boulogne-Billancourt, France, IPSEY operates as a biopharmaceutical company worldwide that offers drugs in the areas of oncology, neuroscience, and rare diseases. The company provides Somatuline, Dysport, Decapeptyl, Cabometyx, Onivyde, and Tazverik.
On December 3, IPSEY and Biomunex Pharmaceuticals announced a global licensing agreement for BMX-502, a bispecific antibody engaging MAIT cells that targets the GPC3 tumor antigen to kill cancer cells. In this exclusive agreement, IPSEY secured global rights to develop, manufacture, and commercialize BMX-502. This partnership will allow IPSEY to expand its pipeline across the ecosystem.
On September 23, IPSEY received approval from the European Commission for Kayfanda&#xAE; (odevixibat) to treat cholestatic pruritus in Alagille Syndrome (ALGS) in children six months or older. This approval further expands IPSEY's rare cholestatic liver disease portfolio.
IPSEY, for the first half period (ended June 30, 2024), reported total revenues of €1.75 billion ($1.82 billion), indicating a 7.9% growth from the prior-year period. Its core <a href="https://www.investopedia.com/terms/o/operatingincome.asp">operating income</a> increased 2.8% year-over-year to €538 million ($560.25 million).
The company's IFRS consolidated net profit came in at €232.30 million ($415.92 million), reflecting an increase of 19.1% from year-ago value, and IFRS EPS amounted to €2.78 per share, up 18.3% year-over-year.
Building on this quarter's momentum, the company's guidance for 2024 anticipates that the full-year IPSEY's total sales growth to be greater than 7%. It also forecasts the core operating margin to be greater than 30% of total sales.
Analysts expect IPSEY's revenue for the fiscal year (ending December 2024) to grow 8.9% year-over-year to $3.67 billion. 
The stock has gained 3.1% intraday to close the last trading session at $28.13.
IPSEY's <a href="https://stocknews.com/powr-ratings/">POWR Ratings</a> reflect this robust outlook. The stock has an overall rating of B, which equates to Buy in our proprietary rating system. The POWR Ratings are calculated by considering 118 different factors, with each factor weighted to an optimal degree.
IPSEY has an A grade for Value and Stability. It is ranked #35 out of 150 stocks in the <a href="https://stocknews.com/category/pharmaceuticals/">Medical - Pharmaceuticals</a> industry. <a href="https://stocknews.com/stock/IPSEY/">Click here</a> to see the additional ratings for IPSEY (Growth, Momentum, Sentiment, and Quality).
Stock #2: ACADIA Pharmaceuticals Inc. (<a href="https://stocknews.com/stock/ACAD/">ACAD</a>)
ACAD is a biopharmaceutical company focused on the development and commercialization of medicines that address unmet medical needs in central nervous system (CNS) disorders and rare diseases.
On November 26, ACAD entered into an exclusive worldwide license agreement with Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. This licensing will help expand ACAD's pipeline and also initiate a Phase 2 study of SAN711 for the treatment of essential tremors.
In the same month, ACAD entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million. From the sales proceeds of PRV, ACAD plans to support its commercial operations and R&amp;D program and invest in future business development.
For the third quarter of 2024, which ended on September 30, ACAD's total revenues increased 18.3% year-over-year, amounting to $250.40 million. Its income from operations came in at $31.64 million compared to a year-ago net loss of $57.78 million. The company's net income stood at $32.77 million compared to the prior-year quarter's loss of $65.18 million, while its EPS came in at $0.20 versus a loss of $0.40 per share last year.
As per the updated financial guidance for the full year 2024, ACAD now forecasts total revenue to be in the range of $940 million to $960 million.
Street expects ACAD's revenue for the fiscal year (ending December 2024) to increase 34.1% year-over-year to $974.12 million. Its EPS for the same period is expected to be $0.69. For the fiscal year 2025, its revenue and EPS are expected to grow by 8.3% and 13.5% from the prior year to $3.88 billion and $0.79, respectively.
ACAD's stock has surged 12.2% over the past six months to close the last trading session at $17.17.
ACAD's bright prospects are reflected in its POWR Ratings. The stock has an overall rating of B, which translates to a Buy in our proprietary rating system.
It also has an A grade for Value and Quality. Within the same industry, it is ranked #26 out of 150 stocks. <a href="https://stocknews.com/stock/ACAD/">Click here</a> to see ACAD's ratings for Growth, Momentum, Stability, and Sentiment.
Stock #1: Neurocrine Biosciences, Inc. (<a href="https://stocknews.com/stock/NBIX/">NBIX</a>)
NBIX discovers, develops, and markets pharmaceuticals for neurological, neuroendocrine, and neuropsychiatric disorders internationally. Its portfolio includes remedies for tardive dyskinesia, Parkinson's disease, endometriosis, and uterine fibroids, supplemented by ongoing clinical programs spanning diverse therapeutic areas.
On December 20, NBIX announced the commercial availability of CRENESSITY&#x2122; (crinecerfont) in the United States. It is exclusively available through PANTHERx Rare, a specialty pharmacy.
In the same month, NBIX announced the U.S. Food and Drug Administration approval for CRENESSITY&#x2122; (crinecerfont), the first new treatment for the classic Congenital Adrenal Hyperplasia (CAH) community. This paradigm-shifting treatment approach is a significant milestone for NBIX and the patients of the CAH community.
In the fiscal third quarter, which ended on September 30, 2024, NBIX's total revenues increased 24.7% year-over-year to $622.10 million. The company reported operating income of $183.80 million, indicating a 30.2% growth from the prior-year quarter. NBIX's non-GAAP net income came in at $189.20 million, up 21.2% year-over-year, while its non-GAAP EPS grew 17.5% from the year-ago value to $1.81.
According to the full-year guidance, NBIX forecasts INGREZZA's net product sales to range from $2.30 billion to $2.32 billion.
The consensus revenue estimate of $630.01 million for the fiscal fourth quarter (ending December 2024) represents a 22.3% increase year-over-year. The consensus EPS estimate of $1.87 for the same quarter indicates a 21.3% improvement year-over-year. The company has an excellent surprise history; it surpassed the consensus revenue estimates in three of the trailing four quarters.
Over the past three months, the stock has gained 16.3%, closing the last trading session at $136.99.
NBIX's promising fundamentals are reflected in its POWR Ratings. It has an overall rating of B, which equates to a Buy in our proprietary rating system.
It has an A grade for Quality and a B for Value. The stock is ranked #22 in the Medical - Pharmaceuticals industry. <a href="https://stocknews.com/stock/NBIX/">Click here</a> to access the additional NBIX ratings (Growth, Momentum, Stability, and Sentiment).
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NBIX shares were trading at $136.53 per share on Tuesday afternoon, down $0.46 (-0.34%). Year-to-date, NBIX has gained 3.62%, versus a 27.70% rise in the benchmark S&amp;P 500 index during the same period.
<hr><div style="clear:both;"></div> <h2>About the Author: ShreyaRathi</h2> <img src='https:/wp-content/uploads/2024/10/0.jpeg' style="float:left; padding:5px;width:125px;"><a href="https://stocknews.com/authors/?author=shreya-rathi">More...</a>The post <a href=https://stocknews.com/news/nbix-ipsey-acad-3-specialty-pharma-stocks-addressing-unmet-medical-needs/>3 Specialty Pharma Stocks Addressing Unmet Medical Needs</a> appeared first on <a href=https://stocknews.com/>StockNews.com</a>

3 Specialty Pharma Stocks Addressing Unmet Medical Needs

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