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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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On Friday, FDA&#39;s Gastrointestinal Drugs Advisory Committee voted 12 to 2—with two abstentions—that the benefits of Intercept Pharmaceutical Inc&#39;s ICPT Ocaliva 25 mg, also known as Obeticholic acid (OCA), don&#39;t outweigh the risks in nonalcoholic steatohepatitis (NASH) 

What Now After FDA AdComm Rebuke for Intercept Pharmaceutical? Analyst Says Approval Of Intercept&#39;s &#39;OCA In NASH May Never Occur

Ipsen SA

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

<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

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

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.

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

<ul>
<li>Ipsen&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/01/b30325339/ipsen-to-acquire-albireo-accelerating-growth-in-rare-disease-with-treatments-for-several-pediatric" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">agreed to acquire</a>&nbsp;Albireo Pharma Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/albo#NASDAQ">ALBO</a>) at $42.00 per share in cash for an initial estimated aggregate consideration of $952 million plus one contingent value right (CVR) per share.&nbsp;</li>
<li>Each CVR will entitle its holder to deferred cash payments of $10.00 per CVR payable upon the FDA approval of Bylvay in the Biliary Atresia indication at the latest by Dec. 31, 2027.</li>
<li>The acquisition of Albireo will provide immediate incremental sales and strengthen Ipsen&#39;s rare disease infrastructure.</li>
<li>Albireo guided for total Bylvay revenues of $24 million for 2022.&nbsp;</li>
<li>The transaction is expected to be dilutive to Ipsen&#39;s core operating income until the end of 2024.&nbsp;</li>
<li>The deal is anticipated to close by the end of Q1 2023.</li>
<li>The lead medicine in Albireo&#39;s pipeline is Bylvay (odevixibat), approved in 2021 in the U.S. for pruritus in patients three months of age and older with progressive familial intrahepatic cholestasis (PFIC) and in the E.U. for PFIC in patients aged six months or older.</li>
<li>As part of the transaction, Ipsen will also acquire Albireo&#39;s clinical stage asset A3907, in development for adult cholestatic liver disease, which could complement Ipsen&#39;s existing development programs.&nbsp;</li>
<li>Price Action:&nbsp;ALBO shares are up 92.59% at $43.95 during the premarket session on the last check Monday.</li>
<li>Photo Via Company</li>
</ul>

ALBO

France-Based Ipsen Acquires Albireo Pharma Enriching Its Rare Disease Portfolio, Pipeline

<ul>
<li>Ipsen SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) announced that the Phase 3 NAPOLI 3 trial of Onivyde plus 5 fluorouracil/leucovorin and oxaliplatin (NALIRIFOX regimen)&nbsp;<a class="editor-rtfLink" href="https://www.businesswire.com/news/home/20221108006021/en/Onivyde%C2%AE-Regimen-Demonstrated-Statistically-Significant-Improvement-in-Overall-Survival-in-Previously-Untreated-Metastatic-Pancreatic-Ductal-Adenocarcinoma" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">met</a>&nbsp;its primary endpoint.</li>
<li>The combination therapy demonstrated a clinically meaningful and statistically significant improvement in overall survival compared to nab-paclitaxel plus gemcitabine in 770 previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).</li>
<li>Progression-free survival (PFS) also showed significant improvement over the comparator arm.&nbsp;</li>
<li>In reaction to the news,&nbsp;Merrimack Pharmaceuticals Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mack#NASDAQ">MACK</a>) shares are up over 200%.</li>
<li>In 2017, Ipsen&nbsp;<a class="editor-rtfLink" href="https://ipsen.com/websites/IPSENCOM-PROD/wp-content/uploads/2017/01/09004923/09-01-2017-FINAL-Ipsen-Press-Release_MERRIMACK-ONIVYDE.pdf" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">gained</a>&nbsp;exclusive commercialization rights for the current and potential future indications of Merrimack&#39;s pancreatic cancer drug Onivyde.&nbsp;</li>
<li>Ipsen agreed to pay $575 million cash at closing plus up to $450 million upon the approval of potential additional indications for Onivyde in the U.S.</li>
<li>In August, the companies reported a primary analysis of the Phase 3 trial of Onivyde for second-line small cell lung cancer (SCLC).&nbsp;</li>
<li>The study did not meet the primary endpoint of overall survival in patients treated with Onivyde versus topotecan.&nbsp;</li>
<li>However, a doubling of the secondary endpoint of the objective response rate in&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/08/28332982/merrimack-pharma-ipsens-cancer-drug-fails-in-overall-survival-measure" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">favor of Onivyde was observed</a>.&nbsp;</li>
<li>Price Action:&nbsp;MACK shares are up 243% at $13.72 during the premarket session on the last check Wednesday.</li>
</ul>

Why Merrimack Shares Are Surging Over 200% Today?

<ul>
<li>Merrimack Pharmaceuticals Inc&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mack#NASDAQ">MACK</a>) partner announced that Ipsen SA (OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) reported a primary analysis of the results of the Phase 3 trial of Onivyde (irinotecan liposomal injection)for second-line small cell lung cancer (SCLC).&nbsp;</li>
<li>The study&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/08/b28329986/merrimack-provides-ipsen-report-of-results-from-phase-iii-resilient-trial-evaluating-onivyde-in-se" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">did not meet the primary endpoint</a>&nbsp;of overall survival in patients treated with Onivyde versus topotecan.&nbsp;</li>
<li>However, a doubling of the secondary endpoint of objective response rate (ORR) in favor of Onivyde was observed.&nbsp;</li>
<li>The safety and tolerability of Onivyde were consistent with its already-known safety profile, and no new safety concerns emerged.&nbsp;</li>
<li>The clinical study results will be communicated with the regulatory agency.&quot;&nbsp;</li>
<li>Ipsen indicated in its update that it would analyze the data further before making decisions about the next steps.</li>
<li>&quot;We will continue to monitor updates from Ipsen regarding the SCLC program,&quot; said Gary Crocker, Chairman, and CEO of Merrimack Pharmaceuticals.&nbsp;</li>
<li>Ipsen expects to publicly report its top-line data from its continuing Phase 3 study of Onivyde in first-line pancreatic ductal adenocarcinoma before the end of 2022.</li>
<li>Price Action:&nbsp;MACK shares are down 13.30% at $4.32 during the market session on the last check Wednesday.</li>
</ul>

Merrimack Pharma-Ipsen's Cancer Drug Fails In Overall Survival Measure

Ipsen SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/06/b27856514/ipsen-to-acquire-epizyme-expanding-its-portfolio-in-oncology" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">agreed to acquire</a>&nbsp;Epizyme Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/epzm#NASDAQ">EPZM</a>) at $1.45 per share for approximately $247 million, plus one contingent value right (CVR) per share.&nbsp;
<ul>
<li>The deal is expected to close by Q3.</li>
<li>The primary focus of the acquisition is on Epizyme&#39;s lead medicine, Tazverik (tazemetostat), a chemotherapy-free EZH2 inhibitor, which was granted FDA Accelerated Approval in 2020.&nbsp;</li>
<li>It is currently indicated for adult patients with relapsed or refractory follicular lymphoma (FL) harboring EZH2 mutations and who did not respond to other treatments.</li>
<li>It is also indicated for patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.</li>
<li>Tazverik is currently in the Phase 3 trial in combination with rituximab and lenalidomide (R2) in patients with relapsed/refractory FL who have received at least one prior therapy.&nbsp;</li>
<li>Initial data readout is expected in 2026.</li>
<li>Each CVR entitles deferred cash payments of $0.30 payable upon the first achievement of $250 million in sales of Tazverik in any period of four consecutive quarters by 2026.</li>
<li>An additional $0.70 per CVR is payable upon FDA approval for Tazverik and R2 combo in second-line follicular lymphoma by 1 January 2028.&nbsp;</li>
<li>Ipsen will also acquire Epizyme&#39;s oral SETD2 inhibitor candidate, EZM0414, currently in Phase 1/1b trial for relapsed or refractory multiple myeloma &amp; diffuse large B-cell lymphoma, as well as preclinical programs focusing on epigenetic targets.</li>
<li>The acquisition of Epizyme will immediately provide incremental sales and leverage the U.S. commercial infrastructure.&nbsp;</li>
<li>Ipsen expects the transaction to be moderately dilutive on its core operating income until the end of 2024.</li>
<li>Price Action:&nbsp;EPZM shares are up 59.33% at $1.52 during the premarket session on the last check Monday.</li>
</ul>

EPZM

Ipsen Scoops Up Blood Cancer-Focused Epizyme - Read Why

<ul>
<li>The&nbsp;<a class="editor-rtfLink" href="https://www.businesswire.com/news/home/20220502005679/en/Ipsen-European-Commission-Approves-Cabometyx%C2%AE-as-a-Second-Line-Treatment-for-People-Living-With-Radioactive-Iodine-Refractory-Differentiated-Thyroid-Cancer" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">European Commission (EC) has approved</a>&nbsp;Ipsen SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) Cabometyx (cabozantinib) as monotherapy in differentiated thyroid carcinoma (DTC) setting.</li>
<li>The approval covers adult patients with locally advanced or metastatic DTC, refractory or not eligible for radioactive iodine, who have progressed during or after systemic therapy.&nbsp;</li>
<li>This EC approval follows the FDA approval announced by&nbsp;Exelixis Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/exel#NASDAQ">EXEL</a>) in September 2021 of Cabometyx for adult and pediatric patients with locally advanced or metastatic DTC.</li>
<li>The approval was based on results from the COSMIC-311 Phase 3 trial, which at a planned interim analysis, demonstrated a significant reduction in the risk of disease progression or death by 78% versus placebo.</li>
<li>The objective response rate also favored Cabometyx with 15% vs. 0% for placebo (p=0.028) but did not meet the criteria for statistical significance.</li>
<li>At a median follow-up of 10.1 months, the final results demonstrated Cabometyx&#39;s median PFS of 11.0 months versus 1.9 months with placebo and a maintained reduction in disease progression or death risk of 78% versus placebo.</li>
<li>Price Action:&nbsp;EXEL shares closed 1.43% higher at $22.66 on Monday.</li>
</ul>

Ipsen - Exelixis' Cabometyx Scores European Approval As Second-Line Treatment For Thyroid Cancer

Exelixis Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/exel#NASDAQ">EXEL</a>) and its partner&nbsp;Ipsen SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) have&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/03/b26294899/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-for-patients-with" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">received a positive opinion</a>&nbsp;from the Committee for Medicinal Products for Human Use (CHMP) for Cabometyx (cabozantinib) for thyroid carcinoma.
<ul>
<li>The opinion covers Cabometyx as a monotherapy for locally advanced or metastatic differentiated thyroid carcinoma (DTC), refractory or not eligible to radioactive iodine (RAI) who have progressed during or after prior systemic therapy.&nbsp;</li>
<li>The European Commission will now review the CHMP recommendation, and a final decision on the application is expected in the coming months.</li>
<li>The CHMP recommendation is based on results from COSMIC-311 Phase 3 trial that demonstrated significant improvement in progression-free survival (PFS) with Cabometyx versus placebo.&nbsp;</li>
<li>Also See:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/02/25633263/bristol-myers-exelixis-tout-additional-opdivocabometyx-combo-data-from-kidney-cancer-trial" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Bristol Myers, Exelixis Tout Additional Opdivo/Cabometyx Combo Data From Kidney Cancer Trial</a>.</li>
<li>The FDA has approved Cabometyx for locally advanced or metastatic DTC.</li>
<li>Cabometyx is currently approved in the European Union for advanced renal cell carcinoma (RCC).</li>
<li>Price Action:&nbsp;EXEL shares are down 0.12% at $21.51&nbsp;during the market session on the last check Friday.</li>
</ul>

EMA's Scientific Committee Backs Expanded Use Of Exelixis, Ipsen's Cabometyx In Thyroid Cancer

<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/22/01/b25177892/health-canada-approves-ipsens-sohonos-palovarotene-capsules-as-the-first-approved-treatment-for-fi" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Health Canada has approved</a>&nbsp;Ipsen SA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) Sohonos (palovarotene capsules) in adults and children aged eight years &amp; above for fibrodysplasia ossificans progressiva (FOP).
<ul>
<li>This decision marks the first approval for Sohonos worldwide.</li>
<li>Sohonos is an oral selective retinoic-acid receptor gamma (RAR&gamma;) agonist indicated to reduce the formation of heterotopic ossification (HO; new bone formation) to treat FOP.&nbsp;</li>
<li>FOP is characterized by new bone formation outside of the normal skeletal system, like in soft connective tissues, in a process is known as heterotopic ossification, which can be preceded by painful soft tissue swelling or &quot;flare-ups.&quot;&nbsp;</li>
<li>Ipsen plans to file in the U.S. in H1 2022 and is in discussions with other regulatory authorities worldwide.</li>
<li>This approval is based on the ongoing MOVE Phase 3 trial data.</li>
<li>The trial is evaluating the efficacy and safety of a chronic/flare-up dosing regimen of palovarotene in decreasing new annualized HO volume in patients with FOP.</li>
<li>Price Action:&nbsp;IPSEY shares closed at $23.66 on Friday.</li>
</ul>

Ipsen's Sohonos Scores Canadian Approval For Rare Connective Tissue Disease

Ipsen SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/12/b24663690/ipsen-and-genfit-enter-into-exclusive-licensing-agreement-for-elafibranor-a-phase-iii-asset-evalua" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">entered into a long-term strategic partnership</a>&nbsp;to develop, manufacture, and commercialize and&nbsp;Genfit SA&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gnft#NASDAQ">GNFT</a>) elafibranor for Primary Biliary Cholangitis (PBC).&nbsp;
<ul>
<li>Under the agreement, Ipsen will pay Genfit up to &euro;480 million, including an upfront cash payment of &euro;120 million and milestone payments up to &euro;360 million, plus tiered double-digit royalties of up to 20%.&nbsp;</li>
<li>Ipsen will also invest &euro;28 million via equity, representing 8% post-issuance in Genfit.</li>
<li>Genfit remains responsible for the Phase 3 ELATIVE trial until completing the double-blind period.&nbsp;</li>
<li>Ipsen will assume responsibility for all additional clinical development, including completion of the long-term extension period of the ELATIVE trial and global commercialization.&nbsp;</li>
<li>The ELATIVE is evaluating the safety and efficacy of elafibranor in 150 PBC patients who have an inadequate response or intolerance to ursodeoxycholic acid (UDCA).</li>
<li>Topline data is expected in early 2023.</li>
<li>Price Action:&nbsp;GNFT shares are up 41.9% at $4.71&nbsp;during the premarket session on the last check Friday.</li>
</ul>

Long Ideas

Contracts

Genfit Shares Rally After Ipsen Buys Rights To Its Late-Stage Kidney Disease Treatment Hopeful

<ul>
<li>Ipsen&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/08/b22481936/ipsen-announces-withdrawal-of-palovarotene-nda-confirming-intention-to-re-submit-following-additio" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">withdrew its US marketing application</a>&nbsp;for palovarotene following discussions with the FDA indicating additional data analyses needed from two pivotal trials.</li>
<li>Palovarotene is an oral, selective RAR&gamma; agonist to prevent heterotropic ossification (new bone formation) as a potential treatment for ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP).</li>
<li>The action date under a Priority Review status was 30 November.</li>
<li>The extra work will take too long to fit into the review cycle, forcing Ipsen to pull the submission and ending hopes of bringing palovarotene to market this year.</li>
<li>Ipsen plans to resubmit to the FDA upon completion of the additional data analyses.</li>
<li>The move surprised some as Ipsen had made strides to resolve issues stemming from a partial clinical hold in 2019 and a failed futility test soon after.</li>
<li>In December 2019, regulators slapped Ipsen with a&nbsp;<a class="editor-rtfLink" href="https://www.ipsen.com/press-releases/ipsen-initiates-partial-clinical-hold-for-palovarotene-ind120181-and-ind135403-studies/" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">partial hold on patients 14 years &amp; younger dosing</a>&nbsp;in Phase 2 and Phase 3 studies.&nbsp;</li>
<li>The hold resulted from &quot;early growth plate closure&quot; reports, a condition that can severely stunt a child&#39;s growth.</li>
<li>In January 2020, the Independent Data Monitoring Committee review said the&nbsp;<a class="editor-rtfLink" href="https://www.ipsen.com/press-releases/ipsens-palovarotene-clinical-program-in-fibrodysplasia-ossificans-progressiva-reaches-prespecified-interim-analysis-futility-criteria/" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">program failed a Phase 3 futility test</a>, resulting in Ipsen pausing dosing in all remaining pediatric patients.</li>
<li>Price Action:&nbsp;IPSEY shares are down 8.66% at $24.25 on the last check Friday.</li>
</ul>

Short Ideas

Ipsen Stock Declines After Pulling Rare Disease Application

<ul>
<li>Ipsen SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) and&nbsp;Exicure Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/xcur#NASDAQ">XCUR</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/08/b22268355/ipsen-and-exicure-enter-into-exclusive-collaboration-targeting-rare-neurodegenerative-disorders" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">have collaborated to research, develop, and commercialize</a>&nbsp;novel Spherical Nucleic Acids (SNAs) as potential investigational treatments for Huntington&#39;s disease and Angelman syndrome.</li>
<li>Oligonucleotides are synthetic structures of nucleic acids that can be used to modulate gene expression via a range of processes, including gene activation, inhibition, and splice-modulation.&nbsp;</li>
<li>Under the agreement, Ipsen will receive exclusive options to license SNA-based therapeutics, and it will pay Exicure a cash upfront payment of $20 million.</li>
<li>Exicure will be responsible for the discovery and certain preclinical development activities.&nbsp;</li>
<li>If Ipsen chooses to exercise its option, it will be responsible for further developing and commercializing the licensed products.&nbsp;</li>
<li>Exicure will receive a $20 million upfront payment and is eligible to receive up to $1 billion in option exercise fees and milestone payments should Ipsen opt into both programs, as well as tiered royalties.</li>
<li>Price Action:&nbsp;XCUR shares are up 31.1% at $1.77 during the premarket session on the last check Monday.</li>
</ul>

XCUR

Exicure Stock Surges On Over $1B Option Licensing Pact With Ipsen For Rare Neurodegenerative Disorders

<ul>
<li>Ipsen SA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>) and privately-held&nbsp;BAKX Therapeutics Inc&nbsp;have signed an&nbsp;<a class="editor-rtfLink" href="https://www.businesswire.com/news/home/20210727005956/en/Ipsen-Strengthens-Its-Pre-clinical-Oncology-Pipeline-With-an-Exclusive-Worldwide-collaboration-With-BAKX-Therapeutics-Inc.-for-BKX-001-Targeting-the-Apoptosis-Pathway" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">exclusive worldwide collaboration agreement</a>&nbsp;to research, develop, manufacture, and commercialize BKX-001 as a potential treatment for leukemia, lymphoma, and solid tumors.</li>
<li>Under the agreement, Ipsen will pay BAKX $14.5 million, comprising an equity investment and an upfront payment, followed by up to $837.5 million in milestone payments.&nbsp;</li>
<li>The companies would also share equally costs and profits.</li>
<li>BKX-001 is an oral small molecule activator of the BCL-2 associated protein- X (BAX).&nbsp;</li>
<li>BKX-001 binds to the trigger site of BAX in a catalytic manner, stimulating a conformational change in BAX to drive apoptosis in tumor cells.</li>
<li>Apoptosis is the naturally occurring process of programmed cell death. Deregulated apoptosis can lead to uncontrolled cell division and the development of a tumor.</li>
<li>Price Action:&nbsp;IPSEY stock was trading at $25.20 on Tuesday.</li>
</ul>

Ipsen Beefs Up Pre-Clinical Oncology Pipeline With Over $850M Deal With BAKX Therapeutics

<ul>
<li>Exelixis Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/exel#NASDAQ">EXEL</a>) and&nbsp;Ipsen&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/ipsey#OTC">IPSEY</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/06/b21737947/exelixis-and-ipsen-announce-cabozantinib-in-combination-with-an-immune-checkpoint-inhibitor-signif" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">have announced mixed interim results</a>&nbsp;from the COSMIC-312 Phase 3 trial evaluating cabozantinib (Cabometyx) in combination with&nbsp;Roche Holding AG&#39;s&nbsp;Tecentriq (atezolizumab) versus&nbsp;Bayer AG&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>) sorafenib in previously untreated advanced hepatocellular carcinoma patients.</li>
<li>Despite failing a key primary endpoint, the company moves at full speed toward a final readout and a potential label expansion.</li>
<li>Cabometyx and Tecentriq reduced the risk of disease progression or death in hepatocellular carcinoma (HCC) patients by 37% compared with sorafenib.&nbsp;</li>
<li>However, it failed to achieve a statistically significant improvement in overall survival at the interim analysis. The company says the probability of hitting the endpoint in time for the final analysis is low.</li>
<li>Nevertheless, the COSMIC-312 study will continue as planned to the final analysis in OS, with a readout expected in early 2022.</li>
<li>The safety data for combo treatment was consistent with the known safety profiles of Cabometyx and Tecentriq, with no new safety signals identified, Exelixis announced.</li>
<li>Price Action: EXEL shares are down 12.7% at $20.45 during the premarket session on the last check Monday.</li>
</ul>

BAYRY

BAYZF

Exelixis Shares Drop On Mixed Results For Cabometyx Combo In Early Liver Cancer

<ul>
<li>European Medicines Agency&#39;s Committee for Medicinal Products for Human Use (CHMP)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/02/b19875618/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-in-combination-wi" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">issued a positive opinion recommending approval</a>&nbsp;of&nbsp;Exelixis Inc&#39;s&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/exel#NASDAQ" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">EXEL</a>) Cabometyx (cabozantinib) in combination with&nbsp;Bristol-Myers Squibb Co&#39;s&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/bmy#NYSE" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">BMY</a>) Opdivo (nivolumab) for advanced renal cell carcinoma.</li>
<li>Exelixis&#39; partner Ipsen Pharma has exclusive rights to commercialize and develop Cabometyx outside of the U.S. and Japan.</li>
<li>The positive opinion follows&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/01/b19278702/exelixis-announces-u-s-fda-approval-of-cabometyx-cabozantinib-in-combination-with-opdivo-nivolumab" style="color: rgb(14, 16, 26); background: transparent; margin-top:0pt; margin-bottom:0pt;; color: #4a6ee0;" target="_blank">FDA approval</a>&nbsp;for Cabometyx plus Opdivo as a first-line treatment of advanced renal cell carcinoma.</li>
<li>Price Action:&nbsp;EXEL shares are 0.05% higher at $21.97, while BMY shares are down 0.2% at $61.9 on the last check Friday.</li>
</ul>

European Medicines Agency's CHMP Backs Approval Of Cabometyx/Opdivo Combo In Kidney Cancer

Dollar General Corp (NYSE: <a class="ticker" href="/stock/dg#NYSE">DG</a>) reported a 3.4% rise in its FQ2 net income rose 3.4% and raised the low end of its earnings forecast for the full year. Dollar General reported its quarterly profit at $146 million, or $0.42 per share, up from $141.2 million, or $0.41 per share, in the year-ago quarter. Its adjusted profit came in at $0.52 per share. Dollar General's net sales climbed to $3.58 billion from $3.21 billion. However, analysts were expecting earnings of $0.48 per share on sales of $3.54 billion. Dollar General's same-store sales surged 5.9%. Dollar General now projects adjusted earnings of $2.22 to $2.30 per share in the fiscal year, versus analysts' estimates of $2.24 per share.

Barnes &amp; Noble Inc (NYSE: <a class="ticker" href="/stock/bks#NYSE">BKS</a>) reported a narrower fiscal first-quarter loss. Barnes &amp; Noble reported a quarterly net loss of $56.6 million, or $0.99 per share, versus a loss of $62.5 million, or $1.12 per share, in the year-ago period. However, analysts were expecting a loss of $0.94 per share. Barnes &amp; Noble's revenue climbed to $1.42 billion, versus analysts' estimates of $1.46 billion.

1-800-Flowers.com Inc (NASDAQ: <a class="ticker" href="/stock/flws#NASDAQ">FLWS</a>) reported a narrower fiscal fourth-quarter loss on Tuesday. 1-800-Flowers reported a quarterly loss of $8,000, or less than a penny share, versus a year-ago loss of $5 million, or $0.08 per share. Its revenue climbed 13% to $187.1 million. However, analysts were expecting earnings of $0.01 per share on revenue of $175 million. 1-800-Flowers' gross margin surged to 39.8% from 38.1%.

DSW Inc (NYSE: <a class="ticker" href="/stock/dsw#NYSE">DSW</a>) reported upbeat quarterly profit and lifted its full-year forecast. DSW reported its Q2 profit at $139.9 million, or $3.96 per share, up from $26.9 million, or $1.00 per share, in the year-ago period. Excluding merger-related items, DSW earned $0.74 per share. Its sales climbed 14.7% to $476.3 million. However, analysts were expecting earnings of $0.63 per share on revenue of $459.4 million. DSW now projects annual diluted earnings of $2.70 to $2.85 per share for the full year, up from its earlier forecast of $2.65 to $2.80 per share. DSW's same-store sales jumped 12.3% during the quarter.

Bank of Nova Scotia (NYSE: <a class="ticker" href="/stock/bns#NYSE">BNS</a>) reported around 22% rise in its quarterly profit on Tuesday. Bank of Nova Scotia reported its Q3 earnings at C$1.29 billion ($1.32 million), or C$1.11 per share, up from C$1.06 billion, or 98 Canadian cents per share, in the year-ago period. On a cash basis, it earned C$1.14 per share. However, analysts were expecting a profit of C$1.12 per share.

OAO Gazprom (OTC: <a class="ticker" href="/stock/ogzpy#OTC">OGZPY</a>) reported a 44% surge in its first quarter net profit. Gazprom's net income attributable to shareholders surged to RUB468.0 billion rubles ($16.3 billion), from RUB324.4 billion, in the year-ago period. Analysts were expecting a net profit of RUB427 billion. Gazprom's sales climbed 38% to RUB1.32 trillion, from RUB954.3 billion. Its operating profit jumped 47% to RUB498.5 billion.

Ipsen (OTC: <a class="ticker" href="/stock/ipsef#OTC">IPSEF</a>) reported a 21% rise in its first-half net income. Ipsen's consolidated net income rose to 91.9 million euros ($133.4 million), or 1.09 euros per share, from 75.6 million, or 0.89, in the year-ago period. Its adjusted earnings per share came in at 1.27 euros. Ipsen's revenue climbed to 619.4 million euros from 585.7 million. Ipsen now projects recurring adjusted operating profit for the year of 190 million to 200 million euros. 

Hon Hai Precision Industry Co (OTC: <a class="ticker" href="/stock/hnhpf#OTC">HNHPF</a>) reported a 23% decline in its second-quarter net profit. Hon Hai's net profit for the period dropped to NT$12.98 billion (US$447 million), from NT$16.75 billion, in the year-ago period. Its revenue surged 23% to NT$633.90 billion from NT$514.53 billion. Analysts were expecting a net profit of NT$12.0 billion.

Earnings

Pre-Market Outlook

Markets

FLWS

HNHPF

OGZPY

Earnings Roundup

Ipsen (OTC: IPSEF) reported a 21% rise in its first-half net income. 

Ipsen's consolidated net income rose to 91.9 million euros ($133.4 million), or 1.09 euros per share, from 75.6 million, or 0.89, in the year-ago period. Its adjusted earnings per share came in at 1.27 euros. Ipsen's revenue climbed to 619.4 million euros from 585.7 million. 

Ipsen now projects recurring adjusted operating profit for the year of 190 million to 200 million euros.

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Ipsen (IPSEF) Forecast

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