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Bayer

Bayer is a German healthcare and agriculture conglomerate. Healthcare provides close to half of the company's sales and includes pharmaceutical drugs as well as vitamins and other consumer healthcare products. The firm's crop science business sells seeds, pesticides, herbicides, and fungicides, which was expanded through its 2018 acquisition of Monsanto.

Bayer AG

On Sunday, Exelixis, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EXEL#NASDAQ">EXEL</a>) revealed topline results from the STELLAR-303 phase 3 pivotal trial of zanzalintinib (100 mg) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46044198/exelixis-announces-zanzalintinib-in-combination-with-an-immune-checkpoint-inhibitor-improved-overa" rel="noreferrer noopener">combined with atezolizumab</a>.
The study includes patients with previously treated non-microsatellite instability (MSI)-high <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">metastatic colorectal cancer (CRC)</a>.
Zanzalintinib in combination with Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) atezolizumab (Tecentriq) demonstrated a statistically significant improvement in overall survival (OS) versus Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) Stivarga (regorafenib).
Also Read: <a href="https://www.benzinga.com/general/biotech/25/05/45418036/exelixis-stock-soars-as-analysts-applaud-raised-2025-guidance-q1-earnings-beat" target="_blank" rel="noreferrer noopener">Exelixis Stock Soars As Analysts Applaud Raised 2025 Guidance, Q1 Earnings Beat</a>
These topline findings are from the final analysis conducted by the Independent Data Monitoring Committee of one of the dual primary endpoints of the STELLAR-303 phase 3 trial.
The trial will proceed to the planned final analysis for the other dual primary endpoint of OS in patients without liver metastases (non-liver metastases, NLM).
The safety profiles of zanzalintinib in combination with atezolizumab and of regorafenib were generally consistent with what has been previously observed, and no new safety signals were identified.
Secondary endpoints of STELLAR-303 include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. Exelixis plans to submit detailed results of STELLAR-303 for presentation at an upcoming medical conference.
Following this positive news, analysts at William Blair said that the announcement &#8220;represents the first pivotal success from the zanzalintinib program, and we are encouraged that the STELLAR-303 study met one of the dual primary endpoints of overall survival among the intent-to-treat population, representing the largest commercial opportunity (risk-adjusted U.S. peak sales of $875 million, according to our estimates).&#8221;
Management had earlier projected that zanzalintinib could reach $5 billion in U.S. net product sales by 2033, with 45% expected from genitourinary cancers, another 45% from gastrointestinal cancers, and the remaining 10% from head-and-neck cancers. Analyst Andy Hsieh asserted that the early positive results from the STELLAR-303 trial mark the first step toward reaching that target.
He added, &#8220;From a stock perspective, given its substantial and likely durable cash flow generation into early 2030, we continue to believe Exelixis provides investors with a highly defensive investment profile. We also believe that the strategic positioning outlined by Exelixis should drive moderate growth into the next decade.&#8221;
Adding to Exelixis&#8217; recent positive developments, its partner Ipsen also recently achieved a regulatory milestone.
On Friday, Exelixis&#8217; partner Ipsen received a positive opinion from the European Medicine Agency&#8217;s Committee for Medicinal Products for Human Use for Cabometyx (cabozantinib) for adult patients with unresectable or metastatic, well-differentiated extra-pancreatic and pancreatic neuroendocrine tumors who have progressed following at least one prior systemic therapy <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/b46022267/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-for-patients-with" rel="noreferrer noopener">other than somatostatin analogs</a>.
A regulatory decision by the European Medicines Agency is anticipated in 2025. In March 2025, the U.S. Food and Drug Administration approved <a href="https://www.benzinga.com/pressreleases/25/06/b46022267/exelixis-partner-ipsen-receives-positive-chmp-opinion-for-cabometyx-cabozantinib-for-patients-with" target="_blank" rel="noreferrer noopener">Cabometyx in this setting</a>.
Price Action: EXEL stock is trading higher by 11.1% to $44.85 at last check Monday.
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Biotech

News

Health Care

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Trading Ideas

General

BAYRY

EXEL

RHHBY

Exelixis' Zanzalintinib Combo Boosts Survival In Colorectal Cancer, Stock Soars

Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) reported on Tuesday that the first quarter of 2025 net profit was 1.3 billion euros (around $1.45 billion), down from 2 billion euros a year ago.
The company reported:
<ul class="wp-block-list">
<li>Adjusted earnings of 65 cents, beating the <a href="https://www.benzinga.com/calendars/earnings" target="_blank" rel="noreferrer noopener">consensus of 38 cents</a>.</li>
<li>Sales reached $14.45 billion (13.74 billion euros), beating the consensus of $13.39 billion.</li>
<li>EBITDA before restructuring and litigation charges fell 7% year-on-year to 4 billion euros in the first quarter.</li>
<li>Earnings were held back by the business performance in the Crop Science Division, higher expenses for the Group-wide long-term incentive (LTI) program, and a negative currency effect of 165 million euros arising primarily from hyperinflationary impacts.</li>
<li>Sales in the agricultural business decreased 3.3% to 7.58 billion euros.</li>
<li>Sales of prescription medicines increased by 4.1% to 4.548&nbsp;billion euros.</li>
<li>The division's new products <a href="https://www.bayer.com/sites/default/files/2025-05/bayer-quarterly-statement-q1-2025.pdf" target="_blank" rel="noreferrer noopener">achieved </a>significant gains</li>
<li>Bayer recorded growth rates of 77.5% for the cancer drug Nubeqa (515 million euros) and 86.6% for Kerendia (161 million euros), for chronic kidney disease associated with type 2 diabetes.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44751934/fda-grants-complete-approval-to-bayers-drug-for-certain-type-cancer-with-mutation" rel="noreferrer noopener">FDA Grants Complete Approval To Bayer&#8217;s Drug For Certain Type Of Cancer With Mutation</a>
Bayer CFO Wolfgang Nickl said: "Based on the current status of tariffs announcements and our mitigation measures, we expect to manage the impact, and we confirm our outlook at constant currencies for the full year 2025."
On Monday, Bayer announced it is reorganizing parts of its Crop Science division in Germany, focusing on how it produces and develops crop protection products. This move is meant to help the company stay competitive globally.
In recent years, generic crop protection makers—mainly in Asia—have created too much supply and are selling products at very low prices, sometimes even below what it costs to produce them in Europe. At the same time, tougher regulations and export restrictions are making things even more difficult.
Bayer will concentrate more on advanced, strategic products that offer farmers clear benefits and are harder for generics to copy. As part of the changes, Bayer will end its operations in Frankfurt by late 2028.
The company's Dormagen site will continue operating and remain Bayer&#8217;s main production hub for crop protection products. However, it will be streamlined to stay competitive. Bayer will stop making generic active ingredients and formulations that are now widely available globally at cheaper prices.
These changes will be rolled out gradually by 2028. They&#8217;re expected to affect about 200 of Dormagen&#8217;s roughly 1,200 employees, mostly those in active ingredient production and formulation.
Price Action: Bayer stock is up 3.33% at $6.97 at the last check on Tuesday.
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Image: Shutterstock

Earnings

Large Cap

Bayer Profit Drops 35%, Launches Overhaul To Counter Generic Pressure

Bayer (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) reported quarterly earnings of $0.65 per share which beat the analyst consensus estimate of $0.38 by 71.05 percent. This is a 15.58 percent decrease over earnings of $0.77 per share from the same period last year. The company reported quarterly sales of $14.45 billion which beat the analyst consensus estimate of $13.39 billion by 7.89 percent. This is a 3.36 percent decrease over sales of $14.95 billion the same period last year.

Earnings Beats

Bayer Q1 Adj. EPS $0.65 Beats $0.38 Estimate, Sales $14.45B Beat $13.39B Estimate

The U.S. Food And Drug Administration (FDA) granted full approval to Bayer AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) Vitrakvi&nbsp;(larotrectinib) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">kinase (</a><a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">NTRK</a><a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">) gene fusion</a>.
Vitrakvi has demonstrated clinically meaningful and durable responses across various&nbsp;NTRK&nbsp;fusion-positive solid tumors. FDA first granted Vitrakvi accelerated approval in November 2018.
The approval is <a target="_blank" href="https://www.businesswire.com/news/home/20250409395229/en/U.S.-FDA-Grants-Full-Approval-of-VITRAKVI-larotrectinib-for-Adult-and-Pediatric-Patients-with-NTRK-Gene-Fusion-Positive-Solid-Tumors" rel="noreferrer noopener">based</a> on data from three multicenter, open-label, single-arm clinical trials.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44146075/bayer-ceo-2025-will-be-most-difficult-year-in-turnaround-plan-expects-improved-performance-from-2026-onwards" rel="noreferrer noopener">Bayer CEO: 2025 Will Be &#8216;Most Difficult&#8217; Year In Turnaround Plan, Expects Improved Performance From 2026 Onwards</a>
The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR).
Pooled efficacy results showed an ORR of 60% with a complete response (CR) rate of 24% and a partial response (PR) rate of 36%.
5% of patients with complete response were pathological complete response.
Patients undergoing a surgical resection whose post-operative pathologic assessment showed no viable tumor cells and negative margins were pathological complete responders provided that no other sites of disease were present. The median DOR was 43.3 months.
Price Action: BAYRY stock closed higher by 2.74% to $5.63 on Thursday.
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</ul>
Photo by JHVEPhoto via Shutterstock

FDA Grants Complete Approval To Bayer's Drug For Certain Type Cancer With Mutation

On Wednesday, Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) reported fourth-quarter 2024 adjusted EPS of $0.28, missing the <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">consensus of $1.00</a>.
The company reported core earnings per share of 1.05 euros, down from 1.85 euros a year ago.
The crop science and drug company reported sales of $12.52 billion (11.73 billion euros), beating the <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $11.30 billion</a>.
For the fourth quarter, Bayer reported a 22% fall in adjusted EBITDA to 2.35 billion euros.
CEO Bill Anderson <a href="https://www.bayer.com/media/en-us/bayer-meets-adjusted-guidance-and-takes-decisive-action-to-tackle-challenges/" target="_blank" rel="noreferrer noopener">called</a> 2025 a &#8220;pivotal year&#8221; for the company. &#8220;It is the second year in Bayer&#8217;s turnaround and will be the most difficult in terms of financial performance, with net sales roughly in line with, and earnings and free cash flow behind the prior year. The company expects improved performance from 2026 onwards,&#8221; he said.
The Bayer Group achieved its adjusted guidance for 2024. &#8220;We have three great businesses with attractive long-term prospects,&#8221; Anderson said at the Financial News Conference on Wednesday. &#8220;However, to get to the opportunities ahead, we first need to steer through what will continue to be challenging times,&#8221;
Bayer&#8217;s Crop Science division aims to improve profitability through key measures in product development, research, production and sales. By 2029, the division expects to add over €1 billion in annual earnings. The plan also includes a broad cost-saving initiative.
Bayer expects the division to grow faster than the market, with innovation contributing more than €3.5 billion in additional sales by 2029. By then, it aims for an EBITDA margin in the mid-20% range, excluding special items.
The German conglomerate forecasts 2025 adjusted EBITDA of between 9.3 billion and 9.8 billion euros and core earnings per share of 4.25 to 4.75 euros.
The company&#8217;s operational belt-tightening efforts generated 500 million euros in savings in 2024 and is expected to deliver another 800 million euros this year.
Bayer said the pharma division should return to growth in 2027 and expand margins beginning in 2028, with sales of Nubeqa and Kerendia expected to reach a combined 2.5 billion euros in 2025.
Price Action: BAYRY stock is up 6.13% at $6.58 at the last check Wednesday
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Guidance

Bayer CEO: 2025 Will Be 'Most Difficult' Year In Turnaround Plan, Expects Improved Performance From 2026 Onwards

Bayer (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) is looking for FY2025 Adj EPS of $4.80-$5.33 vs $4.62 analyst estimate. sees sales of $48.250 billion-$50.239 billion vs $46.40 billion analyst estimate.

Bayer Sees FY2025 Adj EPS $4.80-$5.33 vs $4.62 Est; Sees Sales $48.250B-$50.239B vs $46.40B Est

Bayer (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) reported quarterly earnings of $0.28 per share which missed the analyst consensus estimate of $1.00 by 72 percent. This is a 44 percent decrease over earnings of $0.50 per share from the same period last year. The company reported quarterly sales of $12.52 billion which beat the analyst consensus estimate of $11.30 billion by 10.81 percent. This is a 1.96 percent decrease over sales of $12.77 billion the same period last year.

Earnings Misses

Bayer Q4 Adj $0.28 Misses $1.00 Estimate, Sales $12.52B Beat $11.30B Estimate

On Tuesday, Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) announced the <a href="https://www.benzinga.com//node/42526484">primary endpoint</a> was met in the Phase 3 QUASAR trial investigating EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO)
RVO is&nbsp;a blockage in one of the veins in the retina, the light-sensitive tissue at the back of the eye.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38208816/eye-drug-eylea-price-manipulation-regeneron-faces-us-justice-department-allegations-over-medicare" rel="noreferrer noopener">Eye Drug Eylea Price Manipulation: Regeneron Faces US Justice Department Allegations Over Medicare Pricing Of Its Best-Selling Eye Drug</a>
In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA&nbsp;(aflibercept) Injection 2 mg, the current standard of care.
These data will be submitted to regulatory authorities around the world, with a submission to the FDA planned for the first quarter of 2025.
The safety profile of EYLEA HD (n=591) was similar to EYLEA (n=301) in QUASAR and remained generally consistent with its known safety profile of EYLEA HD in pivotal trials.
EYLEA HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>).
In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed exclusive marketing rights outside of the U.S., where the companies share equally the profits from EYLEA and EYLEA HD sales.
Last year, the FDA approved Eylea HD (aflibercept) Injection 8 mg for wet age-related macular degeneration, diabetic macular edema,&nbsp;<a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/23/08/33967522/regenerons-crucial-eylea-hd-approval-a-shield-against-potential-biosimilar-competit" rel="noreferrer noopener">and diabetic retinopathy (DR)</a>.&nbsp;
Third quarter 2024 U.S. net sales for Eylea HD&nbsp;and Eylea&nbsp;increased 3% versus third quarter 2023 to $1.54&nbsp;billion, including $392 million <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41660999/why-is-regeneron-pharmaceuticals-stock-trading-lower-today" rel="noreferrer noopener">from Eylea HD</a>.
Price Action: REGN stock is up 2.04% at $739.64 at the last check on Tuesday.
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REGN

Regeneron's Best-Selling Eye Drug Eylea's Higher Dose Formulation Meets Primary Goal In Another Form Of Retinal Disease Study

On Friday, the FDA approved BridgeBio Pharma, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for adults with ATTR-CM to reduce cardiovascular death and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42150289/attruby-acoramidis-a-near-complete-ttr-stabilizer-90-approved-by-fda-to-reduce-cardiovascular-deat" rel="noreferrer noopener">cardiovascular-related hospitalization</a>.
The FDA approval is based on ATTRibute-CM Phase 3 study results, which showed that Attruby significantly reduced death and cardiovascular-related hospitalization and improved quality of life.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42072773/bridgebio-pharmas-acoramidis-shows-competitive-edge-against-pfizers-tafamidisa-in-lucrative-but-competitive-attr-cm-market" rel="noreferrer noopener">BridgeBio Pharma&#8217;s Acoramidis Shows Competitive Edge Against Pfizer&#8217;s Tafamidisa In Lucrative But Competitive ATTR-CM Market</a>
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR.
Attruby was designed to mimic a naturally occurring &#8220;rescue mutation&#8221; of the TTR gene (T119M) that targets the root cause of ATTR-CM, the destabilization of the native TTR tetramer.
Through near-complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.
The ATTRibute-CM Phase 3 study enrolled 632 participants with symptomatic ATTR-CM associated with either wild-type or variant TTR.
BridgeBio submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted&nbsp;Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>)&nbsp;exclusive rights to commercialize acoramidis for ATTR-CM in Europe.
The company said it will provide Attruby for free to patients who participated in the trial.
William Blair writes, &#8220;We continue to view a reduction in all-cause mortality on label as a necessary distinction to gain major market share in ATTR-CM alongside Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) tafamidis.&#8221;
Since the Attruby label doesn&#8217;t include data on overall mortality, the William Blair analyst notes Pfizer might shift its marketing focus to emphasize claims about mortality benefits.
Price Action: BBIO stock is up 24.3% at $29.10 during the premarket session at last check Monday.
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Equities

BBIO

FDA Approves BridgeBio Pharma's Drug For Rare Heart Disease, Poised To Challenge Pfizer In Lucrative Yet Competitive Market

On Monday, BridgeBio Pharma, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) presented initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42041623/open-label-extension-data-confirms-sustained-benefit-of-acoramidis-on-cardiovascular-outcomes-incl" rel="noreferrer noopener">Association Scientific Sessions</a>.
ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational small-molecule stabilizer of transthyretin (TTR) gene.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41100250/bridgebio-pharmas-lead-candidate-cuts-mortality-related-hospitalizations-in-patients-with-certain" rel="noreferrer noopener">BridgeBio Pharma&#8217;s Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease</a>
The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.
Key initial results from the OLE study show that continuous treatment with acoramidis led to:
<ul>
<li>A confirmed sustained improvement relative to placebo in time to the first event ( cardiovascular-related hospitalizations (CVH) or All-Cause Mortality (ACM)) starting at Month 3 in ATTRibute-CM</li>
<li>A statistically significant reduction in ACM alone of 36% by Month 36 (p=0.009) and 34% by Month 42 (p=0.006).</li>
<li>A significant reduction of composite ACM and CVH by 46% at Month 36 and 48% at Month 42, building upon the previously presented 42% reduction at Month 30 in ATTRibute-CM.</li>
<li>Acoramidis continues to be well tolerated, with no new clinically significant safety signals identified in this long-term evaluation.</li>
</ul>
The OLE data build on previously reported results from ATTRibute-CM in which acoramidis demonstrated clinically important treatment effects on mortality, CVH, and quality of life, further supporting that greater transthyretin (TTR) stabilization can improve clinical outcomes for patients.
This included a 50% reduction in the cumulative frequency of CVH relative to placebo at Month 30.
BridgeBio&#8217;s marketing application is under FDA review, with a PDUFA action date of November 29, 2024. It also has a marketing application to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) exclusive rights to commercialize ceramides for ATTR-CM in Europe.
William Blair writes that reducing overall mortality is crucial for competing in the ATTR-CM market against Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) tafamidis, which already includes proven mortality benefits on its label from the ATTR-ACT trial.
The analyst writes, &#8220;While Bridge Bio continues to publish analyses of acoramidis demonstrating the TTR stabilizer is safe and efficacious, we deem an on-label claim to all-cause mortality benefit as an important factor for market share in the lucrative, but competitive, ATTR-CM space.&#8221;
Price Action: BBIO stock is up 0.85% at $22.54 at the last check on Tuesday.
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BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market

<ul>
<li>Approximately €70 Million in Upfront and Near-term Payments to Cytokinetics</li>
<li>Up to €490 Million in Commercial Milestone Payments, with</li>
<li>Tiered Royalties on Future Sales</li>
</ul>

CYTK

Cytokinetics And Bayer Partner For Exclusive Development And Commercialization Of Aficamten In Japan

Corporate Outlook We confirm our 2024 Group guidance for currency- and portfolio-adjusted sales growth, currencyadjusted core earnings per share, and free cash flow as published in the 2023 Annual Report. However, in view of the weaker-than-anticipated development of the agricultural market, we are revising some parts of our Group forecast. We are also making adjustments to our guidance at divisional level: While business performance is below our initial expectations at Crop Science and Consumer Health, we now see Pharmaceuticals coming in at the upper end of our revised guidance. A 13 Forecast for 2024 Initial currency-adjusted forecast for 2024 Revised currencyadjusted forecast for 2024 Initial forecast for 2024 at closing rates on Dec. 31, 2023 Revised forecast for 2024 at closing rates on Sept. 30, 2024 € billion Fx &amp; p adj. change (%) € billion Fx &amp; p adj. change (%) € billion Fx &amp; p adj. change (%) € billion Fx &amp; p adj. change (%) Sales 47 to 49 – 1 to + 3 47 to 49 – 1 to + 3 46 to 48 – 1 to + 3 45.5 to 47.5 – 1 to + 3 Crop Science – 1 to + 3 – 3 to – 1 – 1 to + 3 – 3 to – 1 Pharmaceuticals – 4 to 0 0 to + 3 – 4 to 0 0 to + 3 Consumer Health + 3 to + 6 + 1 to + 3 + 3 to + 6 + 1 to + 3 Margin (%) Margin (%) Margin (%) Margin (%) EBITDA before special items1 10.7 to 11.3 10.4 to 10.7 10.4 to 11.0 10.0 to 10.3 Crop Science 20 to 22 18 to 20 20 to 22 18 to 20 Pharmaceuticals 26 to 29 26 to 29 24 to 27 24 to 27 Consumer Health 23 to 24 23 to 24 23 to 24 23 to 24 Financial result (core)2 ~ – 2.3 ~ – 2.0 ~ – 2.2 ~ – 2.0 Tax rate (core)3 ~ 23% 24 to 25% ~ 23% 24 to 25% Free cash flow1 2 to 3 2 to 3 2 to 3 2 to 3 Net financial debt1 32.5 to 33.5 32.5 to 33.5 32.5 to 33.5 32.5 to 33.5 Special items in EBITDA1 – 2 to – 1 – 2 to – 1 – 2 to – 1 – 2 to – 1 € € € € Core earnings per share1 5.10 to 5.50 5.10 to 5.50 4.95 to 5.35 4.80 to 5

BAYZF

Bayer Confirms Its 2024 Guidance, Sales Of €47B-€49B And Core Earnings Per Share Of €5.10-€5.50

Bayer (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) reported quarterly earnings of $0.07 per share which missed the analyst consensus estimate of $0.17 by 61.24 percent. The company reported quarterly sales of $10.956 billion which missed the analyst consensus estimate of $11.533 billion by 5.00 percent. This is a 2.67 percent decrease over sales of $11.257 billion the same period last year.

Bayer Q3 2024 Adj. EPADS $0.07 Misses $0.17 Estimate, Sales $10.956B Miss $11.533B Estimate

On Tuesday, Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant for moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38896489/bayer-highlights-detailed-data-from-twin-late-stage-trials-on-experimental-menopause-candidate-se" rel="noreferrer noopener">adjuvant endocrine therapy</a>.
The EMA <a target="_blank" href="https://www.bayer.com/media/en-us/bayer-submits-eu-marketing-authorization-application-for-elinzanetant-to-treat-moderate-to-severe-vasomotor-symptoms/" rel="noreferrer noopener">submission</a> is based on Phase 3 development program OASIS results.
OASIS 1 and 2 data were published in the Journal of the American Medical Association (<a href="https://doi.org/10.1001/jama.2024.14618" target="_blank" rel="noreferrer noopener">JAMA</a>) in August.
Detailed results of the Phase 3 study OASIS 3, which provided additional efficacy and safety data over 52 weeks, were presented at the Menopause Society annual meeting in September.
The data showed that elinzanetant <a target="_blank" href="https://www.bayer.com/media/en-us/data-from-phase-iii-study-oasis-3-support-efficacy-and-long-term-safety-of-investigational-compound-elinzanetant-in-the-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/" rel="noreferrer noopener">met</a> the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms from baseline to week 12 compared to placebo.
There was no minimum threshold of moderate to severe VMS for inclusion in the study, and at baseline, women had a mean of 6.7 VMS (standard deviation, SD 7.2) in the elinzanetant group and 6.8 in the placebo group (SD 6.2).
After 12 weeks of treatment, VMS was reduced to 1.6 (SD 2.5) in the elinzanetant group and 3.4 (SD 4.2) in the placebo group.
The VMS reductions were maintained throughout the study. In addition, improvements were seen in sleep disturbances and menopause-related quality of life measures with <a target="_blank" href="https://www.benzinga.com/24/03/37822314/bayers-third-menopausal-relief-drug-trial-meets-primary-goal-german-conglomerate-seeks-fda-approval" rel="noreferrer noopener">elinzanetant use over 52 weeks</a>.
Last week, the FDA <a target="_blank" href="https://www.bayer.com/media/en-us/us-food-and-drug-administration-fda-accepts-new-drug-application-for-elinzanetant/" rel="noreferrer noopener">accepted</a> Bayer&#8217;s marketing application for elinzanetant seeking approval for moderate-to-severe vasomotor symptoms.
On Monday, Bayer submitted an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide, seeking&nbsp;approval&nbsp;for the use of darolutamide in combination with androgen deprivation therapy in patients with metastatic hormone-<a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41315864/bayer-seeks-european-approval-for-third-indication-for-cancer-drug-darolutamide" rel="noreferrer noopener">sensitive prostate cancer</a>.
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Photo: Taljat David/Shutterstock.com

Eurozone

Bayer Seeks European Approval For Its Menopause Drug

On Monday, Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) submitted an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide.
Bayer is seeking <a target="_blank" href="https://www.bayer.com/media/en-us/bayer-submits-application-for-third-indication-of-darolutamide-in-the-eu/" rel="noreferrer noopener">approval</a> for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40801594/roivant-sciences-unveils-new-vant-subsidiary-for-in-licensed-pulmonary-hypertension-drug-from-bay" rel="noreferrer noopener">Roivant Sciences Unveils New &#8216;Vant&#8217; Subsidiary For In-Licensed Pulmonary Hypertension Drug From Bayer</a>.
The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries.
Results from the Phase III ARANOTE trial, on which this new submission is based, showed that darolutamide plus&nbsp;ADT&nbsp;significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54), in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40881070/bayer-targets-expanded-use-approval-for-prostate-cancer-drug-reveals-encouraging-data-from-pivota" rel="noreferrer noopener">patients with mHSPC</a>.
Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high- and low-volume mHSPC.
Treatment-emergent adverse events (TEAEs) were low and similar between treatment groups and the safety analysis reconfirmed the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials.
The ARANOTE results were simultaneously presented at the 2024 ESMO Congress and published in&nbsp;The Journal of Clinical Oncology.
Darolutamide is developed jointly by Bayer and a Finnish pharmaceutical company, Orion Corporation.
In June, a Pennsylvania judge drastically reduced a $2.25 billion verdict against Bayer, cutting it down to $400 million in a case involving a man who claimed he developed cancer from using the <a href="https://www.benzinga.com/news/24/06/39185732/judge-slashes-bayers-massive-2b-roundup-verdict-to-400m" target="_blank" rel="noreferrer noopener">company&#8217;s Roundup weedkiller</a>.
Image by PDPics from Pixabay
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Bayer Seeks European Approval For Third Indication For Cancer Drug Darolutamide

Johnson &amp; Johnson&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/jnj#NYSE">JNJ</a>), via its subsidiary called Red River Talc, for the third time, filed for voluntary bankruptcy to resolve thousands of lawsuits related to its talc products. Red River Talc has filed for Chapter 11 bankruptcy to equitably resolve all of JNJ&#39;s present and future talc-related claims in a bankruptcy court in the Southern District of Texas.
JNJ faces more than 62,000 lawsuits for its talc-based products, primarily its baby powders. The lawsuits allege that its talc products contain asbestos, which caused many women to develop ovarian cancer. JNJ insists that talc-based products are safe and do not cause cancer. JNJ has permanently discontinued the sale of its talc-based Johnson&#39;s Baby Powder.
So far this year, JNJ&#39;s shares have risen 4.7% compared with the&nbsp;industry&#39;s 23.5% increase.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/52/78741.jpg?v=633076405" />
Image Source: Zacks Investment Research
<h2>JNJ&#39;s Two Failed Bankruptcy Attempts</h2>
Johnson &amp; Johnson&#39;s subsidiary, LTL Management, which was established to manage claims in the cosmetic talc litigation, filed for voluntary bankruptcy twice in New Jersey. However, both the bankruptcy filings were rejected by courts stating that J&amp;J was not in enough financial stress to qualify for bankruptcy.
<h2>JNJ&#39;s New Plan and 3rd Bankruptcy Filing</h2>
In May 2024, LTL Management proposed a new plan committing to pay claimants a present value of approximately $6.5 billion to be paid over 25 years, which could resolve 99.75% of all pending talc lawsuits against the company.
J&amp;J said that Red River filed the bankruptcy case after it received support from around 83% of current claimants for the proposed bankruptcy plan. This&nbsp;exceeds the 75% approval threshold required by the U.S. Bankruptcy Code to secure confirmation of the proposed plan. Red River also increased its settlement commitment by $1.75 billion to approximately $8 billion.
<h2>Several Rulings Against JNJ in Talc Lawsuits</h2>
Several juries have ruled against Johnson &amp; Johnson in talc lawsuits over the years. In one such ruling, in 2018, JNJ was ordered by a Missouri court to pay $4.7 billion in damages to 22 women who made such allegations, affirming a St. Louis court jury&#39;s verdict given earlier. Though the verdict was reduced to $2.1 billion by an appeals court in June 2020, it still rejected J&amp;J&#39;s appeal to overturn the 2018 jury verdict. JJohnson &amp; Johnson paid the award, which, including interest, totaled approximately $2.5 billion. In April 2023, J&amp;J offered to pay $8.9 billion over a period of 25 years to completely resolve its cosmetic talc litigation.
JNJ believes that resolving the claims via the civil law system would take years and incur significant costs for the company. The talc lawsuits have also hurt the company&#39;s goodwill and reputation. It believes that resolving the litigation through this proposed reorganization plan would be more efficient and would compensate claimants on time. &nbsp;However, some attorneys of the claimants feel Johnson &amp; Johnson is manipulating the bankruptcy process so that it can delay jury trials and also underpay the claimants. However, the higher settlement offer and a high percentage of claimant support may improve JNJ&#39;s chances of success after the previous two failures.
<h2>JNJ&#39;s Zacks Rank and Stocks to Consider</h2>
J&amp;J currently has a Zacks Rank #3 (Hold).
<div class="chart_embed">
<h3>Johnson &amp; Johnson Stock Price and Consensus</h3>
<img alt="Johnson &amp; Johnson Price and Consensus" src="https://staticx-tuner.zacks.com/images/charts/93/1727080281.png" style="height:265px; width:591px" title="" />
Johnson &amp; Johnson price-consensus-chart | Johnson &amp; Johnson Quote
Some better-ranked drug/biotech companies are Eli Lilly (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/lly#NYSE">LLY</a>), Pfizer&nbsp;and Bayer (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>). While Lilly sports a Zacks Rank #1 (Strong Buy), Pfizer and Bayer have a Zacks Rank #2 (Buy) each.
The Zacks Consensus Estimate for Lilly&#39;s 2024 earnings has risen from $13.78 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.44 to $23.97 per share over the same timeframe. Year to date, Lilly&#39;s stock has risen 58.1%.
</div>
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
The Zacks Consensus Estimate for Pfizer&#39;s 2024 earnings has risen from $2.38 to $2.62 per share in the past 60 days, while that for 2025 has risen from $2.74 per share to $2.85 per share. Pfizer&#39;s shares have risen 2.2% year to date.
Pfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.82%.
Estimates for Bayer&#39;s 2024 earnings have risen from $1.35 to $1.38 per share over the past 60 days. For 2025, earnings estimates have risen from $1.42 to $1.44 per share over the same timeframe. Year to date, Bayer&#39;s stock has declined 13.4%.
<a href="https://www.zacks.com/stock/news/2340100/johnson-johnson-files-for-bankruptcy-over-talc-lawsuits-for-the-third-time?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2340100">To read this article on Zacks.com click here.</a>

Management

Markets

Johnson & Johnson Files for Bankruptcy Over Talc Lawsuits for the Third Time

On Monday, Bayer&nbsp;AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) said results from the Phase 3 ARANOTE trial have shown that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54), in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The company adds that darolutamide plus ADT now has &#8216;positive data&#8217; both with and without docetaxel.
The <a target="_blank" href="https://www.bayer.com/media/en-us/darolutamide-plus-adt-significantly-reduced-the-risk-of-radiological-progression-or-death-compared-to-placebo-plus-adt-in-patients-with-mhspc/" rel="noreferrer noopener">results</a> were presented at the 2024 ESMO Congress and simultaneously published in&nbsp;The Journal of Clinical Oncology.
Bayer plans to submit the data from the ARANOTE trial to health authorities globally to support the expanded use of darolutamide in patients with mHSPC.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40801594/roivant-sciences-unveils-new-vant-subsidiary-for-in-licensed-pulmonary-hypertension-drug-from-bay" rel="noreferrer noopener">Roivant Sciences Unveils New &#8216;Vant&#8217; Subsidiary For In-Licensed Pulmonary Hypertension Drug From Bayer</a>.
Darolutamide is already approved for mHSPC under the brand name Nubeqa in combination with ADT and docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
The product was developed jointly by Bayer and a Finnish pharmaceutical company, Orion Corporation.
Consistent benefits in radiological progression-free survival (rPFS) were observed across patient subgroups, including high- and low-volume mHSPC, with a risk reduction by 40% and 70%, respectively.
An analysis of immature data of overall survival (OS), which measures the time from treatment until death from any cause, suggested a potential benefit with darolutamide plus ADT vs. placebo plus ADT.
The ARANOTE data also suggested numerical clinical benefits across all other secondary endpoints, including delaying the time to CRPC, PSA progression, pain progression, and initiation of subsequent systemic therapy compared to placebo plus ADT.
Incidences of treatment-emergent adverse events (TEAEs) were low (most were grade 1 or 2) and similar between treatment arms, and treatment discontinuations due to TEAEs were lower in patients receiving darolutamide compared to placebo plus ADT (6.1% vs 9.0%).
In the second quarter of 2024, Nubeqa <a target="_blank" href="https://www.bayer.com/en/investors/quarterly-reports" rel="noreferrer noopener">generated</a> sales of 380 million euros, up 89% year over year.
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. Prostate cancer diagnoses are projected to increase from 1.4 million annually in 2020 to 2.9 million by 2040.
Image by PDPics from Pixabay
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Bayer Targets Expanded Use Approval For Prostate Cancer Drug, Reveals Encouraging Data From Pivotal Study

Tuesday,&nbsp;Roivant Sciences Ltd.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ROIV#NASDAQ">ROIV</a>) created Pulmovant to in-license from Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) exclusive worldwide rights to develop and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40788639/roivant-unveils-new-pipeline-program-mosliciguat-a-potential-first-in-class-and-best-in-category-i" rel="noreferrer noopener">commercialize mosliciguat</a>.
Bayer received an upfront cash payment of ~$14 million, with up to an additional $280 million agreed upon for future development, regulatory, commercial milestone payments, and tiered high-single-digit sales-based royalties.
Mosliciguat is an inhaled, once-daily sGC activator with targeted delivery to the lungs via a dry powder inhaler.
Pulmovant presented data from the proof-of-concept Phase 1b ATMOS study during the European Respiratory Society Congress.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40778228/whats-going-in-with-vivek-ramaswamy-founded-roivant-sciences-stock-on-monday" rel="noreferrer noopener">What&#8217;s Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday</a>?
The ATMOS Phase 1b trial assessed the efficacy, safety, tolerability, and pharmacokinetics of mosliciguat in participants with pulmonary hypertension aged between 18 and 80. Overall, 38 patients received mosliciguat in this study.
In the per-protocol set of patients (N=20), mosliciguat 1.0, 2.0, and 4.0 mg doses led to mean-max peak reductions in pulmonary vascular resistance&nbsp;(PVR) from baseline of -25.9%, -38.1%, and -36.3%, respectively. The company adds the &#8220;clinically meaningful&#8221; data is &#8220;one of the highest reductions seen in PH trials to date.&#8221;
The company highlights that mosliciguat is unlike other inhaled PH therapies. It requires one inhalation a day, whereas other PH therapies require multiple inhalations at various points during the day.
&#8220;We are impressed with the data generated so far, particularly the PVR results, and we believe its differentiated mechanism as an sGC activator can have maximal impact on PH-ILD patients, a large population with severe disease, high morbidity and mortality, and few treatment options,&#8221; said Matt Gline, Roivant&#8217;s CEO.
Notably, a similar effect on PVR was observed in the pharmacodynamic analysis set (N=37), which included both responsive and non-responsive participants to inhaled nitric oxide (NO).
Pulmovant will advance the clinical program to assess mosliciguat in its global Phase 2 PHocus study in patients with PH-ILD, a subgroup of Group 3 PH.
Approximately 120 patients will be enrolled in the study, starting imminently.
Price Action: ROIV stock is down 1.88% at $12.27 at the last check on Tuesday.
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Contracts

ROIV

Roivant Sciences Unveils New 'Vant' Subsidiary For In-Licensed Pulmonary Hypertension Drug From Bayer

Friday, BridgeBio Pharma Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/g40654449/bridgebio-shares-data-on-serum-ttr-increase-when-switching-participants-from-placebo-and-tafamidis" rel="noreferrer noopener">Society of Cardiology (ESC) 2024</a>.
The data included change from baseline in serum TTR levels in participants receiving acoramidis versus those receiving tafamidis in the placebo group in ATTRibute-CM at Month 30, as well as serum TTR levels in patients who transitioned from placebo and tafamidis to acoramidis.
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Transthyretin amyloidosis (ATTR-CM) occurs when the liver produces faulty transthyretin (TTR) proteins. Clumps of these abnormal proteins (called fibrils) build up in the heart's main pumping chamber.
In participants who switched from Pfizer Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Vyndaqel&nbsp;(tafamidis) and placebo in the ATTRibute-CM study to acoramidis in its open-label extension (OLE), there was a mean of 3.0mg/dL increase in serum TTR at Month 1 of the OLE (n=21, p=0.01) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18, p=0.01).
BridgeBio submitted a marketing application to the FDA, which has been accepted with a PDUFA action date of November 29, and a marketing application to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) exclusive rights to commercialize acoramidis for ATTR-CM in Europe.
Price Action: BBIO stock is up 12.50% at $27.69 at the last check on Friday.
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</ul>

Why Is BridgeBio Pharma Stock Trading Higher On Friday?

Regeneron Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) announced that the European Commission&nbsp;approved odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma&nbsp;or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
The drug has been approved under the brand name Ordspono.
The approval is based on results from the phase I ELM-1 and pivotal phase II ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL.
Regeneron&#39;s shares have rallied 37.3% year to date against the industry&#39;s decline of 0.2%.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/f5/75596.jpg?v=1262470421" />
Image Source: Zacks Investment Research
<h3>Positive Study Results Help REGN</h3>
Results from ELM-2 (n=128), as assessed by an independent review committee, showed an objective response rate (ORR) of 80%, with 73% achieving a complete response&nbsp;in R/R FL.
Results from ELM-2 (n=127) in patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR in R/R DLBLCL.
Results from ELM-1 (n=60) in patients who had progressed after CAR-T therapy, as assessed by an IRC, showed 48% ORR, with 32% achieving a CR.
The approval in the EU is the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell.
Approval in the EU was mostly expected as the European Medicines Agency&#39;s Committee for Medicinal Products for Human Use recommended approval of odronextamab.
The EMA previously granted odronextamab Orphan Designation for FL and DLBCL.
<h3>REGN Suffers Setback With Odronextamab</h3>
Earlier, the company&#39;s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued complete response letters (CRLs) for its BLA for odronextamab in March 2024. The BLA is seeking the approval of the candidate R/R FL and R/R DLBCL.
The sole issue with the approval is related to the enrollment status of the confirmatory trials.
The CRLs (one for R/R FL and one for R/R DLBCL) did not identify any issue with the clinical efficacy or safety, trial design, labeling or manufacturing.
<h3>How Will the Approval Help Regeneron?</h3>
The successful development of these oncology drugs should be a great boost for REGN. It will also reduce its dependence on sales of lead ophthalmology drug Eylea and profits from asthma drug Dupixent for growth.
The firm is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
The company is investigating the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the phase III OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs and early-stage trials with chemotherapy-free combinations.
A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo for perioperative non-small cell lung cancer, was also initiated. A phase II/III study for fianlimab, in combination with Libtayo for perioperative melanoma, was also initiated.
<h3>Regulatory Setbacks Derail REGN</h3>
Last week, REGN received a CRL from the FDA for its BLA for pipeline candidate linvoseltamab.
The BLA is seeking FDA approval for linvoseltamab to treat R/R multiple myeloma that has progressed after at least three prior therapies.
Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company&#39;s product candidate.&nbsp;The CRL delays the potential approval of the candidate.
REGN has a collaboration agreement with Bayer (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>) for Eylea. The company records net product sales of Eylea and Eylea HD in the United States and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with sales of Eylea outside the United States.
Regeneron has a collaboration agreement with Sanofi (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) for Dupixent. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
<h3>Zacks Rank</h3>
Regeneron currently carries a Zacks Rank #3 (Hold).
<a href="https://www.zacks.com/stock/news/2327848/regeneron-s-bispecific-antibody-obtains-ec-nod-for-lymphoma?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2327848">To read this article on Zacks.com click here.</a>

Regeneron's Bispecific Antibody Obtains EC Nod for Lymphoma

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