Dernières nouvelles pour AstraZeneca (NASDAQ:AZN) Stock

AstraZeneca

A merger between Astra of Sweden and Zeneca Group of the United Kingdom formed AstraZeneca in 1999. The firm sells branded drugs across a number of major therapeutic areas, including oncology (about 40% of total revenue), cardiovascular, renal, and metabolic (25%), rare disease (17%), and respiratory and immunology (15%). The majority of sales comes from international markets, with the United States representing close to one third of its sales.

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The U.S. Food and Drug Administration (FDA) on Monday approved AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Imfinzi&nbsp;(durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi&nbsp;as adjuvant monotherapy&nbsp;after radical cystectomy (surgery to remove the bladder) for adult patients with muscle-<a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">invasive bladder cancer (MIBC)</a>.
The FDA approval was based on results from the <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/b44558058/imfinzi-durvalumab-approved-in-the-us-as-first-and-only-perioperative-immunotherapy-for-patients-w" rel="noreferrer noopener">NIAGARA Phase 3 trial</a>.
In a planned interim analysis, the Imfinzi-based&nbsp;perioperative regimen demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus the comparator arm.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44188407/astrazenecas-imfinzi-based-regimen-shows-improved-event-free-survival-in-early-stage-gastric-cancer-patients" rel="noreferrer noopener">AstraZeneca's Imfinzi-Based Regimen Shows Improved Event-Free Survival In Early-Stage Gastric Cancer Patients</a>
The estimated median event-free survival (EFS) has not yet been reached for the Imfinzi arm versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the regimen were event-free at two years compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the regimen were alive at two years compared to 75.2% in the comparator arm.
Concurrently, AstraZeneca's&nbsp;Calquence&nbsp;(acalabrutinib) in combination with bendamustine and rituximab was <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/calquence-recommended-for-eu-approval-in-1l-mcl.html" rel="noreferrer noopener">recommended</a> for approval in the European Union for adult patients with previously untreated mantle cell lymphoma who are not eligible for autologous hematopoietic stem cell transplantation.
The positive opinion was based on the &nbsp;ECHO Phase 3 trial results.
Calquence&nbsp;plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median PFS was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone.
Price Action: AZN stock is down 0.86% at $73.16 at the last check Monday.
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FDA Approves AstraZeneca's Imfinzi As First Perioperative Immunotherapy For Muscle-Invasive Bladder Cancer Patients

Durvalumab (Imfinizi) plus chemotherapy followed by single-agent durvalumab has been approved by the FDA for patients with muscle-invasive bladder cancer after radical cystectomy, according to a press release from the agency.1
The approval was based on results from the <a href="https://www.cancernetwork.com/view/neoadjuvant-durvalumab-chemo-adjuvant-durvalumab-improves-efs-in-cisplatin-eligible-mibc">phase 3 NIAGARA trial (NCT03732677),</a> in which updated results were recently presented at the <a href="https://www.cancernetwork.com/conference/asco-genitourinary-cancer-symposium">2025 ASCO Genitourinary Cancer Symposium</a>.2 Results presented here were focused on efficacy and safety, as well as the impact of pathological complete response (pCR) for patients in the aforementioned population.
Results presented at the <a href="https://www.cancernetwork.com/conference/esmo">2024 European Society of Medical Oncology Congress</a> and subsequently published in the New England Journal of Medicine highlighted that the event-free survival (EFS) was not reached (NR; 95% CI, NR-NR) in the durvalumab arm and 46.1 months (95% CI, 32.23-NR) in the comparator arm (HR, 0.68; 95% CI, 0.56-0.82; P &lt;.0001).3,4 The 12-month EFS rates in either arm included 76.0% vs 69.9%, and the 24-month rates were 67.8% vs 59.8%.

AstraZeneca Announces FDA Approves Adjuvant Durvalumab/Chemo In Muscle-Invasive Bladder Cancer

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President Trump Says Will Be Announcing Pharma Tariffs Soon

The Japanese Ministry of Health, Labour and Welfare on Thursday approved BridgeBio Pharma, Inc.&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) acoramidis, under the brand name Beyonttra, for adults with transthyretin-mediated amyloid <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">cardiomyopathy (ATTR-CM).</a>
Acoramidis is a selective small molecule, orally administered, near-complete (≥90%) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44510729/beyonttra-acoramidis-the-first-near-complete-ttr-stabilizer-90-approved-in-japan-to-treat-attr-cm" rel="noreferrer noopener">transthyretin (TTR) stabilizer</a>.
ATTR-CM is a progressive, fatal disease that presents as an infiltrative, restrictive cardiomyopathy, resulting in heart failure.
AstraZeneca Plc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Alexion will be responsible for all commercial activity for Beyonttra in Japan.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/11/42163927/fda-approves-bridgebio-pharmas-drug-for-rare-heart-disease-poised-to-challenge-pfizer-in-lucrative-yet-competitive-market" rel="noreferrer noopener">FDA Approves BridgeBio Pharma&#8217;s Drug For Rare Heart Disease, Poised To Challenge Pfizer In Lucrative Yet Competitive Market</a>
The approval in Japan is based on results from a Phase 3 open-label, single-arm study conducted in&nbsp;Japan by Alexion, AstraZeneca Rare Disease, and the global ATTRibute-CM Phase 3 study.
In the Japanese trial, acoramidis was generally well tolerated, and 0% mortality was reported during the 30-month acoramidis treatment period.
BridgeBio&#8217;s global ATTRibute-CM Phase 3 trial showed early separation at 3 months in time to the first event (all-cause mortality or cardiovascular-related hospitalization ACM or CVH) durably separated relative to placebo.
Furthermore, in the global ATTRibute-CM trial, acoramidis led to a 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30 and a 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30.
Based on the terms of the agreement, BridgeBio will receive a $30 million milestone payment upon approval in Japan, as well as royalties in the low double digits on sales of acoramidis in Japan, with commercialization efforts planned in the first half of 2025.
Price Action: BBIO stock is up 1.6% at $36.70 at the last check Thursday.
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Japan Approves BridgeBio Pharma-AstraZeneca Partnered Rare Heart Disease Drug

Johnson &amp; Johnson&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) announced results for the gold standard endpoint in cancer treatment of overall survival (OS) from the <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">Phase 3 MARIPOSA study</a>.
Head-to-head comparison data versus AstraZeneca Plc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Tagrisso (osimertinib) showed Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) significantly extended OS in the first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) <a href="https://www.benzinga.com/pressreleases/25/03/n44497192/rybrevant-amivantamab-vmjw-plus-lazcluze-lazertinib-outperforms-osimertinib-with-a-significant-and" target="_blank" rel="noreferrer noopener">or L858R substitution mutations</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44440233/pharmaceutical-firms-say-uk-investment-is-unlikely-unless-payment-levy-is-adressed" rel="noreferrer noopener">Pharmaceutical Firms Say UK Investment Is &#8216;Unlikely&#8217; Unless Payment Levy Is Addressed</a>
Johnson &amp; Johnson said in a Wednesday press release that the median OS is projected to exceed one year beyond the median of three years observed with&nbsp;osimertinib and has not yet been reached.
The pharma giant says this is the first and only study to show a statistically significant and clinically meaningful OS improvement over osimertinib.
At a median follow-up of 37.8 months, patients treated with the chemotherapy-free regimen of first-line Rybrevant plus Lazcluze had a significantly longer OS than those receiving osimertinib.
Median OS for Rybrevant plus Lazcluze has not yet been reached, indicating that survival benefits continue to extend beyond the measured follow-up period.
Comparatively, median OS for osimertinib-treated patients was 36.7 months.
56% of patients treated with Rybrevant plus Lazcluze were alive at three and a half years, compared to 44% of patients on osimertinib.
The Rybrevant plus Lazcluze combination also prolonged multiple secondary endpoints vs. osimertinib, including intracranial PFS, intracranial duration of response (DOR) and intracranial overall response rate (ORR).&nbsp;
Rybrevant plus Lazcluze prolonged the time to symptomatic progression—the time from treatment randomization to the onset of lung cancer symptoms—by more than 14 months compared to osimertinib (43.6 months vs. 29.3 months).
The MARIPOSA study&nbsp;<a target="_blank" href="https://c212.net/c/link/?t=0&amp;l=en&amp;o=4389728-1&amp;h=3239710368&amp;u=https%3A%2F%2Fwww.jnj.com%2Fmedia-center%2Fpress-releases%2Flandmark-phase-3-mariposa-study-shows-rybrevant-amivantamab-vmjw-plus-lazertinib-resulted-in-30-percent-reduction-in-risk-of-disease-progression-or-death-compared-to-osimertinib-in-patients-with-egfr-mutated-non-small-cell-lung-cancer&amp;a=met+its+primary+endpoint" rel="noreferrer noopener">met its primary endpoint</a> in October 2023, showing a statistically significant and clinically meaningful improvement in PFS compared to osimertinib.&nbsp;
Rybrevant plus Lazcluze is approved in&nbsp;the United States,&nbsp;Europe&nbsp;, and other markets worldwide for patients with first-line&nbsp;EGFR-mutated NSCLC.
Price Action: JNJ stock is up 0.58% at $161.96 at the last check Wednesday.
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J&J Drug Combo Outperforms Leading Lung Cancer Treatment In Survival Study

In LAURA Phase III trial, TAGRISSO continues to demonstrate improved overall survival trend in unresectable, Stage III setting
SAVANNAH and ORCHARD Phase II trials show the addition of savolitinib or datopotamab deruxtecan-dlnk to TAGRISSO upon disease progression demonstrates strong clinical activity LAURA Phase III trial of TAGRISSO in unresectable, Stage III EGFRm NSCLC after chemoradiotherapy (CRT) (LBA4).
<ul>
<li>SAVANNAH Phase II trial of TAGRISSO plus savolitinib in advanced EGFRm NSCLC with high levels of MET overexpression and/or amplification following disease progression on 1st-line TAGRISSO (#2O).</li>
<li>ORCHARD Phase II platform trial of TAGRISSO plus datopotamab deruxtecan-dlnk in advanced EGFRm NSCLC following disease progression on 1st-line TAGRISSO (#1O).</li>
<li>FLAURA2 Phase III trial of TAGRISSO plus chemotherapy as 1st-line treatment for advanced EGFRm NSCLC (#53P).</li>
</ul>

Reported Earlier, AstraZeneca's TAGRISSO Data from LAURA, SAVANNAH, And ORCHARD Trials Highlight Continued Survival Gains And Expanded Role in EGFR+ Lung Cancer

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

Syneron Bio, a cutting-edge oral macrocyclic peptide drug biotech company, announced today a strategic collaboration with the global biopharmaceutical leader&nbsp;AstraZeneca&nbsp;to develop potential first-in-class macrocyclic peptides for the treatment of chronic diseases.&nbsp;Under this collaboration,&nbsp;AstraZeneca will gain access to&nbsp;Syneron Bio's innovative Synova&#x2122; platform, an intelligent&nbsp;and high-throughput macrocyclic peptide drug research and development platform, designed to support the advancements of research programmes exploring possible future treatments of chronic diseases,&nbsp;including rare, autoimmune,&nbsp;and metabolic disease.
Under the terms of the agreements, AstraZeneca will provide upfront payments and potential near-term milestone payments totaling $75 million and up to $3.4 billion in additional development and commercial milestones. In addition, tiered royalties will be paid based on global sales. AstraZeneca will also make an equity investment .&nbsp;As a result of this collaboration, Syneron Bio plans to expand its Beijing R&amp;D center.

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Syneron Bio Announces Strategic Collaboration With AstraZeneca To Develop Potential First-In-Class Macrocyclic Peptides For The Treatment Of Chronic Diseases; AstraZeneca Will Provide Upfront Payments And Potential Near-Term Milestone Payments Totaling $75M And Up To $3.4B In Additional Development And Commercial Milestones

AstraZeneca Announced Global Collaboration With Harbour BioMed To Develop Next-Gen Therapeutic Antibodies, Including $105M Equity Investment, $175M Upfront, Up To $4.4B In Milestones, And Acquisition Of 9.15% Newly Issued Shares Of Harbour BioMed

AstraZeneca today announced an investment of $2.5 billion in Beijing to establish its sixth global strategic R&amp;D centre together with major research and manufacturing agreements that will further advance life sciences in China. This investment over the next five years is part of a strategic partnership with the Beijing Municipal Government and the Beijing Economic-Technological Development Area Administrative Office and includes agreements with three biotechs; Harbour BioMed, Syneron Bio, and BioKangtai, and follows the recent Fibrogen announcement. AstraZeneca expects its Beijing workforce to grow to 1,700 employees.

AstraZeneca Announced $2.5B Investment In Beijing To Establish Sixth Global R&D Centre, Sign Major Research And Manufacturing Agreements To Advance Life Sciences In China

<figure class="wp-block-image size-full is-resized"><img loading="lazy" decoding="async" width="900" height="600" src="https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW.png" alt="" class="wp-image-8354" style="width:920px;height:auto" srcset="https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW.png 900w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW-300x200.png 300w,https://contributor-assets.benzinga.com/wp-content/uploads/2025/03/20063705/TYKW-768x512.png 768w" sizes="(max-width: 900px) 100vw, 900px" /></figure>
The medicines company released scanty but promising results for an experimental drug just as its shares were joining the Hong Kong Stock Connect scheme
<h4 class="wp-block-heading">Key Takeaways:</h4>
<ul>
<li>The drug being developed by TYK Medicines targets lung cancer that has spread to the brain, where market competition is already fierce</li>
<li>The market leader in lung cancer drugs, AstraZeneca, declined to comment without seeing more detailed clinical data about the Chinese product</li>
</ul>
A victory in head-to-head clinical trials has the power to shake up the pharmaceutical industry, where companies are competing to deliver the next game-changing drug.
Which is why China's&nbsp;TYK Medicines Inc.&nbsp;(2410.HK) grabbed the sector spotlight this month when it announced that a drug under development had outperformed the world's leading lung cancer treatment in early trials. Investors wondered if they were witnessing the arrival of a new disruptor in the market for cancer therapies.
But the news left many questions still to be answered.
TYK released a short&nbsp;<a href="https://www1.hkexnews.hk/listedco/listconews/sehk/2025/0309/2025030900033.pdf">statement</a>&nbsp;on March 9 saying that its candidate drug TY-9591 had, by one measure, demonstrated greater effectiveness against brain metastases from a type of lung cancer than the best-in-class treatment, osimertinib, developed by the pharma giant&nbsp;AstraZeneca&nbsp;(AZN.US).
However, it was worth reading the fine print about the comparison between the two drugs. The evaluation was made using a limited sample in a Phase Two trial and focused on a specific metric for effects on the brain. On that basis, the drug achieved "notably improved statistical and clinical significance over osimertinib", TYK said.
In a head-to-head trial, a new drug is tested under standardized trial conditions against a proven benchmark treatment. TYK's experimental drug is a tyrosine kinase inhibitor targeting cancers with a genetic mutation known as EGFR. The TYK version deviates from the osimertinib formula by replacing hydrogen atoms with deuterium, with the aim of allowing larger doses to be dispensed safely. The company said that it planned to file a new drug application for its product with Chinese regulators in due course.
EGFR, which stands for epidermal growth factor receptor, is a common mutation seen in lung cancer patients and is therefore a frequent therapy target. AstraZeneca's drug is a third-generation inhibitor in this field, used to treat the most common type of cancer affecting the lungs, non-small cell lung cancer. Osimertinib sales rose16% to $6.58 billion in 2024, confirming the drug's status as the leading weapon against lung cancer.
Investors were excited about a potential challenger. Shares in the Chinese drug developer surged as much as 50% on the first trading day after the announcement, before closing with a gain of 16.18%. Interestingly, TYK shares made their debut that same day in the Hong Kong Stock Connect system, which allows mainland Chinese investors to participate in the market. Trading turnover spiked to 3.39 million shares after languishing at a daily average of 200,000, but the euphoria quickly cooled. The price corrected over three days, falling more than 21% to sink below the pre-announcement level.
What could explain the volatility over four trading days?
<h4 class="wp-block-heading">Clinical findings under scrutiny</h4>
In its statement to the Hong Kong Stock Exchange about the trial results, the company did not reveal detailed data, saying that more comprehensive information would be shared at clinical conferences in China or overseas. Asked for its response, AstraZeneca said it could not comment on the limited data available so far.
The methodology also deserves a closer look. The industry-standard endpoints, or targeted outcomes, in cancer drug trials are overall survival, progression-free survival or disease-free survival. In this case, TYK chose to focus on the intracranial objective response rate, or iORR, which tracks lesions in the brain. Moreover, the study was small in scope with 244 test subjects, leaving a question mark over whether the drug can continue to outperform when it moves into a much larger Phase Three trial.
The competitive picture should also be factored in. Other drugs have beaten TY-9591 to market for treating secondary brain cancer that originated in the lungs. &nbsp;Zorifertinib, jointly developed by Jiangsu Chentai Pharmaceutical Technology and AstraZeneca, launched last November as the world's first EGFR-TKI product specifically aimed at brain tumors triggered by lung cancer.
Novel drug developer TYK was founded in 2017 and went public in Hong Kong in August last year. The IPO prospectus showed that, aside from TY-9591, its 10 other candidate drugs are all at the pre-clinical research stage. With no products yet to sell, the company is far from the breakeven point. It made annual losses of 312 million yuan ($43 million) in 2022 and 383 million yuan the following year, before landing 108 million yuan in the red in the first quarter of 2024. Its pre-IPO financial profile raised other concerns, with net debt of 934 million yuan at the end of last March and a cash reserve of 77.21 million yuan.
The EGFR-TKI marketplace includes at least six products, with more advanced drugs lining up in the Phase Three stage of clinical testing. &nbsp;Companies such as&nbsp;Betta Pharmaceuticals&nbsp;(300558.SZ),&nbsp;Chia Tai Tianqing Pharmaceutical,&nbsp;Shanghai Junshi Biosciences&nbsp;(1877.HK) and&nbsp;Qilu Pharmaceutical&nbsp;have all launched clinical trials for the latest iterations in this product category.
With fierce competition in a fast-evolving market for specialist drugs, it remains to be seen whether TYK Medicines can deliver a standout product.

Equities

A Potential Challenger For AstraZeneca's Blockbuster Lung Cancer Drug?

On Monday, AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) released high-level results from the CALYPSO Phase 3 trial designed to evaluate the efficacy and safety of eneboparatide in adults with chronic hypoparathyroidism.
The study showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) receptor 1 agonist, met its primary endpoint with statistical significance at 24 weeks in adults with chronic hypoparathyroidism (HypoPT) compared to placebo.
The primary <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/eneboparatide-phase-iii-trial-met-primary-endpoint.html" rel="noreferrer noopener">endpoint</a> is a composite of normalization of albumin-adjusted serum calcium levels and independence from active vitamin D and oral calcium therapy.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44188407/astrazenecas-imfinzi-based-regimen-shows-improved-event-free-survival-in-early-stage-gastric-cancer-patients" rel="noreferrer noopener">AstraZeneca&#8217;s Imfinzi-Based Regimen Shows Improved Event-Free Survival In Early-Stage Gastric Cancer Patients</a>
HypoPT is a rare endocrine disease caused by a deficiency of PTH and is characterized by impaired regulation of calcium and phosphate levels in the blood. Eneboparatide was well tolerated.
After the 24-week randomized treatment period, all patients receive eneboparatide in the ongoing long-term extension until 52 weeks. Full efficacy and safety data will be analyzed at 52 weeks.
Concurrently, AstraZeneca and Alteogen <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-enters-license-agreement-with-alteogen-for-subcutaneous-formulations-of-multiple-oncology-assets.html" rel="noreferrer noopener">entered</a> into an exclusive license agreement for ALT-B4, a hyaluronidase utilizing Hybrozyme platform technology.
Under the terms of the agreement, AstraZeneca will acquire worldwide rights to use ALT-B4 to develop and commercialize subcutaneous formulations of several oncology assets.
Alteogen will be responsible for the clinical and commercial supply of ALT-B4 to AstraZeneca.
AstraZeneca will pay Alteogen an upfront payment and additional payments upon achieving specific development, regulatory, and sales-related milestones. Additionally, Alteogen will receive royalties on the sales of the commercialized products.
On Monday, the European Union approved AstraZeneca&#8217;s Imfinzi (durvalumab)&nbsp;as monotherapy for adults with limited-stage small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-approved-in-eu-for-limited-stage-sclc.html" rel="noreferrer noopener">approval</a> is based on results from the&nbsp;ADRIATIC&nbsp;Phase 3 trial.
The trial showed&nbsp;that Imfinzi&nbsp;reduced the risk of death by 27% compared to placebo.
The estimated median overall survival was 55.9 months for&nbsp;Imfinzi&nbsp;versus 33.4 months for placebo. An estimated 57% of patients treated with&nbsp;Imfinzi&nbsp;were alive at three years compared to 48% for placebo.
Imfinzi&nbsp;also reduced the risk of disease progression or death by 24% versus placebo.
The median progression-free survival (PFS) was 16.6 months for&nbsp;Imfinzi&nbsp;versus 9.2 months for placebo. An estimated 46% of patients treated with&nbsp;Imfinzi&nbsp;had not experienced disease progression at two years compared to 34% for placebo.
Earlier on Monday, AstraZeneca agreed to acquire cell therapy focused-EsoBiotec SA for <a target="_blank" href="https://www.benzinga.com/markets/equities/25/03/44352234/astrazeneca-seals-deal-for-esobiotec-to-advance-cell-therapy-details" rel="noreferrer noopener">up to $1 billion</a>.
Price Action: At the last check on Monday, AZN stock was down 1.04% to $76.78 during the premarket session.
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</ul>
Image by Robert Way via Shutterstock

Eventful Monday For AstraZeneca - What's Going On?

EsoBiotec SA, a biotechnology company specializing in in vivo cell therapies, has announced a <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44350232/esobiotec-to-be-acquired-by-astrazeneca-to-advance-cell-therapy-ambition" rel="noreferrer noopener">definitive agreement to be acquired</a> by AstraZeneca PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NYSE">AZN</a>).
The agreement represents a major step forward for EsoBiotec, which has demonstrated encouraging early clinical results with its Engineered NanoBody Lentiviral (ENaBL) platform.
AstraZeneca is acquiring all of EsoBiotec&#8217;s outstanding equity for a total of up to $1 billion. The deal includes an initial $425 million payment at closing, with up to an additional $575 million in contingent consideration based on development and regulatory milestones.
The transaction is expected to be finalized in the second quarter of 2025. EsoBiotec will continue operations in Belgium as a wholly owned subsidiary of AstraZeneca.
&#8220;We believe it has the potential to transform cell therapy and will enable us to scale these innovative treatments so that many more patients around the world can access them. EsoBiotec will accelerate and expand the impact of our recent investments and marks a major step forward in realising our ambition to harness the full potential of cell therapy,&#8221; said AstraZeneca Executive Vice President, Oncology Haematology R&amp;D, Susan Galbraith.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44313315/perspective-therapeutics-cancer-focused-radiotherapy-portfolio-has-upside-potentional-says-analyst" rel="noreferrer noopener">Perspective Therapeutics&#8217; Cancer-Focused Radiotherapy Portfolio Has Upside Potentional, Says Analyst</a>
EsoBiotec&#8217;s&nbsp;ENaBL platform utilizes highly targeted lentiviruses to deliver genetic instructions directly to immune cells like T cells. The technology programs these cells to recognize and destroy cancerous cells or autoreactive cells related to immune-mediated diseases.
In contrast to conventional treatments that require extracting cells from patients, modifying them externally, and enduring prolonged manufacturing periods, ENaBL works by enhancing the immune system within the patient&#8217;s body itself, by administering therapies through a simple intravenous (IV) injection.
AstraZeneca held $5.6 billion in <a target="_blank" href="https://www.sec.gov/Archives/edgar/data/901832/000165495425001189/a1107w.htm" rel="noreferrer noopener">cash </a>and equivalents as of December 31.
Price Action: AZN shares traded lower by 0.66% at $77.08 in premarket at last check Monday.
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<li><a href="https://www.benzinga.com/25/03/44276870/ionis-pharmaceuticals-partners-with-japan-based-ono-pharmaceutical-for-rare-blood-disease-drug-in-over-800-million-deal" target="_blank" rel="noreferrer noopener">Ionis Pharmaceuticals Partners With Japan-Based Ono Pharmaceutical For Rare Blood Disease Drug In Over $800 Million Deal</a></li>
</ul>
Photo via Shutterstock.

AstraZeneca Seals Deal For EsoBiotec To Advance Cell Therapy: Details

Eneboparatide was well tolerated. After the 24-week randomized treatment period, all patients receive eneboparatide in the ongoing long-term extension period until 52 weeks. Full efficacy and safety data will be analyzed at 52 weeks. Alexion plans to share these data with global health authorities and present them at forthcoming medical meetings.
 &nbsp;

The European Union Has Approved AstraZeneca's Imfinzi (Durvalumab) As Monotherapy For Limited-stage Small Cell Lung Cancer Whose Disease Has Not Progressed Following Platinum-based Chemoradiation Therapy

The primary endpoint is a composite of normalization of albumin-adjusted serum calcium levels and independence from active vitamin D and oral calcium therapy.
Eneboparatide was well tolerated. After the 24-week randomised treatment period, all patients receive eneboparatide in the ongoing long-term extension period until 52 weeks. Full efficacy and safety data will be analysed at 52 weeks. Alexion plans to share these data with global health authorities and present them at forthcoming medical meetings.
 &nbsp;

AstraZeneca Released High-level Results From CALYPSO Phase 3 Trial Showing That Eneboparatide (AZP-3601) Met Its Primary Endpoint With Statistical Significance In Adults With Chronic Hypoparathyroidism At 24 Weeks, Compared To Placebo

Alteogen Will Be Responsible For Clinical And Commercial Supply Of ALT-B4 To AstraZeneca
AstraZeneca will make an upfront payment to Alteogen and additional payments upon achievement of specific development, regulatory and sales-related milestones. Additionally, Alteogen will receive royalties on the sales of the commercialised products.
The transaction does not impact AstraZeneca's financial guidance for 2025. &nbsp;

AstraZeneca And Alteogen Have Entered Into An Exclusive License Agreement, AstraZeneca Will Acquire Worldwide Rights To Use ALT-B4 To Develop And Commercialize Subcutaneous Formulations Of Several Oncology Assets

EsoBiotec will become a wholly owned subsidiary of AstraZeneca, with operations in Belgium.
AstraZeneca will acquire all outstanding equity of EsoBiotec for a total consideration of up to $1,000m, on a cash and debt free basis. This will include an initial payment of $425m on deal closing, and up to $575m in contingent consideration based on development and regulatory milestones.
The transaction is expected to close in the second quarter of 2025, subject to customary closing conditions and regulatory clearances.

AstraZeneca To Acquire EsoBiotec For Up To $1B, Advancing In Vivo Cell Therapy Capabilities With Breakthrough ENaBL Platform

H.C. Wainwright &amp; Co. initiated coverage on Thursday for Perspective Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CATX#NASDAQ">CATX</a>), a clinical-stage biotechnology company advancing &#8220;targeted radiotherapy agents&#8221; for cancer treatment.
Analyst Robert Burns initiated a Buy rating and a <a href="https://www.benzinga.com/quote/CATX/analyst-ratings" target="_blank" rel="noreferrer noopener">price target of $10</a>.
The company&#8217;s pipeline comprises:
<ul>
<li>VMT01/02 for melanoma, which is being studied as both monotherapy and in combination with Opdivo (nivolumab).</li>
<li>VMT-α-NET for various neuroendocrine cancers and other SSTR2-expressing tumors.</li>
<li>PSV359 for multiple solid tumor types.</li>
<li>PSV40X for prostate cancer.</li>
</ul>
The company&#8217;s melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for metastatic melanoma and neuroendocrine tumors.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/10/41634528/positive-outlook-for-novartis-as-company-capitalizes-on-growing-treatment-opportuni" rel="noreferrer noopener">Positive Outlook For Novartis As Company Capitalizes On Growing Treatment Opportunities, Analyst Highlights</a>
In January, Perspective Therapeutics&nbsp;revealed updated interim results from its ongoing Phase 1/2a trial of&nbsp;[212Pb]VMT-α-NET. Anti-tumor activities have been observed&nbsp;with a longer follow-up. As of the data cut-off date of Jan. 10, 2025, there were two unconfirmed responses and one confirmed response, <a href="https://www.benzinga.com/general/biotech/25/01/43197970/perspective-therapeutics-touts-encouraging-updated-data-from-gastrointestinal-cancer-trial-stock-soars" target="_blank" rel="noreferrer noopener">as in Cohort 2</a>.
H.C. Wainwright &amp; Co. writes that from a safety perspective, 212Pb-VMT-α-NET appears to be relatively benign at the dose levels tested thus far.
The analyst writes that PSV359 and VMT01/02 constitute upside potential. Burns also notes that in preclinical experiments, VMT01/02 demonstrated high response rates in multiple tested models and &gt;70% complete and durable response when combined with PD1 immunotherapy in a model highly resistant to checkpoint inhibitors
Perspective Therapeutics disclosed initial preclinical results for its FAPtargeted asset, PSV359 and views the preclinical anti-tumor efficacy as encouraging. The analyst also writes it is difficult to benchmark it against 177LuFAP-2286 and PNT6555 because these experiments were performed in a completely different mouse model.
&#8220;Additionally, when we think about potential targets for targeted radioligand therapy (TRT), we believe that most of the targets being pursued by ADCs and/or cell therapy are viable targets for TRT. As such, we view the targeted radioligand space as analogous to where the ADC space was a few years ago,&#8221; Burns writes.
Here are some M&amp;A in the radiopharmaceutical therapeutics&nbsp;space:
<ul>
<li>In 2023, Bristol Myers Squibb &amp; Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) acquired&nbsp;RayzeBio&nbsp;for $62.50 per share in cash, for a total equity value of approximately $4.1 billion, or $3.6 billion net of&nbsp;<a href="https://www.benzinga.com/general/biotech/23/12/36382899/bristol-myers-squibb-takes-on-novartis-eli-lilly-with-rayzebio-4b-deal-in-radiopharmaceuticals" target="_blank" rel="noreferrer noopener">estimated cash acquired</a>.&nbsp;</li>
<li>In 2023, Eli Lilly And Co&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) acquired&nbsp;POINT Biopharma Global for $12.50 per share in cash, an aggregate of&nbsp;<a href="https://www.benzinga.com/general/biotech/23/10/35060421/why-is-cancer-treatment-focused-point-biopharma-stock-trading-higher-today" target="_blank" rel="noreferrer noopener">approximately $1.4 billion</a>.</li>
<li>In 2024, AstraZeneca Plc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) acquired&nbsp;Fusion Pharmaceuticals for $21 per share in cash plus a non-transferable contingent value right of $3 per share in cash payable upon the achievement of a&nbsp;<a href="https://www.benzinga.com/general/biotech/24/03/37818128/astrazenecas-2-4b-fusion-pharmaceuticals-acquisition-signals-shift-in-efforts-from-traditional-re" target="_blank" rel="noreferrer noopener">specified regulatory milestone</a>.</li>
</ul>
CATX Price Action: Perspective Therapeutics stock is down 0.75% at $2.64 at publication Thursday.
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Photo: S_fam photo via Shutterstock

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Initiation

Analyst Ratings

CATX

Perspective Therapeutics' Cancer-Focused Radiotherapy Portfolio Has Upside Potentional, Says Analyst

On Thursday, Vivani Medical, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VANI#NASDAQ">VANI</a>) announced the administration of its first GLP-1 (exenatide, NPM-115) implant in the LIBERATE-1 <a target="_blank" href="https://www.benzinga.com/topic/weight-loss" rel="noreferrer noopener">trial in Australia</a>.
Vivani's lead program, NPM-115, utilizes a miniature, six-month, subdermal, GLP-1 (exenatide) implant under development for chronic weight management in obese or overweight individuals.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/03/44273204/exclusive-vivani-medical-to-spin-off-cortigent-neurostimulation-business-to-create-better-focus-on-individual-entities-and-shareholder-value" rel="noreferrer noopener">EXCLUSIVE: Vivani Medical To Spin Off Cortigent Neurostimulation Business To Create Better Focus On Individual Entities And Shareholder Value</a>
The company also announced full enrollment in the LIBERATE-1 study, which was achieved four weeks after the first subject enrolled, and reaffirmed that top-line results should be available in mid-2025.
In December, Vivani Medical initiated screening and enrollment at two centers in Australia for the first-in-<a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42576062/exclusive-vivani-medical-initiates-first-human-clinical-trial-with-glp-1-implant-for-weight-loss-in-australia" rel="noreferrer noopener">human LIBERATE-1 trial</a>.
The LIBERATE-1 study is exploring the full pharmacokinetic profile of NPM-115, which has demonstrated consistently smooth and minimally fluctuating drug release in vitro and in animal models.
LIBERATE-1 is a Phase 1, first-in-human study of a miniature, ultra-long-acting GLP-1 (exenatide) implant to investigate the safety, tolerability, and full pharmacokinetic profile in obese or overweight subjects.
The trial will enroll participants who are intended to be titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani's exenatide implant (NPM-115, n=8), weekly exenatide injections (Bydureon BCise, n=8), or weekly 1 mg semaglutide injections (Wegovy, n=8) for 9-week treatment duration.
Vivani also expects these results to support the potential application of a GLP-1 (exenatide) implant for type 2 diabetes and other diseases for which GLP-1 treatment has demonstrated or will demonstrate clinical benefit.
AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Bydureon BCise (exenatide 2 mg prolonged-release suspension for injection) is indicated for type-2 diabetes.
Novo Nordisk A/S' (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) semaglutide is approved as Ozempic and Wegovy for diabetes and weight loss, respectively.
Price Action: VANI stock is down 2.74% at $1.01 during the premarket session at the last check Thursday.
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Market-Moving Exclusives

Exclusives

VANI

EXCLUSIVE: Vivani Medical Announces First Implant In Early-Stage Human Study Of GLP-1 Implant For Obesity

On Tuesday, Ionis Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IONS#NASDAQ">IONS</a>)&nbsp;and Ono Pharmaceutical Co., Ltd entered into a license agreement in which Ono obtains exclusive global rights for the development and commercialization of sapablursen, an investigational RNA-targeted <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/b44265240/ionis-and-ono-announce-global-license-agreement-for-sapablursen-in-polycythemia-vera" rel="noreferrer noopener">medicine for polycythemia vera (PV)</a>.
PV is a rare hematologic disease characterized by the overproduction of red blood cells, significantly increasing the risk of serious blood clots, especially in critical organs like the <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">lungs, heart and brain</a>.
Sapablursen is currently being evaluated in adults living with PV in the fully enrolled Phase 2 IMPRSSION study.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/02/43818962/ionis-pharmaceuticals-says-2024-revenue-exceeds-guidance-on-sales-from-diverse-sources-forecasts-over-600-million-in-2025-sales" rel="noreferrer noopener">Ionis Pharmaceuticals Q4 Revenue Growth Exceeds Guidance, Forecasts Over $600 Million In 2025 Sales</a>
Sapablursen received FDA Fast Track designation and orphan drug designation in 2024.
Under the agreement, Ionis will receive a $280 million upfront payment, potentially earning up to $660 million in additional payments based on the achievement of development, regulatory, and sales milestones.
Ionis is also eligible to earn royalties in the mid-teen percentage range on annual net sales of sapablursen.
Ionis will be responsible for completing the ongoing Phase 2 IMPRSSION study, while Ono will be solely responsible for subsequent development, regulatory filings, and commercialization.
&#8220;Ionis remains committed to advancing the wholly owned medicines we choose to commercialize ourselves, which includes our first independent launch currently underway and three additional anticipated launches in the next three years. Streamlining our Ionis-owned portfolio provides financial flexibility, supporting our commitment to invest in and focus on our near and mid-term commercial opportunities and generate substantial revenue growth,&#8221; said Brett P. Monia, Ph.D., CEO of Ionis.
Earlier this week, the European Union approved Ionis Pharmaceutical and AstraZeneca plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Wainzua (eplontersen) for hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, commonly referred to as <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/b44215431/wainzua-eplontersen-approved-in-the-eu-for-the-treatment-of-hereditary-transthyretin-mediated-amyl" rel="noreferrer noopener">hATTR-PN or ATTRv-PN</a>.
Price Action: At the last check on Wednesday, IONS stock was up 1.24% at $33.54.
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</ul>

IONS

Ionis Pharmaceuticals Partners With Japan-Based Ono Pharmaceutical For Rare Blood Disease Drug In Over $800 Million Deal

Press Releases

IMFINZI® (durvalumab)-based regimen demonstrated statistically significant and clinically meaningful improvement in event-free survival in resectable early-stage gastric and gastroesophageal junction cancers

AstraZeneca and Erin Andrews team up to inspire fans to Get Body Checked Against Cancer

EsoBiotec to Be Acquired by AstraZeneca to Advance Cell Therapy Ambition

IgniteData launches cutting edge data integration platform for clinical trials at Cambridge University Hospitals

New study results reinforce TAGRISSO® (osimertinib) as the backbone therapy for EGFR-mutated lung cancer across stages and settings

Lunit to Present AI Study on EGFR Mutation Prediction in NSCLC at AACR 2025 in Collaboration with AstraZeneca

Global Radiotherapy Market Expected to Reach $9.62 Billion By 2030 Realizing Growth Due to Technological Advancements

IMFINZI® (durvalumab) approved in the US as first and only perioperative immunotherapy for patients with muscle-invasive bladder cancer

DESTINY-Gastric05 Phase 3 Trial of ENHERTU® Initiated in Patients with Previously Untreated HER2 Positive Advanced Gastric Cancer

​​AZD0780, a novel oral PCSK9 inhibitor, demonstrated significant LDL cholesterol (LDL-C) reduction in PURSUIT Phase IIb trial

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Nestle Sponsored representing Registered Shares Series B

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How Cosmos Health&#39;s Acquisition Of Almost 100-Year-Old Company, Adding To Capabilities Like Contract Manufacturing, Could Generate Over $10 Million In Annual Gross Profit

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