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Dynavax

11.37

-0.0750-0.66%

Volume:33.84K

Turnover:385.79K

Market Cap:1.41B

PE:56.83

High:11.46

Open:11.38

Low:11.36

Close:11.44

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Overview Company News Filings

PHIO Stock Soars as Safety Panel Clears Skin Cancer Drug for Next Dose

PCRX Stock Soars on Exparel Patent Settlement With Generic Players

RYTM Stock Rises 17% on Meeting Goals in Hypothalamic Obesity Study

Dynavax Technologies (NASDAQ:DVAX) pulls back 3.7% this week, but still delivers shareholders massive 32% CAGR over 5 years

Simply Wall St.

AZN Gets EU Nod for Expanded Use of Two Separate Cancer Drugs

AMGN's Uplizna Gets FDA Nod for 2nd Rare Autoimmune Disease Indication

Dynavax Files Preliminary Proxy Statement

SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare Diseases

DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up

VRTX Provides Mixed Updates for Type 1 Diabetes Pipeline Candidates

AstraZeneca's Imfinzi Gets FDA Nod for Bladder Cancer Indication

Kodiak Q4 Loss Narrower Than Expected, Pipeline Development in Focus

BEAM's IND for BEAM-302 in Genetic Disorder Study Gets FDA Clearance

UBX Stock Down 29% on Mixed Results From Phase II Eye Disease Study

Alnylam Gets FDA Nod for Expanded Use of Amvuttra in Cardiomyopathy

OPTN Stock Soars 53% on Inking $330M Deal to be Acquired by Paratek

Why Dynavax Technologies (DVAX) Stock Might be a Great Pick

IMVT Unlikely to Pursue Batoclimab for MG & CIDP Despite Success

Novartis Reports Updated Positive Data From Phase III SMA Program

JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease

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The phase Ib dose escalation study is evaluating the safety and tolerability of neoadjuvant use of intratumoral PH-762 for cutaneous squamous cell carcinoma, melanoma or Merkel cell carcinoma.The SMC’s decision allowing escalation to the next dose concentration was based on the favorable safety profile of the drug observed in the third cohort of the phase Ib study, which enrolled three patients with cutaneous squamous cell carcinoma. In these patients, injections were well tolerated, with no serious adverse events or dose-limiting toxicities. Pathology results a","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/phio-stock-soars-safety-panel-145300505.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["PHIO","ADMA","BK4144","BAYRY","BK4007","BK4139","DVAX","SMC"],"gpt_icon":0},{"id":"2526846907","title":"PCRX Stock Soars on Exparel Patent Settlement With Generic Players","url":"https://stock-news.laohu8.com/highlight/detail?id=2526846907","media":"Zacks","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526846907?lang=en_us&edition=fundamental","pubTime":"2025-04-08 23:29","pubTimestamp":1744126140,"startTime":"0","endTime":"0","summary":"Shares of Pacira BioSciences PCRX are rising today after the company announced that it has entered into a settlement agreement with Fresenius, Jiangsu Hengrui Pharmaceuticals and eVenus Pharmaceuticals Laboratories, related to patents for Exparel .Following the settlement, which resolves the patent litigation brought by Pacira BioSciences against the companies, Consent Judgments will be filed in multiple courts, preventing Fresenius, like the others, from marketing generic bupivacaine liposome injectable suspension before the relevant patents expire, except as outlined in the agreement.Exparel is PCRX’s flagship pain-management product,which was initially launched in 2012. The drug is indicated for postsurgical local analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.Year to date, shares of Pacira Bi","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/pcrx-stock-soars-exparel-patent-152900546.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"shareholding","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BAYRY","DVAX","BK4139","ADMA","BK4007","PCRX"],"gpt_icon":0},{"id":"2526846182","title":"RYTM Stock Rises 17% on Meeting Goals in Hypothalamic Obesity Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2526846182","media":"Zacks","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526846182?lang=en_us&edition=fundamental","pubTime":"2025-04-08 23:21","pubTimestamp":1744125660,"startTime":"0","endTime":"0","summary":"Shares of Rhythm Pharmaceuticals RYTM rallied 17.1% on Monday after the company announced that it has met the primary endpoint in a late-stage study of its candidate, setmelanotide, for treating acquired hypothalamic obesity.RYTM’s setmelanotide is an MC4R agonist.Per the data readout, the phase III TRANSCENDstudy met its primary endpoint with a statistically significant and clinically meaningful reduction in body mass index  with setmelanotide in adult and pediatric patients compared to placebo. It was observed that all patients with acquired hypothalamic obesity who underwent setmelanotide therapy experienced an average BMI reduction of 16.5% over 52 weeks, whereas those on placebo saw a 3.3% increase.Please note that setmelanotide is already approved as Imcivree in the United States and EU for chronic weight management in adult and pediatric patients aged two years and older with certain genetic conditions. The eligible patient population includes those with monogenic or syndromic o","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/rytm-stock-rises-17-meeting-152100157.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4139","BK4588","DVAX","ADMA","BK4585","BMI","BAYRY","BK4007","RYTM","BK4157"],"gpt_icon":0},{"id":"2526306821","title":"Dynavax Technologies (NASDAQ:DVAX) pulls back 3.7% this week, but still delivers shareholders massive 32% CAGR over 5 years","url":"https://stock-news.laohu8.com/highlight/detail?id=2526306821","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526306821?lang=en_us&edition=fundamental","pubTime":"2025-04-08 23:10","pubTimestamp":1744125013,"startTime":"0","endTime":"0","summary":"Dynavax Technologies Corporation ( NASDAQ:DVAX ) shareholders might be concerned after seeing the share price drop 13...","market":"hk","thumbnail":"https://images.simplywall.st/asset/industry/6111000-choice1-main-header/1585186710114","type":0,"news_type":0,"thumbnails":["https://images.simplywall.st/asset/industry/6111000-choice1-main-header/1585186710114"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-dvax/dynavax-technologies/news/dynavax-technologies-nasdaqdvax-pulls-back-37-this-week-but","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"simplywall_highlight","symbols":["BK4588","BK4112","NDAQ","QLD","USAW.SI","BK4585","MNQmain","IE00BGHQF748.EUR","IE00B64PRP62.GBP","TQQQ","BK4139","NQmain","TSYW.SI","USJW.SI","LU2210150020.SGD","QID","PSQ","IE00B3QW5Z07.USD","LU2210149790.SGD","SQQQ",".IXIC","DVAX","LU2095319765.USD","NVIW.SI","IE00BKPKM429.USD"],"gpt_icon":1},{"id":"2525602133","title":"AZN Gets EU Nod for Expanded Use of Two Separate Cancer Drugs","url":"https://stock-news.laohu8.com/highlight/detail?id=2525602133","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2525602133?lang=en_us&edition=fundamental","pubTime":"2025-04-07 22:53","pubTimestamp":1744037580,"startTime":"0","endTime":"0","summary":"AstraZeneca AZN and partner Daiichi Sankyo announced that the European Commission has approved the expanded use of Enhertu  in breast cancer.The regulatory body has now approved Enhertu as a monotherapy for treating metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting and are not considered suitable for the therapy as the next line of treatment in the European Union .The latest nod in the EU expands the approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow.Year to date, shares of AstraZeneca have risen 4.5% against the industry’s decrease of 5.8%.EU Nod for Enhertu Based on AZN's DESTINY-Breast06 Study Data. The approval in the EU was expected as the Committee for Medicinal Products for Human Use recommended approval of Enhertu for the given indication in ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/azn-gets-eu-nod-expanded-145300661.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU2462157665.USD","LU1829250122.USD","LU0889565916.HKD","LU0109394709.USD","BK4568","IE00BN0W2T93.GBP","DVAX","AZN","BK4532","BK4156","LU2456880835.USD","BK4585","KRYS","IE00BN0W2W23.USD","LU2236285917.USD","BK4533","IE00BN0W2V16.EUR","LU2417539215.USD","JAZZ","LU0823416689.USD","BK4139","BK4007","BK4588","LU0320765992.SGD"],"gpt_icon":0},{"id":"2525734293","title":"AMGN's Uplizna Gets FDA Nod for 2nd Rare Autoimmune Disease Indication","url":"https://stock-news.laohu8.com/highlight/detail?id=2525734293","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2525734293?lang=en_us&edition=fundamental","pubTime":"2025-04-05 01:10","pubTimestamp":1743786600,"startTime":"0","endTime":"0","summary":"Amgen AMGN announced that the FDA has approved its rare disease drug Uplizna  for a new indication. The regulatory body has now approved Uplizna for the treatment of adults living with immunoglobulin G4-related disease , a rare immune-mediated inflammatory condition. This marks the second approved indication for the drug.Uplizna is currently approved in the United States for treating adults with a rare autoimmune disease called neuromyelitis optica spectrum disorder.Following the nod, Uplizna became the first and only drug approved by the FDA for the treatment of IgG4-RD, a chronic disease with a significant unmet medical need.The FDA had previously granted a breakthrough therapy designation to Uplizna for the treatment of IgG4-RD.Year to date, shares of Amgen have rallied 18.9% compared with the industry’s rise of 1.2%.Uplizna's Nod for IgG4-RD Based on AMGN's MITIGATE Study. Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ, Dynavax Technologies Corp","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/amgns-uplizna-gets-fda-nod-171000251.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4532","IE00BN0W2T93.GBP","LU0058720904.USD","BK4139","IE00BJT1NW94.SGD","LU0823416689.USD","LU1023059063.AUD","LU1571399168.USD","LU1061106388.HKD","KRYS","LU0289739699.SGD","IE00BN0W2W23.USD","BK4581","LU2242646821.SGD","BK4007","LU0109394709.USD","BK4566","BK4534","BK4585","AMGN","IE00B4R5TH58.HKD","IE00BFTCPJ56.SGD","LU2242652126.USD","JAZZ","IE0009355771.USD","LU1057294990.SGD","LU0889565916.HKD","LU2089984988.USD","BK4599","LU0122379950.USD","IE00BN0W2V16.EUR","LU1983299246.USD","LU0868494617.USD","IE0002141913.USD","LU2112291526.USD","LU0320765992.SGD","SG9999001440.SGD","DVAX","LU2468319806.SGD","IE00B2B36J28.USD","BK4533","IE00BJJMRZ35.SGD","BK4588"],"gpt_icon":0},{"id":"2524214006","title":"Dynavax Files Preliminary Proxy Statement","url":"https://stock-news.laohu8.com/highlight/detail?id=2524214006","media":"PR Newswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524214006?lang=en_us&edition=fundamental","pubTime":"2025-04-04 05:40","pubTimestamp":1743716400,"startTime":"0","endTime":"0","summary":"Dynavax's Board is Overseeing Record Operational and Financial Performance. Outlines Extensive Engagement with Deep Track and Multiple Attempts to Reach a Resolution. As described in the preliminary proxy filing, Dynavax's strategy is working, and the Board and management team are best positioned to build on the Company's momentum. In addition to detailing the Board's extensive engagement with Deep Track to date, the Company announced that its Board has nominated a slate consisting of four independent directors – Brent MacGregor, Scott Myers, Lauren Silvernail and Elaine Sun – for reelection at the 2025 Annual Meeting.Dynavax has a proven track record of growth and value creation, driven by strategic investment and operational excellence that has delivered total stockholder returns of approximately 300% over the past five years, far exceeding the performance of the NASDAQ Biotechnology Index and the S&P Biotechnology Select Industry Index.Since 2020, with the assistance of a leading in","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/dynavax-files-preliminary-proxy-statement-214000793.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/dynavax-files-preliminary-proxy-statement-214000793.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4139","DVAX"],"gpt_icon":0},{"id":"2524296191","title":"SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare Diseases","url":"https://stock-news.laohu8.com/highlight/detail?id=2524296191","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524296191?lang=en_us&edition=fundamental","pubTime":"2025-04-03 23:27","pubTimestamp":1743694020,"startTime":"0","endTime":"0","summary":"Sanofi SNY announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for the treatment of warm autoimmune hemolytic anemia  and IgG4-related disease .The candidate is being developed in separate mid-stage studies for treating wAIHA and IgG4-RD, two rare diseases.Currently, there are no approved therapies for treating wAIHA and IgG4-RD. Both diseases have a significant unmet medical need.The FDA grants orphan drug designation to support the development of medicines for rare disorders that affect less than 200,000 patients in the United States.Sanofi has developed rilzabrutinib for treating immune thrombocytopenia , another rare, complex autoimmune disorder.A regulatory application seeking approval for rilzabrutinib for treating ITP is currently under review in the United States. A final decision from the FDA is expected on Aug. 29, 2025. The regulatory body has previously granted a fast-track designation and an orphan drug designatio","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/snys-rilzabrutinib-gets-fdas-orphan-152700727.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU0889565916.HKD","BK4585","BK4533","LU0109394709.USD","IE00BFXG1179.USD","BK4532","BK4139","DVAX","IE00BN0W2T93.GBP","BK4007","LU0320765992.SGD","SNY","KRYS","IE00BN0W2V16.EUR","LU0823416689.USD","IE00BN0W2W23.USD","BK4588","JAZZ"],"gpt_icon":0},{"id":"2524326247","title":"DNLI Begins Rolling BLA Submission for Hunter Syndrome Drug, Stock Up","url":"https://stock-news.laohu8.com/highlight/detail?id=2524326247","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524326247?lang=en_us&edition=fundamental","pubTime":"2025-04-03 21:32","pubTimestamp":1743687120,"startTime":"0","endTime":"0","summary":"Shares of Denali Therapeutics DNLI gained 11.8% on Wednesday after the company announced that it has initiated a rolling submission of a biologics license application  for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome . The same has also been received by the Center for Drug Evaluation and Research of the FDA.DNLI reported ongoing collaborative and productive engagement with CDER, aligning with the same on the content of the BLA data package, including the use of CSF HS as a surrogate endpoint for accelerated approval and the path to full approval.Denali expects to complete its BLA submission by mid-May 2025 and is preparing for a potential U.S. commercial launch in late 2025 or early 2026. Tividenofusp alfa, an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase  replacement therapy, enjoys the FDA’s Fast Track and Breakthrough Therapy designations in the United States for MPS II.In the EU, the candidate enjoys the Priority Medicines designation for ","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/dnli-begins-rolling-bla-submission-133200898.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BAYRY","BK4007","BK4139","BK4548","DNLI","BK4535","LU0566484027.USD","DVAX","BK4532","LU1559883803.SGD"],"gpt_icon":1},{"id":"2524449231","title":"VRTX Provides Mixed Updates for Type 1 Diabetes Pipeline Candidates","url":"https://stock-news.laohu8.com/highlight/detail?id=2524449231","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524449231?lang=en_us&edition=fundamental","pubTime":"2025-04-01 22:55","pubTimestamp":1743519300,"startTime":"0","endTime":"0","summary":"Vertex Pharmaceuticals Incorporated VRTX announced updates on its two novel investigational candidates, zimislecel  and VX-264, which are being developed in separate studies for the treatment of type 1 diabetes .Zimislecel is designed for the transplantation of islet cells alone, using immunosuppression to protect the implanted cells. The candidate is in pivotal late-stage development for treating patients with T1D with severe hypoglycemic events  and impaired awareness of hypoglycemia.Meanwhile, VX-264 is being developed following a unique approach that involves the implantation of the islet cells inside an immunoprotective device.Year to date, shares of Vertex have rallied 20.4% compared with the industry’s rise of 3.5%.In the past 60 days, estimates for Jazz Pharmaceuticals’ earnings per share have increased from $22.06 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.13 to $23.35. Year to date, shares of JAZZ have risen 0.8%.In","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/vrtx-provides-mixed-updates-type-145500721.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["IE00B19Z9Z06.USD","IE00BJJMRZ35.SGD","IE00B4R5TH58.HKD","BK4567","LU0566484027.USD","LU1815336091.USD","IE00BJT1NW94.SGD","LU0256863811.USD","LU2237438978.USD","IE00BN0W2W23.USD","BK4023","VERX","IE00B2B36J28.USD","BK4532","IE00BN0W2V16.EUR","BK4588","LU0320765992.SGD","LU1093756168.USD","IE00BN0W2T93.GBP","IE00BFTCPJ56.SGD","LU2362541273.HKD","LU0234570918.USD","KRYS","IE0002141913.USD","LU1430594728.SGD","LU2362540622.SGD","VRTX","LU0757428866.USD","LU1585245621.USD","LU2417539215.USD","BK4533","IE00B19Z3B42.SGD","IE0009355771.USD","LU2362541513.USD","JAZZ","LU2456880835.USD","LU0823416689.USD","DVAX","LU0058720904.USD","IE00B19Z9P08.USD","IE00BZ9MQY76.HKD","LU2462157665.USD","IE00B19Z3581.USD","LU1093756325.SGD","LU2324357040.USD","BK4007","LU1035775433.USD","LU0109394709.USD","LU1069344957.HKD","LU2236285917.USD"],"gpt_icon":0},{"id":"2524917146","title":"AstraZeneca's Imfinzi Gets FDA Nod for Bladder Cancer Indication","url":"https://stock-news.laohu8.com/highlight/detail?id=2524917146","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524917146?lang=en_us&edition=fundamental","pubTime":"2025-04-01 21:31","pubTimestamp":1743514260,"startTime":"0","endTime":"0","summary":"AstraZenecaAZN announced that the FDA has approved its blockbuster drug, Imfinzi, for a bladder cancer indication in the United States.Imfinzi is approved in combination with gemcitabine and cisplatin as a neoadjuvant treatment for muscle-invasive bladder cancer , a type of bladder cancer that has spread into the muscle wall of the bladder. The regulatory filing for the drug was reviewed under the FDA’s Priority Review Pathway. This marks the first approval for Imfinzi for a bladder cancer indication.AstraZeneca’s Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III non-small cell lung cancer, extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries. The drug has also recently been approved for limited-stage small cell lung cancer in the United States and","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/astrazenecas-imfinzi-gets-fda-nod-133100339.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CHMP","BK4087","LU0889565916.HKD","BK4007","BK4585","LU0320765992.SGD","BK4588","AZN","LU0566484027.USD","BK4139","BK4532","BK4568","LU2236285917.USD","LU0109394709.USD","LU2462157665.USD","CORT","LU2417539215.USD","BAYRY","DVAX","LU1829250122.USD","LU2456880835.USD","LU1559883803.SGD"],"gpt_icon":0},{"id":"2523075615","title":"Kodiak Q4 Loss Narrower Than Expected, Pipeline Development in Focus","url":"https://stock-news.laohu8.com/highlight/detail?id=2523075615","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2523075615?lang=en_us&edition=fundamental","pubTime":"2025-03-28 21:45","pubTimestamp":1743169500,"startTime":"0","endTime":"0","summary":"Kodiak SciencesKOD reported a loss of 84 cents per share in the fourth quarter of 2024, narrower than the Zacks Consensus Estimate of a loss of 90 cents. The company had incurred a loss of $1.13 per share in the year-ago quarter.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.The company currently does not have any approved products in its portfolio. As a result, it has yet to generate revenues.Research and development expenses were $31.8 million in the reported quarter, down 32% year over year. The decrease was mainly due to reduced manufacturing activities and forfeitures of equity awards, partially offset by clinical activities from active studies.General and administrative expenses were $14.4 million, down 14% year over year, primarily due to lower non-cash stock-based compensation expenses.Kodiak is also enrolling patients in the phase Ib APEX study, which will evaluate its third investigational candidate, KSI-101, in two new cohorts — cohort 1 in patients w","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/kodiak-q4-loss-narrower-expected-134500496.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4532","LU1951198990.SGD","LU1880398471.USD","LU1559883803.SGD","LU2360106780.USD","BK4139","BK4512","LU2250418816.HKD","LU0823434740.USD","KOD","BAYRY","LU0127658192.USD","BK4573","LU0823434583.USD","LU1989764664.SGD","BK4141","IE00BMPRXR70.SGD","IE0009356076.USD","BK4007","LU2054465674.USD","LU0823421416.USD","LU0823421333.USD","LU1803068979.SGD","BK4505","BK4534","BK4585","LU1951200564.SGD","BK4554","LU1988902786.USD","LU0081259029.USD","LU0642271901.SGD","BK4529","LU2458330243.SGD","LU1880398554.USD","LU1852331112.SGD","LU0082616367.USD","LU2458330169.SGD","LU0979878070.USD","CORT","LU1303367103.USD","IE00B5949003.HKD","BK4543","LU1064131342.USD","IE0004445239.USD","LU2098885051.SGD","BK4605","DVAX","LU1242518857.USD","BK4588"],"gpt_icon":1},{"id":"2522843502","title":"BEAM's IND for BEAM-302 in Genetic Disorder Study Gets FDA Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2522843502","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522843502?lang=en_us&edition=fundamental","pubTime":"2025-03-28 21:26","pubTimestamp":1743168360,"startTime":"0","endTime":"0","summary":"Beam Therapeutics Inc. BEAM announced that the FDA has cleared the investigational new drug  application to begin clinical studies on its pipeline candidate, BEAM-302, for the treatment of alpha-1 antitrypsin deficiency  in the United States.BEAM-302 is a liver-targeting lipid-nanoparticle  formulation of base editing reagents designed to correct the disease-causing PiZ mutation.AATD is an inherited genetic disorder that can cause early onset of emphysema and liver disease. Currently, there are no approved curative treatments for the given indication.In June 2024, Beam Therapeutics dosed the first patient in a phase I/II study on BEAM-302 for the treatment of AATD in the United Kingdom. The candidate has also received clinical trial authorization from New Zealand, Australia, the Netherlands and Ireland.Year to date, shares of Beam Therapeutics have declined 10.6% against the industry’s increase of 3.3%.JAZZ’s earnings beat estimates in three of the trailing four quarters while missing ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/beams-ind-beam-302-genetic-132600403.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4611","BK4139","BK4535","BK4556","BK4505","LU0109394709.USD","IE00BN0W2T93.GBP","JAZZ","LU0823416689.USD","DVAX","BK4585","BK4532","LU0889565916.HKD","IE00BN0W2W23.USD","AAT","BK4007","LU0320765992.SGD","BK4533","IE00BN0W2V16.EUR","BK4160","KRYS","BEAM","BK4588"],"gpt_icon":0},{"id":"2522883832","title":"UBX Stock Down 29% on Mixed Results From Phase II Eye Disease Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2522883832","media":"Zacks","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522883832?lang=en_us&edition=fundamental","pubTime":"2025-03-25 23:51","pubTimestamp":1742917860,"startTime":"0","endTime":"0","summary":"Shares of UNITY Biotechnology UBX crashed 28.8% yesterday, following mixed results from a mid-stage non-inferiority study of its lead candidate, intravitreal UBX1325 compared with Regeneron’s REGN Eylea  in diabetic macular edema  patients.The primary efficacy endpoint of the phase IIb ASPIRE study is demonstrating non-inferiority to Eylea, measured by mean change in Best Corrected Visual Acuity from baseline to the average of weeks 20 and 24. The study enrolled 52 DME patients with poor vision despite prior anti-VEGF treatment and was randomized equally to receive either 10 μg UBX1325 or 2 mg of REGN’s Eylea. UBX1325 is UNITY Biotechnology’s novel BCL-xL inhibitor with a unique mechanism of action.The data readout from the mid-stage DME study demonstrated that treatment with the candidate resulted in vision gains, non-inferior to Regeneron’s Eylea, at weeks 24 and 36 in the difficult-to-treat patient population. Patients treated with UBX1325 achieved a +5.2 letter improvement in visua","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/ubx-stock-down-29-mixed-155100201.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU2362541513.USD","LU1066051498.USD","BK4583","LU2362540622.SGD","LU1571399168.USD","LU2023250504.SGD","LU0234570918.USD","IE00B19Z3581.USD","UBX","LU0058720904.USD","LU2087621335.USD","IE0002270589.USD","LU2237438978.USD","IE00B3T34201.USD","BK4139","IE00BKVL7J92.USD","REGN","LU0109394709.USD","BK4568","LU2106854487.HKD","IE00B19Z3B42.SGD","BK4550","BK4578","LU0289739699.SGD","LU0882574055.USD","IE00B7SZLL34.SGD","LU0114720955.EUR","LU0823416689.USD","DVAX","BK4585","GILD","IE00BSNM7G36.USD","LU0053666078.USD","LU1917777945.USD","BK4532","BK4566","LU0889565916.HKD","LU1430594728.SGD","LU1585245621.USD","LU1066053197.SGD","LU2362541273.HKD","LU0320765992.SGD","LU1839511570.USD","LU2089984988.USD","IE00BZ1G4Q59.USD","LU2468319806.SGD","LU1974910355.USD","BK4588"],"gpt_icon":1},{"id":"2521584612","title":"Alnylam Gets FDA Nod for Expanded Use of Amvuttra in Cardiomyopathy","url":"https://stock-news.laohu8.com/highlight/detail?id=2521584612","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2521584612?lang=en_us&edition=fundamental","pubTime":"2025-03-22 00:46","pubTimestamp":1742575560,"startTime":"0","endTime":"0","summary":"ALNY’s Amvuttra, an RNAi therapeutic, was previously approved in the United States for treating adult patients with polyneuropathy associated with transthyretin-mediated amyloidosis . It is also marketed in the EU for treating hATTR-PN in adult patients with stage 1 or stage 2 polyneuropathy.The FDA’s latest nod makes Amvuttra the first and only therapeutic approved in the United Statesfor both ATTR-CM and hATTR-PN in adults, marking a significant milestone achievement. ATTR-CM is a severe, rapidly progressing, and life-threatening disease affecting an estimated 150,000 people in the United States and over 300,000 globally. Despite its impact, most cases go undiagnosed and untreated, while many patients receiving standard therapies continue to experience disease progression.The approval of Amvuttra’s supplemental new drug application  for the ATTR-CM indication is based on positiveresults from Alnylam’s pivotal phase III HELIOS-B study of the drug, which met all primary and secondary e","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/alnylam-gets-fda-nod-expanded-164600244.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["DVAX","LU0211331839.USD","LU0208291251.USD","ALNY","LU0070302665.USD","BK4566","LU1571399168.USD","LU2087621335.USD","BK4585","LU1585245621.USD","BK4578","IE00BFTCPJ56.SGD","LU0320765489.SGD","IE00B19Z3581.USD","LU0289739699.SGD","IE0002270589.USD","LU0058720904.USD","LU0234570918.USD","IE00BSNM7G36.USD","IE00B19Z3B42.SGD","NVS","IE00BZ1G4Q59.USD","GILD","BK4532","LU2089984988.USD","IE00B2B36J28.USD","LU0109394709.USD","LU0889565916.HKD","BK4139","IE0009355771.USD","IE00B7SZLL34.SGD","IE00BJT1NW94.SGD","IE00BJJMRZ35.SGD","BK4583","BK4007","LU1430594728.SGD","LU1066051498.USD","IE0002141913.USD","BK4568","LU1066053197.SGD","LU1839511570.USD","BK4588","LU0320765992.SGD","LU2468319806.SGD","IE00BKVL7J92.USD","BK4548","BK4550","IE00B4R5TH58.HKD","IE00B3T34201.USD"],"gpt_icon":0},{"id":"2521462258","title":"OPTN Stock Soars 53% on Inking $330M Deal to be Acquired by Paratek","url":"https://stock-news.laohu8.com/highlight/detail?id=2521462258","media":"Zacks","labels":["merge"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2521462258?lang=en_us&edition=fundamental","pubTime":"2025-03-22 00:44","pubTimestamp":1742575440,"startTime":"0","endTime":"0","summary":"Shares of OptiNose OPTN soared 52.5% on Thursday after the company announced that it is set to be acquired by Paratek Pharmaceuticals, a private biotech. This deal will add OPTN’s approved product, Xhance , to the latter’s commercial portfolio.Xhance is an innovative drug-device therapy for chronic rhinosinusitis , with or without nasal polyps. Utilizing its proprietary Exhalation Delivery System, it delivers a corticosteroid directly to the site of inflammation, improving patient outcomes while potentially reducing the need for invasive or costly treatments.The acquisition enables OptiNose to expand Xhance’s market reach, addressing long-standing challenges in adoption. Paratek’s strong commercial infrastructure will help drive awareness, particularly among primary care providers who treat most CRS patients.Paratek’s recently expanded primary care field force, combined with OptiNose’s specialist sales expertise, positions the company to accelerate Xhance’s adoption across both ear, no","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/optn-stock-soars-53-inking-164400660.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"merge","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU1066051498.USD","BK4583","IE0031619046.USD","LU1571399168.USD","IE00B7SZL793.SGD","LU2065731478.USD","LU0234570918.USD","IE00B19Z3581.USD","LU0058720904.USD","LU2087621335.USD","IE0002270589.USD","IE00B3T34201.USD","BK4139","BK4006","IE00BKVL7J92.USD","LU0109394709.USD","BK4568","IE00B19Z3B42.SGD","BK4550","BK4578","LU0289739699.SGD","IE00B7SZLL34.SGD","DVAX","IE00B19Z4B17.USD","IE00B66KJ199.SGD","BK4585","GILD","IE00BSNM7G36.USD","BK4532","BK4566","CRS","LU0889565916.HKD","LU1430594728.SGD","LU1585245621.USD","LU1066053197.SGD","BK4007","LU0320765992.SGD","LU1839511570.USD","OPTN","LU2089984988.USD","IE00BZ1G4Q59.USD","LU2468319806.SGD","BK4588","ARVN"],"gpt_icon":0},{"id":"2521464437","title":"Why Dynavax Technologies (DVAX) Stock Might be a Great Pick","url":"https://stock-news.laohu8.com/highlight/detail?id=2521464437","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2521464437?lang=en_us&edition=fundamental","pubTime":"2025-03-20 22:44","pubTimestamp":1742481840,"startTime":"0","endTime":"0","summary":"One stock that might be an intriguing choice for investors right now is Dynavax Technologies Corporation DVAX. This is because this security in the Medical - Biomedical and Genetics space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective.This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably taking place in the Medical - Biomedical and Genetics space as it currently has a Zacks Industry Rank of 75 out of more than 250 industries, suggesting it is well-positioned from this perspective, especially when compared to other segments out there.Meanwhile, Dynavax Technologies is actually looking pretty good on its own too. The firm has seen solid earnings estimate revision activity over the past month, suggesting analysts are becoming a bit more bullish on the firm’s prospects ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/why-dynavax-technologies-dvax-stock-144400071.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4139","DVAX"],"gpt_icon":0},{"id":"2521461815","title":"IMVT Unlikely to Pursue Batoclimab for MG & CIDP Despite Success","url":"https://stock-news.laohu8.com/highlight/detail?id=2521461815","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2521461815?lang=en_us&edition=fundamental","pubTime":"2025-03-20 22:19","pubTimestamp":1742480340,"startTime":"0","endTime":"0","summary":"Immunovant IMVT announced top-line data from a late-stage study of its investigational candidate, batoclimab, for myasthenia gravis  and initial results from Period 1 of a mid-stage study of the same candidate for chronic inflammatory demyelinating polyneuropathy .IMVT’s Batoclimab Shows Superior Efficacy in MG Patients. The phase III study is evaluating the efficacy and safety of batoclimab in adult patients with moderate to severe MG. Per the data readout, the study met its primary endpoint of mean change from baseline in the MG Activities of Daily Living  score, used to determine the impact of weekly or bi-monthly doses of batoclimab, in acetylcholine receptor antibody positive  patients after 12 weeks.Immunovant reported that MG patients who received the weekly680mg subcutaneous dose of batoclimab achieved a 5.6-point improvement in MG-ADL and a 4.7-point improvement was observed in patients receiving the 340mg dose compared to a 3.6-point improvement in the placebo group at week 1","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/imvt-unlikely-pursue-batoclimab-mg-141900033.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU1430594728.SGD","GILD","BK4550","IE0002270589.USD","LU0320765992.SGD","IE00B7SZLL34.SGD","BK4578","LU0889565916.HKD","LU0109394709.USD","BK4568","IE00BKVL7J92.USD","MG","BK4532","IE00B7SZL793.SGD","BK4566","BK4585","IE00B19Z3B42.SGD","LU1839511570.USD","LU0058720904.USD","LU2089984988.USD","IE00BZ1G4Q59.USD","LU2087621335.USD","IE00B66KJ199.SGD","IE00B19Z3581.USD","BK4007","LU1066053197.SGD","LU0289739699.SGD","LU2468319806.SGD","LU0234570918.USD","ARVN","BK4123","BK4588","IMVT","IE00BSNM7G36.USD","BK4139","LU1585245621.USD","IE0031619046.USD","DVAX","IE00B3T34201.USD","LU1066051498.USD","BK4583","IE00B19Z4B17.USD","LU1571399168.USD"],"gpt_icon":0},{"id":"2520468110","title":"Novartis Reports Updated Positive Data From Phase III SMA Program","url":"https://stock-news.laohu8.com/highlight/detail?id=2520468110","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2520468110?lang=en_us&edition=fundamental","pubTime":"2025-03-20 21:34","pubTimestamp":1742477640,"startTime":"0","endTime":"0","summary":"NovartisNVS reported promising new safety and efficacy results from its phase III studies of investigational intrathecal onasemnogene abeparvovec  in a broad group of patients aged 2 to under 18 years with spinal muscular atrophy . OAV101 IT is an investigational, one-time gene therapy for patients with SMA.Additionally, in the phase IIIb STRENGTH study, treatment with OAV101 IT demonstrated stabilization of motor function over 52 weeks of follow-up in patients who had previously discontinued treatment with Spinraza  or Roche’s RHHBY Evrysdi .SMA, a rare, genetic neuromuscular disease caused by a lack of a functional SMN1 gene, results in the irreversible loss of motor neurons, affecting muscle functions, including breathing, swallowing and basic movement.Year to date, shares of Novartis have gained 14.6% compared with the industry’s 7.2% growth.Novartis presented these data at a recent medical conference held in Dallas, Texas. 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The goal is to make these treatments rapidly available to patients in need.Besides SjD, the FDA has granted FTD to nipocalimab in three other indications, hemolytic disease of the fetus and newborn  and warm autoimmune hemolytic anemia , generalized myasthenia gravis  and fetal neonatal alloimmune thrombocytopenia.The FDA granted Breakthrough Therapy designation to nipocalimab for SjD in November 2024. 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