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Spero Therapeutics Inc.

2.80

+0.03501.27%

Volume:2.01M

Turnover:5.67M

Market Cap:156.27M

PE:-2.18

High:2.93

Open:2.76

Low:2.72

Close:2.76

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Overview Company News Filings

Neumora Stock Hits Record Low on Depression Drug Study Failure

MNPR Stock Skyrockets 384% in 3 Months After Deal With AZN

VSTM Up as NDA for Ovarian Cancer Combo Gets FDA's Priority Review Tag

Puma Biotechnology Stock Rises 24% in 3 Months: Here's Why

JNJ Inks Licensing Deal With Kaken for Eczema Candidate KP-723

BMY Gets EC Nod for Opdivo Plus Yervoy in First-Line Colorectal Cancer

AZN's Tagrisso Gets Approval in the EU for Expanded Use in NSCLC

Spero Therapeutics (SPRO) was downgraded to a Hold Rating at Evercore ISI

VRTX Down as Non-Opioid Drug Shows Similar Pain Reduction as Placebo

Evercore ISI Downgrades Spero Therapeutics to In Line From Outperform, Price Target is $5

MT Newswires Live

Spero Therapeutics Cut to In-Line From Outperform by Evercore ISI Group

MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease

KRYS Reports Upbeat Initial Data From Lung Cancer Study of KB707

REGN's Eylea HD Shows Non-Inferiority to Eylea in Eye Disease Study

GILD's Trodelvy Gets Second Breakthrough Therapy Tag for Lung Cancer

EWTX Stock Rises on Upbeat Data From Rare Muscular Disorder Study

Merck Ends Development of Two Experimental Cancer Drugs

FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC

Spero Therapeutics (SPRO) Loses -9.32% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner

CHMP Endorses Merck's Kidney Cancer Drug for Two Indications

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The study failed to achieve its primary endpoint – treatment with the drug failed to demonstrate a significant improvement over placebo in alleviating depression symptoms, as measured by the Montgomery-Asberg Depression Rating Scale .The study also failed to show statistically significant improvement in the reduction of anhedonia , as assessed by the Snaith-Hamilton Pleasure Scale .The KOASTAL-1 study is one of the three late-stage studies in the KOASTAL program evaluating navacaprant in the MDD indication. Despite the study's failure, Neumora intends to continue the other two studies. In the meantime, management continues to further analyze the study results, as management claimed that the drug showed an efficacy signal in female patients.Following the news, shares of Neumora hit an all-time low of $1.83. The latest anno","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/neumora-stock-hits-record-low-141400263.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":["CSTL","NMRA","SPRO","BK4196","CTMX","BK4139","BK4007","ABVC"],"gpt_icon":0},{"id":"2500974072","title":"MNPR Stock Skyrockets 384% in 3 Months After Deal With AZN","url":"https://stock-news.laohu8.com/highlight/detail?id=2500974072","media":"Zacks","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500974072?lang=en_us&edition=fundamental","pubTime":"2025-01-02 23:02","pubTimestamp":1735830120,"startTime":"0","endTime":"0","summary":"Shares of Monopar Therapeutics MNPR, a clinical-stage biotech, skyrocketed 383.5% in the past three months fueled by a licensing agreement with AstraZeneca AZN, which granted MNPR an exclusive worldwide license to ALXN-1840 . ALXN-1840 is an investigational once-daily, oral medicine, which is being developed for treating Wilson disease, a rare and progressive genetic disease.AstraZeneca had earlier announced that a pivotal phase III study evaluating the candidate for the above indication had met its primary endpoint. Although AZN terminated the ALXN-1840 program in 2023, Monopar took up the candidate upon the request of the Wilson Disease Association. AstraZeneca’s termination of the ALXN-1840 program was based on the review of results from phase II mechanistic studies and discussions with regulatory authorities.In the past six months, shares of Monopar have rallied 525.5% against the industry’s 4.8% decline.Some other top-ranked stocks from the sector areCastle BiosciencesCSTL andSper","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/mnpr-stock-skyrockets-384-3-150200991.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU2462157665.USD","MNPR","LU2236285917.USD","BK4568","AZN","BK4588","BK4007","CSTL","LU0320765992.SGD","BK4139","LU0889565916.HKD","LU1829250122.USD","LU2456880835.USD","LU2417539215.USD","SPRO","LU0109394709.USD","BK4585","BK4196"],"gpt_icon":1},{"id":"2500007971","title":"VSTM Up as NDA for Ovarian Cancer Combo Gets FDA's Priority Review Tag","url":"https://stock-news.laohu8.com/highlight/detail?id=2500007971","media":"Zacks","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2500007971?lang=en_us&edition=fundamental","pubTime":"2025-01-02 22:56","pubTimestamp":1735829760,"startTime":"0","endTime":"0","summary":"Both avutometinib and defactinib have been in-licensed by Verastem from other pharmaceutical companies. Avutometinib is an RAF/MEK clamp, while defactinib is a best-in-class selective FAK inhibitor.In the past three months, shares of Verastem have surged 86.6% against the industry’s 9.5% decline.More on the FDA Acceptance of Avutometinib NDA for LGSOC. At present, there are no FDA-approved treatments specifically for LGSOC, a rare and distinct type of ovarian cancer with unique biology and treatment responses compared to high-grade serous ovarian cancer, representing a huge unmet medical need. Per Verastem, an estimated 6,000-8,000 women in theUnited Statesand 80,000 worldwide suffer from this disease. The standard of care treatment includes hormone therapy and chemotherapy.Currently, the company is enrolling patients with recurrent LGSOC regardless of KRAS mutation status in the global phase III RAMP 301 study, which is expected to serve as a confirmatory study for the initial indica","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/vstm-nda-ovarian-cancer-combo-145600394.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":["CSTL","VSTM","BK4139","SPRO","CTMX","BK4196"],"gpt_icon":0},{"id":"2494335850","title":"Puma Biotechnology Stock Rises 24% in 3 Months: Here's Why","url":"https://stock-news.laohu8.com/highlight/detail?id=2494335850","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2494335850?lang=en_us&edition=fundamental","pubTime":"2024-12-27 23:10","pubTimestamp":1735312200,"startTime":"0","endTime":"0","summary":"Shares of Puma Biotechnology, Inc. PBYI have rallied 24% in the past three months against the industry’s decline of 9.7%.The company’s sole marketed product, Nerlynx , is approved for treating early-stage HER2-positive breast cancer in patients previously treated with Roche’s RHHBY Herceptin-based adjuvant therapy.In the first nine months of 2024, Nerlynx generated sales worth $140.8 million. Sales of the drug improved in the third quarter of 2024 and came ahead of management’s expectations.Owing to the better-than-expected sales, PBYI updated its financial guidance for 2024 during the third quarter of 2024. The company now expects Nerlynx’s product sales to be in the range of $187-$190 million in 2024, compared with the earlier projection of $183-$190 million.The improved sales of Nerlynx have been the primary reason for the stock’s increase during the said time.PBYI expects Nerlynx product sales to be in the band of $46-$48 million in the fourth quarter of 2024. It remain","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/puma-biotechnology-stock-rises-24-151000280.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":["SPRO","BK4139","03165","IMCR","BK4505","PBYI","BK4007","RHHBY"],"gpt_icon":0},{"id":"2494385582","title":"JNJ Inks Licensing Deal With Kaken for Eczema Candidate KP-723","url":"https://stock-news.laohu8.com/highlight/detail?id=2494385582","media":"Zacks","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2494385582?lang=en_us&edition=fundamental","pubTime":"2024-12-27 20:17","pubTimestamp":1735301820,"startTime":"0","endTime":"0","summary":"How the Licensing Deal for the AD Program Benefits JNJ. The licensing deal with Kaken reinforces Johnson & Johnson’s dedication to targeting disease-specific pathways across diverse patient populations, leveraging innovative mechanisms and approaches to revolutionize the treatment of AD and other autoimmune and allergic conditions.Per JNJ, most AD patients fail to achieve remission with currently available treatments, representing a huge unmet medical need. The company believes that the STAT6 program stands out as a promising research area, offering the potential for a safe and effective novel oral therapy for those suffering from AD and other autoimmune diseases.In the past three months, shares of JNJ have lost 10.2% compared with the industry’s 13.8% decline.Some better-ranked stocks from the sector areCastle BiosciencesCSTL,CytomX TherapeuticsCTMX andSpero TherapeuticsSPRO, each sporting a Zacks Rank #1  at present. You can seethe complete list of today’s Zacks #1 Rank stocks 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Gets EC Nod for Opdivo Plus Yervoy in First-Line Colorectal Cancer","url":"https://stock-news.laohu8.com/highlight/detail?id=2494032546","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2494032546?lang=en_us&edition=fundamental","pubTime":"2024-12-25 00:06","pubTimestamp":1735056360,"startTime":"0","endTime":"0","summary":"Bristol Myers Squibb BMY announced that the European Commission has approved the combination of its blockbuster immuno-oncology drug Opdivo  and Yervoy  for a new cancer indication.The EC has approved Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability–high  or mismatch repair deficient  unresectable or metastatic colorectal cancer .Following the latest nod, Opdivo plus Yervoy became the first dual checkpoint inhibitor therapy to be approved for the first-line treatment of MSI-H/dMMR mCRC in the European Union.The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of Opdivo plus Yervoy for the given indication in November.Year to date, shares of Bristol Myers have rallied 12.2% against the industry’s decline of 13.7%.The latest approval for Opdivo plus Yervoy in first-line MSI-H/dMMR mCRC was based on data from the phase III CheckMate -8HW study.Also, the safety profile of Opdivo plus Yervoy","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/tdykziZpl44jUPQqI7k0_g--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/8127f43af74d394c31adc7eb2e1fa286","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/tdykziZpl44jUPQqI7k0_g--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/8127f43af74d394c31adc7eb2e1fa286"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/bmy-gets-ec-nod-opdivo-160600334.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":["LU1074936037.SGD","SPRO","LU2242652126.USD","LU0225771236.USD","LU1868837136.USD","LU0868494617.USD","LU1093756325.SGD","LU1093756168.USD","IE0002141913.USD","LU0096364046.USD","LU1261432733.SGD","CSTL","BK4559","LU0321505439.SGD","LU1868836914.USD","BK4534","LU2242646821.SGD","IE0009355771.USD","BK4585","LU1670710588.SGD","BK4532","BK4139","LU2133065610.SGD","BK4581","BK4588","IMCR","PFS","LU1989771016.USD","LU1670711040.USD","LU0114720955.EUR","BMY","LU2360032135.SGD","LU1585245621.USD","LU1430594728.SGD","LU2125154935.USD","BK4196","LU1032466523.USD","BK4007","IE00B2B36J28.USD","EC","LU0456855351.SGD","IE00BJJMRZ35.SGD","IE00BJT1NW94.SGD","LU0321505868.SGD","LU1571399168.USD","BK4201","LU0225284248.USD","LU1670711123.USD","LU1868837300.USD","IE00BFTCPJ56.SGD"],"gpt_icon":0},{"id":"2493934307","title":"AZN's Tagrisso Gets Approval in the EU for Expanded Use in NSCLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2493934307","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2493934307?lang=en_us&edition=fundamental","pubTime":"2024-12-23 23:56","pubTimestamp":1734969360,"startTime":"0","endTime":"0","summary":"AstraZenecaAZN announced that its blockbuster cancer drug, Tagrisso , has been approved in the EU for expanded use in non-small cell lung cancer .The eligible patient population includes adults with locally advanced, unresectable NSCLC with EGFR exon 19 deletions  or exon 21  substitution mutations whose disease has not progressed during or following platinum-based chemoradiation therapy. The FDAapprovedthis combinationin September for a similar indication.The nod in the EU is based on data from the phase III LAURAstudy, which showed that treatment with Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Patients treated with the drug experienced a median progression-free survival of 39.1 months compared with 5.6 months for patients in the placebo group. The drugs’ safety and tolerability profiles were consistent with prior studies and no new safety concerns were identified.Last month, the EMA’s advisory committee adopted a positive opinion, recommendi","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/spvq99_pwlnf7s60ZXBlKg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/06708d71c63051ca48bf1855727f077b","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/spvq99_pwlnf7s60ZXBlKg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/06708d71c63051ca48bf1855727f077b"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/azns-tagrisso-gets-approval-eu-155600638.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":["AZN","BK4139","LU2462157665.USD","CTMX","LU2236285917.USD","BK4585","SPRO","BK4588","BK4156","LU0320765992.SGD","LU2417539215.USD","LU1829250122.USD","LU0109394709.USD","BK4196","LU2456880835.USD","BK4568","CSTL","LU0889565916.HKD","BK4007"],"gpt_icon":0},{"id":"2493279195","title":"Spero Therapeutics (SPRO) was downgraded to a Hold Rating at Evercore ISI","url":"https://stock-news.laohu8.com/highlight/detail?id=2493279195","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2493279195?lang=en_us&edition=fundamental","pubTime":"2024-12-23 08:05","pubTimestamp":1734912311,"startTime":"0","endTime":"0","summary":"Evercore ISI analyst Gavin Clark-Gartner downgraded Spero Therapeutics (SPRO – Research Report) to a Hold on December 20 and set a price target of ...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/spero-therapeutics-spro-was-downgraded-to-a-hold-rating-at-evercore-isi?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/spero-therapeutics-spro-was-downgraded-to-a-hold-rating-at-evercore-isi?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["SPRO"],"gpt_icon":0},{"id":"2493424389","title":"VRTX Down as Non-Opioid Drug Shows Similar Pain Reduction as Placebo","url":"https://stock-news.laohu8.com/highlight/detail?id=2493424389","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2493424389?lang=en_us&edition=fundamental","pubTime":"2024-12-21 00:13","pubTimestamp":1734711180,"startTime":"0","endTime":"0","summary":"Shares of Vertex Pharmaceuticals Incorporated VRTX were down 11.4% yesterday after the company announced data from a phase II study that evaluated its investigational, oral, highly selective NaV1.8 pain signal inhibitor, suzetrigine, for treating people with painful lumbosacral radiculopathy , a form of peripheral neuropathic pain.Data from the study showed that treatment with suzetrigine led to a statistically significant and clinically meaningful within-group reduction in pain from baseline with a mean change in numeric pain rating scale of -2.02 at week 12, thereby meeting the primary endpoint.However, the placebo arm demonstrated a similar reduction of -1.98 points, indicating not much difference between the two groups.Shares of VRTX were down as investors were not too impressed with the data as it does not clearly demonstrate suzetrigine’s benefit-risk profile.Year to date, shares of Vertex have lost 2.5% compared with the industry’s decline of 13.7%.However, the disappointing dat","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/.WQmSb1MJO1_eLnmBVS1zA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/a1d7049b0977a02a21fd2aa02b46f307","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/.WQmSb1MJO1_eLnmBVS1zA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/a1d7049b0977a02a21fd2aa02b46f307"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/vrtx-down-non-opioid-drug-161300244.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":["LU0058720904.USD","BK4023","LU2456880835.USD","IE00B2B36J28.USD","LU0320765992.SGD","LU0823416689.USD","BK4585","LU1585245621.USD","LU0109394709.USD","BK4533","LU2362541273.HKD","IE0009355771.USD","LU0061475181.USD","LU0256863811.USD","LU0889565916.HKD","LU1035775433.USD","LU2417539215.USD","IE00B4R5TH58.HKD","LU1430594728.SGD","CTMX","IE00BFTCPJ56.SGD","LU1093756325.SGD","CSTL","VRTX","LU1093756168.USD","LU2237438978.USD","LU2462157665.USD","IE0002270589.USD","IE00BJT1NW94.SGD","BK4567","IE00B19Z3581.USD","SPRO","BK4532","LU0079474960.USD","LU1069344957.HKD","LU2362541513.USD","LU2362540622.SGD","BK4588","IE00B894F039.SGD","LU2236285917.USD","LU2324357040.USD","IE00B19Z9P08.USD","IE00B19Z3B42.SGD","IE00B19Z9Z06.USD","IE00BJJMRZ35.SGD","LU1559883803.SGD","VERX","IE00BZ9MQY76.HKD","LU0566484027.USD","LU0234570918.USD"],"gpt_icon":0},{"id":"2492431934","title":"Evercore ISI Downgrades Spero Therapeutics to In Line From Outperform, Price Target is $5","url":"https://stock-news.laohu8.com/highlight/detail?id=2492431934","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492431934?lang=en_us&edition=fundamental","pubTime":"2024-12-20 21:24","pubTimestamp":1734701091,"startTime":"0","endTime":"0","summary":"Evercore ISI Downgrades Spero Therapeutics to In Line From Outperform, Price Target is $5","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","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":"mtnewswires_news","symbols":["SPRO","LENZ"],"gpt_icon":0},{"id":"2492111874","title":"Spero Therapeutics Cut to In-Line From Outperform by Evercore ISI Group","url":"https://stock-news.laohu8.com/highlight/detail?id=2492111874","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492111874?lang=en_us&edition=fundamental","pubTime":"2024-12-20 19:50","pubTimestamp":1734695400,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/SPRO/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  December 20, 2024 06:50 ET (11:50 GMT)","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":null,"symbols":["LENZ","SPRO"],"gpt_icon":0},{"id":"2492486534","title":"MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease","url":"https://stock-news.laohu8.com/highlight/detail?id=2492486534","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492486534?lang=en_us&edition=fundamental","pubTime":"2024-12-20 02:16","pubTimestamp":1734632160,"startTime":"0","endTime":"0","summary":"Mesoblast Limited MESO announced that the FDA has approved Ryoncil  for the treatment of steroid-refractory acute graft versus host disease  in children aged two months and older, including adolescents and teenagers.Following the FDA nod, Ryoncil became the first and only mesenchymal stromal cell therapy to be approved for any indication in the United States.Ryoncil is also the first FDA-approved therapy for pediatric SR-aGvHD, a life-threatening condition with high mortality rates.Shares of MESO were up 40.4% in after-hours trading on Dec. 18. The stock has skyrocketed 456.8% in the year so far against the industry’s decline of 10.5%.The FDA approval was based on data from the phase III study which evaluated Ryoncil for treating children with SR-aGvHD.Data from the same showed that out of 89% of children who had high severity grade C or grade D disease, 70% achieved an overall response by day 28 following treatment with Ryoncil, a measure that predicts survival in aGVHD.A better-ranke","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/0.VF5p.GUKhgU24gMni2XA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/59a827b8514d5d6d47690daa5eb16f24","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/0.VF5p.GUKhgU24gMni2XA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/59a827b8514d5d6d47690daa5eb16f24"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/meso-stock-fda-approves-ryoncil-181600672.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":["BK4139","NVS","LU0211331839.USD","IE00BFTCPJ56.SGD","IE00B4R5TH58.HKD","MESO","IE0009355771.USD","BK4181","IE00BJT1NW94.SGD","BK4585","BK4007","INCY","BK4578","IE00BJJMRZ35.SGD","IE00B2B36J28.USD","BK4218","MSB.AU","IE0002141913.USD","SPRO","BK4532","HST","BK4550","BK4588"],"gpt_icon":0},{"id":"2492025121","title":"KRYS Reports Upbeat Initial Data From Lung Cancer Study of KB707","url":"https://stock-news.laohu8.com/highlight/detail?id=2492025121","media":"Zacks","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492025121?lang=en_us&edition=fundamental","pubTime":"2024-12-20 00:08","pubTimestamp":1734624480,"startTime":"0","endTime":"0","summary":"Krystal BiotechKRYS announced encouraging initial clinical data from an early to mid-stage study of its investigational immunotherapy candidate, KB707, to treat patients with solid tumors of the lung.The phase I/II KYANITE-1 study is evaluating the safety, tolerability and tumor response  of inhaled KB707 as a monotherapy in 37 patients with malignant lesions in the lung. Out of the total enrolled patient population, 17 were diagnosed with advanced non-small cell lung cancer . Two doses of KB707  were evaluated during the dose-escalation phase of the KYANITE-1 study, following which 109PFU was selected for dose expansion.Results showed that patients treated with inhaled KB707 demonstrated early evidence of monotherapy activity with the most therapeutic benefit observed in advanced NSCLC patients, who have progressed after standard-of-care treatments.In the past three months, shares of Krystal Biotech have lost 14.9% compared with theindustry’s 13.3% decline.KB707 is also being develope","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/2NHx6klCutBjAlMNJEM7HQ--~B/aD00MTM7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/b5aeac1c53d022d48463312844fb1baf","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/2NHx6klCutBjAlMNJEM7HQ--~B/aD00MTM7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/b5aeac1c53d022d48463312844fb1baf"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/krys-reports-upbeat-initial-data-160800963.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":["BK4196","SPRO","CSTL","KRYS","CTMX","BK4139"],"gpt_icon":0},{"id":"2492136717","title":"REGN's Eylea HD Shows Non-Inferiority to Eylea in Eye Disease Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2492136717","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492136717?lang=en_us&edition=fundamental","pubTime":"2024-12-18 23:17","pubTimestamp":1734535020,"startTime":"0","endTime":"0","summary":"Eylea is Regeneron’s blockbuster eye disease drug, which is already approved for wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy and RVO.The FDA has also approved Eylea to treat preterm infants with retinopathy of prematurity as well. Eylea HD is a high-dose version of Eylea.In the past three months, shares of REGN have plunged 35.7% compared with the industry’s 10.8% decline.Additionally, about 90% of Eylea HD patients were able to maintain eight-week dosing intervals through the 36-week treatment period. In the QUASAR study, Eylea HD demonstrated a safety profile comparable to that of Eylea. Additionally, it aligned with the established safety profile of Eylea HD observed in previous pivotal studies.Please note that Bayer’s BAYRY HealthCare unit co-develops Eylea withRegeneron. REGN records net product sales of Eylea in the United States. Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losse","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/X5f0KWUqd43xLwLZQjf2Jw--~B/aD0zOTI7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/83114bcf5a91754ed7ae3f6080390cd9","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/X5f0KWUqd43xLwLZQjf2Jw--~B/aD0zOTI7dz02MjA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/83114bcf5a91754ed7ae3f6080390cd9"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/regns-eylea-hd-shows-non-151700259.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":["BK4581","SPRO","IE00B1XK9C88.USD","SG9999001440.SGD","IE00BKVL7J92.USD","LU0114720955.EUR","LU2362541273.HKD","LU0942090050.USD","BK4550","LU1496350502.SGD","LU0943347566.SGD","IE00BSNM7G36.USD","LU0823434583.USD","LU1162221912.USD","LU1914381329.SGD","REGN","LU0689472784.USD","LU0882574055.USD","LU1778281490.HKD","LU0079474960.USD","LU0320765646.SGD","LU1929549753.HKD","LU0820561818.USD","LU0058720904.USD","IE00BWXC8680.SGD","LU0823416689.USD","LU2089984988.USD","LU2362541513.USD","LU2468319806.SGD","LU1093756325.SGD","LU1551013342.USD","BK4566","HD","LU1674673691.USD","BK4504","LU1093756168.USD","LU2362540622.SGD","LU0354030438.USD","LU1674673428.USD","CSTL","BK4567","BAYRY","LU0868494617.USD","BK4196","BK4533","LU0868494708.USD","LU1989772923.USD","LU2023250504.SGD","LU0823411888.USD","LU0234572021.USD"],"gpt_icon":0},{"id":"2492135482","title":"GILD's Trodelvy Gets Second Breakthrough Therapy Tag for Lung Cancer","url":"https://stock-news.laohu8.com/highlight/detail?id=2492135482","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492135482?lang=en_us&edition=fundamental","pubTime":"2024-12-18 23:14","pubTimestamp":1734534840,"startTime":"0","endTime":"0","summary":"Gilead SciencesGILD announced that its first-in-class Trop-2-directed antibody-drug conjugate, Trodelvy, has been granted a second Breakthrough Therapy designationby the FDA for a lung cancer indication. The indicated population includes adult patients with extensive-stage small cell lung cancer  whose disease has progressed on or after platinum-based chemotherapy.Gilead’s Trodelvy is currently approved for second-line or later metastatic triple-negative breast cancer  patients in more than 50 countries and for certain patients with pre-treated HR+/HER2- metastatic breast cancer  in more than 40 countries, including the United States. The first Breakthrough Therapy designation was granted to Trodelvy for the TNBC indication in the United States.Benefits of the FDA’s Breakthrough Therapy Designation Grant. The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/2Uxrul9Xalj9HwUZqlOfZA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/79b7ecb3a59852f0816e6eb69c31b2fe","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/2Uxrul9Xalj9HwUZqlOfZA--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/79b7ecb3a59852f0816e6eb69c31b2fe"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/gilds-trodelvy-gets-second-breakthrough-151400252.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["SPRO","BK4568","LU1430594728.SGD","BK4139","LU0320765992.SGD","GILD","LU1839511570.USD","LU0234570918.USD","LU0289739699.SGD","LU0889565916.HKD","BK4566","IE0002270589.USD","IE00BZ1G4Q59.USD","BK4532","IE00B3T34201.USD","CTMX","LU0109394709.USD","LU0058720904.USD","BK4086","IE00BSNM7G36.USD","BK4583","IE00B19Z3B42.SGD","LU1571399168.USD","CSTL","LU1585245621.USD","IE00BKVL7J92.USD","BK4588","BK4585","LU1066053197.SGD","BK4550","LU2468319806.SGD","LU1066051498.USD","IE00B19Z3581.USD","IE00B7SZLL34.SGD","BK4196","BK4578","LU2087621335.USD","MBC"],"gpt_icon":0},{"id":"2492961333","title":"EWTX Stock Rises on Upbeat Data From Rare Muscular Disorder Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2492961333","media":"Zacks","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492961333?lang=en_us&edition=fundamental","pubTime":"2024-12-17 22:18","pubTimestamp":1734445080,"startTime":"0","endTime":"0","summary":"Shares of Edgewise Therapeutics EWTX were up more than 18% on Monday after it announced positive results from the mid-stage CANYON study on its lead pipeline drug, sevasemten, in patients with a rare genetic disorder called Becker Muscular Dystrophy .The study met its primary endpoint of change from baseline in creatine kinase , a biomarker associated with skeletal muscle damage. Data from the study showed a significant reduction in CK levels in the sevasemten-treated group, with an average decrease of 28% compared to placebo between six and 12 months. The drug was also well-tolerated by study participants.Edgewise remains on schedule to complete recruitment for a pivotal cohort of the CANYON study, called GRAND CANYON, which is expected to be achieved in the first quarter of 2025. If data from this cohort is also positive, management intends to start discussions with the FDA and EMA for seeking approval for sevasemten in the BMD indication.","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/B7EfA6ERTo_QO90H15uyXw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/9c1d11cd27737fac4805145de6e5eee0","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/B7EfA6ERTo_QO90H15uyXw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/9c1d11cd27737fac4805145de6e5eee0"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/ewtx-stock-rises-upbeat-data-141800266.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":["CSTL","BK4588","BK4531","BK4007","CTMX","SPRO","BK4585","BK4539","EWTX","BK4139","BK4196","HCM"],"gpt_icon":0},{"id":"2492962747","title":"Merck Ends Development of Two Experimental Cancer Drugs","url":"https://stock-news.laohu8.com/highlight/detail?id=2492962747","media":"Zacks","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492962747?lang=en_us&edition=fundamental","pubTime":"2024-12-17 22:03","pubTimestamp":1734444180,"startTime":"0","endTime":"0","summary":"Merck MRK decided to discontinue two clinical development programs, namely KeyVibe and KEYFORM, which are evaluating its investigational cancer drugs vibostolimab and favezelimab, respectively.Merck’s decision followed a series of setbacks for both drugs, which were being tested in combination with its blockbuster drug Keytruda for various cancer indications across multiple late-stage studies. After a detailed review of data from the clinical studies on both drugs, management has decided to focus on its other ongoing pipeline programs.Merck’s decision to discontinue development on vibostolimab is based on a pre-planned analysis of data from the two phase III studies, KeyVibe-003 and KeyVibe-007, conducted by an independent data monitoring committee . These studies evaluated the combination of vibostolimab and Keytruda in certain patients with non-small cell lung cancer  compared to Keytruda alone.Keytruda sales benefited from rapid uptake across earlier-stage indications in triple-nega","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/1YvkxNLsEvDesNn9Nqp_Qw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/df847a6f57145ec8b42be7c65f980057","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/1YvkxNLsEvDesNn9Nqp_Qw--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/df847a6f57145ec8b42be7c65f980057"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/merck-ends-development-two-experimental-140300151.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4533","CSTL","LU1023059063.AUD","LU1093756168.USD","SG9999014542.SGD","CTMX","LU0208291251.USD","IE00BJT1NW94.SGD","LU0289739699.SGD","LU1430594728.SGD","SPRO","IE00BJJMRZ35.SGD","IE00BBT3K403.USD","SGXZ57979304.SGD","LU1037948541.HKD","LU1066053197.SGD","SG9999014559.SGD","LU0106261372.USD","IE00BLSP4452.SGD","LU1116320901.HKD","IE0002141913.USD","LU1037948897.HKD","BK4550","LU0861579265.USD","LU1989772840.SGD","LU1093756325.SGD","SG9999002232.USD","LU1066051811.HKD","LU0070302665.USD","LU0266013472.USD","LU1291159041.SGD","LU1974910355.USD","BK4196","IE00BN8TJ469.HKD","LU1066051225.USD","LU1983299246.USD","LU2023250843.SGD","LU2361044865.SGD","IE0009355771.USD","MRK","SG9999002224.SGD","BK4585","SG9999001176.USD","LU1989772923.USD","BK4534","LU1571399168.USD","BK4559","IE00BFTCPJ56.SGD","LU0965509010.AUD","LU0006306889.USD"],"gpt_icon":0},{"id":"2492961008","title":"FDA Gives CRL to J&J's BLA for Subcutaneous Rybrevant in NSCLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2492961008","media":"Zacks","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492961008?lang=en_us&edition=fundamental","pubTime":"2024-12-17 21:21","pubTimestamp":1734441660,"startTime":"0","endTime":"0","summary":"Johnson & Johnson JNJ announced that the FDA has issued a complete response letter  to its biologics license application  seeking approval for the subcutaneous  formulation of its EGFR/MET inhibitor, Rybrevant, for EGFR-mutated non-small cell lung cancer .Rybrevant is currently approved as an intravenous  formulation as a combination therapy for treating NSCLC across different lines of treatment and various mutations.The BLA is seeking approval for a fixed combination of SC Rybrevant and recombinant human hyaluronidase for treating patients with EGFR-mutated NSCLC. The BLA was based on data from the phase III PALOMA-3 study and was granted Priority Review by the FDA in August.The CRL was issued as part of the FDA’s standard pre-approval inspection at a manufacturing facility.Per J&J, the CRL is not related to the product formulation or the efficacy and safety data submitted in the regulatory application. The regulatory body has not requested for any additional clinical studies to be co","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/UjHemYIeF2aWxwD7gqDihg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/74bab520128f201c7e6cc3f67385e761","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/UjHemYIeF2aWxwD7gqDihg--~B/aD00MDA7dz02MzU7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/74bab520128f201c7e6cc3f67385e761"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/fda-gives-crl-j-js-132100512.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["IE0009355771.USD","IE0002141913.USD","SPRO","IE00BGHQF631.EUR","IE00BVYPNV92.GBP","LU0345769631.USD","IE00B3PB1722.GBP","LU1267930813.SGD","BK4559","IE00B7SZLL34.SGD","LU0109394709.USD","BK4550","LU0912757837.SGD","IE00BJT1NW94.SGD","LU1032466523.USD","BK4588","LU2602419157.SGD","LU0882574055.USD","LU1059921491.USD","LU1778281490.HKD","BK4534","AZN","LU1894683348.USD","BK4568","LU2468319806.SGD","LU0466842654.USD","JNJ","LU1057294990.SGD","BK4585","CRL","IE0002270589.USD","CSTL","LU0795875169.SGD","LU1674673428.USD","LU2462157665.USD","LU1280957306.USD","IE00BDGV0183.EUR","BK4196","LU0345770993.USD","LU0889566641.SGD","SG9999002224.SGD","LU1074936037.SGD","LU1244550221.USD","LU2133065610.SGD","LU0345769128.USD","BK4007","SG9999002232.USD","IE00BFTCPJ56.SGD","IE00B19Z3581.USD","LU1221951129.SGD"],"gpt_icon":0},{"id":"2492798885","title":"Spero Therapeutics (SPRO) Loses -9.32% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner","url":"https://stock-news.laohu8.com/highlight/detail?id=2492798885","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492798885?lang=en_us&edition=fundamental","pubTime":"2024-12-17 07:34","pubTimestamp":1734392077,"startTime":"0","endTime":"0","summary":"A downtrend has been apparent in Spero Therapeutics, Inc.  lately with too much selling pressure. The stock has declined 9.3% over the past four weeks. However, given the fact that it is now in oversold territory and Wall Street analysts are majorly in agreement about the company's ability to report better earnings than they predicted earlier, the stock could be due for a turnaround.We use Relative Strength Index , one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator that measures the speed and change of price movements.RSI oscillates between zero and 100. Usually, a stock is considered oversold when its RSI reading falls below 30.Technically, every stock oscillates between being overbought and oversold irrespective of the quality of their fundamentals. And the beauty of RSI is that it helps you quickly and easily check if a stock's price is reaching a point of reversal.The RSI reading of 27.37 for SPRO is an indica","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/apbC75v0joJeGGZArvqIvw--~B/aD02NzU7dz05MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/105b2acef7bf0873f24b78932b1fdc3c","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/apbC75v0joJeGGZArvqIvw--~B/aD02NzU7dz05MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/zacks.com/105b2acef7bf0873f24b78932b1fdc3c"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/spero-therapeutics-spro-loses-9-233437985.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":["SPRO","BK4150","RSI","BK4139"],"gpt_icon":0},{"id":"2492661245","title":"CHMP Endorses Merck's Kidney Cancer Drug for Two Indications","url":"https://stock-news.laohu8.com/highlight/detail?id=2492661245","media":"Zacks","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492661245?lang=en_us&edition=fundamental","pubTime":"2024-12-16 23:57","pubTimestamp":1734364620,"startTime":"0","endTime":"0","summary":"Merck MRK announced that EMA’s Committee for Medicinal Products for Human Use  recommended granting conditional approval to its oral HIF-2α inhibitor, Welireg , for use in two indications associated with renal cell carcinoma .The CHMP recommended Welireg to treat adult patients with von Hippel-Lindau  disease who require therapy for associated RCC, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, not requiring immediate surgery. This committee also endorsed the drug for a second indication to treat adult patients with advanced RCC who have received at least two lines of therapy, which include anti-PD-1 and VEGF-targeted therapies.A final decision from the European Commission on both indications is expected in the first quarter of 2025. If approved, Welireg will be the first systemic treatment for patients with VHL disease-associated tumors in the European Union.The LITESPARK-004 study achieved its major efficacy endpoint, treatment with Welireg achieved an 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