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Aquestive Therapeutics Inc.

3.95

-0.0100-0.25%

Post-market: 3.90-0.0465-1.18%19:21 EST

Volume:1.97M

Turnover:7.80M

Market Cap:481.91M

PE:-5.68

High:4.06

Open:3.93

Low:3.91

Close:3.96

52wk High:7.55

52wk Low:2.12

Shares:122.00M

Float Shares:115.00M

Volume Ratio:0.89

T/O Rate:1.71%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-0.6953

EPS(LYR):-0.5089

ROE:148.50%

ROA:-25.50%

PB:-117.28

PE(LYR):-7.76

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Overview Company News Filings

Aquestive Therapeutics to Present New Anaphylm Clinical Data at AAAAI Annual Meeting

Aquestive Therapeutics Names Dr. Matthew Greenhawt Chief Medical Officer

Press Release: Aquestive Therapeutics Appoints Internationally Recognized Allergist Dr. Matthew Greenhawt as Chief Medical Officer

NASD Most Active Issues

What's Going On With Aquestive Therapeutics Stock After FDA Update For Lead Allergic Treatment?

Benzinga_recent_news

Leerink sees ‘silver lining’ in Aquestive CRL given defined path to approval

Aquestive CRL from FDA ‘clearing event,’ says Oppenheimer

Analysts Offer Insights on Healthcare Companies: Aquestive Therapeutics (AQST) and Artivion (AORT)

Aquestive Therapeutics Shares Gain 38.6%

THOMSON REUTERS

Aquestive Therapeutics Shares Gain 35% Premarket

THOMSON REUTERS

BRIEF-Aquestive Therapeutics Announces FDA Issuance Of Complete Response Letter For Anaphylm

Aquestive's Application for Allergic Reaction Treatment Has Deficiencies, FDA Says

US FDA declines to approve Aquestive's oral drug for allergic reactions

Aquestive Therapeutics Inc: Plans to Request Rapid Review by FDA

THOMSON REUTERS

Aquestive Therapeutics Inc - Deficiencies Limited to Packaging and Administration

THOMSON REUTERS

Aquestive Therapeutics Inc - Company Expects to Resubmit as Early as Q3 2026

THOMSON REUTERS

Aquestive Therapeutics Inc - Plans to Submit in Canada and EU by End of 2026

THOMSON REUTERS

Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™

NASDAQ TRADE HALT HALT NEWS PENDING AT 06:55 AM

NASD Most Active Issues

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While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire  on February 20, 2026, and is solely responsible for the information contained therein.","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260220:nNDL7rBYZF:1","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":null,"symbols":["AQST","LU2210150020.SGD","LU0314104364.USD","SG9999014005.SGD","SG9999014013.SGD","BK4007","EVT.AU","IE00B64PRP62.GBP","BK4585","LU2095319765.USD","IE00BGHQF748.EUR","BK7035","IE00BKPKM429.USD","IE00B3QW5Z07.USD","BK4588","NDAQ","BK4112","SG9999014021.USD","LU2210149790.SGD","SG9999014039.USD"],"gpt_icon":0},{"id":"2612448356","title":"Aquestive Therapeutics Names Dr. Matthew Greenhawt Chief Medical Officer","url":"https://stock-news.laohu8.com/highlight/detail?id=2612448356","media":"Reuters","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612448356?lang=en_us&edition=fundamental","pubTime":"2026-02-18 20:00","pubTimestamp":1771416018,"startTime":"0","endTime":"0","summary":"Aquestive Therapeutics Inc. appointed Matthew Greenhawt, MD, MBA, MSc, as Chief Medical Officer as it prepares to resubmit its Anaphylm  sublingual film application and advance its pipeline. Gary Slatko, who served as interim Chief Medical Officer, will remain with the company as part of the medical team to support the resubmission and potential launch.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aquestive Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire  on February 18, 2026, and is solely responsible for the information contained therein.","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260218:nNDL1wrS3t:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SG9999014013.SGD","LU2095319765.USD","LU2210149790.SGD","NDAQ","IE00BKPKM429.USD","LU0314104364.USD","IE00B3QW5Z07.USD","BK4112","SG9999014005.SGD","SG9999014039.USD","LU2210150020.SGD","BK4585","AQST","IE00BGHQF748.EUR","SG9999014021.USD","BK4007","IE00B64PRP62.GBP","BK4588"],"gpt_icon":0},{"id":"2612448600","title":"Press Release: Aquestive Therapeutics Appoints Internationally Recognized Allergist Dr. Matthew Greenhawt as Chief Medical Officer","url":"https://stock-news.laohu8.com/highlight/detail?id=2612448600","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612448600?lang=en_us&edition=fundamental","pubTime":"2026-02-18 20:00","pubTimestamp":1771416000,"startTime":"0","endTime":"0","summary":"-- Board-certified allergist and leading food allergy and anaphylaxis. WARREN, N.J., Feb. 18, 2026  -- Aquestive Therapeutics, Inc.  , a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the appointment of Matthew Greenhawt, MD, MBA, MSc, as Chief Medical Officer, strengthening its leadership team as the Company prepares to resubmit its Anaphylm New Drug Application  to the United Stated Food and Drug Administration  and advance its clinical pipeline.Dr. Greenhawt is an internationally recognized expert in allergy and immunology with particular expertise in food allergy, anaphylaxis, patient-centered care, and health services and health policy research. He brings extensive clinical, research, and advocacy experience to Aquestive at a critical juncture in the Company's history.\"Dr. Greenhawt's appointment represents another strong addition to the Aquestive leadership team,\" ","market":"fut","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":null,"symbols":["BK4555","BK4139","BK4539","BK4232","BK4099","BK4604","BK4585","CDMO","TM","BK4022","LENZ","BK4007","AQST","R","BK4588","03160"],"gpt_icon":0},{"id":"2608154578","title":"NASD Most Active Issues","url":"https://stock-news.laohu8.com/highlight/detail?id=2608154578","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608154578?lang=en_us&edition=fundamental","pubTime":"2026-02-03 06:43","pubTimestamp":1770072180,"startTime":"0","endTime":"0","summary":"Strive Cl A                 ASST   123,487,824    0.7232    -0.10    -11.92. iShares Bitcoin Trust ETF   IBIT   106,136,011     44.22    -3.27     -6.89. iShares Ethereum Tr ETF     ETHA    97,651,084     17.50    -2.67    -13.24. 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USA Rare Earth              USAR    48,373,482     22.11    -0.31     -1.38","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","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":null,"symbols":["IE00BWXC8680.SGD","LU0820561909.HKD","FUSE","LU1267930730.SGD","IE00B894F039.SGD","BK4547","LU2756315318.SGD","LU2471134879.HKD","LU2063271972.USD","BK4602","LU2543165471.USD","SG9999002620.SGD","LU1861559042.SGD","LU2756315664.SGD","07766","LU2462157665.USD","ETH.USD.CC","IE00BK4W5L77.USD","LU0345770308.USD","SG9999015945.SGD","LU0820562030.AUD","BK4574","LU1145028129.USD","BK4613","LU0466842654.USD","LU2290526834.HKD","LU1066051811.HKD","BK4579","LU2602419157.SGD","LU1429558221.USD","TSLY","TESL","LU1435385759.SGD","LU1674673428.USD","LU0979878070.USD","BK4550","LU1629891620.HKD","IE00BSNM7G36.USD","LU0719512351.SGD","BK4601","LU2750360997.AUD","IE00B19Z8W00.USD","LU0689472784.USD","LU2417539215.USD","SG9999002406.SGD","BK4548","LU1674673691.USD","LU1242518931.SGD","LU2045819591.USD","LU0082616367.USD","ETHA","LU0320765059.SGD","LU0441851309.USD","ETH.USD.HKCC","AQST","BTC.USD.CC","LU1548497426.USD",".IXIC","LU1839390173.USD","IE00B19Z9P08.USD","BK4529","LU2403377893.USD","BK4022","BK4122","BK4141","LU0823411888.USD","BK4561","IE00B19Z9505.USD","TSII","LU0321505439.SGD","LU1232071149.USD","LU1914381329.SGD","LU0964807845.USD","LU2471134952.CNY","BK4594","LU0097036916.USD","LU0234570918.USD","LU2750360641.GBP","IE00B19Z8X17.USD","INTC","LU1861220033.SGD","BK4230","LU2931357623.SGD","IBIT","BK4554","BK4535","LU0345769128.USD","LU1066051498.USD","LU1861558580.USD","LU2360106780.USD","TSYY","BK4551","LU0672654240.SGD","LU0274383776.USD","LU0943347566.SGD","LU1366192091.USD","LU2471134523.USD","SG9999015986.USD","BK4023","BK4592","TSLI","BK4539","LU0345770993.USD","BK4593","BK4581","SG9999013486.USD","LU0823414478.USD","SG9999006266.SGD","NVDA","SG9999013478.USD","BK4604","BK4588","BK4612","BK4512","TSLL","LU2420271590.USD","BK4516","MSTX","TSLW","LU0316494557.USD","LU0077335932.USD","BK4127","LU2213496289.HKD","LU2125910500.SGD","LU2896262040.SGD","BK4585","BK4099","LU1066051225.USD","LU0532188223.SGD","TSLG","LU0348723411.USD","LU2250418816.HKD","LU2087621335.USD","TSLR","LU0708995401.HKD","IE00BJLML261.HKD","TSLZ","SG9999001135.SGD","LU2326559502.SGD","LU2357305700.SGD","CRSH","SGXZ58947870.SGD","IE00BZ9MQY76.HKD","LU1852331112.SGD","LU1551013425.SGD","BK4533","TQQQ","LU0056508442.USD","BK4598","LU1242518857.USD","BK4575","LU2362540622.SGD","TSDD","TSLP","LU1720051017.SGD","TSLQ","SG9999002679.SGD","LU2236285917.USD","TSL","LU2023250330.USD","IE00B1BXHZ80.USD","LU0081259029.USD","BK4527","LU2089985449.USD","LU1839511570.USD","SG9999002414.USD","LU0345769631.USD","LU1778281490.HKD","LU1861215975.USD","TSLO","IE00B19Z9Z06.USD","LU0109391861.USD","LU2249611893.SGD","IE0034235303.USD","04335","BK4605","BK4534","SG9999015952.SGD","SG9999002604.SGD","TSLT","SG9999015978.USD","LU0210536198.USD","BK4543","LU0234572021.USD","LU0321505868.SGD","LU2360107168.USD","BK4511","ASST","BK4555","LU2108987350.USD","LU0323591593.USD","LU0210637038.USD","LU0820561818.USD","IE00B1XK9C88.USD","BK4515","LU2362541513.USD","LU0198837287.USD","IE00BK4W5M84.HKD","LU1551013342.USD","LU1066053197.SGD","TSLS","LU0053666078.USD","LU2362541273.HKD","LU2456880835.USD","SG9999013460.SGD","LU2471134796.USD","LU1720051108.HKD","LU2148611432.USD"],"gpt_icon":1},{"id":"2608891904","title":"What's Going On With Aquestive Therapeutics Stock After FDA Update For Lead Allergic Treatment?","url":"https://stock-news.laohu8.com/highlight/detail?id=2608891904","media":"Benzinga_recent_news","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608891904?lang=en_us&edition=fundamental","pubTime":"2026-02-03 02:12","pubTimestamp":1770055920,"startTime":"0","endTime":"0","summary":"Aquestive received an FDA rejection for its allergy film due to safety and use issues. The company plans new studies and targets resubmission in 2026.","market":"us","thumbnail":"https://cdn.benzinga.com/files/images/story/2026/02/02/Peanut-Allergy.jpeg?optimize=medium&dpr=2&auto=webp&width=240","type":0,"news_type":0,"thumbnails":["https://cdn.benzinga.com/files/images/story/2026/02/02/Peanut-Allergy.jpeg?optimize=medium&dpr=2&auto=webp&width=240"],"rights":{"source":"benzinga_recent_news","url":"https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.benzinga.com/news/fda/26/02/50309975/whats-going-on-with-aquestive-therapeutics-stock-after-fda-update-for-lead-allergic-treatment","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":"benzinga_recent_news","symbols":["LU0757428866.USD","LENZ","BK4530","BK4007","LU0390134368.USD","BK4588","BK4539","BK4181","BK4121","LU1815336091.USD","LU0029874061.USD","BK4139","CRL","BK4218","BK4585","LU0128526141.USD","HF","PK","IE00BFMHRM44.USD","AQST"],"gpt_icon":0},{"id":"2608893244","title":"Leerink sees ‘silver lining’ in Aquestive CRL given defined path to approval","url":"https://stock-news.laohu8.com/highlight/detail?id=2608893244","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608893244?lang=en_us&edition=fundamental","pubTime":"2026-02-02 23:45","pubTimestamp":1770047114,"startTime":"0","endTime":"0","summary":"Leerink analyst Roanna Ruiz was not surprised that Aquestive Therapeutics (AQST) received a Complete Response Letter for Anaphylm given the FDA’s p...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/leerink-sees-silver-lining-in-aquestive-crl-given-defined-path-to-approval-thefly?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/leerink-sees-silver-lining-in-aquestive-crl-given-defined-path-to-approval-thefly?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["LU0128526141.USD","AQST","IE00BFMHRM44.USD","BK4530","LU0757428866.USD","LU0029874061.USD","BK4121","BK4007","LU1815336091.USD","BK4547","BK4585","LU0390134368.USD","BK4588"],"gpt_icon":0},{"id":"2608933078","title":"Aquestive CRL from FDA ‘clearing event,’ says Oppenheimer","url":"https://stock-news.laohu8.com/highlight/detail?id=2608933078","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608933078?lang=en_us&edition=fundamental","pubTime":"2026-02-02 23:40","pubTimestamp":1770046809,"startTime":"0","endTime":"0","summary":"Oppenheimer views the complete response letter from the FDA as a “clearing event” for Aquestive Therapeutics (AQST). The letter “provides assurance...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/aquestive-crl-from-fda-clearing-event-says-oppenheimer-thefly?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/aquestive-crl-from-fda-clearing-event-says-oppenheimer-thefly?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["BK4121","BK4127","AQST","OPY","LU0390134368.USD","LU0029874061.USD","BK4007","LU1815336091.USD","LU0128526141.USD","BK4588","BK4530","BK4585","CRL","IE00BFMHRM44.USD","LU0757428866.USD"],"gpt_icon":0},{"id":"2608860017","title":"Analysts Offer Insights on Healthcare Companies: Aquestive Therapeutics (AQST) and Artivion (AORT)","url":"https://stock-news.laohu8.com/highlight/detail?id=2608860017","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608860017?lang=en_us&edition=fundamental","pubTime":"2026-02-02 23:00","pubTimestamp":1770044416,"startTime":"0","endTime":"0","summary":"There’s a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Aquestive Therapeutics (AQST – Research Report) and ...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-offer-insights-on-healthcare-companies-aquestive-therapeutics-aqst-and-artivion-aort-blurbs?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/analysts-offer-insights-on-healthcare-companies-aquestive-therapeutics-aqst-and-artivion-aort-blurbs?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["HCSG","AORT","BK4585","IE00B19Z4B17.USD","AQST","IE0031619046.USD","BK4137","BK4581","XBI","IE00B7SZL793.SGD","IE00B66KJ199.SGD","LU0128526141.USD","LU0029874061.USD","XLV","BK4588","BK4082","BK4007","LABU"],"gpt_icon":0},{"id":"2608867275","title":"Aquestive Therapeutics Shares Gain 38.6%","url":"https://stock-news.laohu8.com/highlight/detail?id=2608867275","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608867275?lang=en_us&edition=fundamental","pubTime":"2026-02-02 22:35","pubTimestamp":1770042948,"startTime":"0","endTime":"0","summary":null,"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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260202:nL4N3YY1B3:1","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":"reuters_en_live","symbols":["BK4007","AQST"],"gpt_icon":0},{"id":"2608869920","title":"Aquestive Therapeutics Shares Gain 35% Premarket","url":"https://stock-news.laohu8.com/highlight/detail?id=2608869920","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608869920?lang=en_us&edition=fundamental","pubTime":"2026-02-02 20:44","pubTimestamp":1770036267,"startTime":"0","endTime":"0","summary":null,"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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260202:nL4N3YY13I:1","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":"reuters_en_live","symbols":["AQST","BK4007"],"gpt_icon":0},{"id":"2608086930","title":"BRIEF-Aquestive Therapeutics Announces FDA Issuance Of Complete Response Letter For Anaphylm","url":"https://stock-news.laohu8.com/highlight/detail?id=2608086930","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608086930?lang=en_us&edition=fundamental","pubTime":"2026-02-02 20:35","pubTimestamp":1770035719,"startTime":"0","endTime":"0","summary":"BRIEF-Aquestive Therapeutics Announces FDA Issuance Of Complete Response Letter For AnaphylmFeb 2 (Reuters) - Aquestive Therapeutics Inc AQST.O:AQUESTIVE THERAPEUTICS ANNOUNCES FDA ISSUANCE OF COMPLET","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260202:nTUAB1H1WW:1","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":null,"symbols":["BK4007","AQST"],"gpt_icon":0},{"id":"2608866715","title":"Aquestive's Application for Allergic Reaction Treatment Has Deficiencies, FDA Says","url":"https://stock-news.laohu8.com/highlight/detail?id=2608866715","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608866715?lang=en_us&edition=fundamental","pubTime":"2026-02-02 20:22","pubTimestamp":1770034920,"startTime":"0","endTime":"0","summary":"The Food and Drug Administration sent a complete response letter to Aquestive Therapeutics identifying deficiencies in the application for its Anaphylm Sublingual Film allergic reaction treatment.The company said the deficiencies were limited to packaging and administration.\"These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis,\" the company said. \"To resolve the FDA's concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling.\". Aquestive said it would resubmit the application as early as the third quarter and that it remained confident in the effectiveness and safety of Anaphylm.","market":"hk","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://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":"Aquestive's Application for Allergic Reaction Treatment Has Deficiencies, FDA Says","news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["AQST","BK4007"],"gpt_icon":0},{"id":"2608866385","title":"US FDA declines to approve Aquestive's oral drug for allergic reactions","url":"https://stock-news.laohu8.com/highlight/detail?id=2608866385","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608866385?lang=en_us&edition=fundamental","pubTime":"2026-02-02 20:05","pubTimestamp":1770033947,"startTime":"0","endTime":"0","summary":"US FDA declines to approve Aquestive's oral drug for allergic reactionsFeb 2 (Reuters) - 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