{"id":200387,"date":"2025-09-04T20:01:12","date_gmt":"2025-09-04T20:01:12","guid":{"rendered":"https:\/\/www.europesays.com\/us\/200387\/"},"modified":"2025-09-04T20:01:12","modified_gmt":"2025-09-04T20:01:12","slug":"fda-confirms-direct-review-path-for-aquestives-allergy-treatment","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/200387\/","title":{"rendered":"FDA Confirms Direct Review Path For Aquestive’s Allergy Treatment"},"content":{"rendered":"\n

The U.S. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc<\/strong>. (NASDAQ:AQST<\/a>) that an advisory committee meeting is not required for Anaphylm (dibutepinephrine) Sublingual Film<\/a>.<\/p>\n

The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026.<\/p>\n

Anaphylm has the potential to be the first and only FDA-approved,\u00a0non-invasive, orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis<\/a>.<\/p>\n

Also Read: Developer Of EpiPen Alternative Aquestive Stock Undervalued Despite Strong Clinical Data, Analyst Sees Huge Upside<\/a><\/strong><\/p>\n

If approved, people at risk for severe allergic reactions would have a device-free, needle-free epinephrine option.\u00a0Similar in size to a postage stamp, Anaphylm is administered as a thin, dissolvable film placed under the tongue.<\/p>\n

Eleven clinical studies have been completed, with 967 administrations in total (840 single-dose and 127 repeat-dose) for adults and children over 30 kg. The development program also includes a novel trial for oral allergy syndrome demonstrating Anaphylm\u2019s real-world effectiveness.<\/p>\n

In April, Aquestive Therapeutics released topline results from its pediatric study for Anaphylm (epinephrine) sublingual film in patients aged seven to seventeen and weighing over 30 kgs with a personal history of allergic reactions<\/a>.<\/p>\n

Thirty-two patients completed the pediatric study. The PK results were consistent with previous adult studies. Anaphylm was safe and well-tolerated, and no serious adverse events were reported.<\/p>\n

Equity research can be a valuable source of information for learning about a company\u2019s fundamentals.<\/p>\n

Analysts create financial models based on the fundamentals and expected future earnings of a company to arrive at a price target and recommendation for the stock.<\/p>\n

Shares of Aquestive Therapeutics have an average 1-year price target of $10.0, representing an expected upside of 110.3%.<\/p>\n

Price Action:<\/strong> AQST stock is trading higher by 23.09% to $4.86 at last check Thursday.<\/p>\n

Read Next:<\/strong><\/p>\n

Photo via Shutterstock<\/p>\n\n

Date<\/p>\n

Firm<\/p>\n

Action<\/p>\n

From<\/p>\n

To<\/p>\n<\/tr>\n\n\n

Sep 2020<\/p>\n<\/td>\n\n

RBC Capital<\/p>\n<\/td>\n\n

Maintains<\/p>\n<\/td>\n <\/td>\n\n

Outperform<\/p>\n<\/td>\n<\/tr>\n\n\n

Sep 2020<\/p>\n<\/td>\n\n

HC Wainwright & Co.<\/p>\n<\/td>\n\n

Maintains<\/p>\n<\/td>\n <\/td>\n\n

Buy<\/p>\n<\/td>\n<\/tr>\n\n\n

May 2020<\/p>\n<\/td>\n\n

HC Wainwright & Co.<\/p>\n<\/td>\n\n

Maintains<\/p>\n<\/td>\n <\/td>\n\n

Buy<\/p>\n<\/td>\n<\/tr>\n

View More Analyst Ratings for AQST<\/a><\/p>\n

View the Latest Analyst Ratings<\/a><\/p>\n

Up Next: Transform your trading with Benzinga Edge’s one-of-a-kind market trade ideas and tools. Click now to access unique insights<\/strong><\/a> that can set you ahead in today’s competitive market.<\/p>\n","protected":false},"excerpt":{"rendered":"The U.S. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc. (NASDAQ:AQST) that an advisory committee…\n","protected":false},"author":3,"featured_media":200388,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[110965,110960,110962,6434,210,59,1060,110964,110961,110963,67,132,68],"class_list":{"0":"post-200387","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-allergic-reactions","9":"tag-aquestive-therapeutics","10":"tag-epinephrine","11":"tag-food-and-drug-administration","12":"tag-health","13":"tag-inc","14":"tag-medication","15":"tag-prescription-drug-user-fee-act","16":"tag-severe-allergic-reactions","17":"tag-target-action","18":"tag-united-states","19":"tag-unitedstates","20":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/115147812823974100","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/200387","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=200387"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/200387\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/200388"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=200387"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=200387"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=200387"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}