Aquestive Therapeutics

Anaphylm Shows Consistent Efficacy Despite Oral Allergy Syndrome Complications

3 months ago

• Phase 2 trial demonstrates that Anaphylm maintains its pharmacokinetic and pharmacodynamic profiles in patients with Oral Allergy Syndrome, showing comparable or superior effectiveness to intramuscular epinephrine. • Study participants experienced rapid symptom resolution within 12 minutes of Anaphylm administration, compared to 74 minutes without intervention, with angioedema symptoms resolving in approximately 5 minutes. • Research led by Aquestive Therapeutics provides crucial evidence that oral physiological changes during allergic reactions do not compromise Anaphylm's therapeutic effectiveness.

Aquestive Therapeutics Advances Anaphylm NDA Submission and Alopecia Areata Trial

4 months ago

• Aquestive Therapeutics is on track to submit its NDA for Anaphylm sublingual film in Q1 2025, aiming to provide the first orally delivered epinephrine for severe allergic reactions. • The company is actively recruiting for the Anaphylm pediatric clinical trial, expanding access to this potential treatment across different age groups. • Aquestive's AQST-108 topical gel completed a pre-IND meeting with the FDA and is set to begin a Phase 2a trial for alopecia areata in Q2 2025.

VectorY Therapeutics Appoints Jim Scibetta as CEO, Advances ALS Program

5 months ago

• VectorY Therapeutics has appointed Jim Scibetta as its new CEO, succeeding Sander van Deventer, who will transition to President of R&D. • The company's lead program, VTx-002, a vectorized antibody targeting TDP-43 for ALS, is advancing into IND-enabling studies following positive FDA feedback. • VectorY recently completed a $138 million Series A funding round to support the clinical development of VTx-002 and other pipeline programs. • The company has expanded its presence by opening a new office in Boston, alongside its headquarters in Amsterdam.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Aquestive and Insignis Advance Needle-Free Epinephrine Options for Anaphylaxis Treatment

7 months ago

• Aquestive Therapeutics' Anaphylm sublingual film receives positive FDA feedback, reaffirming the NDA submission guidance for Q1 2025, potentially becoming the first orally delivered epinephrine product. • Insignis Therapeutics' IN-001, a needle-free epinephrine sublingual spray, also received positive FDA feedback, with PK/PD trials in healthy subjects potentially leading to NDA submission. • Both Anaphylm and IN-001 offer innovative, user-friendly alternatives to traditional epinephrine injections, addressing the needs of the 33 million Americans with food allergies.

Aquestive Therapeutics Advances Anaphylm and AQST-108, Reports Q3 2024 Financial Results

7 months ago

• Aquestive Therapeutics plans to submit Anaphylm™ (epinephrine) Sublingual Film for FDA approval after completing adult supportive studies, with a pre-NDA meeting scheduled for Q4 2024. • AQST-108 (epinephrine) Topical Gel, a novel prodrug for alopecia areata, is progressing towards a Phase 2a study in 2025, pending FDA alignment after a pre-IND meeting in Q4 2024. • Libervant® (diazepam) Buccal Film is now available through retail channels for patients aged 2-5, supported by a dedicated sales force and nationwide reimbursement coverage. • Aquestive Therapeutics reaffirms its cash runway into 2026, having finished Q3 2024 with approximately $78 million in cash.

FDA Approves Novel Therapies for Frostbite, Food Allergies, and Synovial Sarcoma in 2024

7 months ago

• The FDA approved Aurlumyn (iloprost) in February 2024, the first-ever treatment for severe frostbite, significantly reducing the risk of amputation in affected patients. • Omalizumab (Xolair) received FDA approval in February 2024 to reduce allergic reactions following accidental food exposure, benefiting individuals with life-threatening food allergies. • Tecelra, a T-cell receptor gene therapy, was approved in August 2024 for metastatic synovial sarcoma, marking a significant advancement in treating this rare cancer. • The FDA has authorized 950 AI/ML-enabled medical devices, including 21 in 2024, showing progress in integrating artificial intelligence into healthcare for improved diagnostics and treatments.

Aquestive's Epinephrine Film Demonstrates Rapid Relief for Oral Allergy Syndrome

7 months ago

• Aquestive Therapeutics' Anaphylm, a sublingual epinephrine film, shows symptom relief for oral allergy syndrome (OAS) within two minutes. • The study demonstrated complete symptom resolution in approximately 12 minutes, significantly faster than the 74 minutes without treatment. • Anaphylm's absorption rates remain consistent even with mouth swelling, as confirmed by measurements of epinephrine concentration in the blood. • Aquestive plans to submit a New Drug Application to the FDA in early 2025, with potential launch in early 2026 if approved.

Aquestive's Anaphylm Shows Rapid Symptom Resolution in Oral Allergy Syndrome Study

7 months ago

• Aquestive Therapeutics' Anaphylm sublingual film met both primary and secondary endpoints in an Oral Allergy Syndrome (OAS) challenge study. • The study demonstrated rapid resolution of allergen-related symptoms, beginning as early as two minutes after Anaphylm administration. • Pharmacokinetic profiles of Anaphylm were consistent, regardless of allergen exposure, supporting its reliability in real-world allergic scenarios. • Aquestive is on track for a pre-NDA meeting with the FDA in Q4 2024 and plans to submit an NDA in Q1 2025.

Aquestive's Anaphylm Sublingual Film Shows Rapid Symptom Resolution in Allergy Challenge Study

7 months ago

• Aquestive Therapeutics' Anaphylm sublingual film demonstrated rapid resolution of allergen-related symptoms, beginning within 2 minutes of administration in an Oral Allergy Syndrome (OAS) challenge study. • The study met its primary and secondary endpoints, showing comparable pharmacokinetic profiles of Anaphylm in subjects with and without allergen exposure, indicating consistent drug absorption. • Complete symptom resolution was achieved in an average of 12 minutes, significantly faster than the 74 minutes observed during screening, with swelling resolved within 5 minutes in all instances. • Aquestive plans to request a pre-New Drug Application (NDA) meeting with the FDA in Q4 2024 and anticipates a full product launch of Anaphylm in Q1 2026, pending regulatory approval.

Aquestive's Sublingual Epinephrine Film, Anaphylm, Nears NDA Submission for Anaphylaxis Treatment

7 months ago

• Aquestive Therapeutics anticipates submitting a New Drug Application (NDA) for Anaphylm, a sublingual epinephrine film, to the FDA in the first quarter of 2025. • Anaphylm aims to provide a needle-free, device-free oral option for epinephrine delivery, potentially improving accessibility and ease of use for patients at risk of anaphylaxis. • Clinical data indicates Anaphylm's epinephrine absorption is comparable to autoinjectors like EpiPen, with a faster time to maximum concentration (Tmax). • The sublingual film formulation offers potential stability advantages over traditional epinephrine auto-injectors, particularly in varying temperature conditions.

Aquestive Therapeutics Advances Anaphylm and Alopecia Treatment, Receives Analyst Boost

8 months ago

• Aquestive Therapeutics' Anaphylm sublingual film demonstrated rapid symptom resolution in an oral allergy syndrome challenge study, with a median time of 12 minutes. • The company plans to hold a pre-NDA meeting with the FDA in Q4 2024 and submit the NDA in Q1 2025, targeting a product launch in Q1 2026. • Aquestive is also developing AQST-108, a topical gel for alopecia areata, with a Phase 2 study expected to commence in the second half of 2025. • H.C. Wainwright raised the price target for Aquestive Therapeutics to $10, reflecting the potential of Anaphylm and AQST-108.