Filing search / Incannex Healthcare Limited / "Package"

10-K

2024 FY

IXHL Incannex Healthcare Limited

30 Sep 24

Annual report

7:30am

. A major potential advantage of this strategy is that the nonclinical toxicology data package that is normally required before testing new drugs … on the basis of a complete independent data package qualify for eight years of data exclusivity upon grant of a marketing authorization and an additional two

8-K

EX-99.1

IXHL Incannex Healthcare Limited

5 Aug 24

FDA Review of PsiGAD2 IND complete; clinical trial for Psilocybin Assisted Psychotherapy in Patients with Generalised Anxiety Disorder to Proceed

8:15am

of the application package during the allocated 30-day period. Incannex received communication that the FDA review was completed, and the IND-opening clinical

S-1/A

IXHL Incannex Healthcare Limited

17 Jul 24

IPO registration (amended)

8:47am

with the FDA on the psilocybin-assisted psychotherapy for GAD program. The pre-IND meeting package was prepared with the assistance of Camargo Pharmaceuticals … in the European Union In the EEA, innovative medicinal products approved on the basis of a complete independent data package qualify for eight years

S-1

IXHL Incannex Healthcare Limited

3 Jul 24

IPO registration

6:29am

. The pre-IND meeting package was prepared with the assistance of Camargo Pharmaceuticals LLC, who also attended the meeting with us. The FDA provided … approved on the basis of a complete independent data package qualify for eight years of data exclusivity upon grant of a marketing authorization

8-K

EX-99.1

IXHL Incannex Healthcare Limited

7 May 24

Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder

8:30am

had reviewed the CannQuit-O meeting package and provided recommendations on the proposed clinical development strategy, including patient populations

8-K

EX-99.1

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16 Apr 24

Incannex Healthcare Inc. Quarterly Update, Q1 2024

9:30am

8-K

EX-10.1

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5 Mar 24

Departure of Directors or Certain Officers

6:11am

8-K

EX-99.1

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16 Feb 24

Incannex Complete Successful Pre-IND Meeting with the FDA for CannQuit-N; a Novel Solution for Tobacco Smoking Cessation

8:00am

10-Q

EX-10.14

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14 Feb 24

Quarterly report

6:16am

6-K

EX-99.1

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7 Nov 23

Report of Foreign Private Issuer

6:02am

6-K

EX-99.1

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1 Sep 23

Report of Foreign Private Issuer

12:00am

6-K

EX-99.1

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22 Aug 23

Review of IND Application for IHL-42X by US FDA has been completed; Clinical Trial for Patients with Obstructive Sleep Apnoea May Proceed

6:01am

6-K

EX-99.1

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25 Jul 23

Incannex Completes Positive Pre-IND Meeting with US FDA on IHL-675A for Treatment of Rheumatoid Arthritis

9:42pm

6-K

EX-99.1

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30 Jun 23

Report of Foreign Private Issuer

8:00am

6-K

EX-99.1

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7 Jun 23

Report of Foreign Private Issuer

8:00am

20-F

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28 Oct 22

Annual report (foreign)

6:31am

6-K

EX-99.1

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21 Oct 22

Report of Foreign Private Issuer

6:08am

6-K

EX-99.1

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11 Oct 22

Incannex Completes Positive Pre-IND Meeting with US FDA on IHL-216A for Treatment of Concussion and Traumatic Brain Injury

6:15am

6-K

EX-99.1

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19 Sep 22

Report of Foreign Private Issuer

9:38pm