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Nov. 9, 2015, 8:31 AM
- RedHill Biopharma (NASDAQ:RDHL) and development partner IntelGenx (OTCQX:IGXT) announce that RIZAPORT (RHB-103) has been cleared for sale by the German Federal Institute for Drugs and Medical Devices for the treatment of acute migraines. The national approval of RIZAPORT in Germany was granted under the European Decentralized Procedure in which Germany was the Reference Member State. Clearance in Luxembourg, the Concerned Member State, should happen shortly. Other EU countries have the option of accepting Germany's marketing authorization without requiring a separate application process.
- RIZAPORT, 5 mg and 10 mg, is an oral thin film formulation of rizatriptan benzoate that is the first oral thin film bioequivalent to Merck GmbH's Maxalt Lingua. It is a therapeutic option for patients suffering from dysphagia (difficulty swallowing) and those suffering from migraine-related nausea, which may be 80% of the total migraine population. About 2M Europeans are prone to daily migraine attacks.
- The companies submitted a New Drug Application (NDA) to the U.S. FDA in 2013 but received a Complete Response Letter (CRL) in 2014 citing issues related to CMC (Chemistry, Manufacturing and Controls), which the firms are working to address, including a compliant source of raw material.
- RDHL is up 4% premarket on light volume.
Jul. 20, 2015, 4:06 PM
Dec. 1, 2014, 8:43 AM
- The German Federal Institute for Drugs and Medical Devices has validated the European Marketing Authorization Application (MAA) from RedHill Biopharma Ltd. (NASDAQ:RDHL) and IntelGenx Corp. (OTCQX:IGXT) for Rizaport, an oral thin film formulation of rizatriptan, for the treatment of acute migraines. The German regulator's formal review of the application is now underway with feedback expected in 2H 2015.
- The MAA was submitted under the European Mutual Recognition Procedure with Germay as the reference member state and Luxemburg as the concerned member state.
- The companies submitted an NDA to the FDA in March 2013 but are still working on the issues cited in a Complete Response Letter (CRL) received in February 2014.
Nov. 19, 2014, 7:45 AM
- On Nov. 20, Singular Research will be hosting the Best of the Uncovereds conference in NYC.
- More than 20 "off-the-radar" companies will be presenting. As of now, the following small-caps are expected to present. In aggregate, the companies presenting are followed by more than 29,000 SA users. The number of SA alert subscribers for each symbol follows the symbol:
- ACET 582, ACU 123, OTCQB:ADTM 671, ADES 394, AXPW 1341, BONE 780, LODE 642, DXPE 505, HPJ 931, OTCQX:IGXT 1,244, INTL 1,360, MNTX 497, OTCQB:MEEC 92, LABL 165, NEWT 200, PSEC 16,546, SA 2,459, SPA 305, TREC 213, OTCQX:YGYI 164
Nov. 12, 2014, 10:19 AM
- IntelGenx (OTCQX:IGXT): YTD EPS of -$0.03.
- Cash on hand of $4.4M
Oct. 1, 2014, 11:31 AM
- RedHill Biopharma (RDHL -1.6%) and IntelGenx (OTCQX:IGXT -3%) submit a Marketing Authorization Application to the German Federal Institute for Drugs and Medical Devices seeking European marketing clearance for RHB-103, an oral thin film formulation of rizatriptan for the treatment of acute migraines, under the brand name Rizaport.
- Rizatriptan benzoate is a 5-HT1 receptor agonist. It is the active drug in Merck's Maxalt. Rizaport utilizes IntelGenx's VersaFilm technology.
- The MAA was submitted under the European Mutual Recognition Procedure with Germany as the reference member state.
- The companies submitted an NDA to the FDA in March 2013. The agency responded with a CRL in February 2014 raising questions about chemistry, manufacturing and controls. The firms' efforts to address the issues are ongoing.
Sep. 18, 2014, 12:25 PM
- On Sept. 22, Singular Research will be hosting the Best of the Uncovereds conference in LA.
- Thirty "off-the-radar" companies will be presenting. As of today, the following small-cap companies are expected to present. In aggregate, the companies presenting are followed by more than 13,000 SA users. The number of SA alert subscribers for each symbol follows the symbol:
- AETI 127, AVNW 769, BONE 765, CLIR 805, LODE 620, OTCQB:CRWG 128, HILL 750, DXPE 514, ELLO 0, OTCQX:IGXT 1,249, NNVC 1,632, NEWT 191, TIS 1,084, QUAD 562, REED 748, REX 491, RMCF 459, SALM 230, SPA 305, TESS 282, TREC 211, HTM 1,252
Jul. 18, 2014, 1:09 PM
- IntelGenx (OTCQX:IGXT +6.5%) CEO Dr. Horst G. Zerbe will host a conference call on July 23, 2014 at 10:00 am EDT to update investors on its business and recent management changes.
- The FDA sent the firm a CRL in February stating that it could not approve VersaFilm due to issues pertaining to third party manufacturing, packaging and labeling.
Feb. 4, 2014, 8:44 AM
- The FDA has told IntelGenx (IGXT) and RedHill Biopharma (RDHL -2.8%) that it won't yet approve their VersaFilm oral film treatment for acute migraines, due to issues over third party manufacturing, packaging and labeling.
- However, in a complete response letter, the FDA said it accepted the bioequivalence study and safety information submitted, and that it requires no additional studies.
- IntelGenx and RedHill intend to address the FDA's concerns within weeks, and to advance discussion with potential partners for the commercialization of VersaFilm.
- In addition to seeking FDA approval for the product, IntelGenx and RedHill intend to file for European authorization later this year. (PR)
IntelGenx, through its cutting edge formulation platforms, has developed a broad and diverse product portfolio, including products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis,... More
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