Posts tagged NDA submission
IntelGenx, RedHill Biopharma resubmit RIZAPORT NDA to FDA

IntelGenx (OTCQX:IGXT; TSXV:IGX) and RedHill Biopharma (NASDAQ, TASE:RDHL) resubmitted the 505(b)(2) NDA to the FDA for RIZAPORT 10 mg, an oral thin-film formulation of rizatriptan for the treatment of acute migraines.

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Stifel ups Tetraphase to buy

Stifel upgraded Tetraphase Pharmaceuticals (NASDAQ:TTPH) to “buy” from “hold” and raised its price target to $15 from $8 after the company reported positive top-line results of the IGNITE4 clinical trial evaluating its eravacycline in patients with complicated intra-abdominal infections (cIAI). The stock closed at $6.90 on July 25.

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HCW ups SteadyMed price target to $15

H.C. Wainwright raised its price target for SteadyMed (NASDAQ:STDY) to $15 from $10 after the Patent Trial and Appeal Board ruled in favor of SteadyMed in an inter partes review (IPR) proceeding against United Therapeutics’ 8,497393 patent, finding all 22 claims in the patent unpatentable. The stock closed at $5.80 on March 31.

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Aurinia to begin Phase 3 voclosporin trial in Q2

After an end-of-Phase 2 meeting with the FDA, Aurinia Pharmaceuticals (NASDAQ:AUPH) plans to begin a single Phase 3 clinical trial for voclosporin in the treatment of lupus nephritis (LN).

Aurinia believes the Phase 3 trial, whose design is consistent with the ongoing AURA study, will support a NDA submission.

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ARIAD completes NDA submission for brigatinib

ARIAD Pharmaceuticals (NASDAQ:ARIA) has completed a rolling NDA submission to the FDA for its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib.

ARIAD is seeking U.S. marketing approval of brigatinib for patients with metastatic ALK-positive non-small cell lung cancer who are resistant or intolerant to crizotinib.

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Dipexium completes enrollment in second Phase 3 trial

Dipexium Pharmaceuticals (NASDAQ:DPRX) has completed patient enrollmentin the OneStep-1 pivotal Phase 3 clinical trial of its Locilex broad-spectrum, topical antibiotic peptide.

Last week, the company reached the enrollment objective in the OneStep-2 pivotal trial.

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Dipexium reaches 75% enrolment in Phase 3 trials

Dipexium Pharmaceuticals’ (NASDAQ:DPRX) OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials have reached the 75% enrollment milestone in total, with each study having enrolled nearly the same number of patients.

OneStep-1 and OneStep-2 are identical Phase 3 trials, with 180 patients per clinical trial. They are being conducted under a SPA with the FDA for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.

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