Shares in Aerie Pharmaceuticals (NSDQ:AERI) fell slightly today after the company missed earnings expectations on Wall Street with its third quarter results. The Irvine, Calif.-based company posted a net loss of -$32.4 million, or -89¢ per share, for the 3 months ended Sept. 30, for bottom-line loss of -36% compared with the same period last year. Get […]
Aerie Pharmaceuticals
FDA advisory committee backs Aerie’s Rhopressa eye drug
An FDA advisory committee voted today in favor of Aerie Pharmaceuticals‘ (NSDQ:AERI) Rhopressa product candidate. The dermatologic and ophthalmic drugs advisory committee voted unanimously that clinical trials support the efficacy of Aerie’s netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Nine members of the committee voted to say […]
Nasdaq halts trading of Aerie stock as FDA reviews Rhopressa NDA
Aerie Pharmaceuticals (NSDQ:AERI) said today that Nasdaq has halted trading of the company’s common stock as an FDA committee convenes to review Aerie’s new drug application for its Rhopressa glaucoma and ocular hypertension drug. The Irvine, Calif.-based company submitted the NDA in February and the FDA is slated to finishing reviewing the application by Feb. 28, 2018. Get the full story […]
Aerie launches Ph3 trial for Roclatan eye drug in Europe
Aerie Pharmaceuticals (NSDQ:AERI) said today that it launched its European Mercury 3 late-stage trial of Roclatan in patients with open-angle glaucoma or ocular hypertension. The eye drug is a fixed dose combination of Aerie’s Rhopressa netarsudil ophthalmic solution and a widely-used prostaglandin analogue, latanoprost. The company’s Phase III trial was designed to support regulatory approval and […]
Aerie’s contract manufacturer faces regulatory hurdle
Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
Aerie Pharmaceuticals misses Q2 EPS by a penny
Shares in Aerie Pharmaceuticals (NSDQ:AERI) held steady today after the pharmaceutical company missed EPS estimates on Wall Street with its second quarter results. The Irvine, Calif.-based company posted a net loss of -$28.4 million, or -82¢ per share, with its bottom line down -22.5% compared with the same period last year. Get the full story at our […]
Aerie inks deal for implantable drug-delivery system
Aerie Pharmaceuticals (NSDQ:AERI) said today that it inked a collaborative R&D and licensing agreement with DSM to develop an implantable drug-delivery system for patients with glaucoma and other retinal diseases. DSM has reportedly developed an injectable drug-delivery fiber using polyesteramide polymers that has proven successful in preclinical work with Aerie’s compounds. Get the full story at our sister […]
Aerie touts late-stage safety data for Roclatan eye drops
Aerie Pharmaceuticals (NSDQ:AERI) touted 12-month safety data yesterday from the Phase III registration trial of its Roclatan eye drops for intraocular pressure resulting from glaucoma or ocular hypertension. The study was designed to support Aerie’s new drug application submission to the FDA for Roclatan, which it expects to file in the first half of next year. Get […]
scPharmaceuticals names Tucker as CEO | Personnel Moves – May 1, 2017
scPharmaceuticals said in late April that it named pharma-veteran John Tucker as president & CEO, effective immediately. Tucker was also elected to the company’s board of directors. Tucker formerly served as CEO of Alcresta, where he led regulatory and financing strategies for the company’s 1st product approval and launch. He also worked as Incline Therapeutics’ […]
Aerie resubmits NDA for Rhopressa eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection. Aerie’s Rhopressa eye drops specifically target the eye’s trabecular network – the diseased tissue responsible for […]
Aerie completes enrollment of phase III trial for intraocular pressure eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it completed enrollment for its 2nd phase III registration trial, Mercury 2, evaluating its Roclatan once-daily eye drops for intraocular pressure resulting from glaucoma or ocular hypertension. The company’s Roclatan solution is a fixed dose combination of its drug Rhopressa (netarsudil ophthalmic solution) and latanoprost, a widely prescribed prostaglandin […]