Aridis Pharmaceuticals Inc., of San Jose, Calif., set terms for its IPO, disclosing plans to raise $28 million by offering 2.0 million shares priced in a range of $13 to $15. In its filing, the company said insiders expressed interest in purchasing $25 million worth of the shares, or about 89 percent of the deal. Read More
Imprimis Pharmaceuticals Inc., of San Diego, reported for the second quarter that its revenues were $10.4 million, up 51 percent year-over-year with gross ophthalmology-related revenue of $8.3 million, up 74 percent. Net income for the period was $2.5 million. Shares of Imprimis (NASDAQ:IMMY) closed at $2.71, up 25 cents, on Tuesday. Read More
Praxis Bioresearch LLC, of Menlo Park, Calif., was awarded a $1.5 million fast-track Small Business Innovation Research grant from the National Institutes of Health to support development of PRX-P4-003, an abuse-deterrent dopamine norepinephrine reuptake inhibitor. Read More
The FDA is continuing to churn out guidance at a rapid pace. Tuesday, the agency finalized a 2016 draft guidance on controlling elemental impurities of drugs consistent with the International Council for Harmonisation's "Q3D elemental impurities" guidance. Read More
PERTH, Australia – Melbourne-based Neuren Pharmaceuticals signed a development and commercialization deal with Acadia Pharmaceuticals Inc. worth up to $465 million for North American rights to trofinetide for Rett syndrome and other indications. Read More
Akouos Inc. raised $50 million in a tranched series A financing co-led by 5AM Ventures and New Enterprise Associates (NEA), which first committed to the newly formed gene therapy firm in a $7.6 million seed round in November 2017. Existing seed investor Partners Innovation Fund and new investors Sofinnova Ventures, RA Capital Management and Novartis Venture Fund joined the series A. Read More
Spark Therapeutics Inc. said its experimental hemophilia A therapy, SPK-8011, reduced the annualized need for infusions across all 12 participants in its phase I/II study by 97 percent. But negative immune responses in two of 12, one of which sent a patient to the hospital, sent company shares (NASDAQ:ONCE) down about 28 percent on Tuesday. Plans for phase III trials of the treatment are set to begin in the fourth quarter. Meanwhile, shares of competitor Biomarin Pharmaceutical Inc. (NASDAQ:BMRN), which is developing its own gene therapy for the disorder, climbed, rising about nearly 8 percent. Read More
The team at Bellerophon Therapeutics Inc. intends to further analyze data after an unexpectedly disappointing interim look at the phase III INOvation-1 study testing its inhaled nitric oxide delivery system in pulmonary arterial hypertension (PAH) failed to show sufficient improvements in the six-minute walk distance (6WMD), the primary endpoint. That review prompted the data monitoring committee (DMC) to recommend the study be stopped for futility and sent shares of the Warren, N.J.-based company (NASDAQ:BLPH) falling more than 68 percent Tuesday. Read More
Pressed for details about timing of next steps with gemcabene in dyslipidemia – still on partial clinical hold by the FDA – Gemphire Therapeutics Inc. CEO Steve Gullans said the regulators' demand for more toxicology data is "very recent news, so we haven't had time, working with all the third-party vendors that will be involved, to figure out the exact timeline. We would love to get the 13-week study up and running immediately, but these PPAR alpha knockout mice require some work to get a breeding colony up and rolling. That's why we're targeting the end of the year, beginning of next year. Right now, it's the best estimate we're operating from. That's in keeping with what we've seen in prior work we've done around breeding colonies. Roughly speaking, we would see a nine to 12-month delay over where we were before" the agency made known its decree. Read More
After staring long and hard through the looking glass at Insmed Inc.'s amikacin liposome inhalation suspension (ALIS), the FDA's Antimicrobial Drugs Advisory Committee voted 12-2 Tuesday that the evidence is there to support accelerated approval for ALIS as part of a treatment regimen for adults with nontuberculosis mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who are out of options. Read More
