Today’s Daily Dose brings you news about Achieve Life Sciences’ new achievement; Aeterna’s update on the resubmitted NDA for Macrilen; Auris’ progress in its pipeline; CRISPR’s advancements in its pipeline; NovaBay’s improving financials and the way forward for TherapeuticsMD’s NDA for TX-004HR.
Achieve Life Sciences Inc. (ACHV) has received the go-ahead from the FDA to proceed with the clinical development of Cytisine as a smoking cessation treatment in the U.S.
Cytisine has been approved and marketed in Central and Eastern Europe as a smoking cessation treatment for more than 15 years.
Two prior, large-scale phase III clinical studies of Cytisine, dubbed TASC and CASCAID, conducted in Europe and New Zealand, have demonstrated favorable outcomes.
ACHV closed Thursday’s trading at $2.97, down 14.41%. In after-hours, the stock was up 21.21% to $3.60.
Aeterna Zentaris Inc.’s (AEZS) net loss for the three months ended June 30, 2017 narrowed to $2.6 million or $0.18 per share from $7.0 million or $0.71 per share in the year-ago quarter, thanks to lower operating expenses as well as higher net finance income.
Revenues for the recent second quarter grew to $243,000 from $96,000 in the comparable year-ago quarter.
The Company credits the increase in revenue to the expanded contract to promote *APIFINY which was effective June 1, 2016 and the amortization of the up-front payment received in connection with one of the out-licensing agreements that was entered into in the third quarter of 2016 for Zoptrex.
APIFINY is the only cancer-specific, non-PSA blood test that is designed to aid clinicians in the risk assessment for prostate cancer.
Aeterna discontinued the development of Zoptrex in May of this year following the failure of the compound in a phase III trial in endometrial cancer.
The Company’s resubmitted new drug application seeking approval of Macrilen for the evaluation of growth hormone deficiency in adults is under FDA review – with a decision date set for December 30, 2017. Macrilen was turned down by the FDA in November 2014.
Recently, the Company formed a Strategic Review Committee to consider and evaluate various strategic and financing alternatives to maximize shareholder value.
AEZS closed Thursday’s trading at $1.73, down 3.89%. In after-hours, the stock was up 4.05% to $1.80.
Auris Medical Holding AG (EARS) is making good progress in its pipeline.
The Company has completed enrollment in its phase III trial of AM-111 for Acute Inner Ear Hearing…