ACHV Soars On New Achievement, AEZS Shrinks Q2 Loss, TXMD On Watch
(RTTNews) - 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.
Read on...
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 Loss, dubbed HEALOS, which is being conducted in Europe and Asia. The top-line results from HEALOS are expected in the fourth quarter of this year.
The phase III trial of AM-111 for Acute Inner Ear Hearing Loss, which is being conducted in the US, Canada, and South Korea, is known as ASSENT. The top-line results from ASSENT are anticipated in the second half of 2018.
A phase III trial of Keyzilen (AM-101) for Acute Inner Ear Tinnitus, dubbed TACTT3, which is being conducted in Europe, is expected to complete enrollment in the third quarter of 2017 - with top-line results expected in early 2018.
The Company plans to initiate a second Phase 1 trial of AM-125 for Meniere's disease and other vestibular disorders in the fourth quarter of 2017.
EARS closed Thursday's trading at $0.76, down 3.40%.
CRISPR Therapeutics (CRSP) remains on track to file a clinical trial application in Europe by year-end 2017 for beta-thalassemia.
The Company is making rapid progress in advancing its lead program, CTX101 for the treatment of CD19-positive malignancies, through pre-IND studies and process development for manufacturing.
The Company's net loss for the recent second quarter widened to $22.3 million or $56 per share from $17.2 million or $3.15 in the year-ago quarter, primarily due to higher expenses.
CRSP closed Thursday's trading at $17.80, up 1.31%. In after-hours, the stock was up 1.07% to $17.99.
NovaBay Pharmaceuticals Inc.'s (NBY) net loss for the second quarter of 2017 narrowed to $1.7 million or $0.11 per share on sales of $4.1 million. This compared with a net loss of $2.7 million or $0.36 per share and sales of $2.6 million in the year-ago quarter.
Looking ahead, the Company expects sales of $19 million, up 60% over 2016.
NBY closed Thursday's trading at $4.60, up 8.24%.
SK Capital, a private investment firm focused on the specialty materials, chemicals and pharmaceuticals sectors, has entered into an agreement to acquire Perrigo Company plc's ( PRGO) active pharmaceutical ingredients business - Perrigo API.
The transaction is expected to close during Q4 2017.
PRGO closed Thursday's trading at $76.84, up 15.78%.
TherapeuticsMD Inc. (TXMD) plans to re-submit the NDA for TX-004HR, also known as Yuvvexy, after November 3, 2017.
TX-004HR is an applicator-free vaginal estradiol softgel for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.
The FDA had turned down the Company's request to approve TX-004HR in May of this year, citing lack of long-term endometrial safety data for the product candidate beyond the 12-weeks studied in the pivotal phase 3 study.
On July 5, 2017, the Company submitted additional endometrial safety information to the FDA, as requested by the Agency. An initial review of this information has been completed and the Company has been asked to submit the additional endometrial safety information to the NDA for TX-004HR on or before September 18, 2017.
The FDA has sought six weeks time to perform a comprehensive review of the data, and will meet with the Company on November 3, 2017 to discuss the outcome of the review.
TXMD closed Thursday's trading at $5.68, up 1.97%.
