FDA Nod For GILD, It's Take 2 For AEZS' Macrilen, VRTX Soars On CF Drug Trials

(RTTNews) - Today's Daily Dose brings you news about Aeterna's upcoming make or break event; Aldeyra's clinical trial catalyst of this quarter; FDA approval of Gilead's HCV drug; Inovio's proposed stock offering; Nektar's oral Human Abuse Potential study of NKTR-181 and Vertex Pharma's cystic fibrosis trial results.

Read on...

Shares of Aeterna Zentaris Inc. (AEZS) surged more than 47% in extended trading on Tuesday, following FDA's acceptance of the Company's resubmitted New Drug Application seeking approval of Macrilen for the evaluation of growth hormone deficiency in adults.

The regulatory agency's decision on Macrilen is expected on December 30, 2017.

Macrilen was issued a Complete Response Letter by the FDA in November 2014. Will second time be the charm for Macrilen?

AEZS closed Tuesday's trading at $1.02, down 2.86%. In after-hours, the stock zoomed 47.06% to $1.50.

Aldeyra Therapeutics Inc. (ALDX) announced that the last patient has completed dosing in its phase IIa clinical trial of ADX-102 in Dry Eye Disease. The Company expects to report data from the trial later this quarter.

ALDX closed Tuesday's trading at $4.75, down 2.06%.

The FDA has approved Gilead Sciences Inc.'s (GILD) Vosevi for re-treatment of adults with chronic hepatitis C virus, ahead of the original decision date of August 8, 2017.

Vosevi is a three drug combination of Sofosbuvir, Velpatasvir and Voxilaprevir, and is indicated for the re-treatment of chronic hepatitis C virus infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.

Vosevi sports a boxed warning in its product label regarding the risk of hepatitis B virus reactivation in HCV/HBV coinfected patients.

GILD closed Tuesday's trading at $71.69, up 0.76%.

Shares of Inovio Pharmaceuticals Inc. (INO) were down more than 8% in extended trading on Tuesday, following its proposed public offering of common stock.

The Company intends to offer and sell $75.0 million of shares of its common stock in an underwritten public offering. The underwriters are expected to be granted an option to purchase up to an additional $11.25 million of shares of common stock on the same terms and conditions.

INO closed Tuesday's trading at $7.83, up 0.77%. In after-hours, the stock was down 8.05% to $7.20.

Nektar Therapeutics' (NKTR) oral Human Abuse Potential study of NKTR-181, a first-in-class opioid analgesic, has yielded positive results.

The NKTR-181 HAP study was designed to confirm and assess the relative oral abuse potential of NKTR-181 at its maximum analgesic or therapeutic dose (400 mg) and at a supratherapeutic dose (3 times to 12 times greater than its analgesic dose range of 100 mg to 400 mg) compared to common therapeutic doses of a Schedule II opioid, Oxycodone.

NKTR-181 successfully completed a phase III efficacy study in March of this year.

NKTR closed Tuesday's trading at $21.60, up 4.55%. In after-hours, the stock was up another 1.81% to $21.99.

Otonomy Inc. (OTIC) supplemental New Drug Application for the approval of OTIPRIO as a treatment of acute otitis externa has been accepted for review by the FDA - with a decision date set for March 2, 2018.

OTIPRIO is already indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

Launched in March 2016, OTIPRIO logged in sales of $0.7 million last year.

OTIC closed Tuesday's trading at $18.90, down 3.32%.

Sunesis Pharmaceuticals Inc. (SNSS) has started the phase 1b/2 study of oral SNS-062 in adults with chronic lymphocytic leukemia and other B-Cell malignancies.

The study is designed to enroll up to 124 subjects and is being conducted at five leading sites in the United States.

SNSS closed Tuesday's trading at $2.56, down 0.39%.

Vertex Pharmaceuticals Inc. (VRTX) soared more than 25% in extended trading on Tuesday, following positive data from phase I and phase II studies of three different triple combination regimens involving its drug candidates VX-440 and VX-152 in people with cystic fibrosis who have one F508del mutation and one minimal function mutation (F508del/Min).

The triple combination regimens were VX-440 + Tezacaftor + Ivacaftor, and VX-152 + Tezacaftor + Ivacaftor.

In phase II studies, the mean absolute improvements in percent predicted forced expiratory volume in one second (ppFEV1) was 9.7 and 12.0 percentage points from baseline for the triple combination regimens with VX-152 or VX-440, respectively.

Initial data from a phase I study showed a mean absolute improvement in ppFEV1 of 9.6 percentage points from baseline for the triple combination regimen of VX-659, tezacaftor and ivacaftor in people with one F508del mutation and one minimal function mutation.

VRTX closed Tuesday's trading at $132.16, up 2.28%. In after-hours, the stock was up 25.61% to $166.