FLXN Steers SHIP, NVAX To Report Data In Feb, FDA Nod For AERI, Spectral Shines

(RTTNews) - Today's Daily Dose brings you news about FDA approval of Aerie's eye drug much ahead of the decision date; EyeGate's progress in pivotal anterior uveitis trial; Flexion's initiation of its SHIP trial; Madrigal's stock offering; delay in release of Novavax's NanoFlu vaccine trial data and FDA clearance of Spectral Medical's Apheresis Machine.

Read on...

Aerie Pharmaceuticals Inc. (AERI) on Monday received FDA approval for Rhopressa 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, well ahead of the decision date of February 28, 2018.

The Company is expected to launch Rhopressa by mid-second quarter of 2018.

Another eye drug is in the works, and Aerie expects to file NDA for that drug named Roclatan for lowering IOP in patients with open-angle glaucoma or ocular hypertension in second quarter 2018.

AERI closed Monday's trading at $58.30, down 1.19%.

EyeGate Pharmaceuticals Inc.'s (EYEG) phase III pivotal trial of EGP-437 for treatment of non-infectious anterior uveitis has reached 75% patient enrollment.

The phase III trial is designed to enroll 250 subjects in the U.S. The Company expects topline data to be released in the second quarter of 2018.

Eyegate has an exclusive, worldwide licensing agreement with Valeant Pharmaceuticals International (VRX), through which EyeGate granted Valeant exclusive, worldwide commercial and manufacturing rights to its EyeGate II Delivery System and EGP-437 combination product in the field of uveitis, as well as, a right of last negotiation to license such product for other indications. Valeant also has exclusive, worldwide rights to commercial and manufacture this combination product for the treatment of post-operative ocular inflammation and pain in ocular surgery patients, pursuant to a license agreement executed in February 2017.

EYEG closed Monday's trading at $1.24, down 2.36%.

Flexion Therapeutics Inc. (FLXN) has enrolled the first patient in a clinical trial to evaluate the pharmacokinetics and safety of ZILRETTA in patients with osteoarthritis of the shoulder or hip.

The trial, dubbed "SHIP", is designed to recruit approximately 48 patients in total, including 24 patients with OA of the shoulder and 24 patients with OA of the hip. Flexion expects to report top-line results from the SHIP study in the second half of 2018.

ZILRETTA received its first FDA approval in October of this year for the management of osteoarthritis pain of the knee.

FLXN closed Monday's trading at $24.36, down 3.41%.

Madrigal Pharmaceuticals Inc. (MDGL) has offered to sell 1.5 million shares of its common stock at a public offering price of $83.00 each.

The gross proceeds to Madrigal from the offering are expected to be approximately $125 million. The underwriters have a 30-day option to purchase up to an additional 225,904 shares of common stock. The offering is expected to close on or about December 21, 2017.

The Company's lead drug candidate is MGL-3196, which is under phase II testing in patients with non-alcoholic steatohepatitis (NASH) and heterozygous familial hypercholesterolemia (HeFH).

The NASH trial enrolled 125 patients who were 18 years of age and older with biopsy-confirmed NASH.

On December 6, 2017, the Company announced that MGL-3196 achieved the primary endpoint in the phase II NASH trial.

According to the trial results, there was a statistically significant improvement in the relative decrease in liver fat in patients treated with MGL-3196 compared with placebo at Week 12. About 60% of MGL-3196-treated patients achieved at least 30% liver fat reduction at 12 weeks relative to baseline compared to placebo.

Near-term catalysts:

-- The 36 weeks results from the phase II NASH trial of MGL-3196 are expected in the second quarter of 2018. -- Top-line results from the phase II study of MGL-3196 in heterozygous familial hypercholesterolemia (HeFH) are expected in early 2018.

MDGL closed Monday's trading at $84.04, up 1.90%.

Novavax Inc. (NVAX) announced that as on date, it has enrolled over 3,000 volunteers in its phase III trial of RSV F protein recombinant nanoparticle vaccine (RSV F Vaccine) for infants via maternal immunization.

Based on the current pace of enrollment, the Company expects to conduct an interim analysis in mid-2018, with phase III primary endpoint to be readout in early 2019.

If all goes well as planned, Novavax expects to submit a biologics license application for the RSV F Vaccine by the end of 2019.

As regards its NanoFlu program, the Company now expects a complete phase 1/2 data package in February 2018. The phase I/II clinical trial of the NanoFlu vaccine candidate is in a head-to-head comparison with Fluzone HD. The top-line data from the trial was initially expected before the end of 2017.

NVAX closed Monday's trading at $1.49, up 7.97%. In after-hours, the stock was down 16.11% to $1.49.

Prometic Life Sciences Inc.'s (PLI.TO) (PFSCF.OB) investigational product Ryplazim has been granted orphan drug designation for the treatment of idiopathic pulmonary fibrosis by the FDA.

Another investigational drug of the Company targeting of idiopathic pulmonary fibrosis is PBI-4050, which is entering pivotal Phase 2/3 clinical trials. PBI-4050 was designated Orphan drug by the FDA for the treatment of idiopathic pulmonary fibrosis in February 2015.

Ryplazim is under FDA review for the treatment of patients with congenital plasminogen deficiency, with an action date set for April 14, 2018.

PLI.TO closed Monday's trading at C$1.34, up 6.35%.

Privately-held 60 Degrees Pharmaceuticals has submitted a New Drug Application to the FDA for the use of Tafenoquine to prevent malaria in adults traveling to areas where malaria is prevalent.

"There are real problems with the few anti-malarial drugs we currently have, including both resistance and safety issues. In particular, there can be a problem finding acceptable drugs to safeguard travelers and deployed military personnel. Tafenoquine should prove a useful alternative in combating malaria, noted Dr. Stephen Toovey, Pegasus Research.

Spectral Medical Inc. (EDT.TO) has received FDA clearance for its Spectral Apheresis Machine for use in continuous renal replacement therapy and therapeutic plasma exchange.

The Company has also sought approval for Spectral Apheresis Machine from Health Canada and anticipates a decision in the first half of 2018.

An advanced investigational product in the Company's pipeline is PMX, a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. PMX is under review by the FDA in the U.S.

PMX has been approved for therapeutic use in many countries including Japan, Europe and Canada, and has been used safely and effectively on more than 150,000 patients to date. The product is expected to be launched in Canada commencing in the first quarter of 2018.

EDT.TO closed Monday's trading at C$0.48, up 33.33%.