FDA Approves 1st Drug For Tardive Dyskinesia, AGRX On Track, ITEK, AZRX On Watch

(RTTNews) - Agile Therapeutics Inc. (AGRX) has confirmed its plans to resubmit its NDA for Twirla, an investigational low-dose combined hormonal contraceptive patch, by the end of the second quarter of 2017.

The New Drug Application pre-submission meeting with the FDA took place on March 14, 2017, during which the Company shared preliminary data from SECURE, a phase III trial of Twirla that was conducted to address issues raised by the FDA in its 2013 Complete Response Letter to the Company.

Twirla was turned down by the FDA in 2013.

The results from the SECURE study were reported on January 4, 2017. Although the study results were positive, the stock got slammed that day as the Company said that 51.4% of subjects discontinued prematurely from the study.

Based on the feedback from the FDA, Agile believes it has the necessary information to complete the resubmission of its NDA as planned.

AGRX closed Tuesday's trading at $3.11, up 5.07%.

AzurRx BioPharma Inc.'s (AZRX) lead candidate MS1819 for the treatment of exocrine pancreatic insufficiency associated with chronic pancreatitis has demonstrated early efficacy and favorable safety profile in an ongoing phase IIa trial.

According to the trial results, MS1819 is active, as measured by coefficient of fat absorption (CFA), which is the parameter being measured for the primary efficacy endpoint. There was a favorable dose response of greater than 20% improvement in CFA seen in all patients at either the second or third of the four escalating dosage levels of MS 1819, the Company noted.

The study is expected to be completed in the third quarter of this year.

AZRX closed Tuesday's trading at $3.96, up 2.86%.

A jury in the United State Federal District Court has ordered CONMED Corp.'s (CNMD) subsidiary, SurgiQuest, to pay $2.2 million in compensatory damages with an additional $10.0 million in punitive damages to Lexion Medical LLC.

SurgiQuest is the manufacturer of the AirSeal system, an access management technology for use in laparoscopic and robotic procedures.

The case relates to the litigation between SurgiQuest and Lexion Medical - with underlying claims that SurgiQuest previously engaged in false advertising in marketing literature related to the AirSeal system.

Commenting on the verdict, Daniel Jonas, Esq., CONMED's Executive Vice President, Legal Affairs and General Counsel said, "This litigation will have no impact on the availability of, or CONMED's ability to distribute, our innovative AirSeal access port or the AirSeal IFs unit."

CNMD closed Tuesday's trading at $45.45, up 1.04%.

Idera Pharmaceuticals Inc. (IDRA) has successfully completed the phase I portion of its ongoing phase I/II clinical trial of IMO-2125 in combination with Ipilimumab in metastatic melanoma patients who are refractory to anti-PD-1 therapy - with all the objectives having been met.

According to the study results, IMO-2125 in combination with Ipilimumab demonstrated preliminary evidence of meaningful clinical activity in the anti-PD-1 refractory metastatic melanoma patient population which represents a high unmet medical need. All dose levels have been well tolerated and did not exacerbate the safety issues commonly observed with Ipilimumab, the Company said.

Enrollment has begun for the phase II portion of the trial with the 8mg dose of IMO-2125. The phase I dose escalation of IMO-2125 in combination with Pembrolizumab is ongoing.

IDRA closed Tuesday's trading at $2.24, up 1.82%.

Inotek Pharmaceuticals Corp. (ITEK) has completed patient recruitment in its phase II trial of a fixed-dose combination of trabodenoson and latanoprost for the treatment of glaucoma.

Top-line data from the study are expected in July.

ITEK closed Tuesday's trading at $1.95, up 5.41%.

Inovio Pharmaceuticals Inc.'s (INO) Ebola vaccine has demonstrated robust immune responses with favorable safety profile in expanded stage of its phase I study.

The Company noted that its Ebola vaccine was well-tolerated with a favorable safety profile compared to viral vector-based Ebola vaccines, some of which have been associated with serious adverse events including myalgia, arthralgia, fever, and rash.

Inovio's Ebola vaccine program is funded by a $45 million contract received from DARPA to develop an Ebola vaccine and DNA-based monoclonal antibody therapy.

INO closed Tuesday's trading at $6.15, down 0.32%.

Nabriva Therapeutics AG (NBRV) has completed enrollment in its first phase III trial of lefamulin (IV/oral) in patients with moderate to severe community-acquired bacterial pneumonia.

The trial, dubbed LEAP 1, has enrolled 550 patients. Top-line clinical data from the study are expected in the third quarter of 2017.

The second pivotal phase III trial of oral lefamulin for the treatment of patients with moderate CABP, dubbed LEAP 2, is underway. Patient enrollment in the LEAP 2 trial is expected to be completed in the fourth quarter of 2017 - with top-line data expected to be available in the first quarter of 2018.

NBRV closed Tuesday's trading at $11.53, up 6.96%.

Shares of Neurocrine Biosciences Inc. (NBIX) rose more than 18% in extended trading on Tuesday, following FDA approval of Ingrezza, the Company's drug to treat adults with tardive dyskinesia.

Ingrezza is the first drug approved by the FDA for tardive dyskinesia.

Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips.

There is one more company in the race to bring a tardive dyskinesia drug to market, and it is Teva Pharmaceutical Industries Ltd. (TEVA). Teva's SD-809 for the treatment of tardive dyskinesia is under FDA review, with a decision expected on August 30, 2017.

NBIX closed Tuesday's trading at $41.48, up 2.90%. In after-hours, the stock was up another 18.73% to $49.25.