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AVXS Abuzz, PTCT Slammed For Emflaza Deal, INNL Scouts For Buyer

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Shares of AveXis Inc. (AVXS) were up more than 11% in extended trading on Thursday, following the completion of its phase I clinical study of AVXS-101, the first ever gene therapy studied for the treatment of spinal muscular atrophy Type 1.

According to the trial results, a one-time infusion of AVXS-101 appears to be well-tolerated, with a favorable safety profile, and indicate the potential for a clinically transformative effect on event-free survival, rapid and sustained increases in motor function and achievement of motor milestones never observed in the natural history of this disease, noted the company.

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What's In Store For AVXS Today?

AVXS closed Thursday's trading at $72.78, down 2.80%. In after-hours, the stock was up 11.29% to $81.00.

Agile Therapeutics Inc. (AGRX) is all set to make a poster presentation of data from its phase III clinical trial for its lead product candidate, Twirla, a low-dose combined hormonal contraceptive patch, dubbed SECURE, at the Contraceptive Technology Conferences on March 16 - 18, 2017 in San Francisco, CA and March 29 - April 1, 2017 in Boston, MA.

For more insight and expert analysis of potential investment opportunities in the biotech space, check out our RTT Premium Products.

Twirla was turned down by the FDA in 2013. The SECURE study was conducted to address issues raised by the FDA in its 2013 Complete Response Letter to the company.

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.

AGRX closed Thursday's trading at $2.69, up 13.98%.

BioTime Inc. (BTX) has a couple of catalysts to watch out for in the coming months.

The data from the Company's registrational trial for Renevia in Europe, intended to support approval for use in the treatment of HIV-related facial lipoatrophy in Europe, is expected by mid-2017.

The company is planning to file for EU approval with HIV data in the second half of this year.

Another product candidate in the pipeline is OpRegen, under phase I/IIa clinical trial in the advanced form of dry age-related macular degeneration. Early data from Cohort I of the phase I/IIa trial of OpRegen was reported last December. The Cohort 2 of the trial is expected to be completed this year.

Data from the first and second cohorts in the ongoing phase I/IIa clinical trial are slated to be reported in early May at the Association for Research in Vision and Ophthalmology (ARVO).

BTX closed Thursday's trading at $3.10, up 0.65%.

Shares of Innocoll Holdings plc (INNL) have gained more than 135% over the last 4 trading days.

Commenting on the anomalous movements in its share price this week, Innocoll has confirmed that it is in discussions which may or may not lead to an offer for the entire issued share capital of the Company.

INNL closed Thursday's trading at $1.87, up 36.58%.

PTC Therapeutics Inc. (PTCT) has agreed to acquire all rights to Emflaza, the first treatment approved in the United States for all Duchenne muscular dystrophy (DMD) patients five years and older, regardless of their genetic mutation, from privately-held Marathon Pharmaceuticals LLC.

As part of the agreement, PTC Therapeutics will pay Marathon Pharmaceuticals $75 million in cash plus $65 million in Company stock. Marathon is also entitled to receive payments from PTC based on annual net sales of Emflaza beginning in 2018, which PTC expects will range as a percentage of net sales between the low to mid-20s on a blended average basis. In addition, Marathon has the opportunity to receive a single $50 million sales-based milestone.

The news didn't go down well with PTC investors because Marathon has been accused of setting a very high price of $89,000 for the DMD drug. The active ingredient in Emflaza is deflazacort (a corticosteroid), which according to reports is available in Europe at a price of $1,200. Accused of overpricing, Marathon has delayed the launch of Emflaza, which was approved by the FDA on February 9, 2017.

PTCT closed Thursday's trading at $8.84, down 18.90%.

Tonix Pharmaceuticals Holding Corp. (TNXP) will effect a 1-for-10 reverse stock split of its outstanding common stock on Friday, March 17, 2017.

The reverse stock split is intended to increase the per share trading price of Tonix's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The NASDAQ Global Market.

The reverse stock split will also proportionately reduce the number of shares of authorized common stock from 150 million to 15 million shares, noted the company.

TNXP closed Thursday's trading at $0.38, down 22.49%.

Another company set to implement a reverse split prior to the opening of trading on March 17, 2017, is Rosetta Genomics Ltd. (ROSG)

Rosetta is effecting a 1-for-12 reverse stock split of its share capital to satisfy the $1.00 minimum bid price requirement for continued listing on the NASDAQ Capital Market.

Subsequent to the reverse stock split, there will be approximately 1,870,000 of the Company's ordinary shares issued and outstanding, Rosetta noted.

ROSG closed Thursday's trading at $0.40, down 11.09%.

by RTT Staff Writer

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