Plus   Neg

FDA Snubs PTIE Again, OVID's STARS Fail To Shine, HAIR Keeps Falling

The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Pain Therapeutics Inc. (PTIE)

Lost 47.03% to close Monday's (Aug 6) trading at $1.25.

News: The Company's investigational pain drug Remoxy ER has been rejected by the FDA again. This is the fourth time that a Complete Response Letter has been issued for Remoxy ER.

The New Drug Application for Remoxy had been rejected thrice by the FDA earlier - i.e., in December 2008, June 2011, and September 2016.

In June of this year, an FDA panel had voted 14 to 3 against the approval of Remoxy ER.

2. Ovid Therapeutics Inc. (OVID)

Lost 36.13% to close Monday's trading at $6.08.

News: The Company announced that its phase II trial of OV101 for the treatment of Angelman Syndrome, dubbed STARS, achieved its primary endpoint of safety and tolerability.

STARS was a 12-week study in which patients were randomized to one of three arms: once-daily dose of OV101 at night (15mg), twice-daily dose of OV101 (10mg in the morning and 15mg at night), and placebo.

There was a robust and statistically significant improvement in the first prespecified efficacy endpoint of physician-rated clinical global impressions of improvement (CGI-I) at 12 weeks of treatment in once-daily dose group compared to placebo.

However, an analysis of prespecified subset of scales across the domains of behavior, sleep and gait did not show a statistically significant difference from placebo, according to the Company.

Near-term Catalyst:

Initiate ELARA, an open-label extension study that will enable individuals with Angelman syndrome who completed any prior OV101 study to be eligible to receive the investigational medicine, in the fourth quarter of this year.

3. Restoration Robotics Inc. (HAIR)

Lost 28.62% to close Monday's trading at $2.02. The stock has lost 56% of its value year-to-date.

News: The Company has commenced an underwritten public offering of up to $25 million of shares of its common stock.

The underwriters of the offering are expected to be provided a 30-day option to purchase up to an additional $3.75 million of shares of common stock.

4. Citius Pharmaceuticals Inc. (CTXR)

Lost 17.05% to close Monday's trading at $1.80. The stock touched a new low of $1.75 in intraday trading.

News: No news


A phase III trial of Mino-Lok Therapy in combination with systemic antibiotics in the treatment of catheter-related bloodstream infections enrolled the first patient as recently as February of this year. This trial is planned to enroll 700 patients in 50 participating institutions, all located in the U.S. There will be interim analyses at the 50% and 75% point of the trial as measured by the number of patients treated.
CITI-001 (Halo-Lido), which is being developed to treat hemorrhoids, has successfully completed a phase IIa study.

5. Bioblast Pharma Ltd. (ORPN)

Lost 15.62% to close Monday's trading at $1.08.

News: No news


The Company's lead compound is Trehalose, which is being explored in the indications of oculopharyngeal muscular dystrophy (OPMD) and spinocerebellar ataxia type 3 (SCA3). It is under phase II development.

Recent event:

On July 26, the Company announced that it is seeking a commercial partner for Trehalose.

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