The Daily Biotech Pulse: Osmotica Flies, Catalyst Plummets, GW Pharma On Track To File For Expanded Use Of Epidiolex

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks hitting 52-week highs on May 6)

• Axsome Therapeutics Inc (NASDAQ: AXSM) (FDA agreed to expedite regulatory filings for its depression drug)
• BIO-TECHNE Corp (NASDAQ: TECH)
• Catalyst Pharmaceuticals Inc (NASDAQ: CPRX)
• Dr. Reddy's Laboratories Ltd (NYSE: RDY)
• NeoGenomics, Inc. (NASDAQ: NEO)
• Shockwave Medical Inc (NASDAQ: SWAV)
• TransMedics Group Inc (NASDAQ: TMDX)

Down In The Dumps

(Biotech stocks hitting 52-week lows on May 6)

• Eyegate Pharmaceuticals Inc (NASDAQ: EYEG)
• Novavax, Inc. (NASDAQ: NVAX)
• Psychemedics Corp. (NASDAQ: PMD)

Stock In Focus

Osmotica Rips Higher On Positive Late-Stage Results For Droopy Eyelid Disease

Osmotica Pharmaceuticals PLC (NASDAQ: OSMT) announced positive topline results for its second Phase 3 efficacy and safety clinical trial of RVL and long-term Phase 3 safety study for the treatment of ptosis, or droopy eyelid.

The positive topline results of the Phase 3 study were consistent with prior study results, which showed a statistically significant improvement in the visual field of patients that were administered our once-daily drop. RVL was also well tolerated by patients, the company said.

Armed with the positive results from both late-stage studies, the company said it plans to submit an NDA to the FDA in the third quarter of 2019. The product candidate, if approved, will be on the market as early as the second half of 2020, Osmotica said.

The stock jumped 47.42 percent to $5.72 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, Clinical Trial Readouts, Earnings And IPOs

Roche Presents Positive New Data On Spinal Muscular Dystrophy Drug

Roche Holdings AG Basel ADR (OTC: RHHBY) announced, at the American Association of Neurology, or AAN, 2019 annual meeting, new data from the dose-finding Part 1 of the pivotal FIREFISH trial, which showed infants with Type 1 spinal muscular dystrophy, or SMA, achieved key motor milestones after one year of treatment with its investigational candidate risdiplam.

The study is being done in collaboration with the SMA Foundation and PTC Therapeutics, Inc. (NASDAQ: PTCT).

Also, new findings from the dose-finding Part 1 of SUNFISH study reinforced risdiplam's credentials as a promising therapy for people with Type 2 or 3 SMA.

Roche said it will include the new findings presented at the AAN annual meeting to the regulatory filings with the FDA and the European Medicines Agency.

Catalyst Pharma Plunges On FDA Nod For Rival Drug

Catalyst Pharma shares slumped after the FDA greenlighted privately-held Jacobus Pharmaceutical's Ruzurgi for treating Lambert-Eaton myasthenic syndrome, or LEMS, in patients 6 to less than 17 years of age. LEMS is a rare autoimmune disorder. Catalyst has a rival drug in Firdapse, which is approved for adult use and has a list price of $375,000.

The stock plummeted 42.72 percent to $3.50 in after-hours trading.

GW Pharma Reports Positive Late-Stage Trial Results For Epidiolex, Strong Q1 Performance

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) announced positive topline results for its Phase 3 study of Epidiolex, chemically CBD, CV in the treatment of seizures associated with Tuberculosis Sclerosis Complex, a rare and severe form of childhood-onset epilepsy.

GW Pharma said it intends to submit an sNDA in the fourth quarter of 2019.

Separately, the company reported first-quarter revenues of $39.25 million compared to $3.04 million last year, with $33.5 million of the first-quarter sales coming from Epidiolex. The loss per share narrowed from 20 cents to 14 cents.

The stock climbed 6.22 percent to$191.29 in after-hours trading.

Earnings

Syndax Pharmaceuticals Inc (NASDAQ: SNDX) reported a loss of 53 cents per share for its first quarter compared to a loss of 79 cents last year. Analysts expected a loss of 55 cents per share for the quarter. The company guided second quarter and 2019 operating expenses to $13 million to $14 million, and $60 million to $64 million, respectively.

The stock slipped 11.68 percent to $6.50 in after-hours trading.

TherapeuticsMD Inc (NASDAQ: TXMD)'s first-quarter revenues climbed from $3.8 million in 2018 to $3.9 million in 2019, with Imvexxy sales weak due to patient savings program at its launch . The net loss per share widened from 11 cents to 16 cents. Analysts expected a loss of 17 cents per share on revenues of $5.89 million.

The stock declined 13.19 percent to $3.95 in after-hours trading.

Offerings

Twist Bioscience Corp (NASDAQ: TWST) said it has commenced an underwritten public offering of 3 million shares. The company intends to use the net proceeds from the offering along with existing cash and short-term investment to update its platform and core technologies, among other things.

The stock slid 5.54 percent to $23 in after-hours trading.

On The Radar

Clinical Trial Readouts

GW Pharma is due to present Phase 3 data for Epidiolex being evaluated for Dravet Syndrome at the AAN annual meeting.

Ra Pharmaceuticals Inc (NASDAQ: RARX) will present already-released Phase 2 data for RA101495, or zilucoplan in Myasthenia Gravis, also at AAN annual meeting.

Ionis Pharmaceuticals Inc (NASDAQ: IONS and Biogen Inc (NASDAQ: BIIB) will present Phase 1/2 data for their IONIS-SOD1Rx/BIIB067 for amyotrophic lateral sclerosis as a late-breaker presentation at the AAN annual meeting.

Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN) is scheduled to present Phase 3 data for Zydis ODT formulation of rimegepant for migraine at the AAN annual meeting.

Ovid Therapeutics Inc (NASDAQ: OVID) will present Phase 2 data for OV101 being evaluated for adolescents with Angelman syndrome at the AAN annual meeting.

DURECT Corporation (NASDAQ: DRRX) is due to present preliminary Phase 2 data for alcoholic hepatitis treatment candidate DUR-928.

Earnings

Before the Market Open

• Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
• Allergan plc (NYSE: AGN)
• Avanos Medical Inc (NYSE: AVNS)
• Akorn, Inc. (NASDAQ: AKRX)
• AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG)
• Array Biopharma Inc (NASDAQ: ARRY)
• BioXcel Therapeutics Inc (NASDAQ: BTAI)
• Evofem Biosciences Inc (NASDAQ: EVFM)
• Vericel Corp (NASDAQ: VCEL)
• Clovis Oncology Inc (NASDAQ: CLVS)
• Haemonetics Corporation (NYSE: HAE)
• MannKind Corporation (NASDAQ: MNKD)
• Dova Pharmaceuticals Inc (NASDAQ: DOVA)
• Eagle Pharmaceuticals Inc (NASDAQ: EGRX)
• Galmed Pharmaceuticals Ltd (NASDAQ: GLMD)
• Insmed Incorporated (NASDAQ: INSM)
• Neuronetics Inc (NASDAQ: STIM)

After The Close

• Jazz Pharmaceuticals PLC (NASDAQ: JAZZ)
• Aerie Pharmaceuticals Inc (NASDAQ: AERI)
• Prothena Corporation PLC (NASDAQ: PRTA)
• Cerus Corporation (NASDAQ: CERS)
• Evolent Health Inc (NYSE: EVH)
• Eton Pharmaceuticals Inc (NASDAQ: ETON)
• Enanta Pharmaceuticals Inc (NASDAQ: ENTA)
• Editas Medicine Inc (NASDAQ: EDIT)
• Fulgent Genetics Inc (NASDAQ: FLGT)
• Fate Therapeutics Inc (NASDAQ: FATE)
• Foamix Pharmaceuticals Ltd (NASDAQ: FOMX)
• Myriad Genetics, Inc. (NASDAQ: MYGN)
• Halozyme Therapeutics, Inc. (NASDAQ: HALO)
• Inspire Medical Systems Inc (NYSE: INSP)
• Retrophin Inc (NASDAQ: RTRX)
• Supernus Pharmaceuticals (Inc NASDAQ: SUPN)
• Tocagen Inc (NASDAQ: TOCA)
• Infinity Pharmaceuticals Inc. (NASDAQ: INFI)
• Penumbra Inc (NYSE: PEN)
• Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)
• Kura Oncology Inc (NASDAQ: KURA)
• Iovance Biotherapeutics Inc (NASDAQ: IOVA)