The following is a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech stocks that hit 52-week highs Feb. 5.)
- Alector Inc (NASDAQ: ALEC) (announced granting of Fast Track Designation to its AL101 for the treatment of patients with frontotemporal dementia)
- Arvinas Inc (NASDAQ: ARVN)
- Ascendis Pharma A/S (NASDAQ: ASND)
- Biogen Inc (NASDAQ: BIIB) (won patent challenge on multiple sclerosis drug Tecfidera)
- BioXcel Therapeutics Inc (NASDAQ: BTAI) (announced FDA clearance of IND for BXCL501 to treat opioid withdrawal symptoms)
- ChemoCentryx Inc (NASDAQ: CCXI)
- Eli Lilly And Co (NYSE: LLY)
- Insmed Incorporated (NASDAQ: INSM)
- Halozyme Therapeutics, Inc. (NASDAQ: HALO)
- Insulet Corporation (NASDAQ: PODD)
- Johnson & Johnson (NYSE: JNJ)
- Masimo Corporation (NASDAQ: MASI)
- Medpace Holdings Inc (NASDAQ: MEDP)
- Molecular Templates Inc (NASDAQ: MTEM)
- Novo Nordisk A/S (NYSE: NVO) (reacted to quarterly results )
- Profound Medical Corp (NASDAQ: PROF) (announced retirement of bank debt ahead of schedule)
- PTC Therapeutics, Inc (NASDAQ: PTCT)
- Quest Diagnostics Inc (NYSE: DGX)
- Reata Pharmaceuticals Inc (NASDAQ: RETA)
- Repligen Corporation (NASDAQ: RGEN)
- ResMed Inc. (NYSE: RMD)
- Revance Therapeutics Inc (NASDAQ: RVNC)
- Theravance Biopharma Inc (NASDAQ: TBPH)
- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX)
- ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)
Down In The Dumps
(Biotech stocks that hit 52-week lows Feb. 5.)
- Endologix, Inc. (NASDAQ: ELGX)
- Salarius Pharmaceuticals Inc (NASDAQ: SLRX)
- Spring Bank Pharmaceuticals Inc (NASDAQ: SBPH)
Stocks In Focus Sanofi's Multiple Sclerosis Drug Aces Midstage Trial; Q4 Sales, Net Income Rise
Sanofi SA (NASDAQ: SNY) said a Phase 2b study that evaluated its investigational BTK inhibitor SAR442168 for multiple sclerosis met the primary endpoint, with the candidate significantly reducing disease activity associated with multiple sclerosis. The candidate was also found to be safe and well-tolerated.
Separately, the company released financial results that showed 6.8% net sales growth for the fourth quarter, driven by Dupixent and vaccines, and 253.5% net income growth. The company said it expects 2020 business EPS to grow 5% at constant currency.
Tonix To Stop Enrollment For Late-Stage Study Of PTSD Drug
Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) said it has decided to stop enrollment in the Phase 3 study dubbed RECOVERY that evaluated its Tonmya 5.6mg in treating post-traumatic stress disorder, following interim analysis of data by the Independent Data Monitoring Committee.
The IDMC sought stoppage of the trial for futility as it believed the experimental drug is unlikely to demonstrate a significant improvement in the primary endpoint of overall change from baseline in the severity of PTSD symptoms between the treatment and control arm.
The shares were plunging 59.91% to 68 cents in premarket trading Thursday.
Arrowhead Reports Positive Mid-Phase Results For 2 Cardiometabolic Drug Candidates
Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR) announced positive interim results from ongoing Phase 1/2a studies of its two RNAi-based cardiometabolic candidates: ARO-APOC3, which is being evaluated for severe hypertriglyceridemia, and ARO-ANG3, which being evaluated for dyslipidemias and metabolic diseases.
The company also released fourth-quarter results, showing a sales decline of 15% to $29.46 million and a loss of 3 cents. Analysts estimated a loss of 1 cent per share for the quarter.
The stock was trading 7.5% higher to $47 in Thursday's premarket session.
Misonix Inc (NASDAQ: MSON) reported 17.3% revenue growth on a pro forma basis for its fiscal year second quarter, and its net loss widened year-over-year. The company reiterated its fiscal year 2020 outlook for revenue growth in excess of 20% and gross margins of about 70%.
The stock rose 5.97% to $19 in after-hours trading.
Cardiovascular Systems Inc (NASDAQ: CSII) reported a wider-than-expected seond-quarter loss, while revenue climbed 13.5%. The company raised the low end of its 2020 revenue guidance.
The stock shed 1.94% to $44 in after-hours trading.
Applied Genetic Technologies Corp (NASDAQ: AGTC) said it has commenced an underwritten public offering of 6 million shares of its common stock. All the shares are being offered by the company.
The stock slipped 9.70% to $6.33 in after-hours trading.
On The Radar Clinical Readouts
Jounce Therapeutics Inc (NASDAQ: JNCE) will present at the ASCO-SITC Symposium Phase 1/2 data for vopratelimab, codenamed JTX-2011, in solid tumors.
- ABIOMED, Inc. (NASDAQ: ABMD) (before the market open)
- Bristol-Myers Squibb Co (NYSE: BMY) (before the market open)
- Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) (before the market open)
- Regeneron Pharmaceuticals Inc (NASDAQ: REGN) (before the market open)
- Twist Bioscience Corp (NASDAQ: TWST) (after the close)
- Anavex Life Sciences Corp (NASDAQ: AVXL) (after the close)
- Pacific Biosciences of California (NASDAQ: PACB) (after the close)
- Enanta Pharmaceuticals Inc (NASDAQ: ENTA) (after the close)
- Myriad Genetics, Inc. (NASDAQ: MYGN) (after the close)
- Seattle Genetics, Inc. (NASDAQ: SGEN) (after the close)
- Natus Medical Inc (NASDAQ: NTUS) (after the close)
- LeMaitre Vascular Inc (NASDAQ: LMAT) (after the close)
- Ligand Pharmaceuticals Inc. (NASDAQ: LGND) (after the close)
Beam Therapeutics said it has priced its upsized initial public offering of 10.59 million shares at $17 per share, at the upper end of the estimated price range of $15-$17. The shares of the company, which is engaged in developing therapies based on single-base gene editing, will begin trading on the Nasdaq under the ticker symbol "BEAM."
Contract research organization PPD priced its 60-million share IPO at $27 compared to the initially estimated range of $24-$27. The shares are to be listed on the Nasdaq under the ticker symbol "PPD."
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