The Daily Biotech Pulse: Tonix Slumps On Failed Study, Applied Genetic Announces Offering, Beam Therapeutics, PPD Price IPOs

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 ALEC (announced granting of Fast Track Designation to its AL101 for the treatment of patients with frontotemporal dementia)
• Arvinas Inc ARVN
• Ascendis Pharma A/S ASND
• Biogen Inc BIIB (won patent challenge on multiple sclerosis drug Tecfidera)
• BioXcel Therapeutics Inc BTAI (announced FDA clearance of IND for BXCL501 to treat opioid withdrawal symptoms)
• ChemoCentryx Inc CCXI
• Eli Lilly And Co LLY
• Insmed Incorporated INSM
• Halozyme Therapeutics, Inc. HALO
• Insulet Corporation PODD
• Johnson & Johnson JNJ
• Masimo Corporation MASI
• Medpace Holdings Inc MEDP
• Molecular Templates Inc MTEM
• Novo Nordisk A/S NVO (reacted to quarterly results )
• Profound Medical Corp PROF (announced retirement of bank debt ahead of schedule)
• PTC Therapeutics, Inc PTCT
• Quest Diagnostics Inc DGX
• Reata Pharmaceuticals Inc RETA
• Repligen Corporation RGEN
• ResMed Inc. RMD
• Revance Therapeutics Inc RVNC
• Theravance Biopharma Inc TBPH
• Vertex Pharmaceuticals Incorporated VRTX
• ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks that hit 52-week lows Feb. 5.)

• Endologix, Inc. ELGX
• Salarius Pharmaceuticals Inc SLRX
• Spring Bank Pharmaceuticals Inc SBPH

See also: The Week Ahead In Biotech: Merck, Bristol-Myers Earnings, Conference Presentations In Focus

Stocks In Focus

Sanofi's Multiple Sclerosis Drug Aces Midstage Trial; Q4 Sales, Net Income Rise

Sanofi SA 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 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 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.

Earnings

Misonix Inc 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 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.

Offerings

Applied Genetic Technologies Corp 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 JNCE will present at the ASCO-SITC Symposium Phase 1/2 data for vopratelimab, codenamed JTX-2011, in solid tumors.

Earnings

• ABIOMED, Inc. ABMD (before the market open)
• Bristol-Myers Squibb Co BMY (before the market open)
• Alnylam Pharmaceuticals, Inc. ALNY (before the market open)
• Regeneron Pharmaceuticals Inc REGN (before the market open)
• Twist Bioscience Corp TWST (after the close)
• Anavex Life Sciences Corp AVXL (after the close)
• Pacific Biosciences of California PACB (after the close)
• Enanta Pharmaceuticals Inc ENTA (after the close)
• Myriad Genetics, Inc. MYGN (after the close)
• Seattle Genetics, Inc. SGEN (after the close)
• Natus Medical Inc NTUS (after the close)
• LeMaitre Vascular Inc LMAT (after the close)
• Ligand Pharmaceuticals Inc. LGND (after the close)

IPO

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."

Related Link: Attention Biotech Investors: Mark Your Calendar For These February PDUFA Dates