The Daily Biotech Pulse: Legal Victory For Boston Scientific, Alder Gets New CFO, FDA Go-Ahead For BioXcel

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Dec. 11)

• Imprimis Pharmaceuticals Inc IMMY
• OvaScience Inc MLND
• Osiris Therapeutics, Inc. OSIR

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 11)

• Aptevo Therapeutics Inc APVO
• Biocept Inc BIOC
• BIOLASE Inc BIOL
• Cidara Therapeutics Inc CDTX
• Corvus Pharmaceuticals Inc CRVS
• Curis, Inc. CRIS
• Cyclacel Pharmaceuticals Inc CYCC
• DURECT Corporation DRRX
• IntelliPharmaCeutics Intl IncIPCI
• Jaguar Health Inc JAGX
• Melinta Therapeutics Inc MLNT
• Mesoblast limited MESO
• Midatech Pharma PLC-ADR MTP
• Nemaura Medical Inc NMRD
• NewLink Genetics Corp NLNK
• Ophthotech Corp OPHT
• Ovid Therapeutics Inc OVID
• Pluristem Therapeutics Inc. PSTI
• Prana Biotechnology Limited PRAN
• Psychemedics Corp. PMD
• Reshape Lifesciences Inc RSLS
• SCYNEXIS Inc SCYX
• Sierra Oncology Inc SRRA
• Tenax Therapeutics Inc TENX
• TherapeuticsMD Inc TXMD

See Also: The Week Ahead In Biotech: Conferences, Clinical Trials And Earnings

Stocks In Focus

Alder Appoints Industry Veteran Campoy as CFO

Alder Biopharmaceuticals Inc ALDR announced it appointed Carlos Campoy as its CFO, effective Dec. 12. Campoy is an industry veteran, with over 20 years of experience in the biopharma and healthcare sectors.

"His contributions to our management team will be highly valuable as we continue to build our commercial infrastructure in anticipation of the potential launch of eptinezumab in the first quarter of 2020," CEO Bob Azelby said in a statement.

BioXcel Says FDA Accepts IND Application For Drug To Treat Agitation

BioXcel Therapeutics Inc BTAI said the FDA has accepted its investigational new drug, or IND, application for its lead candidate BXCL501 that is being tested for acute agitation. The company said it would evaluate BXCL501, a proprietary sublingual thin-film formulation of dexmedetomidine, in first-in-human pharmacokinetic and safety studies in healthy volunteers.

The company said, with the FDA acceptance of the IND, it is on track to dose subjects by year-end, with data expected in the first-half of 2019.

The stock was seen rallying 1.98 percent to $4.64 in pre-market trading.

Arrowhead Q3 Loss Widens

Arrowhead Pharmaceuticals Inc ARWR reported Q3 revenues of $16.14 million, down from $31.41 million a year-ago period. The net loss widened from 47 cents to 65 cents.

Boston Scientific Wins Medical Device Patent Litigation With Edwards

Boston Scientific Corporation BSX said a U.S. district court determined that Edwards Lifesciences Corp EW Sapien 3 Aortic Valve infringed its U.S. patent 8,992,608, and that Edwards owes Boston Scientific infringement damages through the end 2016.

Boston Scientific said additional damages and interest incurred from 2017-18 will be determined by the court in post-trial motions.

Also, the jury determined that Boston Scientific's LOTUS Aortic Valve System does not infringe Edwards' Spenser patents. Edwards said it plans to appeal.

Common Stock Offerings/Pricings

Marinus Pharmaceuticals Inc MRNS said it intends to offer 12 million shares of its common stock in an underwritten public offering. All shares are earmarked for the offering are sold by the company. The company said it intends to use the net proceeds for its pre-clinical and clinical program for ganaxolone, among other things.

The stock fell 11.18 percent to $4.53 in after-hours trading.

NeoGenomics, Inc. NEO announced a secondary offering of 10.835 million shares of its common stock, with the shares to be sold by GE Medical Systems Information Technologies.