The Daily Biotech Pulse: Genmab-Novartis Multiple Sclerosis Drug Aces Late-Stage Studies, Akari Nets Orphan Drug Designation

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 on Aug. 30.)

• Inspire Medical Systems Inc INSP
• NextCure Inc NXTC
• Radius Health Inc RDUS
• ResMed Inc. RMD
• Stoke Therapeutics Inc STOK

Down In The Dumps

(Biotech stocks that hit 52-week lows on Aug. 30.)

• ContraFect Corp CFRX
• Ekso Bionics Holdings Inc EKSO
• Rubius Therapeutics Inc RUBY
• Trinity Biotech plc TRIB

Stocks In Focus

Genmab-Novartis' Multiple Sclerosis Drug Found Superior To Sanofi's

GENMAB A/S/S ADR GMAB, which recently listed its shares in the U.S., said Novartis AG NVS, its partner in the development of atumumab, has reported positive results for the investigational compound in Phase 3 studies dubbed ASCLEPIOS I and II.

The companies said the ASCLEPIOS studies — which evaluated the safety and efficacy of monthly subcutaneous atumumab 20mg versus Sanofi SA SNY's teriflunomide 14mg once-daily oral in adults with relapsing forms of multiple sclerosis — met the primary and secondary endpoints.

Based on the ASCLEPIOS data, Novartis, which has licensed the candidate from Genmab, said it plans to initiate submissions to health authorities by the end of 2019.

Akari's Namocopan Gets Orphan Drug Designation

Akari Therapeutics PLC AKTX said the FDA has granted orphan drug designation for its namocopan for the treatment of hematopoietic stem cell transplantation-associated thrombotic microangiopathy. Namocopan also has Fast Track designation for the same indication in pediatric patients.

In pre-market trading Friday, Akari shares were rallying 12.21% to $1.93

Catalyst CFO Departs

Catalyst Biosciences Inc CBIO said its CFO Fletcher Payne is stepping down from the position to pursue another opportunity, effective Aug. 30. The company said it is initiating a search for a successor.

Mesoblast Reports Higher Revenue, Narrower Loss For Q4

Mesoblast limited MESO reported fourth-quarter revenue of $1.97 million, up from $1.7 million in the year-ago quarter. The loss per share narrowed year-over-year from $4.39 to $4.15.

Titan Medical Agrees With Aspire Capital to Sell Up To $35M In Shares

Titan Medical Inc. TMDI said it has entered into a stock purchase agreement with Aspire Capital Fund, under which Aspire Capital has committed to purchase up to $35 million of common shares at Titan's request through Feb. 28, 2022.

Titan said it will immediately sell to Aspire Capital 1.78 million shares at a price of $1.6879 per share to raise gross proceeds of $3 million.

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