The Daily Biotech Pulse: Foamix Jumps on Data, Positive Results for Galapagos-Gilead's Rheumatoid Arthritis Drug, Bausch Health Trims Debt

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

Scaling The Peaks

(Biotech stocks that hit 52-week highs Sept. 11.)

• BioSpecifics Technologies Corp. BSTC
• Genomic Health, Inc. GHDX
• Inogen Inc INGN
• Krystal Biotech Inc KRYS
• Myokardia Inc MYOK
• OptimizeRx Corporation OPRX
• ProQR Therapeutics NV PRQR
• Seattle Genetics, Inc. SGEN
• Sensus Healthcare Inc SRTS
• STAAR Surgical Company STAA

Down In The Dumps

(Biotech stocks that hit 52-week lows Sept. 11.)

• Advaxis, Inc. ADXS (reported a wider-than-expected Q2 loss)
• Constellation Pharmaceuticals Inc CNST
• Genocea Biosciences Inc GNCA
• Genocea Biosciences Inc KALA
• Molecular Templates Inc MTEM
• Otonomy Inc OTIC
• REALM THERAPEUTICS ADR RLM
• XBiotech Inc XBIT

Stocks In Focus

Galapagos-Gilead's Rheumatology Drug Meets Primary Endpoint

GALAPAGOS NV/S ADR GLPG and Gilead Sciences, Inc. GILD said the Phase 3 FINCH 2 study that evaluated their investigational selective JAK1 inhibitor filgotinib for treating adults with moderate-to-severe active rheumatoid arthritis met its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20-percent response, or ACR20, at Week 12.

At Weeks 12 and 24, the proportion of patients achieving ACR50 and ACR70, low disease activity and clinical remission was significantly higher for patients receiving once-daily filgotinib 100 mg or 200 mg compared to patients receiving a placebo.

Galapagos shares rallied 6.57 percent to $109.50 in after-hours trading, while Gilead rose 2.59 percent to $74.10.

Foamix Acne Drug Trial Meets Endpoints

Foamix Pharmaceuticals Ltd FOMX announced positive top-line results for its third Phase 3 clinical trial that evaluated its FMX101 for treating moderate-to-severe acne.

The company said the pipeline candidate met both co-primary endpoints of absolute change from baseline in inflammatory lesion count at Week 12 and Investigator Global Assessment treatment success at Week 12.

FMX101's safety profile was consistent with that determined from the previous two Phase 3 studies.

Foamix shares skyrocketed 56.76 percent to $9.28 in after-hours trading Tuesday.

See also: New Class of Migraine Drug Creates Four-Way Pharma Development Race

Portola Says FDA Sets Dec. 31 Target Date For Approving Andexxa Commercial Launch 

Portola Pharmaceuticals Inc PTLA said the FDA has acknowledged the receipt of its Prior Approval Supplement, or PAS, filing that will allow it to commercially manufacture its anticoagulant antidote Andexxa, which was earlier approved in May 2018.

The company said the PAS has been assigned a PDUFA date of Dec. 31. An approval will allow the company to execute a broader commercial launch of Andexxa in the U.S.

The shares rose 0.8 percent to $29.01 in after-hours trading Tuesday.

Endocyte Prices Public Offering

Endocyte, Inc. ECYT said it has priced its underwritten registered public offering of 9.46 million shares at $18.50 per share, a discount to Tuesday's closing price of $19.55.

The stock shed 0.51 percent to $19.45 in after-hours trading Tuesday.

Bausch Health Reduces Debt Further

Bausch Health Companies Inc BHC said it has paid an additional $57 million of its secured term loans and $50 million of its revolver borrowings, using its cash on hand. With this, the company said it has eliminated all mandatory amortization for the remainder of 2018.

The stock rose 1.5 percent to $20.98 in after-hours trading Tuesday.

On The Radar

Earnings

• Eyepoint Pharmaceuticals Inc EYPT (before the market open)

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