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. (NASDAQ: BSTC)
- Genomic Health, Inc. (NASDAQ: GHDX)
- Inogen Inc (NASDAQ: INGN)
- Krystal Biotech Inc (NASDAQ: KRYS)
- Myokardia Inc (NASDAQ: MYOK)
- OptimizeRx Corporation (NASDAQ: OPRX)
- ProQR Therapeutics NV (NASDAQ: PRQR)
- Seattle Genetics, Inc. (NASDAQ: SGEN)
- Sensus Healthcare Inc (NASDAQ: SRTS)
- STAAR Surgical Company (NASDAQ: STAA)
Down In The Dumps
(Biotech stocks that hit 52-week lows Sept. 11.)
- Advaxis, Inc. (NASDAQ: ADXS) (reported a wider-than-expected Q2 loss)
- Constellation Pharmaceuticals Inc (NASDAQ: CNST)
- Genocea Biosciences Inc (NASDAQ: GNCA)
- Genocea Biosciences Inc (NASDAQ: KALA)
- Molecular Templates Inc (NASDAQ: MTEM)
- Otonomy Inc (NASDAQ: OTIC)
- REALM THERAPEUTICS ADR (NASDAQ: RLM)
- XBiotech Inc (NASDAQ: XBIT)
Stocks In Focus
Galapagos-Gilead's Rheumatology Drug Meets Primary Endpoint
GALAPAGOS NV/S ADR (NASDAQ: GLPG) and Gilead Sciences, Inc. (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: 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 (NYSE: 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
- Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT) (before the market open)
Related Link: Attention Biotech Investors: Mark Your Calendar For These September PDUFA Dates
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