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. 12).
Inogen Inc INGN
Kezar Life Sciences Inc KZR
NuVasive, Inc. NUVA
Pfizer Inc. PFE
PRA Health Sciences Inc PRAH
STRATA Skin Sciences Inc SSKN
Tandem Diabetes Care Inc TNDM
Xencor Inc XNCR
Down In The Dumps
(Biotech stocks that hit 52-week lows Sept. 12.)
Advaxis, Inc. ADXS
Atossa Genetics Inc ATOS
Aytu Bioscience Inc AYTU
Clovis Oncology Inc CLVS
Dynavax Technologies Corporation DVAX
Genocea Biosciences Inc GNCA
Jaguar Health Inc JAGX (filed a form S-1 registration statement with the SEC for common stock offering)
Molecular Templates Inc MTEM
Neon Therapeutics Inc NTGN
OvaScience Inc OVAS
Vital Therapies Inc VTL (announced halting of development of ELAD system, a cell-based therapy for treating acute forms of liver failure, following failed clinical trials)
Stocks In Focus
Progenics Prostate Cancer Detection Candidate Fails To Meet Co-Primary Endpoint
Progenics Pharmaceuticals, Inc. PGNX released top-line data from its Phase 3 trial of 1404, a prostate-specific membrane antigen-targeted small molecule SPECT/CT imaging agent designed to visualize prostate cancer. The study showed that 1404 detected clinically meaningful prostate cancer with specificity ranging among the three readers from 71-75 percent. Yet the co-primary endpoint of sensitivity was not met and ranged among the three readers from 47-51 percent, while trial protocol mandated that the lower limit of the two-sided 95-percent confidence interval for both specificity and sensitivity exceed 60 percent.
The shares slumped 22.78 percent to $5.73 in after-hours trading Wednesday.
Verrica's Pediatric Skin Disease Candidate Meets Endpoint
Verrica Pharmaceuticals Inc VRCA announced positive results for its Phase 2 Innovate clinical trial that evaluated its VP-102, a drug-device combo containing a novel topical solution of 0.7-percent cantharidin for treating molluscum contagiosum.
The company also said it has completed enrollment for the Phase 3 pivotal trials earlier than expected, with the top-line results expected in the first quarter of 2019.
The stock rallied 2.93 percent to $16.85 after-hours Wednesday.
See also: New Class of Migraine Drug Creates Four-Way Pharma Development Race
Biopharmx Announces CEO Appointment
Biopharmx Corp BPMX said it has appointed pharma industry veteran David Tierney as its CEO.
The stock jumped 5.63 percent to 21 cents after-hours Wednesday.
MORPHOSYS, GALAPAGOS Get Antitrust Nod For Drug Collaboration
MORPHOSYS AG/S ADR MOR and GALAPAGOS NV/S ADR GLPG announced receipt of U.S. antitrust clearance for their collaboration agreement for developing and commercialization of their joint program MOR106, which they have exclusively licensed to Novartis AG (ADR) NVS.
The agreement became effective Sept. 10 following the antitrust clearance, and the 95-million euro upfront payment by Novartis to MorphoSys and Galapagos became payable.
MorphoSys shares rallied 0.95 percent to $27.77 after-hours Wednesday.
Offerings
Foamix Pharmaceuticals Ltd FOMX announced a common stock offering of $70 million in shares, with all shares to be sold by the company. The stock fell 3.27 percent to $5.91 after-hours Wednesday.
Xenon Pharmaceuticals Inc XENE said it commenced an underwritten public offering of its common shares pursuant to its existing shelf-registration statement, which was filed in December 2015 and declared effective by the SEC Jan. 5, 2016. The stock rose 1.4 percent to $14.45 after-hours Wednesday.
Galapagos said it has launched a follow-on offering of $300 million in shares in the form of ADSs in a U.S. public offering. The final price per ADS will be determined by the book-building process. The stock slipped 1.01 percent to $118.50.
On The Radar
Clinical Trials
Atossa Genetics Inc ATOS is scheduled to release preliminary Phase 1 data for its Endoxifen for treating male breast cancer and gynecomastia.
Related Link: Attention Biotech Investors: Mark Your Calendar For These September PDUFA Dates
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