The Daily Biotech Pulse: FDA Snub For Gemphire, Ligand Earnings, Insmed's Antibiotic Faces FDA Panel

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

Scaling the Peaks

(Stocks hitting 52-week highs on Aug. 6)

• Bio-Rad Laboratories, Inc. BIO
• BIO-TECHNE Corp TECH
• CAS Medical Systems Inc CASM
• Eli Lilly And Co LLY
• Iradimed Corp IRMD
• Kindred Biosciences Inc KIN
• Medtronic PLC MDT
• Merck & Co., Inc. MRK
• Misonix, Inc. MSON
• NeoGenomics, Inc. NEO
• Pfizer Inc. PFE
• Qiagen NV QGEN
• SurModics, Inc. SRDX(reported Q3 results)

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 6)

• ACADIA Pharmaceuticals Inc. ACAD
• Agenus Inc AGEN
• Arsanis Inc ASNS
• BENITEC BIOPHAR/S ADR BNTC
• Citius Pharmaceuticals Inc CTXR
• Clementia Pharmaceuticals Inc CMTA
• Clovis Oncology Inc CLVS
• Cytori Therapeutics Inc CYTX
• Diffusion Pharmaceuticals Inc DFFN
• Eidos Therapeutics Inc EIDX
• Fortress Biotech FBIO
• Oncolytics Biotech, Inc. (USA) ONCY
• Osiris Therapeutics, Inc. OSIR
• Pain Therapeutics, Inc. PTIE((FDA handed out a complete response letter for its pain medication Remoxy, NASDAQ:DRRX)
• Provention Bio Inc PRVB
• Pulmatrix Inc PULM
• Reshape Lifesciences Inc RSLS
• Translate Bio Inc TBIO
• Vascular Biogenics Ltd VBLT
• VBI Vaccines Inc VBIV
• ZIOPHARM Oncology Inc. ZIOP

Stocks In Focus

Gemphire Faces Setback With Respect to Cholesterol Drug

Gemphire Therapeutics Inc GEMP announced the FDA has sought data from a sub-chronic toxicology study to support lifting of the partial clinical hold imposed on its gemcabene with respect to clinical trials of duration over six months.

The agency also deemed the end-of-Phase 2 meeting and the subsequent initiation of Phase 3 trials investigating gemcabene in dyslipidemia indications and long-term safety exposure trials needed for registration will not take place until the partial hold is lifted.

FDA's objection stems from the fact that it deems PPAR agonists or agents having PPAR-like properties to be potential liver toxins.

With the timeline for lifting the six-month clinical hold pushed forward from July 31, 2018 to Sept. 30, 2019, the company amended its loan agreement with SVB for purposes of the requirement to provide cash security to SVB, or prepayment of the loan. Separately, the company also said it amended its agreement with Pfizer over gemcabene it signed in April 2011, extending the date of the agreed deadline for the first commercial sales.

Gemphire shares slumped 23.71 percent to $5.60 in after-hours trading.

NeoGenomics Slips On News Of Offerings

NeoGenomics said it has commenced an underwritten public offering of $125 million worth of newly-issued common shares.

Shares slid 3.43 percent to $14.36 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates And IPOs

Stocks Reacting to Earnings

Ligand Pharmaceuticals Inc. LGND reported Q3 revenues of $90 million, up from $28 million in the year-ago period. The company reported adjusted earnings per share, or EPS, of $2.59, exceeding the $2.34 consensus estimate. The company raised its FY18 revenue guidance, with both the revenue and EPS guidance above the consensus estimates.

Shares rose 8.5 percent to $245 in after-hours session.

Zogenix, Inc. ZGNX reported a narrower net loss of 83 cents per share for Q2 compared to a loss of 87 cents per share expected by analysts. Separately, the company announced plans to offer 6 million shares in a common stock offering. All shares offered are to be sold by the company.

The stock declined 3.91 percent to $54 in after-hours trading.

InspireMD, Inc. NSPR said Q2 revenues rose 57 percent to $1 million. The company's loss narrowed from $7.30 per share reported a year-ago to 15 cents.

The penny stock rose 8.98 percent to $0.249 in after-hours trading.

Vericel Corp VCEL reported in line Q2 EPS of 15 cents and revenues of $17 million, up from $14 million last year. The company also raised its revenue guidance for the full year.

The stock soared 15.69 percent to $11.80 in after-hours trading.

On The Radar

PDUFA Date/Adcom Meeting

The FDA is set to rule on Vertex Pharmaceuticals Incorporated VRTX's lumacaftor/ivacaftor, combo treatment candidate for cystic fibrosis for patients aged 2 to 5.

FDA's Antimicrobial Drugs Advisory Committee will discuss the NDA for Insmed Incorporated INSM's NDA for mikacin liposome inhalation suspension, indicated to treat nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen.
Clinical Trial Results

Audentes Therapeutics Inc BOLD is due to release Phase 1/2 results of its AT132, which is being evaluated in a study called ASPIRO to treat X-linked myotubular myopathy.

Earnings

Before The Market Open

• Amicus Therapeutics, Inc. FOLD Q2 EPS $(0.33), Inline, Sales $21.3M Beat $19.16M Estimate
• Avadel Pharmaceuticals PLC (ADR) AVDL Q2 EPS $(0.55) Misses $(0.31) Estimate, Sales $29.23M Beat $27.45M Estimate
• Antares Pharma Inc ATRS Q2 EPS $(0.03) Misses $(0.02) Estimate, Sales $14.162M Beat $13.25M Estimate
• Transenterix Inc TRXC Q2 EPS $(0.06), Inline, Sales $6.389M Beat $5.78M Estimate
• Spark Therapeutics Inc ONCE Q2 GAAP EPS $2.07 Up From $(1.86) YoY, Sales $1.483M
• Recro Pharma Inc REPH Q2 EPS $(0.62) Beats $(1.34) Estimate, Sales $21.739M Beat $16.66M Estimate
• Eagle Pharmaceuticals Inc EGRX Q2 EPS $0.95 Beats $0.80 Estimate, Sales $59.3M Beat $51.23M Estimate
• Radius Health Inc RDUS Q2 EPS $(1.52) Misses $(1.35) Estimate, Sales $22.629M Beat $20.46M Estimate
• Merrimack Pharmaceuticals Inc MACK Q2 EPS $(1.33) Misses $(1.28) Estimate
• Syros Pharmaceuticals Inc SYRS Q2 EPS $(0.43) Beats $(0.50) Estimate, Sales $375K Miss $800K Estimate

After Tuesday's Market Close

• HTG Molecular Diagnostics Inc HTGM
• FibroGen Inc FGEN
• Zafgen Inc ZFGN)
• Alder Biopharmaceuticals Inc ALDR
• Athersys, Inc. ATHX
• Arrowhead Pharmaceuticals Inc ARWR
• Bellicum Pharmaceuticals Inc BLCM
• Cara Therapeutics Inc CARA
• Inovio Pharmaceuticals Inc INO
• PTC Therapeutics, Inc. PTCT
• Tocagen Inc TOCA
• Vital Therapies Inc VTL
• Syndax Pharmaceuticals Inc SNDX
• Infinity Pharmaceuticals Inc. INFI
• MacroGenics Inc MGNX
• Jazz Pharmaceuticals PLC JAZZ
• Evolent Health Inc EVH
• Eloxx Pharmaceuticals Inc ELOX
• Enanta Pharmaceuticals Inc ENTA
• Flexion Therapeutics Inc FLXN
• GW Pharmaceuticals PLC- ADR GWPH
• Halozyme Therapeutics, Inc. HALO
• Inogen Inc INGN
• Sunesis Pharmaceuticals, Inc. SNSS
• Miragen Therapeutics Inc MGEN
• Ocular Therapeutix Inc OCUL
• Zafgen Inc ZFGN