The Daily Biotech Pulse: Amarin Braces For Vascepa Adcom Verdict, Biotechs On A Fundraising Spree, Zosano Makes Progress With Migraine Drug Filing

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 Nov. 13.)

  • Antares Pharma Inc ATRS
  • Arrowhead Pharmaceuticals Inc ARWR
  • Bausch Health Companies Inc BHC
  • BioDelivery Sciences International, Inc. BDSI (reacted to its third-quarter results)
  • Bristol-Myers Squibb Co BMY
  • Celgene Corporation CELG
  • China Biologic Products Holdings Inc CBPO
  • Deciphera Pharmaceuticals Inc DCPH
  • Dicerna Pharmaceuticals Inc DRNA
  • Edwards Lifesciences Corp EW
  • ESSA Pharma Inc EPIX
  • GALAPAGOS NV/S ADR GLPG
  • GENMAB A/S/S ADR GMAB
  • Halozyme Therapeutics, Inc. HALO (reacted to its third-quarter results)
  • IGM Biosciences Inc IGMS
  • Insulet Corporation PODD
  • Krystal Biotech Inc KRYS
  • Opiant Pharmaceuticals Inc OPNT (reported an unexpected profit for its third quarter)
  • Recro Pharma Inc REPH
  • Seattle Genetics, Inc. SGEN: filed an arbitration demand to settle dispute with DAIICHI SANKYO/S ADR DSNKY
  • Vertex Pharmaceuticals Incorporated VRTX
  • XOMA Corp XOMA

Down In The Dumps

(Biotech stocks that hit 52-week lows on Nov. 13.)

  • Achieve Life Sciences Inc ACHV
  • Affimed NV AFMD
  • Akebia Therapeutics Inc AKBA
  • Allena Pharmaceuticals Inc ALNA (released its third-quarter results)
  • Aridis Pharmaceuticals Inc ARDS
  • ASLAN PHARMACEU/ADR ASLN
  • Auris Medical Holding Ltd EARS
  • BioCryst Pharmaceuticals, Inc. BCRX (announced common stock offering)
  • Capricor Therapeutics Inc CAPR
  • Cleveland BioLabs, Inc. CBLI
  • Diffusion Pharmaceuticals Inc DFFN (priced its follow-on offering)
  • Genocea Biosciences Inc GNCA
  • Marker Therapeutics MRKR (reacted to third-quarter results)
  • Melinta Therapeutics Inc MLNT (reacted to third-quarter results)
  • Neon Therapeutics Inc NTGN
  • Neuronetics Inc STIM
  • Nuvectra Corp NVTR (filed for bankruptcy protection)
  • Obseva SA OBSV
  • Ocugen Inc OCGN
  • Onconova Therapeutics Inc ONTX
  • OpGen Inc OPGN
  • Oyster Point Pharma Inc OYST (went public on Oct. 31)
  • PDS Biotechnology Corp PDSB
  • Pluristem Therapeutics Inc. PSTI
  • Savara Inc SVRA
  • Seelos Therapeutics Inc SEEL
  • Sierra Oncology Inc SRRA
  • Tetraphase Pharmaceuticals Inc TTPH (reacted to third-quarter results)
  • Unum Therapeutics Inc UMRX (reacted to third-quarter results)
  • Verastem Inc VSTM
  • Vir Biotechnology Inc VIR

Stocks In Focus

Adcom Panel Gives Thumbs Down To Lilly-Boehringer Ingelheim's Type 1 Diabetes Drug 

Eli Lilly And Co LLY and Boehringer Ingelheim said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 against the approval of their empagliflozin 2.5mg as an adjunct to insulin for adults with type 1 diabetes.

"We continue to believe the totality of data from the EASE program indicates a favorable benefit-risk profile for empagliflozin 2.5 mg in adults with type 1 diabetes and look forward to continuing to work with the FDA in this review process," the companies said.

See also: Biotech Stock On The Radar: Alkermes At A Crossroads

Pfenex CFO to Leave Immediately 

Pfenex Inc PFNX said its CFO Susan Knudson has resigned effective Wednesday, citing personal reasons. Knudson will support during the transition period until Feb. 1, 2020, the company said.

Zosano Receives Positive FDA Feedback On Migraine Drug After Pre-NDA Meetings 

Updating on the minutes it received following the pre-NDA meetings with the FDA regarding migraine treatment Qtrypta, Zosano Pharma Corp ZSAN said it believes the information included in its planned NDA will be sufficient for the FDA to file the NDA for substantive review.

The company had two meetings with the FDA: a face-to-face meeting held in September to discuss the non-clinical and clinical portions of the program and a second pre-NDA meeting to discuss chemistry control and manufacturing.

The company expects to file the NDA in December.

The stock rallied 10.34% to $2.24 in pre-market trading.

Offerings

Fulgent Genetics Inc FLGT said it has priced its previously announced underwritten public offering of 2.325 million shares at $11.25 each. The company expects to raise gross proceeds of about $26.2 million from the offering. The offering is expected to close Nov. 18.

The stock fell 12.46% to $11.94 in after-hours trading.

Kadmon Holdings Inc KDMN announced a public offering of shares of its common stock. The company expects to use the proceeds primarily to fund the clinical development of its lead product candidates and R&D.

The stock was down 1.69% at $3.50 in Thursday's premarket session. 

Phio Pharmaceuticals Corp PHIO said it has commenced a proposed public offering of shares. All the shares earmarked for the offering are to be sold by the company.

The company said it plans to use the net proceeds to fund the development of its oncology programs, for R&D activities and general working capital needs.

The stock was down 24.7% at 20 cents in Thursday's premarket session. 

Lipocine Inc LPCN, which recently faced a FDA rejection of its lead male sex hormone deficiency drug, said it has launched a public offering of units consisting of shares of its common stock and warrants to purchase its common stock.

The stock was falling 29.87% to 48 cents in the premarket session. 

Earnings

Edap Tms SA EDAP said its third-quarter revenue climbed 26.7% year-over-year to $11.3 million. The company reversed from a loss of $800,000 in the third quarter of 2018 to a profit of $900,000. The bottom-line results were below expectations.

The stock was down 8.75% at $4.38 in premarket trading.

Cyclacel Pharmaceuticals Inc CYCC's third-quarter net loss narrowed from 18 cents per share in 2018 to 11 cents per share in 2019. Analysts had estimated a loss of 16 cents per share.

As of Sept. 30, the company has cash and cash equivalents of $13 million.

The stock was up 13.39% at 42 cents in the premarket session.

On The Radar

Adcom Meeting

FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet to discuss Amarin Corporation plc AMRN's sNDA for Vascepa for reducing the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels and other risk factors for cardiovascular disease.

The briefing document released Monday ahead of the panel vote showed deliberations in line with expectations.

Clinical Readouts

Jaguar Health Inc JAGX and Roche Holdings AG Basel ADR RHHBY are scheduled to release updated Phase 2 data for mytesi in cancer-related diarrhea.

2019 Connective Tissue Oncology Society Annual Meeting Presentations

Deciphera Pharmaceuticals Inc DCPH: initial Phase 1 data for DCC-3014 in solid tumors

Earnings

  • Brainstorm Cell Therapeutics Inc BCLI (before the market open)
  • BioXcel Therapeutics Inc BTAI (before the market open)
  • Rubius Therapeutics Inc RUBY (before the market open)
  • PhaseBio Pharmaceuticals Inc PHAS (before the market open)
  • Fulcrum Therapeutics Inc FULC (before the market open)
  • Altimmune Inc ALT (before the market open)
  • Vascular Biogenics Ltd VBLT (before the market open)
  • Aytu Bioscience Inc AYTU (after the market close)
  • Dare Bioscience Inc DARE (after the market close)
  • Tricida Inc TCDA (after the market close)
  • aTyr Pharma Inc LIFE (after the market close)
  • OncoCyte Corp OCX (after the market close)
  • Zosano Pharma Corp ZSAN (after the market close)
  • Eton Pharmaceuticals Inc ETON (after the market close)
  • Titan Pharmaceuticals, Inc. TTNP (after the market close)
  • KemPharm Inc KMPH (after the market close)
  • Plus Therapeutics Inc PSTV (after the market close)
  • Zyla Life Sciences ZCOR (after the market close)
  • Osmotica Pharmaceuticals PLC OSMT (after the market close)

Related Link: The Week Ahead In Biotech: Adcom Test For Amarin's Fish Oil Pill, Agile Awaits FDA Verdict

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