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The Daily Biotech Pulse: Verastem's Chinese Duvelisib Licensing Deal, Aldeyra's Positive Dry Eye Disease Drug Trial

Shanthi Rexaline

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

Scaling the Peaks

(Biotech stocks hitting 52-week highs on Sept. 25)

  • Abbott Laboratories (NYSE: ABT)
  • Amarin Corporation plc (NASDAQ: AMRN)
  • Applied Genetic Technologies Corp (NASDAQ: AGTC)
  • Avrobio Inc (NASDAQ: AVRO)
  • Becton Dickinson and Co (NYSE: BDX)
  • BIO-TECHNE Corp (NASDAQ: TECH)
  • CareDx Inc (NASDAQ: CDNA)
  • Cellular Biomedicine Group Inc (NASDAQ: CBMG)
  • Edwards Lifesciences Corp (NYSE: EW)
  • EXACT Sciences Corporation (NASDAQ: EXAS)
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)
  • IMMUTEP LTD/S ADR (NASDAQ: IMMP)
  • Intuitive Surgical, Inc. (NASDAQ: ISRG)
  • Medtronic PLC (NYSE: MDT)
  • OASMIA PHARMACE/ADR (NASDAQ: OASM)
  • Oxford Immunotec Global PLC (NASDAQ: OXFD)( Quest Diagnostics Inc (NYSE: DGX) agreed to acquire the the U.S. laboratory services business of Oxford Immunotec)
  • ResMed Inc. (NYSE: RMD)
  • Seattle Genetics, Inc. (NASDAQ: SGEN)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)
  • Zafgen Inc (NASDAQ: ZFGN)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 25)

  • Aerpio Pharmaceuticals Inc (NASDAQ: ARPO)
  • Biocept Inc (NASDAQ: BIOC)
  • Cellectar Biosciences Inc (NASDAQ: CLRB)
  • ContraVir Pharmaceuticals Inc (NASDAQ: CTRV)
  • DENTSPLY SIRONA Inc (NASDAQ: XRAY)
  • Eidos Therapeutics Inc (NASDAQ: EIDX)
  • Erytech Pharma SA (NASDAQ: ERYP)
  • Flexion Therapeutics Inc (NASDAQ: FLXN)
  • Iterum Therapeutics PLC (NASDAQ: ITRM)
  • Mustang Bio Inc (NASDAQ: MBIO)
  • TG Therapeutics Inc (NASDAQ: TGTX)(an independent data monitoring committee that evaluated its chronic lymphocytic leukemia treatment combo ublituximab and umbralisib found the overall response rate data not mature enough to conduct interim analysis)

Vaccinex Inc (NASDAQ: VCNX)

Related Link: The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Results And IPOs

Stocks In Focus Alderyx Reports Positive Mid-stage Trial Results For Dry Eye Disease Treatment

Aldeyra Therapeutics Inc (NASDAQ: ALDX) announced positive Phase 2b results for its topical ocular reproxalap in patients with dry eye disease.

"Relative to patients treated with vehicle, patients treated with the 0.25% concentration of reproxalap had statistically significant and clinically relevant reductions in the Four-Symptom Ocular Dryness Score (p<0.05) and the Overall Ocular Discomfort Symptom Score (p<0.05)," the company said.

Verastem Licenses Duvelisib to Chinese Pharma Company

Verastem Inc (NASDAQ: VSTM) announced an exclusive licensing agreement with CSPC Pharma of China, which provides for CSPC developing and commercializing Verastem's duvelisib for treating all oncology indications in China.

Duvelisib received FDA approval for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies.

The agreement also provides for Verastem receiving an upfront payment of $15 million and up to $30 million in development milestone payments as well as sales milestone and double-digit percentage royalty payments.

The stock rose 9.09 percent to $7.80 in after-hours trading.

Vanda, Aceto Move On S&P Index Changes

Standard & Poor's announced S&P SmallCap 600 constituent Inogen Inc (NASDAQ: INGN) will replace Rollins, Inc. (NYSE: ROL) in the S&P MidCap 400 Index. Meanwhile, Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) will replace Inogen in the S&P SmallCap 600 Index. These changes are effective prior to the open of trading Oct. 1.

Aceto Corporation (NASDAQ: ACET) is set to leave the S&P Small-cap 600 Index, effective prior to the open of trading on Oct. 2, as it is ranked near the bottom of index and is no longer representative of the small-cap market space.

Vanda rallied 4.39 percent to $21.55, while Aceto slipped 4.24 percent to $2.71.

Aurinia Competes Enrollment of Patients For Lupus Nephritis Treatment Ahead of Schedule

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) said it has completed enrollment of 324 patients with lupus nephritis for the AURORA Phase 3 trial ahead of schedule. The AURORA clinical trial is a global, double-blind, placebo-controlled study to evaluate whether voclosporin when added to background therapy of mycophenolate mofetil/CellCept can increase speed of and overall renal response rates in the presence of low dose steroids, the company said.

The stock rose 2.72 percent to $6.05 in after-hours trading.

On The Radar IPO

Entasis Therapeutics Holdings (NASDAQ: ETTX), a clinical-stage biotech company developing therapies for multi-drug resistant bacteria, priced its upsized offering of 5 million shares at $15, below the estimated price range of $16 to $18. The shares are to be listed on the Nasdaq under the ticker symbol ETTX.

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