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The Daily Biotech Pulse: Decision Day For Regeneron-Sanofi, Vermillion Offering, PDL BioPharma CFO to Depart

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 June 25)

  • ArQule, Inc. (NASDAQ: ARQL)
  • Zai Lab Ltd (NASDAQ: ZLAB)

Down In The Dumps

(Biotech stocks hitting 52-week lows on June 25)

  • AbbVie Inc (NYSE: ABBV)(announced a deal to buy Allergan plc (NYSE: AGN) for $63 billion)
  • Acer Therapeutics Inc (NASDAQ: ACER)(The FDA issued complete response letter to its rare disease drug Edsivo)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Aldeyra Therapeutics Inc (NASDAQ: ALDX)(reported negative results for the late-stage study that evaluated its reproxalap in anterior uveitis)
  • Atara Biotherapeutics Inc (NASDAQ: ATRA)
  • Axcella Health Inc (NASDAQ: AXLA)
  • Biopharmx Corp NYSE: (BPMX) (reported positive results for a Phase 2b clinical trial of BPX-04 in treating moderate-to-severe papulopustular rosacea)
  • CELYAD SA/ADR (NASDAQ: CYAD)
  • Conatus Pharmaceuticals Inc (NASDAQ: CNAT)(announced decision to explore strategic alternatives following failed NASH drug trial)
  • Enochian Biosciences Inc (NASDAQ: ENOB)
  • Evolent Health Inc (NYSE: EVH)
  • Innovate Biopharmaceuticals Inc (NASDAQ: INNT)
  • Myriad Genetics, Inc. (NASDAQ: MYGN)
  • Nuvectra Corp(NASDAQ: NVTR)
  • Puma Biotechnology Inc (NASDAQ: PBYI)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)
  • Sierra Oncology Inc (NASDAQ: SRRA)
  • Surface Oncology Inc (NASDAQ: SURF)
  • Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH)
  • Trillium Therapeutics Inc (NASDAQ: TRIL)

Stocks In Focus DURECT Shares To Transfer Listing To Nasdaq Capital Market

DURECT Corporation (NASDAQ: DRRX) said the Nasdaq has approved the transfer of the listing of its common stock from the Nasdaq Global Market – meant for mid-cap stocks – to the Nasdaq Capital Market – meant for small-cap stocks - effective June 27.

The Nasdaq has also granted an additional 180-day grace period until Dec. 23 to regain compliance with the exchange's minimum bid price requirement.

The stock rose 0.67% to 66 cents in after-hours trading.

Lilly's Heart Drug Gets Fast Track Designation

Eli Lilly And Co (NYSE: LLY) said the FDA has granted Fast Track Designation to empagliflozin, its investigational asset for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure. Lilly is co-developing the drug with Boehringer Ingelheim.

See Also: Adapative Biotechnologies IPO: What You Need To Know

PDL BioPharma CFO To Leave

PDL BioPharma Inc (NASDAQ: PDLI) announced the resignation of its CFO Peter Garcia, effective Aug. 15. The company said Garcia will continue in his role through the filing of its second-quarter 10-Q.

Vistagen Reports Narrower March Quarter Loss

Vistagen Therapeutics Inc (NASDAQ: VTGN) reported a narrower loss of 90 cents per share for the March quarter compared to the loss of $1.12 per share in year-ago quarter.

As of March 31, the company had cash and cash equivalents of about $13.1 million.

View more earnings on IBB

The shares advanced 12.66% to 80 cents in after-hours trading.

Offerings

Global Blood Therapeutics Inc (NASDAQ: GBT) announced an agreement to sell about $200 million of its common stock in a registered underwritten public offering. The company intends to use the net proceeds primarily to fund its clinical development of voxelotor for the treatment of sickle cell disease.

The stock slipped 3.68% to $60.13 in after-hours trading.

Vermillion, Inc. (NASDAQ: VRML)  intends to offer shares of its common stock in an underwritten public offering. The company said the offering is subject to market and other conditions, and that there is no guarantee the offering may be completed or as to the actual size or terms of the offering.

The stock slipped 11.37% to 78 cents in after-hours trading.

The Medicines Company (NASDAQ: MDCO) priced its common stock offering of 4.55 million shares at $33 per share that would raise gross proceeds of about $150 million.

The stock slid 1.16% to $33.37 in after-hours trading.

PDUFA Dates

The FDA will announce its decision on Sanofi SA (NASDAQ: SNY) & Regeneron Pharmaceuticals Inc (NASDAQ: REGN)'s sNDA for Dupixent to be used as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps.

Clinical Trial Readout

Ascendis Pharma A/S (NASDAQ: ASND) will release Phase 3 fliGHt data for its TransCon hGH, which is being evaluated for growth hormone deficiency in children.

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