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The Daily Biotech Pulse: NewLink Genetics Rallies, Breakthrough Designation For Roche, IGM Biosciences Debuts

Shanthi Rexaline

The following is a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Sept. 17.)

  • 10X Genomics Inc (NASDAQ: TXG) (listed its shares on Nasdaq on Sept. 12)
  • AxsomeTherapeutics Inc (NASDAQ: AXSM)
  • Bioanalytical Systems, Inc. (NASDAQ: BASI)
  • BioCardia Inc (NASDAQ: BCDA)
  • Cardiovascular Systems Inc (NASDAQ: CSII)
  • CONMED Corporation (NASDAQ: CNMD)
  • DURECT Corporation (NASDAQ: DRRX) (announced positive results from the Phase 2a study of DUR-928 in people with alcoholic hepatitis)
  • Eidos Therapeutics Inc (NASDAQ: EIDX)
  • Neubase Therapeutics Inc (NASDAQ: NBSE)
  • Radius Health Inc (NASDAQ: RDUS)
  • XOMA Corp (NASDAQ: XOMA)
  • ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)

Down In The Dumps

(Biotech stocks that hit 52-week lows on Sept. 17)

  • Catalyst Biosciences Inc (NASDAQ: CBIO)
  • Kalvista Pharmaceuticals Inc (NASDAQ: KALV)
  • Medigus Ltd (NASDAQ: MDGS)
  • Myovant Sciences Ltd (NYSE: MYOV)
  • Ritter Pharmaceuticals Inc (NASDAQ: RTTR)
  • Sienna Biopharmaceuticals Inc (NASDAQ: SNNA) (filed for Chapter 11 bankruptcy)
  • Titan Pharmaceuticals, Inc. common stock (NASDAQ: TTNP)
  • Viveve Medical Inc (NASDAQ: VIVE)

Stocks In Focus NewLink Genetics-Merck's BLA For Ebola Vaccine Accepted For Priority Review

NewLink Genetics Corp (NASDAQ: NLNK) said the FDA has accepted partner Merck & Co., Inc. (NYSE: MRK)'s BLA for its investigational Ebola vaccine, according the application priority review status. The PDUFA goal date has been set for March 14, 2020.

Potential approval of the vaccine will trigger issuance of a priority review voucher, owned by Merck and in which NewLink has a substantial economic interest. NewLink can then monetize its share of interest in the voucher.

The vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed to NewLink.

NewLink shares were rallying by 16.75% in premarket trading Wednesday. 

Label Expansion ForJ&J's Janssen Prostate Cancer Drug 

Johnson & Johnson (NYSE: JNJ)'s Janssen unit said the FDA has approved Erleada, an androgen receptor inhibitor, for the treatment of patients with metastatic castration-sensitive prostate cancer, or mCSPC. Erleada has already been approved for treating patients with non-metastatic castration-resistant prostate cancer, or nmCRPC.

Roche Snags Breakthrough Designation For Lupus Drug

Roche Holdings AG Basel ADR (OTC: RHHBY)'s Genentech unit said the FDA has granted Breakthrough Therapy Designation for Gazyva in adult patients with lupus nephritis.

The designation was accorded based on data from the Phase 2 NOBILITY study, which showed that Gazyva in combination with standard of care showed enhanced efficacy compared to placebo plus standard of care alone in achieving complete renal response at one year.

See also: Biotech Stock On The Radar: vTv Therapeutics' Diabetes Pipeline

CymaBay Chief Medical Officer to Depart

CymaBay Therapeutics Inc (NASDAQ: CBAY) announced the departure of its chief medical officer Pol Boudes on Sept. 30 as he explores other opportunities. The company said it has initiated a formal search for his replacement.

The stock declined 3.58% to $5.65 in after-hours trading.

Ironwood Sells Chinese Rights For Constipation Drug To AstraZeneca

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) said it has amended its collaboration agreement with AstraZeneca plc (NYSE: AZN) for the development of its constipation medication Linzess in China.

According to the amended agreement, AstrZeneca will acquire Chinese rights to Linzess by paying Ironwood up to $125 million, including non-contingent payments totaling $35 million paid in three installments through 2024 and up to $90 million in commercial milestone payments contingent on the achievement of certain net sales targets.

Ironwood also stands to receive royalties beginning in the mid-single-digit percent and increasing up to 20% based on annual net sales of Linzess in China.

Linzess will be launched in China in the second half of 2019.

Alexion CFO To Leave Later This Year, Names Replacement

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) announced a CFO succession plan, as incumbent Paul Clancy has decided to step down, although he will serve as senior advisor through mid-2020. The company said Aradhana Sarin, currently serving as chief strategy and business officer, will succeed Clancy as CFO.

The stock moved down 1.29% to $106.44 in after-hours trading.

Offerings

Translate Bio Inc (NASDAQ: TBIO) priced an underwritten public offering of 9 million shares of its common stock at $10 per share to raise gross proceeds of $90 million.

The stock fell 9.01% to $10 in after-hours trading.

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) priced its underwritten public offering of 6.25 million shares at $40 per share, for raising gross proceeds of $250 million.

The stock slipped 2.91% to $41.36 in after-hours trading.

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced the commencement of an offering of a $250 million principal amount of its convertible senior notes due 2026.

The stock moved down 7.66% to $40 in after-hours trading.

On The Radar Clinical Trial Readouts

bluebird bio Inc (NASDAQ: BLUE) will present Phase 2/3 data for Lenti-D hematopoietic stem cell gene therapy for cerebral adrenoleukodystrophy at the 13th European Pediatric Neurology Society Congress being held in Athens, Greece.

vTv Therapeutics Inc (NASDAQ: VTVT) is scheduled to present at the European Association for the Study of Diabetes 55th annual meeting being held in Barcelona, Spain with a new Phase 1/2 Simplici-T1 study of liver-selective glucokinase activator TTP399 as an adjunctive treatment for Type 1 diabetes.

IPO

IGM Biosciences priced its IPO of 10.938 million shares at $16, the midpoint of the estimated price range of $15-$17 per share. The shared of the preclinical and clinical-stage immuno-oncology biotech will be listed on the Nasdaq under the ticker symbol "IGMS."

Related Links: The Week Ahead In Biotech: Novo Nordisk And Merck Await FDA Rulings, 2 IPOs On Deck

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