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 TXG (listed its shares on Nasdaq on Sept. 12)
- AxsomeTherapeutics Inc AXSM
- Bioanalytical Systems, Inc. BASI
- BioCardia Inc BCDA
- Cardiovascular Systems Inc CSII
- CONMED Corporation CNMD
- DURECT Corporation DRRX (announced positive results from the Phase 2a study of DUR-928 in people with alcoholic hepatitis)
- Eidos Therapeutics Inc EIDX
- Neubase Therapeutics Inc NBSE
- Radius Health Inc RDUS
- XOMA Corp XOMA
- ZEALAND PHARMA/S ADR ZEAL
Down In The Dumps
(Biotech stocks that hit 52-week lows on Sept. 17)
- Catalyst Biosciences Inc CBIO
- Kalvista Pharmaceuticals Inc KALV
- Medigus Ltd MDGS
- Myovant Sciences Ltd MYOV
- Ritter Pharmaceuticals Inc RTTR
- Sienna Biopharmaceuticals Inc SNNA (filed for Chapter 11 bankruptcy)
- Titan Pharmaceuticals, Inc. common stock TTNP
- Viveve Medical Inc VIVE
Stocks In Focus
NewLink Genetics-Merck's BLA For Ebola Vaccine Accepted For Priority Review
NewLink Genetics Corp NLNK said the FDA has accepted partner Merck & Co., Inc. 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 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 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 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. IRWD said it has amended its collaboration agreement with AstraZeneca plc 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. 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 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. 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. 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 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 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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