Here's a roundup of top developments in the biotech space over the last 24 hours.
Stock In Focus G1 Therapeutics Plans Regulatory Submission For Bone Marrow Preservation Drug
G1 Therapeutics Inc (NASDAQ: GTHX) plans to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation, or preservation of the bone marrow from damage by chemotherapy, in small cell lung cancer, or SCLC. This followed a written feedback from its end-of-Phase 2 meeting with the FDA, and discussions with the European regulatory authorities.
The proposed submissions will be supported by currently available data from three randomized, double-blind, placebo-controlled SCLC clinical trials, as well as safety data collected across all completed and ongoing clinical trials.
The company expects a pre-NDA meeting with the FDA later this year. Following the meeting, the company said it will provide details regarding the NDA submission and timeline. Subsequent to the NDA filing, the company also plans to submit a Marketing Authorization Application with the European Medicines Agency.
The stock soared 21.61 percent to $22.57 in after-hours trading.
Amicus Says Preclinical Studies of Gene Therapy Candidate Show Efficacy In Pompe's Disease
Amicus Therapeutics, Inc. (NASDAQ: FOLD) announced preclinical data from its investigational adeno-associated viral, or AAV, gene therapy program for Pompe disease in mice, which showed robust uptake and glycogen reduction in multiple tissues, including brain and spinal cord.
"Initial findings validate the Amicus/Penn collaboration, as well as the potential of this platform to design constructs that enhance protein targeting across multiple lysosomal disorders," the company said.
The results will be presented as a poster at the American Society of Gene and Cell Therapy 22nd annual meeting in Washington D.C.
The stock was seen slipping 8.48 percent to $12.30 in pre-market trading.
Novartis' Sandoz Unit Strikes Commercialization Agreement For Breast Cancer Biosimilar
Novartis AG (NYSE: NVS)'s Sandoz generic unit announced an agreement with Taiwan's EirGenix to commercialize a biosimilar for Roche Holdings AG Basel ADR (OTC: RHHBY)'s HER-2 positive breast cancer drug Herceptin.
The biosimilar is currently in Phase 3 clinical development for the treatment of HER2+ breast and specific gastric cancer tumors.
EirGenix will be responsible for the development and manufacturing, while Sandoz has the right to commercialize the medicine upon approval in all markets, excluding China and Taiwan.
The agreement provides for EirGenix receiving an upfront payment on signing, milestone payments and also profit share payments for sales in the territories.
Contract research organization Medpace Holdings Inc (NASDAQ: MEDP) reported first-quarter revenues of $200.7 million, up 23.1 percent year-over-year and representing a backlog conversion of 19 percent. Adjusted net income climbed from 55 cents per share to 64 cents per share. The results exceeded estimates.
For 2019, the company expects adjusted net income per share of $2.58-$2.69 on revenues of $813 million to $837 million. The earnings guidance is in line, while the revenue guidance exceeded estimate.
The stock climbed 6.37 percent to $63 in after-hours trading.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported an increase in its revenues from $71.1 million in the first quarter of 2018 to $138.4 million in the first quarter of 2019. Analysts, on average, estimated a loss of 92 cents per share on revenues of $137.03 million.
Tardive dyskinesia drug Ingrezza fetched sales of $136.4 million. The net loss widened from 47 cents per share to $1.12 cents per share, primarily due to in-process R&D in connection with Neurocrine's strategic collaboration with Voyager Therapeutics.
The stock declined 2.31 percent to $75 in after-hours trading.
Mustang Bio Inc (NASDAQ: MBIO), which recently reported positive clinical trial data for its investigational gene therapy for bubble boy disease, is planning to offer and sell, subject to market conditions, shares of its common shares in an underwritten public offering.
"Mustang intends to use the net proceeds from the offering primarily for the continued development of its product candidates, the potential in‐license, acquisition, development and commercialization of other pharmaceutical products and for general corporate purposes," it said.
The stock fell 9.85 percent to $4.12 in after-hours trading.
Magenta Therapeutics Inc (NASDAQ: MGTA) launched a proposed public offering of 4.25 million shares. All shares are to be sold by Magenta. The company said it will use the net proceeds for funding its clinical trials, R&D among other things.
The stock moved down 7.11 percent to $15.80 in after-hours trading.
Repligen Corporation (NASDAQ: RGEN) commenced an underwritten public offering of its common stock. All shares are to be offered by the company. The company said it plans to use the net proceeds to fund its previously-announced acquisition of C Technologies and for working capital and other corporate purposes.
The stock slipped 2.69 percent to $67.04 in after-hours trading.
On The Radar PDUFA Dates
The FDA is set to rule on Heron Therapeutics Inc (NASDAQ: HRTX)'s HTX-001, a fixed-dose combination of the local anesthetic bupivacaine and nonsteroidal anti-inflammatory drug meloxicam, for application into the surgical site to reduce postoperative pain.
The FDA will announce its decision on Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)'s Contepo for complicated urinary tract infections.
• Eli Lilly And Co (NYSE: LLY) (before the market open)
• Meridian Bioscience, Inc. (NASDAQ: VIVO) (before the market open)
• BIO-TECHNE Corp (NASDAQ: TECH) (before the market open)
• Genocea Biosciences Inc (NASDAQ: GNCA) (before the market open)
• Pfizer Inc. (NYSE: PFE) (before the market open)
• NeoGenomics, Inc. (NASDAQ: NEO) (before the market open)
• Merck & Co., Inc. (NYSE: MRK) (before the market open)
• Amgen, Inc. (NASDAQ: AMGN) (after the market close)
• Pulse Biosciences Inc (NASDAQ: PLSE) (after the market close)
• EXACT Sciences Corporation (NASDAQ: EXAS) (after the market close)
• Veracyte Inc (NASDAQ: VCYT) (after the market close)
• Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the market close)
• Evolus Inc (NASDAQ: EOLS) (after the market close)
• Twist Bioscience Corp (NASDAQ: TWST) (after the market close)
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- The Daily Biotech Pulse: Adverum Gets New CFO, Flexion's Osteoarthritis Trial, Bristol-Myers Earnings
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