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Here's a roundup of top developments in the biotech space over the last 24 hours.
(Biotech Stocks Hitting 52-week highs on Feb. 12)
(Biotech Stocks Hitting 52-week lows on Feb. 12)
Allena Pharmaceuticals Inc (NASDAQ:ALNA) has reached an agreement with the FDA on a streamlined design for URIROX-2, the second pivotal clinical trial for reloxaliase, which is being evaluated for treating severe hyperoxaluria.
Following the higher-than-projected kidney stone and urinary oxalate observed in the completed first pivotal Phase 3 URIROX-1 trial and the subsequent engagement with the FDA, the company said it is reducing the target enrollment from 400 subjects to 200 subjects to support a BLA. The FDA has also agreed to a have the first sample size reassessment once 130 subjects reach six months of treatment, rather than 240 subjects.
The study is to include a new sponsor-blinded estimation of conditional probability of achieving the study's primary and key secondary endpoints at the time of the first sample size reassessment.
Allena said the streamlining will potentially reduce the target length and cost of the trial. The company said it plans to submit a protocol amendment for the revised trial design in the first quarter of 2020, and release interim analysis in the third quarter of 2021.
The stock slipped 10.26% to $2.10 in after-hours trading.
Soligenix, Inc. (NASDAQ:SNGX) said the FDA granted Fast Track Designation to its Rivax, heat sable ricin toxin vaccine, for the prevention of ricin intoxication.
The stock was adding 10.31% to $2.81 in pre-market trading.
Bristol-Myers Squibb Co (NYSE:BMY) said the FDA accepted for Priority Review its BLA for lisocabtagene maraleucel , its autologous anti-CD19 CAR T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult patients with relapsed or refractory large cell B-cell lymphoma after at least two prior therapies. The PDUFA date has been set for Aug. 17.
AVEO Oncology (NASDAQ:AVEO) announced publication in the British Journal of Cancer results from a monotherapy Phase 1b/2 trial of tivozanib in patients with advanced, inoperable hepatocellular carcinoma, which showed median progression free survival of 24 weeks and overall survival of 9 months for patients treated at the recommended Phase 2 dose of 1 mg once daily for 21 days followed by seven days off treatment on a 28-day cycle. The overall response rate was 21%, with a significant decrease in soluble plasma VEGFR-2 observed.
The stock moved up 3.71% to 56 cents in after-hours trading.
Deciphera Pharmaceuticals Inc (NASDAQ:DCPH) said the FDA has accepted for Priority Review its NDA for ripretinib, its broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors. The PDUFA date has been fixed for Aug. 13.
Separately, the company announced the commencement of a registered underwritten public offering of $250 million shares of its common stock.
Crispr Therapeutics AG (NASDAQ:CRSP) reported a strong increase in fourth-quarter revenues from $0.1 million to $77 million. The company reversed from a loss of 92 cents per share to a profit of 51 cents per share. Analysts estimated a loss of 63 cents per share on revenues of $35.83 million.
The stock rose 5.89% to $61.15 in after-hours trading.
AvroBio said it has priced its previously announced underwritten offering of 4.35 million shares at $23 per share, which will likely raise gross proceeds of $100 million. The company expects the offering to close on or about Feb. 18.
The stock slipped 9.23% to $24.40 in after-hours trading.
Catalyst Biosciences Inc (NASDAQ:CBIO) said it's offering shares of its common stock in an underwritten public offering. All the shares are being offered by the company.
The stock declined 14.27% to $6.85 in after-hours trading.
ASCO 2020 Genitourinary Cancers Symposium Presentations
Exelixis, Inc. (NASDAQ:EXEL): Phase 1b data for cabozantinib and Roche Holdings AG Basel ADR Common Stock's (OTC:RHHBY) Tecentriq in solid tumors
Advaxis, Inc. (NASDAQ:ADXS): Phase 1/2 data for ADXS-PSA and Merck's Keytruda from the KEYNOTE-046 study in castrate-resistant prostate cancer
TrovaGene Inc (NASDAQ:TROV): new Phase 2 data for onvansertib and zytiga in prostate cancer (Thursday)
Revolution Medicines, a biotech developing targeted cancer therapies using RAS pathway inhibitors, priced its upsized offering of 14 million shares at $17 compared to the initially estimated price range of $14 and $16. The company's shares will begin trading on the Nasdaq under the ticker symbol "RVMD."
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