The Daily Biotech Pulse: Deciphera Cancer Drug Gets Priority Review, Fast Track Designation For Soligenix, Revolution Medicines IPO

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 Feb. 12)

• AbbVie Inc ABBV
• Agile Therapeutics Inc AGRX
• Akebia Therapeutics Inc AKBA
• Allergan plc AGN
• Alnylam Pharmaceuticals, Inc. ALNY
• Anavex Life Sciences Corp AVXL
• Aptose Biosciences Inc APTO
• AtriCure Inc. ATRC
• AVITA MED LTD/S ADR RCEL
• Avrobio Inc AVRO
• Beam Therapeutics Inc BEAM
• Brainstorm Cell Therapeutics Inc BCLI
• ChemoCentryx Inc CCXI
• Cytokinetics, Inc. CYTK
• DexCom, Inc. DXCM
• Esperion Therapeutics Inc ESPR
• Fate Therapeutics Inc FATE
• ITAMAR MED LTD/S ADR ITMR
• Masimo Corporation MASI
• Medpace Holdings Inc MEDP
• NeoGenomics, Inc. NEO
• Novartis AG NVS
• Ocular Therapeutix Inc OCUL
• PAVmed Inc PAVM
• Penumbra Inc PEN
• Prevail Therapeutics Inc PRVL(reacted to the FDA according Orphan Drug Designation to its experimental gene therapy PR001 for treating Gaucher disease)
• PTC Therapeutics, Inc PTCT
• Repligen Corporation RGEN
• Tandem Diabetes Care Inc TNDM
• West Pharmaceutical Services Inc. WST
• Zai Lab Ltd ZLAB
• ZEALAND PHARMA/S ADR ZEAL
• Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Feb. 12)

• ADDEX THERAPEUT/ADR ADXN
• AnPac Bio-Medical Science Co Ltd – ADR ANPC (IPOed in late January)
• Aptevo Therapeutics Inc APVO
• Bellerophon Therapeutics BLPH
• Brickell Biotech Inc BBI
• CASI Pharmaceuticals Inc CASI
• Enzo Biochem, Inc. ENZ
• Happiness Biotech Group Ltd HAPP
• PDS Biotechnology CorpPDSB
• Phio Pharmaceuticals Corp PHIO
• REDHILL BIOPHAR/S ADR RDHL
• Xeris Pharmaceuticals Inc XERS
• Zosano Pharma Corp ZSAN(priced its offering of $8 million worth of stock and warrants)

Stocks In Focus

Allena Reaches Agreement With FDA For Revised Design For Hyperoxaluria Drug Trial

Allena Pharmaceuticals Inc 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's Ricin Toxin Vaccine Gets Fast Track Designation

Soligenix, Inc. 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' CAR T-cell Immunotherapy to Treat Blood Cancer Accepted For Priority Review

Bristol-Myers Squibb Co 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 Reports Publication Of Positive Phase 2 Results For Liver Cancer Therapy

AVEO Oncology 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's Gastrointestinal Stromal Tumor Drug Accepted For Priority Review

Deciphera Pharmaceuticals Inc 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.

Earnings

Crispr Therapeutics AG 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.

Offerings

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 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.

On The Radar

Clinical Readouts

ASCO 2020 Genitourinary Cancers Symposium Presentations

Exelixis, Inc. EXEL: Phase 1b data for cabozantinib and Roche Holdings AG Basel ADR Common Stock's RHHBY Tecentriq in solid tumors
Advaxis, Inc. ADXS: Phase 1/2 data for ADXS-PSA and Merck's Keytruda from the KEYNOTE-046 study in castrate-resistant prostate cancer
TrovaGene Inc TROV: new Phase 2 data for onvansertib and zytiga in prostate cancer (Thursday)

Earnings

• Alkermes Plc ALKS (before the market open)
• Agios Pharmaceuticals Inc AGIO (before the market open)
• West Pharmaceutical Services Inc. WST (before the market open)
• Acorda Therapeutics Inc ACOR (before the market open)
• Blueprint Medicines Corp BPMC (before the market open)
• Evelo Biosciences Inc EVLO (before the market open)
• Genocea Biosciences Inc GNCA (before the market open)
• Incyte Corporation INCY (before the market open)
• Zoetis Inc ZTS (before the market open)
• West Pharmaceutical Services Inc. WST (before the market open)
• Karyopharm Therapeutics Inc KPTI (before the market open)
• Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
• DexCom, Inc. DXCM (after the close)
• Urovant Sciences Ltd UROV (after the close)
• Shockwave Medical Inc SWAV (after the close)
• Ultragenyx Pharmaceutical Inc RARE (after the close)
• Aytu Bioscience Inc AYTU (after the close)
• Bio-Rad Laboratories, Inc. BIO (after the close)

IPOs

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."