Here's a roundup of top developments in the biotech space over the last 24 hours.
Scaling The Peaks
(Biotech stocks hitting 52-week lows on Oct. 3)
- Aprea Therapeutics Inc APRE (IPOed on Thursday)
- Viela Bio Incn VIE (IPOed on Thursday)
Down In The Dumps
(Biotech stocks hitting 52-week lows on Oct. 3)
- Adamas Pharmaceuticals Inc ADMS
- Adaptimmune Therapeutics PLC – ADR ADAP
- Alpine Immune Sciences Inc ALPN
- bluebird bio Inc . BLUE
- Corvus Pharmaceuticals Inc CRVS
- DelMar Pharmaceuticals Inc DMP
- Eloxx Pharmaceuticals Inc ELOX
- Erytech Pharma SA ERYP
- Frequency Therapeutics Inc FREQ(IPOed on Thursday)
- Fulcrum Therapeutics Inc FULC
- Jaguar Health Inc JAGX
- Karuna Therapeutics Inc KRTX
- Kiniksa Pharmaceuticals Ltd KNSA
- Madrigal Pharmaceuticals Inc MDGL
- Neuralstem, Inc. CUR
- Obseva SA OBSV
- Onconova Therapeutics Inc ONTX
- RA Medical Systems Inc RMED
- Sierra Oncology Inc SRRA
- Titan Pharmaceuticals, Inc. TTNP
- Trinity Biotech plc TRIB
- Viveve Medical Inc VIVE
Stocks In Focus
Arbutus Halts Hepatitis B Drug Study
Arbutus Biopharma Corp ABUS decided to discontinue the development of AB-506, an oral capsid inhibitor, which was being evaluated in a Phase 1a/1b trial for the treatment of chronic hepatitis B.
The company attributed the decision to two cases of acute hepatitis observed in the Phase 1a, 28-day trial in healthy volunteers.
As a result of the discontinuation of the AB-506 development, the company is no longer planning to initiate a combination study of AB-506 and AB-729 in the second half of 2020.
The stock plummeted 25.17% to $1.07 in pre-market trading.
Mei Pharma Reports Positive Early-stage Data For Blood Cancer Drug
MEI Pharma Inc MEIP announced updated data from the ongoing Phase 1b study of investigational ME-401, a selective oral inhibitor of PI3K delta, which showed an overall response rate of 78% in relapsed or refractory follicular lymphoma and 89% in refractory/relapsed chronic lymphocytic leukemia or small lymphocytic lymphoma.
On safety, the company noted that grade 3 adverse events of special interest related to ME-401 exposure were observed in less than 10% of patients dose on an intermittent schedule.
The stock was rallying 16.11% to $2.09 in pre-market trading.
Aptevo Higher Following Corporate Update
Aptevo Therapeutics Inc APVO reported preliminary net product sales from Ixinity of about $9 million compared to $5.8 million in the year-ago period.
"Patient conversions onto IXINITY therapy reached their highest level during the current quarter, following the launch of a new, larger assay size and as awareness of IXINITY continues to build," the company said.
The company also said its lead ADAPTIR bispecific antibody candidate being evaluated in a Phase 1/1b trial of patients with acute myeloid leukemia and high-grade myelodysplastic syndrome showed potential clinical activity and no dose-limiting toxicities and no anti-drug antibodies.
Meanwhile, Aptevo decided to discontinue further development of APV0210, which is being evaluated in a Phase 1 study for autoimmune diseases.
The company also announced an expense reduction plan that will reduce annual expenditures by about 30%.
The stock was rising 10.11% to 60 cents in pre-market trading.
J&J's Janssen Unit's Niraparib Gets Breakthrough Therapy Designation For Prostate Cancer
Johnson & Johnson JNJ's Janssen unit said the FDA has granted Breakthrough Therapy Designation for its niraparib for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer, who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy.
A BTD is granted to expedite the development and regulatory review of an investigational drug intended to treat a serious or life-threatening condition.
Offerings
Ovid Therapeutics Inc OVID said it intends to offer shares of its common stock and Series A convertible preferred stock in two concurrent but separate underwritten public offerings. The company said it intends to use the net proceeds primarily to advance the clinical development of its OV101 and OB935 programs.
The stock fell 14.07% to $2.81 in after-hours trading.
Heron Therapeutics Inc HRTX said it has priced an underwritten public offering of 8.57 million shares at $17.50 per share. The company expects the offering to close around Oct. 8. It expects to raise gross proceeds of $150 million from the offering.
The stock was losing 7.05% to $18 in pre-market trading.
On The Radar
Clinical Trial Readouts
Sarepta Therapeutics Inc SRPT is due to release Phase 1/2 , 9-month data for MYO-101 in Duchenne muscular dystrophy.
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