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 June 12)
• Abbott Laboratories ABT
• Avedro Inc AVDR
• Insulet Corporation PODD
• Novocure Ltd NVCR
• ZIOPHARM Oncology Inc. ZIOP
Down In The Dumps
(Biotech stocks that hit 52-week lows June 12)
• Actinium Pharmaceuticals Inc ATNM
• BENITEC BIOPHAR/S ADR BNTC
• MEREO BIOPHARMA/ADR MREO announced that Celgene Corporation CELG decided not to exercise an option to license etigliman, the anti-TIGIT antibody, one of the two product candidates it acquired through its merger with OncoMed.
• Navidea Biopharmaceuticals Inc NAVB
• Obseva SA OBSV
• Savara Inc SVRA(announced failed late-stage study of its pulmonary autoimmune disorder disease candidare)
• Sellas Life Sciences Group Inc SLS
• Seres Therapeutics Inc MCRB (announced common stock offering)
Stocks In Focus
Kezar Life Sciences' Drug Found Effective, Safe In Early Stage Study
Kezar Life Sciences Inc KZR announced results from the Phase 1b open-label dose escalation portion of the MISSION study evaluating its KZR-616 in patients with systemic lupus erythematosus, which showed that the primary goal of enabling the identification of active and well-tolerated doses that meet target levels of immunoproteasome inhibition was met.
The presentation was made at the EULAR Annual European Congress of Rheumatology.
The results also support the development of KZR-616 in lupus nephritis and other autoimmune diseases of high unmet need.
The company also said the Phase 2 portion of the MISSION study in patients with lupus nephritis has been initiated.
The stock shed 3.16% to $9.50 in after-hours trading.
Urovant Q4 Loss Widens
Urovant Sciences Ltd UROV reported a fourth-quarter loss of 96 cents per share, wider than the year-ago loss of 95 cents and the consensus estimate of a loss of 94 cents per share.
The stock rose 4.64% to $7.90 in after-hours trading.
Eton Licenses NDA For Epilepsy Drug
Eton Pharmaceuticals Inc ETON said it has entered into an agreement with Aucta Pharma to acquire marketing rights to ET-105, a formulation of lamotrigine delivered to patients as an oral liquid. Aucta submitted an NDA to the FDA in May, seeking approval for it as an adjunct therapy partial seizures, primary generalized tonic-clonic seizures and generalized seizures of Lennox-Gastaut syndrome in patients 2 and older.
The agreement provides for Eton paying Aucta upto $5 million in a milestone payment, a low double-digit royalty on net sales and the option to receive milestone payments of up to $18 million based on commercial success of the product.
The stock gained 9.38% to $8.75 in after-hours trading.
Offerings
Navidea said it has priced its 8-million share common stock offering at 75 cents per share to generate gross proceeds of $6 million. The offering is said to close on or about June 18.
The stock rallied 16.04% to $1.15 in after-hours trading.
Seres priced its previously announced public offering of 26.67 million shares at $2.25 per share.
The stock rose 1.06% to $2.86 in after-hours trading.
FDA Approves Amgen-Allergan's Herceptin Biosimilar
Amgen, Inc. AMGN and Allergan plc AGN announced FDA approval for Kanjinti, a biosimilar for Herceptin for all approved indications of Herceptin, for treating HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
See also: Micro-Cap Biotech Kezar Life Sciences Trades Sharply Lower On New Data
ArQule's ARQ 531 Shows Substantial Anti-Tumor Activity
ArQule, Inc. ARQL announced preliminary results from its Phase 1 dose escalation study for ARQ 531 in patients with relapsed or refractory hematologic malignancies that showed that the candidate was well-tolerated through 65 mg QD. It demonstrated substantial anti-tumor activity and favorable safety profile, with four out of six evaluable CLL patients from cohort 7 — all with the BTK-C481S mutation — experiencing a partial response.
The data was presented at the European Hematology Association Congress.
The stock was soaring 46.58% to $9.24 in Friday's premarket session.
Beigene Reports Positive Results For Pipeline Assets
Beigene Ltd BGNE announced at the European Hematology Association Congress updated Phase 2 data for tislelizumab in Chinese patients with relapsed or refractory classical Hodgkin lymphoma. The results showed that the pipeline asset demonstrated high anti-tumor activity and was well-tolerated. The company also announced updated results from the Phase 1/2 trial of zanubrutinib in Waldenström's macroglobulinemia, which showed an overall response rate of 81% and a major response rate that includes patients with a partial response or better of 54%, including 23% with a very good partial response.
The stock was rising 1.05% to $126.40 in Friday's premarket session.
Global Blood's Sickle Cell Disease Drug Succeeds In Late-Stage Study
Global Blood Therapeutics Inc GBT presented new results from a Phase 3 study of GBT440 in sickle cell disease, with the study meeting its primary endpoint of an improvement in hemoglobin greater than 1 g/dL at 24 weeks with voxelotor 1500 mg compared with placebo, along with a favorable safety and tolerability profile.
The data was presented at the European Hematology Association Congress.
On The Radar
Clinical Trial Readouts
EULAR Annual European Congress Of Rheumatology Presentations
• Corbus Pharmaceuticals Holdings Inc CRBP: Phase 2 open-label data for lenabasum in dermatomyositis and Phase 2 open-label data for lenabasum in systemic sclerosis.
24th European Hematology Association Congress Presentations
• bluebird bio Inc BLUE: Phase 3 data for LentiGlobin - HGB-212 in transfusion-dependent beta thalassemia, updated Phase 1/2 data for LentiGlobin - HGB-204 in beta-thalassemia and updated Phase 3 data for LentiGlobin - HGB-207 in non-β0/β0 transfusion-dependent thalassemia.
• Blueprint Medicines Corp BPMC: updated Phase 1 data for avapritinib BLU-285 in advanced systemic mastocytosis.
• Sunesis Pharmaceuticals, Inc. SNSS: updated Phase 1/2 data for SNS-062 in advanced B-cell malignancies.
24th World Congress Of Dermatology Presentations
• Incyte Corporation INCY: Phase 2 data for ruxolitinib in atopic dermatitis.
Earnings
• Urovant Sciences Ltd UROV: after the close.
Related Link: What You Should Know About The Eye Care Product That Sent NovaBay Shares Soaring Nearly 900%
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