Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peak
(Biotech Stocks Hitting 52-week Highs June 3)
- Arena Pharmaceuticals, Inc. ARNA
- BioMarin Pharmaceutical Inc. BMRN
- Black Diamond Therapeutics Inc BDTX
- Fortress Biotech FBIO
- Imara Inc IMRA
- Inari Medical Inc NARI
- Intellia Therapeutics Inc NTLA
- Kala Pharmaceuticals Inc KALA
- Keros Therapeutics Inc KROS
- ORIC Pharmaceuticals Inc ORIC
- Phathom Pharmaceuticals Inc PHAT
- Pliant Therapeutics Inc PLRX (went public Wednesday)
- Protara Therapeutics Inc TARA
- Qiagen NV QGEN
- Turning Point Therapeutics Inc TPTX
- United Therapeutics Corporation UTHR
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows June 3)
- Cellectar Biosciences Inc CLRB (priced a $20-million common stock offering)
- Cumberland Pharmaceuticals, Inc. CPIX
- Genfit SA GNFT
Stocks In Focus
Kezar Reports Positive Early Stage Results For KZR-616 In Systemic Lupus Erythematosus
Kezar Life Sciences, Inc. KZR announced updated results from the Phase 1b portion of the Phase 1b/2 MISSION study, which is evaluating the safety and tolerability of KZR-616 in patients with systemic lupus erythematosus with and without nephritis, showing overall improvements across seven measures of disease activity.
Two of two patients with lupus nephritis experienced a greater than 50% reduction in proteinuria, a biomarker of disease severity, according to the company. A positive safety and tolerability profile was observed with step-up dosing of KZR-616, Kezar said.
The stock jumped 48.32% to $6.63 in premarket trading Thursday.
AcelRx Ends Bid For Tetraphase
Following a bidding war for Tetraphase Pharmaceuticals Inc TTPH that saw the contenders sweetening their offers a few times, AcelRx Pharmaceuticals Inc ACRX, one of the contenders, said it does not intend to revise further its offer and that the offer is likely to be terminated by Tetraphase.
This leaves the path clear for a takeover of Tetraphase by Melinta.
AcelRx is eligible to receive a break-up fee of $1.8 million.
AcelRx shares were up 1.55% at $1.31 at the time of publication during Thursday's premarket session, while Tetraphase shares were down 1.34% at $2.21.
See also: The Week Ahead In Biotech: ASCO, Menlo And Merck FDA Decisions, IPOs In The Spotlight
ObSeva Announces Positive Pilot Study Results From Linzagolix In Adenomyosis
Obseva SA OBSV announced the publication in the journal Fertility and Sterility of a case report from a pilot study assessing the use of linzagolix for the treatment of uterine adenomyosis. The study showed the patient treated with linzagolix saw alleviation of symptoms such as cessation of bleeding, improvement in pelvic pain, resolution of anemia and shrinkage of uterus at week 12.
The symptoms continued to improve with the subsequent 12 weeks of treatment, and the effect lingered at eight weeks following the treatment.
Pending confirmation of the results in additional patients, ObsEva said it may pursue additional studies to support supplemental labeling for the treatment of adenomyosis in reproductive-age women.
The stock was down 5.66% at $5 premarket.
Roche Obtains FDA Emergency Use Authorization For Test To Identify High-Risk Coronavirus Patients
Roche Holdings AG Basel ADR Common Stock RHHBY said the FDA has issued an Emergency Use Authorization for the Elecsys IL-6 test, which measures levels of the biomarker interleukin 6 and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation.
AstraZeneca Announces Oncology Partnership With Accent For Up To $1.2B
AstraZeneca plc AZN announced a collaboration with Accent Therapeutics to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins for the treatment of cancer.
The agreement provides for AstraZeneca paying Accent a $55 million upfront and up to about $1.1 billion in total milestones, plus tiered royalties.
In premarket trading, Thursday, AstraZeneca shares were gaining 0.36% to $55.20.
Tiziana Gets NIH Grant For Studying Nasal Anti-CD3 Therapy For Alzheimer's Disease
TIZIANA LF SCIE/S ADR TLSA said the chairman of its Scientific Advisory Board, Dr. Howard Weiner, has received a competitive research grant from the NIH to investigate nasal anti-CD3 for the treatment of Alzheimer's disease.
The company said it has licensed the anti-CD3 mAbs from Brigham and Women's Hospital, Harvard Medical School, Boston, and that it has completed two Phase 1 trials. It also said it expects to initiate two Phase 2 trials shortly for nasally and orally administered Foralumab for the treatment of progressive multiple sclerosis and Crohn's disease, respectively.
The stock was adding 4.89% to $6.87 in premarket trading Thursday.
EULAR Presentations
Gilead Sciences, Inc. GILD and GALAPAGOS NV/S ADR GLPG announced at the at the European League Against Rheumatism, EULAR, E-Congress, Week 52 results from the Phase 3 FINCH 1 and FINCH 3 studies of filgotinib in adults with moderately to severely active rheumatoid arthritis, which demonstrated sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib treatment across RA patient populations.
Novartis AG NVS announced full 52-week results from the Phase 3 PREVENT trial, which reinforced the substantial and sustained benefits of Cosentyx across the axial spondyloarthritis spectrum.
"The study found patients treated with Cosentyx 150 mg showed significant and sustained improvements in signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA) at 52 weeks," the company said.
Novartis shares were rising 0.62% to $86.23 in premarket trading Thursday.
Offerings
Twist Bioscience Corp TWST said it has priced its underwritten public offering of 3.03 million shares of its common stock at $33 per share for gross proceeds of $100 million. The company expects the offering to close on or about June 8.
The stock was down 5.07% at $35.19 premarket.
Aileron Therapeutics Inc ALRN said it has commenced an underwritten public offering of shares of its common stock. All the shares earmarked for the offering are sold by the company.
The stock was down 13.74% at $1.13 premarket.
On The Radar
PDUFA Dates
The FDA is set to rule on Merck & Co., Inc. MRK sNDA for its triple combo antibiotic Recarbrio.
Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates
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