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 May 11)
- HOOKIPA Pharma Inc. (NASDAQ:HOOK)
- Novo Nordisk A/S (NYSE:NVO)
- West Pharmaceutical Services, Inc. (NYSE:WST)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows May 11)
Stocks In Focus
Minerva Announces Positive Results From Phase 3 Open-label Extension Study of Schizophrenia Treatment Candidate
Minerva Neurosciences, Inc. (NASDAQ:NERV) announced results from the 40-week open-label extension of its phase 3 trial of roluperidone for the treatment of negative symptoms of schizophrenia, showing mean improvement in positive symptoms.
This improvement is measured by Positive and Negative Syndrome Scale and Negative Symptom Factor Score observed over one year in patients receiving both 64 mg and 32 mg doses.
"Results provide additional support for continued development of roluperidone and submission of NDA following completion of bioequivalence study and other work to address FDA comments from the Type C meeting held on Nov. 10," the company said.
The stock jumped 34.53% to $3 in after-hours trading.
InflaRx's Vilobelimab Aces Mid-stage Study In Inflammation of Blood Vessels
InflaRx announced positive topline results from its U.S. Phase 2 IXPLORE study with vilobelimab in patients with anti-neutrophil cytoplasmic auto-antibody -associated vasculitis, or AAV.
"Although the sample size of the trial was small and it is difficult to interpret results not powered to show statistical significance, patients across all three treatment groups demonstrated a strong response at week 16, and more patients treated with SOC plus vilobelimab had clinical remissions at various timepoints throughout the study compared to SOC plus placebo," the company said.
The stock rose 1.44% to $3.52 in after-hours trading.
Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates
Lucira Health Announces Availability of COVID-19 Test Kit On Amazon
Lucira said its Lucira CHECK IT COVID-19 test kit is now available on Amazon, Inc. (NASDAQ:AMZN) in the US.
Each LUCIRA CHECK IT test kit provides a PCR quality test result at home in 30 minutes or less. After testing, users can also receive a free, text based digital LUCI PASS verified test result on their phone for work or travel. The product costs $55 and includes free standard shipping.
Morphosys, Incyte Commence Late-stage Study of Combo Treatment In First-line Setting In Diffuse Large B-cell Lymphoma Patients
Tafasitamab is a humanized, monoclonal antibody designed to effectively target the B-cell specific antigen CD19 and to induce immune cell activation.
Sanofi, Cellectis Reach Deal For Alemtuzumab to Be Used as Lymphodepleting Agent In Latter's Clinical Trials
Patients' lymphodepleting regimens reduce host immune cells and should improve allogeneic CAR T-cell expansion and persistence.
As part of the agreement, Sanofi will supply alemtuzumab to support Cellectis' clinical trials and the parties agreed to enter into discussions to execute a commercial supply of alemtuzumab under pre-agreed financial conditions.
Earnings
VolitionRx Limited (NYSE:VNRX) reported a loss for its first quarter that was in line with the consensus.
The stock rose 11.50% to $3.49 in after-hours trading.
Ra Medical Systems, Inc. (NYSE:RMED) said its first-quarter revenues fell from $1.4 million in 20202 to $1.1 million in 2021, and the net loss per share narrowed from $13.98 to $2.48. Analysts had estimates revenues of 990,000 and a loss of $2.94.
The stock moved up 14.46% to $3.80 in after-hours trading.
ClearPoint Neuro, Inc.'s (NASDAQ:CLPT) first-quarter revenues climbed 29% year-over-year to $4 million and the loss per share was 13 cents, flat with the year-ago quarter. Analysts had estimated a loss of 14 cents per share.
The company guided to fiscal year 2021 revenues of $16 million to $17.5 million, ahead of the $15.83 million consensus estimate.
The stock gained 10.42% to $19.50 in after-hours trading.
Offerings
The stock fell 6.19% to $24.25 in after-hours trading.
Axonics, Inc. (NASDAQ:AXNX) priced its public offering of 3.5 million shares of its common stock at a price of $50 per share. The gross proceeds from the offering to Axonics are expected to be $175 million. The offering is expected to close on May 14, subject to the satisfaction of customary closing conditions.
In after-hours trading, the stock was down 4.57% to $50.33.
On The Radar
PDUFA Dates
The Food and Drug Administration is scheduled to rule on Heron Therapeutics, Inc.'s (NASDAQ:HRTX) new drug application for HTX001, which is being evaluated for postoperative pain. This is Heron's third attempt at gaining approval for the investigational drug.
Clinical Readouts
Graybug Vision will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial Wednesday, at 8 am. The mid-stage trial is evaluating its investigational asset GB-102 in wet age-related macular degeneration.
ASGCT Meeting Presentations
Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT): Updated results of a global Phase 1 study of lentiviral mediated gene therapy for adult and pediatric patients with pyruvate kinase deficiency
Cellectis: translational data obtained from the first patients enrolled prior to clinical hold, in the Phase 1 study of UCARTCS1, an allogeneic CAR T-Cell therapy targeting CS1 in patients with relapsed or refractory multiple myeloma
Earnings
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