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 June 30)
- ADC Therapeutics SA ADCT
- Akebia Therapeutics Inc AKBA
- Alterity Therapeutics Ltd ATHE (announced agreement with the FDA regarding Phase 2 study of Parkinsonian disorder drug)
- Calliditas Therapeutics AB ADR CALT
- GENMAB A/S/S ADR GMAB - partner Seattle Genetics, Inc. SGEN announced positive results for antibody-drug conjugate for cervical cancer
- Halozyme Therapeutics, Inc. HALO
- Hologic, Inc. HOLX (reacted to a positive analyst action)
- Legend Biotech Corp LEGN
- Meridian Bioscience, Inc. VIVO
- Mersana Therapeutics Inc MRSN
- Novavax, Inc. NVAX
- Opko Health Inc. OPK
- Pacira Biosciences Inc PCRX
- Pliant Therapeutics Inc PLRX
- ResMed Inc. RMD
- Tandem Diabetes Care Inc TNDM
- Twist Bioscience Corp TWST (announced launch of Twist Respiratory Virus Research Panel for detecting a range of respiratory diseases)
- West Pharmaceutical Services Inc. WST
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows June 30)
- Brickell Biotech Inc BBI
- Iterum Therapeutics PLC ITRM (announced $5-million registered offering)
- Qualigen Therapeutics Inc QLGN
- Sonnet Biotherapeutics Holdings Inc SONN
- VIVUS, Inc. VVUS
Stocks In Focus
T2 Biosystems Pre-Announces In-Line Q2 Revenues, Launches COVID-19 Test In US
T2 Biosystems Inc TTOO announced the U.S. launch of the T2SARS-CoV-2 Panel, its COVID-19 molecular diagnostic test.
The test was developed under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after meeting requirements for an Emergency Use Authorization request to the FDA.
Separately, the company pre-announced second-quarter results and said it expects revenues of $2.4 million to $2.6 million versus $1.8 million in the year-ago period, while analysts estimate revenues of $2.45 million.
The stock was surging 74.8% to $2.22 premarket Wednesday.
Akero Reports Positive Results For Midstage NASH Drug Study
Akero Therapeutics Inc AKRO announced positive results from a 16-week analysis of secondary and exploratory endpoints in its Phase 2a BALANCED study of efruxifermin in patients with nonalcoholic steatohepatitis.
The company said of the 40 treatment responders who had end-of-treatment biopsies, 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score and 28% achieved at least a two-stage improvement in fibrosis.
In addition, 48% of responders achieved NASH resolution with no worsening of fibrosis. Treatment with EFX was generally reported to be well-tolerated, Akero said.
The stock was up 45.26% at $36.20 premarket Wednesday.
Pfizer, Germany's Merck KGaA Announce FDA Nod For Label Expansion For Cancer Drug
Pfizer Inc. PFE and MERCK KGAA/S ADR MKKGY unit EMD Serono said the FDA approved the sBLA for Bavencio for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy.
Aravive To Join Russell 2000, 3000 Indexes
Aravive Inc ARAV said it has been added to the Russell 2000 and Russell 3000 indexes, effective June 29, as part of the 2020 Russell U.S. indexes reconstitution. The stock added 7.39% to $12.50 in after-hours trading.
BeiGene Begins Commercialization of Amgen's Bone Tumor Drug In China
Beigene Ltd BGNE said it has begun commercializing Amgen, Inc.'s AMGN Xgeva (denosumab) in China for the treatment of giant cell tumor of bone. This marks the first Amgen product that has been transitioned to BeiGene for commercialization in China since the commencement of the parties' global strategic oncology collaboration in January 2020, Beigene said.
Matinas Announces Resumption Of Clinical Studies Following COVID-Induced Pause
Matinas BioPharma Holdings Inc MTNB said it has commenced enrollment and started dosing patients in the ENHANCE-IT study, a head-to-head study of MAT9001 vs. Vascepa.
The company expects enrollment to be completed by August and top-line data from the study to be available in the first quarter of 2021.
The company also said it expects to resume dosing patients in the EnACT study imminently, following the recent receipt of necessary governmental and regulatory approvals in Uganda.
Both studies temporarily paused enrollment in March due to the COVID-19 pandemic.
In premarket trading Wednesday, the stock was adding 3.49% to 80 cents.
Earnings
Avid Bioservices Inc's CDMO fourth-quarter revenue fell 26% to $12.6 million and the loss per share widened from 2 cents to 11 cents.
Analysts had expected a wider loss of 16 cents per share.
The company guided fiscal year 2021 revenues to a range of $76 million to $81 million against an $83.85-million consensus estimate.
In after-hours trading, the stock advanced 5.56% to $6.93.
Offerings
Chiasma Inc CHMA, which recently received FDA approval for Mycapssa for the treatment of acromegaly, said it has commenced an underwritten public offering of its common stock, and to certain investors, pre-funded warrants to purchase shares of its common stock.
All of the securities to be sold in the offering are to be sold by the company. The company said it intends to use the net proceeds primarily for the commercialization of Mycapssa.
The stock slipped 14.50% to $4.60 in after-hours trading.
Transenterix Inc TRXC said it has commenced an underwritten offering of common stock. The stock was down 29.78% to 38 cents premarket.
Related Link: Gilead Announces Pricing Of Coronavirus Treatment Remdesivir: 'We Believe All Patients Will Have Access'
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