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 Sept. 23)
- Acceleron Pharma Inc XLRN
- Arena Pharmaceuticals, Inc. ARNA
- Beigene Ltd BGNE
- Blueprint Medicines Corp BPMC
- Cardiff Oncology Inc CRDF
- Castle Biosciences Inc CSTL
- Horizon Therapeutics PLC HZNP (moved on positive sell-side comment on its thyroid eye disease drug)
- InVitae Corp NVTA
- Myovant Sciences Ltd MYOV
- Novo Nordisk A/S NVO
- Pacific Biosciences of California Inc PACB
- SpringWorks Therapeutics Inc SWTX
- TFF Pharmaceuticals Inc TFFP
- Vaxcyte Inc PCVX
Down In The Dumps
(Biotech Stocks Hitting 52-Week Lows Sept. 23)
- Alector Inc ALEC
- Athira Pharma Inc ATHA
- Amarin Corporation plc AMRN
- BELLUS Health Inc BLU
- Corbus Pharmaceuticals Holdings Inc CRBP
- DBV Technologies ADR Representing 0.5 Ord Shs DBVT
- Genetron Holdings Ltd – ADR GTH
- Genfit SA GNFT
- Gritstone Oncology Inc GRTS
- Histogen Inc HSTO
- Hoth Therapeutics Inc HOTH
- Intercept Pharmaceuticals Inc ICPT
- Lexicon Pharmaceuticals, Inc. LXRX
- Neos Therapeutics Inc NEOS
- Neurobo Pharmaceuticals Inc NRBO
- Oncternal Therapeutics Inc ONCT
- PainReform Ltd PRFX
- Pandion Therapeutics Inc PAND
- RA Medical Systems Inc RMED
- Renalytix AI PLC RNLX
- Teligent Inc (NEW JERSEY) TLGT
- Tricida Inc TCDA
- Vaccinex Inc VCNX
Stocks In Focus
Luminex Snags $683.5K BARDA In Funding For COVID-19 Antibody Test
Luminex Corporation LMNX said it has received an award of $683,500 from the Biomedical Advanced Research and Development Authority to support the enhancement of its xMAP SARS-CoV-2 Multi-Antigen IgG Assay. The company intends to submit this enhanced serology assay for an emergency use authorization when the project is completed.
"The xMAP SARS-CoV-2 Multi-Antigen IgG Assay detects antibodies to three different viral antigens — the spike protein, nucleocapsid, and receptor-binding domain — to assess if a person has been infected with SARS-CoV-2," the company said.
In after-hours trading, the stock was down 1.63% at $27.40.
Lexicon Announces Exchange Of Notes In Bid To Reduce Indebtedness
Lexicon announced privately negotiated exchange agreements with certain holders of its 5.25% convertible senior notes due 2021 under which the holders have agreed to exchange $62.55 million in notes for $41.03 million in cash and 8.75 million shares of Lexicon's common stock.
The transactions are expected to close by Sept. 28. Following the closings, $24.95 million in aggregate principal amount of the notes will remain outstanding, the company said.
This transaction, along with other debt reductions, will have reduced Lexicon's outstanding debt by approximately 90% since June 30.
The stock was trading 4.64% higher at $1.58 premarket Thursday.
Ideaya Expands Oncology Study Collaboration With Pfizer
Ideaya Biosciences Inc IDYA said it has expanded its clinical trial collaboration and supply agreement with Pfizer Inc. PFE for an IDEAYA-sponsored clinical combination study of IDE196, to which Pfizer has exclusive worldwide rights.
The study will evaluate IDE196 and crizotinib combination therapy in patients with solid tumors having GNAQ or GNA11 mutations, including metastatic uveal melanoma, skin melanoma, lung cancer and colorectal cancer.
Axsome Migraine Drug Found Superior to Active Comparator Rizatriptan
Axsome Therapeutics Inc AXSM announced new data from the Phase 3 MOMENTUM study of AXS-07, which showed rapid onset of action and reduced symptom recurrence in acute treatment of migraine, as compared to the potent active comparator rizatriptan marketed by Merck & Co., Inc. MRK.
Co-Diagnostics Plans Launch Of Triplet Test In First Week of October
Co-Diagnostics Inc CODX said its Logix Smart ABC Test for diagnosing influenza A, influenza B and COVID-19 is expected to be ready for launch to U.S. CLIA laboratory customers the first week of October.
The stock was trading 6.32% higher at $14.30 premarket.
Ascendis Files For Pediatric Growth Hormone Deficiency Drug In Japan
Ascendis Pharma A/S ASND said it has filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency in Japan to initiate a Phase 3 riGHt trial of TransCon hGH, a long-acting prodrug of somatropin, for the treatment for pediatric growth hormone deficiency.
OraSure's Saliva Collection Device Included In EUA For Quadrant's COVID-19 Test
OraSure Technologies, Inc. OSUR said its ORAcollect RNA saliva collection device has been included in the FDA EUA granted to Quadrant Biosciences Inc. for a COVID-19 laboratory test.
This is the sixth EUA to include a collection device from the company's DNA Genotek subsidiary and the first to exclusively utilize a saliva collection method, OraSure said.
OraSure shares were trading 2.93% higher to $11.95 premarket Thursday.
Aytu Postpones Q4 Earnings Release
Aytu Bioscience Inc AYTU, which was scheduled to report its fiscal year fourth-quarter results Thursday after the close, said it will reschedule the earnings call to allow additional time to finalize financial statements due to the additional workload created by the recently completed acquisition of Innovus Pharmaceuticals and to accommodate scheduling needs related to COVID-19.
The stock was down 3.91% to $1.23 in after-hours trading.
Gilead Sciences, Inc. GILD priced its underwritten public offering of senior unsecured notes in an aggregate principal amount of $7.25 billion, consisting of seven tranches. The offering is expected to close Sept. 30, subject to customary closing conditions.
The company said it intends to use the net proceeds to fund the cash portion of the consideration for buying Immunomedics, Inc. IMMU and also to retire debt.
The stock was trading slightly positive premarket at $63.10.
On The Radar
Dallas, Texas-based Taysha Gene Therapies, Inc. priced its upsized initial public offering of 7.87 million shares of its common stock at $20 versus the estimated price range of $18-$20.
The shares of the company — which is engaged in the development of AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system — will begin trading on the Nasdaq under the ticker symbol "TSHA."
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