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 Dec. 20)
- Acceleron Pharma Inc (NASDAQ: XLRN)
- Adaptive Biotechnologies Corp (NASDAQ: ADPT)
- Allakos Inc (NASDAQ: ALLK)
- Alpine Immune Sciences Inc (NASDAQ: ALPN)
- AtriCure Inc. (NASDAQ: ATRC)
- Beam Therapeutics Inc (NASDAQ: BEAM)
- BioNTech SE – ADR (NASDAQ: BNTX) (the company's coronavirus vaccine candidate received positive recommendation from the European Medicines Agency)
- Bioanalytical Systems, Inc. (NASDAQ: BASI) (reacted to its fourth-quarter results)
- BIO-TECHNE Corp (NASDAQ: TECH)
- Castle Biosciences Inc (NASDAQ: CSTL)
- Cerevel Therapeutics Holdings Inc (NASDAQ: CERE)
- Checkmate Pharmaceuticals Inc (NASDAQ: CMPI)
- Clearpoint Neuro Inc (NASDAQ: CLPT)
- Crispr Therapeutics AG (NASDAQ: CRSP)
- Editas Medicine Inc (NASDAQ: EDIT)
- EXACT Sciences Corporation (NASDAQ: EXAS)
- Guardant Health Inc (NASDAQ: GH)
- Intellia Therapeutics Inc (NASDAQ: NTLA)
- Kodiak Sciences Inc (NASDAQ: KOD)
- Mersana Therapeutics Inc (NASDAQ: MRSN)
- Nantkwest Inc (NASDAQ: NK) ( announced reverse merger with ImmunityBio)
- Natera Inc (NASDAQ: NTRA)
- NeoGenomics, Inc. (NASDAQ: NEO)
- NGM Biopharmaceuticals Inc (NASDAQ: NGM)
- Orphazyme A S ADR (NASDAQ: ORPH)
- Otonomy Inc (NASDAQ: OTIC)
- Pacific Biosciences of California Inc (NASDAQ: PACB)
- PLx Pharma Inc (NASDAQ: PLXP)
- Precigen Inc (NASDAQ: PGEN)
- Pulse Biosciences Inc (NASDAQ: PLSE)
- Sangamo Therapeutics Inc (NASDAQ: SGMO)
- Sarepta Therapeutics Inc (NASDAQ: SRPT)
- Seelos Therapeutics Inc (NASDAQ: SEEL) (announced the receipt of Israeli patent related to drug to treat neurodegenerative disorders)
- Sigilon Therapeutics, Inc. (NASDAQ: SGTX)
- TG Therapeutics Inc common stock (NASDAQ: TGTX)
- Travere Therapeutics Inc (NASDAQ: TVTX)
- Turning Point Therapeutics Inc (NASDAQ: TPTX)
- Twist Bioscience Corp (NASDAQ: TWST)
- Vericel Corp (NASDAQ: VCEL)
- Vistagen Therapeutics Inc (NASDAQ: VTGN)
- XOMA Corp (NASDAQ: XOMA)
- Zai Lab Ltd – ADR (NASDAQ: ZLAB)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Dec. 20)
- AVITA Medical Inc (NASDAQ: RCEL)
- Cortexyme Inc (NASDAQ: CRTX)
- Histogen Inc (NASDAQ: HSTO)
- Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
- Opthea Spon American Depositary Receipts Representing 8 Ord Shs (NASDAQ: OPT)
- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH)
- Virios Therapeutics LLC (NASDAQ: VIRI) (listed on Thursday)
Stocks In Focus
Ziopharm's Taiwanese Joint Venture Gets Nod For Commencing Blood Cancer Study
ZIOPHARM Oncology Inc. (NASDAQ: ZIOP) said the Taiwan Food and Drug Administration has cleared an investigational new drug application from Eden BioCell, a joint venture between Ziopharm and cell therapy company TriArm Therapeutics, for its Phase 1 clinical trial to evaluate patient-derived CD19-specific CAR-T, using Ziopharm's rapid personalized manufacturing technology.
This is an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas and the first clinical study of autologous non-viral CD19-specific CAR-T in Taiwan.
The stock was up 9.64% to $3.07 in after-hours trading.
Chemocentryx Says Avacopan Flunks Mid-stage Ultra-rare Kidney Disease Study
ChemoCentryx Inc (NASDAQ: CCXI) and Vifor Fresenius Medical Care Renal Pharma announced topline data from the ACCOLADE Phase 2 clinical study of avacopan in the ultra-rare kidney disease C3 glomerulopathy, which showed the study did not meet the primary endpoint of showing statistically significant change from baseline to week 26 in the C3G histologic index for disease activity.
"Biopsies, taken at baseline and after 26 weeks of treatment showed that the placebo group worsened by 38% on average in the C3G activity score while the avacopan group improved by 2% on average," the companies said. This 40% average difference between the two treatment arms did not constitute statistical significance due to the high patient to patient variability, they added.
In after-hours trading, the stock plunged 7.92% to $55.
Amgen, AstraZeneca's New Drug to Treat Severe Oral Corticosteroid-dependent Asthma Fails In Late-stage Trial
Amgen, Inc. (NASDAQ: AMGN) and AstraZeneca plc (NASDAQ: AZN) announced the SOURCE Phase 3 trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid dose, without loss of asthma control, with tezepelumab compared to placebo.
The 48-week trial assessed the efficacy and safety of the potential new medicine tezepelumab compared to placebo in 150 severe asthma patients who required maintenance use of oral corticosteroids on top of standard-of-care. Tezepelumab's effect on other efficacy parameters was similar to those observed in previous studies, including the registrational Phase 3 NAVIGATOR study, the companies said.
Cardiff Oncology's Chairman Steps Down; Biopharma Appoints Rodney Markin as New Chairman
Cardiff Oncology Inc (NASDAQ: CRDF) announced the stepping down of Dr. Thomas Adams as Executive Chairman and Chairman of the Board of Directors, effective immediately. Adams will continue to serve on the board, it added. Dr. Rodney Markin has been appointed as new Chairman, the company said.
Unity Biotech Commences Phase 1 Study of Drug Candidate To Treat Diabetic Macular Edema
Ascentage Pharma, a clinical-stage biotech engaged in developing novel therapies for cancers, chronic hepatitis B and age-related diseases, announced that its licensee, Unity Biotechnology Inc. (Nasdaq: UBX) has dosed the first patient in a Phase I clinical study of UBX1325 in patients with diabetic macular edema. UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to Unity by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. The milestone payment was made in common stocks from Unity, totaling 228,310 shares.
In premarket trading, Unity shares were up 9.81% to $5.82.
Soligenix's SGX942 Fails In Phase 3 Study In Severe Oral Mucositis In Head and Neck Cancer Patients
Soligenix, Inc. (NASDAQ: SNGX) announced preliminary top-line results for its pivotal Phase 3 DOM-INNATE trial evaluating SGX942 in the treatment of severe oral mucositis, or SOM, in patients with head and neck cancer receiving chemoradiation. The primary endpoint of median duration of SOM did not achieve the pre-specified criterion for statistical significance, although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group, it added. Despite this clinically meaningful improvement, the variability in the distribution of the data yielded a p-value that was not statistically significant.
The stock was slumping 41.61% to $1.60 in premarket trading.
Tonix In-licenses Tech to Use Oxytocin to Treat Insulin Resistance And Related Syndromes
Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) said it has acquired the exclusive license to the University of Geneva's technology for using oxytocin to treat insulin resistance and related syndromes, including obesity, from privately held Katana Pharmaceuticals, Inc. This license allows Tonix to expand its intranasal potentiated oxytocin development program, TNX-1900, into cardiometabolic syndromes, which include insulin resistance, impaired glucose tolerance, and obesity, it added.
The stock was adding 8.74% to 6 2 cents in premarket trading.
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