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 21)
- Agios Pharmaceuticals, Inc. AGIO (submitted regulatory application for approval of mitapivat for the treatment of adults with pyruvate kinase deficiency)
- AngioDynamics, Inc. ANGO
- Axonics, Inc. AXNX
- Bio-Techne Corporation TECH
- Century Therapeutics, Inc. Common Stock IPSC
- Citius Pharmaceuticals, Inc. CTXR
- Edwards Lifesciences Corporation EW
- Intra-Cellular Therapies, Inc. ITCI
- Intuitive Surgical, Inc. ISRG
- LeMaitre Vascular, Inc. LMAT
- OrthoPediatrics Corp. KIDS
- Protagonist Therapeutics, Inc. PTGX
- Recursion Pharmaceuticals, Inc. RXRX
- ShockWave Medical, Inc. SWAV
- West Pharmaceutical Services, Inc. WST
- Zoetis Inc. ZTS
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows June 21)
- AbCellera Biologics Inc. ABCL
- Aeglea BioTherapeutics, Inc. AGLE
- Alzamend Neuro, Inc. ALZN (went public June 14)
- Aptose Biosciences Inc. APTO
- Atreca, Inc. BCEL
- Biophytis SA BPTS
- Cabaletta Bio, Inc. CABA
- Chembio Diagnostics, Inc. CEMI
- Dyadic International, Inc. DYAI
- ERYTECH Pharma S.A. ERYP
- Impel NeuroPharma, Inc. IMPL
- Inhibikase Therapeutics, Inc. IKT
- Nabriva Therapeutics plc NBRV
- Nautilus, Inc. NLS
- NexImmune, Inc. NEXI
- Osmotica Pharmaceuticals plc OSMT
- Pharming Group N.V. PHAR
- Spruce Biosciences, Inc. SPRB
- Yumanity Therapeutics, Inc. YMTX
Stocks In Focus
Sanofi, Translate Bio Commence Phase 1 Trial Of Investigational mRNA Vaccine Against Seasonal Flu
Sanofi SNY and Translate Bio, Inc. TBIO said they have initiated a Phase 1 clinical trial evaluating an mRNA-based investigational vaccine against seasonal influenza.
The trial, according to the companies, will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus.
In premarket trading Tuesday, Sanofi shares were down 1.33% at $51.92, while Translate Bio shares were adding 2.19% to $19.15.
Cassava Zeroes In On Clinical Research Organization For Phase 3 Alzheimer's Study
Cassava Sciences, Inc. SAVA announced it has selected Premier Research International as its clinical research organization to help conduct the Phase 3 clinical program for simufilam in Alzheimer's disease. Consistent with previous guidance, Cassava Sciences said it plans to initiate this Phase 3 program in the second half of 2021.
Cassava shares were edging up 0.2% to $89.90 in premarket trading Tuesday.
NextCure Announces Publication of Positive Preclinical Data For Cancer Drug
NextCure, Inc. NXTC announced publication of preclinical data in the online journal eLife, with the data establishing NC410 as a novel immunomedicine targeting immune-excluded regions of collagen-rich tumors and enabling normalization of the tumor immune microenvironment.
NC410 is being evaluated in a Phase 1/2 clinical trial in patients with advanced or metastatic solid tumors.
In premarket trading Tuesday, the stock was moving up 1.64% to $8.04.
Fennec's Resubmission Of Drug For Chemotherapy-Induced Ototoxicity Accepted For Review
Fennec Pharmaceuticals Inc. FENC announced that the FDA has accepted for filing the resubmission of its new drug application for Pedmark, a unique formulation of sodium thiosulfate, for the prevention of ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 months old with localized, non-metastatic, solid tumors.
The PDUFA target action date has been set for Nov. 27, 2021.
The stock was rallying 11.92% to $7.42 in premarket trading Tuesday.
Related Link: The Week Ahead In Biotech: Incyte, Ascendis FDA Decisions, Liver Congress Presentations And 4 IPOs
Qiagen Launches Tools To Asset Impact Of CRISPR Gene Editing Technology
QIAGEN N.V. QGEN announced the launch of QIAprep& CRISPR Kit and CRISPR Q-Primer Solutions that allow researchers to analyze edited genetic material with unparalleled speed and efficiency to determine how their interventions have changed the function of the DNA sequence in question.
InhibRx Commences Potential Registration-Enabling Phase 2 Study Of Bone Cancer Treatment
Inhibrx, Inc. INBX announced the initiation of a potential registration-enabling Phase 2 study of INBRX-109 in conventional chondrosarcoma. Chondrosarcoma is an orphan bone cancer with approximately 2,800 new patients diagnosed annually in the U.S. and the European Union. There are currently no therapeutics approved for the treatment of chondrosarcoma.
Gossamer Promotes Richard Ananda To Chief Medical Officer
Gossamer Bio, Inc. GOSS said Richard Aranda, previously SVP and head of clinical development, will be promoted to chief medical officer. Ananda joined Gossamer in February 2018 with responsibilities including oversight of clinical pharmacology, translational medicine and pharmacovigilance.
ViiV To In-License Halozyme Technology For HIV Treatment
ViiV Healthcare, which is majority-owned by GlaxoSmithKline plc GSK, with Pfizer, Inc. PFE and Shionogi & Co., Ltd. SGIOY, announced a global collaboration and license agreement that gives exclusive access to Halozyme Therapeutics, Inc.'s HALO Enhanze drug delivery technology, recombinant human hyaluronidase PH20 enzyme, for specific targets used in the treatment and prevention of HIV.
Under the terms of the agreement, ViiV will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets.
The company is also obligated to make potential future payments of up to $175 million in development and commercial milestones per target.
Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialized medicines using the technology.
Dr. Reddy's To Launch Generic Vascepa In US
Dr. Reddy's Laboratories Limited RDY announced the launch of generic version of Amarin Corporation plc's AMRN icosapent ethyl capsules, 1 gram, approved by the FDA. The capsules have been approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
Amarin shares were down 2.55% to $4.58 in premarket trading Tuesday.
Offerings
Anavex Life Sciences Corp. AVXL, announced that it has entered into a definitive purchase agreement with Deep Track Capital for the issuance and sale of an aggregate of 2.381 million shares of its common stock at a purchase price of $21 per share of common stock in a registered direct offering.
The registered direct offering is expected to close on or about June 24, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering are expected to be approximately $50 million.
The shares were down 12.51% at $22.02 in premarket trading Tuesday.
On The Radar
Clinical Readouts
Innate Pharma S.A. IPHA will present at the International Conference on Malignant Lymphoma virtual meeting with preliminary mycosis fungoides data from the Phase 2 TELLOMAK trial evaluating lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody in development for T-cell lymphomas.
Related Link: Attention Biotech Investors: Mark Your Calendar For June PDUFA Dates
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