Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Precision BioSciences Shares Jump On Gene Editing Pact With Novartis
Precision BioSciences Inc (NASDAQ:DTIL) has entered into an exclusive worldwide in vivo gene editing research and development collaboration and license agreement with Novartis AG (NYSE:NVS)
Under the terms of the agreement, Precision will develop an ARCUS nuclease and conduct in vitro characterization, with Novartis then assuming responsibility for all subsequent research, development, manufacturing, and commercialization activities.
Precision will receive an upfront payment of $75 million and is eligible to receive up to $1.4 billion in additional payments for future milestones.
DTIL shares are up 10.8% at $1.54 during the premarket session.
Athira Pharma's Alzheimer's Candidate Flunks In Mid-Stage Study
Athira Pharma Inc (NASDAQ:ATHA) shares are falling after announcing disappointing topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton (ATH-1017) in mild-to-moderate Alzheimer's disease (AD).
The study did not meet the primary endpoint of a statistically significant change in ERP P300 Latency (patients' memory processing speed) for the modified intent to treat population compared with placebo at 26 weeks in a pooled analysis of the 40 mg and 70 mg dose groups.
Shares are down 65% to $2.95 during the premarket session.
Japan Approves BioMarin's Dwarfism Treatment
The regulatory authority in Japan has approved BioMarin Pharmaceutical Inc's (NASDAQ:BMRN) Voxzogo (vosoritide) for achondroplasia (short-limbed dwarfism) in children of all ages whose growth plates are not closed.
Voxzogo targets the underlying pathophysiology of achondroplasia by downregulating fibroblast growth factor receptor 3 signaling and consequently promoting endochondral bone formation.
In 2021, Voxzogo received approvals in the U.S., Europe, and Brazil.
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Galapagos Bets €225M On CellPoint Marking Its Entry Into Cancer Field
Galapagos (NASDAQ:GLPG) agreed to acquire CellPoint and AboundBio in an all-cash transaction, propelling Galapagos into next-generation cell therapy while significantly broadening its portfolio and capabilities.
The company will pay an upfront amount of €125 million for CellPoint, an additional €100 million upon achieving certain milestones, and $14 million for AboundBio.
Paratek's Broad Spectrum Antibiotic Snags FDA Fast Track Tag For Lung Infection
The FDA has granted Fast Track designation for Paratek Pharmaceuticals Inc's (NASDAQ:PRTK) oral and IV formulations of Nuzyra (omadacycline) for pulmonary Nontuberculous Mycobacterial (NTM) disease caused by Mycobacterium avium complex and Mycobacterium abscessus.
FDA granted Nuzyra orphan drug designation for these infections in August 2021.
Enanta Files COVID-19 Antiviral Patent Infringement Suit Against Pfizer
Enanta Pharmaceuticals Inc (NASDAQ:ENTA) filed suit in United States District Court for the District of Massachusetts against Pfizer Inc (NYSE:PFE), seeking damages for infringement of the U.S. patent on Pfizer's COVID-19 antiviral, Paxlovid.
The U.S. Patent and Trademark Office awarded the patent to Enanta earlier this month based on Enanta's July 2020 patent application describing coronavirus protease inhibitors invented by Enanta scientists.
Ikena Oncology's Mesothelioma Candidate Gets FDA Fast Track Status
The FDA has granted Fast Track designation for Ikena Oncology Inc's (NASDAQ:IKNA) IK-930 for unresectable NF2-deficient malignant pleural mesothelioma.
Earlier in 2022, the FDA granted IK-930 orphan drug designation.
IK-930 is currently being studied in Phase 1 clinical trial as a monotherapy in advanced solid tumors with or without gene alterations in the Hippo pathway.
Krystal Biotech Files US Application For Skin Disorder Gene Therapy
Krystal Biotech Inc (NASDAQ:KRYS) has submitted an FDA marketing application seeking approval of B-VEC (beremagene geperpavec) for dystrophic epidermolysis bullosa (DEB).
B-VEC is an investigational non-invasive, topical gene therapy designed to treat DEB at the molecular level by providing the patient's skin cells with two copies of the COL7A1 gene to make functional COL7 protein.
Apellis Expands R&D Pact with Affilogic For Targeted Complement Therapies
Apellis Pharmaceuticals Inc (NASDAQ:APLS) and Affilogic have expanded their R&D collaboration, which was initially formed in 2018, to include the development of Nanofitins targeting the transferrin receptor (TfR).
TfR enables drugs to be transported across the blood-brain barrier and into the central nervous system.
TfR-specific Nanofitins, also known as brain shuttles, are designed to be combined with other treatment modalities.
Insider Trading
Catalyst Biosciences Inc (NASDAQ:CBIO): Michael Torok reports in 13D filing an 8% stake in the company.
Share are up 8.15% at $1.46 during the premarket session.
Vaxxinity Inc (NASDAQ:VAXX): Executive chairman Lou Reese reported purchasing 100,000 shares at $1.99/share.
Day One Biopharmaceuticals Inc (NASDAQ:DAWN) Investor Len Blavatnik reported purchasing 1.2 million shares at an average of $15.00/share in Form 4 filing.
Offerings
Precision BioSciences Inc (NASDAQ:DTIL) has announced a common stock offering of 35.9 million shares at $1.39/share, for approximately $50.0 million in gross proceeds.
