Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Pluristem Therapeutics Changes its Name To Pluri
Pluristem Therapeutics Inc PSTI will be renamed Pluri Inc and start trading on NASDAQ under the ticker PLUR from July 26.
The change reflects a broader strategy of leveraging its 3D cell expansion technology to develop cell-based products that can be harnessed for various fields beyond medicine.
AstraZeneca's Enhertu Under FDA Priority Review For HER2-Low Metastatic Breast Cancer
The FDA has accepted AstraZeneca Plc AZN and Daiichi Sankyo's DSNKY supplemental application seeking approval for Enhertu (trastuzumab deruxtecan) for unresectable or metastatic HER2-low breast cancer who have received a prior therapy in the metastatic setting.
The application has been granted Priority Review.
The Prescription Drug User Fee Act date is during Q4 of 2022.
Shares are up 1.66% at $66.33 during the premarket session.
CHMP Recommends Approving AstraZeneca's Asthma, Neuromuscular Disorder Treatments
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of AstraZeneca Plc's AZN Ultomiris (ravulizumab) for generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.
Ultomiris would be the first and only approved long-acting C5 complement inhibitor for AChR antibody-positive gMG in the EU if authorized.
The CHMP has also backed AstraZeneca's Tezspire (tezepelumab) as add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high-dose inhaled corticosteroids and other maintenance treatment.
Revelation Biosciences Surges After Encouraging Data From Allergic Rhinitis Study
Revelation Biosciences Inc REVB announced topline data for its Phase 1b CLEAR study to evaluate the effect of intranasal REVTx-99b on nasal challenge allergen in participants with allergic rhinitis to rye grass pollen.
The study met the primary endpoint of the effects of REVTx-99b versus placebo on safety and tolerability.
Exploratory endpoints for efficacy were not met, including no reduction in allergy symptoms and increase in peak nasal inspiratory flow versus placebo.
Revelation management plans to evaluate the future development of this and other ongoing programs.
Shares are surging 127.7% at $1.48 during the premarket session.
KKR Invests In DNA Writing Tech Replay As Private Equity Pushes Into Healthcare
Replay, a genome writing company, reprogramming biology by writing and delivering big DNA, announced its launch with $55 million in seed financing.
The round was led by KKR & Co Inc KKR and OMX Ventures, with additional participation from ARTIS Ventures and Lansdowne Partners, SALT, DeciBio Ventures, and Axial.
The company said it had identified three key challenges that it is working on: Increased payload capacity, the need for an off-the-shelf, low-cost scalable, and extensively genomic engineered cell therapy platform, and lastly, the ability to assemble big DNA.
vTv Therapeutics Shares Jump On Equity Investment
CinPax LLC will buy around 4.1 million shares of vTv Therapeutics Inc VTVT at approximately $2.41 per share, with $6 million paid in cash at closing and the remaining $4 million payable on November 22.
The agreements also provide for the issuance of 1.2 million warrants to CinRx to acquire additional shares that become exercisable upon agreed vesting triggers (including FDA approval of TTP399).
Shares are up 19.5% at 86 cents during the premarket session.
Soligenix Partners With SERB Pharmaceuticals To Supply Ricin Antigen For Ricin Toxin Poisoning Treatment
Soligenix Inc SNGX has signed a worldwide license to supply its ricin antigen to SERB Pharmaceuticals for novel treatment against ricin toxin poisoning.
SERB will leverage its broad-spectrum polyclonal antibody platform.
The antibodies will be generated using a modified form of the ricin toxin, developed by Soligenix.
Shares are up 4.84% at 80 cents during the premarket session.
Tonix Pharmaceuticals Walks Out From COVID-19 Antiviral Pact
Tonix Pharmaceuticals Holding Corp TNXP intends to terminate the exclusive License Agreement with OyaGen Inc related to an antiviral inhibitor of SARS-CoV-2, sangivamycin (TNX-3500).
The company reassessed its long-term commitments and concluded that it was in its best interest to terminate the License Agreement and return the development and commercialization rights to sangivamycin to OyaGen.
Shares are up 15.1% at $1.37 during the premarket session.
On The Radar
Enveric Biosciences Inc ENVB has announced a registered direct offering of 375,000 shares at $8/share and preferred investment options to purchase up to 375,000 additional shares.
The preferred investment options have an exercise price of $7.78 per share.
Shares are slipping 24.4% at $7.30 during the premarket session.
Synthetic Biologics Inc SYN: Reverse stock split at a ratio of one (1) share of common stock for every ten (10) shares.
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