Cathie Wood Adds $7M Of Verve, Trims Stake In CVS-Target Signify Health

Cathie Wood-led ARK Investment Management bought over 330,000 shares of clinical-stage biotechnology company Verve Therapeutics Inc 

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 at an estimated valuation of over $6.9 million, based on Tuesday’s closing price. The purchase was done through the flagship ARK Innovation ETF 

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 and the ARK Genomic Revolution ETF 

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.

The company's stock has lost over 4.5% in five days. On Monday, Verve announced it received a clinical hold letter from the FDA that outlined the information required to resolve the clinical hold on Verve-101.

According to the company, Verve-101 is a novel, investigational gene editing medicine designed to be a single-course treatment to permanently turn off the PCSK9 gene in the liver to reduce disease-driving low-density lipoprotein cholesterol. Verve-101 is currently being evaluated in the heart-1 Phase 1 clinical trial in New Zealand and the United Kingdom, the company said.

The FDA has also requested available clinical data from the ongoing heart-1 trial. In addition, the agency has requested that Verve modify the trial protocol in the United States to incorporate additional contraceptive measures and to increase the length of the staggering interval between dosing of participants. Verve intends to submit a response as expeditiously as possible, the company said.

Verve is the 30th largest holding of ARKK with a weight of 0.29%. The stock has gained over 43% in last six months.

Other Sale: ARK also sold over 7,000 shares of Signify Health Inc 

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. Shares of the company have more than doubled in value over the last six months. CVS Health 

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 said in September it would buy Signify for $8 billion.

https://www.benzinga.com/general/biotech/22/12/29985883/cathie-wood-adds-7m-of-this-clinical-stage-biotech-trims-stake-in-cvs-target-signify-health

Rani Therapeutics Lead Program Achieves Endpoints In Repeat-Dose Part Of Osteoporosis Study

 

• Rani Therapeutics Holdings Inc RANI announced topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102 for osteoporosis. 
• RT-102, the RaniPill GO capsule, contains a proprietary formulation of human parathyroid hormone (1-34) analog (PTH).
• The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering the drug with high reliability to participants via the RaniPill GO.
• Device remnants were excreted without sequelae in all subjects.
• In all 10 participants who completed seven days of daily, consecutive dosing, the RaniPill GO capsule demonstrated an overall drug delivery success rate of 91% over the seven days.
• On Day 7, with more frequent, serial drug sampling after capsule swallowing on that day, the drug delivery success rate was 100%
• RT-102 delivered 20µg of PTH with high bioavailability (relative to 20µg subcutaneous Forteo (teriparatide) in Part 1 of the study), indicating that PTH delivered via RT-102 may be efficacious at doses lower than 20μg.
• The company anticipates initiating a Phase 2 trial of RT-102 in osteoporosis in the second half of 2023.

https://www.benzinga.com/general/biotech/22/12/29990424/rani-therapeutics-lead-program-achieves-endpoints-in-repeat-dose-part-of-osteoporosis-study

MorphoSys Inks Licensing Agreement With Novartis For Preclinical Cancer Programs

 

• MorphoSys AG's 
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   subsidiary Constellation Pharmaceuticals Inc has entered into a global licensing agreement with Novartis AG 
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   to research, develop and commercialize its pre-clinical inhibitors of a novel cancer target. 
• This program was added to MorphoSys' research portfolio following its acquisition of Constellation Pharmaceuticals in 2021 for $1.7 billion.
• "At MorphoSys, we will continue to focus our resources on driving our late- and mid-stage oncology pipeline forward, which has the potential to enhance the standard and quality of care in difficult-to-treat and debilitating types of blood cancers," said Jean-Paul Kress, CEO of MorphoSys. 
• Novartis will assume full responsibility for the program's subsequent research, development, and commercialization activities. 
• As part of the agreement, MorphoSys receives an immediate upfront payment of $23 million. 
• MorphoSys will be eligible to receive milestone payments from Novartis in addition to mid-single- to low-double-digit royalties on program net sales.

https://www.benzinga.com/general/biotech/22/12/29990139/morphosys-inks-licensing-agreement-with-novartis-for-preclinical-cancer-programs