• Fri. Oct 7th, 2022

Daily Biotech Pulse: Teva’s Opioids Settlement, Criminal Investigation Against Cassava, Durable Responses For IN8bio’s Leukemia Therapy

ByVandana Singh

Jul 27, 2022
Daily Biotech Pulse: Teva's Opioids Settlement, Criminal Investigation Against Cassava, Durable Responses For IN8bio's Leukemia Therapy

Here’s a roundup of top developments in the biotech space over the last 24 hours:

The Justice Department has opened a criminal investigation into Cassava Sciences Inc SAVA on whether it manipulated research results for its investigational Alzheimer’s drug, Reuters reported, citing two people familiar with the inquiry.

“To be clear: Cassava Sciences vehemently denies any and all allegations of wrongdoing,” said Kate Watson Moss, a lawyer representing Cassava.

Shares are down 39.5% at $13.15 during the premarket session.

Teva Pharmaceutical Industries Ltd TEVA has agreed with the working group of States’ Attorneys General, counsel for Native American Tribes, and plaintiffs’ lawyers on the primary financial terms of a nationwide opioids settlement.

Teva will pay up to $4.25 billion (including the already settled cases) plus approximately $100 million for the Tribes, spread over 13 years.

IN8bio Inc INAB provided a clinical update from the ongoing Phase 1 trial of INB-100 for patients with high-risk leukemias undergoing haploidentical hematopoietic stem cell transplant (HSCT). 

The data show positive clinical trends, with the first three patients remaining alive and progression-free.

No treatment-emergent serious adverse events were observed. The clinical trial is ongoing and additional patients have been recruited, with updated data expected in late 2022.

Sutro Biopharma Inc STRO announced that the first patient has been dosed in a Phase 1 study of cytokine derivative therapeutic for cancer, resulting from the collaboration between Sutro and Merck & Co Inc MRK.

As a result of this milestone, Sutro will receive a $10 million payment from Merck.

Under the July 2018 collaboration agreement, Sutro has been primarily responsible for preclinical research, developing, and manufacturing cytokine derivatives utilizing its cell-free protein synthesis and site-specific conjugation platforms.

Merck has exclusive worldwide rights to therapeutic candidates derived from the collaboration.

Summit Therapeutics Inc SMMT has appointed Maky Zanganeh as Co-CEO & President, effective immediately. 

Zanganeh was formerly the company’s Chief Operating Officer, having served since she joined the company in November 2020.

Cidara Therapeutics Inc CDTX has submitted a marketing application to the FDA seeking approval for rezafungin for candidemia and invasive candidiasis. 

The company has also entered into a license agreement with Melinta Therapeutics granting it an exclusive license to commercialize rezafungin in the U.S. 

Cidara will receive a $30 million upfront payment and is eligible to receive $60 million in regulatory milestone payments and up to $370 million in commercial milestone payments.

Shares are 21.6% at 83 cents during the premarket session.

Soligenix Inc SNGX has received an agreement from the FDA on an initial pediatric study plan (iPSP) for HyBryte for cutaneous T-cell lymphoma. 

The agreed iPSP stipulates that Soligenix intends to request a complete waiver of pediatric studies upon submission of a marketing application.

The agreement with the FDA on an iPSP is one of the regulatory requirements that must be met before submitting an application.

Shares are up 3.84% at 92 cents during the premarket session.

vTv Therapeutics Inc VTVT has appointed Paul Sekhri as the President and CEO, effective August 1. 

Rich Nelson, who has been serving as Interim CEO since March, will continue to support the company as executive vice president of corporate development, and as a board member.

Offerings

Legend Biotech Corporation LEGN priced an underwritten public offering of 8.14 million American Depositary Shares, each representing two ordinary shares, at $43.00 per ADS, for total gross proceeds of approximately $350 million

AlloVir Inc ALVR has announced a registered direct offering of 27.5 million shares at $4.61 per share. Gross proceeds from the offering will equal approximately $126.6 million

On The Radar

Earnings

Bristol-Myers Squibb Co BMY: Before the market open.

GSK Plc GSK: Before the market open.

Alkermes Plc ALKS: Before the market open.

Viking Therapeutics Inc VKTX: After the market close.

Myovant Sciences Ltd MYOV: After the market close.

Taro Pharmaceutical Industries Ltd TARO: After the market close.



Image and article originally from www.benzinga.com. Read the original article here.