Here’s a roundup of key developments in biotech over the past 24 hours:
The Ministry of Justice has opened a criminal investigation into Cassava Science Inc. SAVA whether he manipulated research results for his experimental Alzheimer’s drug, Reuters reported, citing two people familiar with the investigation.
“To be clear: Cassava Sciences vehemently denies any allegations of wrongdoing,” said Kate Watson Mosslawyer representing Cassava.
The shares are down 39.5% at $13.15 in the premarket session.
Teva Pharmaceutical Industries Ltd SUITS YOU agreed with the Task Force of state attorneys general, Native American tribal attorneys, and plaintiffs’ attorneys on key financial terms for a national opioid settlement.
Teva will pay up to $4.25 billion (including cases already settled) plus about $100 million for the tribes, spread over 13 years.
IN8bio Inc INAB provided a clinical update of the ongoing Phase 1 trial of INB-100 for high-risk leukemia patients undergoing haploidentical hematopoietic stem cell (HSCT) transplantation.
The data shows positive clinical trends, with the first three patients remaining alive and progression-free.
No treatment-related serious adverse events were observed. The clinical trial is ongoing and additional patients have been enrolled, with updated data expected in late 2022.
Sutro Biopharma Inc. STR announced that the first patient has been dosed in a Phase 1 study of a cancer therapeutic cytokine derivative, resulting from the collaboration between Sutro and Merck & Co Inc. M.K.R..
Following this milestone, Sutro will receive a $10 million payment from Merck.
Under the July 2018 collaboration agreement, Sutro was primarily responsible for preclinical research, development and manufacturing of cytokine derivatives using its cell-free protein synthesis and site-specific conjugation platforms.
Merck holds exclusive worldwide rights to the therapeutic candidates resulting from the collaboration.
Therapeutic Summit Inc SMMT named Maky Zanganeh as Co-CEO and Chairman, effective immediately.
Zanganeh previously served as the company’s chief operating officer, having joined the company in November 2020.
Cidara Therapeutic Inc CDTX submitted a marketing application to the FDA seeking approval of rezafungin for candidemia and invasive candidiasis.
The company has also entered into a license agreement with Therapeutic Melinta granting it an exclusive license to market rezafungin in the United States
Cidara will receive an upfront payment of $30 million and is eligible to receive $60 million in regulatory milestone payments and up to $370 million in commercial milestone payments.
The shares are up 21.6% at 83 cents in the premarket session.
Soligenix Inc SNGX received FDA approval for an initial pediatric study design (iPSP) for HyBryte in cutaneous T-cell lymphoma.
The agreed iPSP states that Soligenix intends to request a full pediatric study waiver when submitting a marketing application.
Agreement with the FDA on an iPSP is one of the regulatory requirements that must be met before submitting an application.
The shares are up 3.84% at 92 cents in the premarket session.
vTv Therapeutic Inc TVVT named Paul Sekhri as President and Chief Executive Officer, effective August 1.
Rich Nelsonwho has served as interim CEO since March, will continue to support the company as executive vice president of corporate development and as a member of the board of directors.
Caption Biotech Corporation LINE has priced an underwritten public offering of 8.14 million American Depositary Shares, each representing two common shares, at $43.00 per ADS, for aggregate gross proceeds of approximately $350 million.
AlloVir Inc. ALVR announced a registered direct offering of 27.5 million shares at $4.61 per share. Gross proceeds from the offering will be approximately $126.6 million.
On the radar
Bristol-Myers Squibb Co. BMY: Before market opening.
GSK S.A. GSK: Before market opening.
Alkermes Plc ALKS: Before market opening.
Viking Therapeutics Inc. VKTX: After market close.
Myovant Sciences Ltd MYOV: After market close.
Taro Pharmaceutical Industries Ltd TARO: After market close.