Tuesday’s biggest losers: Color Star Technology, Zosano Pharma, and Homology Medicines
Color Star Technologies announces registered direct offering
Color Star Technology Co. Ltd. (NASDAQ: CSCW) lost 53% after announcing that it has reached a share purchase agreement with some institutional investors to sell common stock and warrants in a registered direct offering. Notably, each unit comprises a common share and a warrant to buy one common share at $0.40 per unit. Before subtracting agent placement fees and other projected offering costs payable by the company, the total proceeds from the securities sale will be around $10 million.
The company will issue 25 million common shares and warrants to buy an additional 25 million common shares to the investors. The warrants will be redeemable at $0.40 per share at first.
Zosano Pharma’s NDA for M207 rejected by the FDA
Zosano Pharma Corporation (NASDAQ: ZSAN) dropped 36.36% after the US FDA issued a response letter about the company’s resubmission of the 505(b)(2) NDA for the Zolmitriptan microneedle system.
(M207). The FDA rejected the company’s resubmitted M207 NDA to fully remedy the flaws indicated in the FDA’s October 2020 Complete Response Letter.
Until the FDA receives a thorough answer, it will not undertake a meaningful review of the application. The FDA noted that Zosano’s strategy for creating a pharmacokinetic link to Zomig Nasal Spray 5 mg, which relied mainly on findings from a recently finished Phase 1 PK study, was insufficient. The CP-2021-001 Study design evaluated the PK of M207 to two successive dosages of 5 mg Zomig NS, and the conditions for re-dosing contained in the label guidelines for 5 mg Zomig Nasal Spray, according to the FDA.
As part of its strategic and financial planning, Zosano is analyzing the next steps. But unfortunately, there are no guarantees that Zosano’s resources will allow it to pursue FDA clearance for M207 in the future.
Homology’s pheNIX gene therapy study halted
Homology Medicines (NASDAQ: FIXX) shares lost 31.74% after the FDA halted its gene therapy study. The FDA has told the firm that the pheNIX gene therapy study of HMI-102 in individuals with phenylketonuria has been halted because of the necessity to change risk mitigation strategies in the research after increased liver function tests were discovered.
On Friday, the genetics medicines firm said that it hopes to obtain a formal clinical hold letter in 30 days. After that, the company will offer an update regarding further clarity from the agency.
COE Arthur Tzianabos stated that the hold on the PKU gene therapy[y study is based on criminal findings in the pheNIX trial and is not related to the company’s CMC/manufacturing capacity or other clinical programs. He said they plan to offer the next steps regarding the program once they meet the FDA.
The pheEDIT gene editing study of HMI-103 for PKU and the juMPStart gene therapy study of HMI-203 for Hunter syndrome are both active clinical trials with results of the programs expected at the end of the year.