Akero Therapeutics files to sell 99.25M shares of common stock for holders 16:3701/2101/21/21
Akero Therapeutics files to sell 1.1M shares of common stock 16:3601/2101/21/21
Phio Pharmaceuticals announces $14M private placement priced at-the-market » 15:3501/2101/21/21
Phio Pharmaceuticals announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $14M through the issuance of an aggregate of 4,560,928 shares of its common stock and warrants to purchase up to an aggregate of 3,420,693 shares of common stock, at a purchase price of $3.07 per share of common stock and associated warrant in a private placement priced at-the-market under Nasdaq rules. The closing of the private placement is expected to occur on or about January 25, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The warrants have an exercise price of $3.00 per share, are exercisable immediately and have a term of five and one-half years. The company currently intends to use the net proceeds from the offering for the development of its immuno-oncology programs, other research and development activities and for general working capital needs.
Praxis Precision Medicines price target raised to $61 from $51 at Wedbush » 08:2101/2101/21/21
Wedbush analyst Laura…
Wedbush analyst Laura Chico raised the firm's price target on Praxis Precision Medicines to $61 from $51 and keeps an Outperform rating on the shares. While Praxis investor focus remains largely on lead asset PRAX-114 in major depressive disorder, the analyst sees the pipeline offering differentiation and optionality. PRAX-562 will begin proof-of-concept studies in SUNCT/SUNA patients mid-2021, and ahead of this she is layering PRAX-562 into her estimates in the SUNCT/SUNA indication. PRAX-114 remains on track to start Phase 2/3 study efforts by the first half of 2021, Chico adds.
Sutro Biopharma says first patient dosed in dose-expansion study of STRO-002 » 07:0501/2101/21/21
Sutro Biopharma announced…
Sutro Biopharma announced the dosing of the first patient in the dose-expansion cohort of the Phase 1 STRO-002 study. STRO-002 is an internally developed, folate receptor alpha targeting antibody-drug conjugate for the potential treatment of ovarian cancer. The dose-expansion cohort will assess the efficacy, safety and tolerability of STRO-002 at 4.3 and 5.2 mg/kg, given every 3 weeks in patients with ovarian cancer. The dose-expansion cohort for FolRalpha-selected endometrial cancer is planned for later this year.
Dynavax appoints Kelly MacDonald as CFO » 16:0701/2001/20/21
Dynavax has appointed…
Dynavax has appointed Kelly MacDonald as Senior VP and CFO. MacDonald will join the company effective March 1. CFO Michael Ostrach is retiring and has agreed to remain available as an advisor to the company thereafter. MacDonald joins Dynavax from Ironwood Pharmaceuticals where she held roles of increasing responsibility. In her final role at Ironwood MacDonald served as Chief Accounting Officer and Vice President, Finance.
Molecular Templates announces FDA acceptance of IND for MT-6402 » 08:1401/1901/19/21
Molecular Templates announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug application for MT-6402, a next-generation ETB targeting PD-L1 that is enabled with MTEM's antigen seeding technology. ETBs enabled with AST have dual mechanisms of action that include the enzymatic destruction of ribosomes and the delivery of viral class I antigens into the targeted tumor to be processed and presented on its cell surface to induce an antigen specific immune response. MTEM expects to start dosing enrolled subjects in a first-in-human Phase 1 study in relapsed/refractory patients with PD-L1-positive solid tumors in 2Q21. The Phase 1 study is planned as a multi-center, open-label, dose escalation and dose expansion trial in the United States and outside of the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment in the clinical trial. Following determination of the maximum tolerated dose or recommended Phase 2 dose, expansion cohorts are planned to study MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts.
Atea Pharmaceuticals appoints Jayanthi Wolf as SVP, regulatory affairs » 07:2001/1901/19/21
Atea Pharmaceuticals (AVIR) announced that it has expanded its senior management team with the appointments of Jayanthi Wolf, Ph.D., SVP of Regulatory Affairs and Jonae Barnes, SVP of Investor Relations and Corporate Communications. Wolf has had an extensive career in research and development at Merck (MRK) over a 19-year period. During her tenure at Merck, she served in a series of roles ranging from scientific to safety assessment and regulatory, with increasing responsibility in global regulatory affairs and clinical safety. Ms. Barnes served most recently as SVP, Investor Relations, Corporate Communications and Internal Communications at Sunovion.
Chiasma appoints John Doyle as CFO » 07:1701/1901/19/21
Chiasma (CHMA) announced…
Chiasma (CHMA) announced the hiring of John Doyle as its new CFO. As previously reported, Mark Fitzpatrick, Chiasma's current President and Principal Financial Officer, will remain with the company in a consulting role through June 30, 2021 to help facilitate a transition of responsibilities to Mr. Doyle. Prior to joining Chiasma, Mr. Doyle served as VP of Finance and Investor Relations at Verastem (VSTM).
C4 Therapeutics announces FDA clearance for CFT7455 IND application » 07:0301/1901/19/21
C4 Therapeutics announced…
C4 Therapeutics announced that the U.S. Food and Drug Administration has cleared the company's investigational new drug application for its lead product candidate, CFT7455, an orally bioavailable MonoDAC targeting IKZF1/3 for the treatment of hematologic malignancies such as multiple myeloma and non-Hodgkin lymphomas, including peripheral T cell lymphoma and mantle cell lymphoma. The FDA has completed its 30-day safety review and granted approval for the company to proceed with the proposed Phase 1/2 clinical trial for CFT7455. The Phase 1/2 clinical trial will be an open-label, two-part dose-escalation and expansion study evaluating CFT7455 across multiple hematologic malignancies. The Phase 1 portion of the trial will explore CFT7455 as a single agent in patients with relapsed or refractory multiple myeloma and non-Hodgkin lymphomas, and in parallel in combination with dexamethasone in R/R MM patients. Following the identification of an optimal dose, the Phase 2 expansion portion of the trial will enroll additional investigational arms including patients with MM, as single agent and in combination with dexamethasone, and as single agent in patients with mantle cell lymphoma and peripheral T-cell lymphoma, two subtypes of NHL. The trial will primarily investigate safety and tolerability, with key secondary objectives to characterize the pharmacokinetic and pharmacodynamic profile and anti-tumor activity of CFT7455.