Target $15
Thursday, June 30, 2022
Akebia Ends License Agreements with Otsuka
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
Akebia to assume responsibility for regulatory review processes previously led by Otsuka
Provention: PDUFA Date Extended to November 17
Provention Bio, Inc. (Nasdaq: PRVB) (the "Company"), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended its review period by three months for the Biologics License Application (BLA) for teplizumab. The extended User Fee Goal date is November 17, 2022.
The Company was also informed that if no major deficiencies are identified during the review period, the FDA plans to communicate proposed labeling and, if necessary, any post-marketing requirement or commitment requests by October 17, 2022.
https://finance.yahoo.com/news/provention-bio-announces-extension-fda-200100558.html
Angion Biomedica Pulls The Plug On Another Kidney Disease Trial
Angion Biomedica Corp (NASDAQ: ANGN) has discontinued the JUNIPER Phase 2 trial of ANG-3070, an oral tyrosine kinase inhibitor, in primary proteinuric kidney diseases, specifically focal segmental glomerulosclerosis and immunoglobulin A nephropathy.
The trial began enrolling patients in December 2021.
A reassessment was conducted following a potential safety signal of an unexpected and substantial decline in kidney function in a patient in the trial's drug treatment arm.
"Based on our ongoing analysis of the risk/benefit profile of ANG-3070 in patients with primary proteinuric kidney disease, we believe it to be in the best interest of patients to discontinue our Phase 2 JUNIPER study at this time..," stated CEO Jay Venkatesan.
Angion expects to report more than $60 million in cash and cash equivalents at the end of Q2.
In April, the company decided to discontinue the development of ANG-3777 after disappointing data.
Talaris Phase 3 Clinical Update
Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today provided a clinical update on its ongoing Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients.
To date, Talaris has enrolled 22 donor-recipient pairs in the Phase 3 FREEDOM-1 study (NCT# 03995901) of FCR001. Seven patients have been successfully dosed at five different trial sites. All three patients who were dosed more than 12 months prior to the data cutoff date have been successfully weaned off all chronic anti-rejection drugs without evidence of rejection and with stable kidney function. All of these patients, including the first patient who is now 24 months post-transplant, continue to remain off all anti-rejection drugs. Furthermore, all patients treated with FCR001 at least three months prior to the data cutoff date have achieved and maintained T-cell chimerism levels >50% at each of the 3-, 6- and 12-month timepoints post-transplant. The safety profile observed was generally consistent with that expected in patients receiving a kidney transplant and an allo-HSCT. Three cases of low-grade acute graft-versus-host disease (aGvHD) were reported, all of which were treatment-responsive and have since resolved. One of these patients is more than 12 months post-transplant and has been successfully weaned off all anti-rejection drugs. As a result of an internal review triggered by the GvHD cases, Talaris has modified its mobilization protocol and added a second post-transplant dose of cyclophosphamide for GvHD prophylaxis. Trial enrollment continues.
Conference Call & Webcast Information
Talaris will host an investor webcast and conference call today at 8:00 a.m. ET to discuss its presentations at the American Transplant Congress (ATC) and provide a data update from its ongoing Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients. To access the conference call, the dial-in numbers are 1-855-605-1739 for domestic callers and 1-914-987-7955 for international callers. The conference ID number for the live call will be 6249115. A live webcast and replay of the conference call will also be available under "Events & Presentations" in the Investors section of the Company's website at www.talaristx.com.
Talaris will host an investor webcast and conference call today at 8:00 a.m. ET to discuss its presentations at the American Transplant Congress (ATC) and provide a data update from its ongoing Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients. To access the conference call, the dial-in numbers are 1-855-605-1739 for domestic callers and 1-914-987-7955 for international callers. The conference ID number for the live call will be 6249115. A live webcast and replay of the conference call will also be available under "Events & Presentations" in the Investors section of the Company's website at www.talaristx.com.
Cyclacel To Test Higher Doses Of Fadraciclib In Solid Tumor Patients
Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC) is adding two dose levels in a protocol amendment to test higher doses of oral fadraciclib before determining the recommended Phase 2 dose anticipated in 2H of 2022, citing the absence of dose-limiting toxicities.
Fifteen patients with advanced solid tumors and lymphomas were treated with oral fadraciclib at all five doses.
In the first oral treatment cycle with fadraciclib, a cutaneous T cell lymphoma patient achieved partial response (PR).
A patient with a peripheral T cell lymphoma achieved a 38% reduction in target lesions.
An endometrial cancer patient achieved stable disease with a 15% reduction of target lesions after the first oral treatment cycle. In an earlier study of intravenous fadraciclib as monotherapy, a patient with MCL1 amplified endometrial cancer achieved confirmed complete response (CR) and remains on study after 2.5 years of treatment.
A pancreatic cancer patient achieved stable disease by the confirmatory scan for five oral treatment cycles.
For CYC140, no dose-limiting toxicities were observed to date in the Phase 1/2 study of oral CYC140.
An ovarian cancer patient in 140-101 achieved stable disease with tumor shrinkage after the first cycle.
Rapid Micro Confirms Unsolicited, Non-Binding Proposal from Kennedy Lewis
Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, today confirmed that it has received an unsolicited, non-binding proposal from Kennedy Lewis Investment Management LLC to acquire all of the outstanding shares of the Company for $5.00 per share in cash.
Consistent with its fiduciary duties and in consultation with its independent advisors, the Rapid Micro Biosystems Board of Directors will carefully review the unsolicited proposal to determine the course of action that it believes is in the best interest of the Company and all Rapid Micro Biosystems shareholders. Rapid Micro Biosystems shareholders do not need to take any action at this time.
https://finance.yahoo.com/news/rapid-micro-biosystems-confirms-receipt-183300893.html
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