"This will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain antibodies," the companies said.
Sorrento Gets Licensure For COVID Tests In California
Sorrento Therapeutics Inc (NASDAQ: SRNE) said it has received CLIA Licensure from the State of California that permits testing of clinical samples. The company said it intends to initially offer three diagnostic tests for SARS-CoV-2 infection – a RT-PCR emergency use authorization-approved test using nasal pharyngeal swab, COVI-STIX, an antigen test using shallow nasal swab, and COVI-TRACE, a high-performance loop-mediated isothermal amplification test for detection of viral RNA using shallow nasal swab.
Sorrento said it intends to initially focus on testing for SARS-CoV-2 infection but expects to expand to include immuno-oncology tests to support its clinical trials.
In after-hours trading, the stock rallied 6.46% to $8.41.
Pfizer's Vaccine Candidate Against Bacterial Infection Accepted For Priority Review
Pfizer said the FDA has accepted for priority review a BLA for its 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
The PDUFA goal date for a decision by the FDA has been set for June 2021.
Rocket Pharma Reports Positive Early-stage Data For Gene Therapy to Treat Rare Genetic Disorder Affecting Heart Muscles
Rocket Pharmaceuticals Inc (NASDAQ: RCKT) announced preliminary data from its open-label, Phase 1 clinical trial of its AAV-based gene therapy candidate RP-A501 for the treatment of Danon Disease, showing the gene therapy was generally well tolerated and provided early evidence of clinical benefit.
Danon Disease is a rare X-linked inherited disorder caused by genetic mutations in the LAMP2 gene resulting in accumulation of autophagosomes and glycogen, particularly in cardiac muscle and other tissues, which ultimately leads to severe and frequently fatal cardiomyopathy.
The stock surged up 33.16% to $42.65 in after-hours trading.
United Therapeutics Gets Orphan Drug Designation For Drug to Treat Idiopathic Pulmonary Fibrosis
United Therapeutics Corporation (NASDAQ: UTHR) said the FDA granted orphan drug designation for treprostinil for the treatment of patients with idiopathic pulmonary fibrosis.
Lilly's Diabetes Drug Aces Late-stage Study
Eli Lilly And Co (NYSE: LLY) announced topline results from a Phase 3 study evaluating tirzepatide in people with type 2 diabetes, showing the investigational asset led to superior A1C and body weight reductions from baseline.
Pluristem to Discontinue Late-stage Stem Cell Therapy Study In Critical Limb Ischemia
Pluristem Therapeutics Inc. (NASDAQ: PSTI) said following interim review of dataset from the pivotal Phase 3 study of PLX-PAD in critical limb ischemia, the independent Data Monitoring Committee said the study is unlikely to meet the primary endpoint by the time of the final analysis.
The lower than anticipated event rate in the placebo group reduced the statistical power of the study to meet its primary endpoint, the company noted. Subsequently, the company decided to terminate the study.
In premarket trading Wednesday, Pluristem shares were down 47.21% to $6.05.
Tricida Slides On Prospects of Delay In Veverimer Approval For Treating Metabolic Acidosis In CKD Patients
Issuing updates on its veverimer's development program, Tricida Inc (NASDAQ: TCDA) said it has revised the protocol for its VALOR-CKD outcome trial to have a group sequential design, with no interim analysis for sample size adjustment, and unblinded interim analyses for early stopping for efficacy after 150 primary endpoint events and 250 primary endpoint events have accrued.
The trial evaluates the effect of treating metabolic acidosis with veverimer on the clinical endpoint of slowing of chronic kidney disease progression.
If this trial is successful, Tricida sees the study as serving as the confirmatory trial for accelerated approval or form the basis for traditional approval of veverimer. Recruitment completion is projected to occur by the end of 2022, it said.
On the regulatory front, Tricida said a Formal Dispute Resolution Request has been submitted to the FDA. If accepted for consideration, a decision is expected in the first quarter of 2021. The timing and next steps for a resubmission of the NDA for veverimer.
"And while we are disappointed that we could not come to a resolution with the Division of Cardiology and Nephrology on the resubmission of our NDA during our Type A meeting, we believe that the focused, single issue FDRR currently represents the best approach to bring veverimer to patients through accelerated approval," said Gerrit Klaerner, Tricida's CEO.
The stock plunged 13.79% to $7 in after-hours trading.
Neurotrope Bioscience Spun Off and Renamed Synaptogenix
Synaptogenix, Inc. (OTC: SNPX), which was formerly Neurotrope, said substantially all of the legacy assets and liabilities of Neurotrope, Inc. have been spun off into the newly renamed company which is trading under the new symbol SNPX.
The spin-off follows the recently announced merger between Metuchen Pharmaceuticals and Neurotrope, Inc. to form Petros Pharmaceuticals, Inc. (NASDAQ:PPTI), completing the strategic step of realigning assets to maximize shareholder value going forward.
Assembly Bioscience to Shutter Its Microbiome Program To Focus On HBV Portfolio
Assembly Biosciences Inc (NASDAQ: ASMB) said it will wind-down its microbiome program, enabling it to prioritize resources and focus on the advancement of its pipeline of novel core inhibitors for chronic HBV.
The company said it is evaluating strategic alternatives for the microbiome program in the interim, and if the efforts do not succeed it plans to wind down the program on or around Jan. 31.
Offerings
IGM Biosciences said it priced its upsized underwritten public offering of shares of its common stock at $90 apiece. The pre-funded warrants issued to some investors to purchase its common shares are priced at $89.99 per pre-funded warrant. The company said it expects to receive total gross proceeds of approximately $200 million from this offering.
Atossa Therapeutics Inc (NASDAQ: ATOS) priced its underwritten public offering, consisting of common stock, warrants and Series C convertible preferred shares, for raising gross proceeds of $20 million. The offering is expected to close Dec. 11.
Close on the heels of its blood cancer therapy data, Curis said it intends to offer shares of its common stock in an underwritten public offering.
Hookipa Pharma Inc (NASDAQ: HOOK) said it intends to offer shares of its common stock and shares of Series A convertible preferred stock in an underwritten public offering. All of the securities in the offering are to be sold by the company.
In after-hours trading, the stock was down 6.82% to $12.70.
Forma announced it has launched a proposed public offering of 4.6 million shares of its common stock. All of the shares are being offered by the company.
On The Radar Clinical Readouts
San Antonio Breast Cancer Symposium Presentations
Infinity Pharma & Arcus Biosciences Inc (NYSE: RCUS): Efficacy and safety of Arcus' etrumadenant + pegylated liposomal doxorubicin ± Infinity's eganelisib in participants with metastatic ovarian and triple negative breast cancer
Infinity Pharma: Poster presentation on initial Phase 2 data from the study evaluating a triple combo of Infinity's eganelisib, Roche's Tecentriq and Bristol-Myers Squibb Co's (NYSE: BMY) chemotherapy medication Arabaxane as first-line (1L) therapy for locally advanced or metastatic triple-negative breast cancer
Evelo Biosciences Inc (NASDAQ: EVLO): Poster presentation of additional data from Phase 1/2 trial of EDP1503 in triple-negative breast cancer
Athenex Inc (NASDAQ: ATNX): Phase 2 data for oral Paclitaxel and Encequidar (oPac+E) in the treatment of cutaneous angiosarcoma, the breast angiosarcoma group
Incyte Corporation (NASDAQ: INCY) and Oncolytics Biotech, Inc. (NASDAQ: ONCY): poster presentation of phase 2 data for Incyte's retifanlimab and the oncolytic virus pelareorep in metastatic triple negative breast cancer
Oncolytics Biotech, Inc. (NASDAQ: ONCY): Phase 2 study to assess overall response rate by inducing an inflammatory phenotype in metastatic breast cancer with the oncolytic reovirus pelareorep in combination with anti-PD-L1 avelumab and paclitaxel
G1 Therapeutics Inc (NASDAQ: GTHX): final analysis of Phase 2 data for Trilaciclib in combination of gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer
Puma Biotechnology Inc (NASDAQ: PBYI): Latest findings from the breast cancer cohort in the SUMMIT Phase 2 study of 'basket' trial of neratinib + trastuzumab + fulvestrant for HER2-mutant, hormone receptor-positive, metastatic breast cancer; Final overall survival analysis from the phase 3 study of neratinib in patients with HER2-positive early-stage breast cancer
ESMO Immuno-oncology Virtual Congress Presentations
Innate Pharma SA (NASDAQ: IPHA): updated results from a Phase 2 study investigating the combination of monalizumab and cetuximab in patients with recurrent or metastatic head and neck squamous cell cancer
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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