Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
---|
Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
---|
Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
---|
Here's a roundup of top developments in the biotech space over the last 24 hours:
(Biotech Stocks Hitting 52-week Highs Oct. 6)
(Biotech Stocks Hitting 52-week Lows Oct. 6)
Moderna, Inc. (NASDAQ:MRNA) announced it will build a state-of-the-art mRNA facility in Africa with the goal of producing up to 500 million doses of vaccines each year at the 50 µg dose level.
The company said it anticipates investing up to $500 million in this new facility, which is expected to include drug substance manufacturing with the opportunity for fill/finish and packaging capabilities at the site. The company expects to begin a process for country and site selection soon.
NeuroMetrix, Inc. (NASDAQ:NURO) said it has submitted a De Novo request to the U.S. Food and Drug Administration for Quell as a prescription treatment for the symptoms of fibromyalgia in adults.
Quell is an advanced, non-invasive, neuromodulation device that is covered by 18 U.S. utility patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card.
The stock was up 16.82% at $10.70 in premarket trading.
Denali Therapeutics, Inc. (NASDAQ:DNLI) announced positive Phase 1 clinical results and regulatory progress for two investigational small molecule therapeutics in development for the treatment of amyotrophic lateral sclerosis at the 2021 Annual Northeast ALS Meeting.
"DNL343 and SAR443820 are designed to modulate distinct biological pathways implicated in ALS, including the integrated stress response and inflammation, respectively. We are pleased that the data generated preclinically and in Phase 1 studies support clinical investigation of both molecules as potential treatments for individuals with ALS," said Carole Ho, Denali's chief medical officer.
Denali is partnering with Sanofi (NASDAQ:SNY) for the development of SAR443820. The companies plan to launch the Phase 2 HIMALAYA trial in adults with ALS in early 2022.
Amgen announced a strategic collaboration agreement with Neumora Therapeutics, Inc.to advance neuroscience discovery, development and commercialization. The companies will collaborate on programs by applying Neumora's proprietary precision neuroscience platform to insights generated by Amgen's deCODE genetics and human data research capabilities.
Neumora also received a $100 million equity investment from Amgen and acquired exclusive global rights to develop and commercialize Amgen programs targeting casein kinase 1 delta and glucocerebrosidase for neurodegenerative diseases.
Amgen shares were up 0.71% at $211.47 in premarket trading.
Related Link: The Week Ahead In Biotech (Oct. 3-9): ChemoCentryx FDA Decision, Conference Presentations, IPOs And More
Brickell Biotech, Inc. (NASDAQ:BBI) announced positive topline results from the Phase 3 pivotal Cardigan I and Cardigan II studies, which evaluated sofpironium bromide gel, 15% as a once daily topical formulation in patients with primary axillary hyperhidrosis.
The company said it plans to submit a new drug application to the NDA by the middle of 2022.
The shares were rallying 31.15% to 86.85 cents in premarket trading.
Bristol-Myers Squibb Company (NYSE:BMY) announced the Phase 2 LATTICE-UC study evaluating deucravacitinib compared to placebo in moderate to severe ulcerative colitis did not meet the primary efficacy endpoint of clinical remission at week 12, nor secondary efficacy endpoints.
The stock was down 1.59% at $58.25.
Biophytis SA (NASDAQ:BPTS) announced that its previously issued audited consolidated financial statements for the fiscal years ended Dec. 31, 2019 and 2020 and unaudited consolidated financial statements for the six-month periods ended June 30, 2021 and 2020 will be restated to correct the its accounting treatment of its convertible notes.
The company said it is in the process of evaluating the impact of these corrections on its financial statements for the affected periods, adding that it does not believe the corrections will affect the cash position.
Biophytis also said it expects, as soon as it is reasonably practical, to file restated financial statements on Form 20-F/A for the years ended Dec. 31, 2019 and 2020, and furnish restated financial statements for the half years ended June 30, 2020 and 2021 on Form 6-K.
CytoDyn Inc. (OTC:CYDY) announced the appointments of Christopher Recknor as senior executive VP of Clinical Operations and Nitya Ray as the chief operating officer.
CytoDyn said it is realigning its management structure to optimize the biologic license application resubmission process for leronlimab in HIV and to advance clinical development potential.
Separately, the company announced an investigator-initiated study for treating triple-negative breast cancer with leronlimab in a humanized TNBC xenograft model.
The study is intended to determine the potential synergistic therapeutic efficacy of leronlimab in combination with immune checkpoint blockade to attempt to raise the standard of care for breast cancer patients, CytoDyn said.
Miromatrix Medical Inc. (NASDAQ:MIRO) said it has successfully completed the first ever heterotopic implant of its bioengineered liver transplant into a large animal. The transplant was part of a preclinical study in collaboration with researchers at Mayo Clinic, designed to assess the initial transplantation and functionality of a bioengineered liver in an acute liver failure model.
Osmotica Pharmaceuticals, plc (NASDAQ:OSMT) announced that it has commenced an underwritten public offering of its ordinary shares and warrants to purchase its ordinary shares.
The stock was plunging 32.35% to $2.07 in premarket trading.
Click here to access Benzinga's FDA Calendar.
The FDA is scheduled to rule on ChemoCentryx, Inc. (NASDAQ:CCXI)'s new drug application for avacopan as a treatment for ANCA-associated vasculitis. After a split Adcom verdict, the FDA extended the review period by three months, thereby pushing forward the PDUFA date.
ANCA-associated vasculitis is a systemic disease in which overactivation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This leads to organ damage and failure, mainly the kidney, and is fatal if not treated.
Presentations at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics
Prelude Therapeutics Incorporated (NASDAQ:PRLD): data from the dose escalation portion of the Phase 1 trial of PRT543 in unselected solid tumor patient populations; data from the dose escalation portion of the Phase 1 trial of PRT811 in solid tumors and high-grade gliomas
Turning Point Therapeutics, Inc. (NASDAQ:TPTX): update from the Phase 2 registrational trial of repotrectinib in TKI-pretreated patients with ROS1+ advanced non-small cell lung cancer and with NTRK+ advanced solid tumors (9 a.m.)
Bicycle Therapeutics plc (NASDAQ:BCYC): data from Phase 1/2 study of BT5528 in patients with advanced malignancies associated with EphA2 expression (12:50 p.m.)
Turning Point & Zai Lab Limited (NASDAQ:ZLAB): Preliminary interim Phase 1 data of elzovantinib (TPX-0022) in patients with advanced solid tumors harboring genetic alterations in MET (9 a.m.)
Forma Therapeutics Holdings, Inc. (NASDAQ:FMTX): initial results from the Phase 1 trial of FT-7051 in men with metastatic castration-resistant prostate cancer
ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC): initial results from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with Pfizer, Inc. (NYSE:PFE)'s Xtandi in patients with metastatic prostate cancer (9 a.m.)
Theseus Pharmaceuticals, Inc. (NASDAQ:THRX) said it has priced its upsized initial public offering of 10 million shares at $16, which is the upper bound of the estimated price range of $14-$16. The shares of the Cambridge, Massachusetts-based biopharma, which is engaged in the development of targeted cancer therapies, will begin trading on the Nasdaq under the ticker symbol "THRX."
Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
Posted In: ADVM AFIB AGTC AKYA AMGN AMTI ANGN APDN APTX ARAV ASRT ATXI AYTU AZYO BBI BCYC BDTX BIVI BMY BPTS