Target to $162 from $178
Monday, August 1, 2022
Outset Medical Resumes Shipment of Tablo Systems for Home
Outset Medical, Inc. (Nasdaq: OM) ("Outset" or the "Company"), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced clearance by the Food and Drug Administration of its previously disclosed 510(k) submission and resumption of Tablo® Hemodialysis System shipments for home use.
The Company also reported financial results for the second quarter ended June 30, 2022 and provided financial guidance for 2022. Revenue for the second quarter totaled $25.1 million, in line with guidance provided on June 13, 2022. Gross margin for the second quarter was 15.1%, compared to 4.2% in the second quarter of 2021 and 14.5% in the first quarter of 2022.
https://finance.yahoo.com/news/outset-medical-resumes-shipment-tablo-140200849.html
ALX fast tracked for head-neck cancer treatment
ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to evorpacept, a next generation CD47 blocker, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma (“HNSCC”).
The FDA’s decision is informed by the results of ALX Oncology’s phase 1 clinical trial, ASPEN-01, that showed preliminary antitumor activity and a favorable safety profile in checkpoint inhibitor-naïve patients with second-line or greater advanced HNSCC treated with evorpacept and pembrolizumab (n=10). The preliminary objective response rate of 40% in this limited population represents an improvement over historical anti-PD-1 monotherapy activity in a similar population and supported the initiation of the ASPEN-03 (NCT04675294) study in May 2021 in collaboration with Merck (known as MSD outside the US and Canada). ASPEN-03 is a randomized phase 2 multi-center study to investigate the anti-tumor efficacy of evorpacept plus pembrolizumab in patients with first-line metastatic or unresectable, recurrent PD-L1 positive HNSCC.
https://finance.yahoo.com/news/alx-oncology-evorpacept-receives-fast-110000706.html
Kazia Shares Tumble After Update From Pivotal Brain Tumor Trial
Kazia Therapeutics Limited (NASDAQ: KZIA) said GBM AGILE, a pivotal study for paxalisib in newly diagnosed glioblastoma, did not meet pre-defined criteria for continuing to a second stage.
Patients enrolled in the first stage of the paxalisib arm will continue on treatment as per protocol, and in follow-up, until completion of the final analysis, which Kazia anticipates receiving in 2H of 2023.
Given that recruitment is complete, the study will not open to the paxalisib arm in Germany or China.
Kazia will work with its licensing partner to determine the way forward in China.
All Kazia personnel remain blinded to efficacy and safety data from the ongoing study.
Kazia CEO, James Garner, commented, "Today's news defines the remaining trajectory of the study, with modestly positive implications for both costs and timelines, and with some specific consequences for regulatory strategy in China. It does not allow us to draw any meaningful inferences about the outcomes of the study, and indeed it is critical for regulatory purposes that we remain blinded to the evolving data."
FDA Removes Clinical Hold On Celyad's Colorectal Cancer Trial
The FDA has lifted the clinical hold on Celyad Oncology SA's (NASDAQ: CYAD) CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the company made changes to the eligibility criteria for the trial.
"We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T," said Charles Morris, Chief Medical Officer of Celyad Oncology.
In February, the company voluntarily paused the CYAD-101-002 trial to investigate reports of two fatalities in the study.
The FDA subsequently put the trial on clinical hold in March.
The CYAD-101-002 Phase 1b trial evaluates CYAD-101 with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) in refractory metastatic colorectal cancer with microsatellite stable (MSS) / mismatch-repair proficient disease.
Why Virax Volatility
Shares of Virax Biolabs (NASDAQ: VRAX) dropped 74% on Friday. The stock closed on Thursday at $20.80, then opened on Friday at $19.92 before climbing to its all-time high of $29 shortly before noon. Soon after that, it began falling and dropped to a low of $9 around 2 p.m. Then, shortly before the market closed, it fell again to $5.40 a share. So, for the day, the stock was initially up 39.4%, and by the end of the day, it was down 74%. The volatility led to the NASDAQ halting trading in the stock several times during the day.
The biotech company, which specializes in the detection and treatment of viral diseases, just began trading on the NASDAQ on July 21 after an initial public offering (IPO).
The share price of the IPO shares was $5, but the IPO didn't fully finish until July 25. Owners of those shares, once they hit $29, began to dump them, doing the classic "sell on the good news" method. That sent the stock into a tailspin amid a flurry of rumors. When it was revealed that the company had told the SEC its annual report, due July 31, would be late by up to 15 days, that added further fuel to the fire.
Earlier this week, Virax said that it had begun distribution of its monkeypox and Varicell-Zoster Viruses PCR detection kits in Europe. On July 23, the World Health Organization declared monkeypox to be a global health emergency, saying more than 16,000 cases had been reported across 75 countries and territories.
As a newly traded company, it may take some time for the biotech stock to find a truer level, so it's likely to stay volatile for a while. There's little question the trading of the $5 shares helped bring the price down, but Virax hasn't issued a quarterly report yet, so it's hard to say what the stock is worth.
The news regarding its PCR tests is certainly positive, and Virax learned through its COVID-19 tests that quick action is needed when an outbreak occurs to have a more viable product.
Aethlon Publishes on Hemopurifier Resin Binding of 7 COVID-19 Variants
Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today announced the publication of a peer-reviewed journal article in PLOS ONE. The article, titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin," contains data demonstrating that the proprietary GNA affinity resin of the Aethlon Hemopurifier® efficiently captures seven clinically relevant variants of the SARS-CoV-2 virus responsible for the COVID-19 pandemic. Viral capture efficiency ranged from 53% to 89% for the variants tested.
"These data demonstrate that the Hemopurifier can effectively capture a wide range of clinically relevant SARS-CoV-2 variants," said Charles J. Fisher, M.D., Chief Executive Officer of Aethlon Medical. "As new variants and subvariants of this virus continue to emerge and induce new waves of the pandemic, health systems need innovative technologies that are agnostic to viral variations. The Hemopurifier may represent an opportunity to overcome this challenge and provide treatment to patients with severe COVID-19."
The Aethlon Hemopurifier, a clinical stage product candidate, is a therapeutic blood filtration system that has been demonstrated to bind and remove life-threatening viruses and harmful exosomes from blood. Aethlon currently is evaluating the safety and feasibility of the Hemopurifier in an active Early Feasibility Study (EFS), analogous to a Phase 1 clinical trial for a drug or biologic, which is designed to enroll up to 40 severe COVID-19 patients [NCT04595903]. The first patient in the study completed Hemopurifier treatment in the trial and nine hospitals are actively screening patients. Aethlon recently announced that the U.S. Food and Drug Administration (FDA) accepted a protocol amendment to the study, notably eliminating the requirement of previous dialysis treatment, which will potentially enable accelerated enrollment in the ongoing study.
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