From Neutral
Friday, November 12, 2021
Why Oncorus Is Crashing
- Oncorus reported initial results from a phase 1 study of experimental immunotherapy ONCR-177.
- The company said that ONCR-177 was well tolerated, with some encouraging efficacy results.
- Investors, however, expected more.
Shares of Oncorus (NASDAQ:ONCR) were crashing 44.7% lower at 11:11 a.m. EST on Friday. The big decline came after the drugmaker announced initial data from its ongoing phase 1 clinical study evaluating experimental immunotherapy ONCR-177 in treating patients with solid tumors.
Oncorus reported that ONCR-177 was well tolerated. It said that there were no dose-limiting toxicities in heavily pretreated patients with surface lesions who were part of the dose-escalation part of the study.
The company also referred to the initial clinical response data as "positive." Oncorus said that three of eight evaluable patients experienced clinical benefit after receiving two doses of ONCR-177.
So why did the biotech stock plunge? Investors were clearly hoping for better results.
Of the three patients who had clinical benefit after being treated with ONCR-177, one with cutaneous melanoma had a partial response (some tumor shrinkage). Investigators observed a clinical response in another patient with squamous cell carcinoma of the head and neck, but no details were provided. The third patient with mucosal melanoma had stable disease (the cancer didn't improve or worsen).
The most important thing to keep in mind about Oncorus' results is that they're still very early. The initial data reported by the company today was only from the first part of a four-part phase 1 study.
Oncorus is moving forward with the other parts of the study. The company expects to begin enrolling patients in the second and third parts by the end of this year. Oncorus hopes to announce additional results beginning in mid-2022.
https://www.fool.com/investing/2021/11/12/why-oncorus-stock-is-crashing-today/
SOC Telemed (TLMD) Stock: Why Price Surged
— SOC Telemed took steps to shore up its balance sheet, reaching an agreement with SLR Investment Corp. to allow the company to accelerate the drawdown of an additional $12.5 million in term debt to bolster its cash position
Updated 2021 Financial Outlook
For the full year 2021, SOC Telemed is providing the following revised financial guidance:
— GAAP Revenue is expected to be in the range of $91.5 million to $93.5 million, with approximately 30% expected to be attributed to Access Physicians, an increase from the prior guidance range of $90 million to $92 million
— The upward guidance revision is the result of improved consultation volume and new implementations
— Adjusted EBITDA is expected to be in the range of $(21.5) million to $(22.5) million, and improvement from the prior guidance range of $(22.0) million to $(25.0) million
https://pulse2.com/soc-telemed-nasdaq-tlmd-stock-why-the-price-surged-today/
AstraZeneca to start taking profit from COVID vaccine after $1B quarterly sales
AstraZeneca (AZN.L) posted quarterly sales of more than $1bn (£750m) for its COVID-19 vaccine on Friday, as it plans to move from its not-for-profit basis.
The pharmaceutical firm, which first produced the coronavirus jab with Oxford University at cost during the pandemic, will now look to start turning a profit from it to help improve margins and offset costs from its antibody treatment.
It said it would “progressively transition the vaccine to modest profitability as new orders are received” from the fourth quarter. But it did not change its earnings forecast.
Its vaccine will remain not-for-profit for low-income nations, but will move to earning modest profits from new orders from richer countries.
Demand for COVID vaccines bumped AstraZeneca’s revenues for the jab to $1.05bn in the period, compared with $894m in the previous three-month period and $275m in the first quarter this year.
Overall revenues for the quarter came in at $9.9bn, a rise of 50%, while revenues for the year to date increased by a third.
However, core earnings per share of $1.08, fell short of analyst forecasts of $1.25, sending the share price as much as 4% lower in London.
“In general, AstraZeneca continues to recognise the heightened risks and uncertainties from the effects of COVID-19,” the company said. “Variations in performance between quarters can be expected to continue.”
Labcorp in Talks to Merge Part of Covance With Syneos
Laboratory Corp. of America Holdings is in talks to combine some of its assets with Syneos Health Inc., according to people with knowledge of the matter.
The companies are discussing a deal in which part of Labcorp’s Covance clinical research division would merge with Syneos, the people said, asking not to be identified because the information is private.
The people said the two North Carolina-based companies are discussing structuring the deal as a so-called Reverse Morris Trust, which provides tax benefits by spinning off an asset before it’s combined. The people said Syneos’s management would run the merged company, although its leadership would include executives from Covance, which has changed its name to Labcorp Drug Development.
The talks are ongoing and there’s no certainty they will lead to a transaction, the people said. The structure of a deal could also still change, they said.
Representatives for Syneos, which has a market value of more than $10 billion, didn’t immediately respond to messages seeking comment outside regular business hours. A spokesperson for Labcorp declined to comment.
Labcorp said in March that it was running a review of the company’s structure and capital allocation because it felt the stock was undervalued.
Labcorp rose 2.8% to $294.88 at 9:57 a.m. in New York trading Friday, giving the company a market value of about $28.2 billion. Syneos fell 6.1% to $96.33, giving it a market value of about $10 billion.
Investment Surge
A combination would add to a boom in activity involving companies like Syneos that support clinical trials as money pours into the development of new treatments and vaccines.
In April, Thermo Fisher Scientific Inc. agreed to buy PPD Inc., a provider of clinical and research services, for $17.4 billion. In July, buyout firm EQT AB and Goldman Sachs Group Inc.’s investment arm agreed to buy Parexel International Corp. for $8.5 billion.
Investors have favored so-called contract research organizations as a way to gain exposure to pharmaceutical spending without the risk of investing directly in biotech or pharmaceutical companies whose success -- or failure -- rides on the therapies they are testing.
Amgen Gets Nod From Euro Panel for Non-Small Cell Lung Cancer Med
First Targeted Therapy for the KRAS G12C Mutation Recommended for Approval in the European Union
Positive Opinion Based on Clinical Results Demonstrating Durable Responses and a Favorable Benefit-Risk Profile With LUMYKRAS
KRAS G12C Mutation Shown to be Present in Approximately 13-15% of Patients in Europe With NSCLC[1],[2]
Amgen (NASDAQ: AMGN) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of LUMYKRAS® (sotorasib), known as LUMAKRAS® in the U.S., for the treatment of adults with advanced non-small-cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. If the European Commission follows the recommendation for approval, LUMYKRAS will be the first targeted therapy available in the European Union (EU) for the KRAS G12C mutation, one of the most prevalent biomarkers in NSCLC.
https://finance.yahoo.com/news/lumykras-sotorasib-receives-positive-opinion-123000178.html
Catalyst Bio halts development for blood clotting disorder med
- Catalyst Biosciences Inc (Get Free Alerts for CBIO) has decided to halt the clinical development of MarzAA (engineered FVIIa) and focus solely on complement programs and protease medicines platforms.
- MarzAA was under development for Factor VII deficiency, a blood clotting disorder.
- The Company said that MarzAA trials had been adversely impacted by pandemic-related logistical challenges, subjects' competition, and increasing prophylaxis therapy availability.
- Catalyst says that it is no longer feasible to deliver top-line data in 2022.
- CBIO will report on the data obtained in the Crimson-1 trial to date for subcutaneous (SQ) MarzAA.
- Halting development of MarzAA will allow the Company to reduce the burn rate by approximately 40%.
- The Company expects to advance the clinical development of CB 4332 and continue to generate development candidates from the protease platform.
- Cash, cash equivalents and, investments for Q3 stood at $64.5 million.
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