Xtant Acquires Spinal Surgical Product Line

 Expands Xtant’s Product Offering with the Leading PMA-Approved Intralaminar Stabilization Device

Strengthens Surgalign’s Balance Sheet as it Embarks on its Digital Health Strategy

Xtant Medical Holdings, Inc. (NYSE American: XTNT), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, and Surgalign Holdings, Inc., (NASDAQ: SRGA), a global medical technology company focused on elevating the standard of care by driving the evolution of digital surgery, today announced the completion of a transaction between the companies.

On February 28, 2023, Xtant Medical and Surgalign entered into a Definitive Agreement and subsequently closed on the transaction whereby Xtant acquired the Coflex® and Cofix product lines from Surgalign for a total consideration of $17 million.

Coflex is an interlaminar stabilization device used after an open decompression that can be performed in various settings, offering a non-fusion treatment option for lumbar spinal stenosis (LSS) patients. The number of patients diagnosed globally with LSS is approximately 2.4 million representing the largest single-growing patient demographic in spine. The Coflex device is the only FDA PMA-approved implant for the treatment of LSS, has been implanted in more than 200,000 patients in over 60 countries, is clinically validated with more than 90 peer reviewed publications and has established Ambulatory Surgery Center (ASC) reimbursement. Cofix is a supplemental fixation device, which is a minimally invasive system intended for use on all levels of the lumbar spine.

https://finance.yahoo.com/news/xtant-medical-acquires-coflex-product-141500510.html

GSK catches up with Pfizer in RSV vaccine race after FDA panel's backing

 A panel of outside advisers to the U.S. health regulator on Wednesday backed GSK Plc's respiratory syncytial virus (RSV) vaccine, setting it up for a race with rival Pfizer to become the first approved U.S. shot against the disease.

The Food and Drug Administration's (FDA) advisory committee voted unanimously in favor of the vaccine, saying the company's clinical study data showed the shot was effective in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above.

The recommendation for GSK's vaccine follows the panel's vote in favor of Pfizer's RSV shot on Tuesday.

Pfizer and GSK are running a tight race to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, according to analysts.

The panel voted 10 to 2 in favor of GSK's vaccine safety when administered to adults aged 60 years and older for the prevention of lower respiratory tract disease caused by the viral infection.

The FDA is scheduled to decide on the vaccine by May, and typically follows the recommendations of its independent panel of experts.

https://www.yahoo.com/entertainment/1-gsk-catches-pfizer-rsv-200522825.html

Top 5 Health Care Stocks That You May Want To Dump In Q1 2023

 The most overbought stocks in the health care sector presents an opportunity to go short on these overvalued companies.

The RSI is a momentum indicator, which compares a stock's strength on days when prices go up to its strength on days when prices go down. When compared to a stock's price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered overbought when the RSI is above 70.

Here’s the latest list of major overbought players in this sector.

Genelux Corp (NASDAQ: GNLX)

• Benchmark initiated coverage on Genelux with a Speculative Buy rating and announced a price target of $10. The company’s stock has a 52-week high of $13.28 .
• RSI Value: 91.91
• GNLX Price Action: Shares of Genelux jumped 15.1% to close at $12.50 on Monday.

Ambrx Biopharma Inc - ADR (NYSE: AMAM)

• Ambrx Biopharma announced initial data from its ongoing Phase 1 APEX-01 trial of ARX517, Ambrx's proprietary anti-PSMA ADC, in prostate cancer patients. The company’s stock has a 52-week high of $7.39.
• RSI Value: 74.65
• AMAM Price Action: Shares of Ambrx Biopharma jumped 11.1% to close at $5.59 on Monday.

Seagen Inc (NASDAQ: SGEN)

• According to a Wall Street Journal report citing people familiar with the matter, Pfizer is in early stage talks to acquire Seagen. The company has a 52-week high of $183.00.
• RSI Value: 86.15
• SGEN Price Action: Shares of Seagen rose 10.4% to close at $178.16 on Monday.

Pulmonx Corp (NASDAQ: LUNG)

• Pulmonx reported better-than-expected Q4 EPS and sales results and issued FY23 revenue guidance above estimates. The company’s 52-week high is $28.30.
• RSI Value: 74.82
• LUNG Price Action: Shares of Pulmonx gained 6% to close at $10.99 on Monday.

Hims & Hers Health Inc (NYSE: HIMS)

• Hims & Hers Health reported better-than-expected Q4 results and issued strong guidance. The company has a 52-week high of $10.06.
• RSI Value: 71.42
• HIMS Price Action: Shares of Hims & Hers Health fell 1.2% to settle at $9.65 on Monday and gained 9.3% in after-hours trading.

https://uk.investing.com/news/stock-market-news/top-5-health-care-stocks-that-you-may-want-to-dump-in-q1-2023-2931799

J&J-Backed Cidara Antiviral Candidate Effectively Prevents Influenza Infection

 

• Cidara Therapeutics Inc (NASDAQ: CDTX) announced efficacy and safety data from a planned interim analysis of the ongoing Phase 2a trial evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain.

• As evidenced by animal efficacy studies, CD388 has the potential to be a long-acting antiviral drug designed to deliver universal prevention of seasonal and pandemic influenza A and B strains.

• A single dose of CD388 decreased influenza viral replication in the upper respiratory tract and lowered influenza incidence rate in a human challenge model compared to a placebo.

• The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals Inc, a unit of Johnson & Johnson (NYSE: JNJ), to develop and commercialize Cidara's Cloudbreak drug-Fc conjugates (DFCs) for the prevention of seasonal and pandemic influenza.

• The interim analysis is based on 56 subjects, with 28 receiving a single dose of CD388 (150 mg) and 28 receiving a placebo.

• Treatment with CD388 was generally well-tolerated, with no treatment-emergent adverse events leading to study discontinuation or serious adverse events reported in the interim analysis.

https://finance.yahoo.com/news/johnson-johnson-backed-antiviral-candidate-175412339.html

OncoSec gives up on stock sale

 OncoSec Medical Inc (NASDAQ: ONCS) stock price soared 102.78% after asking the U.S. Securities and Exchange Commission (SEC) to withdraw its registration statement as it had decided not to proceed with the share issue.

The company initially wanted to issue 6.19 million shares and had filed a registration statement with the SEC at the beginning of February. 

https://www.asktraders.com/analysis/oncosec-medical-oncs-stock-soared-103-despite-lack-of-news/

Mirati financials, update, call

  Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the fourth quarter and full year of 2022 along with recent corporate updates.

"2022 was a momentous year for Mirati, culminating in the approval and launch of KRAZATI™ as a treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation. We believe this is the first of several potentially best-in-class products on the horizon for Mirati," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "In addition to the approval of KRAZATITM, in 2022 we advanced MRTX1719 and MRTX0902 into clinical trials and filed an Investigational New Drug application for MRTX1133. These accomplishments bring us closer to realizing our vision to unlock the promise of a life beyond cancer. We look ahead to 2023 with excitement as the company enters a new phase of commercialization from a strong financial position."

There will be a conference call on February 28, 2023 at 4:30 p.m. ET / 1:30 p.m. PT during which company executives will review financial information for the fourth quarter and full year of 2022 and provide corporate updates.

Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 888-394-8218, confirmation code: 2312901.

A replay of the call will be available approximately 2 hours after the event has ended at the same website.

https://finance.yahoo.com/news/mirati-therapeutics-reports-fourth-quarter-210100646.html

Syndax financials, update, call

 Topline data from AUGMENT-101 KMT2Ar patients expected in the third quarter of 2023 –

–Topline data from the pivotal AGAVE-201 trial on track for mid-2023 –

– Two U.S. registrational filings expected by the end of 2023 –

Financial Update and Guidance

In December 2022, Syndax issued 7,840,909 shares of its common stock at a price to the public of $22.00 per share. This includes the exercise in full by the underwriters of their option to purchase up to 1,022,727 additional shares of common stock. As a result, Syndax received aggregate net proceeds of $162.0 million after deducting underwriting discounts and commissions and estimated offering expenses payable by Syndax.

For the first quarter of 2023, the Company expects research and development expenses to be $30 to $35 million and total operating expenses to be $40 to $45 million. For the full year of 2023, the Company expects research and development expenses to be $160 to $175 million and total operating expenses to be $225 to $240 million.

Conference Call and Webcast

In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Tuesday, February 28, 2023.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website. Alternatively, the conference call may be accessed through the following:

Conference ID: SNDXQ422 
Domestic Dial-in Number: 800-245-3047 
International Dial-in Number: 203-518-9765 
Live webcast: https://www.veracast.com/webcasts/OpenEx/General/SNDXQ4.cfm

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company's website at www.syndax.com approximately 24 hours after the conference call and will be available for 90 days following the call.

https://finance.yahoo.com/news/syndax-pharmaceuticals-reports-fourth-quarter-210300827.html