Here's a roundup of top developments in the biotech space over the last 24 hours.
Stocks In Focus
Athira Names Chief Operating Officer Mark Litton As Next CEO as Leen Kawas Resigns
Athira Pharma, Inc. ATHA announced the appointment of Mark Litton, who was serving as the company's chief operating officer, as its chief executive officer. Litton succeeds Leen Kawas, who has resigned from her position as President and CEO and as a member of the company's board. Kawas was placed on leave after papers she published as a student were found to contain altered research.
Litton will also join the board. Rachel Lenington, the company's chief technology officer and Head of Product Development Strategy, has been appointed as chief operating officer.
The stock was gaining 7.58% to $10.36 in the after-hours trading.
Sanofi, Regeneron Says Dupixent Aces Late-stage Study in Inflammatory Skin Disease Patients
Sanofi SNY and Regeneron Pharmaceuticals, Inc. REGN said a pivotal Phase 3 trial evaluating Dupixent in adults with uncontrolled prurigo nodularis, a chronic type 2 inflammatory skin disease that causes extreme itch and skin lesions, met its primary and all key secondary endpoints. Dupixent significantly reduced itch and skin lesions compared to placebo in this investigational setting.
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Merck Gets European Regulatory Nod For Keytruda-Chemo Combo In First-Line Breast Cancer Setting
Merck & Co., Inc. MRK announced that the European Commission has approved Keytruda, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumors express PD-L1 and who have not received prior chemotherapy for metastatic disease. Triple-negative breast cancer is an aggressive type of breast cancer. This represents Keytruda first approval in Europe in a breast cancer setting.
Roche Announces FDA Approval For Ventana Assay as Companion Diagnostic Test For Tecentriq In Lung Cancer Patients
Roche Holding AG RHHBY announced U.S. Food and Drug Administration approval of the Ventana PD-L1 Assay in non- small cell lung cancer as a companion diagnostic test for Tecentriq, advancing the company's commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare.
CDC Panel Recommends COVID-19 Booster Shots Of Moderna, J&J
Moderna, Inc. MRNA announced that the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend the use of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level in a narrower population.
This included people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 with frequent institutional or occupational exposure to SARS-CoV-2 under the emergency use authorization issued Thursday by the FDA. The positive vote was unanimous with 15 ACIP members recommending the booster.
The CDC panel also recommended Johnson & Johnson JNJ's COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine.
Moderna shares were slipping 2.64% to $330.59 in premarket trading and J&J was edging up 0.07% to $163.51.
23andMe Agrees to Acquire Online Medical Care And Pharmacy Services Platform Lemonaid For $400M
23andMe Holding Co. ME announced the signing of a definitive merger agreement with Lemonaid Health, Inc., an on-demand platform for accessing medical care and pharmacy services online. Under the merger agreement, the purchase price is $400 million, of which 25% will be paid in cash and 75% in shares of 23andMe Class A Common Stock. The acquisition is expected to close by the end of 2021.
The shares were adding 1.65% to $10.50 in premarket trading.
T2 Biosystems Announces Agreement To Distribute Its Products In Asia-Pacific Market
T2 Biosystems, Inc. TTOO announced the execution of territory exclusive distribution agreements in Singapore and South Korea. Under the terms of the agreements, T2 Biosystems will sell T2Dx Instruments, along with T2Bacteria, T2Candida and T2Resistance Panels through these distributors.
The execution of these exclusive distribution agreements marks T2 Biosystems' entry in the Asia-Pacific market, the company said.
In premarket trading, the stock was up 8.95% to 90 cents.
Insider Transactions
Protagonist Therapeutics, Inc. PTGX revealed in a SEC filing that Dinesh Patel, president and CEO of the company, exercised options to buy 40,000 shares of the company.
The stock was down 3.41% at $21.99 in premarket trading.
Adaptive Biotechnologies Corporation ADPT disclosed in a filing Harlan Robins, chief scientific officer of the company, sold 11,200 shares in aggregate. These shares were acquired through exercising of stock options.
Offerings
IVERIC bio, Inc. ISEE priced its upsized underwritten public offering of 9 million shares of its common stock at a price to the public of $16.75 per share. All of the shares are being offered by the company. The gross proceeds from the offering are expected to be approximately $150.8 million.
Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates
On The Radar
Clinical Readouts
28th Annual Congress of the European Society of Gene and Cell Therapy Presentations
AVROBIO, Inc. AVRO: new safety data on the eight patients in the Phase 2 clinical trial who have been treated with AVR-RD-01, an investigational gene therapy for Fabry disease and data from the phase 1/2 study of AVR-RD-02 ex-vivo lentiviral vector, autologous gene therapy for Gaucher disease (Friday)
IPOs
Minerva Surgical, Inc. UTRS, a commercial-stage Medtech company focused on developing minimally invasive solutions to meet the distinct uterine healthcare needs of women, priced its initial public offering of 6.25 million shares at $12 apiece, lower than the estimated price range of $15-$17. The company's shares will begin trading on the Nasdaq under the ticker symbol "UTRS."
Xilio Therapeutics, Inc. XLO a biotech developing tumor-selective immuno-oncology therapies, priced its IPO of 7.353 million shares at $16 per share. The gross proceeds to Xilio from the offering are expected to be approximately $117.6 million. All of the shares are being offered by Xilio. The shares are expected to begin trading on the Nasdaq the ticker symbol "XLO."
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