Sotera Health prices 46.6M-share IPO at $23

 

• Sterilization and lab testing services provider, Sotera Health (SHC) has priced its IPO of 46.6M common shares at $23.00/share, for expected gross proceeds of ~$1.1B.
• Underwriters' over-allotment is an additional 6.99M shares.
• Trading commences today.
• J.P. Morgan, Credit Suisse, Goldman and Jefferies are acting as joint lead book-running managers.
• Closing date is November 24.
• https://seekingalpha.com/news/3638237-sotera-health-prices-46_6m-share-ipo-23

Roche anticipates COVID-19 antibody deliveries in Q1 2021: CEO

 

• Roche (OTCQX:RHHBY) is buckling down to boost supply of COVID-19 antibody treatments and expects first deliveries in Q1 2021, according to CEO Severin Schwan, source Bloomberg.
• Roche and Regeneron Pharmaceuticals (NASDAQ:REGN) have filed for emergency authorization for an antibody cocktail and that could be granted “very soon,” Schwan said in an interview with Bloomberg Television.
• However, the company cautioned that the availability will initially be limited and reserved for patients at high risk.
• “We’re working hard to ramp up production as fast as we can,” Schwan said. “No matter what, irrespective of other therapeutics, the demand for antibody cocktails will by far outstrip supply, so we have to make sure we target really the right patient groups.”
• https://seekingalpha.com/news/3638254-roche-anticipates-covidminus-19-antibody-deliveries-in-q1-2021-ceo-severin-schwan

Precision BioSciences up after gene therapy pact with Eli Lilly

 

• Eli Lilly (NYSE:LLY) and Precision BioSciences (NASDAQ:DTIL) have entered into a research and license agreement to utilize Precision's ARCUS genome editing platform for potential therapies for genetic disorders, with an initial focus on Duchenne muscular dystrophy (DMD) and two other undisclosed gene targets.
• ARCUS platform is derived from a natural genome-editing enzyme called I-CreI, a homing endonuclease that can be optimized to control for potency and specificity.
• Lilly will pay upfront cash of $100M, as well as invest $35M in DTIL's equity. Precision is also eligible to receive up to $420M in milestone payments, as well as tiered royalties ranging from the mid-single digits to low-teens on potential product sales
• Pre-clinical research and IND-enabling activities will be led by Precision, with Lilly then taking the responsibility for clinical development and commercialization. Lilly will have the right to select up to three additional gene targets. Precision can co-fund clinical development of one product in exchange for an increased royalty rate on co-funded product sales.
• Precision hosted a conference call and webcast at 8:30 a.m. ET today.
• https://seekingalpha.com/news/3638267-precision-biosciences-up-20-after-gene-therapy-pact-eli-lilly

FDA OK's Hologic's Aptima HIV-1 Quant Dx assay for HIV diagnosis

 

• The FDA has approved Hologic's (NASDAQ:HOLX) diagnostic claim for its HIV-1 (human immunodeficiency virus type 1) viral load monitoring assay.
• The Aptima HIV-1 Quant Dx assay, a molecular diagnostic test that runs on the fully automated, sample-to-result Panther system is now the first dual-claim assay for both diagnosis and viral load monitoring in U.S.
• The assay utilizes a dual target approach against highly conserved regions in the HIV genome, designed to deliver reliable, consistent qualitative and quantitative results across HIV-1 groups and subtypes.
• The Aptima HIV-1 Quant Dx assay is also CE IVD-marked for both diagnostic and viral load monitoring claims.
• https://seekingalpha.com/news/3638333-fda-oks-hologics-aptima-hivminus-1-quant-dx-assay-for-hiv-diagnosis

ADC lonca US application gets priority review for type of blood cancer

 

• Under priority review status, the FDA has accepted ADC Therapeutics' (NYSE:ADCT) marketing application for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
• Agency's action date is set at May 21, 2021.
• Lonca is also being evaluated in Phase 1/2 (LOTIS 3) trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and Phase 3 (LOTIS 5) confirmatory trial in combination with rituximab in patients with relapsed or refractory DLBCL.
• https://seekingalpha.com/news/3638273-fda-accepts-adc-therapeutics-lonca-us-application-for-type-of-blood-cancer

Inovio INO-5401 + INO-9012 with Libtayo combo shows potential treatment for glioblastoma

 

• Inovio (NASDAQ:INO) announces that data from its novel combination trial of DNA medicines INO-5401 and INO-9012 in combination with PD-1 inhibitor Libtayo (cemiplimab) in the treatment of newly diagnosed glioblastoma (GBM), will be presented at the Society for Neuro-Oncology 2020 Annual Meeting.
• The study demonstrated that INO-5401 + INO-9012 with Libtayo, radiation (RT) and temozolomide (TMZ) are tolerable, immunogenic, and may improve median survival.
• Survival data at 18 months showed that 70% (14/20) of MGMT promoter methylated GBM patients were alive, and 50% (16/32) of MGMT promoter unmethylated patients, which are the more difficult to treat group, were alive.
• Median overall survival (OS) in the unmethylated GBM patients was 17.9 months, which compares favorably to historical controls; Median OS for methylated patients has not yet been reached and the study is ongoing.
• In the unmethylated cohort, 19/22 (86%) subjects and in methylated cohort, 19/22 (86%) subjects had an IFN-gamma T cell response that increased over baseline to one or more of the antigens encoded by INO-5401.
• The combination demonstrated well-tolerated safety profile when given not only with radiation and TMZ, but also with Libtayo, which is being jointly developed by Regeneron (NASDAQ:REGN) and Sanofi (NASDAQ:SNY).
• Additional data will be provided in the coming months.
• https://seekingalpha.com/news/3638311-inovios-inominus-5401-inominus-9012-libtayo-combo-shows-potential-treatment-for-glioblastoma

Trump administration does not support lockdown, school closures: Pence

 The Trump administration does not support another lockdown or school closures to stem the spread of the deadly coronavirus, Vice President Mike Pence said on Thursday, even as infections have hit record highs in recent days in the United States.

Pence made the remarks during a coronavirus task force briefing, in which he also highlighted rising positivity rates for coronavirus tests administered across the country.

https://www.reuters.com/article/us-health-coronavirus-usa-pence/trump-administration-does-not-support-lockdown-school-closures-pence-idUSKBN27Z36O