Surgery Partners, ValueHealth in Strategic Partnership

 Surgery Partners, Inc. (NASDAQ: SGRY) (Surgery Partners) and ValueHealth, LLC (ValueHealth) today announced a strategic partnership that brings Surgery Partners, a leading independent operator of short-stay surgical facilities, together with ValueHealth, a nationally recognized leader in value-based care. This partnership and the complementary strengths of each company will expand access to consumer-focused, high-value sites of care for patients and physicians.

The partnership will:

• Accelerate portfolio expansion through an exclusive partnership to develop future de novo ambulatory surgery centers (ASCs), meeting the growing demand for cost-effective, consumer-focused surgical care.
  

• Deploy ValueHealth’s suite of comprehensive, value-based surgical programs across Surgery Partners’ current and in-development locations, benefiting patients, physicians, payors, and employers who are seeking solutions to reduce escalating surgical costs.
  

• Surgery Partners will assume management services and ValueHealth’s interest in three ASCs and four in-development, fully syndicated de novos, primarily supporting orthopedic specialties. Surgery Partners will continue to partner with ValueHealth on strategic assumption of management services and equity interest as part of the ongoing partnership.

https://finance.yahoo.com/news/surgery-partners-inc-valuehealth-llc-130000722.html

Kymera extends Phase 1 dosing period in update

 IRAK4 degrader KT-474 Phase 1 patient cohort amended to extend dosing from 14 to 28 days, enabling inclusion of exploratory clinical efficacy endpoints and extended safety monitoring

Clinical trials initiated for STAT3 (KT-333) and IRAKIMiD (KT-413) oncology programs

Pre-clinical data presented at AACR on first-in-class MDM2 degrader, KT-253, highlighting the potential benefit of degradation over inhibition and broader clinical opportunities; IND filing planned for 2H22

March 31, 2022 cash balance of approximately $523 million, providing cash runway into 2025

Company to hold quarterly results call at 8am EST (833-740-0921 or 409-937-8885, ID #2984916)

https://finance.yahoo.com/news/kymera-therapeutics-announces-first-quarter-110000366.html

Semler target cut at B. Riley

 Semler Scientific (OTCMKTS:SMLR – Get Rating) had its price target reduced by B. Riley from $70.00 to $60.00 in a research report issued on Tuesday, The Fly reports. B. Riley’s target price indicates a potential upside of 26.74% from the stock’s previous close.

https://www.defenseworld.net/2022/05/03/semler-scientific-otcmktssmlr-pt-lowered-to-60-00-at-b-riley.html

XORTX Initiates Dosing of Human Subjects in Polycystic Kidney Disease Trial

 XORTX Therapeutics Inc. ("XORTX" or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, is pleased to announce that dosing of human subjects has been initiated in the XRX-OXY-101 bridging pharmacokinetics study (“PK Study”).

Successful recruitment for part 1 of this 3-part clinical trial has been completed with 32 subjects receiving study drug. Following administration of the first dose of drug, blood sampling and bioanalytical evaluation will be conducted to characterize the pharmacokinetics and bioavailability of the XRx-008 program’s novel proprietary formulations of oxypurinol for future clinical trials development. Additionally, this PK Study will provide fundamental information for the 505(b)2 filing of the XRx-008 program.

XORTX’s current conducting our clinical trial - XRX-OXY-101 - a “bridging pharmacokinetics” study. Part 1 of the study involves dosing under fasted conditions. Part 2 measures the effect of food on pharmacokinetics (PK) and Part 3 is a multiple dose PK evaluation. Safety evaluation is also an important aspect of the XRX-OXY-101 clinical trial. The study is designed to permit XORTX to characterize the safety and relative bioavailability of the XRx-008 program formulations. Knowledge gained during the conduct of this trial will provide critical guidance regarding the oral dose for our planned registration trial in autosomal dominant polycystic kidney disease (ADPKD).

https://www.globenewswire.com/news-release/2022/05/03/2434392/0/en/XORTX-Initiates-Dosing-of-Human-Subjects-in-the-XRX-OXY-101-Clinical-Trial.html

Novo Nordisk: Blackrock a 5% holder

 Novo Nordisk today announced that the company has been notified by BlackRock, Inc. (Blackrock) as follows:

Blackrock holds as of 25 April 2022 B shares equal to 4.99% of the entire share capital of Novo Nordisk. The total B shares according to section 38 of the Danish Capital Markets Act, and other financial instruments according to section 39(2)(1) of the Danish Capital Markets Act and financial instruments with similar effects according to section 39(2)(2) of the Danish Capital Markets Act held by Blackrock correspond to 5.00% of the entire share capital and below 5% of the voting rights.

Blackrock holds as of 26 April 2022 B shares equal to below 5% of the entire share capital of Novo Nordisk. The total B shares according to section 38 of the Danish Capital Markets Act, and other financial instruments according to section 39(2)(1) of the Danish Capital Markets Act and financial instruments with similar effects according to section 39(2)(2) of the Danish Capital Markets Act held by Blackrock correspond to below 5% of the entire share capital and below 5% of the voting rights.

Blackrock holds as of 27 April 2022 B shares equal to 4.99% of the entire share capital of Novo Nordisk. The total B shares according to section 38 of the Danish Capital Markets Act, and other financial instruments according to section 39(2)(1) of the Danish Capital Markets Act and financial instruments with similar effects according to section 39(2)(2) of the Danish Capital Markets Act held by Blackrock correspond to 5.00% of the entire share capital and below 5% of the voting rights.

https://finance.yahoo.com/news/novo-nordisk-major-shareholder-announcement-150700643.html

Sonoma, MicroSafe Get EPA Approval for Nanocyn® Hospital-Grade Disinfectant in U.S.

 Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA), a global healthcare leader developing and producing patented Microcyn® technology-based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound, eye, oral and nasal care, dermatological conditions and disinfectant use, and its partner, the MicroSafe Group DMCC, received EPA approval for Nanocyn® as a hospital-grade disinfectant in the United States. Nanocyn®, which is manufactured by Sonoma using its patented Microcyn® Technology, is a ready to use hard-surface disinfectant that may reduce the risk of infection by treating hard, non-porous surfaces, making it especially useful in high-risk areas such as hospitals, schools, mass transit, and care facilities.

Nanocyn® hospital-grade disinfectant is currently sold by MicroSafe Group in Europe, the Middle East/West Africa and Australia. Nanocyn has been proven to kill a variety of bacteria, such as Staphylococcus aureus and Pseudomonas aeruginosa, and has a 30 second kill time for many viruses, including norovirus, on hard non-porous surfaces. In May 2020, Nanocyn was entered into the Australian Register of Therapeutic Goods (ARTG) for use against SARS-CoV-2 (COVID-19). Nanocyn utilizes Sonoma’s patented Microcyn technology which has a long, proven record of significantly reducing numerous bacteria, viruses, fungi and spores on many surfaces. For more information see www.sonomapharma.com/literature/.

https://finance.yahoo.com/news/sonoma-pharmaceuticals-microsafe-group-dmcc-100000860.html

Coherus Up; Gets FDA Complete Response Letter, But New Clinical Data Not Needed

 Coherus BioSciences Inc. shares were higher Monday after it and Shanghai Junshi Biosciences Co. Ltd. said they received a U.S. Food and Drug Administration complete response letter, but more clinical data won't be needed.

The companies said they received the letter, which indicates the agency won't approve an application in its current form, for toripalimab in combination with gemcitabine and cisplatin in the first-line treatment of nasopharyngeal carcinoma and toripalimab monotherapy in the second-line or later treatment of NPC.

Coherus shares were up 3.3% at $9.34 after trading in negative territory earlier in the session.

Coherus said it is working close with partner Junshi Biosciences to facilitate the completion of the FDA's review and in late April, responded quickly to an FDA request for a quality process change and implemented required actions.

"The FDA has indicated that the existing toripalimab clinical data are supportive of the BLA submission," said Coherus Chief Executive Denny Lanfear.

Coherus and Junshi said they plan to meet with the FDA directly and expect to resubmit the application by mid-summer 2022.

Mizuho Securities USA analyst Salim Syed said in a note that said it got more information on the letter from company management.

"The requested quality process change doesn't relate to how the product is made, and its implementation should be addressable. Importantly, no additional clinical data was requested. With onsite inspections in China expected to take place during 2H of the year, management is shooting for a potential end-of-the-year approval," Mizuho analyst write.

The Mizuho said Monday's news represents a short-term hurdle.

The FDA not requiring any additional clinical data "implicitly may be validating the potential approvability of the submitted clinical data," the analyst note said.

NPC is a type of aggressive cancer that starts in the upper part of the throat behind the nose and near the base of skull. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the U.S. and Canada.

https://www.marketscreener.com/quote/stock/COHERUS-BIOSCIENCES-INC-18460920/news/Coherus-Up-Gets-FDA-Complete-Response-Letter-But-New-Clinical-Data-Not-Needed-40248525/