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Tuesday, August 15, 2023

CareDx upped to Outperform from Market Perform by Raymond James

 Target $12

https://finviz.com/quote.ashx?t=CDNA&ty=c&ta=1&p=d

Gilead ties up with Tentarix for cancer, inflammatory disease therapies

 Gilead Sciences said on Tuesday it had entered into an agreement with privately held Tentarix Biotherapeutics to develop therapies for cancer and inflammatory diseases.

Tentarix will receive upfront payments and an equity investment totaling $66 million from Gilead, which has the option to buy up to three of the drug developer's units for $80 million each, the companies said.

The deal gives Gilead access to Tentarix's proprietary drug development platform for antibody-based therapies that specifically target immune cells related to the disease without activating other immune cells that may lead to adverse events.

Gilead earlier this month flagged a more than 25% jump in research and development costs owing to multi-year plans it undertook to diversify its pipeline to expand beyond HIV drugs, its strongest revenue driver.

https://finance.yahoo.com/news/1-gilead-ties-tentarix-cancer-131904629.html

Pharvaris upped to Overweight from Equal Weight by Morgan Stanley

Target to $34 from $10

https://finviz.com/quote.ashx?t=PHVS&p=d

Delcath: FDA OKs Treatment for Hepatic-Dominant Metastatic Uveal Melanoma

 HEPZATO KIT is the only FDA approved liver-directed therapy to treat metastatic uveal melanoma

Approval includes treatment naïve and previously treated patients and is not limited by HLA genotype

Delcath to hold Business Update Call on August 15, 2023 at 8:00 a.m. Eastern Time

To participate in this event, dial-in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Tuesday, August 15, 2023
Time: 8:00 AM Eastern Time
Participant Numbers: Toll Free: 1-833-630-1960
International: 1-412-317-1841
Webcast: https://app.webinar.net/rE345LOXL6b

CONFERENCE REPLAY


US Toll Free:

1-877-344-7529

International Toll:

1-412-317-0080

Replay Access Code:

4657227

End Date:

August 21, 2023


https://finance.yahoo.com/news/delcath-systems-inc-announces-fda-011000224.html

Iziana: IND Clearance of Intranasal Foralumab for Treatment of Alzheimer’s

 

  • Foralumab to advance into Phase 2 human clinical trials using the world’s only fully human intranasal anti-CD3 monoclonal antibody

  • Trial to be overseen by Brigham and Women’s Hospital, a founding member of Mass General Brigham Healthcare System

Acelyrin recent highlights

New data from Part A of Phase 2b/3 trial of izokibep in Hidradenitis Suppurativa demonstrated improvements in number of draining tunnels in two-thirds of patients as early as week 4; the placebo-controlled Part B remains on track for top-line data in the third quarter 2023.

Enrollment completed in Phase 2b/3 randomized controlled trial of izokibep in Psoriatic Arthritis; top-line data now accelerated to first quarter 2024 from mid-2024.

Strong cash position of $823.0 million, including gross proceeds from recent IPO of $621.0 million, supports multiple late-stage clinical programs through key milestones across all three clinical programs.     

Company to host conference call and webcast at 4:30 p.m. ET  Monday

ACELYRIN will host a conference call and webcast today, August 14, 2023, at 4:30 p.m. ET to review its second quarter 2023 financial results. A live webcast of the conference call can be accessed in the “Investors & Media” section of ACELYRIN’s website at www.acelyrin.com. A recording of the webcast will be available approximately two hours after the event, and will be archived on the Company’s website for approximately 30 days.

https://finance.yahoo.com/news/acelyrin-inc-reports-second-quarter-200500086.html

China Vow Sweeping Anti-Graft Campaign in Health Care Crackdown

 An anti-corruption campaign in China’s health sector is gathering steam as regulators says their efforts will cover everything from drug companies and manufacturing to hospitals and its medical insurance fund.

The initiative includes a comprehensive look at the entire pharmaceutical industry, and increases penalties and disclosure requirements, the official Xinhua News Agency reported, citing an unidentified official at the National Health Commission.

Previous efforts uncovered individuals in key positions who abused their power, accepted kickbacks and bribes, and engaged in corrupt activities, according to the report. Those actions reduced the benefits of health-care reform and curbed development, hurting the public interest, the unnamed official said, according to Xinhua.

Since news broke in late July that China’s Central Commission for Discipline Inspection was working with the NHC, Ministry of Public Securities and other agencies to weed out corruption, headlines have been filled with reports about hospital chiefs being taken away and bribes to doctors and health-care workers from drug and medical device companies. Rumors of raids and executives whisked away from Chinese and foreign pharmaceutical firms also swirled online.

China’s health-care stocks slumped as sentiment took a hit from the anti-graft crackdown, with the CSI 300 Health Care Index falling 0.5% on Tuesday. It’s down 13% year-to-date.

Nearly 30 hospital chiefs, party secretaries and health officials have been swept up by the anti-graft campaign in the three weeks since it launched. The number of healthcare professionals and officials ensnared in a broader CCDI investigation rose to more than 170 since the beginning of this year, data compiled by Beijing-based healthcare consultancy and media Saibailan shows. Most are from hospitals and government agencies in lower-tier cities across China, indicating the crackdown is far from complete.