Achieve Life Sciences rallies on Buy initiation at Lake Street

Lake Street initiated Achieve Life Sciences (ACHV +11.0%) with a Buy rating, PT $30; past 6 months the stock has generated 117%.

Analyst Thomas Flaten said that Cytisinicline has been marketed in for 40+ years and has a well-established track record in smoking cessation, but has not been developed for commercialization in the U.S.

At the H.C. Wainwright 22nd Annual Global Investment Conference, ACHV indicated that there is a large market opportunity of ~$13B nicotine addiction market; also it has acquired the global rights to cytisinicline from Sopharma AD.

As of the Q2 earnings call transcript, the RAUORA trial results are a landmark because this is the first direct head-to-head comparison of cytisinicline efficacy and safety compared to the current market leader, Chantix.

Preparations for the start of the Phase 3 trial progress, with the aid of leading KOLs in the field; remain optimistic that the first Phase 3 trial will commence in Q4, COVID-19 permitting.

He adds that Achieve is “on the cusp” of starting a pivotal clinical program for cytisinicline in the U.S.

https://seekingalpha.com/news/3615094-achieve-life-sciences-rallies-on-buy-initiation-lake-street

Cardiff Oncology onvansertib sustains clinical benefit in colorectal cancer

Cardiff Oncology rises (CRDF +24.4%) on clinical data that further demonstrates the safety, efficacy and durability of response of onvansertib in KRAS-mutated metastatic colorectal cancer (mCRC). Data were presented at the European Society of Medical Oncology Virtual Congress.

Data demonstrated clinical benefit and durability of response to treatment, with confirmed PRs and patients exceeding one year on treatment without disease progression.

10 of 11 (91%) patients achieved disease control with only 1 patient progressing in <6 months while on treatment. 5 patients achieved a partial response (PR) including 4 patients with confirmed PR with 1 patient going on to curative surgery; 1 patient with an initial PR went off study prior to confirmatory scan due to non-treatment related event.

73% of the patients demonstrated durable response ranging from 6 to >12 months, and 4 patients remain on treatment.

On the safety front, Onvansertib + FOLFIRI/bevacizumab was safe and well tolerated with ~9% of adverse events as severe/serious, none attributable to onvansertib and all being resolved within 2.5 weeks.

The first two onvansertib dose levels (12 and 15 mg/m²) have been cleared for safety; four patients have been treated at the third dose level (18 mg/m²) and two more will be enrolled.

No major or unexpected toxicities have been attributed to onvansertib.

https://seekingalpha.com/news/3615047-cardiff-oncologys-onvansertib-shows-sustained-clinical-benefit-in-colorectal-cancer

Leronlimab update fails to lift CytoDyn, shares down

CytoDyn (OTCQB:CYDY -16.4%) is down on average volume on the heels of its conference call updating its activities related to leronlimab. Key points:

COVID-19: Both the FDA and UK’s MHRA both want to see interim data from the results from the Phase 2 study, CD12, in severe/critical patients before deciding on emergency use authorization/fast track of leronlimab.

Data from 60 mild-to-moderate patients in the Phase 2 study, CD10, shared with MHRA on September 9. May be a candidate for early access program. MHRA wants these data, along with results from other ongoing studies, to be submitted for review. Compilation in process. Site selection for UK study in process.

Working with FDA on protocol for a Phase 3 study assessing four weekly injections in moderately ill COVID-19 patients. Some of these will be considered “long-haulers,” those who have been infected with SARS-CoV-2 but have never fully recovered. Leronlimab may be effective in these patients considering its ability to cross the blood-brain barrier.

Company believes the quickest path to approval is moderately ill patients including long-haulers.

Planned U.S. marketing application in treatment-resistant HIV-1 to be based on 700 mg dose. The Phase 3 study (CD02) was conducted with 350 mg dose, however. A different Phase 3 (CD03) assessed three doses of leronlimab alone (350 mg, 525 mg and 700 mg) in virally suppressed CCR5-tropic HIV-1 patients. Company says the agency has agreed that the 700 mg dose is the one that it will approve but wants to see data from an ongoing monotherapy study to demonstrate efficacy. All patients in this dose arm in CD03 have completed treatment so management believes it has the necessary data to support a BLA filing.

NASH: Phase 2 trial poised to start. Most sites selected. Dosing should commence in mid-to-late November.

Uplisting plan: Nasdaq notified the company that it expects to complete its review of its application for uplisting to the Capital Market tier next week. A $4 share price is a key criterion. If a $3 price comes into play, another threshold, then a net tangible asset test will be involved. Positive equity of $4M – 5M required at time of uplisting. A major investment bank is poised to raise additional capital if necessary. Confident that it can address the “going concern” issue.

Management seeking shareholder sign-off on 25M-share increase in equity incentive plan.

https://seekingalpha.com/news/3614849-leronlimab-update-fails-to-lift-cytodyn-shares-down-16

International arrivals to Abu Dhabi must wear COVID-19 tracking device

International passengers arriving at Abu Dhabi airport will now have to wear a tracking device while they complete a mandatory 14-day home quarantine due to COVID-19, according to state-owned Etihad Airways.

Daily infections in the United Arab Emirates rose this month to their highest since the outbreak started, which officials have largely blamed on people not practicing social distancing.

Those arriving at Abu Dhabi airport would be fitted with a medically approved wristband, which is removed after the 14-days of home quarantine, according to Etihad’s latest travel update.

Those arriving from countries deemed to be a high risk may have to quarantine in a government facility, it said.

A health ministry official on Sept. 10 said 12% of cases in the previous two weeks were from international arrivals while 88% were linked to people gathering in large groups.

The UAE recorded 786 new novel coronavirus cases on Thursday, down from 1,007 on Saturday, it biggest daily total so far.

The UAE, which has seen 82,568 infections and 402 deaths from COVID-19 so far, does not disclose where in the country the cases occur.

Only UAE citizens and residents can currently enter the country through Abu Dhabi airport, though foreign visitors can enter through Dubai.

https://www.reuters.com/article/us-health-coronavirus-emirates-abu-dhabi/international-arrivals-to-abu-dhabi-must-wear-covid-19-tracking-device-idUSKBN2681JH

Hawaii to allow pre-travel test option to skip quarantine on arrival

Hawaii Governor David Ige said on Wednesday the state’s pre-travel testing progam would give travelers the option of potentially avoiding a 14-day quarantine period on arrival from next month.

The pre-travel testing option, which begins on Oct. 15, is seen as one of the key measures for revitalizing state’s tourism-focused economy, while providing protection for the spread of COVID-19, according to a statement bit.ly/2FFHITF from the governor’s office.

The pre-travel testing program, originally planned to be implemented in August, was postponed as coronavirus cases spiked.

“As an alternative to quarantine a traveler must produce evidence of a negative COVID-19 test no earlier than 72-hours prior to their flight arrival in Hawaii,” the statement added.

Tourism is a big part of Hawaii’s economy – more than 10.4 million visitors came to the islands last year, supporting some 216,000 jobs in a population of around 1.4 million, according to the state tourism authority.

Hawaii has reported 10,844 cases of the new coronavirus and 100 deaths, according to Reuters tally as of Sept. 16.

https://www.reuters.com/article/us-health-coronavirus-usa-hawaii/hawaii-to-allow-pre-travel-test-option-to-skip-quarantine-on-arrival-idUSKBN2681LW

South Korea approves Phase 2/3 trials of Celltrion COVID-19 antibody drug

South Korea said on Thursday it has approved Celltrion Inc’s experimental COVID-19 treatment for Phase 2/3 clinical trials, as the firm plans to seek a conditional approval of the antibody drug for an emergency use.

Celltrion has said it would begin commercial production of the drug, CT-P59, this month – likely to amount to around 1 million doses, in anticipation of demand in Korea and overseas.

The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the virus and designed to block it from locking on to human cells.

The Ministry of Food and Drug Safety said safety and efficacy of the drug were shown in the early stage of a trial, and a Phase 2/3 study will be offered to 1,020 participants.

Other companies developing potential COVID-19 treatments include Eli Lilly and Co, Regeneron Pharmaceuticals Inc and AbbVie.

Celltrion said human trials of the treatment will be carried out in 12 countries including Britain, Spain and the United States, and it anticipates primary results by the end of the year.

https://www.reuters.com/article/us-health-coronavirus-celltrion/south-korea-approves-phase-2-3-trials-of-celltrion-covid-19-antibody-drug-idUSKBN2681BQ

Quest Diagnostics offers online option for COVID-19 diagnostic test

Individuals can now purchase a test to diagnose COVID-19 online, through QuestDirect, launched by Quest Diagnostics (NYSE:DGX).

The QuestDirect COVID-19 test can be purchased online with specimen collection available in two ways: at-home or at one of more than 500 Walmart Neighborhood Market drive-thru pharmacy locations across the U.S.

The new test uses the gold standard of COVID-19 diagnostic testing – highly sensitive molecular diagnostic technologies that have received emergency use authorization from the FDA to aid the detection of the RNA of SARS-COV-2.

Physicians are available post-test via telehealth to help consumers with interpretation of the result and referral into appropriate care.

The new service complements the QuestDirect COVID-19 Antibody Test, which was launched in April 2020.

https://seekingalpha.com/news/3614946-quest-diagnostics-offers-online-option-for-covidminus-19-diagnostic-test