Halozyme earns $10M milestone from J&J under Enhanze license

Halozyme Therapeutics (NASDAQ:HALO) will receive a $10M milestone payment from Johnson & Johnson (NYSE:JNJ) unit Janssen Biotech triggered by the first commercial sale of subcutaneous formulation of DARZALEX (daratumumab) in the European Union.

The product utilizes the company’s Enhanze drug delivery technology that Janssen in-licensed in 2014.

https://seekingalpha.com/news/3584890-halozyme-earns-10m-milestone-from-j-and-j-under-enhanze-license

Arcutis enrolls last patient in mid-stage ARQ-154 trial for seborrheic dermatitis

Arcutis Biotherapeutics (ARQT +3.4%) has completed enrollment of its Phase 2 proof of concept clinical trial evaluating roflumilast foam as a potential treatment for seborrheic dermatitis, a chronic or recurrent skin condition that causes red patches and persistent itch.

Topline data is expected in Q4. In addition, the Company has begun enrollment in a long-term safety study of roflumilast foam in patients with seborrheic dermatitis.

The primary endpoint of the trial is achievement of an Investigator Global Assessment Scale score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

https://seekingalpha.com/news/3584932-arcutis-enrolls-last-patient-in-mid-stage-arqminus-154-trial-for-seborrheic-dermatitis

MyoKardia’s danicamtiv shows positive action in mid-stage study

MyoKardia (MYOK -0.8%) announces positive results from a Phase 2a clinical trial evaluating danicamtiv in stable heart failure patients with reduced ejection fraction. The data were presented virtually at the European Society of Cardiology’s Heart Failure Association Discoveries event.

Treatment for seven days showed that danicamtiv was generally well-tolerated and was associated with clinically meaningful improvements in left ventricular (LV) contractility, including statistically significant increases in LV stroke volume without impairing the heart’s ability to relax and fill. It improved left atrial volume and function as well.

Phase 2 studies in patients with dilated cardiomyopathy with certain genetic mutations and patients with reduced systolic function and atrial fibrillation are next up.

Danicamtiv is an orally available small molecule activator of cardiac myosin, a protein that plays an essential role in heart muscle contraction.

https://seekingalpha.com/news/3584936-myokardias-danicamtiv-shows-positive-action-in-mid-stage-study

Invitae to acquire ArcherDx for up to $1.4B

Genetic testing services provider Invitae (NYSE:NVTA) has agreed to acquire privately held cancer molecular diagnostic test developer ArcherDx (RCHR), which filed a preliminary prospectus about two weeks ago for an IPO, for up to ~$1.4B.

Under the terms of the deal, NVTA will pay $325M in cash and 30M shares of its common stock plus up to an additional 27M shares if certain milestones are met. The transaction should close in several months.

In connection with the tie-up, NVTA has arranged financing with a Perceptive Advisors-led syndicate of investors that includes the direct sale of $275M of its common stock at $16.85 (Friday’s close was $18.71) per share plus a $200M credit facility.

Since filing its most recent 10-Q on May 11, NVTA has raised $46M via the at-the-market sale of ~2.6M common shares at an average price of $17.59.

It expects to have ~$425M in cash when the deal closes.

Management hosted a conference call today at 8:00 am ET to discuss the merger.

https://seekingalpha.com/news/3584829-invitae-to-acquire-archerdx-for-up-to-1_4b

Pfizer launches four late-stage studies on vaccine candidates

Pfizer (NYSE:PFE) has initiated Phase 3 clinical trials on vaccine candidates for preventing pneumonia, RSV and meningitis.

20-valent pneumococcal vaccine (20vPnC): Two studies, NCT04382326 and NCT04379713, will assess a four-dose series in healthy infants. The former is aimed at determining immunologic non-inferiority to Prevnar 13.

RSV vaccine (RSVpreF): Study NCT04424316 is assessing the vaccine in infants born to immunized women.

Pentavalent meningococcal vaccine (MenABCWY): Study NCT04440163 is assessing the vaccine in adolescents and young adults aimed at determining non-inferiority to licensed vaccines.

https://seekingalpha.com/news/3584877-pfizer-launches-four-late-stage-studies-on-vaccine-candidates

Walgreens resumes immunization services ahead of flu season

Walgreens Boots Alliance Inc said on Monday it has resumed vaccination services at its pharmacies ahead of the upcoming flu season, which health officials have warned may coincide with a second wave of COVID-19 cases.
The move follows recently updated guidelines here from the U.S. Centers for Disease Control and Prevention, the U.S drugstore chain said.

Walgreens said it was implementing safety measures, including the use of disposable facemasks at all times by its pharmacy staff, in line with the guidance.
Rivals such as CVS Health Corp and Rite Aid Corp have also said they were preparing to meet a surge in demand for flu shots when the season kicks off in October.
Routine immunizations are even more important in the current COVID-19 environment to help reduce the overall burden of respiratory illnesses on the healthcare system, Walgreens said.
https://www.reuters.com/article/us-walgreens-boots-flu/walgreens-resumes-immunization-services-ahead-of-flu-season-idUSKBN23T1QN

South Korea says it is battling ‘second wave’ of coronavirus

Health authorities in South Korea said for the first time on Monday it is in the midst of a “second wave” of novel coronavirus infections around Seoul, driven by small but persistent outbreaks stemming from a holiday in May.

The Korea Centers for Disease Control and Prevention (KCDC) had previously said South Korea’s first wave had never really ended.
But on Monday, KCDC director Jeong Eun-kyeong said it had become clear that a holiday weekend in early May marked the beginning of a new wave of infections focused in the densely populated greater Seoul area, which had previously seen few cases.
“In the metropolitan area, we believe that the first wave was from March to April as well as February to March,” Jeong said at a regular briefing. “Then we see that the second wave which was triggered by the May holiday has been going on.”

At the end of February, South Korea reported a peak of more than 900 cases in a day, in the first large outbreak of the coronavirus outside of China.
An intensive tracking and testing campaign reduced the numbers to single digits by late April.
But just as the country announced it would be easing social distancing guidelines in early May, new cases spiked, driven in part by infections among young people who visited nightclubs and bars in Seoul over the holiday weekend.
“We originally predicted that the second wave would emerge in fall or winter,” Jeong said. “Our forecast turned out to be wrong. As long as people have close contact with others, we believe that infections will continue.”

Seoul Mayor Park Won-soon told a briefing that while daily numbers may be at manageable levels, if recent infection rates continued the city could soon see hundreds of cases a day.
As of midnight Sunday, South Korea reported 17 new coronavirus cases, the first time in nearly a month that daily new cases had dropped below 20. It was a drop from the 48 and 67 cases reported in the previous two days.
South Korea has reported a total of 12,438 cases, with 280 deaths.
https://www.reuters.com/article/us-health-coronavirus-southkorea/south-korea-says-it-is-battling-second-wave-of-coronavirus-idUSKBN23T10M