- Solid Biosciences (SLDB +81.0%) 'shines brightly' today after the FDA lifts hold on Duchenne study, evaluating its gene therapy candidate SGT-001. In November 2019, the study was put on clinical hold, for the second time, after a participant experienced a serious adverse event related to compound, with first hold in March 2018 after a participant was hospitalized for decreased platelet.
- In reaction to today's news, Chardan analyst Gbola Amusa raised the price target to $12.50 from $5 and keeps a Buy rating. According to analyst, today's news is an "important positive" given that manufacturing constraints in the space leave an opportunity for Solid, and the view from many in the market that SGT-001 may not return to the clinic.
- He also notes that Duchenne muscular dystrophy is a "vast opportunity" for gene therapies, and one that could take Solid "significantly past" the new price target with progress.
- https://seekingalpha.com/news/3619058-chardan-raises-solid-biosciences-price-target-250
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Thursday, October 1, 2020
Chardan raises Solid Biosciences price target 250%
DaVita slips on reported Humana snub
Hims agrees deal to go public via SPAC
Online prescription drug company Hims Inc said on Thursday it had agreed to go public by merging with Oaktree Acquisition Corp OAC.N in a deal that values the start-up at $1.6 billion.
It is the latest example of a consumer-facing company opting to go public by merging with a so-called special purpose acquisition company (SPAC) rather than through a traditional initial public offering, following on from the likes of sports betting platform DraftKings Inc DKNG.O.
Hims connects patients with doctors through its website and sells drugs directly to consumers. The brand started primarily by selling hair loss treatments and has since branched out to offer birth control, dermatology, and other drugs.
By merging with the SPAC, which is backed by private equity firm Oaktree Capital Management, Hims will become publicly listed on the New York Stock Exchange.
Reuters reported in July that Hims, whose brand ambassadors include actress-singer Jennifer Lopez and retired baseball star Alex Rodriguez, was exploring going public through a SPAC.
Once considered obscure, SPACs entered the financial mainstream in 2020 after many of Wall Street’s largest players raised money to form their own blank check companies.
A SPAC is a shell company that raises money through an IPO to buy an unspecified operating company to then take public, usually within two years.
With the Hims deal, Oaktree will be capitalizing on the telehealth industry, a sector that has boomed since the coronavirus outbreak began. At the beginning of the pandemic, the Trump administration eased regulations that made it easier for companies and doctors to offer healthcare to patients in their own homes.
Mergers and IPOs have followed. In August, Teladoc Health said it would buy Livongo Health for $18.5 billion. Shares of online prescription drug company GoodRx Holdings Inc jumped after its September IPO.
https://www.reuters.com/article/oaktree-acqsn-ma-hims/hair-loss-treatment-vendor-hims-agrees-deal-to-go-public-idUSL1N2GR1SY
Enlivex up on positive Allocetra results in COVID-19
- Enlivex Therapeutics (NASDAQ:ENLV) reports positive top line results of an investigator-initiated clinical trial of Allocetra in COVID-19 patients in severe/critical condition.
- The trial included five COVID-19 patients, three in severe condition and two in critical condition. All five patients were released from the hospital after an average of 5.5 days (severe) and 8.5 days (critical), following administration of Allocetra, at which time they were all COVID-19 PCR negative.
- There were no reported severe adverse events, and the therapy was well-tolerated.
- The company has determined to shift recruitment of additional patients from the investigator-initiated clinical trial into a larger Phase II clinical trial of COVID-19 patients based on the positive results of the first five COVID-19 patients together with the positive safety and efficacy results of Allocetra in 10 sepsis patients in a previous study.
- The planned Phase IIb trial is expected to commence in Q4.
- https://seekingalpha.com/news/3618709-enlivexplus-5-on-positive-allocetra-results-in-covidminus-19
Pfizer gene therapy Fast Track'd for Duchenne muscular dystrophy
- The FDA has granted Fast Track designation to Pfizer's (NYSE:PFE) investigational gene therapy candidate (PF-06939926) being developed to treat Duchenne muscular dystrophy (DMD).
- Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
- PF-06939926 is currently being evaluated in a Phase 1 study. A Phase 3 should launch in the coming weeks.
- Related ticker: Sarepta Therapeutics (NASDAQ:SRPT)
- https://seekingalpha.com/news/3618726-pfizer-gene-therapy-fast-trackd-for-duchenne-muscular-dystrophy
Humana rolls out 2021 health plans in more counties nationwide
- Humana (NYSE:HUM) announces details of its 2021 Medicare product offerings, including Medicare Advantage and Prescription Drug Plans.
- Beneficiaries will also have new choices through the launch of 69 new MAPD plans across hundreds of additional counties. For 2021, Humana’s MA, including Honor plans, and MAPD plans are all recommended by USAA.
- Humana Honor, a Medicare Advantage plan in its second year, designed with U.S. military veterans in mind, expands into 46 states – up from 27 states in 2020.
- For all MAPD members, benefits include $0 telehealth copays for primary care physician visits, urgent care, and outpatient behavioral health, $0 copays for COVID-19 testing, and a Health Essentials Kit (up to one per year).
- Insulin Savings Program included on about half of Humana’s MAPD plans and a third of PDP plans; members will pay no more than $35 for a 30-day supply of select insulins.
- The Healthy Foods Card is available to all members on D-SNP plans.
- Included with most MAPD and DSNP plans are key extra benefits like dental, vision, over-the-counter allowance, fitness program memberships, and home-delivered meals following an inpatient hospital stay.
- The Medicare Advantage and Prescription Drug Plan Annual Election Period begins Oct. 15 and continues through Dec. 7, 2020.
- Humana PDP will offer enhancements to its current three plans. For 2021, Humana will again offer a co-branded prescription drug plan with Walmart and Sam’s Club pharmacies.
- https://seekingalpha.com/news/3618771-humana-rolls-out-2021-health-plans-in-counties-nationwide
FDA lifts hold on Solid Bio's Duchenne study
- Thinly traded nano cap Solid Biosciences (NASDAQ:SLDB) jumps 61% premarket on robust volume in reaction to the FDA's removal of the clinical hold placed on its Phase 1/2 clinical trial, IGNITE DMD, evaluating gene therapy candidate SGT-001 in patients with Duchenne muscular dystrophy (DMD). The trial was halted pending a review of additional manufacturing information and updated safety and efficacy data.
- The agency suspended the study in November 2019 after a participant experienced a serious adverse event, complement activation, thrombocytopenia, a decrease in red blood cell count, acute kidney injury and cardio-pulmonary insufficiency.
- A hold was also placed on the trial in March 2018 after another participant was hospitalized for decreased platelet count followed by a reduction in red blood cell count and evidence of complement activation.
- https://seekingalpha.com/news/3618777-fda-lifts-hold-on-solid-bios-duchenne-study-shares-rocket-61