Alkermes sues Teva to block generic version of Vivitrol

Subsidiaries of Alkermes plc (NASDAQ:ALKS) have filed a patent infringement litigation in a New Jersey court against Teva Pharmaceutical Industries (NYSE:TEVA) regarding Teva’s U.S. application seeking FDA approval of a generic version of alcohol/opioid dependence med Vivitrol (naltrexone for extended-release injectable suspension).

The filing of a lawsuit is routine for branded drugmakers since it automatically triggers a 30-month stay on an FDA nod for a generic to allow time for the patent dispute to be adjudicated.

Vivitrol accounted for almost 29% of Alkermes’ Q2 revenue ($71.6M/247.5M).

https://seekingalpha.com/news/3612824-alkermes-sues-teva-to-block-generic-version-of-vivitrol

Quest Diagnostics up on raising FY20 guidance

Quest Diagnostics (NYSE:DGX) +2% expects FY20 GAAP EPS $7.42-$8.92 from prior guidance of $5.66-$7.66 –

FY20 Adjusted EPS $7.50-$9.00 from previous outlook of $6.60-$8.60 vs. $8.03.

Net revenue $8.4B-$8.8B from guidance of $8.0B-$8.6B vs. $8.55B

FY20 Cash provided by operations to be at least $1.45B from prior outlook of at least $1.25B.

Since the company reported its financial performance for the second quarter of 2020 on July 23, 2020, organic testing volumes in its base business (excluding COVID-19 molecular and antibody testing and the impact of acquisitions), continued to recover faster than anticipated through the end of August. Organic base testing volumes declined high single digits in July and mid-to-high single digits in August on a percentage basis versus the prior year.  COVID-19 molecular and antibody testing volumes remain consistent with the company’s previous outlook.

https://seekingalpha.com/news/3612827-quest-diagnosticsplus-2-on-raising-fy20-guidance

Anavex completes mid-stage study of lead drug in rare brain development disorder

Anavex Life Sciences (NASDAQ:AVXL) has completed a Phase 2 clinical trial evaluating Anavex 2-73 (blarcamesine) in patients with Rett syndrome, a rare inherited neurological disorder that occurs primarily in girls that leads to severe impairments. The company plans to release topline results next quarter.

Orally available blarcamesine is a sigma-1 receptor (S1R) agonist. S1Rs play a key role in the modulation of neurotransmission. It is also being investigated for the potential treatment of Parkinson’s disease dementia and mild-to-moderate Alzheimer’s disease.

https://seekingalpha.com/news/3612834-anavex-completes-mid-stage-study-of-lead-drug-in-rare-brain-development-disorder

Dyne Therapeutics sets IPO terms

 

Dyne Therapeutics (DYN), a developer of therapies for muscle diseases plans an IPO of 10.3M shares, to be priced in a range of $16 to $18.

J.P. Morgan, Jefferies, Piper Sandler and Stifel are underwriting the deal.

Proceeds will be used to finance R&D, develop the FORCE platform and for general corporate purposes.

https://seekingalpha.com/news/3612839-dyne-therapeutics-sets-ipo-terms

Corvus Pharma up on encouraging CPI-006 data in COVID-19

Corvus Pharmaceuticals (NASDAQ:CRVS) jumps 10% premarket after announcing updated data from its ongoing Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19.

The Company has submitted a manuscript describing the initial results from the first two cohorts (five patients receiving 0.3 mg dose and five patients receiving 1.0 mg dose) for publication online at medRxiv.org. The key highlights are as follows:

Nine of 9 patients with pre-treatment serum samples had low pre-treatment levels of anti-SARS-CoV-2 antibodies independent of the duration of their prior COVID-19 symptoms.

IgG and IgM antibody titers against the SARS-CoV-2 trimeric spike and/or receptor binding domain increased in 8 of 8 evaluable patients within seven days of receiving the treatment. In five patients measured, the antibodies were neutralizing.

In all patients evaluated, the antibody responses, including Neutralizing antibody titers continued to increase out to 28 days post treatment with CPI-006.

In three of three patients tested to-date, CD4 and CD8 T effector memory cells increased by day 28 and these cells were shown to respond specifically to SARS-CoV-2 viral antigens.

In addition, all of these patients were discharged from the hospital with clinical improvement and none experienced any drug-related safety issues.

The study has completed enrollment in the third cohort (3.0 mg dose of CPI-006) of five patients, with the overall study expected to enroll up to 30 patients.

“CPI-006’s unique immunotherapy approach to treating COVID-19 may provide advantages over other therapies in development. Specifically compared to passively administered monoclonal antibody approaches, we believe CPI-006 could trigger B cell activation at much lower antibody dose levels and provide activity against potential new mutant variants,” said Richard A. Miller, M.D., President and CEO.

Additional data are expected in late 2020.

https://seekingalpha.com/news/3612898-corvus-pharmaplus-10-on-encouraging-cpiminus-006-data-in-covidminus-19

Zai Lab Zeluja OKd in China for 1st-line maintenance treatment of ovarian cancer

The China National Medical Products Administration has approved Zai Lab’s (NASDAQ:ZLAB) supplemental New Drug Application (sNDA) for ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

ZEJULA is also being evaluated in China for the treatment of patients with advanced or metastatic gastric cancer who failed prior treatment.

https://seekingalpha.com/news/3612849-zai-labs-zeluja-okd-in-china-for-first-line-maintenance-treatment-of-ovarian-cancer

J&J files U.S. application for expanded use of Darzalex Faspro

Johnson & Johnson’s (NYSE:JNJ) The Janssen Pharmaceutical Companies has filed a supplemental marketing application with the FDA seeking approval to use Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, to treat patients with light chain amyloidosis, a rare and potentially fatal protein folding disorder that leads to multiple organ failure.

The filing is being reviewed under an FDA initiative called Project Orbis which allows concurrent submission and review of cancer medicine applications among international regulatory agencies.

Darzalex Faspro is currently approved in the U.S. for five indications in multiple myeloma. Subcutaneous administration is enabled by Halozyme Therapeutics’ (NASDAQ:HALO) Enhanze technology.

https://seekingalpha.com/news/3612850-j-and-j-files-u-s-application-for-expanded-use-of-darzalex-faspro