Lannett up on advancement of Lantus biosimilar

Lannett Company (NYSE:LCI) announces positive results from the first human study evaluating it and alliance partner HEC Group’s insulin glargine, a biosimilar to Sanofi’s (NASDAQ:SNY) top diabetes seller Lantus.

It plans to meet with the FDA in the coming months to clarify a registration path.

Lantus accounted for 60% of Sanofi’s Q3 diabetes sales.

https://seekingalpha.com/news/3523573-lannett-up-4-premarket-on-advancement-of-lantus-biosimilar

Bristol-Myers’ Orencia nabs accelerated review status

The FDA designates Bristol-Myers Squibb’s (NYSE:BMY) Orencia (abatacept) a Breakthrough Therapy for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

https://seekingalpha.com/news/3523581-bristol-myers-orencia-nabs-accelerated-review-status-for-preventing-gvhd

EyePoint up on expanded access of Dexycu

EyePoint Pharmaceuticals (NASDAQ:EYPT) has entered into a formal two-year contract with one of the largest integrated delivery systems in the U.S. to offer DEXYCU (dexamethasone intraocular suspension 9%) within its network.

This agreement opens up new distribution channels in California, Washington, Georgia, Colorado and mid-Atlantic states.

Shares are up 12% premarket.

https://seekingalpha.com/news/3523586-eyepoint-up-12-premarket-on-expanded-access-of-dexycu

Omeros’ narsoplimab successful in pivotal HSCT-TMA study

Omeros (NASDAQ:OMER) is up 4% premarket on light volume in response to positive data from a pivotal Phase 2 clinical trial evaluating narsoplimab (OMS721) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (blood clots in tiny blood vessels) (HSCT-TMA), a frequently lethal complication of HSCT.

The study met the primary efficacy endpoint showing that 56% of patients receiving at least one dose of narsoplimab, a MASP-2 inhibitor, achieved complete responder status as did 68% who received narsoplimab for at least four weeks.

It initiated the rolling submission of its U.S. marketing application in October. The data will also support a marketing application in Europe.

No new safety signals were observed.

Management hosted a conference call this morning at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3523589-omeros-narsoplimab-successful-in-pivotal-hsct-tma-study-shares-up-4-premarket

Ra Pharma commences mid-stage study of zilucoplan in rare type of myopathy

Dosing is underway in a 24-subject Phase 2 clinical trial evaluating Ra Pharmaceuticals’ (NASDAQ:RARX) zilucoplan for the treatment of immune-mediated necrotizing myopathy, a rare type of idiopathic (cause unknown) inflammatory myopathy (muscle fiber dysfunction) characterized by muscle weakness, necrosis (uncontrolled cell death) and elevated creatinine kinase (CK) levels.

The primary endpoint is the change from baseline in CK levels at week 8 versus placebo. The estimated primary completion date is November 2020.

https://seekingalpha.com/news/3523600-ra-pharma-commences-mid-stage-study-of-zilucoplan-in-rare-type-of-myopathy

Anavex up on long-term blarcamesine data in Alzheimer’s

Anavex Life Sciences (NASDAQ:AVXL) is up 7% premarket on average volume on the heels of two-year data from a Phase 2a extension study evaluating Anavex 2-73 (blarcamesine) in patients with mild-to-moderate Alzheimer’s disease. The results are being presented at the Clinical Trials on Alzheimer’s Disease Conference in San Diego.

At week 104, patients receiving blarcamesine experienced a lower decline (-1.1) in MMSE score (Alzheimer’s scale) compared to the control cohort (-4.4) from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) database (p<0.01).

A Phase 2b/3 study in early Alzheimer’s patients is in process. The primary endpoints are the changes from baseline in two scales, ADAS-Cog and ADCS-ADL, at week 48 compared to placebo. The estimated primary completion date is September 2021.

https://seekingalpha.com/news/3523612-anavex-up-7-premarket-on-long-term-blarcamesine-data-in-alzheimers

Analyst action, Dec. 4

CNS Pharmaceuticals (NASDAQ:CNSP) initiated with Speculative Buy rating at Benchmark.

Proteostasis Therapeutics (NASDAQ:PTI) resumed with Overweight rating and $8 (203% upside) price target at Cantor Fitzgerald. Shares up 3% premarket.

SpringWorks Therapeutics (NASDAQ:SWTX) initiated with Buy rating and $33 (27% upside) price target at H.C. Wainwright.

STAAR Surgical Company (NASDAQ:STAA) initiated with Buy rating and $46 (25% upside) price target at BTIG Research.

Cidara Therapeutics (NASDAQ:CDTX) upgraded to Buy at WBB Securities.

Zimmer Biomet Holdings (NYSE:ZBH) upgraded to Strong Buy with a $170 (19% upside) price target at Raymond James. Shares up 1% premarket.

ViewRay (NASDAQ:VRAY) downgraded to Neutral with a $199 price target at Compass Point. Shares down 6% premarket in response to its equity offering.

https://seekingalpha.com/news/3523632-raymond-james-likes-zimmer-biomet-in-premarket-analyst-action