Alexion confident with current value-creating path, no sale planned

In a statement, Alexion Pharmaceuticals (NASDAQ:ALXN) says it has established a “strong foundation” to drive growth and boost shareholder value and does not plan to pursue an outright sale as proposed by shareholder Elliott Advisors.

Management cites it new leadership team, a refined strategy to convert the market to Ultomiris (ravulizumab-cwvz) from Soliris (eculizumab), the expansion of current assets into new diseases and a revamped pipeline.

Shares up 6% premarket on modest volume.

https://seekingalpha.com/news/3524429-alexion-confident-current-value-creating-path-no-sale-planned

Dr. Reddy’s launches Deferasirox oral suspension and film-coated tablets in U.S.

Dr. Reddy’s Laboratories (NYSE:RDY) has launched Deferasirox Tablets for Oral Suspension and Deferasirox Film-Coated Tablets, 90 mg and 360 mg, a therapeutically equivalent generic version of Novartis Pharma AG’s Exjade (deferasirox) Tablets for Oral Suspension and Jadenu (deferasirox) Film-Coated Tablets 90, 180 and 360 mg, respectively.

The Exjade and Jadenu brand had U.S. sales of ~$113M MAT and $470M MAT, respectively for year ending in September 2019 according to IQVIA Health.

https://seekingalpha.com/news/3524321-dr-reddys-launches-deferasirox-oral-suspension-and-film-coated-tablets-in-u-s

FDA places partial clinical hold on studies of Ipsen’s palovarotene

The FDA has instituted a partial clinical hold on four studies evaluating Ipsen’s (OTCPK:IPSEY) palovarotene due to a potential safety signal in patients under the age of 14. Specifically, there have been reports of early growth plate closure in patients with fibrodysplasia ossificans progressiva (FOP), a rare disorder characterized by the gradual replacement of tendons and ligaments with bone, who were treated with the RARγ agonist.

The affected trials are two Phase 2 studies in FOP (PVO-1A-204 and PVO-1A-202), one Phase 2 in osteochondroma (PVO-2A-201) and one Phase 3 in FOP.

Treatment of patients in the osteochondroma study will be suspended since it primarily involves children up to the age of 14.

Participants in the FOP studies older than 14 will continue receiving treatment.

Recruitment of new patients below the age of 14 will be suspended in all four trials.

Palovarotene is the lead drug developed at Clementia Pharmaceuticals, acquired by Ipsen in April for up to $1.3B.

https://seekingalpha.com/news/3524373-fda-places-partial-clinical-hold-on-studies-of-ipsens-palovarotene

Analyst action, Dec. 6

Amedisys (NASDAQ:AMED) initiated with Market Perform rating and $170 (3% upside) price target at BMO.

Athenex (NASDAQ:ATNX) initiated with Buy rating and $28 (70% upside) price target at SunTrust.

Gossamer Bio (NASDAQ:GOSS) initiated with Overweight rating and $34 (38% upside) price target at Cantor Fitzgerald.

Odonate Therapeutics (NASDAQ:ODT) initiated with Sell rating and $26 (22% downside risk) price target at Goldman Sachs.

Puma Biotechnology (NASDAQ:PBYI) initiated with Buy rating and $15 (102% upside) price target at H.C. Wainwright. Shares up 6% premarket.

Sierra Oncology (NASDAQ:SRRA) initiated with Outperform rating and $1.20 (213% upside) price target at Oppenheimer. Shares up 30% premarket.

Epizyme (NASDAQ:EPZM) upgraded to Overweight with a $22 (44% upside) price target at Morgan Stanley.

HCA Healthcare (NYSE:HCA) upgraded to Buy with a $160 (14% upside) price target at BofA Merrill Lynch.

Sage Therapeutics (NASDAQ:SAGE) upgraded to Market Perform at SVB Leerink. Shares up 2% premarket.

Anthem (NYSE:ANTM) downgraded to Neutral with a $330 (15% upside) price target at BofAML.

Teladoc (NYSE:TDOC) downgraded to Hold with an $80 (1% upside) price target at Jefferies. Shares down 2% premarket.

https://seekingalpha.com/news/3524390-bofaml-likes-hca-in-premarket-analyst-action

Biohaven up on continuation of troriluzole study in Alzheimer's

Based on a futility analysis by the independent Data Safety Monitoring Board, the ongoing Phase 2/3 clinical trial evaluating Biohaven Pharmaceuticals’ (NYSE:BHVN) troriluzole in Alzheimer’s disease patients will continue as planned.

The primary endpoints are the change from baseline in two AD scales, ADAS-Cog 11 and CDR-Sum of boxes, at week 48 compared to placebo. The estimated completion date is December 2020.

On another note, the USPTO has issued a new composition of matter patent covering troriluzole with an expiration date of February 26, 2036.

https://seekingalpha.com/news/3524395-biohaven-up-8-premarket-on-continuation-of-troriluzole-study-in-alzheimers

Novartis developing 25+ blockbusters – R&D Day

At its R&D Day in London yesterday, Novartis (NYSE:NVS) detailed its development efforts. Key points:

25+ potential blockbusters in development, 16 advanced platform therapies and 160+ projects in the clinic (500+ clinical trials).

80+ regulatory submissions expected 2020 – 2022.

Key filings expected in 2020: alpelisib for PROS, AVSX-101 for SMA Type 2/3, Entresto for HFpEF, fevipiprant for asthma, 177Lu-PSMA-617 for mCRPC and spartalizumab combo for metastatic melanoma.

Phase 2 pipeline includes over 60 projects.

Over 50 filings expected in China through 2023.

Key emerging assets: iscalimab (CFZ533) in transplant, Sjögren’s syndrome; LNP023 in renal diseases and RA; MBG453 in myeloid disorders and TQJ230 for lowering CV risk.

Near-term late-stage data readouts/product launches include ofatumumab in relapsing forms of MS, fevipiprant in asthma, Lu-PSMA-617 in prostate cancer, ligelizumab in spontaneous urticaria and canakinumab in non-small cell lung cancer.

https://seekingalpha.com/news/3524343-novartis-developing-25-blockbusters-r-and-d-day

Epizyme +2.6% as Morgan Stanley joins other bulls

Epizyme (NASDAQ:EPZM) is up 2.6% postmarket after its last cautious analyst holdout joined others in the bull column.

Morgan Stanley raised its recommendation to Overweight from Equal Weight, where it was a lone holdout.

The firm set its price target to $22, implying 44% upside.

https://seekingalpha.com/news/3524254-epizymeplus-2_6-morgan-stanley-joins-bulls