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Wednesday, October 23, 2019

BeyondSpring starts late-stage study for preventing chemo-induced neutropenia

The first patient has been enrolled in a Phase 3 clinical trial, Study 106, evaluating BeyondSpring’s (BYSI -4.1%) lead candidate Plinabulin for the prevention of chemotherapy-induced neutropenia (CIN) (abnormally low levels of a type of immune cell call neutrophils).
Participants will be receiving a chemo regimen called TAC (taxotere, doxorubicin and cyclophosphamide) plus Amgen’s Neulasta (pegfilgrastim) plus Plinabulin while those in the comparator arm will receive TAC + Neulasta.
The company plans to file marketing applications for both CIN and NSCLC (also in Phase 3) indications in China in Q1 2020 and in the U.S. later in 2020.
Plinabulin is a small molecule activator of a protein called GEF-H1.
https://seekingalpha.com/news/3508437-beyondspring-commences-late-stage-study-plinabulin-preventing-chemo-induced-neutropenia

Abiomed up 5% in extended timeline for Abbott’s head-to-head heart pump study

Abiomed (ABMD +4.7%) perks up on average volume in apparent response to a longer-than-expected completion date, December 2021, for Abbott’s (ABT +0.7%SHIELD II study comparing its HeartMate PHP catheter with any of Abiomed’s Impella pumps for use in high-risk percutaneous coronary intervention (PCI).
Abbott suspended clinical development of the device, acquired in the 2017 St. Jude Medical merger, in February 2017 on safety issues. In its recall notice, the company cited eight reports of pumps stopping during high-risk procedures to unblock blood vessels. St. Jude acquired the device via its $3.3B tie-up with Thoratec in late 2015.
https://seekingalpha.com/news/3508456-abiomed-5-percent-extended-timeline-abbotts-head-head-heart-pump-study

Biogen sell-side actions

Biogen (BIIB -0.7%) is treading water today after yesterday’s 26% pop when it announced that it had resuscitated left-for-dead Alzheimer’s drug aducanumab and planned to file a U.S. marketing application next quarter. Shares peaked at $318 intraday (+42%) before retracing as investors absorbed the news and likelihood of approval.
Guggenheim’s Yatin Suneja (Buy/$365) and Leerink’s Geoffrey Porges (Outperform/$350) were quick to upgrade considering that aducanumab was once regarded as an asset capable of generating $10B in sales, although Mr. Porges rates the potential FDA nod as an even money proposition, as does Oppenheimer’s Jay Olsen (Outperform/$338).
RBC’s Brian Abrahams, Piper’s Christopher Raymond and Stifel’s Paul Matteis maintain their Neutral ratings citing conflicting clinical data and uncertainty with regulatory approval.
Credit Suisse’s Evan Seigerman, Morgan Stanley’s Matthew Harrison and BofA Merrill Lynch’s Geoff Meacham maintain their Underperform ratings, lacking confidence in the “new analysis” and likelihood of an FDA rejection unless the agency relaxes its approval criteria (they may want to relook at the data supporting the nod for Sarepta Therapeutics’ DMD med Exondys 51).
https://seekingalpha.com/news/3508594-sell-siders-cautious-potential-fda-nod-biogens-aducanumab

Foamix Enters Into Manufacturing and Supply Agreement

Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, today announced that it has entered into a long term contract manufacturing and supply agreement with ASM Aerosol-Service (“ASM”) for the Company’s recently approved AMZEEQ™ (minocycline) topical foam, 4% for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older and for its product candidate FMX103 (minocycline) topical foam, 1.5% for the potential treatment of moderate to severe papulopustular rosacea in adults. Under the terms of the agreement, ASM will manufacture and supply AMZEEQ and FMX103 at its facility in Möhlin, Switzerland.
“This agreement represents another milestone in our overall strategy to bring AMZEEQ to market in January 2020 and to commercialize FMX103 when and if approved by the FDA,” said David Domzalski, Chief Executive Officer of Foamix. “Entering into a manufacturing contract with ASM is a critical step in securing our supply chain, which we believe will ensure the availability of supply once we launch AMZEEQ and, if approved, FMX103.”
With the receipt of FDA approval of AMZEEQ (formerly known as FMX101) and entry into the contract manufacturing and supply agreement with ASM, the Company now has access to up to an additional $20 million of financing under its existing credit agreement with Perceptive and OrbiMed to fund the commercial launches of AMZEEQ and, pending FDA approval, FMX103.
https://www.biospace.com/article/releases/foamix-enters-into-manufacturing-and-supply-agreement-for-amzeeq-and-fmx103triggers-availability-of-non-dilutive-capital-under-existing-credit-agreement-with-perceptive-and-orbimed/

J&J’s Janssen Seeks European Expansion of Tremfya for Psoriatic Arthritis

Johnson & Johnson’s (JNJ) Janssen Pharmaceutical Cos. unit on Wednesday said it filed for European Medicines Agency expanded approval of Tremfya for adults with active psoriatic arthritis.
The drug maker said it estimated that up to a third of the 14 million Europeans suffering from psoriasis will also develop psoriatic arthritis, a chronic inflammatory disease characterized by joint inflammation and the skin lesions associated with psoriasis.
Janssen received European Union approval in November 2017 for Tremfya in adults with moderate to severe plaque psoriasis.

https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-J-J-s-Janssen-Seeks-European-Expansion-of-Tremfya-for-Psoriatic-Arthritis-29439836/

Lilly raises EPS guidance after Q3 earnings beat

Eli Lilly (NYSE:LLY) Q3 results:
Revenue: $5,476.6M (+3.2%).
Net income: $1,253.9M (+9.1%); non-GAAP net income: $1,360.0M (+5.2%); EPS: $1.37 (+22.3%); non-GAAP EPS: $1.48 (+10.4%).
Key product sales: Trulicity: $1,011.5M (+23.9%); Humalog: $648.9M (-2.4%); Alimta: $508.2M (-2.4%); Forteo: $370.7M (-5.1%); Taltz: $340.0M (+28.8%); Humulin: $321.8M (flat); Jardiance: $240.7M (+44.2%); Emgality: $47.7M.
2019 guidance: Revenue: $22.0B – 22.5B (unch); EPS: $8.59 – 8.69 from $8.58 – 8.68; non-GAAP EPS: $5.75 – 5.85 from $5.67 – 5.77.

Analyst actions, Oct. 23

DexCom (NASDAQ:DXCM) initiated with Buy rating and $190 (26% upside) price target at Stifel.
Insulet (NASDAQ:PODD) initiated with Hold rating and $163 (8% upside) price target at Stifel.
Senseonics (NYSEMKT:SENS) initiated with Buy rating and $2 (111% upside) price target at Stifel.
Biogen (NASDAQ:BIIB) upgraded to Buy with a $365 (29% upside) price target at Guggenheim. Upgraded to Outperform with a $350 price target at SVB Leerink on the news that it plans to file a U.S. marketing for Alzheimer’s med aducanumab. Raymond James is not on board, though, saying that the FDA will give the application the thumbs down. Shares up 2% premarket.
Walgreens Boots Alliance (NASDAQ:WBA) downgraded to Neutral with a $63 (14% upside) price target at JPMorgan. Shares down 1% premarket.
https://seekingalpha.com/news/3508277-sell-siders-upgrade-biogen-aducanumab-prospects-raymond-james-doubts