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The Daily Biotech Pulse: FDA Greenlights AbbVie's Psoriasis Drug, Novartis Earnings, Patent Notification For MediciNova

Shanthi Rexaline

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks hitting 52-week highs on April 22)

  • BIONDVAX PHARMA/S ADR (NASDAQ: BVXV)
  • Eidos Therapeutics Inc, (NASDAQ: EIDX)

Down In The Dumps

(Biotech stocks hitting 52-week lows on April 22)

  • Achaogen Inc (NASDAQ: AKAO)
  • Arbutus Biopharma Corp (NASDAQ: ABUS)
  • CELLECT BIOTECH/S ADR (NASDAQ: APOP)
  • Spring Bank Pharmaceuticals Inc (NASDAQ: SBPH)
  • Zafgen Inc (NASDAQ: ZFGN)

Stock In Focus Novartis Reports Strong Quarterly Results, Raises FY19 Core Operating Income Guidance

Novartis AG (NYSE: NVS) reported strong first-quarter results, with 2 percent net sales growth, thanks to 11 percent volume growth mainly from Cosentyx, Entresto, Lutathera, Promacta and Kisqali. Core operating income climbed 9 percent.

The company expects net sales for 2019 to grow in mid-single digit in constant currency, with innovative medicines growing in mid-single digits and Sandoz generic business likely showing flat growth. It revised up its core operating income growth guidance to high-single digits in constant currency.

In pre-market trading Wednesday, Novartis shares were up 3.4 percent to $78.48.

AbbVie's Psoriasis Drug Gets FDA Nod

AbbVie Inc (NYSE: ABBV) said the FDA approved its Skyrizi, or risankizumab-rzaa, an interlukin-23 inhibitor, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

"The approval of SKYRIZI is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time," said Michael Severino, President, AbbVie.

The stock was up 1 percent to $79.50 in pre-market trading.

See Also: Raymond James Stays Bullish As Intuitive Surgical Falls On Quarterly Results: 'We Would Buy On Any Weakness'

FDA Approves Boston Scientific's Valve Replacement System

Boston Scientific Corporation (NYSE: BSX) said the FDA approved its LOTUS Edge Aortic Valve System – its transcatheter aortic valve replacement technology, for use in patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.

View more earnings on IBB

The company said it plans a controlled launch in the U.S. in the coming weeks.

The stock rose 2.06 percent to $36.63 in after-hours trading.

MediciNova Allowed Patent Claim Regarding Brain Cancer Drug

MediciNova, Inc. (NASDAQ: MNOV) said the U.S. Patent and Trademark Office has allowed it a patent regarding its pipeline asset MN-166, or ibudilast, for treating glioblastoma as part of combination therapy.

"Once issued, the patent maturing from this allowed patent application is expected to expire no earlier than December 2037," the company said.

The stock rose 2.23 percent to $10.99 in after-hours trading.

Akari Q4 Net Loss Narrows

Akari Therapeutics PLC (NASDAQ: AKTX), which recently announced FDA approval for two generic drugs, reported a narrower loss of $3.5 million for the fourth quarter of 2018 compared to a loss of $12.1 million last year.

As of December 31, 2018, the Company had cash of $5.4 million, as compared to cash of $28.1 million as of December 31, 2017. The company also said it received a R&D cash tax credit of $4.9 million in the first quarter.

In pre-market trading Wednesday, Akari shares were up 10.82 percent to $4.30.

Merit Medical Q1 Beats Estimates

Merit Medical Systems, Inc. ( (NASDAQ: MMSI) reported first-quarter non-GAAP EPS of 37 cents, a penny ahead of estimates. Sales of $238.3 million represented 17.4 percent year-over-year growth and exceeded the $236.53 million consensus estimate.

On The Radar Earnings

Boston Scientific (before the market open)
Biogen Inc (NASDAQ: BIIB) (before the market open)
Integra Lifesciences Holdings Corp (NASDAQ: IART) (before the market open)
Varian Medical Systems, Inc. (NYSE: VAR) (after the market close)

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