Benzinga's Daily Biotech Pulse: FDA Greenlights Tandem Diabetes' Insulin Pump, More IPOs On Tap

Shanthi Rexaline
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In this article:

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

Scaling the Peaks

(Stocks hitting 52-week highs on June 21)

  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)

  • FibroGen Inc (NASDAQ: FGEN)

  • Heron Therapeutics Inc (NASDAQ: HRTX)(announced its pain treatment candidate HTX-011 received Breakthrough Therapy designation from the FDA)

  • Myovant Sciences Ltd (NYSE: MYOV)

  • NeoGenomics, Inc. (NASDAQ: NEO)

Down In The Dumps

(Stocks hitting 52-week lows on June 21)

  • Agenus Inc (NASDAQ: AGEN)

  • Auris Medical Holding AG (NASDAQ: EARS)

  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)

  • Cellectar Biosciences Inc (NASDAQ: CLRB)

  • DelMar Pharmaceuticals Inc (NASDAQ: DMPI)

  • Enzo Biochem, Inc. (NYSE: ENZ)

  • Immune Pharmaceuticals Inc (NASDAQ: IMNP)

  • MeiraGTx Holdings PLC (NASDAQ: MGTX)

  • Mustang Bio Inc (NASDAQ: MBIO)

  • Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV)

  • Oncobiologics Inc (NASDAQ: ONS)

  • Opiant Pharmaceuticals Inc (NASDAQ: OPNT)

  • Reshape Lifesciences Inc (NASDAQ: RSLS)

  • Soligenix, Inc. Common Stock (NASDAQ: SNGX)

  • ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)

See Also: The Week Ahead In Biotech: Conferences, Clinical Trials And IPOs

Stocks In Focus FDA Approves Expanded Use of Medtronic's Insulin Pump

Medtronic PLC (NYSE: MDT) said the FDA approved the use of its MiniMed 670G system in patients with type 1 diabetes seven years and older.

The pump was originally approved last September for use in patients aged over 14 years.

FDA Accepts Bristol-Myers Squibb's sBLA For Combo Therapy For NSCLC

Bristol-Myers Squibb Co (NYSE: BMY) said the FDA accepted its supplemental biologic license application for its opdivo-yervoy combo immunotherapy for treating first-line advanced NSCLC in patients with tumor mutation burden of over 10 mutations per megabase. The company said the PDUFA date is set for Feb. 20, 2019.

The application was based on results from Part 1 of CheckMate-227 study, a global Phase 3 study.

Tandem Diabetes' New Insulin Pump Receives FDA Nod

Tandem Diabetes Care Inc (NASDAQ: TNDM) announced FDA approval for its t:slim X2 insulin pump with basal-IQ technology.

"This is the first automated insulin delivery system approved for use by children as young as 6 years old, and the first insulin pump designated as compatible with integrated continuous glucose monitoring (iCGM) devices," the company said.

The company expects the device to be available in the U.S. in August.

Shares soared 22.6 percent to $24.90 in after-hours trading.

On The Radar IPOs

Autolus Therapeutics priced its 8.23 million initial public offering at $17 for gross proceeds of $150 million. The shares will begin trading on the Nasdaq under the ticker symbol (NASDAQ: AUTL). The company is a developer of next-gen programmed T cell therapies for cancer treatment.

ElectroCore announced that it has priced its 4.33 million share-IPO at $15 per share. The shares will begin to trade on the Nasdaq under the ticker symbol (NASDAQ: ECOR). The company's proprietary non-invasive vagus nerve stimulation, or nVNS therapy, is meant to treat multiple conditions in neurology and rheumatology.

Other Events

  • American Diabetes Association's 78th Scientific Sessions gets underway in Orlando, Florida.

  • World Congress On Gastrointestinal Cancer June held in Barcelona, Spain, continues for the second day.

FDA Tidbits

The FDA said it's reconsidering the draft guidance on evaluating analytical studies in a bid to foster greater efficiency in biosimilar development.

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