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

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 AERI
• FibroGen Inc FGEN
• Heron Therapeutics Inc HRTX(announced its pain treatment candidate HTX-011 received Breakthrough Therapy designation from the FDA)
• Myovant Sciences Ltd MYOV
• NeoGenomics, Inc. NEO

Down In The Dumps

(Stocks hitting 52-week lows on June 21)

• Agenus Inc AGEN
• Auris Medical Holding AG EARS
• Celldex Therapeutics, Inc. CLDX
• Cellectar Biosciences Inc CLRB
• DelMar Pharmaceuticals Inc DMPI
• Enzo Biochem, Inc. ENZ
• Immune Pharmaceuticals Inc IMNP
• MeiraGTx Holdings PLC MGTX
• Mustang Bio Inc MBIO
• Nabriva Therapeutics PLC – ADR NBRV
• Oncobiologics Inc ONS
• Opiant Pharmaceuticals Inc OPNT
• Reshape Lifesciences Inc RSLS
• Soligenix, Inc. Common Stock SNGX
• ZIOPHARM Oncology Inc. 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 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 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 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 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 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.