The Daily Biotech Pulse: Immunomedics' Bottom-Line Miss; Kala, Regeneron Await FDA Verdict

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

Scaling the Peaks

(Biotech stocks that hit 52-week highs Aug. 23.)

• Abbott Laboratories ABT
• Avanos Medical Inc AVNS
• BIO-TECHNE Corp TECH
• CareDx Inc CDNA
• DexCom, Inc. DXCM
• Emergent Biosolutions Inc EBS
• Myriad Genetics, Inc. MYGN
• Neogen Corporation NEOG
• Novocure Ltd NVCR
• Repligen Corporation RGEN
• SurModics, Inc. SRDX
• Tandem Diabetes Care Inc TNDM
• Xeris Pharmaceuticals Inc XERS

Down In The Dumps

(Biotech stocks that hit 52-week lows Aug. 23)

• Aclaris Therapeutics Inc ACRS
• INTEC PHARMA ORD NTEC
• IntelliPharmaCeutics Intl Inc (USA) IPCI

See also: The Week Ahead In Biotech: Conferences, PDUFA Dates, Earnings And IPOs

Stocks In Focus

PTC Completes Agilis Buy

PTC Therapeutics, Inc. PTCT announced the completion of its acquisition of privately held Agilis Biotherapeutics, which is engaged in the advancement of innovative gene therapy programs for rare genetic disorders affecting the central nervous system.

The acquisition adds to PTC's portfolio an adeno-associated virus gene therapy that treats aromatic L-Amino acid decarboxylase deficiency.

Global Blood Cord Reports Higher Q1 Results

Global Cord Blood Corp CO reported a fiscal-year first-quarter revenues of 233.8 million yuan compared to 224.2 million yuan in the year-ago quarter. Earnings per share came in at 0.62 yuan vs. 0.61 yuan last year.

The stock rose 2.16 percent to $7.10 in after-hours trading.

Immunomedics Q4 Loss Widened; Misses Estimate

Immunomedics, Inc. IMMU said its Q4 revenues fell from $600,000 in 2017 to $400,000 in 2018. The net loss widened from 48 cents to 68 cents per share, while analysts had estimated a loss of 22 cents per share for the quarter.

The stock fell 2.13 percent to $21.62 in after-hours trading.

On The Radar

• The FDA is due to give its verdict on Kala Pharmaceuticals Inc KALA's NDA for Inveltys, which is being evaluated for inflammation and pain in patients who have undergone ocular surgery.
• Regeneron Pharmaceuticals Inc REGN and partner Sanofi SA (ADR) SNY are knocking the FDA's door for the use of Praluent injection in patients with heterozygous familial hypercholesterolemia with apheresis, an invasive procedure to remove LDL cholesterol from the blood.

FDA Tidbits

MMJ International said it has sought FDA permission to carry out clinical research to develop a pharmaceutical-grade, cannabis-based medicine derived from the natural extracts of the marijuana plant to treat symptoms associated with multiple sclerosis and Huntington's disease.

In a statement, the FDA said all 17 companies that were warned in May have stopped selling nicotine containing e-liquids used in e-cigarettes, with labeling or advertising resembling kid-friendly food products.

In a separate communique, the FDA said it has added four more tropical diseases, including Lassa fever, to its priority review voucher program. The program is designed to encourage development of new drug and biological products to prevent or treat certain tropical diseases affecting millions of people throughout the world.

Related Link: Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates