The Daily Biotech Pulse: FDA Snub For Allergan, Myriad's Q4 Beat, Mallinckrodt's Stannsoporfin

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 Aug. 21)

• Acer Therapeutics Inc ACER
• Avanos Medical Inc AVNS(Raymond James upgraded the shares from Market Perform to Outperform)
• Becton Dickinson and Co BDX
• BioLife Solutions Inc BLFS
• BIO-TECHNE Corp TECH
• DexCom, Inc. DXCM
• Emergent Biosolutions Inc EBS
• Masimo Corporation MASI
• Medtronic PLC MDT(reported above-consensus Q2 EPS)
• Merck & Co., Inc. MRK
• Neogen Corporation NEOG
• Repligen Corporation RGEN
• Teva Pharmaceutical Industries Ltd (ADR) ADR TEVA
• Seattle Genetics, Inc. SGEN

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 21)

• Pain Therapeutics, Inc. PTIE
• Trinity Biotech plc (ADR) TRIB

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

Stocks In Focus

Allergan Receives CRL For its Uterine Bleeding Medication

Allergan plc AGN said the FDA issued a complete response letter, or CRL, for its ulipristal acetate for treating abnormal uterine bleeding in women with uterine fibroids.

The company noted that the FDA cited safety concerns regarding ESYMA post-marketing reports outside the U.S.

The stock slid 2.1 percent to $187.10 in after-hours trading.

Myriad Genetics Q4 EPS Beats Estimates; Guidance Trails

Myriad Genetics, Inc. MYGN reported fiscal year fourth-quarter revenues of $200.9 million compared to $199.6 million last year. Adjusted earnings per share rose from 29 cents to 38 cents, ahead of the 33 cents per share consensus estimate. However, the fiscal-year 2019 guidance came in below expectations.

The stock rose 1.07 percent to $43.30 in after-hours trading.

On The Radar

Mallinckrodt PLC MNK recived a CRL from the FDA on its Stannsoporfin for treating neonates at risk for developing severe hyperbilirubinemia, or severe jaundice. The FDA provided guidance regarding areas of further evaluation for resubmitting Stannsoporfin NDA. Until the company meets with FDA, it doesn't expect to make decision related to future efforts in the development of the product