Benzinga's Daily Biotech Pulse: Mylan's Neulasta Biosimilar Approved, Portola's CEO To Retire, Regenxbio To Join S&P SmallCap Index

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 4)

• ABIOMED, Inc. ABMD
• AngioDynamics, Inc. ANGO
• Arena Pharmaceuticals, Inc. ARNA
• ASLAN PHARMACEUTICALS ADR REP 5 ORD ASLN
• Athersys, Inc. ATHX
• Baxter International Inc BAX
• CONMED Corporation CNMD
• Deciphera Pharmaceuticals Inc DCPH
• Edwards Lifesciences Corp EW
• Evolus Inc EOLS
• Genomic Health, Inc. GHDX
• Haemonetics Corporation HAE
• Heron Therapeutics Inc HRTX
• Immunomedics, Inc. IMMU
• Jazz Pharmaceuticals PLC JAZZ
• Neogen Corporation NEOG
• Neurocrine Biosciences, Inc. NBIX
• Rocket Pharmaceuticals Inc RCKT
• Xencor Inc XNCR

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on June 4)

• ContraVir Pharmaceuticals Inc CTRV
• Hancock Jaffe Laboratories Inc HJLI
• Imv Inc IMV
• Jounce Therapeutics Inc JNCE
• Obalon Therapeutics Inc OBLN
• PAVmed Inc PAVM
• Puma Biotechnology Inc PBYI
• EnteroMedics RSLS
• Scpharmaceuticals Inc SCPH
• TESARO Inc TSRO

Stocks In Focus

Verastem Presents Data On 2 Lead Candidates At ASCO, Signs Licensing Agreement In Japan

Verastem Inc VSTM announced data pertaining to its two lead candidates, namely duvelisib and defactinib, at the ASCO annual meeting, the former tested for refractory chronic lymphocytic lymphoma and follicular lymphoma, while the latter for various cancers including ovarian, non-small cell lung cancer and mesothelioma, in combination with immunotherapeutic agents.

The DUO crossover extension data showed that oral duvelisib monotherapy produced 73 percent overall response rate and a 15-month median progression-free survival.

The Phase 1 study of defactinib in combination with Keytruda and gemcitabine for treating advanced pancreatic cancer showed the triplet was well tolerated, while the dosing for the Phase 2 study was also established. The combo therapy also showed promising signs of clinical activity.

Separately, Verastem announced a licensing agreement with Japan's Yakult Honsha, which provides for the latter getting the rights to develop and commercialize Verastem's duvelisib in Japan. Verastem gets a $10 million upfront payment and up to an additional $90 million in milestone payments.

Roche Gets Priority Review Status For Bleeding Disorder Drug

Roche Holdings AG Basel ADR Common Stock RHHBY's Genetech unit said the FDA has granted priority review status for its Hemlibra – chemically emicizumab-kxwh – for treating hemophilia A without factor VIII inhibitors. The status reduces the review period from the standard 10 months to six months, with the PDUFA action likely to be Oct. 4, 2018.

Biogen, Japan's Partner's Alzheimer's Drug Aces Mid-stage Trial

Japan's Eisai and Biogen Inc BIIB announced a Phase 2 study that evaluated their elenbecestat for mild-to-moderate Alzheimer's disease showed the pipeline candidate was generally safe and well tolerated.

The results also showed a statistically significant difference in amyloid beta levels in brain, as measured by amyloid-PET.

Regenxbio to Join S&P SmallCap 600 Index

Standard & Poor's announced Regenxbio Inc RGNX will replace General Cable Corporation BGC in the S&P SmallCap 600 Index, as General Cable is being acquired by Prysmian Group.

Regenxbio stock rallied 6.39 percent to $53.25 in after-hours trading.

See Also: The Week Ahead In Biotech: ASCO Presentations Dominate The Headlines

Merck, AstraZeneca's Prostate Cancer Drug Found Effective

AstraZeneca plc (ADR) AZN and Merck & Co., Inc. MRK announced that their Lynparza, a PARP inhibitor, in combination with the current standard-of-care, abiraterone, showed clinical improvement in median progression-free survival, relative to abiraterone monotherapy in patients with castration-resistant prostate cancer. The data was presented at the ASCO and was also published in Lancet Oncology.

FDA Approves Mylan's Neulasta Biosimilar

The FDA greenlighted Mylan NV MYL's Fulphila, the first biosimilar for Amgen, Inc. AMGN's Neulasta, which is indicated to reduce the chance of infection in patients with non-myeloid cancer receiving myelosuppressive chemotherapy.

Mylan rose 5.43 percent to $40.59 in after-hours Monday, while Amgen fell 1.45 percent to $182.75.

Portola CEO To Retire

Portola Pharmaceuticals Inc PTLA announced CEO William Lis is planning to retire as CEO and member of the board by August. Even as the company initiated a search for replacing Lis, it appointed John Curnutte and Mardi Dier as interim Co-Presidents, in addition to their currently served positions.

Deciphera Announces Common Stock Offering

Deciphera said it has commenced a proposed public offering of 3.75 million shares. Although the company has filed the registration statement with the SEC, it has net yet become effective.

The stock fell 6.81 percent to $35.70 after hours.

Collegium Founder to Step Down as CEO

Collegium Pharmaceutical Inc COLL announced founder Michael Heffernan will step down as CEO, effective June 30, 2018, and will be replaced by Joseph Ciaffoni, who is currently serving as chief operating officer. Founder Heffernan will, however, continue to serve as the Chairman of the Board.

On The Radar

2018 American Society of Clinical Oncology Annual Meeting concludes.

ZEALAND PHARMA/S ADR ZEAL is due to present Phase 2 data for its Glepaglutide for treating short bowel syndrome at the Digestive Disease Week meeting.