The Daily Biotech Pulse: FDA Nod For Sanofi, BioCryst's Edema Drug In Japan, Myriad's Q1 Disappointment

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Nov. 4)

• Agile Therapeutics Inc AGRX(follow-on rally following positive Adcom verdict for Twirla)
• Amgen, Inc. AMGN
• Beigene Ltd BGNE
• Bioanalytical Systems, Inc. BASI
• Bio-Rad Laboratories, Inc.BIO
• Cabaletta Bio Inc CABA
• Deciphera Pharmaceuticals Inc DCPH
• Frequency Therapeutics Inc FREQ
• Horizon Therapeutics PLC HZNP
• Karyopharm Therapeutics Inc KPTI(reacted to its third-quarter results)
• Oyster Point Pharma Inc OYST (IPOed Oct. 31)
• Phathom Pharmaceuticals Inc PHAT
• Recro Pharma Inc REPH
• ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 4)

• Cleveland BioLabs, Inc. CBLI
• Helius Medical Technologies Inc HSDT
• Mersana Therapeutics Inc MRSN
• Midatech Pharma PLC-ADR MTP
• Rockwell Medical Inc RMTI
• Tetraphase Pharmaceuticals Inc TTPH

Stocks In Focus

Seattle Genetics Claims Rights To Disputed Antibody-Drug Conjugate Intellectual Property

Following the filing of a declaratory judgment action by DAIICHI SANKYO/S ADR DSNKY,Seattle Genetics, Inc. SGEN said the antibody-drug conjugate tech used in Daiichi Sankyo's metastatic cancer drug candidate DS-820, among others, rightfully belongs to it.

"The linker and other ADC technology used in these drug candidates are improvements to Seattle Genetics' pioneering ADC technology, the ownership of which are automatically assigned to Seattle Genetics under the terms of the agreement," the company said.

Eisai Sells Royalty Rights To Anticancer Agent to Royalty Pharma For Up To $330M

Eisai Co., Ltd ESALY has entered into an agreement to transfer the rights to receive royalties on sales outside of Japan for an investigational anti-cancer agent tazemetostat to Royalty Pharma.

Tazemetostat is being developed by Epizyme Inc EPZM. Under an agreement with Epizyme, Eisai is liable to pay royalties on net sales in Japan, while also undertaking the responsibility to develop and commercialize tazemetostat in Japan. Eisai, however, is eligible to receive royalties on net sales in all regions outside of Japan, which it has now sold to Rpyalty Pharma for an upfront payment of $110 million and an additional $220 million upon marketing approvals in the U.S. for certain indications.

See Also: The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight

Sanofi Gets FDA Approval For Influenza Vaccine For Adults

Sanofi SA SNY said the FDA has approved its sBLA for Fluzone high-dose quadrivalent for use in adults 65 years of age and older. Fluzone high-dose was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. The quadrivalent contains an additional influenza B strain.

Sanofi said it will make available the Fluzone high-dose quadrivalent for immunization during the 2020-2021 influenza season.

Adamis Says No Word Yet On Opioid Overdose Drug From FDA

Adamis Pharmaceuticals Corp ADMP said it has not received any notification from the FDA on its NDA for Zimhi high-dose naloxone injection product for the treatment of opioid overdose. The PDUFA action date was previously fixed for Oct. 31.

BioCryst Out-Licenses Japanese Rights To Edema Drug For Up To $42M

BioCryst Pharmaceuticals, Inc. BCRX said it has licensed Japanese commercialization rights for BCX7353 to Toni Pharma for an upfront payment of $22 million. The company is also eligible to receive up to an additional $20 million upon achievement of certain milestones, and royalties ranging from mid-teens to potentially 40% of Japanese sales of BCX7353.

BCX7353 is an oral, once-daily treatment for the prevention of hereditary angioedema attacks.

BioCryst plans to make regulatory submission for the asset in Japan in the first quarter of 2020.

Takeda Divests OTC & Prescription Drugs In CIS For Up To $660M

Takeda Pharmaceutical Co Ltd TAK said it has agreed to divest a portfolio of select products to STADA Arzneimittel for up to $660 million. The portfolio earmarked for divestment includes over-the-counter and prescription pharma products exclusively in Russia, Georgia and a number of countries from the CIS.

The divestment is the fourth in the past six months, and is in line with its goal of divestment of about $10 billion in U.S. non-core assets to focus on its five key business areas and also pursue deleveraging following its Shire acquisition.

Earnings

Fulgent Genetics Inc's FLGT third-quarter revenues rose 84% year-over-year to $10.3 million, with billable tests climbing 272% to 20,697. On a non-GAAP basis, the company reported a profit of 14 cents per share compared to break-even results in the year-ago quarter. Analysts estimated EPS of 3 cents per share on revenues of $8.45 million.

The stock rallied 19.04% to $11.19 in after-hours trading.

ChemoCentryx Inc's CCXI third-quarter revenues climbed from $9 million in 2018 to $10.6 million in 2019. The loss per share remained flat at 22 cents. Analysts had estimated a loss of 28 cents per share.

The stock gained 11.86% to $10.47 in after-hours trading.

Tandem Diabetes Care Inc's TNDM third-quarter sales jumped 105% to $94.7 million, with worldwide pump shipments increasing 112% to $17,839 pumps. The net loss per share narrowed from 62 cents to 9 cents.

Analysts, on average, estimated a loss of 20 cents per share on sales of $89.14 million.

The company tightened its 2019 sales guidance from $350 million-$365 million to $358 million-$365 million. This compares to $361 million consensus estimate.

The stock slipped 10.51% to $56.01 in after-hours trading.

Myriad Genetics, Inc.'s MYGN fiscal first-quarter revenues fell 9% year-over-year to $186.3 million. Adjusted EPS fell from 43 cents to 8 cents.

The molecular diagnostics company issued below-consensus guidance for the fiscal year 2020 and the second quarter.

The stock plunged 35.33% to $22.70 in after-hours trading.

On The Radar

Earnings

• Avanos Medical Inc AVNS (before the market open)
• Antares Pharma Inc ATRS (before the market open)
• Evelo Biosciences Inc EVLO (before the market open)
• Zimmer Biomet Holdings Inc ZBH (before the market open)
• Blueprint Medicines Corp BPMC (before the market open)
• Intra-Cellular Therapies Inc ITCI (before the market open)
• Catalent Inc CTLT (before the market open)
• Chimerix Inc CMRX (before the market open)
• Viking Therapeutics Inc VKTX (before the market open)
• Neuronetics Inc STIM (before the market open)
• Oxford Immunotec Global PLC OXFD (before the market open)
• Vericel Corp VCEL (before the market open)
• Intercept Pharmaceuticals Inc ICPT (before the market open)
• Mylan NV MYL (before the market open)
• Regeneron Pharmaceuticals Inc REGN (before the market open)
• Curis, Inc. CRIS (before the market open)
• Mallinckrodt PLC MNK (before the market open)
• Akcea Therapeutics Inc AKCA (after the market close)
• Ligand Pharmaceuticals Inc. LGND (after the market close)
• GW Pharmaceuticals PLC- ADR GWPH (after the market close)
• Allogene Therapeutics Inc ALLO (after the market close)
• BioTelemetry Inc BEAT (after the market close)
• Theravance Biopharma Inc TBPH (after the market close)
• Provention Bio Inc PRVB (after the market close)
• Ultragenyx Pharmaceutical Inc RARE (after the market close)
• Supernus Pharmaceuticals Inc SUPN (after the market close)
• Chiasma Inc CHMA (after the market close)
• Insulet Corporation PODD (after the market close)
• VIVUS, Inc. VVUS (after the market close)
• TRACON Pharmaceuticals Inc TCON (after the market close)
• Xencor Inc XNCR (after the market close)
• Kura Oncology Inc KURA (after the market close)
• Eloxx Pharmaceuticals Inc ELOX (after the market close)
• Fate Therapeutics Inc FATE (after the market close)
• G1 Therapeutics Inc GTHX (after the market close)
• Prothena Corporation PLC PRTA (after the market close)
• Inspire Medical Systems Inc INSP (after the market close)
• CymaBay Therapeutics Inc CBAY (after the market close)
• Dermira Inc DERM (after the market close)
• Otonomy Inc OTIC (after the market close)
• Portola Pharmaceuticals Inc PTLA (after the market close)