The Daily Biotech Pulse: Gilead Signs Manufacturing Deal For Remdesivir, Bristol-Myers Gets Refuse-To-File Letter

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 May 12)

• Acceleron Pharma Inc XLRN(reacted to its first-quarter results)
• Allogene Therapeutics Inc ALLO
• Arcturus Therapeutics Ltd ARCT
• Arvinas Inc ARVN
• Ascendis Pharma A/S ASND
• AtriCure Inc. ATRC
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• BioSig Technologies Inc BSGM
• BIO-TECHNE Corp TECH
• BioXcel Therapeutics Inc BTAI(announced its first-quarter results)
• Black Diamond Therapeutics Inc BDTX(reacted to its first-quarter results)
• ChemoCentryx Inc CCXI(reacted to its first-quarter results)
• Cytokinetics, Inc. CYTK
• CytomX Therapeutics Inc CTMX
• Cytosorbents Corp CTSO(announced European approval for Cytosorb)
• Emergent Biosolutions Inc EBS
• Exelixis, Inc. EXEL
• GENMAB A/S/S ADR GMAB
• Halozyme Therapeutics, Inc. HALO(announced its first-quarter results)
• Horizon Therapeutics PLC HZNP
• Imara Inc IMRA
• Immunomedics, Inc. IMMU
• Immunovant Inc IMVT
• Kiniksa Pharmaceuticals Ltd KNSA
• Keros Therapeutics Inc KROS
• MacroGenics Inc MGNX
• Masimo Corporation MASI
• Mersana Therapeutics Inc MRSN
• Minerva Neurosciences Inc NERV
• Moderna Inc MRNA(received Fast Track designation for its coronavirus vaccine)
• Myokardia Inc MYOK
• Natera Inc NTRA
• NGM Biopharmaceuticals Inc NGM
• Novavax, Inc. NVAX(announced grant up to $384 million CEPI funding for its coronavirus vaccine progeam)
• Protagonist Therapeutics Inc PTGX(priced its 7 million common stock offering)
• Repligen Corporation RGEN
• Scpharmaceuticals Inc SCPH
• TG Therapeutics Inc common stock TGTX(reacted to its first-quarter results)
• Translate Bio Inc TBIO
• United Therapeutics Corporation UTHR
• Vertex Pharmaceuticals Incorporated VRTX
• West Pharmaceutical Services Inc. WST
• Zai Lab Ltd ZLAB
• Zynex Inc. ZYXI

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 12)

• Genfit SA GNFT ( announced NASH candidate flunked a late-stage study)

Stocks In Focus

Bristol-Myers, Bluebird bio's BLA For Multiple Myeloma Immunotherapy Rejected By FDA

Bristol-Myers Squibb Co BMY and bluebird bio Inc BLUE said they have received a Refusal to File letter from the FDA regarding the BLA for idecabtagene vicleucel for patients with heavily pre-treated relapsed and refractory multiple myeloma. The submission was in March.

The FDA deemed the Chemistry, Manufacturing and Control module of the BLA requires further detail to complete the review and had not requested additional data. Bristol-Myers Squibb said it's planning to resubmit the BLA no later than the end of July

Edap Signs Deal To Distribute Exact Imaging's Mico-ultrasound Diagnostic Devices

Edap Tms SA EDAP announced the signing of an exclusive worldwide distribution agreement with Exact Imaging to distribute the latter's micro-ultrasound diagnostic devices alongside its Focal One high intensity focused ultrasound treatment solution.

"The combination of these technologies represents the most complete end-to-end solution, from diagnosis through treatment, available to urologists today," Edap said.

The stock rallied 15.47% to $2.50 in after-hours trading.

Merck Unit To Acquire US Rights of Sentinel's Animal Parasiticide Products For $400M

Merck & Co., Inc.'s MRK Animal Health unit signed a definitive agreement to acquire the U.S. rights to SENTINEL FLAVOR TABS and SENTINEL SPECTRUM Chews, both parasiticide products, in the Companion Animal category for $400 million. The deal is expected to close in the middle of 2020.

In after-hours trading, the stock fell 1.53% to $76.01.

Genocea Highlights Advantages Of Neoantigen T-Cell Therapy Targeting Cancers

Following a KOL symposium, Genocea Biosciences Inc GNCA said its GEN-011 embraces the advantages of TIL therapy while improving on its limitations. The company also said it has established a robust, scalable manufacturing process, PLANET, using peripheral blood T cells to ensure greater activity and durability for larger patient populations.

"In GEN-011, Genocea is creating a transformative ATLAS-enabled, peripheral blood-derived T cell therapy," said Chip Clark, Genocea's CEO.

The company said it expects to file an IND in the second quarter and release initial clinical data in the first half of 2020.
The stock climbed 21.48% to $3.28 in after-hours trading.

Aerpio Amends Licensing Agreement With Gossamer For Inflammatory Bowel Disease Drug; Gossamer Reports Positive Phase 1 Results

Aerpio Pharmaceuticals Inc ARPO announced a restructuring of the licensing deal it has with a subsidiary of Gossamer Bio Inc GOSS for its HIF-1 alpha stabilizer GB004, which is being developed for inflammatory bowel disease. The amended terms call for an immediate payment of $15 million to Aerpio and a total of $90 million in milestone payments related to regulatory approvals and commercial sales.

Aerpio is also eligible to receive tiered royalties on sales of licensed products at percentages ranging from the low to mid-single digits.

Meanwhile, Gossamer announced promising top-line results from its Phase 1b study of GB004 in patients with active mild-to-moderate ulcerative colitis.

In after-hours trading, Aerpio shares soared 44.45% to 90 cents and Gossamer Bio gained 2.61% to $16.30.

Mylan Signs Non-Exclusive Licensing to Manufacture and Supply Gilead's Remdesivir In Low- and Mid-Income Countries

Mylan NV MYL announced a non-exclusive licensing agreement with Gilead Sciences, Inc. GILD, which provides for the former acquiring the rights to manufacture and distribute the latter's antiviral drug remdesivir in 127 low- and middle-income countries, including India.

Mylan also said it's confident it will be able to develop and make available a bioequivalent version of remdesivir in the coming months.

Separately, Indian pharmaceutical company Cipla announced a non-exclusive licensing agreement with Gilead to manufacture remdesivir.

In after-hours trading, Mylan shares rose 3.57% to $16.81.

Earnings

Adaptive Biotechnologies Corp's ADPT first-quarter revenues climbed 65% to $20.9 million. The net loss per share narrowed from $1.45 cents to 25 cents. The company withdrew its 2020 guidance. The results trailed expectations.

The stock fell 9.35% to $34.50 in after-hours trading.

Opiant Pharmaceuticals Inc OPNT reported first-quarter revenues of $4.3 million, up 12% year-over-year. The net loss per share narrowed from 44 cents to 40 cents. The results were below expectations.

The company also said it expects to file NDA for its lead drug OPNT003 - nasal nalmefene, for opioid overdose – in early 2021.

In pre-market trading Wednesday, the stock declined 7.60% to $10.82.

aTyr Pharma Inc LIFE reported revenues of $8.1 million in the first quarter of 2020 compared to no revenues a year-ago. Revenues consisted primarily of licensing revenue from the Kyorin Agreement. The company reported a profit of 25 cents per share compared to a loss of $2.54 cents per share a year ago. The results exceeded expectations.

The stock gained 7.49% to $4.16 in pre-market trading.

Clearpoint Neuro Inc CLPT reported a loss of 13 cents per share on revenues of $3.12 million for the first quarter of 2020. In the year-ago period, the company reported a loss of 11 cents per share on revenues of $2.47 million.

The stock retreated 9.60% to $3.20 in pre-market trading.

Offerings

Myokardia priced its underwritten public offering of 5.25 million shares at $105.00 per share. The offering is expected to close on or about May 15.

Insulet Corporation PODD priced its $500 million common stock registered underwritten offering at $211.00 per share, in which the company will sell 2.37 million shares

In after-hours trading, the stock slipped 3.94% to $212.

Oyster Point Pharma Inc OYST said it has commenced an underwritten public offering of 2.5 million shares of its common stock. All the shares are being offered by the company.

The stock fell 6.74% to $30.01 in after-hours trading.

On The Radar

Earnings

• PDS Biotechnology Corp PDSB (before the market open)
• Veru Inc VERU (before the market open)
• Fulcrum Therapeutics Inc FULC (before the market open)
• Applied Genetic Technologies Corp AGTC (before the market open)
• BioLife Solutions Inc BLFS (after the close)
• DiaMedica Therapeutics Inc DMAC (after the close)
• Viela Bio Inc VIE (after the close)
• Biocept Inc BIOC (after the close)
• Eyenovia Inc EYEN (after the close)
• Edap Tms SA EDAP (after the close)
• RA Medical Systems Inc RMED (after the close)
• TRACON Pharmaceuticals Inc TCON (after the close)
• Brickell Biotech Inc BBI (after the close)
• HTG Molecular Diagnostics Inc HTGM (after the close)

Clinical Readouts

Avrobio Inc AVRO is scheduled to make an oral presentation at the American Society of Gene and Cell Therapy virtual meeting new data from the Phase 2 trial of AVR-RD-01 for Fabry. The company will also make an oral presentation of new data from the collaborator-sponsored Phase 1/2 clinical trial of AVR-RD-04 in cystinosis. Another oral presentation on new data from Apreclinical research program for a gene therapy for Pompe disease is also scheduled.

Ultragenyx Pharmaceutical Inc RARE is due to present updated data from the first three cohorts of a Phase 1/2 study of DTX301 in treating ornithine transcarbamylase deficiency.