The Daily Biotech Pulse: Gilead's Filgotinib Stumbles With FDA, J&J Laps Up Momenta In $6.5B Deal, 2 IPOs

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 18)

• Avenue Therapeutics Inc ATXI
• Checkmate Pharmaceuticals Inc CMPI
• DarioHealth Corp DRIO
• iTeos Therapeutics Inc ITOS
• Merit Medical Systems, Inc. MMSI
• Natera Inc NTRA
• Nurix Therapeutics Inc NRIX
• Otonomy Inc OTIC
• Pacific Biosciences of California Inc PACB
• Pacira Biosciences Inc PCRX
• PDL BioPharma Inc PDLI
• Principia Biopharma Inc PRNB
• Qiagen NV QGEN
• Shockwave Medical Inc SWAV
• Silk Road Medical Inc SILK
• Syros Pharmaceuticals Inc SYRS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 18)

• Acorda Therapeutics Inc ACOR
• Alector Inc ALEC
• Eyepoint Pharmaceuticals Inc EYPT
• Interpace Biosciences Inc IDXG(announced receipt of letters from recently departed employees regarding billing and compliance issues)
• Iterum Therapeutics PLC ITRM
• NanoVibronix Inc NAOV
• Poseida Therapeutics, Inc. PSTX( announced clinical hold on its Phase 1 prostate cancer study)
• Predictive Oncology Inc POAI
• Recro Pharma Inc REPH
• Unity Biotechnology Inc UBX

Stocks In Focus

Venrock Reports Purchase of 451K Unum Shares

Unum Therapeutics Inc UMRX shares advanced after Venrock Healthcare Partners III L.P. said in a filing it has purchased 451,000 shares of Unum's common stock in a series of transactions effected between Aug. 14 and Aug. 18, bringing the total number of shares owned by the fund to 4.355 million

The stock climbed 16.24% to $3.15 in after-hours trading.

Gilead's Filgotinib Face Rejection at the FDA Altar

Gilead Sciences, Inc. GILD said the FDA has issued a complete response letter for its NDA for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis. The agency has sought data from the MANTA and MANTA-RAy studies, which look into whether filgotinib has an impact of sperm parameters, before completing the review, while also expressing concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.
Top-line results from the two additional studies which the FDA has requested is expected to be released in the first half of 2021, Gilead said.

Gilead is partnering with GALAPAGOS NV/S ADR GLPG for the development of filgotinib.

In pre-market trading, Gilead shares were down 6.02% to $64.90.

J&J to Buy Momenta For $6.5B In Cash

Johnson & Johnson JNJ said it has entered into a definitive agreement to acquire Momenta Pharmaceuticals, Inc. MNTA for $52.50 per share in an all-cash transaction, implying a fully-diluted equity value of $6.5 billion. The agreement was unanimously approved by boards of both companies.

Momenta shares were jumping 68.48% to $51.91.

Sorrento Terminates Services of CFO; Patent Filed For A Competing Saliva-based COVID-19 Test

Sorrento Therapeutics Inc SRNE said in a filing that it has terminated services of CFO Jiong Shao as CFO, effective immediately, and has appointed Najjam Asghar, who was serving as the principal financial officer and principal accounting officer, to the role of CFO on an interim basis.

Separately, Switerzland's Achiko said it has filed a provisional patent over the technology involved in a non-intrusive and affordable novel saliva COVID-19 test kit, named Gumnuts. The company holds the exclusive commercialization rights for the test. Clinical trials are to begin shortly and the test could be made commercially available by the end of 2020, Achiko said.
Incidentally, Sorrento had licensed a rapid saliva test kit from the Columbia University in late July.

Sorrento shares tumbled 13.52% to $10.62 in after-hours trading.

Accelerate Diagnostics Gets Emergency Use Authorization For COVID-19 Antibody Testing System

Accelerate Diagnostics Inc AXDX and ioCheck, Inc., a privately-held San Francisco-based company, said the FDA has issued an emergency use authorization for the BioCheck SARS-CoV-2 IgM and IgG Combo Test and fully-automated MS-Fast instrument.

Accelerate has a collaboration agreement with ioCheck to commercialize the serology-based testing platform.

The MS-Fast system and BioCheck SARS-CoV-2 chemiluminescence tests are capable of processing human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection, Accelerate said.

The stock gained 9.84% to $16.30 in after-hours trading.

Centogene Begins to Offer Walk-in COVID-19 Test Facility at Hamburg Airport

Centogene NV CNTG announced the opening of its new walk-in COVID-19 test facility at Hamburg Airport.

The stock was up 1.24% to $12.29 in after-hours trading.

Regeneron, Roche to Collaborate to Scale Up Manufacturing of Antibody Cocktail For COVID-19

Regeneron Pharmaceuticals Inc REGN and Roche Holdings AG's RHHBY Genentech unit announced a collaboration to develop REGN-COV2, the former's investigational antiviral antibody combination.

REGN-COV2 provides a treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, the companies said. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.

Albireo To Shelve NASH Study After Mixed Results From Phase 2 Proof-of-concept Study

Albireo Pharma Inc ALBO said the Phase 2 proof-of-concept study that evaluated its elobixibat for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis achieved the primary endpoint of reduction of low-density lipoprotein cholesterol but did not achieve proof-of-concept for other key NASH measures.

Elobixibat is an ileal bile acid transporter inhibitor currently approved in Japan for chronic constipation.

"Based on the results of this study, we have made the decision not to pursue further development of elobixibat in NASH," said Ron Cooper, CEO of Albireo.

Earnings

Supernus Pharmaceuticals Inc SUPN reported a 21% year-over-year increase in second-quarter revenues to $126.73 million, and earnings per share climbed from 61 cents to 65 cents, ahead of the 42-cent per share consensus estimate. The company reinstated its fiscal year 2020 guidance and updated it, to reflect the acquisition of the PD products.

The stock rose 2.67% to $25.72 in after-hours trading.

Offerings

Eyenovia Inc EYEN said it intends to offer and sell shares of its common stock in an underwritten public offering. All of the shares in the proposed offering are to be sold by the company.

The stock plummeted 16.93% to $3.73 in after-hours trading.

On The Radar

IPOs

La Jolla, California-based InhibRx, a clinical-stage biotechnology company with a pipeline of novel biologic therapeutic candidates, with particular focus on oncology, priced its upsized initial public offering, or IPO, of 6 million shares of its common stock at $17, the mid-point of the estimated price range of $16-$18. The shares are to be listed on the Nasdaq under the ticker symbol INBX.

Harmony Biosciences Holdings Inc, a Plymouth, Pennsylvania-based commercial-stage pharmaceutical company focused on innovative therapies for patients living with rare neurological disorders, priced its upsized IPO of 5.35 million shares of its common stock at $24, above the estimated price range of $20-$23. The shares will be listed on the Nasdaq under the ticker symbol HRMY.