The Daily Biotech Pulse: FibroGen Fudges Safety Data, Novartis Strikes Cancer Drug Collaboration, Immutep Gains On Patent Award

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 April 6)

• AngioDynamics, Inc. ANGO
• Ardelyx, Inc. ARDX
• Cara Therapeutics, Inc. CARA (announced impending addition to S&P SmallCap 600 Index)
• IDEAYA Biosciences, Inc. IDYA
• Longboard Pharmaceuticals, Inc. LBPH
• MacroGenics, Inc. MGNX
• Medtronic plc MDT
• MiMedx Group, Inc. MDXG
• Myriad Genetics, Inc. MYGN
• PAVmed Inc. PAVM
• PRA Health Sciences, Inc. PRAH
• Surmodics, Inc. SRDX
• Varian Medical Systems, Inc. VAR

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 6)

• ACADIA Pharmaceuticals Inc. ACAD (extended sell-off on adverse FDA verdict and sell-side downgrades )
• Achilles Therapeutics plc ACHL (IPOed Wednesday)
• Galecto, Inc. GLTO
• Gracell Biotechnologies Inc. GRCL
• IMARA Inc. IMRA
• Lucira Health, Inc. LHDX
• Metacrine, Inc. MTCR

Stocks In Focus

FibroGen Discloses Anomaly In Safety Data For Its Anemia Treatment Even as Adcom Schedule Is Confirmed

FibroGen, Inc. FGEN said it was notified by the FDA that the regulatory agency has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee on July 15 to review the new drug application for roxadustat for the treatment of anemia of chronic kidney disease in both dialysis-dependent and non-dialysis-dependent patients.

FibroGen is co-developing the drug with AstraZeneca PLC AZN.

The PDUFA date was originally scheduled for March 20, and in early March the company said the FDA has convened an Adcom review, likely delaying the decision.

Separately, FibroGen said it became aware that the primary cardiovascular safety analyses it submitted to the FDA included post-hoc changes to the stratification factors. The company has decided to clarify the issue with the FDA.

"There is no change in the underlying roxadustat data, or to the efficacy analyses from the Phase 3 program," the company added.

FibroGen shares slumped 28.26% to $24.85 in after-hours trading.

Immutep Announces European Patent Award Relating to Out-licensed Antibody Treatment Candidate

Immutep Limited IMMP said it has been granted a patent entitled 'Combination therapies comprising antibody molecules to LAG-3' by the European Patent Office.

The patent related to embodiments of LAG525, a humanized form of Immutep's IMP701 antibody which is out-licensed to Novartis AG NVS. The patent is co-owned by Novartis and Immutep and will expire on July 28, 2036.

Immutep gained 5.96% to $3.19 in after-hours trading.

Novartis Enters Cancer Drug Collaboration With Artios For Up to $1.3B To Strengthen Its Radioligand Portfolio

Artios Pharma Limited, a precision medicine company developing cancer therapies, announced a global research collaboration with Novartis to discover and validate next generation DNA damage response, or DDR, targets to enhance Novartis' Radioligand Therapies, RLT.

Under the three-year collaboration, Artios and Novartis will perform target discovery and validation, and Novartis will select up to three exclusive DDR targets, and receive worldwide rights on these targets to be utilized with its RLT's.

The agreement provides for Novartis making an up-front payment of $20 million and provide near term research funding to support the collaboration. Artios will also be eligible to receive discovery, development, regulatory and sales-based milestones up to $1.3 billion, in addition to royalty payments on net sales of products commercialized by Novartis.

Related Link: Attention Biotech Investors: Mark Your Calendar For April PDUFA Dates

Lilly-Incyte and Pfizer Announce Extension In Review Period For Atopic Dermatitis Candidates

Eli Lilly and Company LLY and Incyte INCY said the FDA has extended the review period for the supplemental NDA for baricitinib for the treatment of adults with moderate to severe atopic dermatitis by three months. The new PDUFA schedule is early third quarter.

The extension is to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA.
This extension, Lilly said, does not affect its previously-issued financial guidance for 2021. Baricitinib was discovered by Incyte and licensed to Lilly, and is being evaluated in multiple indications.

Separately, Pfizer, Inc. PFE said the FDA has extended the review period for its NDA for abrocitinib in atopic dermatitis and its sNDA for Xeljanz/Xeljanz XR, in patients with active ankylosing spondylitis. Reviews of both the applications have been extended by three months to early third quarter.

TransMedics' OCS Heart System Gets FDA Panel Backing

TransMedics Group, Inc. TMDX said the Circulatory Systems Device Advisory Panel convened by the FDA has issued a favorable vote in support of approval of the OCS Heart System to the FDA's Office of Health Technology 2. \

The panel voted 12 to 5 that the benefits of the OCS Heart System outweigh its risks. The panel voted 10 to 6 that there is reasonable assurance that the OCS Heart System is effective, and 9 to 7 that there is reasonable assurance of the OCS Heart System's safety.

Roche Launches Test To Aid In Cancer Diagnosis

Roche Holding AG RHHBY announced the launch of the Elecsys Anti-p53 immunoassay for the in vitro quantitative determination of anti-p53 antibodies. This test is used to diagnose throat cancer, bowel cancer and breast cancer in patients, in conjunction with other diagnostic tests. The assay is now available for all markets accepting the CE Mark.

Qiagen launches Ultra-fast Sequencing Solution For Genomic Surveillance of COVID-19 Variants

QIAGEN N.V. QGEN announced the launch of new ultra-fast sequencing solution named QIAseq DIRECT SARS-CoV-2 Kit for high-throughput genomic surveillance. The test kit, according to the company, halves both library preparation times and plasticware use.
High-throughput NGS is increasingly being used to conduct genomic surveillance and research on new and potentially dangerous COVID-19 variants that continue to emerge, the company said.

The stock was up 4% to $51.97 in after-hours trading.

Alkermes to Initiate Phase 3 Study of Its Cancer Immunotherapy In Combination With Merck's Keytruda

Alkermes plc ALKS announced that it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc. (MRK) for a planned phase 3 study to evaluate its immunotherapy candidate nemvaleukin alfa in combination with Merck's Keytruda, in comparison to investigator choice chemotherapy in patients with platinum-resistant ovarian cancer.

Under the terms of the agreement, Alkermes is responsible for conducting the phase 3 study, which is planned to initiate in the second half of 2021.

Offerings

Homology Medicines, Inc. FIXX said it intends to offer and sell, subject to market and other conditions, $50 million of its common stock in an underwritten public offering.

The stock retreated 10.22% to $8.35 in after-hours trading.

Outset Medical, Inc. OM announced the commencement of a proposed underwritten public offering of 2.5 million shares of its common stock by Outset and 2.5 million shares of its common stock by certain of its stockholders.

The stock slid 4.48% to $55.50 in after-hours trading.

Ionis Pharmaceuticals, Inc. IONS said it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2026 in a private placement to qualified institutional buyers.

In after-hours trading, the stock was down 4.55% to $45.10.