The Daily Biotech Pulse: Aurinia Rips Higher On Positive Readout, Sesen Bio On Track For Vicinium BLA Submission

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 Dec. 4)

• Allakos Inc ALLK(announced exploration of strategic options, including a potential sale)
• Allergan plc AGN
• Alnylam Pharmaceuticals, Inc. ALNY
• Applied Therapeutics Inc APLT
• Audentes Therapeutics Inc BOLD
• Axsome Therapeutics Inc AXSM
• Bausch Health Companies Inc BHC
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• Cue Biopharma Inc CUE
• Deciphera Pharmaceuticals Inc DCPH
• DexCom, Inc. DXCM
• Dicerna Pharmaceuticals Inc DRNA
• Flexion Therapeutics Inc FLXN
• GALAPAGOS NV/S ADR GLPG
• Global Blood Therapeutics Inc GBT
• Gossamer Bio Inc GOSS
• Incyte Corporation INCY
• Inspire Medical Systems Inc INSP
• IVERIC bio Inc ISEE
• Jounce Therapeutics Inc JNCE
• Kodiak Sciences Inc KOD
• Krystal Biotech Inc KRYS
• Merck & Co., Inc. MRK
• Morphosys Ag MOR
• Myokardia Inc MYOK
• Neurocrine Biosciences, Inc. NBIX
• Nevro Corp NVRO
• Relmada Therapeutics Inc RLMD(announced pricing of its common stock offering)
• Vertex Pharmaceuticals Incorporated VRTX
• Xenon Pharmaceuticals Inc XENE
• Zai Lab Ltd ZLAB
• Zimmer Biomet Holdings Inc ZBH

Down In The Dumps

(Biotech Stocks Hitting 52-week lows on Dec. 4)

• Akers Biosciences Inc AKER
• Brickell Biotech Inc BBI
• Centogene NV CNTG
• Neon Therapeutics Inc NTGN
• Predictive Oncology Inc POAI
• Theratechnologies Inc THTX
• X T L Biopharmaceuticals Ltd XTLB

Stocks In Focus

Aurinia Says Drug To Treat Kidney Inflammation Due To Lupus Met Study Objectives

Aurinia Pharmaceuticals Inc AUPH announced positive safety and efficacy data from its pivotal Phase 3 study of voclosporin, in combination with mycophenolate and low-dose corticosteroids, in the treatment of lupus nephritis.

The global study that evaluated 357 patients with active lupus nephritis met its primary endpoint of renal response rates of 40.8% for voclosporin compared to 22.5% for the control arm, the company said. The study also met all pre-specified hierarchical secondary endpoints, which included renal response at 24 weeks, partial renal response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio less than or equal to 0.5 and time to 50% reduction in UPCR.

The company said it plans an NDA submission during the first half of 2020.

The stock skyrocketed 119.9% to $18.45 in after-hours trading.

Novartis Confident Of Sustaining Long-Term Growth

Coinciding with its investor day held in London, Novartis AG NVS said it's well positioned to sustain long-term growth, supported by catalyst-rich near term with pipeline progress across the portfolio. The company said it has 60 projects in Phase 2 pipeline, with over 10 advancing into Phase 3 or pivotal trials each year in 2020 and 2021.

See Also: Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates

Allena Announces Initiatives, Including Job Cuts, Amid Focus On Enteric Hyperoxaluria Drug

Allena Pharmaceuticals Inc ALNA announced a clinical and corporate update, wherein it said it would undertake several initiatives to realign resources to support the continued development of its orally administered enzyme for the treatment of patients with enteric hyperoxaluria.

The company said it plans to re-engage with the FDA with a request to modify the trial design of the URIROX-2 trial, including a reduction in the target enrollment, conducting an earlier interim analysis of data and modifying the requirements to file for accelerated approval of the initial BLA. It expects to meet with the FDA in early 2020 in this regard.

In a bid to focus resources on its reloxaliase programs, the company announced implementation of several initiatives, including limiting the opening of new trial sites for its URIROX-2 trial, delaying planned investments in manufacturing, and a reduction in workforce that would cut the salary bill by 30%.

The stock added 3.90% to $2.40 in after-hours trading.

Acadia Aces Late-Stage Study of Pimavanserin in Dementia-related Pyschosis

ACADIA Pharmaceuticals Inc. ACAD presented at the 12th Clinical Trials On Alzheimer's Disease, or CTAD, meeting positive top-line results from the Phase 3 HARMONY study of pimavanserin for the treatment of dementia-related psychosis. The company noted that the investigational therapy met the primary endpoint by reducing the risk of relapse of psychosis by 2.8 fold compared to placebo. It also met the key secondary endpoint by significantly reducing risk of discontinuation for any reason by 2.2 fold.

The company said it plans to meet with the FDA in the first half of 2020 regarding a supplemental NDA submission.

The stock gained 2.76% to $45.50 in after-hours trading.

Titan Medical Found In Violation Of 2 Nasdaq Listing Standards

Titan Medical Inc. TMDI said it has received a notification from the Nasdaq on Nov. 27, intimating it regarding non-compliance with the minimum bid price requirement, as the closing bid price of the stock was below $1 for 30 consecutive business days. It is also found in violation of the listing standard regarding the minimum market value.

The company has time until May 25, 2020 to regain compliance.

The stock moved down 5% to 57 cents in after-hours trading.

Sesen Has Successful Pre-BLA Meeting With FDA On Vicinium In Bladder Cancer

Sesen Bio Inc SESN announced successful completion of a constructive Type B pre-BLA meeting with the FDA regarding the final chemistry, manufacturing and controls content of its BLA for Vicinium, its lead product candidate being evaluated for high-risk, non-muscle invasive bladder cancer. The company said it plans to initiate the BLA in December, in line with the original timeline.

The stock rose 5.83% to $1.27 in after-hours trading.

Offerings

Omeros Corporation OMER, which announced Wednesday positive late-stage data for its drug for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy, said it has commenced an underwritten public offering of its common stock.

The stock fell 8.46% to $13.95 in after-hours trading.

Ardelyx Inc ARDX said it has commenced an underwritten public offering of up to $80 million worth of its shares. All shares are to be offered by the company.

The stock slipped 6.30% to $6.39 in after-hours trading.

Millendo Therapeutics Inc MLND said it has priced its underwritten public offering of 4.17 million shares at $6 apiece. The company expects to raise gross proceeds of $25 million from the offering. The offering is expected to close Dec. 9.

The stock tumbled 18.81% to $6.30 in after-hours trading.

On The Radar

Clinical Trial Readouts

Biogen Inc BIIB is scheduled to present at the CTAD, meeting, detailed data from the Phase 3 EMERGE study of aducanumab in Alzheimer's disease.

Cassava Sciences Inc SAVA is due to present at the CTAD meeting, Phase 2a data for PTI-125 in Alzheimer's disease

Cytokinetics, Inc. CYTK will present at the > International Alliance of ALS/MND annual meeting, responder and subgroup analyses of data from the Phase 2 study of Reldesemtiv in amyotrophic lateral sclerosis.