The Daily Biotech Pulse: FDA Panel Review For Alkermes, Axovant Gets Rare Pediatric Disease Designation, 2 IPOs

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 Oct. 8)

• 10X Genomics Inc TXG
• Aclaris Therapeutics Inc ACRS
• Adaptive Biotechnologies Corp ADPT
• Alexion Pharmaceuticals, Inc. ALXN
• Arena Pharmaceuticals, Inc. ARNA
• argenx SE – ADR ARGX
• Bio-Rad Laboratories, Inc. BIO
• Brainstorm Cell Therapeutics Inc BCLI
• Cardiff Oncology Inc CRDF
• CareDx Inc CDNA
• Castle Biosciences Inc CSTL
• Denali Therapeutics Inc DNLI
• EXACT Sciences Corporation EXAS
• Fate Therapeutics Inc FATE
• Horizon Therapeutics PLC HZNP
• Insmed Incorporated INSM
• Inspire Medical Systems Inc INSP
• InVitae Corp NVTA
• Insulet Corporation PODD
• Jazz Pharmaceuticals PLC JAZZ
• Kura Oncology Inc KURA
• Madrigal Pharmaceuticals Inc MDGL
• Mirati Therapeutics Inc MRTX
• Novocure Ltd NVCR
• Ocular Therapeutix Inc OCUL
• Pacific Biosciences of California Inc PACB
• SI-Bone Inc SIBN
• SpringWorks Therapeutics Inc SWTX
• Stoke Therapeutics Inc STOK
• Tandem Diabetes Care Inc TNDM
• TG Therapeutics Inc common stock TGTX
• Turning Point Therapeutics Inc TPTX
• Ultragenyx Pharmaceutical Inc RARE
• Veracyte Inc VCYT
• Vericel Corp VCEL
• Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 8)

• Aziyo Biologics Inc AZYO (listed Thursday)
• Silence Therapeutics ADR SLN

Stocks In Focus

Selecta Biosciences Enters Into Licensing and Option Agreement For Kidney Disease Drug

Selecta Biosciences Inc SELB said it has entered into a research license and option agreement with IGAN Biosciences, Inc. to study Selecta's ImmTOR immune tolerance platform in combination with IGAN's immunoglobulin A protease for the treatment of IgA Nephropathy. Before exercising its option to enter into an exclusive license agreement, Selecta said it will conduct preclinical research to evaluate the utility of the combination of ImmTOR and IGAN's IgA protease.

The agreement necessitates Selecta making an initial payment to IGAN, and if it exercises its option to enter into an exclusive license agreement, IGAN will receive an additional payment and will be eligible for additional development, regulatory, and commercial milestone payments, as well as tiered royalties on net product sales, Selecta said.

The stock rose 24.35% to $2.40 in after-hours trading.

GenMark Expects Q3 Revenues to Exceed Estimates, Announces EUA For Second Diagnostic Panel

GenMark Diagnostics, Inc GNMK announced preliminary third-quarter results, expecting revenues of $42.6 million, up 104% year-over-year. The consensus estimate for the quarter is $38.09 million. The company said its ePlex molecular diagnostic systems sales surged up 187% to $38.09 million. The company expects gross margin to expand from 34% in the third quarter of 2019 to 38-39%.

Separately, the company said it received emergency use authorization for its ePlex Respiratory Pathogen Panel 2. In less than two hours, the test provides results for more than 20 viruses and bacteria that cause common and often serious respiratory infections, including COVID-19, flu, bronchitis and the common cold, it added.

In after-hours trading, the stock was up 12.59% to $16.10.

Axovant's Inherited Neurological Disorder Gene Therapy Gets Rare Pediatric Disease Designation

Axovant Gene Therapies Ltd AXGT said it has received rare pediatric disease designation from the FDA for AXO-AAV-GM1, an AAV9-based gene therapy delivered via a single intravenous administration that is in Phase 1/2 development for GM1 gangliosidosis.

The stock was rallying 7.55% to $4.13 in pre-market trading.

Emergent Biosolutions Plasma-derived Therapy Tested In NIAID-sponsored Late-stage COVID-19 Study

Emergent Biosolutions Inc EBS announced the initiation of the Phase 3 clinical trial evaluating plasma-derived therapy COVID-HIG as a potential treatment for hospitalized patients with COVID-19. The study is sponsored by the NIAID.

The study will evaluate the safety, tolerability, and efficacy of hyperimmune globulin products derived from plasma of individuals who have recovered from COVID-19 and have developed neutralizing antibodies to SARS-CoV-2. The randomized controlled clinical trial assigns participants to receive infusions of either a placebo or one of four hyperimmune globulin products, which includes Emergent's COVID-HIG, with a background therapy of remdesivir in all groups, Emergent said.

On The Radar

Adcom Calendar

A joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will reviewAlkermes Plc's ALKS NDA for olanzapine/samidorphan oral tablets for the proposed indications of schizophrenia and bipolar I disorder.

The committees will discuss the efficacy, safety, and benefit-risk profile of the combo treatment.

IPOs

Kronos Bio, Inc., a clinical-stage biopharma engaged in the discovery and development of novel cancer therapeutics designed to transform patient outcomes by targeting dysregulated transcription, priced its initial public offering, or IPO, of 13.16 million shares of its common stock at $19.00 apiece, for raising gross proceeds of $250 million. The company had earlier estimated a price range of $16-$18.

The shares will begin trading on the Nasdaq under the ticker symbol KRON.

Spruce Biosciences, Inc., a biopharma focusing on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, priced its upsized IPO of 6 million shares at $15 per share, at the midpoint of the estimated price range of $14-$16. Gross proceeds from the offering are estimated at $90 million.

The shares will begin trading on the Nasdaq under the symbol SPRB.

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