The Daily Biotech Pulse: Eli Lily Revenues Trail Estimates, Moderna Gets Fast Track Designation, MacroGenics' Lukewarm Breast Cancer Data

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 Oct. 22)

Applied Therapeutics Inc APLT
Arrowhead Pharmaceuticals Inc ARWR
AVITA MED LTD/S ADR RCEL
Bio-Rad Laboratories, Inc. Class A BIO
BioNTech SE – ADR BNTX (IPOed Oct.10)
Bristol-Myers Squibb Co BMY(reported positive results for Opdivo/Yervoy combo in lung cancer)
Celgene Corporation CELG
Constellation Pharmaceuticals Inc CNST
Molecular Templates Inc MTEM

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 22)

Adaptive Biotechnologies Corp ADPT
Brickell Biotech Inc BBI
Castle Biosciences Inc CSTL
CELYAD SA/ADR CYAD
Chimerix Inc CMRX
Cocrystal Pharma Inc COCP
Invivo Therapeutics Holdings Corp NVIV
Mirum Pharmaceuticals Inc MIRM

Strongbridge Biopharma plc SBBP

Titan Medical Inc. TMDI

Trinity Biotech plc TRIB

Unum Therapeutics Inc UMRX

Stocks In Focus

Moderna's mRNA Therapy Gets Fast Track Designation

Moderna Inc MRNA, which IPOed late last year, said the FDA has granted Fast Track designation for mRNA-3927, its investigational mRNA therapeutic for propionic acidemia, which is caused by the inability of the body to breakdown certain proteins and fats which leads to the build-up of toxic chemical.

Fast Track designation is meant to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need. It bestows the advantages of early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.

The stock rose 3.96% to $16.55 in after-hours trading.

MacroGenics Reports Unimpressive Overall Survival, Safety Data For Breast Cancer Drug

MacroGenics Inc MGNX announced top-line results from the second pre-specified interim overall survival analysis for the Phase 3 SOPHIA study of margetuximab in patients with HER2-positive metastatic breast cancer who have been previously treated with anti-HER2-targeted therapies, which showed that margetuximab and chemotherapy treated patients had an overall survival of 21.6 months compared to Herceptin-chemo combination's 19.8 months.

Among the approximately 85% of patients carrying a CD16A 158F allele, the median OS was prolonged by 4.3 months in the margetuximab arm compared to the trastuzumab arm.

On safety, the company noted that Grade 3 or greater adverse events occurred in 55% patients on the margetuximab arm compared to 53% on the Herceptin arm.

The stock slipped 14.96% to $9.38 in after-hours trading.

Soleno Shares Drop On Plans for a Secondary Offering

Soleno Therapeutics Inc SLNO intends to offer and sell shares of its common stock in an underwritten public offering. The company said the offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering,

The stock fell 16.67% to $1.25 in after-hours trading.

AngioDynamics CFO To Leave

Medical device maker AngioDynamics, Inc. ANGO announced the resignation of its CFO Michael Greiner and the appointment of Stephen Trowbridge, SVP and General Counsel, to the position on an interim basis.

The company clarified that Greiner will remain with the company to facilitate a smooth transition of duties up to the filing of the second fiscal quarter 10-Q. While stating that the CFO transition is unrelated to its business performance, financial reporting or controls, the company said it is reaffirming its previously issued financial guidance for fiscal year 2020.

Tonix Awarded Patent For Active Ingredient of its Posttraumatic Stress Disorder Drug

Tonix Pharmaceuticals Holding Corp TNXP said the U.S. Patent and Trademark Office issued a patent on tianeptine oxalate salts and polymorphs, which included claims directed to crystalline tianeptine oxalate salts, and disclosures directed to methods of using those crystalline forms and their compositions.

The salt is the active ingredient of TNX-601, which is being developed as a potential treatment for posttraumatic stress disorder and also as a potential treatment for neurocognitive dysfunction associated with corticosteroid use

The patent is expected to provide market exclusivity until 2037.

Bausch Health Acquires U.S. and Canadian Licensing Rights to Clearside's Eye Inflammation Drug

Bausch Health Companies Inc BHC and its Bausch + Lomb unit said they have acquired an exclusive license for the commercialization and development of Clearside Biomedical Inc CLSD's investigational therapy Xipere in the U.S. and Canada. Xipere is being evaluated as a targeted treatment of macular edema associated with uveitis.

Clearside stands to receive up to $20 million prior to the launch, and additional payments based on certain sales-based milestones and regulatory approvals for additional indications. The company is also entitled to receive tiered royalties based on annual net sales in the U.S. and Canada.

Clearside expects to resubmit the NDA to the FDA for review in the first quarter of 2020.

Clearside shares were rallying 20.85% to 96 cents in pre-market trading.

On The Radar

Clinical Trial Readouts

Arvinas Inc ARVN is scheduled to present initial Phase 1 data on ARV-110 for treating castration-resistant prostate cancer at the Targeted Protein Degradation Summit. The company will also present Phase 1 data for ARV-471 in ER+ positive/HER2-negative breast cancer at the summit.

Bellerophon Therapeutics Inc BLPH is due to present Phase 2b additional cohort 1data at the CHEST meeting.

Axovant Gene Therapies Ltd AXGT is scheduled to present Phase 1/2 data for AXO-Lenti-PD in Parkinson's disease and AXO-AAV-GM2 in GM2 gangliosidosis. Both presentations are to be made at the ESGCT annual Congress.

Earnings

Eli Lilly And Co LLY (reported better-than-expected third-quarter earnings per share but below-consensus revenues)
Alkermes Plc ALKS (reported a third-quarter beat and raised its full-year earnings expectations)
Alexion Pharmaceuticals, Inc. ALXN (reported a beat-and-raise quarter)
Boston Scientific Corporation BSX
BioMarin Pharmaceutical Inc. BMRN (after the close)
Edwards Lifesciences Corp EW (after the close)
Varian Medical Systems, Inc. VAR
LeMaitre Vascular Inc LMAT (after the close)