The Daily Biotech Pulse: Merck Completes Organon Spin-Off, Auris Repositions As RNA Therapeutic Company With Trasir Purchase, Replimune's Readout

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 June 2)

BioCryst Pharmaceuticals, Inc. BCRX (moved on retail buying that took hold of the market)
BioNTech SE BNTX
BriaCell Therapeutics Corp. BCTX (announced positive results for breast cancer study)
Centessa Pharmaceuticals Limited CNTA (went public Friday)
GT Biopharma, Inc. GTBP
Lantheus Holdings, Inc. LNTH
Moderna, Inc. MRNA
Paratek Pharmaceuticals, Inc. PRTK
Sesen Bio, Inc. SESN (announced a global supply agreement for Vicineum drug substance and drug product with its Chinese partner, Qilu Pharmaceutical)
Treace Medical Concepts, Inc. TMCI

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 2)

4D pharma plc LBPS
Black Diamond Therapeutics, Inc. BDTX
Bolt Biotherapeutics, Inc. BOLT -announced an oncology collaboration with Genmab A/S GMAB
Connect Biopharma Holdings Limited CNTB
MorphoSys AG MOR - announced a deal to buy Constellation Pharmaceuticals, Inc. CNST
Neoleukin Therapeutics, Inc. NLTX
Orphazyme A/S ORPH
Sigilon Therapeutics, Inc. SGTX
Travere Therapeutics, Inc. TVTX
Vivos Therapeutics, Inc. VVOS

Stocks In Focus

Wave Life Sciences Announces Positive Preclinical Data

Wave Life Sciences Ltd. WVE announced the first proof-of-concept preclinical data for its ADAR-mediated RNA editing program in alpha-1 antitrypsin deficiency. Up to 40% editing of human SERPINA1 Z-allele mRNA in the liver was observed at a single timepoint, which resulted in a therapeutically meaningful increase in circulating functional wild-type AAT protein, the company said.

This initial in vivo study utilized Wave's proprietary transgenic mouse model, which has both the human SERPINA1 Z-allele as well as human ADAR that is expressed comparably to human cells.

The stock fell 3.42% to $6.50 in after-hours trading.

Amryt's Regulatory Application For Genetic Skin Disorder Accepted For Priority Review By FDA

Amryt AMYT said the FDA has granted priority review for Amryt's new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa.

Oleogel-S10 is a potential treatment for the cutaneous manifestations of junctional and dystrophic EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is no approved treatment.

The PDUFA goal date has been set for Nov. 30.

Mesoblast March Quarter Revenues Trail Estimates

Mesoblast Limited MESO reported March quarter results, showing revenues of $1.92 million, down from $12.20 million in the year-ago period. The loss per share widened from 2.84 cents to 4.39 cents.

Analysts, on average, estimated a loss of 11 cents per share on revenues of $16.99 million.

The stock slipped 2.39% to $7.36 in after-hours trading.

Replimune Announces Positive Results For RP1, RP2 Programs

Replimune Group, Inc. REPL announced updated data from its Phase 2 skin cancer cohorts combining RP1 with Bristol-Myers Squibb Company's BMY Opdivo and data from its Phase 1 study of RP2 alone and in combination with Opdivo, that continued to provide strong support for development in its lead indications.

Additionally, Replimune announced plans to initiate a Phase 2 clinical trial program in tumor types that metastasize to the liver.

The stock was up 4.83% at $38 in premarket trading Thursday.

Merck Completes Spin-Off Of Organon

Merck & Co., Inc. MRK announced it has completed the spinoff of Organon & Co.

Merck's goal with the spinoff was to create two patient-focused companies with enhanced strategic and operational focus, improved agility, simplified operating models, optimized capital structures and improved financial profiles. The transaction, according to the company, will deliver significant benefits for both Merck and Organon and create value for Merck shareholders.

The spinoff is expected to allow Merck to increase its focus on key growth pillars, achieve higher revenue and EPS growth rates and enable incremental operating efficiencies of approximately $1.5 billion, which are expected to be achieved over three years, with approximately $500 million realized during 2021. In connection with the spinoff, Merck received a distribution from Organon of approximately $9 billion.

Shares of Organon will be listed and commence trading Thursday on the New York Stock Exchange under the symbol "OGN."

Merck shares were up 0.55% at $72.74.

Oric Reports Positive Phase 1b Data For ORIC-101-Chemo Combo In Solid Tumor

ORIC Pharmaceuticals, Inc. ORIC announced initial safety data from an ongoing Phase 1b study evaluating ORIC-101 in combination with nab-paclitaxel in advanced solid tumors, showing the combination regimen at the recommended Phase 2 dose was well-tolerated.

Treatment-related adverse events were primarily Grade 1 or 2, with no treatment-related discontinuations.

The company noted that translational data showed pharmacodynamic modulation of GR biomarkers and high rates of GR expression in tumor types of interest. Antitumor activity was demonstrated across multiple advanced solid tumors in heavily pretreated patients, including those previously treated with a taxane-based therapy.

Extended progression-free survival was observed in patients with late-line relapsed pancreatic cancer who had previously progressed on or after nab-paclitaxel.

Dyne Announces Departure Of Chief Scientific Officer

Dyne Therapeutics, Inc. DYN announced that Romesh Subramanian is stepping down as chief scientific officer for personal reasons and will continue to serve as an advisor to Dyne. Oxana Beskrovnaya, who has served as Dyne's senior vice president, head of research since January 2020, has been appointed as CSO.

Auris Medical Buys Privately Held Trasir As Part Of Pivot To RNA Therapeutics

Auris Medical Holding Ltd. EARS announced the acquisition of privately held Trasir Therapeutics, Inc, a pioneer in extrahepatic oligonucleotide delivery.

The purchase price comprises 0.77 million common shares of the acquiring Company, the assumption of certain selling shareholders' cash outlays as well as a future share-based payment contingent on reaching a specific development milestone.

The transaction, which closed on June 1, is the starting point for a strategic repositioning under which Auris intends to focus on the development of RNA therapeutics while in the medium term aiming to spin off or divest its existing assets in neurotology, rhinology and allergology.

Dr. Samuel Wickline, Trasir's founder and professor of medicine, has been appointed chief scientific officer.

The stock was up 11.11% at $4.10 in premarket trading Thursday.

Offerings

Syneos Health, Inc. SYNH announced it commenced an underwritten secondary offering by affiliates of Thomas H. Lee Partners, L.P. and Advent International Corporation, of an aggregate of 10.852 million shares of its common stock. The company clarified that it is not selling any shares and will not receive any proceeds from the sale of the shares by the selling stockholders in the offering.

The stock slipped 4.22% to $81.95 in after-hours trading.

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