The Daily Biotech Pulse: Novartis Settles Lawsuit For $678M, Sarepta In-Licenses Gene Therapy Pre-Treatment, Unity Biotech Outlines Second-Half Catalysts

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 July 1)

• AbbVie Inc ABBV
• ADC Therapeutics SA ADCT
• Affimed NV AFMD
• Agios Pharmaceuticals Inc AGIO
• Akero Therapeutics Inc AKRO (announced positive results for mid-stage study of NASH drug)
• Amgen, Inc. AMGN (reacted to a favorable court ruling on its Enbrel patent litigation)
• Aptinyx Inc APTX
• BioMarin Pharmaceutical Inc. BMRN
• Corbus Pharmaceuticals Holdings Inc CRBP
• Crispr Therapeutics AG CRSP
• Halozyme Therapeutics, Inc. HALO
• Hologic, Inc. HOLX
• Legend Biotech Corp LEGN
• Liminal BioSciences Inc LMNL (announced commencement of convalescent plasma collection from donors who have recovered from COVID-19 and upcoming catalysts)
• Natera Inc NTRA
• Opko Health Inc. OPK
• Pacira Biosciences Inc PCRX
• Tandem Diabetes Care Inc TNDM
• Twist Bioscience Corp TWST
• Ultragenyx Pharmaceutical Inc RARE (announced FDA approval for drug to treat long-chain fatty acid oxidation disorders)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 1)

• ADiTx Therapeutics Inc ADTX
• Fusion Pharmaceuticals Inc FUSN
• Generation Bio Co GBIO
• Hoth Therapeutics Inc HOTH
• Iterum Therapeutics PLC ITRM
• Repare Therapeutics Inc RPTX

Stocks In Focus

Novartis Finalizes $678M Settlement In US Lawsuit Over Kickbacks Paid To Doctors

Novartis AG NVS said it has finalized its previously disclosed agreement with the U.S. Attorney's Office for the Southern District of New York, the New York State attorney general and relator Oswald Bilotta resolving a civil suit challenging speaker programs and other promotional events conducted from 2002 through 2011 by Novartis in the U.S.

The litigation pertains to Novartis allegedly spending millions of dollars on incentive programs to doctors who steered patients toward drugs from its cardiovascular division in exchange for illegal kickbacks.

As part of this settlement, Novartis said it will pay $678 million and has agreed to new corporate integrity obligations with the Office of Inspector General of the Department of Health & Human Services that will change how the company delivers peer-to-peer programs in the U.S. The company said it had fully provisioned for this settlement in July 2019.

The stock was down 0.66% at $87.27 premarket Thursday.

Merck Closes Licensing Transaction With Ridgeback To Advance COVID-19 Treatment Candidate

Merck & Co., Inc. MRK announced the closing of its collaboration and licensing agreement with antiviral biotech Ridgeback Biotherapeutics following the FTC granting early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

The companies noted that all closing requirements have been completed for the previously announced partnership transaction to advance the development of EIDD-2801, an investigational, orally available antiviral agent in early clinical development for the treatment of patients with COVID-19.

The stock was trading 0.87% higher at $78.80 at the time of publication Thursday.

See also: The Week Ahead In Biotech (June 28- July 4): Pending Clinical Readouts In Focus During A Short Holiday Week

BeiGene Announces Acceptance Of Chinese Regulatory Application For Tislelizumab Label Expansion

Beigene Ltd BGNE said the Center for Drug Evaluation of the China National Medical Products Administration has accepted a supplemental new drug application for its anti-PD-1 antibody tislelizumab in patients with previously treated unresectable hepatocellular carcinoma, the most common form of liver cancer.

Unity Biotech Announces Second-Half Clinical Catalysts

Offering a clinical trial update, Unity Biotechnology Inc UBX said it expects to release top-line 12-week results from Phase 2 study of UBX0101 in osteoarthritis in the third quarter. The company also said it plans to initiate a first-in-human study of UBX1325 in age-related eye diseases in the second half of 2020.

Sarepta In-Licenses Pre-Treatment Candidate For Its Gene Therapies For $407.5M

Sarepta Therapeutics Inc SRPT and Hansa Biopharma announced an agreement under which Sarepta is granted an exclusive worldwide license to develop and promote imlifidase as a pre-treatment to enable Sarepta gene therapy treatment in Duchenne muscular dystrophy and Limb-girdle muscular dystrophy.

Sarepta will pay Hansa $10 million upfront and up to $397.5 million in development, regulatory and sales milestone payments. 

The agreement calls for Sarepta assuming responsibility for conducting pre-clinical and clinical studies with imlifidase and any subsequent regulatory approvals, and also promoting imlifidase as a pre-treatment to Sarepta's gene therapies following potential approval.

Offerings

Zomedica Pharmaceuticals Corp ZOM said it has priced its previously announced public offering of 187.5 million shares of its common stock, together with short-term warrants, to purchase up to 187.5 million common shares at a combined public offering price of 16 cents per share and accompanying warrant.

Each common share is being sold in the offering together with one two-year warrant to purchase one common share at an exercise price of 16 cents per common share, the company said. Zomedica expects to raise gross proceeds of $30 million from the offering.

The stock was down 33.26% premarket at 15 cents.

Neoleukin Therapeutics Inc NLTX said it intends to offer up to 5 million shares of its common stock and, in lieu of common stock, to certain investors pre-funded warrants to purchase shares of its common stock in an underwritten public offering. All of the securities are being offered by the company.

The stock slipped 6% to $15.99 in after-hours trading.

BioLife Solutions Inc BLFS said it intends to offer shares of its common stock for sale in an underwritten public offering. The company said it expects to use the gross proceeds for general corporate purposes.

The stock was down 7.61% premarket at $14.82. 

Related Link: Gilead Announces Pricing Of Coronavirus Treatment Remdesivir: 'We Believe All Patients Will Have Access'